EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by section 4008(h)(2)(A)(i) of Pub. L. 101-508

effective as if included in the enactment of the Omnibus Budget

Reconciliation Act of 1987, Pub. L. 100-203, see section

4008(h)(2)(P) of Pub. L. 101-508, set out as a note under section

1395i-3 of this title.

Amendment by section 4152(a)(2) of Pub. L. 101-508 applicable to

items furnished on or after Jan. 1, 1991, see section 4152(a)(3) of

Pub. L. 101-508, set out as a note under section 1395m of this

title.

Section 4153(b)(2)(C) of Pub. L. 101-508 provided that: "The

amendments made by subparagraphs (A) and (B) [amending this section

and section 1395y of this title] shall apply to items furnished on

or after January 1, 1991."

Amendment by section 4155(a), (d) of Pub. L. 101-508 applicable

to services furnished on or after Jan. 1, 1991, see section 4155(e)

of Pub. L. 101-508, set out as a note under section 1395k of this

title.

Amendment by section 4157(a) of Pub. L. 101-508 applicable to

services furnished on or after Jan. 1, 1991, see section 4157(d) of

Pub. L. 101-508, set out as a note under section 1395k of this

title.

Amendment by section 4161(a)(1), (2), (5) of Pub. L. 101-508

applicable to services furnished on or after Oct. 1, 1991, see

section 4161(a)(8) of Pub. L. 101-508, set out as a note under

section 1395k of this title.

Section 4161(b)(5) of Pub. L. 101-508 provided that: "This

subsection [amending this section and section 1395oo of this title

and enacting provisions set out as a note below] shall take effect

on October 1, 1991, except that the amendment made by paragraph (4)

[amending section 1395oo of this title] shall apply to cost reports

for periods beginning on or after October 1, 1991."

Amendment by section 4162(a) of Pub. L. 101-508 applicable with

respect to partial hospitalization services provided on or after

Oct. 1, 1991, see section 4162(c) of Pub. L. 101-508, set out as a

note under section 1395k of this title.

Amendment by section 4163(a) of Pub. L. 101-508 applicable to

screening mammography performed on or after Jan. 1, 1991, see

section 4163(e) of Pub. L. 101-508, set out as a note under section

1395l of this title.

Section 4201(d)(3)[(4)] of Pub. L. 101-508 provided that: "The

amendments made by paragraphs (1) and (2) [amending this section

and section 1395rr of this title] shall apply to items and services

furnished on or after July 1, 1991."

Section 4207(d)(4), formerly 4027(d)(3), of Pub. L. 101-508, as

renumbered and amended by Pub. L. 103-432, title I, Sec. 160(d)(4),

(10), Oct. 31, 1994, 108 Stat. 4444, provided that: "The amendment

made by paragraph (1) [amending this section] shall apply with

respect to home health agency cost reporting periods beginning on

or after July 1, 1991."

EFFECTIVE DATE OF 1989 AMENDMENTS

Amendment by section 6112(e)(1) of Pub. L. 101-239 applicable

with respect to items furnished on or after Jan. 1, 1990, see

section 6112(e)(4) of Pub. L. 101-239, set out as a note under

section 1395m of this title.

Amendment by section 6113(a)-(b)(2) of Pub. L. 101-239 applicable

to services furnished on or after July 1, 1990, see section 6113(e)

of Pub. L. 101-239, set out as a note under section 1395l of this

title.

Amendment by section 6114(a), (d) of Pub. L. 101-239 applicable

to services furnished on or after Apr. 1, 1990, see section 6114(f)

of Pub. L. 101-239, set out as a note under section 1395u of this

title.

Section 6115(d) of Pub. L. 101-239 provided that: "The amendments

made by this section [amending this section and sections 1395y,

1395aa, 1395bb, 1396a, and 1396n of this title] shall apply to

screening pap smears performed on or after July 1, 1990."

Amendment by section 6131(a)(2) of Pub. L. 101-239 applicable

with respect to therapeutic shoes and inserts furnished on or after

July 1, 1989, with additional provisions regarding applicability of

the increase under section 1395l(o)(2)(C) of this title, see

section 6131(c) of Pub. L. 101-239, set out as a note under section

1395l of this title.

Section 6141(b) of Pub. L. 101-239 provided that: "The amendments

made by subsection (a) [amending this section] shall take effect on

the date of the enactment of this Act [Dec. 19, 1989]."

Section 6213(d) of Pub. L. 101-239, as amended by Pub. L.

101-508, title IV, Sec. 4207(k)(4), formerly Sec. 4027(k)(4), Nov.

5, 1990, 104 Stat. 1388-125, renumbered Pub. L. 103-432, title I,

Sec. 160(d)(4), Oct. 31, 1994, 108 Stat. 4444, provided that: "The

amendments made by subsections (a) through (c) of this section

[amending this section] shall apply to services furnished on or

after October 1, 1989."

Amendment by section 101(a) of Pub. L. 101-234 effective Jan. 1,

1990, see section 101(d) of Pub. L. 101-234, set out as a note

under section 1395c of this title.

Amendment by section 201(a) of Pub. L. 101-234 effective Jan. 1,

1990, see section 201(c) of Pub. L. 101-234, set out as a note

under section 1320a-7a of this title.

EFFECTIVE DATE OF 1988 AMENDMENT

Section 8423(b) of Pub. L. 100-647 provided that: "The amendments

made by subsection (a) [amending this section] shall be effective

with respect to services furnished on or after January 1, 1989."

Section 8424(b) of Pub. L. 100-647 provided that: "The amendment

made by subsection (a) [amending this section] shall become

effective with respect to services provided after December 31,

1988."

Amendment by Pub. L. 100-485 effective as if included in the

enactment of the Medicare Catastrophic Coverage Act of 1988, Pub.

L. 100-360, see section 608(g)(1) of Pub. L. 100-485, set out as a

note under section 704 of this title.

Amendment by section 104(d)(4) of Pub. L. 100-360 effective Jan.

1, 1989, except as otherwise provided, and applicable to inpatient

hospital deductible for 1989 and succeeding years, to care and

services furnished on or after Jan. 1, 1989, to premiums for

January 1989 and succeeding months, and to blood or blood cells

furnished on or after Jan. 1, 1989, see section 104(a) of Pub. L.

100-360, set out as a note under section 1395d of this title.

Amendment by section 202(a) of Pub. L. 100-360 applicable to

items dispensed on or after Jan. 1, 1990, see section 202(m)(1) of

Pub. L. 100-360, set out as a note under section 1395u of this

title.

Amendment by section 203(b), (e)(1) of Pub. L. 100-360 applicable

to items and services furnished on or after Jan. 1, 1990, see

section 203(g) of Pub. L. 100-360, set out as a note under section

1320c-3 of this title.

Amendment by section 204(a) of Pub. L. 100-360 applicable to

screening mammography performed on or after Jan. 1, 1990, see

section 204(e) of Pub. L. 100-360, set out as a note under section

1395m of this title.

Amendment by section 205(b) of Pub. L. 100-360 applicable to

items and services furnished on or after Jan. 1, 1990, see section

205(f) of Pub. L. 100-360, set out as a note under section 1395k of

this title.

Section 206(b) of Pub. L. 100-360, which provided that the

amendment of this section by section 206(a) of Pub. L. 100-360

applied to services furnished in cases of initial periods of home

health services beginning on or after January 1, 1990, was repealed

by Pub. L. 101-234, title II, Sec. 201(a), Dec. 13, 1989, 103 Stat.

1981.

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by section 411(d)(5)(A), (g)(3)(H),

(h)(1)(B)-(3)(A), (4)(D), (5)-(7)(A), (E), (F), (i)(3),

(4)(C)(iii), (l)(1)(B), (C) of Pub. L. 100-360, as it relates to a

provision in the Omnibus Budget Reconciliation Act of 1987, Pub. L.

100-203, effective as if included in the enactment of that

provision in Pub. L. 100-203, see section 411(a) of Pub. L.

100-360, set out as a Reference to OBRA; Effective Date note under

section 106 of Title 1, General Provisions.

Section 411(d)(1)(B)(ii) of Pub. L. 100-360 provided that: "The

amendment made by clause (i) [amending this section] shall apply to

equipment furnished on or after the effective date provided in

section 4021(c) of OBRA [Pub. L. 100-203, set out below]."

EFFECTIVE DATE OF 1987 AMENDMENT

Section 4009(e)(2) of Pub. L. 100-203 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

with respect to services furnished on or after April 1, 1988."

Section 4021(c) of Pub. L. 100-203 provided that: "Except as

otherwise provided, the amendments made by subsections (a) and (b)

[enacting section 1395bbb of this title and amending this section]

shall apply to home health agencies as of the first day of the 18th

calendar month that begins after the date of the enactment of this

Act [Dec. 22, 1987]."

Section 4026(a)(2) of Pub. L. 100-203, as amended by Pub. L.

100-360, title IV, Sec. 411(d)(5)(B), July 1, 1988, 102 Stat. 775,

provided that: "The amendment made by paragraph (1) [amending this

section] shall apply to cost reporting periods beginning on or

after July 1, 1989."

Section 4064(e)(2) of Pub. L. 100-203 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to diagnostic tests performed on or after January 1, 1990."

Section 4065(c) of Pub. L. 100-203 provided that: "The amendments

made by this section [amending this section and section 1395rr of

this title] shall become effective on January 1, 1988."

Section 4070(c)(2) of Pub. L. 100-203 provided that:

"(A) The amendments made by subsection (b) [amending this section

and sections 1395l and 1395n of this title] shall become effective

on the date of enactment of this Act [Dec. 22, 1987].

"(B) The Secretary of Health and Human Services shall implement

the amendments made by subsection (b) so as to ensure that there is

no additional cost to the medicare program by reason of such

amendments."

Section 4071(b) of Pub. L. 100-203 provided that:

"(1) The provisions of subsection (e) of section 4072 of this

subpart [section 4072(e) of Pub. L. 100-203, set out below] shall

apply to this section [amending this section] in the same manner as

it applies to section 4072. [Amendments became effective pursuant

to final report dated Apr. 26, 1993. See Cong. Rec., vol. 139, pt.

7, p. 10460, Ex. Comm. 1254.]

"(2) In conducting the demonstration project pursuant to

paragraph (1), in order to determine the cost effectiveness of

including influenza vaccine in the medicare program, the Secretary

of Health and Human Services is required to conduct a demonstration

of the provision of influenza vaccine as a service for medicare

beneficiaries and to expend $25,000,000 each year of the

demonstration project for this purpose. In conducting this

demonstration, the Secretary is authorized to purchase in bulk

influenza vaccine and to distribute it in a manner to make it

widely available to medicare beneficiaries, to develop projects to

provide vaccine in the same manner as other covered medicare

services in large scale demonstration projects, including statewide

projects, and to engage in other appropriate use of moneys to

provide influenza vaccine to medicare beneficiaries and evaluate

the cost effectiveness of its use. In determining cost

effectiveness, the Secretary shall consider the direct cost of the

vaccine, the utilization of vaccine which might otherwise not have

occurred, the costs of illnesses and nursing home days avoided, and

other relevant factors, except that extended life for beneficiaries

shall not be considered to reduce the cost effectiveness of the

vaccine."

Section 4072(e) of Pub. L. 100-203 provided that:

"(1) The amendments made by this section [amending this section

and sections 1395l, 1395y, 1395aa, 1395bb, 1396a, and 1396n of this

title] shall become effective (if at all) in accordance with

paragraph (2).

"(2)(A) The Secretary of Health and Human Services (in this

paragraph referred to as the 'Secretary'), shall establish a

demonstration project to begin on October 1, 1988, to test the

cost-effectiveness of furnishing therapeutic shoes under the

medicare program to the extent provided under the amendments made

by this section to a sample group of medicare beneficiaries.

"(B)(i) The demonstration project under subparagraph (A) shall be

conducted for an initial period of 24 months. Not later than

October 1, 1990, the Secretary shall report to the Congress on the

results of such project. If the Secretary finds, on the basis of

existing data, that furnishing therapeutic shoes under the medicare

program to the extent provided under the amendments made by this

section is cost-effective, the Secretary shall include such finding

in such report, such project shall be discontinued, and the

amendments made by this section shall become effective on November

1, 1990.

"(ii) If the Secretary determines that such finding cannot be

made on the basis of existing data, such project shall continue for

an additional 24 months. Not later than April 1, 1993, the

Secretary shall submit a final report to the Congress on the

results of such project. The amendments made by this section shall

become effective on the first day of the first month to begin after

such report is submitted to the Congress unless the report contains

a finding by the Secretary that furnishing therapeutic shoes under

the medicare program to the extent provided under the amendments

made by this section is not cost-effective (in which case the

amendments made by this section shall not become effective)."

[Amendments by section 4072 of Pub. L. 100-203 became effective

pursuant to final report dated Apr. 26, 1993. See Cong. Rec., vol.

139, pt. 7, p. 10460, Ex. Comm. 1252.]

Amendment by section 4073(a), (c) of Pub. L. 100-203 effective

with respect to services performed on or after July 1, 1988, see

section 4073(e) of Pub. L. 100-203, set out as a note under section

1395k of this title.

Section 4074(c) of Pub. L. 100-203 provided that: "The amendments

made by this section [amending this section] shall be effective

with respect to services performed on or after January 1, 1988."

Section 4075(b) of Pub. L. 100-203 provided that: "The amendment

made by subsection (a) [amending this section] shall apply to drugs

dispensed on or after the date of the enactment of this Act [Dec.

22, 1987]."

Section 4076(b) of Pub. L. 100-203 provided that: "The amendments

made by this section [amending this section] shall apply with

respect to services furnished on or after January 1, 1989."

Section 4077(a)(2) of Pub. L. 100-203 provided that: "The

amendment made by paragraph (1) [amending this section] shall be

effective with respect to services furnished on or after the date

of enactment of this Act [Dec. 22, 1987]."

Amendment by section 4077(b)(1), (4) of Pub. L. 100-203 effective

with respect to services performed on or after July 1, 1988, see

section 4077(b)(5) of Pub. L. 100-203, as amended, set out as a

note under section 1395k of this title.

Amendment by section 4084(c)(1) of Pub. L. 100-203 applicable to

services furnished after Dec. 31, 1988, see section 4084(c)(3) of

Pub. L. 100-203, as added, set out as a note under section 1395l of

this title.

Amendments by section 4201(a)(1), (b)(1), (d)(1), (2), (5) of

Pub. L. 100-203 applicable to services furnished on or after Oct.

1, 1990, without regard to whether regulations to implement such

amendments are promulgated by such date, except as otherwise

specifically provided in section 1395i-3 of this title, see section

4204(a) of Pub. L. 100-203, as amended, set out as an Effective

Date note under section 1395i-3 of this title.

EFFECTIVE DATE OF 1986 AMENDMENTS

Section 9305(c)(4) of Pub. L. 99-509 provided that: "The

amendments made by this subsection [amending this section and

section 1395bb of this title] shall apply to hospitals as of one

year after the date of the enactment of this Act [Oct. 21, 1986]."

Section 9313(a)(3) of Pub. L. 99-509 provided that: "The

amendments made by this paragraph [probably means "this subsection"

which amended this section and section 1395ff of this title] take

effect on the date of the enactment of this Act [Oct. 21, 1986]."

Amendment by section 9320(b), (c), (f) of Pub. L. 99-509

applicable to services furnished on or after Jan. 1, 1989, with

exceptions for hospitals located in rural areas which meet certain

requirements related to certified registered nurse anesthetists,

see section 9320(i), (k) of Pub. L. 99-509, as amended, set out as

notes under section 1395k of this title.

Section 9335(c)(2) of Pub. L. 99-509 provided that: "The

amendments made by paragraph (1) [amending this section] shall

apply to immunosuppressive drugs furnished on or after January 1,

1987."

Section 9336(b) of Pub. L. 99-509 provided that: "The amendment

made by subsection (a) [amending this section] shall apply to

services furnished on or after April 1, 1987."

Amendment by section 9337(d) of Pub. L. 99-509 applicable to

expenses incurred for outpatient occupational therapy services

furnished on or after July 1, 1987, see section 9337(e) of Pub. L.

99-509, set out as a note under section 1395k of this title.

Section 9338(f) of Pub. L. 99-509 provided that: "The amendments

made by this section [amending this section and section 1395u of

this title] shall apply to services furnished on or after January

1, 1987."

Section 9107(c)(2) of Pub. L. 99-272 provided that: "The

amendments made by subsection (b) [amending this section] shall

apply to cost reporting periods beginning on or after October 1,

1985."

Section 9110(b) of Pub. L. 99-272 provided that: "The amendments

made by subsection (a) [amending this section] shall be applied as

though they were originally included in the Deficit Reduction Act

of 1984 [Pub. L. 98-369]."

Section 9202(i)(2) of Pub. L. 99-272 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to cost reporting periods beginning on or after July 1, 1985."

Amendment by section 9219(b)(1)(B) of Pub. L. 99-272 effective as

if originally included in the Deficit Reduction Act of 1984, Pub.

L. 98-369, see section 9219(b)(1)(D) of Pub. L. 99-272, set out as

a note under section 1395u of this title.

Section 9219(b)(3)(B) of Pub. L. 99-272 provided that: "The

amendment made by subparagraph (A) [amending this section] shall be

effective as if it had been originally included in the Social

Security Amendments of 1983 [Pub. L. 98-21]."

EFFECTIVE DATE OF 1984 AMENDMENTS

Amendment by Pub. L. 98-617 effective as if originally included

in the Deficit Reduction Act of 1984, Pub. L. 98-369, see section

3(c) of Pub. L. 98-617, set out as a note under section 1395f of

this title.

Section 2314(c)(1), (2) of Pub. L. 98-369 provided that:

"(1) Clause (i) of section 1861(v)(1)(O) of the Social Security

Act [subsec. (v)(1)(O)(i) of this section] shall not apply to

changes of ownership of assets pursuant to an enforceable agreement

entered into before the date of the enactment of this Act [July 18,

1984].

"(2) Clause (iii) of section 1861(v)(1)(O) of such Act [subsec.

(v)(1)(O)(iii) of this section] shall apply to costs incurred on or

after the date of the enactment of this Act."

Section 2318(c) of Pub. L. 98-369 provided that: "The amendments

made by this section [amending this section] shall apply to

services furnished on or after the date of the enactment of this

Act [July 18, 1984]."

Amendment by section 2319(a) of Pub. L. 98-369 applicable to cost

reporting periods beginning on or after July 1, 1984, see section

2319(c) of Pub. L. 98-369, set out as an Effective Date note under

section 1395yy of this title.

Amendment by section 2321(e) of Pub. L. 98-369 applicable to

items and services furnished on or after July 18, 1984, see section

2321(g) of Pub. L. 98-369, set out as a note under section 1395f of

this title.

Section 2322(b) of Pub. L. 98-369 provided that: "The amendments

made by subsection (a) [amending this section] shall be effective

with respect to services furnished on or after the date of the

enactment of this Act [July 18, 1984]."

Amendment by section 2323(a) of Pub. L. 98-369 applicable to

services furnished on or after Sept. 1, 1984, see section 2323(d)

of Pub. L. 98-369, set out as a note under section 1395l of this

title.

Section 2324(b) of Pub. L. 98-369 provided that: "The amendments

made by subsection (a) [amending this section] shall be effective

with respect to items and services purchased on or after the date

of the enactment of this Act [July 18, 1984]."

Amendment by section 2335(b) of Pub. L. 98-369 effective July 18,

1984, see section 2335(g) of Pub. L. 98-369, set out as a note

under section 1395f of this title.

Section 2340(c) of Pub. L. 98-369 provided that: "The amendments

made by this section [amending this section and section 1396d of

this title] shall become effective on the date of the enactment of

this Act [July 18, 1984]."

Amendment by section 2341(a), (c) of Pub. L. 98-369 applicable to

services furnished on or after July 18, 1984, see section 2341(d)

of Pub. L. 98-369, set out as a note under section 1395k of this

title.

Amendment by section 2342(a) of Pub. L. 98-369 applicable to

plans of care established on or after July 18, 1984, see section

2342(c) of Pub. L. 98-369, set out as a note under section 1395n of

this title.

Section 2343(c) of Pub. L. 98-369 provided that: "The amendments

made by subsections (a) and (b) [amending this section] shall

become effective on the date of the enactment of this Act [July 18,

1984]."

Amendment by section 2354(b)(18)-(29) of Pub. L. 98-369 effective

July 18, 1984, but not to be construed as changing or affecting any

right, liability, status, or interpretation which existed (under

the provisions of law involved) before that date, see section

2354(e)(1) of Pub. L. 98-369, set out as a note under section

1320a-1 of this title.

EFFECTIVE DATE OF 1983 AMENDMENTS

Amendment by section 602(d) of Pub. L. 98-21 applicable to items

and services furnished by or under arrangement with a hospital

beginning with its first cost reporting period that begins on or

after Oct. 1, 1983, any change in a hospital's cost reporting

period made after November 1982 to be recognized for such purposes

only if the Secretary finds good cause therefor, see section

604(a)(1) of Pub. L. 98-21, set out as a note under section 1395ww

of this title.

Amendment by Pub. L. 97-448 effective as if originally included

in the provision of the Tax Equity and Fiscal Responsibility Act of

1982, Pub. L. 97-248, to which such amendment relates, see section

309(c)(1) of Pub. L. 97-448, set out as a note under section 426 of

this title.

EFFECTIVE DATE OF 1982 AMENDMENT

Amendment by section 101(a)(2) of Pub. L. 97-248 applicable to

cost reporting periods beginning on or after Oct. 1, 1982, see

section 101(b)(1) of Pub. L. 97-248, set out as an Effective Date

note under section 1395ww of this title.

Section 102(b) of Pub. L. 97-248, as amended by Pub. L. 98-21,

title VI, Sec. 605(a), Apr. 20, 1983, 97 Stat. 169, provided that:

"The amendment made by subsection (a) [amending this section] shall

be effective with respect to cost reporting periods beginning on or

after October 1, 1983."

Section 103(b) of Pub. L. 97-248 provided that: "The amendment

made by subsection (a) [amending this section] shall be effective

with respect to cost reporting periods ending after September 30,

1982, but in the case of any cost reporting period beginning before

October 1, 1982, any reduction in payments under title XVIII of the

Social Security Act [this subchapter] to a hospital or skilled

nursing facility resulting from such amendment shall be imposed

only in proportion to the part of the period which occurs after

September 30, 1982."

Section 105(b) of Pub. L. 97-248 provided that: "The amendment

made by subsection (a) [amending this section] shall be effective

with respect to cost reporting periods beginning on or after the

date of the enactment of this Act [Sept. 3, 1982]."

Section 106(b) of Pub. L. 97-248 provided that: "The amendment

made by subsection (a) [amending this section] shall be effective

with respect to any costs incurred under title XVIII of the Social

Security Act [this subchapter], except that it shall not apply to

costs which have been allowed prior to the date of the enactment of

this Act [Sept. 3, 1982] pursuant to the final court order affirmed

by a United States Court of Appeals."

Section 107(b) of Pub. L. 97-248 provided that: "The amendment

made by subsection (a) [amending this section] shall be effective

with respect to costs incurred after the date of the enactment of

this Act [Sept. 3, 1982]."

Amendment by section 109(b)(2) of Pub. L. 97-248 effective Sept.

3, 1982, see section 109(c)(1) of Pub. L. 97-248, set out as a note

under section 1395xx of this title.

Section 109(c)(3) of Pub. L. 97-248 provided that: "The amendment

made by subsection (b)(1) [amending this section] shall not apply

to contracts entered into before the date of the enactment of this

Act [Sept. 3, 1982]."

Amendment by section 122(d) of Pub. L. 97-248 applicable to

hospice care provided on or after Nov. 1, 1983, see section

122(h)(1) of Pub. L. 97-248, as amended, set out as a note under

section 1395c of this title.

Section 128(e) of Pub. L. 97-248, as amended by Pub. L. 99-514,

Sec. 2, Oct. 22, 1986, 100 Stat. 2095, provided that:

"(1) Any amendment to the Omnibus Budget Reconciliaton

[Reconciliation] Act of 1981 [Pub. L. 97-35] made by this section

[amending provisions set out as notes under sections 426 and 1395x

of this title] shall be effective as if it had been originally

included in the provision of the Omnibus Budget Reconciliation Act

of 1981 to which such amendment relates.

"(2) Except as otherwise provided in this section, any amendment

to the Social Security Act [this chapter] or the Internal Revenue

Code of 1986 [formerly I.R.C. 1954] [Title 26, Internal Revenue

Code] made by this section (other than subsection (d)) [amending

this section and sections 1395y, 1395cc, and 1395uu of this title

and section 162 of Title 26] shall be effective as if it had been

originally included as a part of that provision of the Social

Security Act or Internal Revenue Code of 1986 to which it relates,

as such provision of such Act or Code was amended by the Omnibus

Budget Reconciliaton [Reconciliation] Act of 1981 [Pub. L. 97-35].

"(3) The amendments made by subsection (d) [amending this section

and sections 1395u, 1395bb, 1395cc, and 1395gg of this title] shall

take effect upon enactment [Sept. 3, 1982]."

Amendment by section 148(b) of Pub. L. 97-248 effective with

respect to contracts entered into or renewed on or after Sept. 3,

1982, see section 149 of Pub. L. 97-248, set out as an Effective

Date note under section 1320c of this title.

EFFECTIVE DATE OF 1981 AMENDMENT

Section 2102(b)(1) of Pub. L. 97-35 provided that: "The

amendments made by subsection (a) [amending this section], shall

apply to services provided on or after the first day of the first

month beginning after the date of the enactment of this Act [Aug.

13, 1981]."

Amendment by section 2121(c), (d) of Pub. L. 97-35 applicable to

services furnished in detoxification facilities for inpatient stays

beginning on or after the tenth day after Aug. 13, 1981, see

section 2121(i) of Pub. L. 97-35, set out as a note under section

1395d of this title.

Section 2141(c) of Pub. L. 97-35 provided that:

"(1) Subject to paragraph (2), the amendment made by subsection

(a) [amending this section] shall apply to cost reporting periods

ending after September 30, 1981.

"(2) In the case of a cost reporting period beginning before

October 1, 1981, any reduction in payments resulting from the

amendment made by subsection (a) shall be imposed only in

proportion to the part of the period that occurs after September

30, 1981."

Section 2143(b) of Pub. L. 97-35, as amended by Pub. L. 97-248,

title I, Sec. 128(c)(1), Sept. 3, 1982, 96 Stat. 367, provided

that:

"(1) Subject to paragraph (2), the amendment made by subsection

(a) [amending this section] shall apply to cost reporting periods

ending after September 30, 1981.

"(2) In the case of a cost reporting period beginning before

October 1, 1981, any reduction in payments resulting from the

amendment made by subsection (a) shall be imposed only in

proportion to the part of the period that occurs after September

30, 1981."

Section 2144(b) of Pub. L. 97-35 provided that:

"(1) Subject to paragraph (2), the amendment made by subsection

(a) [amending this section] shall apply to cost reporting periods

ending after September 30, 1981.

"(2) In the case of a cost reporting period beginning before

October 1, 1981, any reduction in payments resulting from the

amendment made by subsection (a) shall be imposed only in

proportion to the part of the period that occurs after September

30, 1981."

For effective date, savings, and transitional provisions relating

to amendment by section 2193(c)(9) of Pub. L. 97-35, see section

2194 of Pub. L. 97-35, set out as a note under section 701 of this

title.

EFFECTIVE DATE OF 1980 AMENDMENTS

Amendment by Pub. L. 96-611 effective July 1, 1981, and

applicable to services furnished on or after that date, see section

2 of Pub. L. 96-611, set out as a note under section 1395l of this

title.

Section 902(c) of Pub. L. 96-499 provided that: "The amendments

made by this section [amending this section and sections 1320c-7

and 1396a of this title] shall become effective on the date of

[probably should be "on"] which final regulations, promulgated by

the Secretary to implement such amendments, are first issued; and

those regulations shall be issued not later than the first day of

the sixth month following the month in which this Act is enacted

[December 1980]."

Section 930(s) of Pub. L. 96-499 provided that:

"(1) the amendments made by this section [amending this section,

sections 426, 1395c, 1395d, 1395f, 1395h, 1395k, 1395l, and 1395n

of this title, and section 231f of Title 45, Railroads, and

repealing section 1395m of this title] shall become effective with

respect to services furnished on or after July 1, 1981, except that

the amendments made by subsections (n)(1) and (o) [amending this

section and section 1395h of this title] shall become effective on

the date of the enactment of this Act [Dec. 5, 1980].

"(2) The Secretary of Health and Human Services shall take

administrative action to assure that improvements, in accordance

with the amendment made by subsection (n)(1) [amending this

section], will be made not later than June 30, 1981."

Amendment by section 931(c), (d) of Pub. L. 96-499 effective Apr.

1, 1981, see section 931(e) of Pub. L. 96-499, set out as a note

under section 1395d of this title.

Amendment by section 933(c)-(e) of Pub. L. 96-499 effective with

respect to a comprehensive outpatient rehabilitation facility's

first accounting period beginning on or after July 1, 1981, see

section 933(h) of Pub. L. 96-499, set out as a note under section

1395k of this title.

Amendment by section 936(a) of Pub. L. 96-499 applicable with

respect to services provided on or after July 1, 1981, see section

936(d) of Pub. L. 96-499, set out as a note under section 1395f of

this title.

Section 937(c) of Pub. L. 96-499, as amended by Pub. L. 98-369,

div. B, title III, Sec. 2354(c)(1)(B), July 18, 1984, 98 Stat.

1102, provided that: "The amendment made by subsection (a)

[amending this section] shall apply to services furnished on or

after July 1, 1981."

Section 938(b) of Pub. L. 96-499 provided that: "The amendments

made by subsection (a) [amending this section] shall apply to

services furnished on or after January 1, 1981."

Section 948(c)(1) of Pub. L. 96-499 provided that: "The

amendments made by subsection (a) [amending this section and

section 1395k of this title] shall apply with respect to cost

accounting periods beginning on or after October 1, 1978. A

hospital's election under section 1861(b)(7)(A) of the Social

Security Act [subsec. (b)(7)(A) of this section] (as administered

in accordance with section 15 of Public Law 93-233) as of September

30, 1978, shall constitute such hospital's election under such

section (as amended by subsection (a)(1)) on and after October 1,

1978, until otherwise provided by the hospital."

Section 951(c) of Pub. L. 96-499 provided that: "The amendments

made by this section [amending this section] shall take effect on

January 1, 1981."

EFFECTIVE DATE OF 1978 AMENDMENT

Amendment by Pub. L. 95-292 effective with respect to services,

supplies, and equipment furnished after the third calendar month

beginning after June 13, 1978, except that provisions for the

implementation of an incentive reimbursement system for dialysis

services furnished in facilities and providers to become effective

with respect to a facility's or provider's first accounting period

beginning after the last day of the twelfth month following the

month of June 1978, and except that provisions for reimbursement

rates for home dialysis to become effective on Apr. 1, 1979, see

section 6 of Pub. L. 95-292, set out as a note under section 426 of

this title.

EFFECTIVE DATE OF 1977 AMENDMENTS

Section 501(c) of Pub. L. 95-216 provided that: "The amendments

made by this section [amending this section and section 1395u of

this title] shall be effective in the case of items and services

furnished after the date of the enactment of this Act [Dec. 20,

1977]."

Amendment by Pub. L. 95-210 applicable to services rendered on or

after the first day of the third calendar month which begins after

Dec. 31, 1977, see section 1(j) of Pub. L. 95-210, set out as a

note under section 1395k of this title.

Amendment by section 3(a)(2) of Pub. L. 95-142 effective Oct. 25,

1977, see section 3(e) of Pub. L. 95-142, set out as an Effective

Date note under section 1320a-3 of this title.

Amendment by section 19(b)(1) of Pub. L. 95-142 effective with

respect to operation of a hospital, skilled nursing facility, or

intermediate care facility on and after the first day of its first

fiscal year which begins after the end of the six-month period

beginning on the date a uniform reporting system is established

under section 1320a(a) of this title for that type of health

services facility, except that for other types of facilities or

organizations effective with respect to operations on and after the

first day of its first fiscal year which begins after such date as

the Secretary determines to be appropriate for the implementation

of the reporting requirement for that type of facility or

organization, see section 19(c)(2) of Pub. L. 95-142, set out as a

note under section 1396a of this title.

Section 21(c)(1) of Pub. L. 95-142 provided that: "The amendments

made by subsection (a) [amending this section] shall be effective

on the first day of the first calendar quarter which begins more

than six months after the date of enactment of this Act [Oct. 25,

1977]."

EFFECTIVE DATE OF 1975 AMENDMENT

Section 106(b) of Pub. L. 94-182 provided that: "Subject to

subsection (c) [enacting provisions set out below], the amendment

made by subsection (a) [amending this section] shall be effective

on the first day of the sixth month which begins after the date of

enactment of this Act [Dec. 31, 1975]."

Section 112(d) of Pub. L. 94-182 provided that: "The amendments

made by this section [amending this section and sections 1320c-17

and 1395g of this title] shall be effective with respect to

utilization review activities conducted on and after the first day

of the first month which begins more than 30 days after the date of

enactment of this Act [Dec. 31, 1975]."

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by section 211(b), (c)(2) of Pub. L. 92-603 applicable

to services furnished with respect to admissions occurring after

Dec. 31, 1972, see section 211(d) of Pub. L. 92-603, set out as a

note under section 1395f of this title.

Section 223(h) of Pub. L. 92-603 provided that: "The amendments

made by this section [amending this section and section 1395cc of

this title] shall be effective with respect to accounting periods

beginning after December 31, 1972."

Section 227(g) of Pub. L. 92-603 provided that: "The amendments

made by this section [amending this section and sections 1395f,

1395k, 1395n, 1395u, and 1395cc of this title] shall apply with

respect to accounting periods beginning after June 30, 1973."

Section 234(i) of Pub. L. 92-603 provided that: "The amendments

made by this section [amending this section and sections 1395f,

1395z, and 1395bb of this title] shall apply with respect to any

provider of services for fiscal years (of such provider) beginning

after the fifth month following the month in which this Act is

enacted [October 1972]."

Section 246(c) of Pub. L. 92-603 provided that: "The amendments

made by this section [amending this section and section 1396 of

this title] shall be effective July 1, 1973."

Section 251(d) of Pub. L. 92-603, as amended by Pub. L. 93-233,

Sec. 17(a), Dec. 31, 1973, 87 Stat. 967, provided that:

"(1) The amendments made by subsection (a) [amending this section

and sections 1395l and 1395k of this title] shall apply with

respect to services furnished on or after July 1, 1973.

"(2) The amendments made by subsection (b) [amending this section

and section 1395n of this title] shall apply with respect to

services furnished on or after the date of enactment of this Act

[Oct. 30, 1972].

"(3) The amendments made by subsection (c) [amending this

section] shall be effective with respect to accounting periods

beginning after the month in which there are promulgated, by the

Secretary of Health, Education, and Welfare, final regulations

implementing the provisions of section 1861(v)(5) of the Social

Security Act [subsec. (v)(5) of this section]."

Section 252(b) of Pub. L. 92-603 provided that: "The amendment

made by subsection (a) [amending this section] shall apply only

with respect to items furnished on or after the date of the

enactment of this Act [Oct. 30, 1972]."

Amendment by section 256(b) of Pub. L. 92-603 applicable with

respect to admissions occurring after the second month following

the month of enactment of Pub. L. 92-603 which was approved on Oct.

30, 1972, see section 256(d) of Pub. L. 92-603, set out as a note

under section 1395f of this title.

Section 264(b) of Pub. L. 92-603 provided that: "The amendment

made by subsection (a) [amending this section] shall apply only

with respect to services performed on or after the date of the

enactment of this Act [Oct. 30, 1972]."

Section 273(b) of Pub. L. 92-603 provided that: "The amendments

made by this section [amending this section] shall be effective

with respect to services furnished after June 30, 1973."

Section 276(b) of Pub. L. 92-603 provided that: "The amendment

made by this section [amending this section] shall apply with

respect to accounting periods beginning after December 31, 1972."

Amendment by section 283(a) of Pub. L. 92-603 to apply with

respect to services rendered after Dec. 31, 1972, see section

283(c) of Pub. L. 92-603, set out as a note under section 1395n of

this title.

EFFECTIVE DATE OF 1968 AMENDMENT

Section 127(c) of Pub. L. 90-248 provided that: "The amendments

made by subsections (a) and (b) [amending this section and section

1395y of this title] shall apply with respect to services furnished

after December 31, 1967."

Amendment by section 129(a), (b), (c)(9)(C), (10), (11) of Pub.

L. 90-248 applicable with respect to services furnished after Mar.

31, 1968, see section 129(d) of Pub. L. 90-248, set out as a note

under section 1395d of this title.

Amendment by section 132(a) of Pub. L. 90-248 applicable with

respect to items purchased after Dec. 31, 1967, see section 132(c)

of Pub. L. 90-248, set out as a note under section 1395l of this

title.

Amendment by section 133(a), (b) of Pub. L. 90-248 applicable

with respect to services furnished after June 30, 1968, see section

133(g) of Pub. L. 90-248, set out as a note under section 1395k of

this title.

Section 134(b) of Pub. L. 90-248 provided that: "The amendment

made by subsection (a) [amending this section] shall apply with

respect to services furnished after December 31, 1967."

Amendment by section 143(a) of Pub. L. 90-248 effective July 1,

1966, see section 143(d) of Pub. L. 90-248, set out as a note under

section 1395d of this title.

Section 144(e) of Pub. L. 90-248 provided that: "The amendments

made by this section [amending this section] shall apply with

respect to services furnished after March 31, 1968."

EFFECTIVE DATE OF 1966 AMENDMENT

Amendment by Pub. L. 89-713 effective Nov. 2, 1966, see section 6

of Pub. L. 89-713, set out as a note under section 6091 of Title

26, Internal Revenue Code.

IMPLEMENTATION OF AMENDMENTS BY PUB. L. 105-277

Pub. L. 105-277, div. J, title V, Sec. 5101(i), Oct. 21, 1998,

112 Stat. 2681-916, provided that:

"(1) In general. - The Secretary of Health and Human Services

shall promptly issue (without regard to chapter 8 of title 5,

United States Code) such regulations or program memoranda as may be

necessary to effect the amendments made by this section [amending

this section, sections 1395r and 1395fff of this title, and

provisions set out as notes under section 1395fff of this title]

for cost reporting periods beginning during fiscal year 1999.

"(2) Use of payment amounts and limits from published tables. -

"(A) Per beneficiary limits. - In effecting the amendments made

by subsection (a) [amending this section] for cost reporting

periods beginning in fiscal year 1999, the 'median' referred to

in section 1861(v)(1)(L)(vi)(I) of the Social Security Act

[subsec. (v)(1)(L)(vi)(I) of this section] for such periods shall

be the national standardized per beneficiary limitation specified

in Table 3C published in the Federal Register on August 11, 1998

(63 FR 42926) and the 'standardized regional average of such

costs' referred to in section 1861(v)(1)(L)(v)(I) of such Act

[subsec. (v)(1)(L)(v)(I) of this section] for a census division

shall be the sum of the labor and nonlabor components of the

standardized per beneficiary limitation for that census division

specified in Table 3B published in the Federal Register on that

date (63 FR 42926) (or in Table 3D as so published with respect

to Puerto Rico and Guam), and adjusted to reflect variations in

wages among different geographic areas as specified in Tables 4a

and 4b published in the Federal Register on that date (63 FR

42926-42933).

"(B) Per visit limits. - In effecting the amendments made by

subsection (b) [amending this section] for cost reporting periods

beginning in fiscal year 1999, the limits determined under

section 1861(v)(1)(L)(i)(V) of such Act [subsec. (v)(1)(L)(i)(V)

of this section] for cost reporting periods beginning during such

fiscal year shall be equal to the per visit limits as specified

in Table 3A published in the Federal Register on August 11, 1998

(63 FR 42925) and as subsequently corrected, multiplied by

106/105 , and adjusted to reflect variations in wages among

different geographic areas as specified in Tables 4a and 4b

published in the Federal Register on August 11, 1998 (63 FR

42926-42933)."

STUDY ON EXPANSION OF MEDICAL NUTRITION THERAPY SERVICES BENEFIT

Pub. L. 106-554, Sec. 1(a)(6) [title I, Sec. 105(f)], Dec. 21,

2000, 114 Stat. 2763, 2763A-472, provided that: "Not later than

July 1, 2003, the Secretary of Health and Human Services shall

submit to Congress a report that contains recommendations with

respect to the expansion to other medicare beneficiary populations

of the medical nutrition therapy services benefit (furnished under

the amendments made by this section [amending this section and

sections 1395l and 1395u of this title])."

STUDY ON MEDICARE COVERAGE OF ROUTINE THYROID SCREENING

Pub. L. 106-554, Sec. 1(a)(6) [title I, Sec. 123], Dec. 21, 2000,

114 Stat. 2763, 2763A-478, provided that:

"(a) Study. - The Secretary of Health and Human Services shall

request the National Academy of Sciences, and as appropriate in

conjunction with the United States Preventive Services Task Force,

to conduct a study on the addition of coverage of routine thyroid

screening using a thyroid stimulating hormone test as a preventive

benefit provided to medicare beneficiaries under title XVIII of the

Social Security Act [this subchapter] for some or all medicare

beneficiaries. In conducting the study, the Academy shall consider

the short-term and long-term benefits, and costs to the medicare

program, of such addition.

"(b) Report. - Not later than 2 years after the date of the

enactment of this Act [Dec. 21, 2000], the Secretary of Health and

Human Services shall submit a report on the findings of the study

conducted under subsection (a) to the Committee on Ways and Means

and the Committee on Commerce [now Committee on Energy and

Commerce] of the House of Representatives and the Committee on

Finance of the Senate."

GAO STUDY ON COVERAGE OF SURGICAL FIRST ASSISTING SERVICES OF

CERTIFIED REGISTERED NURSE FIRST ASSISTANTS

Pub. L. 106-554, Sec. 1(a)(6) [title IV, Sec. 433], Dec. 21,

2000, 114 Stat. 2763, 2763A-526, provided that:

"(a) Study. - The Comptroller General of the United States shall

conduct a study on the effect on the medicare program under title

XVIII of the Social Security Act [this subchapter] and on medicare

beneficiaries of coverage under the program of surgical first

assisting services of certified registered nurse first assistants.

The Comptroller General shall consider the following when

conducting the study:

"(1) Any impact on the quality of care furnished to medicare

beneficiaries by reason of such coverage.

"(2) Appropriate education and training requirements for

certified registered nurse first assistants who furnish such

first assisting services.

"(3) Appropriate rates of payment under the program to such

certified registered nurse first assistants for furnishing such

services, taking into account the costs of compensation,

overhead, and supervision attributable to certified registered

nurse first assistants.

"(b) Report. - Not later than 1 year after the date of the

enactment of this Act [Dec. 21, 2000], the Comptroller General

shall submit to Congress a report on the study conducted under

subsection (a)."

MEDPAC STUDY AND REPORT ON MEDICARE COVERAGE OF SERVICES PROVIDED

BY CERTAIN NONPHYSICIAN PROVIDERS

Pub. L. 106-554, Sec. 1(a)(6) [title IV, Sec. 435], Dec. 21,

2000, 114 Stat. 2763, 2763A-527, provided that:

"(a) Study. -

"(1) In general. - The Medicare Payment Advisory Commission

shall conduct a study to determine the appropriateness of

providing coverage under the medicare program under title XVIII

of the Social Security Act [this subchapter] for services

provided by a -

"(A) surgical technologist;

"(B) marriage counselor;

"(C) marriage and family therapist;

"(D) pastoral care counselor; and

"(E) licensed professional counselor of mental health.

"(2) Costs to program. - The study shall consider the

short-term and long-term benefits, and costs to the medicare

program, of providing the coverage described in paragraph (1).

"(b) Report. - Not later than 18 months after the date of the

enactment of this Act [Dec. 21, 2000], the Commission shall submit

to Congress a report on the study conducted under subsection (a),

together with any recommendations for legislation that the

Commission determines to be appropriate as a result of such study."

DEVELOPMENT OF PATIENT ASSESSMENT INSTRUMENTS

Pub. L. 106-554, Sec. 1(a)(6) [title V, Sec. 545], Dec. 21, 2000,

114 Stat. 2763, 2763A-551, provided that:

"(a) Development. -

"(1) In general. - Not later than January 1, 2005, the

Secretary of Health and Human Services shall submit to the

Committee on Ways and Means and the Committee on Commerce [now

Committee on Energy and Commerce] of the House of Representatives

and the Committee on Finance of the Senate a report on the

development of standard instruments for the assessment of the

health and functional status of patients, for whom items and

services described in subsection (b) are furnished, and include

in the report a recommendation on the use of such standard

instruments for payment purposes.

"(2) Design for comparison of common elements. - The Secretary

shall design such standard instruments in a manner such that -

"(A) elements that are common to the items and services

described in subsection (b) may be readily comparable and are

statistically compatible;

"(B) only elements necessary to meet program objectives are

collected; and

"(C) the standard instruments supersede any other assessment

instrument used before that date.

"(3) Consultation. - In developing an assessment instrument

under paragraph (1), the Secretary shall consult with the

Medicare Payment Advisory Commission, the Agency for Healthcare

Research and Quality, and qualified organizations representing

providers of services and suppliers under title XVIII [this

subchapter].

"(b) Description of Services. - For purposes of subsection (a),

items and services described in this subsection are those items and

services furnished to individuals entitled to benefits under part

A, or enrolled under part B, or both of title XVIII of the Social

Security Act [part A or part B of this subchapter] for which

payment is made under such title [this subchapter], and include the

following:

"(1) Inpatient and outpatient hospital services.

"(2) Inpatient and outpatient rehabilitation services.

"(3) Covered skilled nursing facility services.

"(4) Home health services.

"(5) Physical or occupational therapy or speech-language

pathology services.

"(6) Items and services furnished to such individuals

determined to have end stage renal disease.

"(7) Partial hospitalization services and other mental health

services.

"(8) Any other service for which payment is made under such

title as the Secretary determines to be appropriate."

CONFORMING REFERENCES TO PREVIOUS PART C

Section 4002(f)(1) of Pub. L. 105-33 provided that: "Any

reference in law (in effect before the date of the enactment of

this Act [Aug. 5, 1997]) to part C of title XVIII of the Social

Security Act [part C of this subchapter] is deemed a reference to

part D of such title [this part] (as in effect after such date)."

DEADLINE FOR PUBLICATION OF DETERMINATION ON COVERAGE OF SCREENING

BARIUM ENEMA

Section 4104(a)(2) of Pub. L. 105-33 provided that: "Not later

than the earlier of the date that is January 1, 1998, or 90 days

after the date of the enactment of this Act [Aug. 5, 1997], the

Secretary of Health and Human Services shall publish notice in the

Federal Register with respect to the determination under paragraph

(1)(D) of section 1861(pp) of the Social Security Act (42 U.S.C.

1395x(pp)), as added by paragraph (1), on the coverage of a

screening barium enema as a colorectal cancer screening test under

such section."

ESTABLISHMENT OF OUTCOME MEASURES FOR BENEFICIARIES WITH DIABETES

Section 4105(c) of Pub. L. 105-33 provided that:

"(1) In general. - The Secretary of Health and Human Services, in

consultation with appropriate organizations, shall establish

outcome measures, including glysolated hemoglobin (past 90-day

average blood sugar levels), for purposes of evaluating the

improvement of the health status of medicare beneficiaries with

diabetes mellitus.

"(2) Recommendations for modifications to screening benefits. -

Taking into account information on the health status of medicare

beneficiaries with diabetes mellitus as measured under the outcome

measures established under paragraph (1), the Secretary shall from

time to time submit recommendations to Congress regarding

modifications to the coverage of services for such beneficiaries

under the medicare program."

VACCINES OUTREACH EXPANSION

Section 4107 of Pub. L. 105-33 provided that:

"(a) Extension of Influenza and Pneumococcal Vaccination

Campaign. - In order to increase utilization of pneumococcal and

influenza vaccines in medicare beneficiaries, the Influenza and

Pneumococcal Vaccination Campaign carried out by the Health Care

Financing Administration in conjunction with the Centers for

Disease Control and Prevention and the National Coalition for Adult

Immunization, is extended until the end of fiscal year 2002.

"(b) Authorization of Appropriation. - There are hereby

authorized to be appropriated for each of fiscal years 1998 through

2002, $8,000,000 for the Campaign described in subsection (a). Of

the amount so authorized to be appropriated in each fiscal year, 60

percent of the amount so appropriated shall be payable from the

Federal Hospital Insurance Trust Fund, and 40 percent shall be

payable from the Federal Supplementary Medical Insurance Trust

Fund."

STUDY ON PREVENTIVE AND ENHANCED BENEFITS

Section 4108 of Pub. L. 105-33 directed the Secretary of Health

and Human Services to request the National Academy of Sciences to

analyze the expansion or modification of preventive or other

benefits provided to medicare beneficiaries under this subchapter,

and not later than 2 years after Aug. 5, 1997, to submit a report

on the findings of the analysis to Congress.

UTILIZATION GUIDELINES

Section 4513(c) of Pub. L. 105-33 provided that: "The Secretary

of Health and Human Services shall develop and implement

utilization guidelines relating to the coverage of chiropractic

services under part B of title XVIII of the Social Security Act

[part B of this subchapter] in cases in which a subluxation has not

been demonstrated by X-ray to exist."

AUTHORIZING PAYMENT FOR PARAMEDIC INTERCEPT SERVICE PROVIDERS IN

RURAL COMMUNITIES

Pub. L. 105-33, title IV, Sec. 4531(c), Aug. 5, 1997, 111 Stat.

452, as amended by Pub. L. 106-113, div. B, Sec. 1000(a)(6) [title

IV, Sec. 412(a)], Nov. 29, 1999, 113 Stat. 1536, 1501A-377,

provided that: "In promulgating regulations to carry out section

1861(s)(7) of the Social Security Act (42 U.S.C. 1395x(s)(7)) with

respect to the coverage of ambulance service, the Secretary of

Health and Human Services may include coverage of advanced life

support services (in this subsection referred to as 'ALS intercept

services') provided by a paramedic intercept service provider in a

rural area if the following conditions are met:

"(1) The ALS intercept services are provided under a contract

with one or more volunteer ambulance services and are medically

necessary based on the health condition of the individual being

transported.

"(2) The volunteer ambulance service involved -

"(A) is certified as qualified to provide ambulance service

for purposes of such section,

"(B) provides only basic life support services at the time of

the intercept, and

"(C) is prohibited by State law from billing for any

services.

"(3) The entity supplying the ALS intercept services -

"(A) is certified as qualified to provide such services under

the medicare program under title XVIII of the Social Security

Act [this subchapter], and

"(B) bills all recipients who receive ALS intercept services

from the entity, regardless of whether or not such recipients

are medicare beneficiaries.

For purposes of this subsection, an area shall be treated as a

rural area if it is designated as a rural area by any law or

regulation of the State or if it is located in a rural census tract

of a metropolitan statistical area (as determined under the most

recent Goldsmith Modification, originally published in the Federal

Register on February 27, 1992 (57 Fed. Reg. 6725))."

[Pub. L. 106-113, div. B, Sec. 1000(a)(6) [title IV, Sec.

412(b)], Nov. 29, 1999, 113 Stat. 1536, 1501A-377, provided that:

"The amendment made by subsection (a) [amending section 4531(c) of

Pub. L. 105-33, set out above] takes effect on January 1, 2000, and

applies to ALS intercept services furnished on or after such

date."]

NO EXCEPTIONS PERMITTED BASED ON AMENDMENT TO SUBSECTION (V)(1)(L)

Section 4601(b) of Pub. L. 105-33 provided that: "The Secretary

of Health and Human Services shall not consider the amendment made

by subsection (a) [amending this section] in making any exemptions

and exceptions pursuant to section 1861(v)(1)(L)(ii) of the Social

Security Act (42 U.S.C. 1395x(v)(1)(L)(ii))."

STUDY ON DEFINITION OF HOMEBOUND

Section 4613 of Pub. L. 105-33 provided that:

"(a) Study. - The Secretary of Health and Human Services shall

conduct a study of the criteria that should be applied, and the

method of applying such criteria, in the determination of whether

an individual is homebound for purposes of qualifying for receipt

of benefits for home health services under the medicare program.

Such criteria shall include the extent and circumstances under

which a person may be absent from the home but nonetheless qualify.

"(b) Report. - Not later than October 1, 1998, the Secretary

shall submit a report to Congress on the study conducted under

subsection (a). The report shall include specific recommendations

on such criteria and methods."

REVISIONS OF COVERAGE FOR IMMUNOSUPPRESSIVE DRUG THERAPY

Section 160(c) of Pub. L. 103-432 provided that: "The Secretary

of Health and Human Services may administer section 1861(s)(2)(J)

of the Social Security Act (42 U.S.C. 1395x(s)(2)(J)) in a manner

such that the months of coverage of drugs described in such section

are provided consecutively, so long as the total number of months

of coverage provided is the same as the number of months described

in such section."

FREEZE IN PER VISIT COST LIMITS FOR HOME HEALTH SERVICES

Section 13564(a)(1) of Pub. L. 103-66 provided that: "The

Secretary of Health and Human Services shall not provide for any

change in the per visit cost limits for home health services under

section 1861(v)(1)(L) of such Act [subsec. (v)(1)(L) of this

section] for cost reporting periods beginning on or after July 1,

1994, and before July 1, 1996, except as may be necessary to take

into account the amendment made by subsection (b)(1) [amending this

section]. The effect of the preceding sentence shall not be

considered by the Secretary in making adjustments pursuant to

section 1861(v)(1)(L)(ii) of such Act to the payment limits for

such services during such cost reporting periods."

STUDY AND REPORT ON EFFECTS OF COVERAGE OF OSTEOPOROSIS DRUGS

Section 4156(b) of Pub. L. 101-508 directed Secretary of Health

and Human Services to conduct a study analyzing effects of coverage

of osteoporosis drugs under part B of this subchapter on health of

individuals enrolled under such part and utilization of inpatient

hospital and extended care services by such individuals, and, by

not later than Oct. 1, 1994, to submit a report to Congress on such

study, which was to include recommendations regarding expansion of

coverage under the medicare program of items and services for

individuals with post-menopausal osteoporosis as the Secretary

considered appropriate.

PRODUCTIVITY SCREENING GUIDELINES APPLICATION TO STAFF IN RURAL

HEALTH CLINICS

Section 4161(b)(3) of Pub. L. 101-508 provided that: "In

employing any screening guideline in determining the productivity

of physicians, physician assistants, nurse practitioners, and

certified nurse-midwives in a rural health clinic, the Secretary of

Health and Human Services shall provide that the guideline shall

take into account the combined services of such staff (and not

merely the service within each class of practitioner)."

DEVELOPMENT OF PROSPECTIVE PAYMENT SYSTEM FOR HOME HEALTH SERVICES

Section 4207(c), formerly 4027(c), of Pub. L. 101-508, as

renumbered and amended by Pub. L. 103-432, title I, Sec. 160(d)(4),

(9), Oct. 31, 1994, 108 Stat. 4444; Pub. L. 105-362, title VI, Sec.

601(b)(2), Nov. 10, 1998, 112 Stat. 3286, directed Secretary of

Health and Human Services to develop a proposal to modify the

current system under which payment is made for home health services

under this subchapter or a proposal to replace such system with a

system under which such payments would be made on the basis of

prospectively determined rates, with Secretary to submit to

Congress by not later than Apr. 1, 1993, the research findings upon

which the proposal was to be based, and directed Prospective

Payment Assessment Commission to submit to Congress by not later

than Mar. 1, 1994, an analysis of and comments on the proposal.

APPLICATION OF BUDGET-NEUTRAL BASIS

Section 4207(d)(2), formerly 4027(d)(2), of Pub. L. 101-508, as

renumbered by Pub. L. 103-432, title I, Sec. 160(d)(4), Oct. 31,

1994, 108 Stat. 4444, provided that: "In updating the wage index

for establishing limits under section 1861(v)(1)(L)(iii) of the

Social Security Act [subsec. (v)(1)(L)(iii) of this section], the

Secretary shall ensure that aggregate payments to home health

agencies under title XVIII of such Act [this subchapter] will be no

greater or lesser than such payments would have been without regard

to such update."

TRANSITION PROVISIONS FOR DETERMINING REASONABLE COSTS FOR HOME

HEALTH AGENCY SERVICES

Section 4207(d)(3), formerly 4027(d)(3), of Pub. L. 101-508, as

renumbered by Pub. L. 103-432, title I, Sec. 160(d)(4), Oct. 31,

1994, 108 Stat. 4444, provided that, notwithstanding subsec.

(v)(1)(L)(iii) of this section, the Secretary of Health and Human

Services was to, in determining the limits of reasonable costs

under this subchapter with respect to services furnished by a home

health agency, utilize a wage index equal to (1) for cost reporting

periods beginning on or after July 1, 1991, and on or before June

30, 1992, a combined area wage index consisting of 67 percent of

the area wage index applicable to such home health agency,

determined using the survey of the 1982 wages and wage-related

costs of hospitals in the United States, and 33 percent of the area

wage index applicable to hospitals located in the geographic area

in which the home health agency was located, determined using the

survey of the 1988 wages and wage-related costs of hospitals in the

United States, and (2) for cost reporting periods beginning on or

after July 1, 1992, and on or before June 30, 1993, a combined area

wage index consisting of 33 percent of the area wage index

applicable to such home health agency, determined using the survey

of the 1982 wages and wage-related costs of hospitals in the United

States, and 67 percent of the area wage index applicable to

hospitals located in the geographic area in which the home health

agency was located, determined using the survey of the 1988 wages

and wage-related costs of hospitals in the United States.

PERMITTING DENTIST TO SERVE AS HOSPITAL MEDICAL DIRECTOR

Section 6025 of Pub. L. 101-239 provided that: "Notwithstanding

the requirement that the responsibility for organization and

conduct of the medical staff of an institution be assigned only to

a doctor of medicine or osteopathy in order for the institution to

participate as a hospital under the medicare program, an

institution that has a doctor of dental surgery or of dental

medicine serving as its medical director shall be considered to

meet such requirement if the laws of the State in which the

institution is located permit a doctor of dental surgery or of

dental medicine to serve as the medical staff director of a

hospital."

RECOGNITION OF COSTS OF CERTAIN HOSPITAL-BASED NURSING SCHOOLS

Section 6205(a)(1)(A) of Pub. L. 101-239 provided that: "The

reasonable costs incurred by a hospital in training students of a

hospital-based nursing school shall be allowable as reasonable

costs under title XVIII of the Social Security Act [this

subchapter] and reimbursed under such title on the same basis as if

they were allowable direct costs of a hospital-operated educational

program (other than an approved graduate medical education program)

if, before June 15, 1989, and thereafter, the hospital demonstrates

that for each year, it incurs at least 50 percent of the costs of

training nursing students at such school, the nursing school and

the hospital share some common board members, and all instruction

is provided at the hospital or, if in another building, a building

on the immediate grounds of the hospital."

[Section 6205(a)(2) of Pub. L. 101-239 provided that: "Paragraph

(1)(A) [set out above] shall apply with respect to cost reporting

periods beginning on or after the date of the enactment of this Act

[Dec. 19, 1989] and on or before the date on which the Secretary

issues regulations pursuant to subsection (b)(2)(A) [set out as a

note under section 1395ww of this title]."]

DISSEMINATION OF RURAL HEALTH CLINIC INFORMATION

Section 6213(e) of Pub. L. 101-239 directed Secretary of Health

and Human Services, not later than 60 days after Dec. 19, 1989, in

consultation with the Director of the Office of Rural Health

Policy, to disseminate to health care facilities and to the chief

executive officer, chief health officer, and chief human services

officer of each State, applications and other necessary information

to enable such a facility to apply for designation as a rural

health clinic for the purposes of this subchapter and subchapter

XIX of this chapter.

TREATMENT OF CERTAIN FACILITIES AS RURAL HEALTH CLINICS

Section 6213(f) of Pub. L. 101-239 provided that: "The Secretary

of Health and Human Services shall not deny certification of a

facility as a rural health clinic under section 1861(aa)(2) of the

Social Security Act [subsec. (aa)(2) of this section] if the

facility is located on an island and would otherwise be qualified

to be certified as such a facility but for the requirement that the

services of a physician assistant or nurse practitioner be provided

in the facility."

CONTINUED USE OF HOME HEALTH WAGE INDEX IN EFFECT PRIOR TO JULY 1,

1989, UNTIL AFTER JULY 1, 1991

Section 6222 of Pub. L. 101-239 provided that: "Notwithstanding

the requirement of section 1861(v)(1)(L)(iii) of the Social

Security Act [subsec. (v)(1)(L)(iii) of this section], the

Secretary of Health and Human Services shall, in determining the

limits of reasonable costs under title XVIII of the Social Security

Act [this subchapter] with respect to services furnished by home

health agencies, continue to utilize the wage index that was in

effect for cost reporting periods beginning before July 1, 1989,

until cost reporting periods beginning on or after July 1, 1991."

PAYMENT FOR MEDICAL ESCORT OR MEDICAL ATTENDANT ON COMMERCIAL

AIRLINER ALLOWED

Section 8427 of Pub. L. 100-647 provided that:

"(a) In General. - The Secretary of Health and Human Services

shall provide that in cases where (as of the date of the enactment

of this Act [Nov. 10, 1988]) transportation on a commercial

airliner is covered under section 1861(s)(7) of the Social Security

Act [subsec. (s)(7) of this section], the Secretary shall also

provide for payment for medically necessary services of a medical

escort or medical attendant.

"(b) Effective Period. - Subsection (a) shall apply to payment

for services furnished during the 5-year period beginning on July

1, 1989."

SKILLED NURSING FACILITY; ACCESS AND VISITATION RIGHTS

Section 411(l)(2)(E) of Pub. L. 100-360 provided that: "Effective

as of the date of the enactment of this Act [July 1, 1988] and

until the effective date of section 1819(c) of such Act [see

Effective Date note set out under section 1395i-3 of this title],

section 1861(j) of the Social Security Act [subsec. (j) of this

section] is deemed to include the requirement described in section

1819(c)(3)(A) of such Act [section 1395i-3(c)(3)(A) of this title]

(as added by section 4201(a)(3) of OBRA)."

MORATORIUM ON PRIOR AUTHORIZATION FOR HOME HEALTH AND POST-HOSPITAL

EXTENDED CARE SERVICES

Section 4039(e) of Pub. L. 100-203 provided that: "The Secretary

of Health and Human Services shall not implement any voluntary or

mandatory program of prior authorization for home health services,

extended care services, or post-hospital extended care services

under part A or B of title XVIII of the Social Security Act [part A

or B of this subchapter] at any time prior to six months after the

date on which the Congress receives the report required under

section 9305(k)(4) of the Omnibus Budget Reconciliation Act of 1986

[section 9305(k)(4) of Pub. L. 99-509, set out below]."

DELAY IN PUBLISHING REGULATIONS WITH RESPECT TO DEEMING STATUS OF

ENTITIES

Section 4039(f) of Pub. L. 100-203 provided that: "The Secretary

of Health and Human Services (in this subsection referred to as the

'Secretary') shall not deem any entity to be a provider of services

(as defined in section 1861(u) of the Social Security Act [subsec.

(u) of this section]) for purposes of title XVIII of such Act [this

subchapter] -

"(1) on any date prior to 6 months after the date on which the

Secretary has published a proposed rule with respect to the

deeming of the entity, and

"(2) until the Secretary publishes a final rule with respect to

the deeming of the entity."

DEVELOPMENT OF UNIFORM NEEDS ASSESSMENT INSTRUMENT

Section 9305(h) of Pub. L. 99-509 directed Secretary of Health

and Human Services to develop a uniform needs assessment instrument

that could be used by discharge planners, hospitals, nursing

facilities, other health care providers, and fiscal intermediaries

in evaluating individual's need for post-hospital extended care

services, home health services, and long-term care services of

health-related or supportive nature, and further provided for

creation of advisory panel to assist Secretary and for a report to

Congress not later than Jan. 1, 1989.

PRIOR AND CONCURRENT AUTHORIZATION DEMONSTRATION PROJECT

Section 9305(k) of Pub. L. 99-509 directed Secretary of Health

and Human Services to conduct a demonstration program concerning

prior and concurrent authorization for post-hospital extended care

services and home health services furnished under part A or part B

of this subchapter, which was to include at least four projects and

was to be initiated by not later than Jan. 1, 1987, under which the

Secretary was to monitor the acceptance of individuals entitled to

benefits under this subchapter by providers to ensure that the

placement of such individuals was not delayed until the results of

prior and concurrent review were known, and further directed

Secretary to evaluate the demonstration program and report to

Congress on such evaluation no later than Feb. 1, 1989.

CONSIDERATIONS IN ESTABLISHING LIMITS ON PAYMENT FOR HOME HEALTH

SERVICES

Section 9315(b) of Pub. L. 99-509 provided that: "In establishing

limitations under section 1861(v)(1)(L) of the Social Security Act

[subsec. (v)(1)(L) of this section] on payment for home health

services for cost reporting periods beginning on or after July 1,

1986, the Secretary of Health and Human Services shall -

"(1) base such limitations on the most recent data available,

which data may be for cost reporting periods beginning no earlier

than October 1, 1983; and

"(2) take into account the changes in costs of home health

agencies for billing and verification procedures that result from

the Secretary's changing the requirements for such procedures, to

the extent the changes in costs are not reflected in such data.

Paragraph (2) shall apply to changes in requirements effected

before, on, or after July 1, 1986."

COMPTROLLER GENERAL STUDY AND REPORT ON COST LIMITS FOR HOME HEALTH

SERVICES

Section 9315(c) of Pub. L. 99-509 directed Comptroller General to

study and report to Congress, not later than Feb. 1, 1988, on

appropriateness and impact on medicare beneficiaries of applying

the per visit cost limits for home health services under subsec.

(v)(1)(L) of this section on a discipline-specific basis, rather

than on an aggregate basis, for all home health services furnished

by an agency, and appropriateness of the percentage limits so

established.

REDUCTION IN PAYMENT TO AVOID DUPLICATE PAYMENT FOR SERVICES OF

PHYSICIAN ASSISTANTS

Section 9338(d) of Pub. L. 99-509 directed Secretary of Health

and Human Services to reduce the amount of payments otherwise made

to hospitals and skilled nursing facilities under this subchapter

to eliminate estimated duplicate payments for historical or current

costs attributable to services described in section 1395x(s)(2)(K)

of this title, prior to repeal by Pub. L. 101-508, title IV, Sec.

4002(f), Nov. 5, 1990, 104 Stat. 1388-36, effective as if included

in the enactment of Pub. L. 99-509.

STUDY AND REPORT ON PAYMENTS FOR PHYSICIAN ASSISTANTS

Section 9338(e) of Pub. L. 99-509 directed Secretary to report to

Congress, by Apr. 1, 1988, concerning adjustments to amount of

payment made, under part B for services described in subsec.

(s)(2)(K) of this section, to ensure that amount of such payments

reflects approximate cost of furnishing the services, taking into

account compensation costs and overhead and supervision costs

attributable to physician assistants.

COST LIMITS FOR ROUTINE SERVICES FOR URBAN AND RURAL HOSPITAL-BASED

SKILLED NURSING FACILITIES; COST REPORTING PERIODS BEGINNING ON OR

AFTER OCTOBER 1, 1982, AND PRIOR TO JULY 1, 1984

Section 2319(d) of Pub. L. 98-369 provided that: "Notwithstanding

limits on the cost of skilled nursing facilities which may have

been issued under section 1861(v) of the Social Security Act

[subsec. (v) of this section] prior to the date of the enactment of

this Act [July 18, 1984], in the case of cost reporting periods

beginning on or after October 1, 1982, and prior to July 1, 1984,

the cost limits for routine services for urban and rural

hospital-based skilled nursing facilities shall be 112 percent of

the mean of the respective routine costs for urban and rural

hospital-based skilled nursing facilities."

STUDY AND REPORT RELATING TO REQUIREMENTS THAT CORE SERVICES BE

FURNISHED DIRECTLY BY HOSPICES

Section 2343(d) of Pub. L. 98-369 directed Secretary of Health

and Human Services to conduct a study of necessity and

appropriateness of requirements that certain "core" services be

furnished directly by a hospice, as required under subsec.

(dd)(2)(A)(ii)(I) of this section and report results of such study

to Congress with the report required under section 122(i)(1)

[122(j)(1)] of the Tax Equity and Fiscal Responsibility Act of 1982

(Pub. L. 97-248), set out as a note under section 1395f of this

title.

REPORT ON EFFECT OF 1982 AMENDMENT ON HOSPITAL-BASED SKILLED

NURSING FACILITIES

Section 605(b) of Pub. L. 98-21 directed Secretary of Health and

Human Services, prior to Dec. 31, 1983, to complete a study and

report to Congress with respect to (1) effect which implementation

of section 102 of the Tax Equity and Fiscal Responsibility Act of

1982, amending this section, would have on hospital-based skilled

nursing facilities, given the differences (if any) in patient

populations served by such facilities and by community-based

skilled nursing facilities and (2) impact on skilled nursing

facilities of hospital prospective payment systems, and

recommendations concerning payment of skilled nursing facilities.

Section 2319(e) of Pub. L. 98-369 directed Secretary of Health

and Human Services to submit to Congress, prior to Dec. 1, 1984,

the report required under section 605(b) of the Social Security

Amendments of 1983 (Pub. L. 87-21), set out above.

ELIMINATION OF PRIVATE ROOM SUBSIDY

Section 111 of Pub. L. 97-248 provided that:

"(a) The Secretary of Health and Human Services shall, pursuant

to section 1861(v)(2) of the Social Security Act [subsec. (v)(2) of

this section], not allow as a reasonable cost the estimated amount

by which the costs incurred by a hospital or skilled nursing

facility for nonmedically necessary private accommodations for

medicare beneficiaries exceeds the costs which would have been

incurred by such hospital or facility for semiprivate

accommodations.

"(b) The Secretary of Health and Human Services shall first issue

such final regulations (whether on an interim or other basis) as

may be necessary to implement subsection (a) by October 1, 1982. If

such regulations are promulgated on an interim final basis, the

Secretary shall take such steps as may be necessary to provide

opportunity for public comment, and appropriate revision based

thereon, so as to provide that such regulations are not on an

interim basis later than January 31, 1983."

REGULATIONS REGARDING ACCESS TO BOOKS AND RECORDS

Section 952(b) of Pub. L. 96-499, as added by Pub. L. 97-248,

title I, Sec. 127(2), Sept. 3, 1982, 96 Stat. 366, provided that:

"Unless the Secretary of Health and Human Services first publishes

final regulations prescribing the criteria and procedures described

in the last sentence of section 1861(v)(1)(I) of the Social

Security Act [subsec. (v)(1)(I) of this section] by January 1,

1983, after providing a period of not less than 60 days for public

comment on proposed regulations, the amendment made by subsection

(a) [amending this section] shall only apply to books, documents,

and records relating to services furnished (pursuant to contract or

subcontract) on or after the date on which final regulations of the

Secretary are first published."

COMPLIANCE WITH THE LIFE SAFETY CODE OR STATE FIRE AND SAFETY CODE

Section 915(b) of Pub. L. 96-499 provided that: "Any institution

(or part of an institution) which complied with the requirements of

section 1861(j)(13) of the Social Security Act [subsec. (j)(13) of

this section] on the day before the date of the enactment of this

Act [Dec. 5, 1980] shall, so long as such compliance is maintained

(either by meeting the applicable provisions of the Life Safety

Code (21st edition, 1967, or 23d edition, 1973), with or without

waivers of specific provisions, or by meeting the applicable

provisions of a fire and safety code imposed by State law as

provided for in such section 1861(j)(13)), be considered (for

purposes of titles XVIII or XIX of such Act [this subchapter or

subchapter XIX of this chapter]) to be in compliance with the

requirements of such section 1861(j)(13), as it is amended by

subsection (a) of this section."

Section 106(c) of Pub. L. 94-182 provided that: "Any institution

(or part of an institution) which complied with the requirements of

section 1861(j)(13) of the Social Security Act [subsec. (j)(13) of

this section] on the day preceding the first day referred to in

subsection (b) [enacting provisions set out as a note under this

section] shall, so long as such compliance is maintained (either by

meeting the applicable provisions of the Life Safety Code (21st

edition, 1967), with or without waivers of specific provisions, or

by meeting the applicable provisions of a fire and safety code

imposed by State law as provided for in such section 1861(j)(13)),

be considered (for purposes of titles XVIII and XIX of such Act)

[subchapters XVIII and XIX of this chapter] to be in compliance

with the requirements of such section 1861(j)(13), as it is amended

by subsection (a) of this section."

PRIVATE, NONPROFIT HEALTH CARE CLINICS QUALIFYING, AS OF JULY 1,

1977, AS RURAL HEALTH CLINICS

Section 1(e) of Pub. L. 95-210 provided that: "Any private,

nonprofit health care clinic that -

"(1) on July 1, 1977, was operating and located in an area

which on that date (A) was not an urbanized area (as defined by

the Bureau of the Census) and (B) had a supply of physicians

insufficient to meet the needs of the area (as determined by the

Secretary), and

"(2) meets the definition of a rural health clinic under

section 1861(aa)(2) [subsec. (aa)(2) of this section] or section

1905(l) of the Social Security Act [section 1396d(l) of this

title], except for clause (i) of section 1861(aa)(2) [subsec.

(aa)(2) of this section],

shall be considered, for the purposes of title XVIII or XIX,

respectively, of the Social Security Act [this subchapter or

subchapter XIX of this chapter], as satisfying the definition of a

rural health clinic under such section."

PROMULGATION OF REGULATIONS DEFINING COSTS CHARGEABLE TO PERSONAL

FUNDS OF PATIENTS IN SKILLED NURSING FACILITIES; DATE OF ISSUANCE

Section 21(b) of Pub. L. 95-142 provided that: "The Secretary of

Health, Education, and Welfare [now Health and Human Services]

shall, by regulation, define those costs which may be charged to

the personal funds of patients in skilled nursing facilities who

are individuals receiving benefits under the provisions of title

XVIII [this subchapter], or under a State plan approved under the

provisions of title XIX [subchapter XIX of this chapter], of the

Social Security Act, and those costs which are to be included in

the reasonable cost or reasonable charge for extended care services

as determined under the provisions of title XVIII, or for skilled

nursing and intermediate care facility services as determined under

the provisions of title XIX, of such Act."

[Section 21(c)(2) of Pub. L. 95-142 provided that: "The Secretary

of Health, Education, and Welfare shall issue the regulations

required under subsection (b) [set out above] within ninety days

after the date of enactment of this Act [Oct. 25, 1977]."]

HOME HEALTH SERVICES; GRANTS FOR ESTABLISHMENT, OPERATION,

STAFFING, ETC., OF PUBLIC AND NONPROFIT PRIVATE AGENCIES AND

ENTITIES; PROCEDURES; PAYMENTS; AUTHORIZATION OF APPROPRIATIONS

Pub. L. 94-63, title VI, Sec. 602, July 29, 1975, 89 Stat. 346,

as amended by Pub. L. 94-460, title III, Sec. 302, Oct. 8, 1976, 90

Stat. 1960; Pub. L. 95-83, title III, Sec. 310, Aug. 1, 1977, 91

Stat. 397, which provided for a program of home health services and

of training of professional and paraprofessional personnel, was

repealed by Pub. L. 95-626, title II, Sec. 207(b), Nov. 10, 1978,

92 Stat. 3586, effective Oct. 1, 1978.

PAYMENT FOR SERVICE OF PHYSICIANS RENDERED IN A TEACHING HOSPITAL

FOR ACCOUNTING PERIODS BEGINNING AFTER JUNE 30, 1975, AND PRIOR TO

OCTOBER 1, 1978; STUDIES, REPORTS, ETC.; EFFECTIVE DATES

Pub. L. 93-233, Sec. 15(a)(1), (b)-(d), Dec. 31, 1973, 87 Stat.

965, as amended by Pub. L. 93-368, Sec. 7, Aug. 7, 1974, 88 Stat.

422; Pub. L. 94-368, Sec. 1, July 16, 1976, 90 Stat. 997; Pub. L.

95-292, Sec. 7, June 13, 1978, 92 Stat. 316, provided that for the

cost accounting periods beginning after June 30, 1975, and prior to

October 1, 1978, subsec. (b) of this section will be administered

as if paragraph (7) of subsec. (b) read as follows: "(7) a

physician where the hospital has a teaching program approved as

specified in paragraph (6), if (A) the hospital elects to receive

any payment due under this title [this subchapter] for reasonable

costs of such services, and (B) all physicians in such hospital

agree not to bill charges for professional services rendered in

such hospital to individuals covered under the insurance program

established by this title [this subchapter]", provided for studies

with respect to methods of reimbursement for physicians' services

under subchapters XVIII and XIX of this chapter in hospitals which

have a teaching program and a determination as to how and to what

extent such funds are utilized, and provided that a final report be

submitted to the Secretary of Health, Education, and Welfare, the

Committee on Finance of the Senate, and the Committee on Ways and

Means of the House of Representatives not later than Mar. 1, 1976.

PHYSICAL THERAPY SERVICES REQUIREMENTS; EFFECTIVE DATE POSTPONEMENT

Section 17(a) of Pub. L. 93-233 provided that: "In the

administration of title XVIII of the Social Security Act [this

subchapter], the amount payable thereunder with respect to physical

therapy and other services referred to in section 1861(v)(5)(A) of

such Act [subsec. (v)(5)(A) of this section] (as added by section

151(c) [251(c)] of the Social Security Amendments of 1972) shall be

determined (for the period with respect to which the amendment made

by such section 151(c) [251(c)] would, except for the provisions of

this section, be applicable) in like manner as if the 'December 31,

1972', which appears in such subsection (d)(3) of such section 151

[251(d)(3), set out as Effective Date of 1972 Amendment note

above], read 'the month in which there are promulgated, by the

Secretary of Health, Education, and Welfare [now Health and Human

Services], final regulations implementing the provisions of section

1861(v)(5) of the Social Security Act [subsec. (v)(5) of this

section]'."

PAYMENT FOR DURABLE MEDICAL EQUIPMENT

Section 245(a)-(c) of Pub. L. 92-603 provided that:

"(a) The Secretary is authorized to conduct reimbursement

experiments designed to eliminate unreasonable expenses resulting

from prolonged rentals of durable medical equipment described in

section 1861(s)(6) of the Social Security Act [subsec. (s)(6) of

this section].

"(b) Such experiment may be conducted in one or more geographic

areas, as the Secretary deems appropriate, and may, pursuant to

agreements with suppliers, provide for reimbursement for such

equipment on a lump-sum basis whenever it is determined (in

accordance with guidelines established by the Secretary) that a

lump-sum payment would be more economical than the anticipated

period of rental payments. Such experiments may also provide for

incentives to beneficiaries (including waiver of the 20 percent

coinsurance amount applicable under section 1833 of the Social

Security Act [section 1395l of this title]) to purchase used

equipment whenever the purchase price is at least 25 percent less

than the reasonable charge for new equipment.

"(c) The Secretary is authorized, at such time as he deems

appropriate, to implement on a nationwide basis any such

reimbursement procedures which he finds to be workable, desirable

and economical and which are consistent with the purposes of this

section."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254c, 254c-14, 254e,

254t, 255, 256, 295p, 296, 297n, 300t-12, 426-1, 1301, 1320a-1,

1320a-3, 1320a-7b, 1320c-3, 1320c-11, 1320d, 1395a, 1395d, 1395f,

1395g, 1395h, 1395i-3, 1395i-4, 1395k, 1395l, 1395m, 1395n, 1395r,

1395u, 1395w-3, 1395w-4, 1395w-22, 1395y, 1395z, 1395aa, 1395bb,

1395cc, 1395dd, 1395ee, 1395mm, 1395nn, 1395pp, 1395qq, 1395rr,

1395tt, 1395uu, 1395ww, 1395yy, 1395bbb, 1395eee, 1395fff, 1396a,

1396b, 1396d, 1396g, 1396n, 1396r, 1396u-2, 3032c, 11151 of this

title; title 10 sections 1074j, 1077, 1079; title 25 sections

1621d, 1621k; title 26 sections 101, 213, 7702B.

-FOOTNOTE-

(!1) So in original. The word "and" probably should not appear.

(!2) So in original. Probably should be followed by "and".

(!3) So in original. Probably should be "regulations".

(!4) So in original. Probably should be followed by a closing

parenthesis.

(!5) So in original. Probably should be "subclauses."

(!6) See References in Text note below.

(!7) See References in Text note below.

(!8) So in original.

(!9) See References in Text note below.

(!10) So in original. Probably should be "paragraph (2)(H)(i)".

(!11) So in original. Probably should be "critical access".

-End-

-CITE-

42 USC Sec. 1395y 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395y. Exclusions from coverage and medicare as secondary

payer

-STATUTE-

(a) Items or services specifically excluded

Notwithstanding any other provision of this subchapter, no

payment may be made under part A or part B of this subchapter for

any expenses incurred for items or services -

(1)(A) which, except for items and services described in a

succeeding subparagraph, are not reasonable and necessary for the

diagnosis or treatment of illness or injury or to improve the

functioning of a malformed body member,

(B) in the case of items and services described in section

1395x(s)(10) of this title, which are not reasonable and

necessary for the prevention of illness,

(C) in the case of hospice care, which are not reasonable and

necessary for the palliation or management of terminal illness,

(D) in the case of clinical care items and services provided

with the concurrence of the Secretary and with respect to

research and experimentation conducted by, or under contract

with, the Medicare Payment Advisory Commission or the Secretary,

which are not reasonable and necessary to carry out the purposes

of section 1395ww(e)(6) of this title,(!1)

(E) in the case of research conducted pursuant to section

1320b-12 of this title, which is not reasonable and necessary to

carry out the purposes of that section,

(F) in the case of screening mammography, which is performed

more frequently than is covered under section 1395m(c)(2) of this

title or which is not conducted by a facility described in

section 1395m(c)(1)(B) of this title, in the case of screening

pap smear and screening pelvic exam, which is performed more

frequently than is provided under section 1395x(nn) of this

title, and, in the case of screening for glaucoma, which is

performed more frequently than is provided under section

1395x(uu) of this title,

(G) in the case of prostate cancer screening tests (as defined

in section 1395x(oo) of this title), which are performed more

frequently than is covered under such section,

(H) in the case of colorectal cancer screening tests, which are

performed more frequently than is covered under section 1395m(d)

of this title, and

(I) the frequency and duration of home health services which

are in excess of normative guidelines that the Secretary shall

establish by regulation;

(2) for which the individual furnished such items or services

has no legal obligation to pay, and which no other person (by

reason of such individual's membership in a prepayment plan or

otherwise) has a legal obligation to provide or pay for, except

in the case of Federally qualified health center services;

(3) which are paid for directly or indirectly by a governmental

entity (other than under this chapter and other than under a

health benefits or insurance plan established for employees of

such an entity), except in the case of rural health clinic

services, as defined in section 1395x(aa)(1) of this title, in

the case of Federally qualified health center services, as

defined in section 1395x(aa)(3) of this title, in the case of

services for which payment may be made under section 1395qq(e) of

this title, and in such other cases as the Secretary may specify;

(4) which are not provided within the United States (except for

inpatient hospital services furnished outside the United States

under the conditions described in section 1395f(f) of this title

and, subject to such conditions, limitations, and requirements as

are provided under or pursuant to this subchapter, physicians'

services and ambulance services furnished an individual in

conjunction with such inpatient hospital services but only for

the period during which such inpatient hospital services were

furnished);

(5) which are required as a result of war, or of an act of war,

occurring after the effective date of such individual's current

coverage under such part;

(6) which constitute personal comfort items (except, in the

case of hospice care, as is otherwise permitted under paragraph

(1)(C));

(7) where such expenses are for routine physical checkups,

eyeglasses (other than eyewear described in section 1395x(s)(8)

of this title) or eye examinations for the purpose of

prescribing, fitting, or changing eyeglasses, procedures

performed (during the course of any eye examination) to determine

the refractive state of the eyes, hearing aids or examinations

therefor, or immunizations (except as otherwise allowed under

section 1395x(s)(10) of this title and subparagraph (B), (F),

(G), or (H) of paragraph (1));

(8) where such expenses are for orthopedic shoes or other

supportive devices for the feet, other than shoes furnished

pursuant to section 1395x(s)(12) of this title;

(9) where such expenses are for custodial care (except, in the

case of hospice care, as is otherwise permitted under paragraph

(1)(C));

(10) where such expenses are for cosmetic surgery or are

incurred in connection therewith, except as required for the

prompt repair of accidental injury or for improvement of the

functioning of a malformed body member;

(11) where such expenses constitute charges imposed by

immediate relatives of such individual or members of his

household;

(12) where such expenses are for services in connection with

the care, treatment, filling, removal, or replacement of teeth or

structures directly supporting teeth, except that payment may be

made under part A of this subchapter in the case of inpatient

hospital services in connection with the provision of such dental

services if the individual, because of his underlying medical

condition and clinical status or because of the severity of the

dental procedure, requires hospitalization in connection with the

provision of such services;

(13) where such expenses are for -

(A) the treatment of flat foot conditions and the

prescription of supportive devices therefor,

(B) the treatment of subluxations of the foot, or

(C) routine foot care (including the cutting or removal of

corns or calluses, the trimming of nails, and other routine

hygienic care);

(14) which are other than physicians' services (as defined in

regulations promulgated specifically for purposes of this

paragraph), services described by section 1395x(s)(2)(K) of this

title, certified nurse-midwife services, qualified psychologist

services, and services of a certified registered nurse

anesthetist, and which are furnished to an individual who is a

patient of a hospital or critical access hospital by an entity

other than the hospital or critical access hospital, unless the

services are furnished under arrangements (as defined in section

1395x(w)(1) of this title) with the entity made by the hospital

or critical access hospital;

(15)(A) which are for services of an assistant at surgery in a

cataract operation (including subsequent insertion of an

intraocular lens) unless, before the surgery is performed, the

appropriate utilization and quality control peer review

organization (under part B of subchapter XI of this chapter) or a

carrier under section 1395u of this title has approved of the use

of such an assistant in the surgical procedure based on the

existence of a complicating medical condition, or

(B) which are for services of an assistant at surgery to which

section 1395w-4(i)(2)(B) of this title applies;

(16) in the case in which funds may not be used for such items

and services under the Assisted Suicide Funding Restriction Act

of 1997 [42 U.S.C. 14401 et seq.];

(17) where the expenses are for an item or service furnished in

a competitive acquisition area (as established by the Secretary

under section 1395w-3(a) of this title) by an entity other than

an entity with which the Secretary has entered into a contract

under section 1395w-3(b) of this title for the furnishing of such

an item or service in that area, unless the Secretary finds that

the expenses were incurred in a case of urgent need, or in other

circumstances specified by the Secretary;

(18) which are covered skilled nursing facility services

described in section 1395yy(e)(2)(A)(i) of this title and which

are furnished to an individual who is a resident of a skilled

nursing facility during a period in which the resident is

provided covered post-hospital extended care services (or, for

services described in section 1395x(s)(2)(D) of this title, which

are furnished to such an individual without regard to such

period), by an entity other than the skilled nursing facility,

unless the services are furnished under arrangements (as defined

in section 1395x(w)(1) of this title) with the entity made by the

skilled nursing facility;

(19) which are for items or services which are furnished

pursuant to a private contract described in section 1395a(b) of

this title;

(20) in the case of outpatient occupational therapy services or

outpatient physical therapy services furnished as an incident to

a physician's professional services (as described in section

1395x(s)(2)(A) of this title), that do not meet the standards and

conditions (other than any licensing requirement specified by the

Secretary) under the second sentence of section 1395x(p) of this

title (or under such sentence through the operation of section

1395x(g) of this title) as such standards and conditions would

apply to such therapy services if furnished by a therapist;

(21) where such expenses are for home health services

(including medical supplies described in section 1395x(m)(5) of

this title, but excluding durable medical equipment to the extent

provided for in such section) furnished to an individual who is

under a plan of care of the home health agency if the claim for

payment for such services is not submitted by the agency; or

(22) subject to subsection (h) of this section, for which a

claim is submitted other than in an electronic form specified by

the Secretary.

Paragraph (7) shall not apply to Federally qualified health center

services described in section 1395x(aa)(3)(B) of this title. In

making a national coverage determination (as defined in paragraph

(1)(B) of section 1395ff(f) of this title) the Secretary shall

ensure that the public is afforded notice and opportunity to

comment prior to implementation by the Secretary of the

determination; meetings of advisory committees established under

section 1314(f) of this title with respect to the determination are

made on the record; in making the determination, the Secretary has

considered applicable information (including clinical experience

and medical, technical, and scientific evidence) with respect to

the subject matter of the determination; and in the determination,

provide a clear statement of the basis for the determination

(including responses to comments received from the public), the

assumptions underlying that basis, and make available to the public

the data (other than proprietary data) considered in making the

determination.

(b) Medicare as secondary payer

(1) Requirements of group health plans

(A) Working aged under group health plans

(i) In general

A group health plan -

(I) may not take into account that an individual (or the

individual's spouse) who is covered under the plan by

virtue of the individual's current employment status with

an employer is entitled to benefits under this subchapter

under section 426(a) of this title, and

(II) shall provide that any individual age 65 or older

(and the spouse age 65 or older of any individual) who has

current employment status with an employer shall be

entitled to the same benefits under the plan under the same

conditions as any such individual (or spouse) under age 65.

(ii) Exclusion of group health plan of a small employer

Clause (i) shall not apply to a group health plan unless

the plan is a plan of, or contributed to by, an employer that

has 20 or more employees for each working day in each of 20

or more calendar weeks in the current calendar year or the

preceding calendar year.

(iii) Exception for small employers in multiemployer or

multiple employer group health plans

Clause (i) also shall not apply with respect to individuals

enrolled in a multiemployer or multiple employer group health

plan if the coverage of the individuals under the plan is by

virtue of current employment status with an employer that

does not have 20 or more individuals in current employment

status for each working day in each of 20 or more calendar

weeks in the current calendar year and the preceding calendar

year; except that the exception provided in this clause shall

only apply if the plan elects treatment under this clause.

(iv) Exception for individuals with end stage renal disease

Subparagraph (C) shall apply instead of clause (i) to an

item or service furnished in a month to an individual if for

the month the individual is, or (without regard to

entitlement under section 426 of this title) would upon

application be, entitled to benefits under section 426-1 of

this title.

(v) "Group health plan" defined

In this subparagraph, and subparagraph (C), the term "group

health plan" has the meaning given such term in section

5000(b)(1) of the Internal Revenue Code of 1986, without

regard to section 5000(d) of such Code.

(B) Disabled individuals in large group health plans

(i) In general

A large group health plan (as defined in clause (iii)) may

not take into account that an individual (or a member of the

individual's family) who is covered under the plan by virtue

of the individual's current employment status with an

employer is entitled to benefits under this subchapter under

section 426(b) of this title.

(ii) Exception for individuals with end stage renal disease

Subparagraph (C) shall apply instead of clause (i) to an

item or service furnished in a month to an individual if for

the month the individual is, or (without regard to

entitlement under section 426 of this title) would upon

application be, entitled to benefits under section 426-1 of

this title.

(iii) "Large group health plan" defined

In this subparagraph, the term "large group health plan"

has the meaning given such term in section 5000(b)(2) of the

Internal Revenue Code of 1986, without regard to section

5000(d) of such Code.

(C) Individuals with end stage renal disease

A group health plan (as defined in subparagraph (A)(v)) -

(i) may not take into account that an individual is

entitled to or eligible for benefits under this subchapter

under section 426-1 of this title during the 12-month period

which begins with the first month in which the individual

becomes entitled to benefits under part A of this subchapter

under the provisions of section 426-1 of this title, or, if

earlier, the first month in which the individual would have

been entitled to benefits under such part under the

provisions of section 426-1 of this title if the individual

had filed an application for such benefits; and

(ii) may not differentiate in the benefits it provides

between individuals having end stage renal disease and other

individuals covered by such plan on the basis of the

existence of end stage renal disease, the need for renal

dialysis, or in any other manner;

except that clause (ii) shall not prohibit a plan from paying

benefits secondary to this subchapter when an individual is

entitled to or eligible for benefits under this subchapter

under section 426-1 of this title after the end of the 12-month

period described in clause (i). Effective for items and

services furnished on or after February 1, 1991, and before

August 5, 1997,(!2) (with respect to periods beginning on or

after February 1, 1990), this subparagraph shall be applied by

substituting "18-month" for "12-month" each place it appears.

Effective for items and services furnished on or after August

5, 1997,(!2) (with respect to periods beginning on or after the

date that is 18 months prior to August 5, 1997), clauses (i)

and (ii) shall be applied by substituting "30-month" for

"12-month" each place it appears.

(D) Treatment of certain members of religious orders

In this subsection, an individual shall not be considered to

be employed, or an employee, with respect to the performance of

services as a member of a religious order which are considered

employment only by virtue of an election made by the religious

order under section 3121(r) of the Internal Revenue Code of

1986.

(E) General provisions

For purposes of this subsection:

(i) Aggregation rules

(I) All employers treated as a single employer under

subsection (a) or (b) of section 52 of the Internal Revenue

Code of 1986 shall be treated as a single employer.

(II) All employees of the members of an affiliated

service group (as defined in section 414(m) of such Code)

shall be treated as employed by a single employer.

(III) Leased employees (as defined in section 414(n)(2)

of such Code) shall be treated as employees of the person

for whom they perform services to the extent they are so

treated under section 414(n) of such Code.

In applying sections of the Internal Revenue Code of 1986

under this clause, the Secretary shall rely upon regulations

and decisions of the Secretary of the Treasury respecting

such sections.

(ii) "Current employment status" defined

An individual has "current employment status" with an

employer if the individual is an employee, is the employer,

or is associated with the employer in a business

relationship.

(iii) Treatment of self-employed persons as employers

The term "employer" includes a self-employed person.

(F) Limitation on beneficiary liability

An individual who is entitled to benefits under this

subchapter and is furnished an item or service for which such

benefits are incorrectly paid is not liable for repayment of

such benefits under this paragraph unless payment of such

benefits was made to the individual.

(2) Medicare secondary payer

(A) In general

Payment under this subchapter may not be made, except as

provided in subparagraph (B), with respect to any item or

service to the extent that -

(i) payment has been made, or can reasonably be expected to

be made, with respect to the item or service as required

under paragraph (1), or

(ii) payment has been made, or can reasonably be expected

to be made promptly (as determined in accordance with

regulations) under a workmen's compensation law or plan of

the United States or a State or under an automobile or

liability insurance policy or plan (including a self-insured

plan) or under no fault insurance.

In this subsection, the term "primary plan" means a group

health plan or large group health plan, to the extent that

clause (i) applies, and a workmen's compensation law or plan,

an automobile or liability insurance policy or plan (including

a self-insured plan) or no fault insurance, to the extent that

clause (ii) applies.

(B) Conditional payment

(i) Repayment required

Any payment under this subchapter with respect to any item

or service to which subparagraph (A) applies shall be

conditioned on reimbursement to the appropriate Trust Fund

established by this subchapter when notice or other

information is received that payment for such item or service

has been or could be made under such subparagraph. If

reimbursement is not made to the appropriate Trust Fund

before the expiration of the 60-day period that begins on the

date such notice or other information is received, the

Secretary may charge interest (beginning with the date on

which the notice or other information is received) on the

amount of the reimbursement until reimbursement is made (at a

rate determined by the Secretary in accordance with

regulations of the Secretary of the Treasury applicable to

charges for late payments).

(ii) Action by United States

In order to recover payment under this subchapter for such

an item or service, the United States may bring an action

against any entity which is required or responsible

(directly, as a third-party administrator, or otherwise) to

make payment with respect to such item or service (or any

portion thereof) under a primary plan (and may, in accordance

with paragraph (3)(A) collect double damages against that

entity), or against any other entity (including any physician

or provider) that has received payment from that entity with

respect to the item or service, and may join or intervene in

any action related to the events that gave rise to the need

for the item or service. The United States may not recover

from a third-party administrator under this clause in cases

where the third-party administrator would not be able to

recover the amount at issue from the employer or group health

plan and is not employed by or under contract with the

employer or group health plan at the time the action for

recovery is initiated by the United States or for whom it

provides administrative services due to the insolvency or

bankruptcy of the employer or plan.

(iii) Subrogation rights

The United States shall be subrogated (to the extent of

payment made under this subchapter for such an item or

service) to any right under this subsection of an individual

or any other entity to payment with respect to such item or

service under a primary plan.

(iv) Waiver of rights

The Secretary may waive (in whole or in part) the

provisions of this subparagraph in the case of an individual

claim if the Secretary determines that the waiver is in the

best interests of the program established under this

subchapter.

(v) Claims-filing period

Notwithstanding any other time limits that may exist for

filing a claim under an employer group health plan, the

United States may seek to recover conditional payments in

accordance with this subparagraph where the request for

payment is submitted to the entity required or responsible

under this subsection to pay with respect to the item or

service (or any portion thereof) under a primary plan within

the 3-year period beginning on the date on which the item or

service was furnished.

(C) Treatment of questionnaires

The Secretary may not fail to make payment under subparagraph

(A) solely on the ground that an individual failed to complete

a questionnaire concerning the existence of a primary plan.

(3) Enforcement

(A) Private cause of action

There is established a private cause of action for damages

(which shall be in an amount double the amount otherwise

provided) in the case of a primary plan which fails to provide

for primary payment (or appropriate reimbursement) in

accordance with such paragraphs (1) and (2)(A).

(B) Reference to excise tax with respect to nonconforming group

health plans

For provision imposing an excise tax with respect to

nonconforming group health plans, see section 5000 of the

Internal Revenue Code of 1986.

(C) Prohibition of financial incentives not to enroll in a

group health plan or a large group health plan

It is unlawful for an employer or other entity to offer any

financial or other incentive for an individual entitled to

benefits under this subchapter not to enroll (or to terminate

enrollment) under a group health plan or a large group health

plan which would (in the case of such enrollment) be a primary

plan (as defined in paragraph (2)(A)). Any entity that violates

the previous sentence is subject to a civil money penalty of

not to exceed $5,000 for each such violation. The provisions of

section 1320a-7a of this title (other than subsections (a) and

(b)) shall apply to a civil money penalty under the previous

sentence in the same manner as such provisions apply to a

penalty or proceeding under section 1320a-7a(a) of this title.

(4) Coordination of benefits

Where payment for an item or service by a primary plan is less

than the amount of the charge for such item or service and is not

payment in full, payment may be made under this subchapter

(without regard to deductibles and coinsurance under this

subchapter) for the remainder of such charge, but -

(A) payment under this subchapter may not exceed an amount

which would be payable under this subchapter for such item or

service if paragraph (2)(A) did not apply; and

(B) payment under this subchapter, when combined with the

amount payable under the primary plan, may not exceed -

(i) in the case of an item or service payment for which is

determined under this subchapter on the basis of reasonable

cost (or other cost-related basis) or under section 1395ww of

this title, the amount which would be payable under this

subchapter on such basis, and

(ii) in the case of an item or service for which payment is

authorized under this subchapter on another basis -

(I) the amount which would be payable under the primary

plan (without regard to deductibles and coinsurance under

such plan), or

(II) the reasonable charge or other amount which would be

payable under this subchapter (without regard to

deductibles and coinsurance under this subchapter),

whichever is greater.

(5) Identification of secondary payer situations

(A) Requesting matching information

(i) Commissioner of Social Security

The Commissioner of Social Security shall, not less often

than annually, transmit to the Secretary of the Treasury a

list of the names and TINs of medicare beneficiaries (as

defined in section 6103(l)(12) of the Internal Revenue Code

of 1986) and request that the Secretary disclose to the

Commissioner the information described in subparagraph (A) of

such section.

(ii) Administrator

The Administrator of the Health Care Financing

Administration shall request, not less often than annually,

the Commissioner of the Social Security Administration to

disclose to the Administrator the information described in

subparagraph (B) of section 6103(l)(12) of the Internal

Revenue Code of 1986.

(B) Disclosure to fiscal intermediaries and carriers

In addition to any other information provided under this

subchapter to fiscal intermediaries and carriers, the

Administrator shall disclose to such intermediaries and

carriers (or to such a single intermediary or carrier as the

Secretary may designate) the information received under

subparagraph (A) for purposes of carrying out this subsection.

(C) Contacting employers

(i) In general

With respect to each individual (in this subparagraph

referred to as an "employee") who was furnished a written

statement under section 6051 of the Internal Revenue Code of

1986 by a qualified employer (as defined in section

6103(l)(12)(E)(iii) of such Code), as disclosed under

subparagraph (B), the appropriate fiscal intermediary or

carrier shall contact the employer in order to determine

during what period the employee or employee's spouse may be

(or have been) covered under a group health plan of the

employer and the nature of the coverage that is or was

provided under the plan (including the name, address, and

identifying number of the plan).

(ii) Employer response

Within 30 days of the date of receipt of the inquiry, the

employer shall notify the intermediary or carrier making the

inquiry as to the determinations described in clause (i). An

employer (other than a Federal or other governmental entity)

who willfully or repeatedly fails to provide timely and

accurate notice in accordance with the previous sentence

shall be subject to a civil money penalty of not to exceed

$1,000 for each individual with respect to which such an

inquiry is made. The provisions of section 1320a-7a of this

title (other than subsections (a) and (b)) shall apply to a

civil money penalty under the previous sentence in the same

manner as such provisions apply to a penalty or proceeding

under section 1320a-7a(a) of this title.

(D) Obtaining information from beneficiaries

Before an individual applies for benefits under part A of

this subchapter or enrolls under part B of this subchapter, the

Administrator shall mail the individual a questionnaire to

obtain information on whether the individual is covered under a

primary plan and the nature of the coverage provided under the

plan, including the name, address, and identifying number of

the plan.

(6) Screening requirements for providers and suppliers

(A) In general

Notwithstanding any other provision of this subchapter, no

payment may be made for any item or service furnished under

part B of this subchapter unless the entity furnishing such

item or service completes (to the best of its knowledge and on

the basis of information obtained from the individual to whom

the item or service is furnished) the portion of the claim form

relating to the availability of other health benefit plans.

(B) Penalties

An entity that knowingly, willfully, and repeatedly fails to

complete a claim form in accordance with subparagraph (A) or

provides inaccurate information relating to the availability of

other health benefit plans on a claim form under such

subparagraph shall be subject to a civil money penalty of not

to exceed $2,000 for each such incident. The provisions of

section 1320a-7a of this title (other than subsections (a) and

(b)) shall apply to a civil money penalty under the previous

sentence in the same manner as such provisions apply to a

penalty or proceeding under section 1320a-7a(a) of this title.

(c) Drug products

No payment may be made under part B of this subchapter for any

expenses incurred for -

(1) a drug product -

(A) which is described in section 107(c)(3) of the Drug

Amendments of 1962,

(B) which may be dispensed only upon prescription,

(C) for which the Secretary has issued a notice of an

opportunity for a hearing under subsection (e) of section 355

of title 21 on a proposed order of the Secretary to withdraw

approval of an application for such drug product under such

section because the Secretary has determined that the drug is

less than effective for all conditions of use prescribed,

recommended, or suggested in its labeling, and

(D) for which the Secretary has not determined there is a

compelling justification for its medical need; and

(2) any other drug product -

(A) which is identical, related, or similar (as determined in

accordance with section 310.6 of title 21 of the Code of

Federal Regulations) to a drug product described in paragraph

(1), and

(B) for which the Secretary has not determined there is a

compelling justification for its medical need,

until such time as the Secretary withdraws such proposed order.

(d) Repealed. Pub. L. 100-93, Sec. 8(c)(1)(A), Aug. 18, 1987, 101

Stat. 692

(e) Item or service by excluded individual or entity or at

direction of excluded physician; limitation of liability of

beneficiaries with respect to services furnished by excluded

individuals and entities

(1) No payment may be made under this subchapter with respect to

any item or service (other than an emergency item or service, not

including items or services furnished in an emergency room of a

hospital) furnished -

(A) by an individual or entity during the period when such

individual or entity is excluded pursuant to section 1320a-7,

1320a-7a, 1320c-5 or 1395u(j)(2) of this title from participation

in the program under this subchapter; or

(B) at the medical direction or on the prescription of a

physician during the period when he is excluded pursuant to

section 1320a-7, 1320a-7a, 1320c-5 or 1395u(j)(2) of this title

from participation in the program under this subchapter and when

the person furnishing such item or service knew or had reason to

know of the exclusion (after a reasonable time period after

reasonable notice has been furnished to the person).

(2) Where an individual eligible for benefits under this

subchapter submits a claim for payment for items or services

furnished by an individual or entity excluded from participation in

the programs under this subchapter, pursuant to section 1320a-7,

1320a-7a, 1320c-5, 1320c-9 (as in effect on September 2, 1982),

1395u(j)(2), 1395y(d) (as in effect on August 18, 1987), or 1395cc

of this title, and such beneficiary did not know or have reason to

know that such individual or entity was so excluded, then, to the

extent permitted by this subchapter, and notwithstanding such

exclusion, payment shall be made for such items or services. In

each such case the Secretary shall notify the beneficiary of the

exclusion of the individual or entity furnishing the items or

services. Payment shall not be made for items or services furnished

by an excluded individual or entity to a beneficiary after a

reasonable time (as determined by the Secretary in regulations)

after the Secretary has notified the beneficiary of the exclusion

of that individual or entity.

(f) Utilization guidelines for provision of home health services

The Secretary shall establish utilization guidelines for the

determination of whether or not payment may be made, consistent

with paragraph (1)(A) of subsection (a) of this section, under part

A or part B of this subchapter for expenses incurred with respect

to the provision of home health services, and shall provide for the

implementation of such guidelines through a process of selective

postpayment coverage review by intermediaries or otherwise.

(g) Contracts with utilization and quality control peer review

organizations

The Secretary shall, in making the determinations under

paragraphs (1) and (9) of subsection (a) of this section, and for

the purposes of promoting the effective, efficient, and economical

delivery of health care services, and of promoting the quality of

services of the type for which payment may be made under this

subchapter, enter into contracts with utilization and quality

control peer review organizations pursuant to part B of subchapter

XI of this chapter.

(h) Waiver of electronic form requirement

(1) The Secretary -

(A) shall waive the application of subsection (a)(22) of this

section in cases in which -

(i) there is no method available for the submission of claims

in an electronic form; or

(ii) the entity submitting the claim is a small provider of

services or supplier; and

(B) may waive the application of such subsection in such

unusual cases as the Secretary finds appropriate.

(2) For purposes of this subsection, the term "small provider of

services or supplier" means -

(A) a provider of services with fewer than 25 full-time

equivalent employees; or

(B) a physician, practitioner, facility, or supplier (other

than provider of services) with fewer than 10 full-time

equivalent employees.

(i) Awards and contracts for original research and experimentation

of new and existing medical procedures; conditions

In order to supplement the activities of the Medicare Payment

Advisory Commission under section 1395ww(e) of this title in

assessing the safety, efficacy, and cost-effectiveness of new and

existing medical procedures, the Secretary may carry out, or award

grants or contracts for, original research and experimentation of

the type described in clause (ii) of section 1395ww(e)(6)(E) of

this title with respect to such a procedure if the Secretary finds

that -

(1) such procedure is not of sufficient commercial value to

justify research and experimentation by a commercial

organization;

(2) research and experimentation with respect to such procedure

is not of a type that may appropriately be carried out by an

institute, division, or bureau of the National Institutes of

Health; and

(3) such procedure has the potential to be more cost-effective

in the treatment of a condition than procedures currently in use

with respect to such condition.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1862, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 325; amended

Pub. L. 90-248, title I, Secs. 127(b), 128, Jan. 2, 1968, 81 Stat.

846, 847; Pub. L. 92-603, title II, Secs. 210, 211(c)(1), 229(a),

256(c), Oct. 30, 1972, 86 Stat. 1382, 1384, 1408, 1447; Pub. L.

93-233, Sec. 18(k)(3), Dec. 31, 1973, 87 Stat. 970; Pub. L. 93-480,

Sec. 4(a), Oct. 26, 1974, 88 Stat. 1454; Pub. L. 94-182, title I,

Sec. 103, Dec. 31, 1975, 89 Stat. 1051; Pub. L. 95-142, Secs. 7(a),

13(a), (b)(1), (2), Oct. 25, 1977, 91 Stat. 1192, 1197, 1198; Pub.

L. 95-210, Sec. 1(f), Dec. 13, 1977, 91 Stat. 1487; Pub. L. 96-272,

title III, Sec. 308(a), June 17, 1980, 94 Stat. 531; Pub. L.

96-499, title IX, Secs. 913(b), 936(c), 939(a), 953, Dec. 5, 1980,

94 Stat. 2620, 2640, 2647; Pub. L. 96-611, Sec. 1(a)(3), Dec. 28,

1980, 94 Stat. 3566; Pub. L. 97-35, title XXI, Secs. 2103(a)(1),

2146(a), 2152(a), Aug. 13, 1981, 95 Stat. 787, 800, 802; Pub. L.

97-248, title I, Secs. 116(b), 122(f), (g)(1), 128(a)(2)-(4), 142,

148(a), Sept. 3, 1982, 96 Stat. 353, 362, 366, 381, 394; Pub. L.

97-448, title III, Sec. 309(b)(10), Jan. 12, 1983, 96 Stat. 2409;

Pub. L. 98-21, title VI, Secs. 601(f), 602(e), Apr. 20, 1983, 97

Stat. 162, 163; Pub. L. 98-369, div. B, title III, Secs. 2301(a),

2304(c), 2313(c), 2344(a)-(c), 2354(b)(30), (31), July 18, 1984, 98

Stat. 1063, 1068, 1078, 1095, 1101, 1102; Pub. L. 99-272, title IX,

Secs. 9201(a), 9307(a), 9401(c)(1), Apr. 7, 1986, 100 Stat. 170,

193, 199; Pub. L. 99-509, title IX, Secs. 9316(b), 9319(a), (b),

9320(h)(1), 9343(c)(1), Oct. 21, 1986, 100 Stat. 2007, 2010, 2011,

2016, 2040; Pub. L. 99-514, Sec. 2, Oct. 22, 1986, 100 Stat. 2095;

Pub. L. 100-93, Secs. 8(c)(1), (3), 10, Aug. 18, 1987, 101 Stat.

692, 693, 696; Pub. L. 100-203, title IV, Secs. 4009(j)(6)(C),

4034(a), 4036(a)(1), 4039(c)(1), 4072(c), 4085(i)(15), (16), Dec.

22, 1987, 101 Stat. 1330-59, 1330-77, 1330-79, 1330-82, 1330-117,

1330-133; Pub. L. 100-360, title II, Secs. 202(d), 204(d)(2),

205(e)(1), title IV, Sec. 411(f)(4)(D)(i), (i)(4)(D), July 1, 1988,

102 Stat. 715, 729, 731, 778, 790; Pub. L. 100-485, title VI, Sec.

608(d)(7), (24)(C), Oct. 13, 1988, 102 Stat. 2415, 2421; Pub. L.

101-234, title II, Sec. 201(a), Dec. 13, 1989, 103 Stat. 1981; Pub.

L. 101-239, title VI, Secs. 6003(g)(3)(D)(xi), 6103(b)(3)(B),

6115(b), 6202(a)(2)(A), (b)(1), (e)(1), 6411(d)(2), Dec. 19, 1989,

103 Stat. 2154, 2199, 2219, 2228, 2229, 2234, 2271; Pub. L.

101-508, title IV, Secs. 4107(b), 4153(b)(2)(B), 4157(c)(1),

4161(a)(3)(C), 4163(d)(2), 4203(a)(1), (b), (c)(1), 4204(g)(1),

Nov. 5, 1990, 104 Stat. 1388-62, 1388-84, 1388-89, 1388-94,

1388-100, 1388-107, 1388-112; Pub. L. 103-66, title XIII, Secs.

13561(a)(1), (b)-(d)(1), (e)(1), 13581(b)(1), Aug. 10, 1993, 107

Stat. 593, 594, 611; Pub. L. 103-432, title I, Secs. 145(c)(1),

147(e)(6), 151(a)(1)(A), (C), (2)(A), (b)(3)(A), (B), (c)(1),

(4)-(6), (9)(B), 156(a)(2)(D), 157(b)(7), Oct. 31, 1994, 108 Stat.

4427, 4430, 4432-4436, 4441, 4442; Pub. L. 104-224, Sec. 1, Oct. 2,

1996, 110 Stat. 3031; Pub. L. 104-226, Sec. 1(b)(1), Oct. 2, 1996,

110 Stat. 3033; Pub. L. 105-12, Sec. 9(a)(1), Apr. 30, 1997, 111

Stat. 26; Pub. L. 105-33, title IV, Secs. 4022(b)(1)(B), 4102(c),

4103(c), 4104(c)(3), 4201(c)(1), 4319(b), 4432(b)(1),

4507(a)(2)(B), 4511(a)(2)(C), 4541(b), 4603(c)(2)(C), 4614(a),

4631(a)(1), (b), (c)(1), 4632(a), 4633(a), (b), Aug. 5, 1997, 111

Stat. 354, 361, 362, 365, 373, 394, 420, 441, 442, 456, 471, 474,

486, 487; Pub. L. 106-113, div. B, Sec. 1000(a)(6) [title III,

Secs. 305(b), 321(k)(10)], Nov. 29, 1999, 113 Stat. 1536,

1501A-362, 1501A-367; Pub. L. 106-554, Sec. 1(a)(6) [title I, Sec.

102(c), title III, Sec. 313(a), title IV, Sec. 432(b)(1), title V,

Sec. 522(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A-468, 2763A-499,

2763A-526, 2763A-546; Pub. L. 107-105, Sec. 3(a), Dec. 27, 2001,

115 Stat. 1006.)

-REFTEXT-

REFERENCES IN TEXT

Parts A and B of this subchapter, referred to in text, are

classified to sections 1395c et seq. and 1395j et seq.,

respectively, of this title.

Section 1395ww(e)(6) of this title, referred to in subsec.

(a)(1)(D), was repealed by Pub. L. 105-33, title IV, Sec.

4022(b)(1)(A)(i), Aug. 5, 1997, 111 Stat. 354.

Part B of subchapter XI of this chapter, referred to in subsecs.

(a)(15) and (g), is classified to section 1320c et seq. of this

title.

The Assisted Suicide Funding Restriction Act of 1997, referred to

in subsec. (a)(16), is Pub. L. 105-12, Apr. 30, 1997, 111 Stat. 23,

which is classified principally to chapter 138 (Sec. 14401 et seq.)

of this title. For complete classification of this Act to the Code,

see Short Title note set out under section 14401 of this title and

Tables.

The Internal Revenue Code of 1986, referred to in subsec. (b), is

classified generally to Title 26, Internal Revenue Code.

Section 107(c)(3) of the Drug Amendments of 1962, referred to in

subsec. (c)(1)(A), is section 107(c)(3) of Pub. L. 87-781, title I,

Oct. 10, 1962, 76 Stat. 788, which is set out as an Effective Date

of 1962 Amendment note under section 321 of Title 21, Food and

Drugs.

-MISC1-

AMENDMENTS

2001 - Subsec. (a)(22). Pub. L. 107-105, Sec. 3(a)(1), added par.

(22).

Subsec. (h). Pub. L. 107-105, Sec. 3(a)(2), added subsec. (h).

2000 - Subsec. (a). Pub. L. 106-554, Sec. 1(a)(6) [title V, Sec.

522(b)], inserted at end "In making a national coverage

determination (as defined in paragraph (1)(B) of section 1395ff(f)

of this title) the Secretary shall ensure that the public is

afforded notice and opportunity to comment prior to implementation

by the Secretary of the determination; meetings of advisory

committees established under section 1314(f) of this title with

respect to the determination are made on the record; in making the

determination, the Secretary has considered applicable information

(including clinical experience and medical, technical, and

scientific evidence) with respect to the subject matter of the

determination; and in the determination, provide a clear statement

of the basis for the determination (including responses to comments

received from the public), the assumptions underlying that basis,

and make available to the public the data (other than proprietary

data) considered in making the determination."

Subsec. (a)(1)(F). Pub. L. 106-554, Sec. 1(a)(6) [title I, Sec.

102(c)], struck out "and," after "section 1395m(c)(1)(B) of this

title," and inserted at end "and, in the case of screening for

glaucoma, which is performed more frequently than is provided under

section 1395x(uu) of this title,".

Subsec. (a)(3). Pub. L. 106-554, Sec. 1(a)(6) [title IV, Sec.

432(b)(1)], struck out second comma after "section 1395x(aa)(1) of

this title" and inserted "in the case of services for which payment

may be made under section 1395qq(e) of this title," after "section

1395x(aa)(3) of this title,".

Subsec. (a)(18). Pub. L. 106-554, Sec. 1(a)(6) [title III, Sec.

313(a)], substituted "during a period in which the resident is

provided covered post-hospital extended care services (or, for

services described in section 1395x(s)(2)(D) of this title, which

are furnished to such an individual without regard to such

period)," for "or of a part of a facility that includes a skilled

nursing facility (as determined under regulations),".

1999 - Subsec. (a)(7). Pub. L. 106-113, Sec. 1000(a)(6) [title

III, Sec. 321(k)(10)], substituted "subparagraph" for

"subparagraphs".

Subsec. (a)(21). Pub. L. 106-113, Sec. 1000(a)(6) [title III,

Sec. 305(b)], inserted "(including medical supplies described in

section 1395x(m)(5) of this title, but excluding durable medical

equipment to the extent provided for in such section)" after "home

health services".

1997 - Subsec. (a)(1)(D). Pub. L. 105-33, Sec. 4022(b)(1)(B),

substituted "Medicare Payment Advisory Commission" for "Prospective

Payment Assessment Commission".

Subsec. (a)(1)(F). Pub. L. 105-33, Sec. 4102(c), inserted "and

screening pelvic exam" after "screening pap smear".

Subsec. (a)(1)(G). Pub. L. 105-33, Sec. 4103(c)(1), added subpar.

(G).

Subsec. (a)(1)(H). Pub. L. 105-33, Sec. 4104(c)(3)(A), added

subpar. (H).

Subsec. (a)(1)(I). Pub. L. 105-33, Sec. 4614(a), added subpar.

(I).

Subsec. (a)(7). Pub. L. 105-33, Sec. 4104(c)(3)(B), substituted

"(G), or (H)" for "or (G)".

Pub. L. 105-33, Sec. 4103(c)(2), substituted "subparagraphs (B),

(F), or (G) of paragraph (1)" for "paragraph (1)(B) or under

paragraph (1)(F)".

Subsec. (a)(14). Pub. L. 105-33, Sec. 4511(a)(2)(C), substituted

"section 1395x(s)(2)(K) of this title" for "section

1395x(s)(2)(K)(i) or 1395x(s)(2)(K)(iii) of this title".

Pub. L. 105-33, Sec. 4201(c)(1), substituted "critical access"

for "rural primary care" wherever appearing.

Subsec. (a)(16). Pub. L. 105-12 added par. (16).

Subsec. (a)(17). Pub. L. 105-33, Sec. 4319(b), added par. (17).

Subsec. (a)(18). Pub. L. 105-33, Sec. 4432(b)(1), added par.

(18).

Subsec. (a)(19). Pub. L. 105-33, Sec. 4507(a)(2)(B), added par.

(19).

Subsec. (a)(20). Pub. L. 105-33, Sec. 4541(b), added par. (20).

Subsec. (a)(21). Pub. L. 105-33, Sec. 4603(c)(2)(C), added par.

(21).

Subsec. (b)(1)(B)(i). Pub. L. 105-33, Sec. 4631(a)(1)(A),

substituted "in clause (iii))" for "in clause (iv))".

Subsec. (b)(1)(B)(iii), (iv). Pub. L. 105-33, Sec. 4631(a)(1)(B),

(C), redesignated cl. (iv) as (iii) and struck out heading and text

of former cl. (iii). Text read as follows: "Clause (i) shall only

apply to items and services furnished on or after January 1, 1987,

and before October 1, 1998."

Subsec. (b)(1)(C). Pub. L. 105-33, Sec. 4631(b), in concluding

provisions, substituted "August 5, 1997" for "October 1, 1998" and

inserted at end "Effective for items and services furnished on or

after August 5, 1997, (with respect to periods beginning on or

after the date that is 18 months prior to August 5, 1997), clauses

(i) and (ii) shall be applied by substituting '30-month' for

'12-month' each place it appears."

Subsec. (b)(1)(F). Pub. L. 105-33, Sec. 4633(b), added subpar.

(F).

Subsec. (b)(2)(B)(ii). Pub. L. 105-33, Sec. 4633(a), substituted

"(directly, as a third-party administrator, or otherwise) to make

payment" for "under this subsection to pay" and inserted at end

"The United States may not recover from a third-party administrator

under this clause in cases where the third-party administrator

would not be able to recover the amount at issue from the employer

or group health plan and is not employed by or under contract with

the employer or group health plan at the time the action for

recovery is initiated by the United States or for whom it provides

administrative services due to the insolvency or bankruptcy of the

employer or plan."

Subsec. (b)(2)(B)(v). Pub. L. 105-33, Sec. 4632(a), added cl.

(v).

Subsec. (b)(5)(C)(iii). Pub. L. 105-33, Sec. 4631(c)(1), struck

out heading and text of cl. (iii). Text read as follows: "Clause

(ii) shall not apply to inquiries made after September 30, 1998."

Subsec. (i). Pub. L. 105-33, Sec. 4022(b)(1)(B), substituted

"Medicare Payment Advisory Commission" for "Prospective Payment

Assessment Commission" in introductory provisions.

1996 - Subsec. (b)(5)(B). Pub. L. 104-226, Sec. 1(b)(1)(A),

substituted "under subparagraph (A) for purposes of carrying out

this subsection" for "under -

"(i) subparagraph (A), and

"(ii) section 1320b-14 of this title,

for purposes of carrying out this subsection".

Subsec. (b)(5)(C)(i). Pub. L. 104-226, Sec. 1(b)(1)(B),

substituted "disclosed under subparagraph (B)" for "disclosed under

subparagraph (B)(i)".

Subsec. (h). Pub. L. 104-224 struck out subsec. (h) which

required Secretary to provide registry of all cardiac pacemaker

devices and pacemaker leads for which payment was made under this

chapter.

1994 - Subsec. (a)(1)(F). Pub. L. 103-432, Sec. 145(c)(1),

substituted "is not conducted by a facility described in section

1395m(c)(1)(B) of this title" for "or which does not meet the

standards established under section 1395m(c)(3) of this title".

Subsec. (a)(14). Pub. L. 103-432, Sec. 156(a)(2)(D)(i), inserted

"or" at end.

Pub. L. 103-432, Sec. 147(e)(6), substituted "section

1395x(s)(2)(K)(i) or 1395x(s)(2)(K)(iii) of this title" for

"section 1395x(s)(2)(K)(i) of this title".

Subsec. (a)(15). Pub. L. 103-432, Sec. 156(a)(2)(D)(ii),

substituted period for "; or" at end.

Subsec. (a)(16). Pub. L. 103-432, Sec. 156(a)(2)(D)(iii), struck

out par. (16) which read as follows: "furnished in connection with

a surgical procedure for which a second opinion is required under

section 1320c-13(c)(2) of this title and has not been obtained."

Subsec. (b)(1)(A)(i)(II). Pub. L. 103-432, Sec. 151(c)(1)(A),

substituted "older (and the spouse age 65 or older of any

individual) who has current employment status with an employer" for

"over (and the individual's spouse age 65 or older) who is covered

under the plan by virtue of the individual's current employment

status with an employer".

Subsec. (b)(1)(A)(ii). Pub. L. 103-432, Sec. 151(c)(1)(B),

substituted "employer that has 20 or more employees" for "employer

or employee organization that has 20 or more individuals in current

employment status".

Subsec. (b)(1)(A)(v). Pub. L. 103-432, Sec. 151(c)(9)(B), made

technical amendment to directory language of Pub. L. 103-66, Sec.

13561(e)(1)(D). See 1993 Amendment note below.

Subsec. (b)(1)(C). Pub. L. 103-432, Sec. 151(c)(5), substituted

"paying benefits secondary to this subchapter when" for "taking

into account that" in closing provisions.

Pub. L. 103-432, Sec. 151(c)(4), substituted "this subparagraph"

for "clauses (i) and (ii)" after "February 1, 1990)," in last

sentence.

Subsec. (b)(2)(B)(i). Pub. L. 103-432, Sec. 151(b)(3)(A), (B),

substituted "Repayment required" for "Primary plans" in heading and

inserted at end "If reimbursement is not made to the appropriate

Trust Fund before the expiration of the 60-day period that begins

on the date such notice or other information is received, the

Secretary may charge interest (beginning with the date on which the

notice or other information is received) on the amount of the

reimbursement until reimbursement is made (at a rate determined by

the Secretary in accordance with regulations of the Secretary of

the Treasury applicable to charges for late payments)."

Subsec. (b)(2)(C). Pub. L. 103-432, Sec. 151(a)(1)(C), added

subpar. (C).

Subsec. (b)(3)(C). Pub. L. 103-432, Sec. 157(b)(7), substituted

"group health plan or a large group health plan" for "group health

plan" in heading and text, struck out ", unless such incentive is

also offered to all individuals who are eligible for coverage under

the plan" after "(as defined in paragraph (2)(A))", and substituted

"(other than subsections (a) and (b))" for "(other than the first

sentence of subsection (a) and other than subsection (b))".

Subsec. (b)(5)(C)(i). Pub. L. 103-432, Sec. 151(c)(6),

substituted "section 6103(l)(12)(E)(iii) of such Code" for "section

6103(l)(12)(D)(iii) of such Code".

Subsec. (b)(5)(D). Pub. L. 103-432, Sec. 151(a)(1)(A), added

subpar. (D).

Subsec. (b)(6). Pub. L. 103-432, Sec. 151(a)(2)(A), added par.

(6).

1993 - Subsec. (b)(1)(A)(i). Pub. L. 103-66, Sec. 13561(e)(1)(A),

amended subcls. (I) and (II) generally. Prior to amendment, subcls.

(I) and (II) read as follows:

"(I) may not take into account, for any item or service furnished

to an individual 65 years of age or older at the time the

individual is covered under the plan by reason of the current

employment of the individual (or the individual's spouse), that the

individual is entitled to benefits under this subchapter under

section 426(a) of this title, and

"(II) shall provide that any employee age 65 or older, and any

employee's spouse age 65 or older, shall be entitled to the same

benefits under the plan under the same conditions as any employee,

and the spouse of such employee, under age 65."

Subsec. (b)(1)(A)(ii). Pub. L. 103-66, Sec. 13561(e)(1)(B),

substituted "unless the plan is a plan of, or contributed to by, an

employer or employee organization that has 20 or more individuals

in current employment status" for "unless the plan is sponsored by

or contributed to by an employer that has 20 or more employees".

Subsec. (b)(1)(A)(iii). Pub. L. 103-66, Sec. 13561(e)(1)(C),

substituted "by virtue of current employment status with an

employer that does not have 20 or more individuals in current

employment status for each working day in each of 20 or more

calendar weeks in the current calendar year and" for "by virtue of

employment with an employer that does not have 20 or more employees

for each working day in each of 20 or more calendar weeks in the

current calendar year or".

Subsec. (b)(1)(A)(iv). Pub. L. 103-66, Sec. 13561(c)(2),

substituted "Subparagraph (C) shall apply instead of clause (i)"

for "Clause (i) shall not apply" and inserted "(without regard to

entitlement under section 426 of this title)" after "individual is,

or".

Subsec. (b)(1)(A)(v). Pub. L. 103-66, Sec. 13561(e)(1)(D), as

amended by Pub. L. 103-432, Sec. 151(c)(9)(B), inserted before

period at end ", without regard to section 5000(d) of such Code".

Subsec. (b)(1)(B). Pub. L. 103-66, Sec. 13561(e)(1)(E),

substituted "individuals" for "active individuals" in heading.

Subsec. (b)(1)(B)(i). Pub. L. 103-66, Sec. 13561(e)(1)(F),

substituted "clause (iv)) may not take into account that an

individual (or a member of the individual's family) who is covered

under the plan by virtue of the individual's current employment

status with an employer" for "clause (iv)(II)) may not take into

account that an active individual (as defined in clause (iv)(I))".

Subsec. (b)(1)(B)(ii). Pub. L. 103-66, Sec. 13561(c)(2),

substituted "Subparagraph (C) shall apply instead of clause (i)"

for "Clause (i) shall not apply" and inserted "(without regard to

entitlement under section 426 of this title)" after "individual is,

or".

Subsec. (b)(1)(B)(iii). Pub. L. 103-66, Sec. 13561(b),

substituted "1998" for "1995".

Subsec. (b)(1)(B)(iv). Pub. L. 103-66, Sec. 13561(e)(1)(G),

amended heading and text generally. Prior to amendment, text

defined "active individual" and "large group health plan".

Subsec. (b)(1)(C). Pub. L. 103-66, Sec. 13561(c)(1), (3),

substituted "or eligible for benefits under this subchapter under"

for "benefits under this subchapter solely by reason of" in cl. (i)

and concluding provisions and substituted "before October 1, 1998"

for "on or before January 1, 1996" in concluding provisions.

Subsec. (b)(1)(E). Pub. L. 103-66, Sec. 13561(e)(1)(H), added

cls. (ii) and (iii).

Pub. L. 103-66, Sec. 13561(d)(1), added subpar. (E).

Subsec. (b)(5)(B). Pub. L. 103-66, Sec. 13581(b)(1)(A),

substituted "under - " for "under subparagraph (A) for the purposes

of carrying out this subsection." and added cls. (i) and (ii) and

concluding provisions.

Subsec. (b)(5)(C)(i). Pub. L. 103-66, Sec. 13581(b)(1)(B),

substituted "subparagraph (B)(i)" for "subparagraph (B)".

Subsec. (b)(5)(C)(iii). Pub. L. 103-66, Sec. 13561(a)(1),

substituted "1998" for "1995".

1990 - Subsec. (a). Pub. L. 101-508, Sec. 4161(a)(3)(C)(iii),

inserted at end "Paragraph (7) shall not apply to Federally

qualified health center services described in section

1395x(aa)(3)(B) of this title."

Subsec. (a)(1)(A). Pub. L. 101-508, Sec. 4163(d)(2)(A)(i),

substituted "a succeeding subparagraph" for "subparagraph (B), (C),

(D), or (E)".

Subsec. (a)(1)(F). Pub. L. 101-508, Sec. 4163(d)(2)(A)(ii)-(iv),

added subpar. (F).

Subsec. (a)(2). Pub. L. 101-508, Sec. 4161(a)(3)(C)(i), inserted

before semicolon at end ", except in the case of Federally

qualified health center services".

Subsec. (a)(3). Pub. L. 101-508, Sec. 4161(a)(3)(C)(ii), inserted

", in the case of Federally qualified health center services, as

defined in section 1395x(aa)(3) of this title," after "section

1395x(aa)(1) of this title,".

Subsec. (a)(7). Pub. L. 101-508, Sec. 4163(d)(2)(B), inserted "or

under paragraph (1)(F)" after "paragraph (1)(B)".

Pub. L. 101-508, Sec. 4153(b)(2)(B), inserted "(other than

eyewear described in section 1395x(s)(8) of this title)" after

first reference to "eyeglasses".

Subsec. (a)(14). Pub. L. 101-508, Sec. 4157(c)(1), inserted ",

services described by section 1395x(s)(2)(K)(i) of this title,

certified nurse-midwife services, qualified psychologist services,

and services of a certified registered nurse anesthetist," after

"this paragraph)" and struck out before semicolon at end "or are

services of a certified registered nurse anesthetist".

Subsec. (a)(15). Pub. L. 101-508, Sec. 4107(b), designated

existing provisions as par. (A), substituted ", or" for "; or" at

end, and added par. (B).

Subsec. (b)(1)(B)(iii). Pub. L. 101-508, Sec. 4203(b),

substituted "October 1, 1995" for "January 1, 1992".

Subsec. (b)(1)(C). Pub. L. 101-508, Sec. 4203(c)(1)(B), inserted

at end "Effective for items and services furnished on or after

February 1, 1991, and on or before January 1, 1996, (with respect

to periods beginning on or after February 1, 1990), clauses (i) and

(ii) shall be applied by substituting '18-month' for '12-month'

each place it appears."

Subsec. (b)(1)(C)(i). Pub. L. 101-508, Sec. 4203(c)(1)(A),

substituted "during the 12-month period which begins with the first

month in which the individual becomes entitled to benefits under

part A of this subchapter under the provisions of section 426-1 of

this title, or, if earlier, the first month in which the individual

would have been entitled to benefits under such part under the

provisions of section 426-1 of this title if the individual had

filed an application for such benefits; and" for "during the

12-month period which begins with the earlier of -

"(I) the month in which a regular course of renal dialysis is

initiated, or

"(II) in the case of an individual who receives a kidney

transplant, the first month in which he would be eligible for

benefits under part A of this subchapter (if he had filed an

application for such benefits) under the provisions of section

426-1(b)(1)(B) of this title; and".

Subsec. (b)(3)(C). Pub. L. 101-508, Sec. 4204(g)(1), added

subpar. (C).

Subsec. (b)(5)(C)(iii). Pub. L. 101-508, Sec. 4203(a)(1),

substituted "September 30, 1995" for "September 30, 1991".

1989 - Pub. L. 101-239, Sec. 6202(b)(1)(A), inserted "and

medicare as secondary payer" in section catchline.

Subsec. (a)(1)(A). Pub. L. 101-234 repealed Pub. L. 100-360, Sec.

204(d)(2)(A)(i), and provided that the provisions of law amended or

repealed by such section are restored or revived as if such section

had not been enacted, see 1988 Amendment note below.

Subsec. (a)(1)(E). Pub. L. 101-239, Sec. 6103(b)(3)(B),

substituted "section 1320b-12" for "section 1395ll(c)".

Subsec. (a)(1)(F). Pub. L. 101-239, Sec. 6115(b), inserted before

semicolon at end ", and, in the case of screening pap smear, which

is performed more frequently than is provided under 1395x(nn) of

this title".

Pub. L. 101-234 repealed Pub. L. 100-360, Sec.

204(d)(2)(A)(ii)-(iv), and provided that the provisions of law

amended or repealed by such section are restored or revived as if

such section had not been enacted, see 1988 Amendment note below.

Subsec. (a)(1)(G), (6), (7). Pub. L. 101-234 repealed Pub. L.

100-360, Secs. 204(d)(2)(B), 205(e)(1), and provided that the

provisions of law amended or repealed by such sections are restored

or revived as if such sections had not been enacted, see 1988

Amendment notes below.

Subsec. (a)(14). Pub. L. 101-239, Sec. 6003(g)(3)(D)(xi),

substituted "hospital or rural primary care hospital" for

"hospital" in three places.

Subsec. (b). Pub. L. 101-239, Sec. 6202(b)(1)(B), amended heading

and text generally, substituting pars. (1) to (4) relating to

medicare as secondary payer for former pars. (1) to (5) relating to

items or services paid under workmen's compensation laws and end

stage renal disease program.

Subsec. (b)(1)(D). Pub. L. 101-239, Sec. 6202(e)(1), added

subpar. (D).

Subsec. (b)(5). Pub. L. 101-239, Sec. 6202(a)(2)(A), added par.

(5).

Subsec. (c). Pub. L. 101-234 repealed Pub. L. 100-360, Sec.

202(d), and provided that the provisions of law amended or repealed

by such section are restored or revived as if such section had not

been enacted, see 1988 Amendment note below.

Subsec. (e)(1). Pub. L. 101-239, Sec. 6411(d)(2), inserted ", not

including items or services furnished in an emergency room of a

hospital" after "(other than an emergency item or service".

1988 - Subsec. (a)(1)(A). Pub. L. 100-360, Sec. 204(d)(2)(A)(i),

substituted "a succeeding subparagraph" for "subparagraph (B), (C),

(D), or (E)".

Subsec. (a)(1)(F). Pub. L. 100-360, Sec. 204(d)(2)(A)(ii)-(iv),

added subpar. (F) relating to screening mammography.

Subsec. (a)(1)(G). Pub. L. 100-360, Sec. 205(e)(1)(A), as amended

by Pub. L. 100-485, Sec. 608(d)(7), added subpar. (G) relating to

in-home care for chronically dependent individuals.

Subsec. (a)(6). Pub. L. 100-360, Sec. 205(e)(1)(B), inserted "and

except, in the case of in-home care, as is otherwise permitted

under paragraph (1)(G)" after "paragraph (1)(C)".

Subsec. (a)(7). Pub. L. 100-360, Sec. 204(d)(2)(B), inserted "or

under paragraph (1)(F)" after "(1)(B)".

Subsec. (a)(15). Pub. L. 100-360, Sec. 411(f)(4)(D)(i), inserted

"(including subsequent insertion of an intraocular lens)" after

"operation".

Subsec. (c). Pub. L. 100-360, Sec. 202(d), designated existing

provisions as par. (1), redesignated former par. (1) as subpar.

(A), redesignated former subpars. (A) to (D) as cls. (i) to (iv),

redesignated former par. (2) as subpar. (B), redesignated former

subpar. (A) as cl. (i) and substituted "subparagraph (A)" for

"paragraph (1)", redesignated former subpar. (B) as cl. (ii), and

added par. (2) prohibiting payment for expenses incurred for a

covered outpatient drug if the drug is dispensed in a quantity

exceeding a supply of 30 days with an exception.

Subsec. (e)(1). Pub. L. 100-360, Sec. 411(i)(4)(D)(i), as amended

by Pub. L. 100-485, Sec. 608(d)(24)(C)(i), designated existing

provisions of subsec. (e) as par. (1), redesignated former par. (1)

as subpar. (A), substituted ", 1320a-7a, 1320c-5 or 1395u(j)(2)"

for "or section 1320a-7a", redesignated former par. (2) as subpar.

(B), and substituted ", 1320a-7a, 1320c-5 or 1395u(j)(2)" for "or

section 1320a-7a".

Subsec. (e)(2). Pub. L. 100-360, Sec. 411(i)(4)(D)(ii), as

amended by Pub. L. 100-485, Sec. 608(d)(24)(C)(ii), amended former

section 1395aaa of this title by striking out the catchline

"Limitation of liability of beneficiaries with respect to services

furnished by excluded individuals and entities", substituting "(2)"

for the section designation, inserting "1395u(j)(2)," in text, and

transferring the text to par. (2) of subsec. (e) of this section.

1987 - Subsec. (a)(1)(A). Pub. L. 100-203, Sec. 4085(i)(15),

substituted "(D), or (E)" for "or (D)".

Subsec. (a)(8). Pub. L. 100-203, Sec. 4072(c), inserted ", other

than shoes furnished pursuant to section 1395x(s)(12) of this

title" before semicolon.

Subsec. (a)(14). Pub. L. 100-203, Sec. 4085(i)(16), substituted

"a patient" for "an patient".

Pub. L. 100-203, Sec. 4009(j)(6)(C), made technical amendment to

Pub. L. 99-509, Sec. 9320(h)(1). See 1986 Amendment note below.

Subsec. (b)(2)(A)(ii). Pub. L. 100-203, Sec. 4036(a)(1),

substituted "can reasonably be expected to be made under such a

plan" for "the Secretary determines will be made under such a plan

as promptly as would otherwise be the case if payment were made by

the Secretary under this subchapter".

Subsec. (b)(4)(B)(i). Pub. L. 100-203, Sec. 4034(a), substituted

"subsection (b) of section 5000 of the Internal Revenue Code of

1986 without regard to subsection (d) of such section" for "section

5000(b) of the Internal Revenue Code of 1986".

Subsec. (d). Pub. L. 100-93, Sec. 8(c)(1)(A), struck out subsec.

(d), which provided that no payment be made under this subchapter

for any item or services to an individual by a person where

Secretary determines such person knowingly and willfully made any

false statement or representation of a material fact, submitted

excessive bills or requests, or furnished excessive services or

supplies, and provided a dissatisfied person with a hearing on

determination of the Secretary.

Subsec. (e) [formerly Sec. 1395aaa]. Pub. L. 100-93, Sec. 10,

added par. (2). See 1988 Amendment note above.

Pub. L. 100-93, Sec. 8(c)(1)(B), amended subsec. (e) generally.

Prior to amendment, subsec. (e) read as follows: "No payment may be

made under this subchapter with respect to any item or service

furnished by a physician or other individual during the period when

he is barred pursuant to section 1320a-7 of this title from

participation in the program under this subchapter."

Subsec. (h)(1)(B). Pub. L. 100-203, Sec. 4039(c)(1)(A),

substituted "law (and any amount paid to a provider under any such

warranty)," for "law,".

Subsec. (h)(1)(D). Pub. L. 100-203, Sec. 4039(c)(1)(B), inserted

"in determining the amount subject to repayment under paragraph

(2)(C)," after "(3),".

Subsec. (h)(2)(C). Pub. L. 100-203, Sec. 4039(c)(1)(C), added

subpar. (C).

Subsec. (h)(4). Pub. L. 100-93, Sec. 8(c)(3), substituted

"subsections (c), (f), and (g) of section 1320a-7 of this title"

for "paragraphs (2) and (3) of subsection (d) of this section".

Subsec. (h)(4)(B). Pub. L. 100-203, Sec. 4039(c)(1)(D),

substituted ", has improperly" for "or has improperly" and inserted

"or has failed to make repayment to the Secretary as required under

paragraph (2)(C)," after "(2)(B),".

1986 - Subsec. (a)(1)(E). Pub. L. 99-509, Sec. 9316(b), added

subpar. (E).

Subsec. (a)(14). Pub. L. 99-509, Sec. 9343(c)(1), substituted

"patient" for "inpatient".

Pub. L. 99-509, Sec. 9320(h)(1), as amended by Pub. L. 100-203,

Sec. 4009(j)(6)(C), inserted "or are services of a certified

registered nurse anesthetist" after "hospital" at end.

Subsec. (a)(15). Pub. L. 99-272, Sec. 9307(a), added par. (15).

Subsec. (a)(16). Pub. L. 99-272, Sec. 9401(c)(1), added par.

(16).

Subsec. (b)(2)(A). Pub. L. 99-514 substituted "Internal Revenue

Code of 1986" for "Internal Revenue Code of 1954".

Subsec. (b)(3)(A)(i). Pub. L. 99-272, Sec. 9201(a)(1),

substituted "(or to the spouse of such individual)" for "who is

under 70 years of age during any part of such month (or to the

spouse of such individual, if the spouse is under 70 years of age

during any part of such month)".

Subsec. (b)(3)(A)(iii). Pub. L. 99-272, Sec. 9201(a)(2), struck

out "and ending with the month before the month in which such

individual attains the age of 70" after "section 426(a) of this

title".

Subsec. (b)(3)(A)(iv). Pub. L. 99-514 substituted "Internal

Revenue Code of 1986" for "Internal Revenue Code of 1954".

Subsec. (b)(4). Pub. L. 99-509, Sec. 9319(a), added par. (4).

Subsec. (b)(5). Pub. L. 99-509, Sec. 9319(b), added par. (5).

1984 - Subsec. (a)(12). Pub. L. 98-369, Sec. 2354(b)(30), struck

out second comma after "dental procedure".

Subsec. (b)(1). Pub. L. 98-369, Sec. 2344(a), substituted "to be

made promptly" for "to be made" and "has been or could be made

under such a law" for "has been made under such a law", and

inserted "In order to recover payment made under this subchapter

for an item or service, the United States may bring an action

against any entity which would be responsible for payment with

respect to such item or service (or any portion thereof) under such

a law, policy, plan, or insurance, or against any entity (including

any physician or provider) which has been paid with respect to such

item or service under such law, policy, plan, or insurance, and may

join or intervene in any action related to the events that gave

rise to the need for such item or service. The United States shall

be subrogated (to the extent of payment made under this subchapter

for an item or service) to any right of an individual or any other

entity to payment with respect to such item or service under such a

law, policy, plan, or insurance."

Subsec. (b)(2)(B). Pub. L. 98-369, Sec. 2344(b), substituted "has

been or could be made under a plan" for "has been made under a

plan", and inserted "In order to recover payment made under this

subchapter for an item or service, the United States may bring an

action against any entity which would be responsible for payment

with respect to such item or service (or any portion thereof) under

such a plan, or against any entity (including any physician or

provider) which has been paid with respect to such item or service

under such plan, and may join or intervene in any action related to

the events that gave rise to the need for such item or service. The

United States shall be subrogated (to the extent of payment made

under this subchapter for an item or service) to any right of an

individual or any other entity to payment with respect to such item

or service under such a plan."

Subsec. (b)(3)(A)(i). Pub. L. 98-369, Sec. 2301(a), struck out

"over 64 but" before "under 70 years" in two places.

Subsec. (b)(3)(A)(ii). Pub. L. 98-369, Sec. 2344(c), substituted

"has been or could be made under a group health plan" for "has been

made under a group health plan", and inserted "In order to recover

payment made under this title for an item or service, the United

States may bring an action against any entity which would be

responsible for payment with respect to such item or service (or

any portion thereof) under such a plan, or against any entity

(including any physician or provider) which has been paid with

respect to such item or service under such plan, and may join or

intervene in any action related to the events that gave rise to the

need for such item or service. The United States shall be

subrogated (to the extent of payment made under this title for an

item or service) to any right of an individual or any other entity

to payment with respect to such item or service under such a plan."

Subsec. (b)(3)(A)(iii). Pub. L. 98-369, Sec. 2354(b)(31),

inserted "before the month" after "ending with the month".

Subsec. (h). Pub. L. 98-369, Sec. 2304(c), added subsec. (h).

Subsec. (i). Pub. L. 98-369, Sec. 2313(c), added subsec. (i).

1983 - Subsec. (a)(1)(A). Pub. L. 98-21, Sec. 601(f)(1), inserted

reference to subpar. (D).

Subsec. (a)(1)(D). Pub. L. 98-21, Sec. 601(f)(2)-(4), added

subpar. (D).

Subsec. (a)(14). Pub. L. 98-21, Sec. 602(e), added par. (14).

Subsec. (b)(3)(A)(i). Pub. L. 97-448 inserted "in any month"

after "service furnished", and "during any part of such month"

after "70 years of age" wherever appearing.

1982 - Subsec. (a)(1). Pub. L. 97-248, Sec. 122(f)(1), designated

existing provisions as subpars. (A) and (B), in subpar. (A) as so

designated inserted exception to provisions for items and services

described in subpar. (B) or (C), substituted "and" for "or" as the

connector between provisions, and added subpar. (C).

Subsec. (a)(6). Pub. L. 97-248, Sec. 122(f)(2), inserted

"(except, in the case of hospice care, as is otherwise permitted

under paragraph (1)(C))".

Subsec. (a)(7). Pub. L. 97-248, Sec. 122(f)(3), substituted

"paragraph (1)(B)" for "paragraph (1)".

Subsec. (a)(9). Pub. L. 97-248, Sec. 122(f)(4), inserted

"(except, in the case of hospice care, as is otherwise permitted

under paragraph (1)(C))".

Subsec. (b)(1). Pub. L. 97-248, Sec. 128(a)(2), struck out "or

plan" after "service has been made under such a law".

Subsec. (b)(2)(A). Pub. L. 97-248, Sec. 128(a)(3), substituted

"section 162(i)(2)" for "section 162(h)(2)".

Subsec. (b)(2)(B). Pub. L. 97-248, Sec. 128(a)(4), inserted

"furnished" before "to an individual".

Subsec. (b)(3). Pub. L. 97-248, Sec. 116(b), added par. (3).

Subsec. (d)(1)(C). Pub. L. 97-248, Sec. 148(a), substituted "on

the basis of information acquired by the Secretary in the

administration of this subchapter" for ", on the basis of reports

transmitted to him in accordance with section 1320c-6 of this title

(or, in the absence of any such report, on the basis of such data

as he acquires in the administration of the program under this

subchapter),".

Subsec. (f). Pub. L. 97-248, Sec. 122(g)(1), substituted

"paragraph (1)(A)" for "paragraph (1)".

Subsec. (g). Pub. L. 97-248, Sec. 142, added subsec. (g).

1981 - Subsec. (b). Pub. L. 97-35, Sec. 2146(a), designated

existing provisions as par. (1) and added par. (2).

Subsec. (c). Pub. L. 97-35, Sec. 2103(a)(1), added subsec. (c).

Subsec. (f). Pub. L. 97-35, Sec. 2152(a), added subsec. (f).

1980 - Subsec. (a)(1). Pub. L. 96-611, Sec. 1(a)(3)(A), inserted

", or, in the case of items and services described in section

1395x(s)(10) of this title, which are not reasonable and necessary

for the prevention of illness" after "of a malformed body member".

Subsec. (a)(7). Pub. L. 96-611, Sec. 1(a)(3)(B), inserted

"(except as otherwise allowed under section 1395x(s)(10) of this

title and paragraph (1))" after "immunizations".

Subsec. (a)(12). Pub. L. 96-499, Sec. 936(c), inserted "or

because of the severity of the dental procedure," after "and

clinical status".

Subsec. (a)(13)(C). Pub. L. 96-499, Sec. 939(a), struck out ",

warts," after "corns".

Subsec. (b). Pub. L. 96-499, Sec. 953, inserted "or under an

automobile or liability insurance policy or plan (including a

self-insured plan) or under no fault insurance" and ", policy,

plan, or insurance" after "or a State" and ", policy, plan, or

insurance" after "law or plan" and inserted provision authorizing

the Secretary to waive the provisions of this subsection in the

case of an individual claim if he determined that the probability

of recovery or amount involved did not warrant the pursuit of the

claim.

Subsec. (d)(4). Pub. L. 96-272 added par. (4).

Subsec. (e). Pub. L. 96-499, Sec. 913(b), substituted provisions

barring payment under this subchapter with respect to items or

services furnished by a physician or other individual during a

period when such physician or other individual was barred pursuant

to section 1320a-7 of this title from participation under this

subchapter for provisions authorizing the Secretary to suspend a

physician or individual practitioner from participation under this

subchapter upon determining that such physician or practitioner had

been convicted of a criminal offense related to such physician's or

practitioner's involvement in the programs under this subchapter or

the program under subchapter XIX of this chapter.

1977 - Subsec. (a)(3). Pub. L. 95-210 substituted "except in the

case of rural health clinic services, as defined in section

1395x(aa)(1) of this title, and in such other cases as the

Secretary may specify" for "except in such cases as the Secretary

may specify".

Subsec. (d)(1)(B). Pub. L. 95-142, Sec. 13(b)(1), struck out

requirement for concurrence of appropriate program review team for

finding of Secretary under this paragraph.

Subsec. (d)(1)(C). Pub. L. 95-142, Sec. 13(b)(2), substituted

provisions relating to determinations by the Secretary on the basis

of reports transmitted to him in accordance with section 1320c-6 of

this title or other data acquired in the administration of this

subchapter, for provisions relating to determinations by the

Secretary with the concurrence of appropriate review team members.

Subsec. (d)(4). Pub. L. 95-142, Sec. 13(a), struck out par. (4)

which set forth provisions relating to appointment and functions of

program review teams.

Subsec. (e). Pub. L. 95-142, Sec. 7(a), added subsec. (e).

1975 - Subsec. (c). Pub. L. 94-182 struck out subsec. (c)

prohibiting payments to Federal employees under this subchapter

unless a determination and certification by the Secretary of a

modification of any health benefits plan under chapter 89 of Title

5 was made which would allow a Federal employee benefits under part

A or B of this subchapter.

1974 - Subsec. (c). Pub. L. 93-480 substituted "January 1, 1976"

for "January 1, 1975".

1973 - Subsec. (a)(12). Pub. L. 93-233 substituted "the provision

of such dental services if the individual, because of his

underlying medical condition and clinical status, requires

hospitalization in connection with the provision of such services"

for "a dental procedure where the individual suffers from

impairments of such severity as to require hospitalization".

1972 - Subsec. (a)(4). Pub. L. 92-603, Sec. 211(c)(1), inserted

reference to physicians' services and ambulance services furnished

an individual in conjunction with emergency inpatient hospital

services.

Subsec. (a)(12). Pub. L. 92-603, Sec. 256(c), authorized payment

under part A in the case of inpatient hospital services in

connection with a dental procedure where the individual suffers

from impairments of such severity as to require hospitalization.

Subsec. (c). Pub. L. 92-603, Sec. 210, added subsec. (c).

Subsec. (d). Pub. L. 92-603, Sec. 229(a), added subsec. (d).

1968 - Subsec. (a)(7). Pub. L. 90-248, Sec. 128, prohibited

payment for procedures performed (during the course of any eye

examination) to determine the refractive state of the eyes.

Subsec. (a)(13). Pub. L. 90-248, Sec. 127(b), added par. (13).

EFFECTIVE DATE OF 2001 AMENDMENT

Pub. L. 107-105, Sec. 3(b), Dec. 27, 2001, 115 Stat. 1007,

provided that: "The amendments made by subsection (a) [amending

this section] shall apply to claims submitted on or after October

16, 2003."

EFFECTIVE DATE OF 2000 AMENDMENT

Amendment by section 1(a)(6) [title I, Sec. 102(c)] of Pub. L.

106-554 applicable to services furnished on or after Jan. 1, 2002,

see section 1(a)(6) [title I, Sec. 102(d)] of Pub. L. 106-554, set

out as a note under section 1395x of this title.

Amendment by section 1(a)(6) [title III, Sec. 313(a)] of Pub. L.

106-554 applicable to services furnished on or after Jan. 1, 2001,

see section 1(a)(6) [title III, Sec. 313(c)] of Pub. L. 106-554,

set out as a note under section 1395u of this title.

Amendment by section 1(a)(6) [title IV, Sec. 432(b)(1)] of Pub.

L. 106-554 applicable to services furnished on or after July 1,

2001 see section 1(a)(6) [title IV, Sec. 432(c)] of Pub. L.

106-554, set out as a note under section 1395u of this title.

Amendment by section 1(a)(6) [title V, Sec. 522(b)] of Pub. L.

106-554 applicable with respect to a review of any national or

local coverage determination filed, a request to make such a

determination made, and a national coverage determination made, on

or after Oct. 1, 2001, see section 1(a)(6) [title V, Sec. 522(d)]

of Pub. L. 106-554, set out as a note under section 1314 of this

title.

EFFECTIVE DATE OF 1999 AMENDMENT

Amendment by section 1000(a)(6) [title III, Sec. 305(b)] of Pub.

L. 106-113 applicable to payments for services provided on or after

Nov. 29, 1999, see Sec. 1000(a)(6) [title III, Sec. 305(c)] of Pub.

L. 106-113, set out as a note under section 1395u of this title.

Amendment by section 1000(a)(6) [title III, Sec. 321(k)(10)] of

Pub. L. 106-113 effective as if included in the enactment of the

Balanced Budget Act of 1997, Pub. L. 105-33, except as otherwise

provided, see section 1000(a)(6) [title III, Sec. 321(m)] of Pub.

L. 106-113, set out as a note under section 1395d of this title.

EFFECTIVE DATE OF 1997 AMENDMENTS

Amendment by Pub. L. 105-12 effective Apr. 30, 1997, and

applicable to Federal payments made pursuant to obligations

incurred after Apr. 30, 1997, for items and services provided on or

after such date, subject to also being applicable with respect to

contracts entered into, renewed, or extended after Apr. 30, 1997,

as well as contracts entered into before Apr. 30, 1997, to the

extent permitted under such contracts, see section 11 of Pub. L.

105-12, set out as an Effective Date note under section 14401 of

this title.

Amendment by section 4022(b)(1)(B) of Pub. L. 105-33 effective

Nov. 1, 1997, the date of termination of the Prospective Payment

Assessment Commission and the Physician Payment Review Commission,

see section 4022(c)(2) of Pub. L. 105-33, set out as an Effective

Date; Transition; Transfer of Functions note under section 1395b-6

of this title.

Amendment by section 4102(c) of Pub. L. 105-33 applicable to

items and services furnished on or after Jan. 1, 1998, see section

4102(e) of Pub. L. 105-33, set out as a note under section 1395l of

this title.

Amendment by section 4103(c) of Pub. L. 105-33 applicable to

items and services furnished on or after Jan. 1, 2000, see section

4103(e) of Pub. L. 105-33, set out as a note under section 1395l of

this title.

Amendment by section 4104(c)(3) of Pub. L. 105-33 applicable to

items and services furnished on or after Jan. 1, 1998, see section

4104(e) of Pub. L. 105-33, set out as a note under section 1395l of

this title.

Amendment by section 4201(c)(1) of Pub. L. 105-33 applicable to

services furnished on or after Oct. 1, 1997, see section 4201(d) of

Pub. L. 105-33, set out as a note under section 1395f of this

title.

Amendment by section 4432(b)(1) of Pub. L. 105-33 applicable to

items and services furnished on or after July 1, 1998, see section

4432(d) of Pub. L. 105-33, set out as a note under section 1395i-3

of this title.

Amendment by section 4507(a)(2)(B) of Pub. L. 105-33 applicable

with respect to contracts entered into on and after Jan. 1, 1998,

see section 4507(c) of Pub. L. 105-33, set out as a note under

section 1395a of this title.

Amendment by section 4511(a)(2)(C) of Pub. L. 105-33 applicable

with respect to services furnished and supplies provided on and

after Jan. 1, 1998, see section 4511(e) of Pub. L. 105-33, set out

as a note under section 1395k of this title.

Amendment by section 4541(b) of Pub. L. 105-33 applicable to

services furnished on or after Jan. 1, 1998, including portions of

cost reporting periods occurring on or after such date, see section

4541(e) of Pub. L. 105-33, set out as a note under section 1395l of

this title.

Amendment by section 4603(c)(2)(C) of Pub. L. 105-33 applicable

to cost reporting periods beginning on or after Oct. 1, 1999,

except as otherwise provided, see section 4603(d) of Pub. L.

105-33, set out as an Effective Date note under section 1395fff of

this title.

Section 4614(c) of Pub. L. 105-33 provided that: "The amendments

made by this section [amending this section] apply to services

furnished on or after October 1, 1997."

Section 4632(b) of Pub. L. 105-33 provided that: "The amendments

made by this section [amending this section] apply to items and

services furnished on or after the date of the enactment of this

Act [Aug. 5, 1997]."

Section 4633(c) of Pub. L. 105-33 provided that: "The amendments

made by this section [amending this section] apply to items and

services furnished on or after the date of the enactment of this

Act [Aug. 5, 1997]."

EFFECTIVE DATE OF 1994 AMENDMENT

Amendment by section 145(c)(1) of Pub. L. 103-432 applicable to

mammography furnished by a facility on and after the first date

that the certificate requirements of section 263b(b) of this title

apply to such mammography conducted by such facility, see section

145(d) of Pub. L. 103-432, set out as a note under section 1395m of

this title.

Amendment by section 147(e)(6) of Pub. L. 103-432 effective as if

included in the enactment of Pub. L. 101-508, see section 147(g) of

Pub. L. 103-432, set out as a note under section 1320a-3a of this

title.

Section 151(a)(2)(B) of Pub. L. 103-432 provided that: "The

amendment made by subparagraph (A) [amending this section] shall

apply with respect to items and services furnished on or after the

expiration of the 120-day period beginning on the date of the

enactment of this Act [Oct. 31, 1994]."

Section 151(b)(3)(C) of Pub. L. 103-432 provided that: "The

amendments made by this paragraph [amending this section] shall

apply to payments for items and services furnished on or after the

date of the enactment of this Act [Oct. 31, 1994]."

Section 151(c)(1), (9) of Pub. L. 103-432 provided that the

amendment made by that section is effective as if included in the

enactment of Pub. L. 103-66.

Section 151(c)(4) of Pub. L. 103-432 provided that the amendment

made by that section is effective as if included in the enactment

of Pub. L. 101-508.

Section 151(c)(5), (6) of Pub. L. 103-432 provided that the

amendment made by that section is effective as if included in the

enactment of Pub. L. 101-239.

Amendment by section 156(a)(2)(D) of Pub. L. 103-432 applicable

to services provided on or after Oct. 31, 1994, see section

156(a)(3) of Pub. L. 103-432, set out as a note under section

1320c-3 of this title.

Section 157(b)(8) of Pub. L. 103-432 provided that: "The

amendments made by this subsection [amending this section, section

1395mm of this title, and provisions set out as notes under section

1395mm of this title] shall take effect as if included in the

enactment of OBRA-1990 [Pub. L. 101-508]."

EFFECTIVE DATE OF 1993 AMENDMENT

Section 151(c)(10) of Pub. L. 103-432 provided that: "The

amendment made by section 13561(e)(1)(G) of OBRA-1993 [Pub. L.

103-66, amending this section], to the extent it relates to the

definition of large group health plan, shall be effective as if

included in the enactment of OBRA-1989 [Pub. L. 101-239]."

Amendment by section 13561(d)(1) of Pub. L. 103-66 effective 90

days after Aug. 10, 1993, see section 13561(d)(3) of Pub. L.

103-66, set out as a note under section 5000 of Title 26, Internal

Revenue Code.

Section 13561(e)(1)(D) of Pub. L. 103-66, as amended by Pub. L.

103-432, title I, Sec. 151(c)(9)(A), Oct. 31, 1994, 108 Stat. 4436,

provided that the amendment made by that section is effective as if

included in the enactment of Pub. L. 101-239.

Section 13581(d) of Pub. L. 103-66 provided that: "The amendments

made by this section [enacting section 1320b-14 of this title and

amending this section, section 1396a of this title, and section

552a of Title 5, Government Organization and Employees] shall take

effect on January 1, 1994."

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by section 4153(b)(2)(B) of Pub. L. 101-508 applicable

to items furnished on or after Jan. 1, 1991, see section

4153(b)(2)(C) of Pub. L. 101-508, set out as a note under section

1395x of this title.

Amendment by section 4157(c)(1) of Pub. L. 101-508 applicable to

services furnished on or after Jan. 1, 1991, see section 4157(d) of

Pub. L. 101-508, set out as a note under section 1395k of this

title.

Amendment by section 4161(a)(3)(C) of Pub. L. 101-508 applicable

to services furnished on or after Oct. 1, 1991, see section

4161(a)(8) of Pub. L. 101-508, set out as a note under section

1395k of this title.

Amendment by section 4163(d)(2)(A)(i)-(iii), (B) of Pub. L.

101-508 applicable to screening mammography performed on or after

Jan. 1, 1991, see section 4163(e) of Pub. L. 101-508, as amended,

set out as a note under section 1395l of this title.

Section 4163(d)(3) of Pub. L. 101-508, as added by Pub. L.

103-432, title I, Sec. 147(f)(5)(A), Oct. 31, 1994, 108 Stat. 4431,

provided that: "The amendment made by paragraph (2)(A)(iv)

[amending this section] shall apply to screening pap smears

performed on or after July 1, 1990."

Section 4204(g)(2) of Pub. L. 101-508 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to incentives offered on or after the date of the enactment of this

Act [Nov. 5, 1990]."

EFFECTIVE DATE OF 1989 AMENDMENTS

Amendment by section 6115(b) of Pub. L. 101-239 applicable to

screening pap smears performed on or after July 1, 1990, see

section 6115(d) of Pub. L. 101-239, set out as a note under section

1395x of this title.

Amendment by section 6202(b)(1) of Pub. L. 101-239 applicable to

items and services furnished after Dec. 19, 1989, see section

6202(b)(5) of Pub. L. 101-239, set out as a note under section 162

of Title 26, Internal Revenue Code.

Section 6202(e)(2) of Pub. L. 101-239 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to items and services furnished on or after October 1, 1989."

Amendment by Pub. L. 101-234 effective Jan. 1, 1990, see section

201(c) of Pub. L. 101-234, set out as a note under section 1320a-7a

of this title.

EFFECTIVE DATE OF 1988 AMENDMENTS

Amendment by Pub. L. 100-485 effective as if included in the

enactment of the Medicare Catastrophic Coverage Act of 1988, Pub.

L. 100-360, see section 608(g)(1) of Pub. L. 100-485, set out as a

note under section 704 of this title.

Amendment by section 202(d) of Pub. L. 100-360 applicable to

items dispensed on or after Jan. 1, 1990, see section 202(m)(1) of

Pub. L. 100-360, set out as a note under section 1395u of this

title.

Amendment by section 204(d)(2) of Pub. L. 100-360 applicable to

screening mammography performed on or after Jan. 1, 1990, see

section 204(e) of Pub. L. 100-360, set out as a note under section

1395m of this title.

Amendment by section 205(e)(1) of Pub. L. 100-360 applicable to

items and services furnished on or after Jan. 1, 1990, see section

205(f) of Pub. L. 100-360, set out as a note under section 1395k of

this title.

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by section 411(i)(4)(D) of Pub. L. 100-360, as

it relates to a provision in the Omnibus Budget Reconciliation Act

of 1987, Pub. L. 100-203, effective as if included in the enactment

of that provision in Pub. L. 100-203, see section 411(a) of Pub. L.

100-360, set out as a Reference to OBRA; Effective Date note under

section 106 of Title 1, General Provisions.

Section 411(f)(4)(D)(ii) of Pub. L. 100-360 provided that: "The

amendment made by clause (i) [amending this section] shall apply to

operations performed on or after 60 days after the date of the

enactment of this Act [July 1, 1988]."

EFFECTIVE DATE OF 1987 AMENDMENTS

Section 4009(j)(6) of Pub. L. 100-203, provided that the

amendment made by that section is effective as if included in the

enactment of Pub. L. 99-509.

Section 4034(b) of Pub. L. 100-203 provided that: "The amendment

made by subsection (a) [amending this section] shall be effective

as if included in the enactment of section 9319(a) of the Omnibus

Budget Reconciliation Act of 1986 [Pub. L. 99-509]."

Section 4036(a)(2) of Pub. L. 100-203 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

with respect to items and services furnished on or after 30 days

after the date of the enactment of this Act [Dec. 22, 1987]."

Section 4039(c)(2) of Pub. L. 100-203 provided that: "The

amendments made by paragraph (1) [amending this section] shall

become effective on January 1, 1988."

For effective date of amendment by section 4072(c) of Pub. L.

100-203, see section 4072(e) of Pub. L. 100-203, set out as a note

under section 1395x of this title.

Amendment by Pub. L. 100-93 effective at end of fourteen-day

period beginning Aug. 18, 1987, and inapplicable to administrative

proceedings commenced before end of such period, see section 15(a)

of Pub. L. 100-93, set out as a note under section 1320a-7 of this

title.

EFFECTIVE DATE OF 1986 AMENDMENTS

Section 9319(f) of Pub. L. 99-509 provided that:

"(1) Except as provided in paragraph (2), the amendments made by

this section [enacting section 5000 of Title 26, Internal Revenue

Code, and amending this section and sections 1395p and 1395r of

this title] shall apply to items and services furnished on or after

January 1, 1987.

"(2) The amendments made by subsection (c) [amending sections

1395p and 1395r of this title] shall apply to enrollments occurring

on or after January 1, 1987."

Amendment by section 9320(h)(1) of Pub. L. 99-509 applicable to

services furnished on or after Jan. 1, 1989, with exceptions for

hospitals located in rural areas which meet certain requirements

related to certified registered nurse anesthetists, see section

9320(i), (k) of Pub. L. 99-509, as amended, set out as notes under

section 1395k of this title.

Amendment by section 9343(c)(1) of Pub. L. 99-509 applicable to

services furnished after June 30, 1987, see section 9343(h)(2) of

Pub. L. 99-509, as amended, set out as a note under section 1395l

of this title.

Section 9201(d)(1) of Pub. L. 99-272 provided that: "The

amendments made by subsection (a) [amending this section] shall

apply with respect to items and services furnished on or after May

1, 1986."

Amendment by section 9307(a) of Pub. L. 99-272 applicable to

services performed on or after Apr. 1, 1986, see section 9307(e) of

Pub. L. 99-272, set out as a note under section 1320c-3 of this

title.

EFFECTIVE DATE OF 1984 AMENDMENT

Section 2301(c)(1) of Pub. L. 98-369 provided that: "The

amendment made by subsection (a) [amending this section] shall be

effective with respect to items and services furnished on or after

January 1, 1985."

Amendment by section 2304(c) of Pub. L. 98-369 applicable to

pacemaker devices and leads implanted or removed on or after the

effective date of final regulations promulgated to carry out such

amendment, see section 2304(d) of Pub. L. 98-369, set out as a note

below.

Section 2313(e) of Pub. L. 98-369 provided that: "The amendments

made by this section [amending this section and section 1395ww of

this title] shall become effective on the date of the enactment of

this Act [July 18, 1984]."

Section 2344(d) of Pub. L. 98-369 provided that: "The amendments

made by this section [amending this section] shall apply to items

and services furnished on or after the date of the enactment of

this Act [July 18, 1984]."

Amendment by section 2354(b)(30), (31) of Pub. L. 98-369

effective July 18, 1984, but not to be construed as changing or

affecting any right, liability, status, or interpretation which

existed (under the provisions of law involved) before that date,

see section 2354(e)(1) of Pub. L. 98-369, set out as a note under

section 1320a-1 of this title.

EFFECTIVE DATE OF 1983 AMENDMENTS

Amendment by section 601(f) of Pub. L. 98-21 applicable to items

and services furnished by or under arrangement with a hospital

beginning with its first cost reporting period that begins on or

after Oct. 1, 1983, any change in a hospital's cost reporting

period made after November 1982 to be recognized for such purposes

only if the Secretary finds good cause therefor, and amendment by

section 602(e)(3) of Pub. L. 98-21 effective Oct. 1, 1983, see

section 604(a)(1), (2) of Pub. L. 98-21, set out as a note under

section 1395ww of this title.

Amendment by Pub. L. 97-448 effective as if originally included

as a part of this section as this section was amended by the Tax

Equity and Fiscal Responsibility Act of 1982, Pub. L. 97-248, see

section 309(c)(2) of Pub. L. 97-448, set out as a note under

section 426-1 of this title.

EFFECTIVE DATE OF 1982 AMENDMENT

Amendment by section 116(b) of Pub. L. 97-248 applicable with

respect to items and services furnished on or after Jan. 1, 1983,

see section 116(c) of Pub. L. 97-248, set out as a note under

section 623 of Title 29, Labor.

Amendment by section 122(f), (g)(1) of Pub. L. 97-248 applicable

to hospice care provided on or after Nov. 1, 1983, see section

122(h)(1) of Pub. L. 97-248, as amended, set out as a note under

section 1395c of this title.

Amendment by section 128(a)(2)-(4) of Pub. L. 97-248 effective as

if originally included as part of this section as this section was

amended by the Omnibus Budget Reconciliation Act of 1981, Pub. L.

97-35, see section 128(e)(2) of Pub. L. 97-248, set out as a note

under section 1395x of this title.

Amendment by sections 142 and 148(a) of Pub. L. 97-248 effective

with respect to contracts entered into or renewed on or after Sept.

3, 1982, see section 149 of Pub. L. 97-248, set out as an Effective

Date note under section 1320c of this title.

EFFECTIVE DATE OF 1981 AMENDMENT

Section 2103(a)(2) of Pub. L. 97-35 provided that: "The amendment

made by paragraph (1) [amending this section] shall apply with

respect to expenses incurred on or after October 1, 1981."

Section 2146(c)(1) of Pub. L. 97-35 provided that: "The

amendments made by subsection (a) [amending this section] shall

become effective on October 1, 1981."

EFFECTIVE DATE OF 1980 AMENDMENTS

Amendment by Pub. L. 96-611 effective July 1, 1981, and

applicable to services furnished on or after that date, see section

2 of Pub. L. 96-611, set out as a note under section 1395l of this

title.

Amendment by section 936(c) of Pub. L. 96-499 applicable with

respect to services provided on or after July 1, 1981, see section

936(d) of Pub. L. 96-499, set out as a note under section 1395f of

this title.

Section 939(b) of Pub. L. 96-499 provided that: "The amendment

made by subsection (a) [amending this section] shall apply with

respect to services furnished on or after July 1, 1981."

EFFECTIVE DATE OF 1977 AMENDMENTS

Amendment by Pub. L. 95-210 applicable to services rendered on or

after first day of third calendar month which begins after Dec. 31,

1977, see section 1(j) of Pub. L. 95-210, set out as a note under

section 1395k of this title.

Section 13(c) of Pub. L. 95-142 provided that: "The amendments

made by this section [amending this section and sections 1320c-6

and 1395cc of this title] shall take effect on the date of the

enactment of this Act [Oct. 25, 1977]."

EFFECTIVE DATE OF 1973 AMENDMENT

Amendment by Pub. L. 93-233 effective with respect to admissions

subject to the provisions of section 1395(a)(2) of this title which

occur after Dec. 31, 1973, see section 18(z-3)(2) of Pub. L.

93-233, set out as a note under section 1395f of this title.

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by section 211(c)(1) of Pub. L. 92-603 applicable to

services furnished with respect to admissions occurring after Dec.

31, 1972, see section 211(d) of Pub. L. 92-603, set out as a note

under section 1395f of this title.

Amendment by section 256(c) of Pub. L. 92-603 applicable with

respect to admissions occurring after the second month following

the month of enactment of Pub. L. 92-603 which was approved on Oct.

30, 1972, see section 256(d) of Pub. L. 92-603, set out as a note

under section 1395f of this title.

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment by section 127(b) of Pub. L. 90-248 applicable with

respect to services furnished after Dec. 31, 1967, see section

127(c) of Pub. L. 90-248, set out as a note under section 1395x of

this title.

NOTIFICATION TO PHYSICIANS OF EXCESSIVE HOME HEALTH VISITS

Section 4614(b) of Pub. L. 105-33 provided that: "The Secretary

of Health and Human Services may establish a process for notifying

a physician in cases in which the number of home health visits,

furnished under title XVIII of the Social Security Act [this

subchapter] pursuant to a prescription or certification of the

physician, significantly exceeds such threshold (or thresholds) as

the Secretary specifies. The Secretary may adjust such threshold to

reflect demonstrated differences in the need for home health

services among different beneficiaries."

DISTRIBUTION OF QUESTIONNAIRE BY CONTRACTOR

Section 151(a)(1)(B) of Pub. L. 103-432 provided that: "The

Secretary of Health and Human Services shall enter into an

agreement with an entity not later than 60 days after the date of

the enactment of the Social Security Act Amendments of 1994 [Oct.

31, 1994], to distribute the questionnaire described in section

1862(b)(5)(D) of the Social Security Act [subsec. (b)(5)(D) of this

section] (as added by subparagraph (A))."

RETROACTIVE EXEMPTION FOR CERTAIN SITUATIONS INVOLVING RELIGIOUS

ORDERS

Section 13561(f) of Pub. L. 103-66 provided that: "Section

1862(b)(1)(D) of the Social Security Act [subsec. (b)(1)(D) of this

section] applies, with respect to items and services furnished

before October 1, 1989, to any claims that the Secretary of Health

and Human Services had not identified as of that date as subject to

the provisions of section 1862(b) of such Act."

GAO STUDY OF EXTENSION OF SECONDARY PAYER PERIOD

Section 4203(c)(2) of Pub. L. 101-508, as amended by Pub. L.

103-432, title I, Sec. 151(c)(7), Oct. 31, 1994, 108 Stat. 4436,

directed Comptroller General to conduct study of impact of second

sentence of subsec. (b)(1)(C) of this section and to submit

preliminary report to Congress not later than Jan. 1, 1993, and

final report not later than Jan. 1, 1995.

DEADLINE FOR FIRST TRANSMITTAL AND REQUEST OF MATCHING INFORMATION

Section 6202(a)(2)(B) of Pub. L. 101-239 provided that: "The

Commissioner of Social Security shall first -

"(i) transmit to the Secretary of the Treasury information

under paragraph (5)(A)(i) of section 1862(b) of the Social

Security Act [subsec. (b)(5)(A)(i) of this section] (as inserted

by subparagraph (A)), and

"(ii) request from the Secretary disclosure of information

described in section 6013(l)(12)(A) of the Internal Revenue Code

of 1986 [26 U.S.C. 6013(l)(12)(A)],

by not later than 14 days after the date of the enactment of this

Act [Dec. 19, 1989]."

DESIGNATION OF PEDIATRIC HOSPITALS AS MEETING CERTIFICATION AS

HEART TRANSPLANT FACILITY

Section 4009(b) of Pub. L. 100-203 provided that: "For purposes

of determining whether a pediatric hospital that performs pediatric

heart transplants meets the criteria established by the Secretary

of Health and Human Services for facilities in which the heart

transplants performed will be considered to meet the requirement of

section 1862(a)(1)(A) of the Social Security Act [subsec. (a)(1)(A)

of this section], the Secretary shall treat such a hospital as

meeting such criteria if -

"(1) the hospital's pediatric heart transplant program is

operated jointly by the hospital and another facility that meets

such criteria,

"(2) the unified program shares the same transplant surgeons

and quality assurance program (including oversight committee,

patient protocol, and patient selection criteria), and

"(3) the hospital demonstrates to the satisfaction of the

Secretary that it is able to provide the specialized facilities,

services, and personnel that are required by pediatric heart

transplant patients."

APPROVAL OF SURGICAL ASSISTANTS FOR PROCEDURES PERFORMED APRIL 1,

1986, TO DECEMBER 15, 1986

Section 1895(b)(16)(C) of Pub. L. 99-514 provided that: "For

purposes of section 1862(a)(15) of the Social Security Act (42

U.S.C. 1395y(a)(15)), added by section 9307(a)(3) of COBRA, and for

surgical procedures performed during the period beginning on April

1, 1986, and ending on December 15, 1986, a carrier is deemed to

have approved the use of an assistant in a surgical procedure,

before the surgery is performed, based on the existence of a

complicating medical condition if the carrier determines after the

surgery is performed that the use of the assistant in the procedure

was appropriate based on the existence of a complicating medical

condition before or during the surgery."

EXTENDING WAIVER OF LIABILITY PROVISIONS TO HOSPICE PROGRAMS

Section 9305(f) of Pub. L. 99-509, as amended by Pub. L. 100-360,

title IV, Sec. 426(a), July 1, 1988, 102 Stat. 814; Pub. L.

101-508, title IV, Sec. 4008(a)(2), Nov. 5, 1990, 104 Stat.

1388-44, provided that:

"(1) In general. - The Secretary of Health and Human Services

shall, for purposes of determining whether payments to a hospice

program should be denied pursuant to section 1862(a)(1)(C) of the

Social Security Act [subsec. (a)(1)(C) of this section], apply

(under section 1879(a) of such Act [section 1395pp(a) of this

title]) a presumption of compliance of 2.5 percent (based on the

number of days of hospice care billed) in a manner substantially

similar to that provided to home health agencies under policies in

effect as of July 1, 1985.

"(2) Effective date. - Paragraph (1) shall apply to hospice care

furnished on or after the first day of the first month that begins

at least 6 months after the date of the enactment of this Act [Oct.

21, 1986] and before December 31, 1995."

[Section 4008(a)(3) of Pub. L. 101-508 provided that: "The

amendments made by paragraphs (1) and (2) [amending section 9305(f)

of Pub. L. 99-509, set out above, and section 9126(c) of Pub. L.

99-272, set out below] shall take effect on the date of the

enactment of this Act [Nov. 5, 1990]."]

STUDY OF IMPACT ON DISABLED BENEFICIARIES AND FAMILY OF AMENDMENTS

RELATING TO LARGE GROUP HEALTH PLANS AND MEDICARE AS SECONDARY

PAYER

Section 9319(e) of Pub. L. 99-509 directed Comptroller General to

study and report to Congress, not later than Mar. 1, 1990, the

impact of the amendments made by this section (enacting section

5000 of Title 26, Internal Revenue Code, and amending this section

and sections 1395p and 1395r of this title) on access of disabled

individuals and members of their family to employment and health

insurance, such report to include information relating to number of

disabled medicare beneficiaries for whom medicare has become

secondary, either through their employment or the employment of a

family member, amount of savings to the medicare program achieved

annually through this provision, and effect on employment, and

employment-based health coverage, of disabled individuals and

family members.

REINSTATEMENT OF WAIVER OF LIABILITY PRESUMPTION

Section 9126(c) of Pub. L. 99-272, as amended by Pub. L. 100-360,

title IV, Sec. 426(b), July 1, 1988, 102 Stat. 814; Pub. L.

101-508, title IV, Sec. 4008(a)(1), Nov. 5, 1990, 104 Stat.

1388-44, provided that: "The Secretary of Health and Human Services

shall, for purposes of determining whether payments to a skilled

nursing facility should be denied pursuant to section 1862(a)(1)(A)

of the Social Security Act [subsec. (a)(1)(A) of this section],

apply the same presumption of compliance (5 percent) as in effect

under regulations as of July 1, 1985. Such presumption shall apply

for the period beginning with the first month beginning after the

date of the enactment of this Act [Apr. 7, 1986] and ending on

December 31, 1995."

HOME HEALTH WAIVER OF LIABILITY

Section 9205 of Pub. L. 99-272, as amended by Pub. L. 100-360,

title IV, Sec. 426(d), July 1, 1988, 102 Stat. 814; Pub. L.

103-432, title I, Sec. 158(b)(1), Oct. 31, 1994, 108 Stat. 4442,

provided that: "The Secretary of Health and Human Services shall,

for purposes of determining whether payments to a home health

agency should be denied pursuant to section 1862(a)(1)(A) of the

Social Security Act [subsec. (a)(1)(A) of this section], apply a

presumption of compliance (2.5 percent) in the same manner as under

the regulations in effect as of July 1, 1985. Such presumption

shall apply until December 31, 1995."

[Section 158(b)(2) of Pub. L. 103-432 provided that: "The

amendment made by paragraph (1) [amending section 9205 of Pub. L.

99-272, set out above] shall take effect as if included in the

enactment of OBRA-1990 [Pub. L. 101-508]."]

RECOMMENDATIONS AND GUIDELINES FOR ELIMINATION OF ASSISTANTS AT

SURGERY; REPORT TO CONGRESS

Section 9307(d) of Pub. L. 99-272 provided that the Secretary of

Health and Human Services, after consultation with the Physician

Payment Review Commission, develop recommendations and guidelines

respecting other surgical procedures for which an assistant at

surgery was generally not medically necessary and circumstances

under which use of an assistant at surgery was generally

appropriate but should be subject to prior approval of an

appropriate entity and that the Secretary report to Congress, not

later than January 1, 1987, on these recommendations and

guidelines.

PACEMAKER REIMBURSEMENT REVIEW AND REFORM; PROMULGATION OF

REGULATIONS; EFFECTIVE DATE OF PACEMAKER REGISTRATION

Section 2304(d) of Pub. L. 98-369 provided that: "The Secretary

of Health and Human Services shall promulgate final regulations to

carry out this section and the amendment made by this section

[amending this section and enacting provisions set out as a note

under section 1395l of this title] prior to January 1, 1985, and

the amendment made by subsection (c) [amending this section] shall

apply to pacemaker devices and leads implanted or removed on or

after the effective date of such regulations."

PAYMENT FOR DEBRIDEMENT OF MYCOTIC TOENAILS

Section 2325 of Pub. L. 98-369 provided that: "The Secretary

shall provide, pursuant to section 1862(a) of the Social Security

Act [subsec. (a) of this section], that payment will not be made

under part B of title XVIII of such Act [part B of this subchapter]

for a physician's debridement of mycotic toenails to the extent

such debridement is performed for a patient more frequently than

once every 60 days, unless the medical necessity for more frequent

treatment is documented by the billing physician."

INTERIM WAIVER IN CERTAIN CASES OF BILLING RULE FOR ITEMS AND

SERVICES OTHER THAN PHYSICIANS' SERVICES

Section 602(k) of Pub. L. 98-21, as amended by Pub. L. 99-272,

title IX, Sec. 9112(a), Apr. 7, 1986, 100 Stat. 163, provided that:

"(1) The Secretary of Health and Human Services may, for any cost

reporting period beginning prior to October 1, 1986, waive the

requirements of sections 1862(a)(14) and 1866(a)(1)(H) of the

Social Security Act [subsec. (a)(14) of this section and section

1395cc(a)(1)(H) of this title] in the case of a hospital which has

followed a practice, since prior to October 1, 1982, of allowing

direct billing under part B of title XVIII of such Act [part B of

this subchapter] for services (other than physicians' services) so

extensively, that immediate compliance with those requirements

would threaten the stability of patient care. Any such waiver shall

provide that such billing may continue to be made under part B of

such title but that the payments to such hospital under part A of

such title [part A of this subchapter] shall be reduced by the

amount of the billings for such services under part B of such

title. If such a waiver is granted, at the end of the waiver period

the Secretary may provide for such methods of payments under part A

as is appropriate, given the organizational structure of the

institution.

"(2) In the case of a hospital which is receiving payments

pursuant to a waiver under paragraph (1), payment of the adjustment

for indirect costs of approved educational activities shall be made

as if the hospital were receiving under part A of title XVIII of

the Social Security Act all the payments which are made under part

B of such title solely by reason of such waiver.

"(3) Any waiver granted under paragraph (1) shall provide that,

with respect to those items and services billed under part B of

title XVIII of the Social Security Act solely by reason of such

waiver -

"(A) payment under such part shall be equal to 100 percent of

the reasonable charge or other applicable payment base for the

items and services; and

"(B) the entity furnishing the items and services must agree to

accept the amount paid pursuant to subparagraph (A) as the full

charge for the items and services."

[Section 9112(b) of Pub. L. 99-272 provided that:

["(1) Section 602(k)(2) of the Social Security Amendments of 1983

(as added by subsection (a)) [set out above] shall apply to cost

reporting periods beginning on or after January 1, 1986.

["(2) Section 602(k)(3) of the Social Security Amendments of 1983

(as added by subsection (a)) [set out above] shall apply to items

and services furnished after the end of the 10-day period beginning

on the date of the enactment of this Act [Apr. 7, 1986]."]

PROHIBITION OF PAYMENT FOR INEFFECTIVE DRUGS

Section 115(b) of Pub. L. 97-248 provided that: "No provision of

law limiting the use of funds for purposes of enforcing or

implementing section 1862(c) [subsec. (c) of this section] or

section 1903(i)(5) [section 1396b(i)(5) of this title] of the

Social Security Act, section 2103 of the Omnibus Budget

Reconciliation Act of 1981 [section 2103 of Pub. L. 97-35, amending

sections 1395y and 1396b of this title and enacting provisions set

out as notes under sections 1395y and 1396b of this title], or any

rule or regulation issued pursuant to any such section (including

any provision contained in, or incorporated by reference into, any

appropriation Act or resolution making continuing appropriations)

shall apply to any period after September 30, 1982, unless such

provision of law is enacted after the date of the enactment of this

Act [Sept. 3, 1982] and specifically states that such provision is

to supersede this section."

ESTABLISHMENT AND IMPLEMENTATION OF GUIDELINES

Section 2152(b) of Pub. L. 97-35 directed the Secretary of Health

and Human Services to establish, and provide for the implementation

of, the guidelines described in subsec. (f) of this section not

later than Oct. 1, 1981.

REPORT TO CONGRESSIONAL COMMITTEES ON IMPLEMENTATION OF

CERTIFICATION REQUIREMENTS RELATING TO MODIFICATION OF HEALTH

BENEFITS PLAN OR PROGRAM; FAILURE TO SUBMIT REPORT

Section 4(b) of Pub. L. 93-480 provided that the Civil Service

Commission and the Secretary of Health, Education, and Welfare

submit a report on or before Mar. 1, 1975, on the steps which have

been taken, and the steps which are planned, to enable the

Secretary to make the determination and certification referred to

in former subsec. (c) of this section and that if such report is

not submitted by Mar. 1, 1975, the date specified in former subsec.

(c) shall be deemed to be July 1, 1975, rather than Jan. 1, 1976.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1314, 1320a-7a, 1320c,

1320c-3, 1320c-7, 1320c-8, 1395h, 1395l, 1395m, 1395p, 1395r,

1395u, 1395w-22, 1395x, 1395cc, 1395ff, 1395gg, 1395oo, 1395pp,

1395ss, 1395ww, 1395ddd, 1395eee, 1395ggg, 1396b of this title;

title 10 section 1095; title 26 sections 5000, 6103; title 45

section 231f.

-FOOTNOTE-

(!1) See References in Text note below.

(!2) So in original. The comma probably should not appear.

-End-

-CITE-

42 USC Sec. 1395z 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395z. Consultation with State agencies and other

organizations to develop conditions of participation for

providers of services

-STATUTE-

In carrying out his functions, relating to determination of

conditions of participation by providers of services, under

subsections (e)(9), (f)(4), (j)(15),(!1) (o)(6), (cc)(2)(I), and

(!2) (dd)(2), and (mm)(1) of section 1395x of this title, or by

ambulatory surgical centers under section 1395k(a)(2)(F)(i) of this

title, the Secretary shall consult with appropriate State agencies

and recognized national listing or accrediting bodies, and may

consult with appropriate local agencies. Such conditions prescribed

under any of such subsections may be varied for different areas or

different classes of institutions or agencies and may, at the

request of a State, provide higher requirements for such State than

for other States; except that, in the case of any State or

political subdivision of a State which imposes higher requirements

on institutions as a condition to the purchase of services (or of

certain specified services) in such institutions under a State plan

approved under subchapter I, XVI, or XIX of this chapter, the

Secretary shall impose like requirements as a condition to the

payment for services (or for the services specified by the State or

subdivision) in such institutions in such State or subdivision.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1863, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 325; amended

Pub. L. 92-603, title II, Sec. 234(g)(2), Oct. 30, 1972, 86 Stat.

1413; Pub. L. 96-499, title IX, Secs. 933(f), 934(c)(1), Dec. 5,

1980, 94 Stat. 2636, 2639; Pub. L. 97-248, title I, Sec. 122(g)(2),

Sept. 3, 1982, 96 Stat. 362; Pub. L. 98-369, div. B, title III,

Secs. 2335(c), 2349(b)(1), 2354(b)(32), July 18, 1984, 98 Stat.

1090, 1097, 1102; Pub. L. 100-360, title II, Secs. 203(e)(2),

204(c)(1), July 1, 1988, 102 Stat. 725, 728; Pub. L. 101-234, title

II, Sec. 201(a), Dec. 13, 1989, 103 Stat. 1981; Pub. L. 101-239,

title VI, Sec. 6003(g)(3)(C)(ii), Dec. 19, 1989, 103 Stat. 2152;

Pub. L. 101-508, title IV, Sec. 4163(c)(1), Nov. 5, 1990, 104 Stat.

1388-99; Pub. L. 103-432, title I, Sec. 145(c)(2), Oct. 31, 1994,

108 Stat. 4427.)

-REFTEXT-

REFERENCES IN TEXT

Subsection (j) of section 1395x of this title, referred to in

text, was amended generally by Pub. L. 100-203, title IV, Sec.

4201(a)(1), Dec. 22, 1987, 101 Stat. 1330-160, and, as so amended,

does not contain a par. (15).

-MISC1-

AMENDMENTS

1994 - Pub. L. 103-432 struck out "or whether screening

mammography meets the standards established under section

1395m(c)(3) of this title," before "the Secretary shall consult".

1990 - Pub. L. 101-508 inserted "or whether screening mammography

meets the standards established under section 1395m(c)(3) of this

title," after "section 1395k(a)(2)(F)(i) of this title,".

1989 - Pub. L. 101-239 substituted "(jj)(3), and (mm)(1)" for

"and (jj)(3)".

Pub. L. 101-234 repealed Pub. L. 100-360, Secs. 203(e)(2),

204(c)(1), and provided that the provisions of law amended or

repealed by such sections are restored or revived as if such

sections had not been enacted, see 1988 Amendment notes below.

1988 - Pub. L. 100-360, Sec. 204(c)(1), inserted "or whether

screening mammography meets the standards established under section

1395m(e)(3) of this title," after "1395k(a)(2)(F)(i) of this

title,".

Pub. L. 100-360, Sec. 203(e)(2), substituted "(dd)(2), and

(jj)(3)" for "and (dd)(2)".

1984 - Pub. L. 98-369, Sec. 2335(c), struck out "(g)(4)," after

"(e)(9), (f)(4),".

Pub. L. 98-369, Sec. 2354(b)(32), substituted "(j)(15)" for

"(j)(11)".

Pub. L. 98-369, Sec. 2349(b)(1), substituted "appropriate State

agencies" for "the Health Insurance Benefits Advisory Council

established by section 1395dd of this title, appropriate State

agencies,".

1982 - Pub. L. 97-248 substituted "(cc)(2)(I), and (dd)(2)" for

"and (cc)(2)(I)".

1980 - Pub. L. 96-499, Sec. 933(f), substituted "(o)(6), and

(cc)(2)(I) of section 1395x" for "and (o)(6) of section 1395x".

Pub. L. 96-499, Sec. 934(c)(1), inserted "or by ambulatory

surgical centers under section 1395k(a)(2)(F)(i) of this title,".

1972 - Pub. L. 92-603 substituted "subsections (e)(9), (f)(4),

(g)(4), (j)(11), and (o)(6) of section 1395x of this title" for

"subsections (e)(8), (f)(4), (g)(4), (j)(10), and (o)(5) of section

1395x of this title".

EFFECTIVE DATE OF 1994 AMENDMENT

Amendment by Pub. L. 103-432 applicable to mammography furnished

by a facility on and after the first date that the certificate

requirements of section 263b(b) of this title apply to such

mammography conducted by such facility, see section 145(d) of Pub.

L. 103-432, set out as a note under section 1395m of this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-508 applicable to screening mammography

performed on or after Jan. 1, 1991, see section 4163(e) of Pub. L.

101-508, set out as a note under section 1395l of this title.

EFFECTIVE DATE OF 1989 AMENDMENT

Amendment by Pub. L. 101-234 effective Jan. 1, 1990, see section

201(c) of Pub. L. 101-234, set out as a note under section 1320a-7a

of this title.

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by section 203(e)(2) of Pub. L. 100-360 applicable to

items and services furnished on or after Jan. 1, 1990, see section

203(g) of Pub. L. 100-360, set out as a note under section 1320c-3

of this title.

Amendment by section 204(c)(1) of Pub. L. 100-360 applicable to

screening mammography performed on or after Jan. 1, 1990, see

section 204(e) of Pub. L. 100-360, set out as a note under section

1395m of this title.

EFFECTIVE DATE OF 1984 AMENDMENT

Amendment by section 2335(c) of Pub. L. 98-369 effective July 18,

1984, see section 2335(g) of Pub. L. 98-369, set out as a note

under section 1395f of this title.

Amendment by section 2349(b)(1) of Pub. L. 98-369 effective July

18, 1984, see section 2349(c) of Pub. L. 98-369, set out as a note

under section 907a of this title.

Amendment by section 2354(b)(32) of Pub. L. 98-369 effective July

18, 1984, but not to be construed as changing or affecting any

right, liability, status, or interpretation which existed (under

the provisions of law involved) before that date, see section

2354(e)(1) of Pub. L. 98-369, set out as a note under section

1320a-1 of this title.

EFFECTIVE DATE OF 1982 AMENDMENT

Amendment by Pub. L. 97-248 applicable to hospice care provided

on or after Nov. 1, 1983, see section 122(h)(1) of Pub. L. 97-248,

as amended, set out as a note under section 1395c of this title.

EFFECTIVE DATE OF 1980 AMENDMENT

Amendment by section 933(f) of Pub. L. 96-499 effective with

respect to a comprehensive outpatient rehabilitation facility's

first accounting period beginning on or after July 1, 1981, see

section 933(h) of Pub. L. 96-499, set out as a note under section

1395k of this title.

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by Pub. L. 92-603 applicable with respect to providers

of services for fiscal years beginning after the fifth month

following October 1972, see section 234(i) of Pub. L. 92-603, set

out as a note under section 1395x of this title.

TERMINATION OF ADVISORY COUNCILS

Advisory councils in existence on Jan. 5, 1973, to terminate not

later than the expiration of the 2-year period following Jan. 5,

1973, unless, in the case of a council established by the President

or an officer of the Federal Government, such council is renewed by

appropriate action prior to the expiration of such 2-year period,

or in the case of a council established by the Congress, its

duration is otherwise provided by law. See sections 3(2) and 14 of

Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the

Appendix to Title 5, Government Organization and Employees.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 1395bb of this title;

title 45 section 231f.

-FOOTNOTE-

(!1) See References in Text note below.

(!2) So in original. The word "and" probably should not appear.

-End-

-CITE-

42 USC Sec. 1395aa 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395aa. Agreements with States

-STATUTE-

(a) Use of State agencies to determine compliance by providers of

services with conditions of participation

The Secretary shall make an agreement with any State which is

able and willing to do so under which the services of the State

health agency or other appropriate State agency (or the appropriate

local agencies) will be utilized by him for the purpose of

determining whether an institution therein is a hospital or skilled

nursing facility, or whether an agency therein is a home health

agency, or whether an agency is a hospice program or whether a

facility therein is a rural health clinic as defined in section

1395x(aa)(2) of this title, a critical access hospital, as defined

in section 1395x(mm)(1) of this title, or a comprehensive

outpatient rehabilitation facility as defined in section

1395x(cc)(2) of this title, or whether a laboratory meets the

requirements of paragraphs (16) and (17) of section 1395x(s) of

this title, or whether a clinic, rehabilitation agency or public

health agency meets the requirements of subparagraph (A) or (B), as

the case may be, of section 1395x(p)(4) of this title, or whether

an ambulatory surgical center meets the standards specified under

section 1395k(a)(2)(F)(i) of this title. To the extent that the

Secretary finds it appropriate, an institution or agency which such

a State (or local) agency certifies is a hospital, skilled nursing

facility, rural health clinic, comprehensive outpatient

rehabilitation facility, home health agency, or hospice program (as

those terms are defined in section 1395x of this title) may be

treated as such by the Secretary. Any State agency which has such

an agreement may (subject to approval of the Secretary) furnish to

a skilled nursing facility, after proper request by such facility,

such specialized consultative services (which such agency is able

and willing to furnish in a manner satisfactory to the Secretary)

as such facility may need to meet one or more of the conditions

specified in section 1395i-3(a) of this title. Any such services

furnished by a State agency shall be deemed to have been furnished

pursuant to such agreement. Within 90 days following the completion

of each survey of any health care facility, ambulatory surgical

center, rural health clinic, comprehensive outpatient

rehabilitation facility, laboratory, clinic, agency, or

organization by the appropriate State or local agency described in

the first sentence of this subsection, the Secretary shall make

public in readily available form and place, and require (in the

case of skilled nursing facilities) the posting in a place readily

accessible to patients (and patients' representatives), the

pertinent findings of each such survey relating to the compliance

of each such health care facility, ambulatory surgical center,

rural health clinic, comprehensive outpatient rehabilitation

facility, laboratory, clinic, agency, or organization with (1) the

statutory conditions of participation imposed under this subchapter

and (2) the major additional conditions which the Secretary finds

necessary in the interest of health and safety of individuals who

are furnished care or services by any such health care facility,

ambulatory surgical center, rural health clinic, comprehensive

outpatient rehabilitation facility, laboratory, clinic, agency, or

organization. Any agreement under this subsection shall provide for

the appropriate State or local agency to maintain a toll-free

hotline (1) to collect, maintain, and continually update

information on home health agencies located in the State or

locality that are certified to participate in the program

established under this subchapter (which information shall include

any significant deficiencies found with respect to patient care in

the most recent certification survey conducted by a State agency or

accreditation survey conducted by a private accreditation agency

under section 1395bb of this title with respect to the home health

agency, when that survey was completed, whether corrective actions

have been taken or are planned, and the sanctions, if any, imposed

under this subchapter with respect to the agency) and (2) to

receive complaints (and answer questions) with respect to home

health agencies in the State or locality. Any such agreement shall

provide for such State or local agency to maintain a unit for

investigating such complaints that possesses enforcement authority

and has access to survey and certification reports, information

gathered by any private accreditation agency utilized by the

Secretary under section 1395bb of this title, and consumer medical

records (but only with the consent of the consumer or his or her

legal representative).

(b) Payment in advance or by way of reimbursement to State for

performance of functions of subsection (a)

The Secretary shall pay any such State, in advance or by way of

reimbursement, as may be provided in the agreement with it (and may

make adjustments in such payments on account of overpayments or

underpayments previously made), for the reasonable cost of

performing the functions specified in subsection (a) of this

section, and for the Federal Hospital Insurance Trust Fund's fair

share of the costs attributable to the planning and other efforts

directed toward coordination of activities in carrying out its

agreement and other activities related to the provision of services

similar to those for which payment may be made under part A of this

subchapter, or related to the facilities and personnel required for

the provision of such services, or related to improving the quality

of such services.

(c) Use of State or local agencies to survey hospitals

The Secretary is authorized to enter into an agreement with any

State under which the appropriate State or local agency which

performs the certification function described in subsection (a) of

this section will survey, on a selective sample basis (or where the

Secretary finds that a survey is appropriate because of substantial

allegations of the existence of a significant deficiency or

deficiencies which would, if found to be present, adversely affect

health and safety of patients), provider entities that, pursuant to

subsection (a) or (b)(1) of section 1395bb of this title, are

treated as meeting the conditions or requirements of this

subchapter. The Secretary shall pay for such services in the manner

prescribed in subsection (b) of this section.

(d) Fulfillment of requirements by States

The Secretary may not enter an agreement under this section with

a State with respect to determining whether an institution therein

is a skilled nursing facility unless the State meets the

requirements specified in section 1395i-3(e) of this title and

section 1395i-3(g) of this title and the establishment of remedies

under sections 1395i-3(h)(2)(B) and 1395i-3(h)(2)(C) of this title

(relating to establishment and application of remedies).

(e) Prohibition of user fees for survey and certification

Notwithstanding any other provision of law, the Secretary may not

impose, or require a State to impose, any fee on any facility or

entity subject to a determination under subsection (a) of this

section, or any renal dialysis facility subject to the requirements

of section 1395rr(b)(1) of this title, for any such determination

or any survey relating to determining the compliance of such

facility or entity with any requirement of this subchapter (other

than any fee relating to section 263a of this title).

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1864, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 326; amended

Pub. L. 90-248, title I, Sec. 133(f), title II, Sec. 228(b), Jan.

2, 1968, 81 Stat. 852, 904; Pub. L. 92-603, title II, Secs. 244(a),

277, 278(a)(16), (b)(15), 299D(a), Oct. 30, 1972, 86 Stat. 1422,

1452-1454, 1461; Pub. L. 95-210, Sec. 1(i), Dec. 13, 1977, 91 Stat.

1488; Pub. L. 96-499, title IX, Secs. 933(g), 934(c)(2), Dec. 5,

1980, 94 Stat. 2639; Pub. L. 96-611, Sec. 1(a)(2), Dec. 28, 1980,

94 Stat. 3566; Pub. L. 97-248, title I, Sec. 122(g)(3), Sept. 3,

1982, 96 Stat. 362; Pub. L. 98-369, div. B, title III, Sec.

2354(b)(17), July 18, 1984, 98 Stat. 1101; Pub. L. 99-509, title

IX, Sec. 9320(h)(3), Oct. 21, 1986, 100 Stat. 2016; Pub. L.

100-203, title IV, Secs. 4025(a), 4072(d), 4201(a)(2), (d)(4),

4202(a)(1), (c), 4203(a)(1), 4212(b), Dec. 22, 1987, 101 Stat.

1330-74, 1330-117, 1330-160, 1330-174, 1330-179, 1330-212, as

amended Pub. L. 100-360, title IV, Sec. 411(l)(1)(C), (6)(B), July

1, 1988, 102 Stat. 804, as amended Pub. L. 100-485, title VI, Sec.

608(d)(20)(B), (C), (27)(B), Oct. 13, 1988, 102 Stat. 2419, 2420,

2422; Pub. L. 100-360, title II, Secs. 203(e)(3), 204(c)(2),

(d)(3), title IV, Sec. 411(d)(4)(A), July 1, 1988, 102 Stat. 725,

728, 729, 774; Pub. L. 101-234, title II, Sec. 201(a), Dec. 13,

1989, 103 Stat. 1981; Pub. L. 101-239, title VI, Secs.

6003(g)(3)(C)(iii), 6115(c), Dec. 19, 1989, 103 Stat. 2152, 2219;

Pub. L. 101-508, title IV, Secs. 4154(d)(1), 4163(c)(2), 4207(g),

formerly 4027(g), Nov. 5, 1990, 104 Stat. 1388-85, 1388-100,

1388-123; Pub. L. 103-432, title I, Secs. 145(c)(3), 160(a)(1),

(d)(4), Oct. 31, 1994, 108 Stat. 4427, 4443, 4444; Pub. L. 104-134,

title I, Sec. 101(d) [title V, Sec. 516(c)(1)], Apr. 26, 1996, 110

Stat. 1321-211, 1321-247; renumbered title I, Pub. L. 104-140, Sec.

1(a), May 2, 1996, 110 Stat. 1327; Pub. L. 105-33, title IV, Secs.

4106(c), 4201(c)(1), Aug. 5, 1997, 111 Stat. 368, 373.)

-REFTEXT-

REFERENCES IN TEXT

Part A of this subchapter, referred to in subsec. (b), is

classified to section 1395c et seq. of this title.

-MISC1-

AMENDMENTS

1997 - Subsec. (a). Pub. L. 105-33, Sec. 4201(c)(1), substituted

"critical access" for "rural primary care".

Pub. L. 105-33, Sec. 4106(c), substituted "paragraphs (16) and

(17)" for "paragraphs (15) and (16)".

1996 - Subsec. (c). Pub. L. 104-134, in first sentence,

substituted at end "provider entities that, pursuant to subsection

(a) or (b)(1) of section 1395bb of this title, are treated as

meeting the conditions or requirements of this subchapter." for

"hospitals which have an agreement with the Secretary under section

1395cc of this title and which are accredited by the Joint

Commission on Accreditation of Hospitals."

1994 - Subsec. (a). Pub. L. 103-432, Sec. 160(a)(1)(B), struck

out "or (in the case of a laboratory that does not participate or

seek to participate in the medicare program) the requirements of

section 263a of this title" after "section 1395x(s) of this title"

in first sentence.

Pub. L. 103-432, Sec. 145(c)(3), struck out ", or whether

screening mammography meets the standards established under section

1395m(c)(3) of this title" after "section 1395k(a)(2)(F)(i) of this

title" in first sentence.

Subsec. (e). Pub. L. 103-432, Sec. 160(a)(1)(A), inserted before

period at end "(other than any fee relating to section 263a of this

title)".

1990 - Subsec. (a). Pub. L. 101-508, Sec. 4163(c)(2), inserted

before period at end of first sentence ", or whether screening

mammography meets the standards established under section

1395m(c)(3) of this title".

Pub. L. 101-508, Sec. 4154(d)(1), substituted "section 1395x(s)

of this title or (in the case of a laboratory that does not

participate or seek to participate in the medicare program) the

requirements of section 263a of this title," for "section 1395x(s)

of this title," in first sentence.

Subsec. (e). Pub. L. 101-508, Sec. 4207(g), formerly Sec.

4027(g), as renumbered by Pub. L. 103-432, Sec. 160(d)(4), added

subsec. (e).

1989 - Subsec. (a). Pub. L. 101-239, Sec. 6115(c), substituted

"paragraphs (15) and (16)" for "paragraphs (14) and (15)".

Pub. L. 101-239, Sec. 6003(g)(3)(C)(iii), inserted ", a rural

primary care hospital, as defined in section 1395x(mm)(1) of this

title," after "1395x(aa)(2) of this title".

Pub. L. 101-234 repealed Pub. L. 100-360, Secs. 203(e)(3),

204(c)(2), (d)(3), and provided that the provisions of law amended

or repealed by such sections are restored or revived as if such

sections had not been enacted, see 1988 and 1989 Amendment notes.

1988 - Subsec. (a). Pub. L. 100-360, Sec. 411(l)(6)(B), amended

Pub. L. 100-203, Sec. 4212(b), see 1987 Amendment note below.

Pub. L. 100-360, Sec. 411(l)(1)(C), as added by Pub. L. 100-485,

Sec. 608(d)(27)(B), added Pub. L. 100-203, Sec. 4201(d)(4), see

1987 Amendment note below.

Pub. L. 100-360, Sec. 411(d)(4)(A)(i), as amended by Pub. L.

100-485, Sec. 608(d)(20)(B)(i), substituted "most recent

certification survey conducted by a State agency or accreditation

survey conducted by a private accreditation agency under section

1395bb of this title with respect to the home health agency," for

"most recent certification survey conducted with respect to the

agency,".

Pub. L. 100-360, Sec. 411(d)(4)(A)(ii)(I), as amended by Pub. L.

100-485, Sec. 608(d)(20)(C), substituted "such State or local

agency to maintain a unit" for "such agency to maintain a unit".

Pub. L. 100-360, Sec. 411(d)(4)(A)(ii)(II), as amended by Pub. L.

100-485, Sec. 608(d)(20)(B)(ii), substituted "utilized by the

Secretary under section 1395bb of this title" for "pursuant to an

agreement with the Secretary under this section".

Pub. L. 100-360, Sec. 204(d)(3), substituted "paragraphs (14) and

(15)" for "paragraphs (13) and (14)".

Pub. L. 100-360, Sec. 204(c)(2), inserted ", or whether screening

mammography meets the standards established under section

1395m(e)(3) of this title" after "section 1395k(a)(2)(F)(i) of this

title".

Pub. L. 100-360, Sec. 203(e)(3), inserted "or a home intravenous

drug therapy provider," after "hospice program" and substituted

"hospice program, or home intravenous drug therapy provider" for

"or hospice program".

1987 - Subsec. (a). Pub. L. 100-203, Sec. 4212(b), which directed

an amendment of subsec. (a) identical to Pub. L. 100-203, Sec.

4202(c), was amended generally by Pub. L. 100-360, Sec.

411(l)(6)(B), so that it does not amend this section but rather

section 1396r of this title.

Pub. L. 100-203, Sec. 4202(c), inserted ", and require (in the

case of skilled nursing facilities) the posting in a place readily

accessible to patients (and patients' representatives)," after

"place" in fifth sentence.

Pub. L. 100-203, Sec. 4201(d)(4), as added by Pub. L. 100-360,

Sec. 411(l)(1)(C), as added by Pub. L. 100-485, Sec. 608(d)(27)(B),

substituted "conditions specified in section 1395i-3(a) of this

title" for "conditions specified in section 1395x(j) of this

title".

Pub. L. 100-203, Sec. 4072(d), substituted "paragraphs (13) and

(14)" for "paragraphs (12) and (13)" in first sentence.

Pub. L. 100-203, Sec. 4025(a), inserted at end "Any agreement

under this subsection shall provide for the appropriate State or

local agency to maintain a toll-free hotline (1) to collect,

maintain, and continually update information on home health

agencies located in the State or locality that are certified to

participate in the program established under this subchapter (which

information shall include any significant deficiencies found with

respect to patient care in the most recent certification survey

conducted with respect to the agency, when that survey was

completed, whether corrective actions have been taken or are

planned, and the sanctions, if any, imposed under this subchapter

with respect to the agency) and (2) to receive complaints (and

answer questions) with respect to home health agencies in the State

or locality. Any such agreement shall provide for such agency to

maintain a unit for investigating such complaints that possesses

enforcement authority and has access to survey and certification

reports, information gathered by any private accreditation agency

pursuant to an agreement with the Secretary under this section, and

consumer medical records (but only with the consent of the consumer

or his or her legal representative)."

Subsec. (d). Pub. L. 100-203, Sec. 4203(a)(1), inserted before

period at end "and the establishment of remedies under sections

1395i-3(h)(2)(B) and 1395i-3(h)(2)(C) of this title (relating to

establishment and application of remedies)".

Pub. L. 100-203, Sec. 4202(a)(1), inserted "and section

1395i-3(g) of this title" before period at end.

Pub. L. 100-203, Sec. 4201(a)(2), added subsec. (d).

1986 - Subsec. (a). Pub. L. 99-509 substituted "paragraphs (12)

and (13)" for "paragraphs (11) and (12)".

1984 - Subsec. (c). Pub. L. 98-369 struck out "the" after "Joint

Commission on".

1982 - Subsec. (a). Pub. L. 97-248 inserted "or whether an agency

is a hospice program" and substituted "home health agency, or

hospice program" for "or home health agency".

1980 - Subsec. (a). Pub. L. 96-611 substituted "requirements of

paragraphs (11) and (12) of section 1395x(s) of this title" for

"requirements of paragraphs (10) and (11) of section 1395x(s) of

this title".

Pub. L. 96-499, Sec. 933(g), inserted "or a comprehensive

outpatient rehabilitation facility as defined in section

1395x(cc)(2) of this title" after "section 1395x(aa)(2) of this

title" and "comprehensive outpatient rehabilitation facility,"

after "rural health clinic" in four places.

Pub. L. 96-499, Sec. 934(c)(2), inserted ", or whether an

ambulatory surgical center meets the standards specified under

section 1395k(a)(2)(F) of this title" after "section 1395x(p)(4) of

this title" and "ambulatory surgical center," after "health care

facility," in three places.

1977 - Subsec. (a). Pub. L. 95-210 expanded enumeration of

institutions and agencies included under coverage of this

subsection by inserting references to rural health clinics in five

places.

1972 - Subsec. (a). Pub. L. 92-603, Secs. 277, 278(a)(16),

(b)(15), 299D(a), provided for the furnishing of specialized

consultative services to skilled nursing facilities, authorized the

Secretary to make public the pertinent findings of each survey

within 90 days following the completion of each survey of any

health care facility, etc., and substituted "skilled nursing

facility" for "extended care facility".

Subsec. (c). Pub. L. 92-603, Sec. 244(a), added subsec. (c).

1968 - Subsec. (a). Pub. L. 90-248, Sec. 133(f), inserted clause

at end of first sentence for determining whether a clinic,

rehabilitation agency, or public health agency meets the

requirements of section 1395x(p)(4)(A) or (B) of this title.

Pub. L. 90-248, Sec. 228(b), struck out last sentence providing

for utilization of State facilities to provide consultative

services to institutions furnishing medical care, covered in

section 1396a(a)(24) of this title.

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by section 4106(c) of Pub. L. 105-33 applicable to bone

mass measurements performed on or after July 1, 1998, see section

4106(d) of Pub. L. 105-33, set out as a note under section 1395x of

this title.

Amendment by section 4201(c)(1) of Pub. L. 105-33 applicable to

services furnished on or after Oct. 1, 1997, see section 4201(d) of

Pub. L. 105-33, set out as a note under section 1395f of this

title.

EFFECTIVE DATE OF 1994 AMENDMENT

Amendment by section 145(c)(3) of Pub. L. 103-432 applicable to

mammography furnished by a facility on and after the first date

that the certificate requirements of section 263b(b) of this title

apply to such mammography conducted by such facility, see section

145(d) of Pub. L. 103-432, set out as a note under section 1395m of

this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Section 4154(d)(2) of Pub. L. 101-508 provided that: "The

amendment made by paragraph (1) [amending this section] shall take

effect as if included in the enactment of the Clinical Laboratory

Improvement Amendments of 1988 [Pub. L. 100-578]."

Amendment by section 4163(c)(2) of Pub. L. 101-508 applicable to

screening mammography performed on or after Jan. 1, 1991, see

section 4163(e) of Pub. L. 101-508, set out as a note under section

1395l of this title.

EFFECTIVE DATE OF 1989 AMENDMENTS

Amendment by section 6115(c) of Pub. L. 101-239 applicable to

screening pap smears performed on or after July 1, 1990, see

section 6115(d) of Pub. L. 101-239, set out as a note under section

1395x of this title.

Amendment by Pub. L. 101-234 effective Jan. 1, 1990, see section

201(c) of Pub. L. 101-234, set out as a note under section 1320a-7a

of this title.

EFFECTIVE DATE OF 1988 AMENDMENTS

Amendment by Pub. L. 100-485 effective as if included in the

enactment of the Medicare Catastrophic Coverage Act of 1988, Pub.

L. 100-360, see section 608(g)(1) of Pub. L. 100-485, set out as a

note under section 704 of this title.

Amendment by section 203(e)(3) of Pub. L. 100-360 applicable to

items and services furnished on or after Jan. 1, 1990, see section

203(g) of Pub. L. 100-360, set out as a note under section 1320c-3

of this title.

Amendment by section 204(c)(2), (d)(3) of Pub. L. 100-360

applicable to screening mammography performed on or after Jan. 1,

1990, see section 204(e) of Pub. L. 100-360, set out as a note

under section 1395m of this title.

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by section 411(d)(4)(A), (l)(1)(C), (6)(B) of

Pub. L. 100-360, as it relates to a provision in the Omnibus Budget

Reconciliation Act of 1987, Pub. L. 100-203, effective as if

included in the enactment of that provision in Pub. L. 100-203, see

section 411(a) of Pub. L. 100-360, set out as a Reference to OBRA;

Effective Date note under section 106 of Title 1, General

Provisions.

EFFECTIVE DATE OF 1987 AMENDMENT

Section 4025(c), formerly Sec. 4025(b), of Pub. L. 100-203, as

redesignated and amended by Pub. L. 100-360, title IV, Sec.

411(d)(4)(B)(i), July 1, 1988, 102 Stat. 774, provided that: "The

amendment made by this section [amending this section and section

1395bb of this title] shall apply with respect to agreements

entered into or renewed on or after the date of enactment of this

Act [Dec. 22, 1987]."

For effective date of amendment by section 4072(d) of Pub. L.

100-203, see section 4072(e) of Pub. L. 100-203, set out as a note

under section 1395x of this title.

Amendments by sections 4201(a)(2), (d)(4) and 4202(a)(1), (c) of

Pub. L. 100-203 applicable to services furnished on or after Oct.

1, 1990, without regard to whether regulations to implement such

amendments are promulgated by such date, except as otherwise

specifically provided in section 1395i-3 of this title, see section

4204(a) of Pub. L. 100-203, as amended, set out as an Effective

Date note under section 1395i-3 of this title.

Amendment by section 4203(a)(1) of Pub. L. 100-203 applicable

Jan. 1, 1988, except as otherwise specifically provided in section

1395i-3 of this title, without regard to whether regulations to

implement such amendment are promulgated by such date, and in

applying amendment by section 4203(a)(1) of Pub. L. 100-203 for

services furnished by a skilled nursing facility before Oct. 1,

1990, any reference to a requirement of section 1395i-3(b), (c), or

(d) of this title is deemed a reference to section 1395x(j) of this

title, see section 4204(b) of Pub. L. 100-203, as added by Pub. L.

100-485, set out as an Effective Date note under section 1395i-3 of

this title.

EFFECTIVE DATE OF 1986 AMENDMENT

Amendment by Pub. L. 99-509 applicable to services furnished on

or after Jan. 1, 1989, with exceptions for hospitals located in

rural areas which meet certain requirements related to certified

registered nurse anesthetists, see section 9320(i), (k) of Pub. L.

99-509, as amended, set out as notes under section 1395k of this

title.

EFFECTIVE DATE OF 1984 AMENDMENT

Amendment by Pub. L. 98-369 effective July 18, 1984, but not to

be construed as changing or affecting any right, liability, status,

or interpretation which existed (under the provisions of law

involved) before that date, see section 2354(e)(1) of Pub. L.

98-369, set out as a note under section 1320a-1 of this title.

EFFECTIVE DATE OF 1982 AMENDMENT

Amendment by Pub. L. 97-248 applicable to hospice care provided

on or after Nov. 1, 1983, see section 122(h)(1) of Pub. L. 97-248,

as amended, set out as a note under section 1395c of this title.

EFFECTIVE DATE OF 1980 AMENDMENTS

Amendment by Pub. L. 96-611 effective July 1, 1981, and

applicable to services furnished on or after that date, see section

2 of Pub. L. 96-611, set out as a note under section 1395l of this

title.

For effective date of amendment by section 933(g) of Pub. L.

96-499, see section 933(h) of Pub. L. 96-499, set out as a note

under section 1395k of this title.

EFFECTIVE DATE OF 1977 AMENDMENT

Amendment by Pub. L. 95-210 applicable to services rendered on or

after first day of third calendar month which begins after Dec. 31,

1977, see section 1(j) of Pub. L. 95-210, set out as a note under

section 1395k of this title.

EFFECTIVE DATE OF 1972 AMENDMENT

Section 299D(c) of Pub. L. 92-603 provided that: "The provisions

of this section [amending this section and section 1396a of this

title] shall be effective beginning January 1, 1973, or within 6

months following the enactment of this Act [Oct. 30, 1972],

whichever is later."

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment by section 133(f) of Pub. L. 90-248 applicable with

respect to services furnished after June 30, 1968, see section

133(g) of Pub. L. 90-248, set out as a note under section 1395k of

this title.

Section 228(b) of Pub. L. 90-248 provided that the amendment made

by such section 228(b) is effective July 1, 1969.

USE OF STATE OR LOCAL AGENCIES IN EVALUATING LABORATORIES

Section 160(a)(2) of Pub. L. 103-432 provided that: "An agreement

made by the Secretary of Health and Human Services with a State

under section 1864(a) of the Social Security Act [subsec. (a) of

this section] may include an agreement that the services of the

State health agency or other appropriate State agency (or the

appropriate local agencies) will be utilized by the Secretary for

the purpose of determining whether a laboratory meets the

requirements of section 353 of the Public Health Service Act

[section 263a of this title]."

NURSE AID TRAINING AND COMPETENCY EVALUATION, FAILURE BY STATE TO

MEET GUIDELINES

Section 4008(h)(1)(A) of Pub. L. 101-508 provided that: "The

Secretary of Health and Human Services may not refuse to enter into

an agreement or cancel an existing agreement with a State under

section 1864 of the Social Security Act [this section] on the basis

that the State failed to meet the requirement of section

1819(e)(1)(A) of such Act [section 1395i-3(e)(1)(A) of this title]

before the effective date of guidelines, issued by the Secretary,

establishing requirements under section 1819(f)(2)(A) of such Act,

if the State demonstrates to the satisfaction of the Secretary that

it has made a good faith effort to meet such requirement before

such effective date."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 263a-2, 1320a-7,

1320a-7a, 1395i-3, 1395x, 1395bb, 1395bbb, 1396a of this title;

title 45 section 231f.

-End-

-CITE-

42 USC Sec. 1395bb 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395bb. Effect of accreditation

-STATUTE-

(a) In general

Except as provided in subsection (b) (!1) of this section and the

second sentence of section 1395z of this title, if -

(1) an institution is accredited as a hospital by the Joint

Commission on Accreditation of Hospitals, and

(2)(A) such institution authorizes the Commission to release to

the Secretary upon his request (or such State agency as the

Secretary may designate) a copy of the most current accreditation

survey of such institution made by such Commission, together with

any other information directly related to the survey as the

Secretary may require (including corrective action plans),(!2)

(B) such Commission releases such a copy and any such

information to the Secretary,

then, such institution shall be deemed to meet the requirements of

the numbered paragraphs of section 1395x(e) of this title; except -

(3) paragraph (6) thereof, and

(4) any standard, promulgated by the Secretary pursuant to

paragraph (9) thereof, which is higher than the requirements

prescribed for accreditation by such Commission.

If such Commission, as a condition for accreditation of a hospital,

requires a utilization review plan (or imposes another requirement

which serves substantially the same purpose), requires a discharge

planning process (or imposes another requirement which serves

substantially the same purpose), or imposes a standard which the

Secretary determines is at least equivalent to the standard

promulgated by the Secretary as described in paragraph (4) of this

subsection, the Secretary is authorized to find that all

institutions so accredited by such Commission comply also with

clause (A) or (B) of section 1395x(e)(6) of this title or the

standard described in such paragraph (4), as the case may be.

(b) Accreditation by American Osteopathic Association or other

national accreditation body

(1) In addition, if the Secretary finds that accreditation of a

provider entity (as defined in paragraph (4)) by the American

Osteopathic Association or any other national accreditation body

demonstrates that all of the applicable conditions or requirements

of this subchapter (other than the requirements of section 1395m(j)

of this title or the conditions and requirements under section

1395rr(b) of this title) are met or exceeded -

(A) in the case of a provider entity not described in paragraph

(3)(B), the Secretary shall treat such entity as meeting those

conditions or requirements with respect to which the Secretary

made such finding; or

(B) in the case of a provider entity described in paragraph

(3)(B), the Secretary may treat such entity as meeting those

conditions or requirements with respect to which the Secretary

made such finding.

(2) In making such a finding, the Secretary shall consider, among

other factors with respect to a national accreditation body, its

requirements for accreditation, its survey procedures, its ability

to provide adequate resources for conducting required surveys and

supplying information for use in enforcement activities, its

monitoring procedures for provider entities found out of compliance

with the conditions or requirements, and its ability to provide the

Secretary with necessary data for validation.

(3)(A) Except as provided in subparagraph (B), not later than 60

days after the date of receipt of a written request for a finding

under paragraph (1) (with any documentation necessary to make a

determination on the request), the Secretary shall publish a notice

identifying the national accreditation body making the request,

describing the nature of the request, and providing a period of at

least 30 days for the public to comment on the request. The

Secretary shall approve or deny a request for such a finding, and

shall publish notice of such approval or denial, not later than 210

days after the date of receipt of the request (with such

documentation). Such an approval shall be effective with respect to

accreditation determinations made on or after such effective date

(which may not be later than the date of publication of the

approval) as the Secretary specifies in the publication notice.

(B) The 210-day and 60-day deadlines specified in subparagraph

(A) shall not apply in the case of any request for a finding with

respect to accreditation of a provider entity to which the

conditions and requirements of section (!3) 1395i-3 and 1395x(j) of

this title apply.

(4) For purposes of this section, the term "provider entity"

means a provider of services, supplier, facility, clinic, agency,

or laboratory.

(c) Disclosure of accreditation survey

The Secretary may not disclose any accreditation survey (other

than a survey with respect to a home health agency) made and

released to him by the Joint Commission on Accreditation of

Hospitals, the American Osteopathic Association, or any other

national accreditation body, of an entity accredited by such body,

except that the Secretary may disclose such a survey and

information related to such a survey to the extent such survey and

information relate to an enforcement action taken by the Secretary.

(d) Deficiencies

Notwithstanding any other provision of this subchapter, if the

Secretary finds that a provider entity has significant deficiencies

(as defined in regulations pertaining to health and safety), the

entity shall, after the date of notice of such finding to the

entity and for such period as may be prescribed in regulations, be

deemed not to meet the conditions or requirements the entity has

been treated as meeting pursuant to subsection (a) or (b)(1) of

this section.

(e) State or local accreditation

For provisions relating to validation surveys of entities that

are treated as meeting applicable conditions or requirements of

this subchapter pursuant to subsection (a) or (b)(1) of this

section, see section 1395aa(c) of this title.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1865, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 326; amended

Pub. L. 92-603, title II, Secs. 234(h), 244(b), Oct. 30, 1972, 86

Stat. 1413, 1423; Pub. L. 97-248, title I, Secs. 122(g)(4),

128(d)(3), Sept. 3, 1982, 96 Stat. 362, 367; Pub. L. 98-369, div.

B, title III, Secs. 2345(a), 2346(a), July 18, 1984, 98 Stat. 1096;

Pub. L. 99-509, title IX, Secs. 9305(c)(3), 9320(h)(3), Oct. 21,

1986, 100 Stat. 1990, 2016; Pub. L. 100-203, title IV, Secs.

4025(b), 4072(d), Dec. 22, 1987, 101 Stat. 1330-117, as amended

Pub. L. 100-360, title IV, Sec. 411(d)(4)(B)(ii), July 1, 1988, 102

Stat. 774; Pub. L. 100-360, title II, Secs. 204(c)(3), (d)(3), July

1, 1988, 102 Stat. 728, 729; Pub. L. 100-485, title VI, Sec.

608(d)(20)(D), Oct. 13, 1988, 102 Stat. 2420; Pub. L. 101-234,

title II, Sec. 201(a), Dec. 13, 1989, 103 Stat. 1981; Pub. L.

101-239, title VI, Secs. 6003(g)(3)(C)(iv), 6019(a)-(c), 6115(c),

Dec. 19, 1989, 103 Stat. 2153, 2165, 2166, 2219; Pub. L. 101-508,

title IV, Sec. 4163(c)(3), Nov. 5, 1990, 104 Stat. 1388-100; Pub.

L. 103-432, title I, Sec. 145(c)(4), Oct. 31, 1994, 108 Stat. 4427;

Pub. L. 104-134, title I, Sec. 101(d) [title V, Sec. 516(b),

(c)(2)], Apr. 26, 1996, 110 Stat. 1321-211, 1321-246, 1321-247;

renumbered title I, Pub. L. 104-140, Sec. 1(a), May 2, 1996, 110

Stat. 1327.)

-REFTEXT-

REFERENCES IN TEXT

Subsection (b) of this section, referred to in subsec. (a), was

redesignated subsec. (d) and a new subsec. (b) added by Pub. L.

104-134, title I, Sec. 101(d) [title V, Sec. 516(b)(1), (3)], Apr.

26, 1996, 110 Stat. 1321-211, 1321-246; renumbered title I, Pub. L.

104-140, Sec. 1(a), May 2, 1996, 110 Stat. 1327.

-MISC1-

AMENDMENTS

1996 - Subsec. (a). Pub. L. 104-134, Sec. 101(d) [title V, Sec.

516(b)(2), (3)], struck out after second sentence: "In addition, if

the Secretary finds that accreditation of an entity by the American

Osteopathic Association or any other national accreditation body

provides reasonable assurance that any or all of the conditions of

section 1395k(a)(2)(F)(i), 1395x(e), 1395x(f), 1395x(j), 1395x(o),

1395x(p)(4)(A) or (B), paragraphs (15) and (16) of section

1395x(s), section 1395x(aa)(2), 1395x(cc)(2), 1395x(dd)(2), or

1395x(mm)(1) of this title, as the case may be, are met, he may, to

the extent he deems it appropriate, treat such entity as meeting

the condition or conditions with respect to which he made such

finding." and redesignated fourth sentence as subsec. (c).

Subsec. (b). Pub. L. 104-134, Sec. 101(d) [title V, Sec.

516(b)(3)], added subsec. (b). Former subsec. (b) redesignated (d).

Subsec. (c). Pub. L. 104-134, Sec. 101(d) [title V, Sec.

516(b)(2)], redesignated fourth sentence of subsec. (a) as subsec.

(c).

Subsec. (d). Pub. L. 104-134, Sec. 101(d) [title V, Sec.

516(b)(1), (c)(2)(A)], redesignated subsec. (b) as (d) and

substituted "a provider entity" for "a hospital", "the entity" for

"the hospital" in two places, and "the conditions or requirements

the entity has been treated as meeting pursuant to subsection (a)

or (b)(1) of this section" for "the requirements of the numbered

paragraphs of section 1395x(e) of this title".

Subsec. (e). Pub. L. 104-134, Sec. 101(d) [title V, Sec.

516(c)(2)(B)], added subsec. (e).

1994 - Subsec. (a). Pub. L. 103-432 struck out "1395m(c)(3),"

after "conditions of section 1395k(a)(2)(F)(i)," in closing

provisions.

1990 - Subsec. (a). Pub. L. 101-508 inserted "1395m(c)(3)," after

"1395k(a)(2)(F)(i)," in second sentence.

1989 - Subsec. (a). Pub. L. 101-239, Sec. 6115(c), substituted

"paragraphs (15) and (16)" for "paragraphs (14) and (15)".

Pub. L. 101-239, Sec. 6019(b), inserted before period at end ",

except that the Secretary may disclose such a survey and

information related to such a survey to the extent such survey and

information relate to an enforcement action taken by the

Secretary".

Pub. L. 101-239, Sec. 6003(g)(3)(C)(iv), substituted

"1395x(dd)(2), or 1395x(mm)(1) of this title" for "or 1395x(dd)(2)

of this title" in third sentence.

Pub. L. 101-234 repealed Pub. L. 100-360, Sec. 204(c)(3), (d)(3),

and provided that the provisions of law amended or repealed by such

section are restored or revived as if such section had not been

enacted, see 1988 and 1989 Amendment notes.

Subsec. (a)(2). Pub. L. 101-239, Sec. 6019(a), designated

existing provisions as subpar. (A), struck out "(if it is included

within a survey described in section 1395aa(c) of this title)"

after "such institution", inserted ", together with any other

information directly related to the survey as the Secretary may

require (including corrective action plans)" after "by such

Commission", and added subpar. (B).

Subsec. (b). Pub. L. 101-239, Sec. 6019(c), struck out "following

a survey made pursuant to section 1395aa(c) of this title" after

"if the Secretary finds".

1988 - Subsec. (a). Pub. L. 100-360, Sec. 411(d)(4)(B)(ii), as

amended by Pub. L. 100-485, Sec. 608(d)(20)(D), added Pub. L.

100-203, Sec. 4025(b), see 1987 Amendment note below.

Pub. L. 100-360, Sec. 204(d)(3), substituted "paragraphs (14) and

(15)" for "paragraphs (13) and (14)" in third sentence.

Pub. L. 100-360, Sec. 204(c)(3), inserted "1395m(e)(3)," after

"1395k(a)(2)(F)(i)," in third sentence.

1987 - Subsec. (a). Pub. L. 100-203, Sec. 4072(d), substituted

"paragraphs (13) and (14)" for "paragraphs (12) and (13)" in

penultimate sentence.

Pub. L. 100-203, Sec. 4025(b), as added by Pub. L. 100-360, Sec.

411(d)(4)(B)(ii), as amended by Pub. L. 100-485, Sec.

608(d)(20)(D), inserted "(other than a survey with respect to a

home health agency)" after "survey" in last sentence.

1986 - Subsec. (a). Pub. L. 99-509, Sec. 9305(c)(3), inserted ",

requires a discharge planning process (or imposes another

requirement which serves substantially the same purpose)" after

"the same purpose)", and "clause (A) or (B) of" after "comply also

with" in second sentence.

Pub. L. 99-509, Sec. 9320(h)(3), substituted "paragraphs (12) and

(13)" for "paragraphs (11) and (12)" in third sentence.

1984 - Subsec. (a). Pub. L. 98-369, Sec. 2346(a), in provisions

following par. (4), substituted "section 1395k(a)(2)(F)(i),

1395x(e), 1395x(f), 1395x(j), 1395x(o), 1395x(p)(4)(A) or (B),

paragraphs (11) and (12) of section 1395x(s), section 1395x(aa)(2),

1395x(cc)(2), or 1395x(dd)(2) of this title" for "section 1395x(e),

(j), (o), or (dd) of this title", and substituted "entity" for

"institution or agency" in two places.

Pub. L. 98-369, Sec. 2345(a), struck out "(on a confidential

basis)" after "release to the Secretary" in par. (2), and inserted

provision that the Secretary may not disclose any accreditation

survey made and released to him by the Joint Commission on

Accreditation of Hospitals, the American Osteopathic Association,

or any other national accreditation body, of an entity accredited

by such body, in provisions following par. (4).

1982 - Subsec. (a). Pub. L. 97-248, Sec. 122(g)(4), substituted

"(o), or (dd)" for "or (o)".

Subsec. (b). Pub. L. 97-248, Sec. 128(d)(3), substituted "a

hospital" for "an institution" and "the hospital" for "such

institution".

1972 - Pub. L. 92-603 designated existing provisions as subsec.

(a), inserted reference to subsec. (b) of this section in opening

provisions, redesignated existing provisions as pars. (1) and (3)

and added pars. (2) and (4) and in provisions following par. (4)

inserted provisions for the imposition of a standard which the

Secretary determines is at least equivalent to the standard

promulgated by the Secretary as described in par. (4), and added

subsec. (b).

EFFECTIVE DATE OF 1994 AMENDMENT

Amendment by Pub. L. 103-432 applicable to mammography furnished

by a facility on and after the first date that the certificate

requirements of section 263b(b) of this title apply to such

mammography conducted by such facility, see section 145(d) of Pub.

L. 103-432, set out as a note under section 1395m of this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-508 applicable to screening mammography

performed on or after Jan. 1, 1991, see section 4163(e) of Pub. L.

101-508, set out as a note under section 1395l of this title.

EFFECTIVE DATE OF 1989 AMENDMENTS

Section 6019(d) of Pub. L. 101-239 provided that:

"(1) Except as provided in paragraph (2), the amendments made by

this section [amending this section] shall take effect on the date

of the enactment of this Act [Dec. 19, 1989].

"(2) The amendments made by subsection (a) [amending this

section] shall take effect 6 months after the date of the enactment

of this Act."

Amendment by section 6115(c) of Pub. L. 101-239 applicable to

screening pap smears performed on or after July 1, 1990, see

section 6115(d) of Pub. L. 101-239, set out as a note under section

1395x of this title.

Amendment by Pub. L. 101-234 effective Jan. 1, 1990, see section

201(c) of Pub. L. 101-234, set out as a note under section 1320a-7a

of this title.

EFFECTIVE DATE OF 1988 AMENDMENTS

Amendment by Pub. L. 100-485 effective as if included in the

enactment of the Medicare Catastrophic Coverage Act of 1988, Pub.

L. 100-360, see section 608(g)(1) of Pub. L. 100-485, set out as a

note under section 704 of this title.

Amendment by section 204(c)(3), (d)(3) of Pub. L. 100-360

applicable to screening mammography performed on or after Jan. 1,

1990, see section 204(e) of Pub. L. 100-360, set out as a note

under section 1395m of this title.

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by section 411(d)(4)(B)(ii) of Pub. L. 100-360,

as it relates to a provision in the Omnibus Budget Reconciliation

Act of 1987, Pub. L. 100-203, effective as if included in the

enactment of that provision in Pub. L. 100-203, see section 411(a)

of Pub. L. 100-360, set out as a Reference to OBRA; Effective Date

note under section 106 of Title 1, General Provisions.

EFFECTIVE DATE OF 1987 AMENDMENT

Amendment by section 4025(b) of Pub. L. 100-203 applicable with

respect to agreements entered into or renewed on or after Dec. 22,

1987, see section 4025(c) of Pub. L. 100-203, as amended, set out

as a note under section 1395aa of this title.

For effective date of amendment by section 4072(d) of Pub. L.

100-203, see section 4072(e) of Pub. L. 100-203, set out as a note

under section 1395x of this title.

EFFECTIVE DATE OF 1986 AMENDMENT

Amendment by section 9305(c)(3) of Pub. L. 99-509 applicable to

hospitals as of one year after Oct. 21, 1986, see section

9305(c)(4) of Pub. L. 99-509, set out as a note under section 1395x

of this title.

Amendment by section 9320(h)(3) of Pub. L. 99-509 applicable to

services furnished on or after Jan. 1, 1989, with exceptions for

hospitals located in rural areas which meet certain requirements

related to certified registered nurse anesthetists, see section

9320(i), (k) of Pub. L. 99-509, as amended, set out as notes under

section 1395k of this title.

EFFECTIVE DATE OF 1984 AMENDMENT

Section 2345(b) of Pub. L. 98-369 provided that: "The amendments

made by this section [amending this section] shall become effective

on the date of the enactment of this Act [July 18, 1984], and shall

apply with respect to surveys released to the Secretary on, before,

or after such date."

Section 2346(b) of Pub. L. 98-369 provided that: "The amendments

made by this section [amending this section] shall become effective

on the date of the enactment of this Act [July 18, 1984]."

EFFECTIVE DATE OF 1982 AMENDMENT

Amendment by section 122(g)(4) of Pub. L. 97-248 applicable to

hospice care provided on or after Nov. 1, 1983, see section

122(h)(1) of Pub. L. 97-248, as amended, set out as a note under

section 1395c of this title.

Amendment by section 128(d)(3) of Pub. L. 97-248 effective Sept.

3, 1982, see section 128(e)(3) of Pub. L. 97-248, set out as a note

under section 1395x of this title.

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by section 234(h) of Pub. L. 92-603 applicable with

respect to providers of services for fiscal years beginning after

the fifth month following October 1972, see section 234(i) of Pub.

L. 92-603, set out as a note under section 1395x of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1320c-9, 1395w-22, 1395x,

1395aa of this title.

-FOOTNOTE-

(!1) See References in Text note below.

(!2) So in original. Probably should be followed by "and".

(!3) So in original. Probably should be "sections".

-End-

-CITE-

42 USC Sec. 1395cc 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395cc. Agreements with providers of services

-STATUTE-

(a) Filing of agreements; eligibility for payment; charges with

respect to items and services

(1) Any provider of services (except a fund designated for

purposes of section 1395f(g) and section 1395n(e) of this title)

shall be qualified to participate under this subchapter and shall

be eligible for payments under this subchapter if it files with the

Secretary an agreement -

(A)(i) not to charge, except as provided in paragraph (2), any

individual or any other person for items or services for which

such individual is entitled to have payment made under this

subchapter (or for which he would be so entitled if such provider

of services had complied with the procedural and other

requirements under or pursuant to this subchapter or for which

such provider is paid pursuant to the provisions of section

1395f(e) of this title), and (ii) not to impose any charge that

is prohibited under section 1396a(n)(3) of this title,

(B) not to charge any individual or any other person for items

or services for which such individual is not entitled to have

payment made under this subchapter because payment for expenses

incurred for such items or services may not be made by reason of

the provisions of paragraph (1) or (9) of section 1395y(a) of

this title, but only if (i) such individual was without fault in

incurring such expenses and (ii) the Secretary's determination

that such payment may not be made for such items and services was

made after the third year following the year in which notice of

such payment was sent to such individual; except that the

Secretary may reduce such three-year period to not less than one

year if he finds such reduction is consistent with the objectives

of this subchapter,

(C) to make adequate provision for return (or other

disposition, in accordance with regulations) of any moneys

incorrectly collected from such individual or other person,

(D) to promptly notify the Secretary of its employment of an

individual who, at any time during the year preceding such

employment, was employed in a managerial, accounting, auditing,

or similar capacity (as determined by the Secretary by

regulation) by an agency or organization which serves as a fiscal

intermediary or carrier (for purposes of part A or part B, or

both, of this subchapter) with respect to the provider,

(E) to release data with respect to patients of such provider

upon request to an organization having a contract with the

Secretary under part B of subchapter XI of this chapter as may be

necessary (i) to allow such organization to carry out its

functions under such contract, or (ii) to allow such organization

to carry out similar review functions under any contract the

organization may have with a private or public agency paying for

health care in the same area with respect to patients who

authorize release of such data for such purposes,

(F)(i) in the case of hospitals which provide inpatient

hospital services for which payment may be made under subsection

(b), (c), or (d) of section 1395ww of this title, to maintain an

agreement with a professional standards review organization (if

there is such an organization in existence in the area in which

the hospital is located) or with a utilization and quality

control peer review organization which has a contract with the

Secretary under part B of subchapter XI of this chapter for the

area in which the hospital is located, under which the

organization will perform functions under that part with respect

to the review of the validity of diagnostic information provided

by such hospital, the completeness, adequacy, and quality of care

provided, the appropriateness of admissions and discharges, and

the appropriateness of care provided for which additional

payments are sought under section 1395ww(d)(5) of this title,

with respect to inpatient hospital services for which payment may

be made under part A of this subchapter (and for purposes of

payment under this subchapter, the cost of such agreement to the

hospital shall be considered a cost incurred by such hospital in

providing inpatient services under part A of this subchapter, and

(I) shall be paid directly by the Secretary to such organization

on behalf of such hospital in accordance with a rate per review

established by the Secretary, (II) shall be transferred from the

Federal Hospital Insurance Trust Fund, without regard to amounts

appropriated in advance in appropriation Acts, in the same manner

as transfers are made for payment for services provided directly

to beneficiaries, and (III) shall not be less in the aggregate

for a fiscal year than the aggregate amount expended in fiscal

year 1988 for direct and administrative costs (adjusted for

inflation and for any direct or administrative costs incurred as

a result of review functions added with respect to a subsequent

fiscal year) of such reviews),

(ii) in the case of hospitals, critical access hospitals,

skilled nursing facilities, and home health agencies, to maintain

an agreement with a utilization and quality control peer review

organization (which has a contract with the Secretary under part

B of subchapter XI of this chapter for the area in which the

hospital, facility, or agency is located) to perform the

functions described in paragraph (3)(A),

(G) in the case of hospitals which provide inpatient hospital

services for which payment may be made under subsection (b) or

(d) of section 1395ww of this title, not to charge any individual

or any other person for inpatient hospital services for which

such individual would be entitled to have payment made under part

A of this subchapter but for a denial or reduction of payments

under section 1395ww(f)(2) of this title,

(H)(i) in the case of hospitals which provide services for

which payment may be made under this subchapter and in the case

of critical access hospitals which provide critical access

hospital services, to have all items and services (other than

physicians' services as defined in regulations for purposes of

section 1395y(a)(14) of this title, and other than services

described by section 1395x(s)(2)(K) of this title, certified

nurse-midwife services, qualified psychologist services, and

services of a certified registered nurse anesthetist) (I) that

are furnished to an individual who is a patient of the hospital,

and (II) for which the individual is entitled to have payment

made under this subchapter, furnished by the hospital or

otherwise under arrangements (as defined in section 1395x(w)(1)

of this title) made by the hospital,

(ii) in the case of skilled nursing facilities which provide

covered skilled nursing facility services -

(I) that are furnished to an individual who is a resident of

the skilled nursing facility during a period in which the

resident is provided covered post-hospital extended care

services (or, for services described in section 1395x(s)(2)(D)

of this title, that are furnished to such an individual without

regard to such period), and

(II) for which the individual is entitled to have payment

made under this subchapter,

to have items and services (other than services described in

section 1395yy(e)(2)(A)(ii) of this title) furnished by the

skilled nursing facility or otherwise under arrangements (as

defined in section 1395x(w)(1) of this title) made by the skilled

nursing facility,

(I) in the case of a hospital or critical access hospital -

(i) to adopt and enforce a policy to ensure compliance with

the requirements of section 1395dd of this title and to meet

the requirements of such section,

(ii) to maintain medical and other records related to

individuals transferred to or from the hospital for a period of

five years from the date of the transfer, and

(iii) to maintain a list of physicians who are on call for

duty after the initial examination to provide treatment

necessary to stabilize an individual with an emergency medical

condition,

(J) in the case of hospitals which provide inpatient hospital

services for which payment may be made under this subchapter, to

be a participating provider of medical care under any health plan

contracted for under section 1079 or 1086 of title 10, or under

section 1713 (!1) of title 38, in accordance with admission

practices, payment methodology, and amounts as prescribed under

joint regulations issued by the Secretary and by the Secretaries

of Defense and Transportation, in implementation of sections 1079

and 1086 of title 10,

(K) not to charge any individual or any other person for items

or services for which payment under this subchapter is denied

under section 1320c-3(a)(2) of this title by reason of a

determination under section 1320c-3(a)(1)(B) of this title,

(L) in the case of hospitals which provide inpatient hospital

services for which payment may be made under this subchapter, to

be a participating provider of medical care under section 1703 of

title 38, in accordance with such admission practices, and such

payment methodology and amounts, as are prescribed under joint

regulations issued by the Secretary and by the Secretary of

Veterans Affairs in implementation of such section,

(M) in the case of hospitals, to provide to each individual who

is entitled to benefits under part A of this subchapter (or to a

person acting on the individual's behalf), at or about the time

of the individual's admission as an inpatient to the hospital, a

written statement (containing such language as the Secretary

prescribes consistent with this paragraph) which explains -

(i) the individual's rights to benefits for inpatient

hospital services and for post-hospital services under this

subchapter,

(ii) the circumstances under which such an individual will

and will not be liable for charges for continued stay in the

hospital,

(iii) the individual's right to appeal denials of benefits

for continued inpatient hospital services, including the

practical steps to initiate such an appeal, and

(iv) the individual's liability for payment for services if

such a denial of benefits is upheld on appeal,

and which provides such additional information as the Secretary

may specify,

(N) in the case of hospitals and critical access hospitals -

(i) to make available to its patients the directory or

directories of participating physicians (published under

section 1395u(h)(4) of this title) for the area served by the

hospital or critical access hospital,

(ii) if hospital personnel (including staff of any emergency

or outpatient department) refer a patient to a nonparticipating

physician for further medical care on an outpatient basis, the

personnel must inform the patient that the physician is a

nonparticipating physician and, whenever practicable, must

identify at least one qualified participating physician who is

listed in such a directory and from whom the patient may

receive the necessary services,

(iii) to post conspicuously in any emergency department a

sign (in a form specified by the Secretary) specifying rights

of individuals under section 1395dd of this title with respect

to examination and treatment for emergency medical conditions

and women in labor, and

(iv) to post conspicuously (in a form specified by the

Secretary) information indicating whether or not the hospital

participates in the medicaid program under a State plan

approved under subchapter XIX of this chapter,

(O) to accept as payment in full for services that are covered

under this subchapter and are furnished to any individual

enrolled with a Medicare+Choice organization under part C of this

subchapter or with an eligible organization (i) with a

risk-sharing contract under section 1395mm of this title, under

section 1395mm(i)(2)(A) of this title (as in effect before

February 1, 1985), under section 1395b-1(a) of this title, or

under section 222(a) of the Social Security Amendments of 1972,

and (ii) which does not have a contract establishing payment

amounts for services furnished to members of the organization the

amounts that would be made as a payment in full under this

subchapter (less any payments under sections 1395ww(d)(11) and

1395ww(h)(3)(D) of this title) if the individuals were not so

enrolled,

(P) in the case of home health agencies which provide home

health services to individuals entitled to benefits under this

subchapter who require catheters, catheter supplies, ostomy bags,

and supplies related to ostomy care (described in section

1395x(m)(5) of this title), to offer to furnish such supplies to

such an individual as part of their furnishing of home health

services,

(Q) in the case of hospitals, skilled nursing facilities, home

health agencies, and hospice programs, to comply with the

requirement of subsection (f) of this section (relating to

maintaining written policies and procedures respecting advance

directives),

(R) to contract only with a health care clearinghouse (as

defined in section 1320d of this title) that meets each standard

and implementation specification adopted or established under

part C of subchapter XI of this chapter on or after the date on

which the health care clearinghouse is required to comply with

the standard or specification, and

(S) in the case of a hospital that has a financial interest (as

specified by the Secretary in regulations) in an entity to which

individuals are referred as described in section

1395x(ee)(2)(H)(ii) of this title, or in which such an entity has

such a financial interest, or in which another entity has such a

financial interest (directly or indirectly) with such hospital

and such an entity, to maintain and disclose to the Secretary (in

a form and manner specified by the Secretary) information on -

(i) the nature of such financial interest,

(ii) the number of individuals who were discharged from the

hospital and who were identified as requiring home health

services, and

(iii) the percentage of such individuals who received such

services from such provider (or another such provider).

In the case of a hospital which has an agreement in effect with an

organization described in subparagraph (F), which organization's

contract with the Secretary under part B of subchapter XI of this

chapter is terminated on or after October 1, 1984, the hospital

shall not be determined to be out of compliance with the

requirement of such subparagraph during the six month period

beginning on the date of the termination of that contract.

(2)(A) A provider of services may charge such individual or other

person (i) the amount of any deduction or coinsurance amount

imposed pursuant to section 1395e(a)(1), (a)(3), or (a)(4), section

1395l(b), or section 1395x(y)(3) of this title with respect to such

items and services (not in excess of the amount customarily charged

for such items and services by such provider), and (ii) an amount

equal to 20 per centum of the reasonable charges for such items and

services (not in excess of 20 per centum of the amount customarily

charged for such items and services by such provider) for which

payment is made under part B of this subchapter or which are

durable medical equipment furnished as home health services (but in

the case of items and services furnished to individuals with

end-stage renal disease, an amount equal to 20 percent of the

estimated amounts for such items and services calculated on the

basis established by the Secretary). In the case of items and

services described in section 1395l(c) of this title, clause (ii)

of the preceding sentence shall be applied by substituting for 20

percent the proportion which is appropriate under such section. A

provider of services may not impose a charge under clause (ii) of

the first sentence of this subparagraph with respect to items and

services described in section 1395x(s)(10)(A) of this title and

with respect to clinical diagnostic laboratory tests for which

payment is made under part B of this subchapter. Notwithstanding

the first sentence of this subparagraph, a home health agency may

charge such an individual or person, with respect to covered items

subject to payment under section 1395m(a) of this title, the amount

of any deduction imposed under section 1395l(b) of this title and

20 percent of the payment basis described in section 1395m(a)(1)(B)

of this title. In the case of items and services for which payment

is made under part B of this subchapter under the prospective

payment system established under section 1395l(t) of this title,

clause (ii) of the first sentence shall be applied by substituting

for 20 percent of the reasonable charge, the applicable copayment

amount established under section 1395l(t)(5) (!1) of this title. In

the case of services described in section 1395l(a)(8) of this title

or section 1395l(a)(9) of this title for which payment is made

under part B of this subchapter under section 1395m(k) of this

title, clause (ii) of the first sentence shall be applied by

substituting for 20 percent of the reasonable charge for such

services 20 percent of the lesser of the actual charge or the

applicable fee schedule amount (as defined in such section) for

such services.

(B) Where a provider of services has furnished, at the request of

such individual, items or services which are in excess of or more

expensive than the items or services with respect to which payment

may be made under this subchapter, such provider of services may

also charge such individual or other person for such more expensive

items or services to the extent that the amount customarily charged

by it for the items or services furnished at such request exceeds

the amount customarily charged by it for the items or services with

respect to which payment may be made under this subchapter.

(C) A provider of services may in accordance with its customary

practice also appropriately charge any such individual for any

whole blood (or equivalent quantities of packed red blood cells, as

defined under regulations) furnished him with respect to which a

deductible is imposed under section 1395e(a)(2) of this title,

except that (i) any excess of such charge over the cost to such

provider for the blood (or equivalent quantities of packed red

blood cells, as so defined) shall be deducted from any payment to

such provider under this subchapter, (ii) no such charge may be

imposed for the cost of administration of such blood (or equivalent

quantities of packed red blood cells, as so defined), and (iii)

such charge may not be made to the extent such blood (or equivalent

quantities of packed red blood cells, as so defined) has been

replaced on behalf of such individual or arrangements have been

made for its replacement on his behalf. For purposes of this

subparagraph, whole blood (or equivalent quantities of packed red

blood cells, as so defined) furnished an individual shall be deemed

replaced when the provider of services is given one pint of blood

for each pint of blood (or equivalent quantities of packed red

blood cells, as so defined) furnished such individual with respect

to which a deduction is imposed under section 1395e(a)(2) of this

title.

(D) Where a provider of services customarily furnishes items or

services which are in excess of or more expensive than the items or

services with respect to which payment may be made under this

subchapter, such provider, notwithstanding the preceding provisions

of this paragraph, may not, under the authority of subparagraph

(B)(ii) of this paragraph, charge any individual or other person

any amount for such items or services in excess of the amount of

the payment which may otherwise be made for such items or services

under this subchapter if the admitting physician has a direct or

indirect financial interest in such provider.

(3)(A) Under the agreement required under paragraph (1)(F)(ii),

the peer review organization must perform functions (other than

those covered under an agreement under paragraph (1)(F)(i)) under

the third sentence of section 1320c-3(a)(4)(A) of this title and

under section 1320c-3(a)(14) of this title with respect to

services, furnished by the hospital, critical access hospital,

facility, or agency involved, for which payment may be made under

this subchapter.

(B) For purposes of payment under this subchapter, the cost of

such an agreement to the hospital, critical access hospital,

facility, or agency shall be considered a cost incurred by such

hospital, critical access hospital, facility, or agency in

providing covered services under this subchapter and shall be paid

directly by the Secretary to the peer review organization on behalf

of such hospital, critical access hospital, facility, or agency in

accordance with a schedule established by the Secretary.

(C) Such payments -

(i) shall be transferred in appropriate proportions from the

Federal Hospital Insurance Trust Fund and from the Federal

Supplementary Medical Insurance Trust Fund, without regard to

amounts appropriated in advance in appropriation Acts, in the

same manner as transfers are made for payment for services

provided directly to beneficiaries, and

(ii) shall not be less in the aggregate for a fiscal year -

(I) in the case of hospitals, than the amount specified in

paragraph (1)(F)(i)(III), and

(II) in the case of facilities, critical access hospitals,

and agencies, than the amounts the Secretary determines to be

sufficient to cover the costs of such organizations' conducting

the activities described in subparagraph (A) with respect to

such facilities, critical access hospitals, or agencies under

part B of subchapter XI of this chapter.

(b) Termination or nonrenewal of agreements

(1) A provider of services may terminate an agreement with the

Secretary under this section at such time and upon such notice to

the Secretary and the public as may be provided in regulations,

except that notice of more than six months shall not be required.

(2) The Secretary may refuse to enter into an agreement under

this section or, upon such reasonable notice to the provider and

the public as may be specified in regulations, may refuse to renew

or may terminate such an agreement after the Secretary -

(A) has determined that the provider fails to comply

substantially with the provisions of the agreement, with the

provisions of this subchapter and regulations thereunder, or with

a corrective action required under section 1395ww(f)(2)(B) of

this title,

(B) has determined that the provider fails substantially to

meet the applicable provisions of section 1395x of this title,

(C) has excluded the provider from participation in a program

under this subchapter pursuant to section 1320a-7 of this title

or section 1320a-7a of this title, or

(D) has ascertained that the provider has been convicted of a

felony under Federal or State law for an offense which the

Secretary determines is detrimental to the best interests of the

program or program beneficiaries.

(3) A termination of an agreement or a refusal to renew an

agreement under this subsection shall become effective on the same

date and in the same manner as an exclusion from participation

under the programs under this subchapter becomes effective under

section 1320a-7(c) of this title.

(c) Refiling after termination or nonrenewal; agreements with

skilled nursing facilities

(1) Where the Secretary has terminated or has refused to renew an

agreement under this subchapter with a provider of services, such

provider may not file another agreement under this subchapter

unless the Secretary finds that the reason for the termination or

nonrenewal has been removed and that there is reasonable assurance

that it will not recur.

(2) Where the Secretary has terminated or has refused to renew an

agreement under this subchapter with a provider of services, the

Secretary shall promptly notify each State agency which administers

or supervises the administration of a State plan approved under

subchapter XIX of this chapter of such termination or nonrenewal.

(d) Decision to withhold payment for failure to review long-stay

cases

If the Secretary finds that there is a substantial failure to

make timely review in accordance with section 1395x(k) of this

title of long-stay cases in a hospital, he may, in lieu of

terminating his agreement with such hospital, decide that, with

respect to any individual admitted to such hospital after a

subsequent date specified by him, no payment shall be made under

this subchapter for inpatient hospital services (including

inpatient psychiatric hospital services) after the 20th day of a

continuous period of such services. Such decision may be made

effective only after such notice to the hospital and to the public,

as may be prescribed by regulations, and its effectiveness shall

terminate when the Secretary finds that the reason therefor has

been removed and that there is reasonable assurance that it will

not recur. The Secretary shall not make any such decision except

after reasonable notice and opportunity for hearing to the

institution or agency affected thereby.

(e) "Provider of services" defined

For purposes of this section, the term "provider of services"

shall include -

(1) a clinic, rehabilitation agency, or public health agency

if, in the case of a clinic or rehabilitation agency, such clinic

or agency meets the requirements of section 1395x(p)(4)(A) of

this title (or meets the requirements of such section through the

operation of section 1395x(g) of this title), or if, in the case

of a public health agency, such agency meets the requirements of

section 1395x(p)(4)(B) of this title (or meets the requirements

of such section through the operation of section 1395x(g) of this

title), but only with respect to the furnishing of outpatient

physical therapy services (as therein defined) or (through the

operation of section 1395x(g) of this title) with respect to the

furnishing of outpatient occupational therapy services; and

(2) a community mental health center (as defined in section

1395x(ff)(3)(B) of this title), but only with respect to the

furnishing of partial hospitalization services (as described in

section 1395x(ff)(1) of this title).

(f) Maintenance of written policies and procedures

(1) For purposes of subsection (a)(1)(Q) of this section and

sections 1395i-3(c)(2)(E), 1395l(s), 1395w-25(i), 1395mm(c)(8), and

1395bbb(a)(6) of this title, the requirement of this subsection is

that a provider of services, Medicare+Choice organization, or

prepaid or eligible organization (as the case may be) maintain

written policies and procedures with respect to all adult

individuals receiving medical care by or through the provider or

organization -

(A) to provide written information to each such individual

concerning -

(i) an individual's rights under State law (whether statutory

or as recognized by the courts of the State) to make decisions

concerning such medical care, including the right to accept or

refuse medical or surgical treatment and the right to formulate

advance directives (as defined in paragraph (3)), and

(ii) the written policies of the provider or organization

respecting the implementation of such rights;

(B) to document in a prominent part of the individual's current

medical record whether or not the individual has executed an

advance directive;

(C) not to condition the provision of care or otherwise

discriminate against an individual based on whether or not the

individual has executed an advance directive;

(D) to ensure compliance with requirements of State law

(whether statutory or as recognized by the courts of the State)

respecting advance directives at facilities of the provider or

organization; and

(E) to provide (individually or with others) for education for

staff and the community on issues concerning advance directives.

Subparagraph (C) shall not be construed as requiring the provision

of care which conflicts with an advance directive.

(2) The written information described in paragraph (1)(A) shall

be provided to an adult individual -

(A) in the case of a hospital, at the time of the individual's

admission as an inpatient,

(B) in the case of a skilled nursing facility, at the time of

the individual's admission as a resident,

(C) in the case of a home health agency, in advance of the

individual coming under the care of the agency,

(D) in the case of a hospice program, at the time of initial

receipt of hospice care by the individual from the program, and

(E) in the case of an eligible organization (as defined in

section 1395mm(b) of this title) or an organization provided

payments under section 1395l(a)(1)(A) of this title or a

Medicare+ÐChoice organization, at the time of enrollment of the

individual with the organization.

(3) In this subsection, the term "advance directive" means a

written instruction, such as a living will or durable power of

attorney for health care, recognized under State law (whether

statutory or as recognized by the courts of the State) and relating

to the provision of such care when the individual is incapacitated.

(4) For construction relating to this subsection, see section

14406 of this title (relating to clarification respecting assisted

suicide, euthanasia, and mercy killing).

(g) Penalties for improper billing

Except as permitted under subsection (a)(2) of this section, any

person who knowingly and willfully presents, or causes to be

presented, a bill or request for payment inconsistent with an

arrangement under subsection (a)(1)(H) of this section or in

violation of the requirement for such an arrangement, is subject to

a civil money penalty of not to exceed $2,000. The provisions of

section 1320a-7a of this title (other than subsections (a) and (b))

shall apply to a civil money penalty under the previous sentence in

the same manner as such provisions apply to a penalty or proceeding

under section 1320a-7a(a) of this title.

(h) Dissatisfaction with determination of Secretary; appeal by

institutions or agencies; single notice and hearing

(1) Except as provided in paragraph (2), an institution or agency

dissatisfied with a determination by the Secretary that it is not a

provider of services or with a determination described in

subsection (b)(2) of this section shall be entitled to a hearing

thereon by the Secretary (after reasonable notice) to the same

extent as is provided in section 405(b) of this title, and to

judicial review of the Secretary's final decision after such

hearing as is provided in section 405(g) of this title, except

that, in so applying such sections and in applying section 405(l)

of this title thereto, any reference therein to the Commissioner of

Social Security or the Social Security Administration shall be

considered a reference to the Secretary or the Department of Health

and Human Services, respectively.

(2) An institution or agency is not entitled to separate notice

and opportunity for a hearing under both section 1320a-7 of this

title and this section with respect to a determination or

determinations based on the same underlying facts and issues.

(i) Intermediate sanctions for psychiatric hospitals

(1) If the Secretary determines that a psychiatric hospital which

has an agreement in effect under this section no longer meets the

requirements for a psychiatric hospital under this subchapter and

further finds that the hospital's deficiencies -

(A) immediately jeopardize the health and safety of its

patients, the Secretary shall terminate such agreement; or

(B) do not immediately jeopardize the health and safety of its

patients, the Secretary may terminate such agreement, or provide

that no payment will be made under this subchapter with respect

to any individual admitted to such hospital after the effective

date of the finding, or both.

(2) If a psychiatric hospital, found to have deficiencies

described in paragraph (1)(B), has not complied with the

requirements of this subchapter -

(A) within 3 months after the date the hospital is found to be

out of compliance with such requirements, the Secretary shall

provide that no payment will be made under this subchapter with

respect to any individual admitted to such hospital after the end

of such 3-month period, or

(B) within 6 months after the date the hospital is found to be

out of compliance with such requirements, no payment may be made

under this subchapter with respect to any individual in the

hospital until the Secretary finds that the hospital is in

compliance with the requirements of this subchapter.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1866, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 327; amended

Pub. L. 90-248, title I, Secs. 129(c)(12), 133(c), 135(b), Jan. 2,

1968, 81 Stat. 849, 851, 852; Pub. L. 92-603, title II, Secs.

223(e), (g), 227(d)(2), 229(b), 249A(b)-(d), 278(a)(17), (b)(18),

281(c), Oct. 30, 1972, 86 Stat. 1394, 1406, 1409, 1427, 1453-1455;

Pub. L. 95-142, Secs. 3(b), 8(b), 13(b)(3), 15(a), Oct. 25, 1977,

91 Stat. 1178, 1194, 1195, 1198, 1200; Pub. L. 95-210, Sec. 2(e),

Dec. 13, 1977, 91 Stat. 1489; Pub. L. 95-292, Sec. 4(e), June 13,

1978, 92 Stat. 315; Pub. L. 96-272, title III, Sec. 308(b), June

17, 1980, 94 Stat. 531; Pub. L. 96-499, title IX, Sec. 916(a), Dec.

5, 1980, 94 Stat. 2623; Pub. L. 96-611, Sec. 1(b)(4), Dec. 28,

1980, 94 Stat. 3566; Pub. L. 97-35, title XXI, Sec. 2153, Aug. 13,

1981, 95 Stat. 802; Pub. L. 97-248, title I, Secs. 122(g)(5), (6),

128(a)(5), (d)(4), 144, Sept. 3, 1982, 96 Stat. 362, 366, 367, 393;

Pub. L. 97-448, title III, Sec. 309(a)(5), (b)(11), Jan. 12, 1983,

96 Stat. 2408, 2409; Pub. L. 98-21, title VI, Sec. 602(f), (l),

Apr. 20, 1983, 97 Stat. 163, 166; Pub. L. 98-369, div. B, title

III, Secs. 2303(f), 2315(d), 2321(c), 2323(b)(3), 2335(d), 2347(a),

2348(a), 2354(b)(33), (34), July 18, 1984, 98 Stat. 1066, 1080,

1084, 1086, 1090, 1096, 1097, 1102; Pub. L. 99-272, title IX, Secs.

9121(a), 9122(a), 9401(b)(2)(F), 9402(a), 9403(b), Apr. 7, 1986,

100 Stat. 164, 167, 199, 200; Pub. L. 99-509, title IX, Secs.

9305(b)(1), 9320(h)(2), 9332(e)(1), 9337(c)(2), 9343(c)(2), (3),

9353(e)(1), Oct. 21, 1986, 100 Stat. 1989, 2016, 2025, 2034, 2040,

2047; Pub. L. 99-514, title XVIII, Sec. 1895(b)(5), Oct. 22, 1986,

100 Stat. 2933; Pub. L. 99-576, title II, Sec. 233(a), Oct. 28,

1986, 100 Stat. 3265; Pub. L. 100-93, Sec. 8(d), Aug. 18, 1987, 101

Stat. 693; Pub. L. 100-203, title IV, Secs. 4012(a), 4062(d)(4),

4085(i)(17), (28), 4097(a), (b), 4212(e)(4), Dec. 22, 1987, 101

Stat. 1330-60, 1330-109, 1330-133, 1330-140, 1330-213, as amended

Pub. L. 100-360, title IV, Sec. 411(i)(4)(C)(vi), (j)(5), July 1,

1988, 102 Stat. 790, 791; Pub. L. 100-360, title I, Sec. 104(d)(5),

title II, Secs. 201(b), (d), 202(h)(1), title IV, Sec.

411(c)(2)(A)(i), (C), (g)(1)(D), July 1, 1988, 102 Stat. 689, 702,

718, 772, 782, as amended Pub. L. 100-485, title VI, Sec.

608(d)(3)(F), (19)(A), Oct. 13, 1988, 102 Stat. 2414, 2419; Pub. L.

100-485, title VI, Sec. 608(f)(1), Oct. 13, 1988, 102 Stat. 2424;

Pub. L. 101-234, title I, Sec. 101(a), title II, Sec. 201(a), title

III, Sec. 301(b)(4), (d)(1), Dec. 13, 1989, 103 Stat. 1979, 1981,

1985, 1986; Pub. L. 101-239, title VI, Secs. 6003(g)(3)(D)(xii),

(xiii), 6017, 6018(a), 6020, 6112(e)(3), Dec. 19, 1989, 103 Stat.

2154, 2165, 2166, 2216; Pub. L. 101-508, title IV, Secs.

4008(b)(3)(B), (m)(3)(G)[(F)], 4153(d)(1), 4157(c)(2), 4162(b)(2),

4206(a), Nov. 5, 1990, 104 Stat. 1388-44, 1388-54, 1388-84,

1388-89, 1388-96, 1388-115; Pub. L. 102-54, Sec. 13(q)(3)(F), June

13, 1991, 105 Stat. 280; Pub. L. 102-83, Sec. 5(c)(2), Aug. 6,

1991, 105 Stat. 406; Pub. L. 103-296, title I, Sec. 108(c)(5), Aug.

15, 1994, 108 Stat. 1485; Pub. L. 103-432, title I, Secs.

106(b)(1)(B), 147(e)(7), 156(a)(2)(E), 160(d)(2), Oct. 31, 1994,

108 Stat. 4406, 4430, 4441, 4443; Pub. L. 104-191, title II, Sec.

262(b)(1), Aug. 21, 1996, 110 Stat. 2031; Pub. L. 105-12, Sec.

9(a)(2), Apr. 30, 1997, 111 Stat. 26; Pub. L. 105-33, title IV,

Secs. 4002(d), (e), 4201(c)(1), 4302(a), 4321(b), 4432(b)(5)(F),

4511(a)(2)(D), 4523(b), 4541(a)(3), 4641(a), 4714(b)(1), Aug. 5,

1997, 111 Stat. 329, 373, 382, 395, 422, 442, 449, 456, 487, 510;

Pub. L. 106-113, div. B, Sec. 1000(a)(6) [title III, Sec.

321(k)(11), (12)], Nov. 29, 1999, 113 Stat. 1536, 1501A-368; Pub.

L. 106-554, Sec. 1(a)(6) [title III, Sec. 313(b)(3)], Dec. 21,

2000, 114 Stat. 2763, 2763A-499.)

-REFTEXT-

REFERENCES IN TEXT

Parts A and B of this subchapter, referred to in subsec. (a), are

classified to sections 1395c et seq. and 1395j et seq.,

respectively, of this title.

Part B of subchapter XI of this chapter, referred to in subsec.

(a)(1), (3)(C)(ii)(II), is classified to section 1320c et seq. of

this title.

Section 1713 of title 38, referred to in subsec. (a)(1)(J), was

renumbered section 1781 of title 38 by Pub. L. 107-135, title II,

Sec. 208(c)(1), (2), Jan. 23, 2002, 115 Stat. 2463.

Part C of this subchapter, referred to in subsec. (a)(1)(O), is

classified to section 1395w-21 et seq. of this title.

Section 222(a) of the Social Security Amendments of 1972,

referred to in subsec. (a)(1)(O)(i), is section 222(a) of Pub. L.

92-603, which is set out as a note under section 1395b-1 of this

title.

Part C of subchapter XI of this chapter, referred to in subsec.

(a)(1)(R), is classified to section 1320d et seq. of this title.

Section 1395l(t)(5) of this title, referred to in subsec.

(a)(2)(A), was redesignated section 1395l(t)(8) of this title by

Pub. L. 106-113, div. B, Sec. 1000(a)(6) [title II, Secs.

201(a)(1), 202(a)(2)], Nov. 29, 1999, 113 Stat. 1536, 1501A-336,

1501A-342.

-MISC1-

AMENDMENTS

2000 - Subsec. (a)(1)(H)(ii)(I). Pub. L. 106-554 inserted "during

a period in which the resident is provided covered post-hospital

extended care services (or, for services described in section

1395x(s)(2)(D) of this title, that are furnished to such an

individual without regard to such period)" after "skilled nursing

facility".

1999 - Subsec. (a)(1)(I)(iii). Pub. L. 106-113, Sec. 1000(a)(6)

[title III, Sec. 321(k)(11)(A)], substituted comma for semicolon at

end.

Subsec. (a)(1)(N)(iv). Pub. L. 106-113, Sec. 1000(a)(6) [title

III, Sec. 321(k)(11)(B)], struck out "and" at end.

Subsec. (a)(1)(O). Pub. L. 106-113, Sec. 1000(a)(6) [title III,

Sec. 321(k)(11)(C)], substituted comma for semicolon at end.

Subsec. (a)(1)(Q). Pub. L. 106-113, Sec. 1000(a)(6) [title III,

Sec. 321(k)(12)(A)], substituted comma for semicolon at end.

Subsec. (a)(1)(R). Pub. L. 106-113, Sec. 1000(a)(6) [title III,

Sec. 321(k)(12)(B)], inserted ", and" at end.

1997 - Subsec. (a)(1)(A). Pub. L. 105-33, Sec. 4714(b)(1),

designated existing provisions as cl. (i) and inserted before comma

at end ", and (ii) not to impose any charge that is prohibited

under section 1396a(n)(3) of this title".

Subsec. (a)(1)(F)(ii). Pub. L. 105-33, Sec. 4201(c)(1),

substituted "critical access" for "rural primary care".

Subsec. (a)(1)(H). Pub. L. 105-33, Sec. 4511(a)(2)(D),

substituted "section 1395x(s)(2)(K) of this title" for "section

1395x(s)(2)(K)(i) or 1395x(s)(2)(K)(iii) of this title".

Pub. L. 105-33, Sec. 4432(b)(5)(F), designated existing

provisions as cl. (i), redesignated former cls. (i) and (ii) as

subcls. (I) and (II), respectively, and added cl. (ii).

Pub. L. 105-33, Sec. 4201(c)(1), substituted "critical access"

for "rural primary care" in two places.

Subsec. (a)(1)(I), (N). Pub. L. 105-33, Sec. 4201(c)(1),

substituted "critical access" for "rural primary care" in

introductory provisions of subpars. (I) and (N) and in subpar.

(N)(i).

Subsec. (a)(1)(O). Pub. L. 105-33, Sec. 4002(e), struck out "in

the case of hospitals and skilled nursing facilities," before "to

accept as payment in full for", "inpatient hospital and extended

care" after "to accept as payment in full for", and "(in the case

of hospitals) or limits (in the case of skilled nursing

facilities)" after "the organization the amounts"; inserted "with a

Medicare+Choice organization under part C of this subchapter or"

after "any individual enrolled" and "(less any payments under

sections 1395ww(d)(11) and 1395ww(h)(3)(D) of this title)" after

"under this subchapter".

Subsec. (a)(1)(S). Pub. L. 105-33, Sec. 4321(b), added subpar.

(S).

Subsec. (a)(2)(A). Pub. L. 105-33, Sec. 4541(a)(3), which

directed the amendment of subsec. (a)(2)(A)(ii) by inserting the

following at the end "In the case of services described in section

1395l(a)(8) of this title or section 1395l(a)(9) of this title for

which payment is made under part B of this subchapter under section

1395m(k) of this title, clause (ii) of the first sentence shall be

applied by substituting for 20 percent of the reasonable charge for

such services 20 percent of the lesser of the actual charge or the

applicable fee schedule amount (as defined in such section) for

such services.", was executed by inserting the material at the end

of subpar. (A) to reflect the probable intent of Congress.

Pub. L. 105-33, Sec. 4523(b), which directed the amendment of

subsec. (a)(2)(A)(ii) by inserting the following at the end "In the

case of items and services for which payment is made under part B

of this subchapter under the prospective payment system established

under section 1395l(t) of this title, clause (ii) of the first

sentence shall be applied by substituting for 20 percent of the

reasonable charge, the applicable copayment amount established

under section 1395l(t)(5) of this title.", was executed by

inserting the material at the end of subpar. (A) to reflect the

probable intent of Congress.

Subsec. (a)(3). Pub. L. 105-33, Sec. 4201(c)(1), substituted

"critical access" for "rural primary care" wherever appearing.

Subsec. (b)(2)(D). Pub. L. 105-33, Sec. 4302(a), added subpar.

(D).

Subsec. (f)(1). Pub. L. 105-33, Sec. 4002(d)(1), inserted

"1395w-25(i)," after "1395l(s)," and ", Medicare+Choice

organization," after "provider of services" in introductory

provisions.

Subsec. (f)(1)(B). Pub. L. 105-33, Sec. 4641(a), substituted "in

a prominent part of the individual's current medical record" for

"in the individual's medical record".

Subsec. (f)(2)(E). Pub. L. 105-33, Sec. 4002(d)(2), inserted "or

a Medicare+Choice organization" after "section 1395l(a)(1)(A) of

this title".

Subsec. (f)(4). Pub. L. 105-12 added par. (4).

1996 - Subsec. (a)(1)(R). Pub. L. 104-191 added subpar. (R).

1994 - Subsec. (a)(1)(H). Pub. L. 103-432, Sec. 147(e)(7),

substituted "section 1395x(s)(2)(K)(i) or 1395x(s)(2)(K)(iii) of

this title" for "section 1395x(s)(2)(K)(i) of this title".

Subsec. (a)(2)(A). Pub. L. 103-432, Sec. 156(a)(2)(E), struck out

", with respect to items and services furnished in connection with

obtaining a second opinion required under section 1320c-13(c)(2) of

this title (or a third opinion, if the second opinion was in

disagreement with the first opinion)," after "section

1395x(s)(10)(A) of this title".

Subsec. (d). Pub. L. 103-432, Sec. 106(b)(1)(B), substituted

"long-stay cases in a hospital" for "long-stay cases in a hospital

or skilled nursing facility", "such hospital" for "such hospital or

facility" in two places, "period of such services" for "period of

such services or for post-hospital extended care services after

such day of a continuous period of such care as is prescribed in or

pursuant to regulations, as the case may be", and "notice to the

hospital" for "notice to the hospital, or (in the case of a skilled

nursing facility) to the facility and the hospital or hospitals

with which it has a transfer agreement,".

Subsec. (f)(1). Pub. L. 103-432, Sec. 160(d)(2), substituted

"1395l(s)" for "1395l(r)" in introductory provisions.

Subsec. (h)(1). Pub. L. 103-296 inserted before period at end ",

except that, in so applying such sections and in applying section

405(l) of this title thereto, any reference therein to the

Commissioner of Social Security or the Social Security

Administration shall be considered a reference to the Secretary or

the Department of Health and Human Services, respectively".

1991 - Subsec. (a)(1)(J). Pub. L. 102-83 substituted "section

1713 of title 38" for "section 613 of title 38".

Subsec. (a)(1)(L). Pub. L. 102-83 substituted "section 1703 of

title 38" for "section 603 of title 38".

Pub. L. 102-54 substituted "Secretary of Veterans Affairs" for

"Administrator of Veterans' Affairs".

1990 - Subsec. (a)(1)(F)(i). Pub. L. 101-508, Sec.

4008(m)(3)(G)[(F)](i), substituted ")," for comma at end.

Subsec. (a)(1)(F)(ii). Pub. L. 101-508, Sec.

4008(m)(3)(G)[(F)](ii), substituted "paragraph (3)(A)," for

"paragraph (4)(A);".

Subsec. (a)(1)(H). Pub. L. 101-508, Sec. 4157(c)(2), inserted

"services described by section 1395x(s)(2)(K)(i) of this title,

certified nurse-midwife services, qualified psychologist services,

and" after "and other than".

Subsec. (a)(1)(I)(i). Pub. L. 101-508, Sec. 4008(b)(3)(B),

inserted "and to meet the requirements of such section" after

"section 1395dd of this title".

Subsec. (a)(1)(P). Pub. L. 101-508, Sec. 4153(d)(1), substituted

"catheters, catheter supplies, ostomy bags, and supplies related to

ostomy care" for "ostomy supplies".

Subsec. (a)(1)(Q). Pub. L. 101-508, Sec. 4206(a)(1), added

subpar. (Q).

Subsec. (e). Pub. L. 101-508, Sec. 4162(b)(2), substituted

"include - " and pars. (1) and (2) for "include a clinic,

rehabilitation agency, or public health agency if, in the case of a

clinic or rehabilitation agency, such clinic or agency meets the

requirements of section 1395x(p)(4)(A) of this title (or meets the

requirements of such section through the operation of section

1395x(g) of this title), or if, in the case of a public health

agency, such agency meets the requirements of section

1395x(p)(4)(B) of this title (or meets the requirements of such

section through the operation of section 1395x(g) of this title),

but only with respect to the furnishing of outpatient physical

therapy services (as therein defined) or (through the operation of

section 1395x(g) of this title) with respect to the furnishing of

outpatient occupational therapy services."

Subsec. (f). Pub. L. 101-508, Sec. 4206(a)(2), added subsec. (f).

1989 - Subsec. (a)(1)(F)(i)(III). Pub. L. 101-234, Sec.

301(b)(4), (d)(1), amended subcl. (III) identically substituting

"fiscal year)" for "fiscal year))" before "of such reviews," at

end.

Subsec. (a)(1)(F)(ii). Pub. L. 101-239, Sec.

6003(g)(3)(D)(xii)(I), inserted "rural primary care hospitals,"

after "hospitals,".

Subsec. (a)(1)(H). Pub. L. 101-239, Sec. 6003(g)(3)(D)(xii)(II),

inserted "and in the case of rural primary care hospitals which

provide rural primary care hospital services" after "payment may be

made under this subchapter".

Subsec. (a)(1)(I). Pub. L. 101-239, Sec. 6018(a)(1), amended

subpar. (I) generally. Prior to amendment, subpar. (I) read as

follows: "in the case of a hospital and in the case of a rural

primary care hospital, to comply with the requirements of section

1395dd of this title to the extent applicable,".

Pub. L. 101-239, Sec. 6003(g)(3)(D)(xii)(III), inserted "and in

the case of a rural primary care hospital" after "hospital".

Subsec. (a)(1)(N). Pub. L. 101-239, Sec. 6003(g)(3)(D)(xii)(IV),

substituted "hospitals and rural primary care hospitals" for

"hospitals" in introductory provisions and "hospital or rural

primary care hospital," for "hospital," in cl. (i).

Subsec. (a)(1)(N)(iii), (iv). Pub. L. 101-239, Sec. 6018(a)(2),

added cls. (iii) and (iv).

Subsec. (a)(1)(P). Pub. L. 101-239, Sec. 6112(e)(3), added

subpar. (P).

Subsec. (a)(2)(A). Pub. L. 101-234, Sec. 201(a), repealed Pub. L.

100-360, Secs. 201(b), (d), 202(h)(1), and provided that the

provisions of law amended or repealed by such sections are restored

or revived as if such sections had not been enacted, see 1988

Amendment notes below.

Subsec. (a)(2)(B). Pub. L. 101-239, Sec. 6017, redesignated cl.

(i) as subpar. (B) and struck out cl. (ii) which authorized charges

for items or services more expensive than determined to be

necessary and which have not been requested by the individual to

the extent that such costs in the second fiscal period preceding

the fiscal period in which such charges are imposed exceed

necessary costs, under certain circumstances.

Subsec. (a)(3)(A), (B). Pub. L. 101-239, Sec.

6003(g)(3)(D)(xiii)(I), substituted "hospital, rural primary care

hospital," for "hospital," wherever appearing.

Subsec. (a)(3)(C)(ii)(II). Pub. L. 101-239, Sec.

6003(g)(3)(D)(xiii)(II), substituted "facilities, rural primary

care hospitals," for "facilities" in two places.

Subsec. (d). Pub. L. 101-234, Sec. 101(a), repealed Pub. L.

100-360, Sec. 104(d)(5), and provided that the provisions of law

amended or repealed by such section are restored or revived as if

such section had not been enacted, see 1988 Amendment note below.

Subsec. (i). Pub. L. 101-239, Sec. 6020, added subsec. (i).

1988 - Subsec. (a)(1)(M). Pub. L. 100-360, Sec. 411(c)(2)(C)(i),

as added by Pub. L. 100-485, Sec. 608(d)(19)(A), struck out "and"

at end.

Subsec. (a)(1)(N). Pub. L. 100-360, Sec. 411(c)(2)(C)(ii), as

added by Pub. L. 100-485, Sec. 608(d)(19)(A), substituted ", and"

for period at end.

Subsec. (a)(1)(O). Pub. L. 100-360, Sec. 411(c)(2)(A)(i),

substituted cls. (i) and (ii) for "with a risk-sharing contract

under section 1395mm of this title".

Subsec. (a)(2)(A). Pub. L. 100-360, Sec. 201(d), substituted

"section 1395l(d)(1) of this title" for "section 1395l(c) of this

title" in second sentence.

Pub. L. 100-360, Sec. 411(g)(1)(D), substituted "section

1395m(a)(1)(B) of this title" for "section 1395m(a)(2) of this

title" in last sentence.

Pub. L. 100-360, Sec. 202(h)(1), inserted "1395m(c)," after

"1395l(b)," and "and in the case of covered outpatient drugs,

applicable coinsurance percent (specified in section 1395m(c)(2)(C)

of this title) of the lesser of the actual charges for the drugs or

the payment limit (established under section 1395m(c)(3) of this

title)" after "established by the Secretary".

Pub. L. 100-360, Sec. 201(b), inserted at end "A provider of

services may not impose a charge under the first sentence of this

subparagraph for services for which payment is made to the provider

pursuant to section 1395l(c) of this title (relating to

catastrophic benefits)."

Subsec. (a)(3)(C)(ii). Pub. L. 100-360, Sec. 411(j)(5), made

technical correction to directory language of Pub. L. 100-203, Sec.

4097(b), see 1987 Amendment note below.

Subsec. (d). Pub. L. 100-360, Sec. 104(d)(5), as amended by Pub.

L. 100-485, Sec. 608(d)(3)(F), struck out "post-hospital" before

"extended care services".

Subsec. (f). Pub. L. 100-485, Sec. 608(f)(1), struck out subsec.

(f) which provided for termination or decertification and

alternatives thereto.

Subsec. (g). Pub. L. 100-360, Sec. 411(i)(4)(C)(vi), added Pub.

L. 100-203, Sec. 4085(i)(28), see 1987 Amendment note below.

1987 - Subsec. (a)(1)(F)(i)(III). Pub. L. 100-203, Sec. 4097(a),

substituted "1988" for "1986" and inserted "and for any direct or

administrative costs incurred as a result of review functions added

with respect to a subsequent fiscal year" after "inflation".

Subsec. (a)(1)(O). Pub. L. 100-203, Sec. 4012(a), added subpar.

(O).

Subsec. (a)(2)(A). Pub. L. 100-203, Sec. 4062(d)(4), inserted at

end "Notwithstanding the first sentence of this subparagraph, a

home health agency may charge such an individual or person, with

respect to covered items subject to payment under section 1395m(a)

of this title, the amount of any deduction imposed under section

1395l(b) of this title and 20 percent of the payment basis

described in section 1395m(a)(2) of this title."

Subsec. (a)(3). Pub. L. 100-93, Sec. 8(d)(1), redesignated par.

(4) as (3) and struck out former par. (3) which read as follows:

"The Secretary may refuse to enter into or renew an agreement under

this section with a provider of services if any person who has a

direct or indirect ownership or control interest of 5 percent or

more in such provider, or who is an officer, director, agent, or

managing employee (as defined in section 1320a-5(b) of this title)

of such provider, is a person described in section 1320a-5(a) of

this title."

Subsec. (a)(3)(C)(ii). Pub. L. 100-203, Sec. 4097(b), as amended

by Pub. L. 100-360, Sec. 411(j)(5), amended cl. (ii) generally.

Prior to amendment, cl. (ii) read as follows: "shall not be less in

the aggregate for hospitals, facilities, and agencies for a fiscal

year than the amounts the Secretary determines to be sufficient to

cover the costs of such organizations' conducting the activities

described in subparagraph (A) with respect to such hospitals,

facilities, or agencies under part B of subchapter XI of this

chapter."

Subsec. (a)(4). Pub. L. 100-93, Sec. 8(d)(1)(B), redesignated

par. (4) as (3).

Subsec. (b). Pub. L. 100-93, Sec. 8(d)(2), amended subsec. (b)

generally, substituting pars. (1) to (3) for former pars. (1) to

(5).

Subsec. (c)(1). Pub. L. 100-93, Sec. 8(d)(3), (4), substituted

"the Secretary has terminated or has refused to renew an agreement

under this subchapter with a provider of services" for "an

agreement filed under this subchapter by a provider of services has

been terminated by the Secretary" and inserted "or nonrenewal"

after "termination".

Subsec. (c)(2). Pub. L. 100-203, Sec. 4212(e)(4), redesignated

par. (3) as (2) and struck out former par. (2) which read as

follows: "In the case of a skilled nursing facility participating

in the programs established by this subchapter and subchapter XIX

of this chapter, the Secretary may enter into an agreement under

this section only if such facility has been approved pursuant to

section 1396i(a) of this title, and the term of any such agreement

shall be in accordance with the period of approval of eligibility

specified by the Secretary pursuant to such section."

Subsec. (c)(3). Pub. L. 100-203, Sec. 4212(e)(4), redesignated

par. (3) as (2).

Pub. L. 100-93, Sec. 8(d)(3), (4), substituted "the Secretary has

terminated or has refused to renew an agreement under this

subchapter with a provider of services" for "an agreement filed

under this subchapter by a provider of services has been terminated

by the Secretary" and inserted "or nonrenewal" after "termination".

Subsec. (g). Pub. L. 100-203, Sec. 4085(i)(28), as added by Pub.

L. 100-360, Sec. 411(i)(4)(C)(vi), substituted "money penalty" for

"monetary penalty" in first sentence and amended second sentence

generally. Prior to amendment, second sentence read as follows:

"Such a penalty shall be imposed in the same manner as civil

monetary penalties are imposed under section 1320a-7a of this title

with respect to actions described in subsection (a) of that

section."

Pub. L. 100-203, Sec. 4085(i)(17), substituted "inconsistent with

an arrangement under subsection (a)(1)(H) of this section or in

violation of the requirement for such an arrangement" for "for a

hospital outpatient service for which payment may be made under

part B of this subchapter and such bill or request violates an

arrangement under subsection (a)(1)(H) of this section".

Subsec. (h). Pub. L. 100-93, Sec. 8(d)(5), added subsec. (h).

1986 - Subsec. (a)(1)(F). Pub. L. 99-509, Sec. 9353(e)(1)(A),

designated existing provisions as cl. (i) and in cl. (i), as so

designated, redesignated former cls. (i) to (iii) as subcls. (I) to

(III), and added cl. (ii).

Pub. L. 99-272, Sec. 9402(a), redesignated cl. (iv) as (iii) and

in cl. (iii), as so redesignated, substituted "1986" for "1982",

and struck out former cl. (iii) which provided that the cost of

such agreement to the hospital shall not be less than amount which

reflects the rates per review established in fiscal year 1982 for

both direct and administrative costs (adjusted for inflation).

Subsec. (a)(1)(H). Pub. L. 99-509, Sec. 9343(c)(2), struck out

"inpatient hospital" after "hospitals which provide" and

substituted "a patient" for "an inpatient".

Pub. L. 99-509, Sec. 9320(h)(2), inserted ", and other than

services of a certified registered nurse anesthetist" after

"section 1395y(a)(14) of this title".

Subsec. (a)(1)(I). Pub. L. 99-514 redesignated subpar. (I)

relating to agreement not to charge for certain items and services

as subpar. (K).

Pub. L. 99-272, Sec. 9403(b), added subpar. (I) relating to

agreement not to charge for certain items or services.

Pub. L. 99-272, Sec. 9121(a), added subpar. (I) relating to

compliance with the requirements of section 1395dd of this title.

Subsec. (a)(1)(J). Pub. L. 99-272, Sec. 9122(a), added subpar.

(J).

Subsec. (a)(1)(K). Pub. L. 99-514 redesignated subpar. (I)

relating to agreement not to charge for certain items and services

as subpar. (K).

Subsec. (a)(1)(L). Pub. L. 99-576 added subpar. (L).

Subsec. (a)(1)(M). Pub. L. 99-509, Sec. 9305(b)(1), added subpar.

(M).

Subsec. (a)(1)(N). Pub. L. 99-509, Sec. 9332(e)(1), added subpar.

(N).

Subsec. (a)(2)(A). Pub. L. 99-272, Sec. 9401(b)(2)(F), inserted

", with respect to items and services furnished in connection with

obtaining a second opinion required under section 1320c-13(c)(2) of

this title (or a third opinion, if the second opinion was in

disagreement with the first opinion)," after "1395x(s)(10)(A) of

this title" in last sentence.

Subsec. (a)(4). Pub. L. 99-509, Sec. 9353(e)(1)(B), added par.

(4).

Subsec. (e). Pub. L. 99-509, Sec. 9337(c)(2), inserted in second

sentence "(or meets the requirements of such section through the

operation of section 1395x(g) of this title)" in two places, and

inserted "or (through the operation of section 1395x(g) of this

title) with respect to the furnishing of outpatient occupational

therapy services" after "(as therein defined)".

Subsec. (g). Pub. L. 99-509, Sec. 9343(c)(3), added subsec. (g).

1984 - Subsec. (a)(1)(E). Pub. L. 98-369, Sec. 2354(b)(33),

inserted a comma at end.

Subsec. (a)(1)(F). Pub. L. 98-369, Sec. 2315(d), substituted

"(b), (c), or (d)" for "(c) or (d)".

Pub. L. 98-369, Sec. 2347(a)(1), substituted "maintain an

agreement with a professional standards review organization (if

there is such an organization in existence in the area in which the

hospital is located) or with a utilization and quality control peer

review organization which has a contract with the Secretary under

part B of subchapter XI of this chapter for the area in which the

hospital is located, under which the organization" for "maintain an

agreement with a utilization and quality control peer review

organization (if there is such an organization which has a contract

with the Secretary under part B of subchapter XI of this chapter

for the area in which the hospital is located) under which the

organization".

Pub. L. 98-369, Sec. 2347(a)(2), repealed amendment made by Pub.

L. 98-21, Sec. 602(l)(1). See 1983 Amendment note below.

Subsec. (a)(2)(A). Pub. L. 98-369, Sec. 2303(f), inserted "and

with respect to clinical diagnostic laboratory tests" after

"section 1395x(s)(10) of this title".

Pub. L. 98-369, Sec. 2321(c), inserted "or which are durable

medical equipment furnished as home health services" after "part B

of this subchapter".

Pub. L. 98-369, Sec. 2323(b)(3), substituted "section

1395x(s)(10)(A) of this title" for "section 1395x(s)(10) of this

title".

Subsec. (b)(3). Pub. L. 98-369, Sec. 2335(d)(1), substituted

"(including inpatient psychiatric hospital services)" for

"(including tuberculosis hospital services and inpatient

psychiatric hospital services)".

Pub. L. 98-369, Sec. 2354(b)(34), realigned margin of par. (3).

Subsec. (b)(4). Pub. L. 98-369, Sec. 2348(a), substituted "more

than 30 days after such effective date" for "after the calendar

year in which such termination is effective".

Subsec. (d). Pub. L. 98-369, Sec. 2335(d)(2), substituted

"(including inpatient psychiatric hospital services)" for

"(including inpatient tuberculosis hospital services and inpatient

psychiatric hospital services)".

1983 - Subsec. (a)(1). Pub. L. 98-21, Sec. 602(l)(2), inserted

provision at end of par. (1) that in the case of a hospital which

has an agreement in effect with an organization described in

subparagraph (F), which organization's contract with the Secretary

under part B of subchapter XI terminates on or after October 1,

1984, the hospital shall not be determined to be out of compliance

with the requirement of such subparagraph during the six month

period beginning on the date of the termination of that contract.

Subsec. (a)(1)(F). Pub. L. 98-21, Sec. 602(l)(1), which provided

that, effective Oct. 1, 1984, subpar. (F) is amended by

substituting "(with an organization" for "(if there is such an

organization", was repealed by Pub. L. 98-369, Sec. 2347(a)(2),

effective July 18, 1984.

Subsec. (a)(1)(F) to (H). Pub. L. 98-21, Sec. 602(f)(1), added

subpars. (F) to (H).

Subsec. (a)(2)(A). Pub. L. 97-448, Sec. 309(b)(11), inserted a

comma after "1395e(a)(1)".

Pub. L. 97-448, Sec. 309(a)(5), amended directory language of

Pub. L. 97-248, Sec. 122(g)(5), to correct an error, and did not

involve any change in text. See 1982 Amendment note below.

Subsec. (a)(2)(B)(ii). Pub. L. 98-21, Sec. 602(f)(2), inserted

"and except with respect to inpatient hospital costs with respect

to which amounts are payable under section 1395ww(d) of this title"

after "(except with respect to emergency services)" in provision

preceding subcl. (I).

1982 - Subsec. (a)(1)(B). Pub. L. 97-248, Sec. 128(d)(4),

inserted "of section 1395y(a) of this title".

Subsec. (a)(1)(E). Pub. L. 97-248, Sec. 144, added subpar. (E).

Subsec. (a)(2)(A). Pub. L. 97-248, Sec. 122(g)(5), as amended by

Pub. L. 97-448, Sec. 309(a)(5), substituted "(a)(3), or (a)(4)" for

"or (a)(3)".

Subsec. (b). Pub. L. 97-248, Sec. 128(a)(5), in provisions

preceding par. (1), struck out "(and in the case of a skilled

nursing facility, prior to the end of the term specified in

subsection (a)(1) of this section)" after "may be terminated".

Subsec. (b)(4)(A). Pub. L. 97-248, Sec. 122(g)(6), inserted "or

hospice care" after "home health services".

1981 - Subsec. (a)(1). Pub. L. 97-35 struck out provision

following subpar. (D) which provided that an agreement with a

skilled nursing facility be for a term not exceeding 12 months with

the exception that the Secretary could extend the time in specified

situations.

1980 - Subsec. (a)(2)(A). Pub. L. 96-611 inserted provision that

a provider of services may not impose a charge under clause (ii) of

the first sentence of this subparagraph with respect to items and

services described in section 1395x(s)(10) of this title for which

payment is made under part B of this subchapter.

Subsec. (c)(3). Pub. L. 96-272 added par. (3).

Subsec. (f). Pub. L. 96-499 added subsec. (f).

1978 - Subsec. (a)(2)(A). Pub. L. 95-292 provided for computation

of and charging of coinsurance amounts for items and services

furnished individuals with end stage renal disease on the basis

established by the Secretary.

Subsec. (a)(3). Pub. L. 95-142, Sec. 8(b)(1), added par. (3).

Subsec. (b)(2)(G). Pub. L. 95-142, Sec. 8(b)(2), added cl. (G).

1977 - Subsec. (a)(1)(D). Pub. L. 95-142, Sec. 15(a), added

subpar. (D).

Subsec. (b)(2)(C). Pub. L. 95-142, Sec. 3(b), designated existing

provisions as subcl. (i) and added subcl. (ii).

Subsec. (b)(2)(F). Pub. L. 95-142, Sec. 13(b)(3), substituted "of

a quality which fails to meet professionally recognized standards

of health care" for "harmful to individuals or to be of a grossly

inferior quality", and struck out provisions relating to approval

by an appropriate program review team.

Subsec. (c)(2). Pub. L. 95-210 substituted "section 1396i(a) of

this title" for "section 1396i of this title".

1972 - Subsec. (a)(1). Pub. L. 92-603, Secs. 227(d)(2), 249A(b),

278(a)(17), (b)(18), 281(c), substituted "Any provider of services

(except a fund designated for purposes of section 1395f(g) and

section 1395n(e) of this title)" for "Any provider of services",

"skilled nursing facility" for "extended care facility", inserted

provision that the agreement be for a term of not to exceed 12

months with an allowable extension of 2 months under specified

circumstances, redesignated subpar. (B) as (C) and added subpar.

(B).

Subsec. (a)(2)(B). Pub. L. 92-603, Sec. 223(e), designated

existing provisions as cl. (i) and added cl. (ii).

Subsec. (a)(2)(C). Pub. L. 92-603, Sec. 223(g)(2), substituted

"this subparagraph" for "clause (iii) of the preceding sentence".

Subsec. (a)(2)(D). Pub. L. 92-603, Sec. 223(g)(1), added subpar.

(D).

Subsec. (b). Pub. L. 92-603, Secs. 229(b), 249A(c), 278(a)(17),

inserted "(and in the case of an extended care facility, prior to

the end of the term specified in subsection (a)(1) of this

section)" in provision preceding par. (1), in par. (2), added cls.

(D) to (F), and in par. (3), substituted "(including tuberculosis

hospital services and inpatient psychiatric hospital services) or

post-hospital extended care services, with respect to services

furnished after the effective date of such termination, except that

payment may be made for up to thirty days with respect to inpatient

institutional services furnished to any eligible individual who was

admitted to such institution prior to" for "(including inpatient

tuberculosis hospital services and inpatient psychiatric hospital

services) or post-hospital extended care services, with respect to

such services furnished to any individual who is admitted to the

hospital or extended care facility furnishing such services on or

after" and substituted "skilled nursing facility" for "extended

care facility".

Subsec. (c). Pub. L. 92-603, Sec. 249A(d), designated existing

provisions as par. (1) and added par. (2).

Subsec. (d). Pub. L. 92-603, Sec. 278(a)(17), substituted

"skilled nursing facility" for "extended care facility" and "a" for

"an".

1968 - Subsec. (a)(2)(A). Pub. L. 90-248, Sec. 129(c)(12)(A)(i),

(ii), substituted "or (a)(3)" for ", (a)(2), or (a)(4)" in cl. (i),

and deleted "or, in the case of outpatient hospital diagnostic

services, for which payment is made under part A" in cl. (ii).

Subsec. (a)(2)(C). Pub. L. 90-248, Sec. 129(c)(12)(B),

substituted "1395e(a)(2)" for "1395e(a)(3)".

Pub. L. 90-248, Sec. 135(b), authorized a provider of services to

charge for blood in accordance with its customary practices,

included, in addition to whole blood for which a provider of

services may charge, equivalent quantities of packed red blood

cells, and provided that blood furnished an individual will be

deemed replaced when the provider is given one pint of blood for

each pint of blood (or equivalent quantities of packed red blood

cells) furnished the individual to which the three pint deductible

applies.

Subsec. (e). Pub. L. 90-248, Sec. 133(c), added subsec. (e).

EFFECTIVE DATE OF 2000 AMENDMENT

Amendment by Pub. L. 106-554 applicable to services furnished on

or after Jan. 1, 2001, see section 1(a)(6) [title III, Sec. 313(c)]

of Pub. L. 106-554, set out as a note under section 1395u of this

title.

EFFECTIVE DATE OF 1999 AMENDMENT

Amendment by Pub. L. 106-113 effective as if included in the

enactment of the Balanced Budget Act of 1997, Pub. L. 105-33,

except as otherwise provided, see section 1000(a)(6) [title III,

Sec. 321(m)] of Pub. L. 106-113, set out as a note under section

1395d of this title.

EFFECTIVE DATE OF 1997 AMENDMENTS

Amendment by Pub. L. 105-12 effective Apr. 30, 1997, and

applicable to Federal payments made pursuant to obligations

incurred after Apr. 30, 1997, for items and services provided on or

after such date, subject to also being applicable with respect to

contracts entered into, renewed, or extended after Apr. 30, 1997,

as well as contracts entered into before Apr. 30, 1997, to the

extent permitted under such contracts, see section 11 of Pub. L.

105-12, set out as an Effective Date note under section 14401 of

this title.

Amendment by section 4201(c)(1) of Pub. L. 105-33 applicable to

services furnished on or after Oct. 1, 1997, see section 4201(d) of

Pub. L. 105-33, set out as a note under section 1395f of this

title.

Amendment by section 4302(a) of Pub. L. 105-33 effective Aug. 5,

1997, and applicable to the entry and renewal of contracts on or

after such date, see section 4302(c) of Pub. L. 105-33, set out as

a note under section 1395u of this title.

Amendment by section 4321(b) of Pub. L. 105-33 effective as of

date specified by Secretary of Health and Human Services in

regulations to be issued by Secretary not later than date which is

one year after Aug. 5, 1997, see section 4321(d)(2) of Pub. L.

105-33, set out as an Effective Date note under section 1320b-16 of

this title.

Amendment by section 4432(b)(5)(F) of Pub. L. 105-33 applicable

to items and services furnished on or after July 1, 1998, see

section 4432(d) of Pub. L. 105-33, set out as a note under section

1395i-3 of this title.

Amendment by section 4511(a)(2)(D) of Pub. L. 105-33 applicable

with respect to services furnished and supplies provided on and

after Jan. 1, 1998, see section 4511(e) of Pub. L. 105-33, set out

as a note under section 1395k of this title.

Amendment by section 4541(a)(3) of Pub. L. 105-33 applicable to

services furnished on or after Jan. 1, 1999, see section 4541(e) of

Pub. L. 105-33, set out as a note under section 1395l of this

title.

Section 4641(b) of Pub. L. 105-33 provided that: "The amendment

made by subsection (a) [amending this section] shall apply to

provider agreements entered into, renewed, or extended on or after

such date (not later than 1 year after the date of the enactment of

this Act [Aug. 5, 1997]) as the Secretary of Health and Human

Services specifies."

Amendments by section 4714(b)(1) of Pub. L. 105-33 applicable to

payment for (and with respect to provider agreements with respect

to) items and services furnished on or after Aug. 5, 1997, see

section 4714(c) of Pub. L. 105-33, set out as a note under section

1396a of this title.

EFFECTIVE DATE OF 1994 AMENDMENTS

Section 106(b)(2) of Pub. L. 103-432 provided that: "The

amendments made by paragraph (1) [amending this section and section

1395f of this title] shall take effect as if included in the

enactment of OBRA-1987 [Pub. L. 100-203]."

Amendment by section 147(e)(7) of Pub. L. 103-432 effective as if

included in the enactment of Pub. L. 101-508, see section 147(g) of

Pub. L. 103-432, set out as a note under section 1320a-3a of this

title.

Amendment by section 156(a)(2)(E) of Pub. L. 103-432 applicable

to services provided on or after Oct. 31, 1994, see section

156(a)(3) of Pub. L. 103-432, set out as a note under section

1320c-3 of this title.

Amendment by Pub. L. 103-296 effective Mar. 31, 1995, see section

110(a) of Pub. L. 103-296, set out as a note under section 401 of

this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Section 4008(b)(4) of Pub. L. 101-508 provided that: "The

amendments made by this subsection [amending this section and

section 1395dd of this title] shall apply to actions occurring on

or after the first day of the sixth month beginning after the date

of the enactment of this Act [Nov. 5, 1990]."

Section 4153(d)(2) of Pub. L. 101-508, as amended by Pub. L.

103-432, title I, Sec. 135(e)(7), Oct. 31, 1994, 108 Stat. 4424,

provided that: "The amendment made by paragraph (1) [amending this

section] shall take effect as if included in the enactment of the

Omnibus Budget Reconciliation Act of 1989 [Pub. L. 101-239]."

Amendment by section 4157(c)(2) of Pub. L. 101-508 applicable to

services furnished on or after Jan. 1, 1991, see section 4157(d) of

Pub. L. 101-508, set out as a note under section 1395k of this

title.

Amendment by section 4162(b)(2) of Pub. L. 101-508 applicable

with respect to partial hospitalization services provided on or

after Oct. 1, 1991, see section 4162(c) of Pub. L. 101-508, set out

as a note under section 1395k of this title.

Amendment by section 4206(a) of Pub. L. 101-508 applicable with

respect to services furnished on or after the first day of the

first month beginning more than 1 year after Nov. 5, 1990, see

section 4206(e)(1) of Pub. L. 101-508, set out as a note under

section 1395i-3 of this title.

EFFECTIVE DATE OF 1989 AMENDMENTS

Section 6018(b) of Pub. L. 101-239 provided that: "The amendments

made by subsection (a) [amending this section] shall take effect on

the first day of the first month that begins more than 180 days

after the date of the enactment of this Act [Dec. 19, 1989],

without regard to whether regulations to carry out such amendments

have been promulgated by such date."

Amendment by section 6112(e)(3) of Pub. L. 101-239 applicable

with respect to items furnished on or after Jan. 1, 1990, see

section 6112(e)(4) of Pub. L. 101-239, set out as a note under

section 1395m of this title.

Amendment by section 101(a) of Pub. L. 101-234 effective Jan. 1,

1990, see section 101(d) of Pub. L. 101-234, set out as a note

under section 1395c of this title.

Amendment by section 201(a) of Pub. L. 101-234 effective Jan. 1,

1990, see section 201(c) of Pub. L. 101-234, set out as a note

under section 1320a-7a of this title.

EFFECTIVE DATE OF 1988 AMENDMENTS

Amendment by section 608(d)(3)(F), (19)(A) of Pub. L. 100-485

effective as if included in the enactment of the Medicare

Catastrophic Coverage Act of 1988, Pub. L. 100-360, and amendment

by section 608(f)(1) of Pub. L. 100-485 effective Oct. 13, 1988,

see section 608(g)(1), (2) of Pub. L. 100-485, set out as a note

under section 704 of this title.

Amendment by section 104(d)(5) of Pub. L. 100-360 effective Jan.

1, 1989, except as otherwise provided, and applicable to inpatient

hospital deductible for 1989 and succeeding years, to care and

services furnished on or after Jan. 1, 1989, to premiums for

January 1989 and succeeding months, and to blood or blood cells

furnished on or after Jan. 1, 1989, see section 104(a) of Pub. L.

100-360, set out as a note under section 1395d of this title.

Amendment by section 202(h)(1) of Pub. L. 100-360 applicable to

items dispensed on or after Jan. 1, 1990, see section 202(m)(1) of

Pub. L. 100-360, set out as a note under section 1395u of this

title.

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by section 411(c)(2)(C), (g)(1)(D),

(i)(4)(C)(vi), (j)(5) of Pub. L. 100-360, as it relates to a

provision in the Omnibus Budget Reconciliation Act of 1987, Pub. L.

100-203, effective as if included in the enactment of that

provision in Pub. L. 100-203, see section 411(a) of Pub. L.

100-360, set out as a Reference to OBRA; Effective Date note under

section 106 of Title 1, General Provisions.

Section 411(c)(2)(A)(ii) of Pub. L. 100-360 provided that: "The

amendment made by clause (i) [amending this section] shall apply to

admissions occurring on or after the first day of the fourth month

beginning after the date of the enactment of this Act [July 1,

1988]."

EFFECTIVE DATE OF 1987 AMENDMENTS

Amendment by section 4012(a) of Pub. L. 100-203 applicable to

admissions occurring on or after Apr. 1, 1988, or, if later, the

earliest date the Secretary can provide the information required

under section 4012(c) of Pub. L. 100-203 [42 U.S.C. 1395mm note] in

machine readable form, see section 4012(d) of Pub. L. 100-203, set

out as a note under section 1395mm of this title.

Amendment by section 4062(d)(4) of Pub. L. 100-203 applicable to

covered items (other than oxygen and oxygen equipment) furnished on

or after Jan. 1, 1989, and to oxygen and oxygen equipment furnished

on or after June 1, 1989, see section 4062(e) of Pub. L. 100-203,

as amended, set out as a note under section 1395f of this title.

Section 4085(i)(17) of Pub. L. 100-203 provided that the

amendment made by such section 4085(i)(17) is effective as if

included in the enactment of Pub. L. 99-509.

Section 4097(c) of Pub. L. 100-203 provided that: "The amendments

made by this section [amending this section] shall apply with

respect to fiscal years beginning on or after October 1, 1988."

Amendment by section 4212(e)(4) of Pub. L. 100-203 applicable to

nursing facility services furnished on or after Oct. 1, 1990,

without regard to whether regulations implementing such amendment

are promulgated by such date, except as otherwise specifically

provided in section 1396r of this title, with transitional rule,

see section 4214(a), (b)(2) of Pub. L. 100-203, as amended, set out

as an Effective Date note under section 1396r of this title.

Amendment by Pub. L. 100-93 effective at end of fourteen-day

period beginning Aug. 18, 1987, and inapplicable to administrative

proceedings commenced before end of such period, see section 15(a)

of Pub. L. 100-93, set out as a note under section 1320a-7 of this

title.

EFFECTIVE DATE OF 1986 AMENDMENTS

Section 233(b) of Pub. L. 99-576 provided that: "The amendments

made by subsection (a) [amending this section] shall apply to

inpatient hospital services provided pursuant to admissions to

hospitals occurring after June 30, 1987."

Amendment by Pub. L. 99-514 effective, except as otherwise

provided, as if included in enactment of the Consolidated Omnibus

Budget Reconciliation Act of 1985, Pub. L. 99-272, see section

1895(e) of Pub. L. 99-514, set out as a note under section 162 of

Title 26, Internal Revenue Code.

Section 9305(b)(2) of Pub. L. 99-509 provided that: "The

Secretary of Health and Human Services shall first prescribe the

language required under section 1866(a)(1)(M) of the Social

Security Act [subsec. (a)(1)(M) of this section] not later than six

months after the date of the enactment of this Act [Oct. 21, 1986].

The requirement of such section shall apply to admissions to

hospitals occurring on such date (not later than 60 days after the

date such language is first prescribed) as the Secretary shall

provide."

Amendment by section 9320(h)(2) of Pub. L. 99-509 applicable to

services furnished on or after Jan. 1, 1989, with exceptions for

hospitals located in rural areas which meet certain requirements

related to certified registered nurse anesthetists, see section

9320(i), (k) of Pub. L. 99-509, as amended, set out as notes under

section 1395k of this title.

Section 9332(e)(2) of Pub. L. 99-509 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to agreements under section 1866(a) of the Social Security Act

[subsec. (a) of this section] as of October 1, 1987."

Amendment by section 9337(c)(2) of Pub. L. 99-509 applicable to

expenses incurred for outpatient occupational therapy services

furnished on or after July 1, 1987, see section 9337(e) of Pub. L.

99-509, set out as a note under section 1395k of this title.

Amendment by section 9343(c)(2), (3) of Pub. L. 99-509 applicable

to services furnished after June 30, 1987, see section 9343(h)(4)

of Pub. L. 99-509, as amended, set out as a note under section

1395l of this title.

Section 9353(e)(3)(A) of Pub. L. 99-509 provided that: "The

amendments made by paragraph (1) [amending this section] shall

apply to provider agreements as of October 1, 1987."

Amendment by section 9121(a) of Pub. L. 99-272 effective on first

day of first month that begins at least 90 days after Apr. 7, 1986,

see section 9121(c) of Pub. L. 99-272, set out as a note under

section 1395dd of this title.

Section 9122(b) of Pub. L. 99-272, as amended by Pub. L. 99-514,

title XVIII, Sec. 1895(b)(6), Oct. 22, 1986, 100 Stat. 2933,

provided that: "The amendments made by subsection (a) [amending

this section] shall apply to inpatient hospital services provided

pursuant to admissions to hospitals occurring on or after January

1, 1987."

Section 9402(c)(1) of Pub. L. 99-272 provided that: "The

amendments made by subsection (a) [amending this section] shall

become effective on the date of the enactment of this Act [Apr. 7,

1986]."

Amendment by section 9403(b) of Pub. L. 99-272 effective Apr. 7,

1986, see section 9403(c) of Pub. L. 99-272, set out as a note

under section 1320c-3 of this title.

EFFECTIVE DATE OF 1984 AMENDMENT

Amendment by section 2303(f) of Pub. L. 98-369 applicable to

clinical diagnostic laboratory tests furnished on or after July 1,

1984, but not applicable to clinical diagnostic laboratory tests

furnished to inpatients of a provider operating under a waiver

granted pursuant to section 602(k) of Pub. L. 98-21, set out as a

note under section 1395y of this title, see section 2303(j)(1), (3)

of Pub. L. 98-369, set out as a note under section 1395l of this

title.

Amendment by section 2315(d) of Pub. L. 98-369 effective as

though included in the enactment of the Social Security Amendments

of 1983, Pub. L. 98-21, see section 2315(g) of Pub. L. 98-369, set

out as an Effective and Termination Dates of 1984 Amendment note

under section 1395ww of this title.

Amendment by section 2321(c) of Pub. L. 98-369 applicable to

items and services furnished on or after July 18, 1984, see section

2321(g) of Pub. L. 98-369, set out as a note under section 1395f of

this title.

Amendment by section 2323(b)(3) of Pub. L. 98-369 applicable to

services furnished on or after Sept. 1, 1984, see section 2323(d)

of Pub. L. 98-369, set out as a note under section 1395l of this

title.

Amendment by section 2335(d) of Pub. L. 98-369 effective July 18,

1984, see section 2335(g) of Pub. L. 98-369, set out as a note

under section 1395f of this title.

Amendment by section 2347(a) of Pub. L. 98-369 effective July 18,

1984, see section 2347(d) of Pub. L. 98-369, set out as a note

under section 1320c-2 of this title.

Section 2348(b) of Pub. L. 98-369 provided that: "The amendment

made by this section [amending this section] shall apply to

terminations issued on or after the date of the enactment of this

Act [July 18, 1984]."

Amendment by section 2354(b)(33), (34) of Pub. L. 98-369

effective July 18, 1984, but not to be construed as changing or

affecting any right, liability, status, or interpretation which

existed (under the provisions of law involved) before that date,

see section 2354(e)(1) of Pub. L. 98-369, set out as a note under

section 1320a-1 of this title.

EFFECTIVE DATE OF 1983 AMENDMENTS

Section 602(l) of Pub. L. 98-21, as amended by Pub. L. 98-369,

div. B, title III, Sec. 2347(a)(2), July 18, 1984, 98 Stat. 1096,

provided that the amendment made by that section is effective Oct.

1, 1984.

Amendment by section 602(f)(2) of Pub. L. 98-21 applicable to

items and services furnished by or under arrangement with a

hospital beginning with its first cost reporting period that begins

on or after Oct. 1, 1983, any change in a hospital's cost reporting

period made after November 1982 to be recognized for such purposes

only if the Secretary finds good cause therefor, see section

604(a)(1) of Pub. L. 98-21, set out as a note under section 1395ww

of this title.

Subsec. (a)(1)(F) to (H) of this section, as added by section

602(f)(1)(C) of Pub. L. 98-21, effective Oct. 1, 1983, see section

604(a)(2) of Pub. L. 98-21, set out as a note under section 1395ww

of this title.

Amendment by section 309(a)(5) of Pub. L. 97-448 effective as if

originally included in the provision of the Tax Equity and Fiscal

Responsibility Act of 1982, Pub. L. 97-248, to which such amendment

relates, see section 309(c)(1) of Pub. L. 97-448, set out as a note

under section 426 of this title.

Amendment by section 309(b)(11) of Pub. L. 97-448 effective as if

originally included as a part of this section as this section was

amended by the Tax Equity and Fiscal Responsibility Act of 1982,

Pub. L. 97-248, see section 309(c)(2) of Pub. L. 97-448, set out as

a note under section 426-1 of this title.

EFFECTIVE DATE OF 1982 AMENDMENT

Amendment by section 122(g)(5), (6) of Pub. L. 97-248 applicable

to hospice care provided on or after Nov. 1, 1983, see section

122(h)(1) of Pub. L. 97-248, as amended, set out as a note under

section 1395c of this title.

Amendment by section 128(a)(5) of Pub. L. 97-248 effective as if

originally included as part of this section as this section was

amended by the Omnibus Budget Reconciliation Act of 1981, Pub. L.

97-35, see section 128(e)(2) of Pub. L. 97-248, set out as a note

under section 1395x of this title.

Amendment by section 128(d)(4) of Pub. L. 97-248 effective Sept.

3, 1982, see section 128(e)(3) of Pub. L. 97-248, set out as a note

under section 1395x of this title.

Amendment by section 144 of Pub. L. 97-248 effective with respect

to contracts entered into or renewed on or after Sept. 3, 1982, see

section 149 of Pub. L. 97-248, set out as an Effective Date note

under section 1320c of this title.

EFFECTIVE DATE OF 1980 AMENDMENT

Amendment by Pub. L. 96-611 effective July 1, 1981, and

applicable to services furnished on or after that date, see section

2 of Pub. L. 96-611, set out as a note under section 1395l of this

title.

EFFECTIVE DATE OF 1978 AMENDMENT

Amendment by Pub. L. 95-292 effective with respect to services,

supplies, and equipment furnished after the third calendar month

beginning after June 13, 1978, except that provisions for the

implementation of an incentive reimbursement system for dialysis

services furnished in facilities and providers to become effective

with respect to a facility's or provider's first accounting period

beginning after the last day of the twelfth month following the

month of June 1978, and except that provisions for reimbursement

rates for home dialysis to become effective on Apr. 1, 1979, see

section 6 of Pub. L. 95-292, set out as a note under section 426 of

this title.

EFFECTIVE DATE OF 1977 AMENDMENTS

Section 2(f) of Pub. L. 95-210 provided that:

"(1) The amendments made by this section [amending this section

and sections 1396a, 1396d, and 1396i of this title] shall (except

as otherwise provided in paragraph (2)) apply to medical assistance

provided, under a State plan approved under title XIX of the Social

Security Act [subchapter XIX of this chapter], on and after the

first day of the first calendar quarter that begins more than six

months after the date of enactment of this Act [Dec. 13, 1977].

"(2) In the case of a State plan for medical assistance under

title XIX of the Social Security Act [subchapter XIX of this

chapter] which the Secretary determines requires State legislation

in order for the plan to meet the additional requirements imposed

by the amendments made by this section, the State plan shall not be

regarded as failing to comply with the requirements of such title

[subchapter] solely on the basis of its failure to meet these

additional requirements before the first day of the first calendar

quarter beginning after the close of the first regular session of

the State legislature that begins after the date of enactment of

this Act [Dec. 13, 1977]."

Amendment by section 3(b) of Pub. L. 95-142 effective Oct. 25,

1977, see section 3(e) of Pub. L. 95-142, set out as an Effective

Date note under section 1320a-3 of this title.

Amendment by section 8(b) of Pub. L. 95-142 [amending this

section] applicable with respect to contracts, agreements, etc.,

made on and after first day of fourth month beginning after Oct.

25, 1977, see section 8(e) of Pub. L. 95-142, set out as an

Effective Date note under section 1320a-5 of this title.

Amendment by section 13(b)(3) of Pub. L. 95-142 effective Oct.

25, 1977, see section 13(c) of Pub. L. 95-142, set out as a note

under section 1395y of this title.

Section 15(b) of Pub. L. 95-142 provided that: "The amendments

made by subsection (a) [amending this section] shall apply with

respect to agreements entered into or renewed on and after the date

of enactment of this Act [Oct. 25, 1977]."

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by section 223(e), (g) of Pub. L. 92-603 effective with

respect to accounting periods beginning after Dec. 31, 1972, see

section 223(h) of Pub. L. 92-603, set out as a note under section

1395x of this title.

Amendment by section 227(d)(2) of Pub. L. 92-603 applicable with

respect to accounting periods beginning after June 30, 1973, see

section 227(g) of Pub. L. 92-603, set out as a note under section

1395x of this title.

Section 249A(e) of Pub. L. 92-603 provided that: "The provisions

of this section [enacting section 1396 of this title and amending

this section] shall be effective with respect to agreements filed

with the Secretary under section 1866 of the Social Security Act

[this section] by skilled nursing facilities (as defined in section

1861(j) of such Act [section 1395x(j) of this title]) before, on,

or after the date of enactment of this Act [Oct. 30, 1972], but

accepted by him on or after such date."

Amendment by section 281(c) of Pub. L. 92-603 applicable in the

case of notices sent to individuals after 1968, see section 281(g)

of Pub. L. 92-603, set out as a note under section 1395gg of this

title.

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment by section 129(c)(12) of Pub. L. 90-248 applicable with

respect to services furnished after Mar. 31, 1968, see section

129(d) of Pub. L. 90-248, set out as a note under section 1395d of

this title.

Amendment by section 133(c) of Pub. L. 90-248 applicable with

respect to services furnished after June 30, 1968, see section

133(g) of Pub. L. 90-248, set out as a note under section 1395k of

this title.

Amendment by section 135(b) of Pub. L. 90-248 applicable with

respect to payment for blood (or packed red blood cells) furnished

an individual after Dec. 31, 1967, see section 135(d) of Pub. L.

90-248, set out as a note under section 1395e of this title.

EFFECT ON STATE LAW

Section 4206(c) of Pub. L. 101-508 provided that: "Nothing in

subsections (a) and (b) [amending this section and sections 1395l

and 1395mm of this title] shall be construed to prohibit the

application of a State law which allows for an objection on the

basis of conscience for any health care provider or any agent of

such provider which, as a matter of conscience, cannot implement an

advance directive."

REPORTS TO CONGRESS ON NUMBER OF HOSPITALS TERMINATING OR NOT

RENEWING PROVIDER AGREEMENTS

Section 233(c) of Pub. L. 99-576 provided that:

"(1) The Secretary of Health and Human Services shall

periodically submit to the Congress a report on the number of

hospitals that have terminated or failed to renew an agreement

under section 1866 of the Social Security Act [this section] as a

result of the additional conditions imposed under the amendments

made by subsection (a) [amending this section].

"(2) Not later than October 1, 1987, the Administrator of

Veterans' Affairs shall submit to the Committees on Veterans'

Affairs of the Senate and House of Representatives a report

regarding implementation of this section [amending this section].

Thereafter, the Administrator shall notify such committees if any

hospital terminates or fails to renew an agreement described in

paragraph (1) for the reasons described in that paragraph."

[For termination, effective May 15, 2000, of provisions of law

requiring submittal to Congress of any annual, semiannual, or other

regular periodic report listed in House Document No. 103-7 (in

which item 7 on page 96 identifies a report on "Hospitals that have

terminated or failed to renew an agreement under section 1866 of

Social Security Act as a result of the additional conditions

imposed" authorized by 42 U.S.C. 1395cc note), see section 3003 of

Pub. L. 104-66, as amended, set out as a note under section 1113 of

Title 31, Money and Finance.]

Section 9122(d) of Pub. L. 99-272 provided that: "The Secretary

of Health and Human Services shall report to Congress periodically

on the number of hospitals that have terminated or failed to renew

an agreement under section 1866 of the Social Security Act [this

section] as a result of the additional conditions imposed under the

amendments made by subsection (a) [amending this section]."

[For termination, effective May 15, 2000, of provisions of law

requiring submittal to Congress of any annual, semiannual, or other

regular periodic report listed in House Document No. 103-7 (in

which item 7 on page 96 identifies a report on "Hospitals that have

terminated or failed to renew an agreement under section 1866 of

Social Security Act as a result of the additional conditions

imposed" authorized by 42 U.S.C. 1395cc note), see section 3003 of

Pub. L. 104-66, as amended, set out as a note under section 1113 of

Title 31, Money and Finance.]

DELAY IN IMPLEMENTATION OF REQUIREMENT THAT HOSPITALS MAINTAIN

AGREEMENTS WITH UTILIZATION AND QUALITY CONTROL PEER REVIEW

ORGANIZATION

Section 2347(b) of Pub. L. 98-369 provided that: "Notwithstanding

section 604(a)(2) of the Social Security Amendments of 1983

[section 604(a)(2) of Pub. L. 98-21, set out as an Effective Date

of 1983 Amendment note under section 1395ww of this title], the

requirement that a hospital maintain an agreement with a

utilization and quality control peer review organization, as

contained in section 1866(a)(1)(F) of the Social Security Act

[subsec. (a)(1)(F) of this section], shall become effective on

November 15, 1984."

INTERIM WAIVER IN CERTAIN CASES OF BILLING RULE FOR ITEMS AND

SERVICES OTHER THAN PHYSICIANS' SERVICES

For authority to waive the requirements of subsec. (a)(1)(H) of

this section for any cost period prior to Oct. 1, 1986, where

immediate compliance would threaten the stability of patient care,

see section 602(k) of Pub. L. 98-21, set out as a note under

section 1395y of this title.

PRIVATE SECTOR REVIEW INITIATIVE

Section 119 of Pub. L. 97-248 provided that:

"(a) The Secretary of Health and Human Services shall undertake

an initiative to improve medical review by intermediaries and

carriers under title XVIII of the Social Security Act [this

subchapter] and to encourage similar review efforts by private

insurers and other private entities. The initiative shall include

the development of specific standards for measuring the performance

of such intermediaries and carriers with respect to the

identification and reduction of unnecessary utilization of health

services.

"(b) Where such review activity results in the denial of payment

to providers of services under title XVIII of the Social Security

Act [this subchapter], such providers shall be prohibited, in

accordance with sections 1866 and 1879 of such title [this section

and section 1395pp of this title], from collecting any payments

from beneficiaries unless otherwise provided under such title."

AGREEMENTS FILED AND ACCEPTED PRIOR TO OCT. 30, 1972, DEEMED TO BE

FOR SPECIFIED TERM ENDING DEC. 31, 1973

Section 249A(f) of Pub. L. 92-603 provided that: "Notwithstanding

any other provision of law, any agreement, filed by a skilled

nursing facility (as defined in section 1861(j) of the Social

Security Act [section 1395x(j) of this title]) with the Secretary

under section 1866 of such Act [this section] and accepted by him

prior to the date of enactment of this Act [Oct. 30, 1972], which

was in effect on such date shall be deemed to be for a specified

term ending on December 31, 1973."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1320a-7a, 1320b-16,

1395f, 1395i-3, 1395l, 1395m, 1395n, 1395w-22, 1395x, 1395y,

1395dd, 1395mm, 1395tt, 1395vv, 1395ww, 1395bbb, 1395ccc, 1396a,

1396i, 1396m, 1396r, 14406 of this title; title 5 section 8904.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 1395cc-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395cc-1. Demonstration of application of physician volume

increases to group practices

-STATUTE-

(a) Demonstration program authorized

(1) In general

The Secretary shall conduct demonstration projects to test and,

if proven effective, expand the use of incentives to health care

groups participating in the program under this subchapter that -

(A) encourage coordination of the care furnished to

individuals under the programs under parts A and B of this

subchapter by institutional and other providers, practitioners,

and suppliers of health care items and services;

(B) encourage investment in administrative structures and

processes to ensure efficient service delivery; and

(C) reward physicians for improving health outcomes.

Such projects shall focus on the efficiencies of furnishing

health care in a group-practice setting as compared to the

efficiencies of furnishing health care in other health care

delivery systems.

(2) Administration by contract

Except as otherwise specifically provided, the Secretary may

administer the program under this section in accordance with

section 1395cc-2 of this title.

(3) Definitions

For purposes of this section, terms have the following

meanings:

(A) Physician

Except as the Secretary may otherwise provide, the term

"physician" means any individual who furnishes services which

may be paid for as physicians' services under this subchapter.

(B) Health care group

The term "health care group" means a group of physicians (as

defined in subparagraph (A)) organized at least in part for the

purpose of providing physicians' services under this

subchapter. As the Secretary finds appropriate, a health care

group may include a hospital and any other individual or entity

furnishing items or services for which payment may be made

under this subchapter that is affiliated with the health care

group under an arrangement structured so that such individual

or entity participates in a demonstration under this section

and will share in any bonus earned under subsection (d) of this

section.

(b) Eligibility Criteria

(1) In general

The Secretary is authorized to establish criteria for health

care groups eligible to participate in a demonstration under this

section, including criteria relating to numbers of health care

professionals in, and of patients served by, the group, scope of

services provided, and quality of care.

(2) Payment method

A health care group participating in the demonstration under

this section shall agree with respect to services furnished to

beneficiaries within the scope of the demonstration (as

determined under subsection (c) of this section) -

(A) to be paid on a fee-for-service basis; and

(B) that payment with respect to all such services furnished

by members of the health care group to such beneficiaries shall

(where determined appropriate by the Secretary) be made to a

single entity.

(3) Data reporting

A health care group participating in a demonstration under this

section shall report to the Secretary such data, at such times

and in such format as the Secretary requires, for purposes of

monitoring and evaluation of the demonstration under this

section.

(c) Patients within scope of demonstration

(1) In general

The Secretary shall specify, in accordance with this

subsection, the criteria for identifying those patients of a

health care group who shall be considered within the scope of the

demonstration under this section for purposes of application of

subsection (d) of this section and for assessment of the

effectiveness of the group in achieving the objectives of this

section.

(2) Other criteria

The Secretary may establish additional criteria for inclusion

of beneficiaries within a demonstration under this section, which

may include frequency of contact with physicians in the group or

other factors or criteria that the Secretary finds to be

appropriate.

(3) Notice requirements

In the case of each beneficiary determined to be within the

scope of a demonstration under this section with respect to a

specific health care group, the Secretary shall ensure that such

beneficiary is notified of the incentives, and of any waivers of

coverage or payment rules, applicable to such group under such

demonstration.

(d) Incentives

(1) Performance target

The Secretary shall establish for each health care group

participating in a demonstration under this section -

(A) a base expenditure amount, equal to the average total

payments under parts A and B of this subchapter for patients

served by the health care group on a fee-for-service basis in a

base period determined by the Secretary; and

(B) an annual per capita expenditure target for patients

determined to be within the scope of the demonstration,

reflecting the base expenditure amount adjusted for risk and

expected growth rates.

(2) Incentive bonus

The Secretary shall pay to each participating health care group

(subject to paragraph (4)) a bonus for each year under the

demonstration equal to a portion of the medicare savings realized

for such year relative to the performance target.

(3) Additional bonus for process and outcome improvements

At such time as the Secretary has established appropriate

criteria based on evidence the Secretary determines to be

sufficient, the Secretary shall also pay to a participating

health care group (subject to paragraph (4)) an additional bonus

for a year, equal to such portion as the Secretary may designate

of the saving to the program under this subchapter resulting from

process improvements made by and patient outcome improvements

attributable to activities of the group.

(4) Limitation

The Secretary shall limit bonus payments under this section as

necessary to ensure that the aggregate expenditures under this

subchapter (inclusive of bonus payments) with respect to patients

within the scope of the demonstration do not exceed the amount

which the Secretary estimates would be expended if the

demonstration projects under this section were not implemented.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1866A, as added Pub. L.

106-554, Sec. 1(a)(6) [title IV, Sec. 412(a)], Dec. 21, 2000, 114

Stat. 2763, 2763A-509.)

-REFTEXT-

REFERENCES IN TEXT

Parts A and B of this subchapter, referred to in subsecs.

(a)(1)(A) and (d)(1)(A), are classified to sections 1395c et seq.

and 1395j et seq., respectively, of this title.

-MISC1-

GAO REPORT

Pub. L. 106-554, Sec. 1(a)(6) [title IV, Sec. 412(b)], Dec. 21,

2000, 114 Stat. 2763, 2763A-515, provided that: "Not later than 2

years after the date on which the demonstration project under

section 1866A of the Social Security Act [this section], as added

by subsection (a), is implemented, the Comptroller General of the

United States shall submit to Congress a report on such

demonstration project. The report shall include such

recommendations with respect to changes to the demonstration

project that the Comptroller General determines appropriate."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 1395cc-2 of this title.

-End-

-CITE-

42 USC Sec. 1395cc-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395cc-2. Provisions for administration of demonstration

program

-STATUTE-

(a) General administrative authority

(1) Beneficiary eligibility

Except as otherwise provided by the Secretary, an individual

shall only be eligible to receive benefits under the program

under section 1395cc-1 of this title (in this section referred to

as the "demonstration program") if such individual -

(A) is enrolled under the program under part B of this

subchapter and entitled to benefits under part A of this

subchapter; and

(B) is not enrolled in a Medicare+Choice plan under part C of

this subchapter, an eligible organization under a contract

under section 1395mm of this title (or a similar organization

operating under a demonstration project authority), an

organization with an agreement under section 1395l(a)(1)(A) of

this title, or a PACE program under section 1395eee of this

title.

(2) Secretary's discretion as to scope of program

The Secretary may limit the implementation of the demonstration

program to -

(A) a geographic area (or areas) that the Secretary

designates for purposes of the program, based upon such

criteria as the Secretary finds appropriate;

(B) a subgroup (or subgroups) of beneficiaries or individuals

and entities furnishing items or services (otherwise eligible

to participate in the program), selected on the basis of the

number of such participants that the Secretary finds consistent

with the effective and efficient implementation of the program;

(C) an element (or elements) of the program that the

Secretary determines to be suitable for implementation; or

(D) any combination of any of the limits described in

subparagraphs (A) through (C).

(3) Voluntary receipt of items and services

Items and services shall be furnished to an individual under

the demonstration program only at the individual's election.

(4) Agreements

The Secretary is authorized to enter into agreements with

individuals and entities to furnish health care items and

services to beneficiaries under the demonstration program.

(5) Program standards and criteria

The Secretary shall establish performance standards for the

demonstration program including, as applicable, standards for

quality of health care items and services, cost-effectiveness,

beneficiary satisfaction, and such other factors as the Secretary

finds appropriate. The eligibility of individuals or entities for

the initial award, continuation, and renewal of agreements to

provide health care items and services under the program shall be

conditioned, at a minimum, on performance that meets or exceeds

such standards.

(6) Administrative review of decisions affecting individuals and

entities furnishing services

An individual or entity furnishing services under the

demonstration program shall be entitled to a review by the

program administrator (or, if the Secretary has not contracted

with a program administrator, by the Secretary) of a decision not

to enter into, or to terminate, or not to renew, an agreement

with the entity to provide health care items or services under

the program.

(7) Secretary's review of marketing materials

An agreement with an individual or entity furnishing services

under the demonstration program shall require the individual or

entity to guarantee that it will not distribute materials that

market items or services under the program without the

Secretary's prior review and approval.

(8) Payment in full

(A) In general

Except as provided in subparagraph (B), an individual or

entity receiving payment from the Secretary under a contract or

agreement under the demonstration program shall agree to accept

such payment as payment in full, and such payment shall be in

lieu of any payments to which the individual or entity would

otherwise be entitled under this subchapter.

(B) Collection of deductibles and coinsurance

Such individual or entity may collect any applicable

deductible or coinsurance amount from a beneficiary.

(b) Contracts for program administration

(1) In general

The Secretary may administer the demonstration program through

a contract with a program administrator in accordance with the

provisions of this subsection.

(2) Scope of program administrator contracts

The Secretary may enter into such contracts for a limited

geographic area, or on a regional or national basis.

(3) Eligible contractors

The Secretary may contract for the administration of the

program with -

(A) an entity that, under a contract under section 1395h or

1395u of this title, determines the amount of and makes

payments for health care items and services furnished under

this subchapter; or

(B) any other entity with substantial experience in managing

the type of program concerned.

(4) Contract award, duration, and renewal

(A) In general

A contract under this subsection shall be for an initial term

of up to three years, renewable for additional terms of up to

three years.

(B) Noncompetitive award and renewal for entities administering

part A or part B payments

The Secretary may enter or renew a contract under this

subsection with an entity described in paragraph (3)(A) without

regard to the requirements of section 5 of title 41.

(5) Applicability of Federal Acquisition Regulation

The Federal Acquisition Regulation shall apply to program

administration contracts under this subsection.

(6) Performance standards

The Secretary shall establish performance standards for the

program administrator including, as applicable, standards for the

quality and cost-effectiveness of the program administered, and

such other factors as the Secretary finds appropriate. The

eligibility of entities for the initial award, continuation, and

renewal of program administration contracts shall be conditioned,

at a minimum, on performance that meets or exceeds such

standards.

(7) Functions of program administrator

A program administrator shall perform any or all of the

following functions, as specified by the Secretary:

(A) Agreements with entities furnishing health care items and

services

Determine the qualifications of entities seeking to enter or

renew agreements to provide services under the demonstration

program, and as appropriate enter or renew (or refuse to enter

or renew) such agreements on behalf of the Secretary.

(B) Establishment of payment rates

Negotiate or otherwise establish, subject to the Secretary's

approval, payment rates for covered health care items and

services.

(C) Payment of claims or fees

Administer payments for health care items or services

furnished under the program.

(D) Payment of bonuses

Using such guidelines as the Secretary shall establish, and

subject to the approval of the Secretary, make bonus payments

as described in subsection (c)(2)(A)(ii) (!1) of this section

to entities furnishing items or services for which payment may

be made under the program.

(E) Oversight

Monitor the compliance of individuals and entities with

agreements under the program with the conditions of

participation.

(F) Administrative review

Conduct reviews of adverse determinations specified in

subsection (a)(6) of this section.

(G) Review of marketing materials

Conduct a review of marketing materials proposed by an entity

furnishing services under the program.

(H) Additional functions

Perform such other functions as the Secretary may specify.

(8) Limitation of liability

The provisions of section 1320c-6(b) of this title shall apply

with respect to activities of contractors and their officers,

employees, and agents under a contract under this subsection.

(9) Information sharing

Notwithstanding section 1306 of this title and section 552a of

title 5, the Secretary is authorized to disclose to an entity

with a program administration contract under this subsection such

information (including medical information) on individuals

receiving health care items and services under the program as the

entity may require to carry out its responsibilities under the

contract.

(c) Rules applicable to both program agreements and program

administration contracts

(1) Records, reports, and audits

The Secretary is authorized to require entities with agreements

to provide health care items or services under the demonstration

program, and entities with program administration contracts under

subsection (b) of this section, to maintain adequate records, to

afford the Secretary access to such records (including for audit

purposes), and to furnish such reports and other materials

(including audited financial statements and performance data) as

the Secretary may require for purposes of implementation,

oversight, and evaluation of the program and of individuals' and

entities' effectiveness in performance of such agreements or

contracts.

(2) Bonuses

Notwithstanding any other provision of law, but subject to

subparagraph (B)(ii), the Secretary may make bonus payments under

the demonstration program from the Federal Health Insurance Trust

Fund and the Federal Supplementary Medical Insurance Trust Fund

in amounts that do not exceed the amounts authorized under the

program in accordance with the following:

(A) Payments to program administrators

The Secretary may make bonus payments under the program to

program administrators.

(B) Payments to entities furnishing services

(i) In general

Subject to clause (ii), the Secretary may make bonus

payments to individuals or entities furnishing items or

services for which payment may be made under the

demonstration program, or may authorize the program

administrator to make such bonus payments in accordance with

such guidelines as the Secretary shall establish and subject

to the Secretary's approval.

(ii) Limitations

The Secretary may condition such payments on the

achievement of such standards related to efficiency,

improvement in processes or outcomes of care, or such other

factors as the Secretary determines to be appropriate.

(3) Antidiscrimination limitation

The Secretary shall not enter into an agreement with an entity

to provide health care items or services under the demonstration

program, or with an entity to administer the program, unless such

entity guarantees that it will not deny, limit, or condition the

coverage or provision of benefits under the program, for

individuals eligible to be enrolled under such program, based on

any health status-related factor described in section

300gg-1(a)(1) of this title.

(d) Limitations on judicial review

The following actions and determinations with respect to the

demonstration program shall not be subject to review by a judicial

or administrative tribunal:

(1) Limiting the implementation of the program under subsection

(a)(2) of this section.

(2) Establishment of program participation standards under

subsection (a)(5) of this section or the denial or termination

of, or refusal to renew, an agreement with an entity to provide

health care items and services under the program.

(3) Establishment of program administration contract

performance standards under subsection (b)(6) of this section,

the refusal to renew a program administration contract, or the

noncompetitive award or renewal of a program administration

contract under subsection (b)(4)(B) of this section.

(4) Establishment of payment rates, through negotiation or

otherwise, under a program agreement or a program administration

contract.

(5) A determination with respect to the program (where

specifically authorized by the program authority or by subsection

(c)(2) of this section) -

(A) as to whether cost savings have been achieved, and the

amount of savings; or

(B) as to whether, to whom, and in what amounts bonuses will

be paid.

(e) Application limited to parts A and B

None of the provisions of this section or of the demonstration

program shall apply to the programs under part C of this

subchapter.

(f) Reports to Congress

Not later than two years after December 21, 2000, and biennially

thereafter for six years, the Secretary shall report to Congress on

the use of authorities under the demonstration program. Each report

shall address the impact of the use of those authorities on

expenditures, access, and quality under the programs under this

subchapter.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1866B, as added Pub. L.

106-554, Sec. 1(a)(6) [title IV, Sec. 412(a)], Dec. 21, 2000, 114

Stat. 2763, 2763A-511.)

-REFTEXT-

REFERENCES IN TEXT

Parts A, B, and C of this subchapter, referred to in subsecs.

(a)(1) and (e), are classified to sections 1395c et seq., 1395j et

seq., and 1395w-21 et seq., respectively, of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 1395cc-1 of this title.

-FOOTNOTE-

(!1) So in original. Subsec. (c)(2)(A) of this section does not

contain clauses.

-End-

-CITE-

42 USC Sec. 1395dd 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395dd. Examination and treatment for emergency medical

conditions and women in labor

-STATUTE-

(a) Medical screening requirement

In the case of a hospital that has a hospital emergency

department, if any individual (whether or not eligible for benefits

under this subchapter) comes to the emergency department and a

request is made on the individual's behalf for examination or

treatment for a medical condition, the hospital must provide for an

appropriate medical screening examination within the capability of

the hospital's emergency department, including ancillary services

routinely available to the emergency department, to determine

whether or not an emergency medical condition (within the meaning

of subsection (e)(1) of this section) exists.

(b) Necessary stabilizing treatment for emergency medical

conditions and labor

(1) In general

If any individual (whether or not eligible for benefits under

this subchapter) comes to a hospital and the hospital determines

that the individual has an emergency medical condition, the

hospital must provide either -

(A) within the staff and facilities available at the

hospital, for such further medical examination and such

treatment as may be required to stabilize the medical

condition, or

(B) for transfer of the individual to another medical

facility in accordance with subsection (c) of this section.

(2) Refusal to consent to treatment

A hospital is deemed to meet the requirement of paragraph

(1)(A) with respect to an individual if the hospital offers the

individual the further medical examination and treatment

described in that paragraph and informs the individual (or a

person acting on the individual's behalf) of the risks and

benefits to the individual of such examination and treatment, but

the individual (or a person acting on the individual's behalf)

refuses to consent to the examination and treatment. The hospital

shall take all reasonable steps to secure the individual's (or

person's) written informed consent to refuse such examination and

treatment.

(3) Refusal to consent to transfer

A hospital is deemed to meet the requirement of paragraph (1)

with respect to an individual if the hospital offers to transfer

the individual to another medical facility in accordance with

subsection (c) of this section and informs the individual (or a

person acting on the individual's behalf) of the risks and

benefits to the individual of such transfer, but the individual

(or a person acting on the individual's behalf) refuses to

consent to the transfer. The hospital shall take all reasonable

steps to secure the individual's (or person's) written informed

consent to refuse such transfer.

(c) Restricting transfers until individual stabilized

(1) Rule

If an individual at a hospital has an emergency medical

condition which has not been stabilized (within the meaning of

subsection (e)(3)(B) of this section), the hospital may not

transfer the individual unless -

(A)(i) the individual (or a legally responsible person acting

on the individual's behalf) after being informed of the

hospital's obligations under this section and of the risk of

transfer, in writing requests transfer to another medical

facility,

(ii) a physician (within the meaning of section 1395x(r)(1)

of this title) has signed a certification that (!1) based upon

the information available at the time of transfer, the medical

benefits reasonably expected from the provision of appropriate

medical treatment at another medical facility outweigh the

increased risks to the individual and, in the case of labor, to

the unborn child from effecting the transfer, or

(iii) if a physician is not physically present in the

emergency department at the time an individual is transferred,

a qualified medical person (as defined by the Secretary in

regulations) has signed a certification described in clause

(ii) after a physician (as defined in section 1395x(r)(1) of

this title), in consultation with the person, has made the

determination described in such clause, and subsequently

countersigns the certification; and

(B) the transfer is an appropriate transfer (within the

meaning of paragraph (2)) to that facility.

A certification described in clause (ii) or (iii) of subparagraph

(A) shall include a summary of the risks and benefits upon which

the certification is based.

(2) Appropriate transfer

An appropriate transfer to a medical facility is a transfer -

(A) in which the transferring hospital provides the medical

treatment within its capacity which minimizes the risks to the

individual's health and, in the case of a woman in labor, the

health of the unborn child;

(B) in which the receiving facility -

(i) has available space and qualified personnel for the

treatment of the individual, and

(ii) has agreed to accept transfer of the individual and to

provide appropriate medical treatment;

(C) in which the transferring hospital sends to the receiving

facility all medical records (or copies thereof), related to

the emergency condition for which the individual has presented,

available at the time of the transfer, including records

related to the individual's emergency medical condition,

observations of signs or symptoms, preliminary diagnosis,

treatment provided, results of any tests and the informed

written consent or certification (or copy thereof) provided

under paragraph (1)(A), and the name and address of any on-call

physician (described in subsection (d)(1)(C) of this section)

who has refused or failed to appear within a reasonable time to

provide necessary stabilizing treatment;

(D) in which the transfer is effected through qualified

personnel and transportation equipment, as required including

the use of necessary and medically appropriate life support

measures during the transfer; and

(E) which meets such other requirements as the Secretary may

find necessary in the interest of the health and safety of

individuals transferred.

(d) Enforcement

(1) Civil money penalties

(A) A participating hospital that negligently violates a

requirement of this section is subject to a civil money penalty

of not more than $50,000 (or not more than $25,000 in the case of

a hospital with less than 100 beds) for each such violation. The

provisions of section 1320a-7a of this title (other than

subsections (a) and (b)) shall apply to a civil money penalty

under this subparagraph in the same manner as such provisions

apply with respect to a penalty or proceeding under section

1320a-7a(a) of this title.

(B) Subject to subparagraph (C), any physician who is

responsible for the examination, treatment, or transfer of an

individual in a participating hospital, including a physician

on-call for the care of such an individual, and who negligently

violates a requirement of this section, including a physician who

-

(i) signs a certification under subsection (c)(1)(A) of this

section that the medical benefits reasonably to be expected

from a transfer to another facility outweigh the risks

associated with the transfer, if the physician knew or should

have known that the benefits did not outweigh the risks, or

(ii) misrepresents an individual's condition or other

information, including a hospital's obligations under this

section,

is subject to a civil money penalty of not more than $50,000 for

each such violation and, if the violation is is (!2) gross and

flagrant or is repeated, to exclusion from participation in this

subchapter and State health care programs. The provisions of

section 1320a-7a of this title (other than the first and second

sentences of subsection (a) and subsection (b)) shall apply to a

civil money penalty and exclusion under this subparagraph in the

same manner as such provisions apply with respect to a penalty,

exclusion, or proceeding under section 1320a-7a(a) of this title.

(C) If, after an initial examination, a physician determines

that the individual requires the services of a physician listed

by the hospital on its list of on-call physicians (required to be

maintained under section 1395cc(a)(1)(I) of this title) and

notifies the on-call physician and the on-call physician fails or

refuses to appear within a reasonable period of time, and the

physician orders the transfer of the individual because the

physician determines that without the services of the on-call

physician the benefits of transfer outweigh the risks of

transfer, the physician authorizing the transfer shall not be

subject to a penalty under subparagraph (B). However, the

previous sentence shall not apply to the hospital or to the

on-call physician who failed or refused to appear.

(2) Civil enforcement

(A) Personal harm

Any individual who suffers personal harm as a direct result

of a participating hospital's violation of a requirement of

this section may, in a civil action against the participating

hospital, obtain those damages available for personal injury

under the law of the State in which the hospital is located,

and such equitable relief as is appropriate.

(B) Financial loss to other medical facility

Any medical facility that suffers a financial loss as a

direct result of a participating hospital's violation of a

requirement of this section may, in a civil action against the

participating hospital, obtain those damages available for

financial loss, under the law of the State in which the

hospital is located, and such equitable relief as is

appropriate.

(C) Limitations on actions

No action may be brought under this paragraph more than two

years after the date of the violation with respect to which the

action is brought.

(3) Consultation with peer review organizations

In considering allegations of violations of the requirements of

this section in imposing sanctions under paragraph (1), the

Secretary shall request the appropriate utilization and quality

control peer review organization (with a contract under part B of

subchapter XI of this chapter) to assess whether the individual

involved had an emergency medical condition which had not been

stabilized, and provide a report on its findings. Except in the

case in which a delay would jeopardize the health or safety of

individuals, the Secretary shall request such a review before

effecting a sanction under paragraph (1) and shall provide a

period of at least 60 days for such review.

(e) Definitions

In this section:

(1) The term "emergency medical condition" means -

(A) a medical condition manifesting itself by acute symptoms

of sufficient severity (including severe pain) such that the

absence of immediate medical attention could reasonably be

expected to result in -

(i) placing the health of the individual (or, with respect

to a pregnant woman, the health of the woman or her unborn

child) in serious jeopardy,

(ii) serious impairment to bodily functions, or

(iii) serious dysfunction of any bodily organ or part; or

(B) with respect to a pregnant women (!3) who is having

contractions -

(i) that there is inadequate time to effect a safe transfer

to another hospital before delivery, or

(ii) that transfer may pose a threat to the health or

safety of the woman or the unborn child.

(2) The term "participating hospital" means hospital that has

entered into a provider agreement under section 1395cc of this

title.

(3)(A) The term "to stabilize" means, with respect to an

emergency medical condition described in paragraph (1)(A), to

provide such medical treatment of the condition as may be

necessary to assure, within reasonable medical probability, that

no material deterioration of the condition is likely to result

from or occur during the transfer of the individual from a

facility, or, with respect to an emergency medical condition

described in paragraph (1)(B), to deliver (including the

placenta).

(B) The term "stabilized" means, with respect to an emergency

medical condition described in paragraph (1)(A), that no material

deterioration of the condition is likely, within reasonable

medical probability, to result from or occur during the transfer

of the individual from a facility, or, with respect to an

emergency medical condition described in paragraph (1)(B), that

the woman has delivered (including the placenta).

(4) The term "transfer" means the movement (including the

discharge) of an individual outside a hospital's facilities at

the direction of any person employed by (or affiliated or

associated, directly or indirectly, with) the hospital, but does

not include such a movement of an individual who (A) has been

declared dead, or (B) leaves the facility without the permission

of any such person.

(5) The term "hospital" includes a critical access hospital (as

defined in section 1395x(mm)(1) of this title).

(f) Preemption

The provisions of this section do not preempt any State or local

law requirement, except to the extent that the requirement directly

conflicts with a requirement of this section.

(g) Nondiscrimination

A participating hospital that has specialized capabilities or

facilities (such as burn units, shock-trauma units, neonatal

intensive care units, or (with respect to rural areas) regional

referral centers as identified by the Secretary in regulation)

shall not refuse to accept an appropriate transfer of an individual

who requires such specialized capabilities or facilities if the

hospital has the capacity to treat the individual.

(h) No delay in examination or treatment

A participating hospital may not delay provision of an

appropriate medical screening examination required under subsection

(a) of this section or further medical examination and treatment

required under subsection (b) of this section in order to inquire

about the individual's method of payment or insurance status.

(i) Whistleblower protections

A participating hospital may not penalize or take adverse action

against a qualified medical person described in subsection

(c)(1)(A)(iii) of this section or a physician because the person or

physician refuses to authorize the transfer of an individual with

an emergency medical condition that has not been stabilized or

against any hospital employee because the employee reports a

violation of a requirement of this section.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1867, as added Pub. L.

99-272, title IX, Sec. 9121(b), Apr. 7, 1986, 100 Stat. 164;

amended Pub. L. 99-509, title IX, Sec. 9307(c)(4), Oct. 21, 1986,

100 Stat. 1996; Pub. L. 99-514, title XVIII, Sec. 1895(b)(4), Oct.

22, 1986, 100 Stat. 2933; Pub. L. 100-203, title IV, Sec.

4009(a)(1), formerly Sec. 4009(a)(1), (2), Dec. 22, 1987, 101 Stat.

1330-56, 1330-57; Pub. L. 100-360, title IV, Sec. 411(b)(8)(A)(i),

July 1, 1988, 102 Stat. 772; Pub. L. 100-485, title VI, Sec.

608(d)(18)(E), Oct. 13, 1988, 102 Stat. 2419; Pub. L. 101-239,

title VI, Secs. 6003(g)(3)(D)(xiv), 6211(a)-(h), Dec. 19, 1989, 103

Stat. 2154, 2245-2248; Pub. L. 101-508, title IV, Secs.

4008(b)(1)-(3)(A), 4207(a)(1)(A), (2), (3), (k)(3), formerly

4027(a)(1)(A), (2), (3), (k)(3), Nov. 5, 1990, 104 Stat. 1388-44,

1388-117, 1388-124, renumbered and amended Pub. L. 103-432, title

I, Sec. 160(d)(4), (5)(A), Oct. 31, 1994, 108 Stat. 4444; Pub. L.

105-33, title IV, Sec. 4201(c)(1), Aug. 5, 1997, 111 Stat. 373.)

-REFTEXT-

REFERENCES IN TEXT

Part B of subchapter XI of this chapter, referred to in subsec.

(d)(3), is classified to section 1320c et seq. of this title.

-MISC1-

PRIOR PROVISIONS

A prior section 1395dd, act Aug. 14, 1935, ch. 531, title XVIII,

Sec. 1867, as added July 30, 1965, Pub. L. 89-97, title I, Sec.

102(a), 79 Stat. 329; amended Jan. 2, 1968, Pub. L. 90-248, title

I, Sec. 164(a), 81 Stat. 873; Oct. 30, 1972, Pub. L. 92-603, title

II, Sec. 288, 86 Stat. 1457, related to creation, composition,

meetings, and functions of the Health Insurance Benefits Advisory

Council and the appointment of a Chairman and members thereto, and

qualifications, terms of office, compensation, and reimbursement of

travel expenses of members, prior to repeal by Pub. L. 98-369, div.

B, title III, Sec. 2349(a), July 18, 1984, 98 Stat. 1097, eff. July

18, 1984.

AMENDMENTS

1997 - Subsec. (e)(5). Pub. L. 105-33 substituted "critical

access" for "rural primary care".

1994 - Subsec. (d)(3). Pub. L. 103-432, Sec. 160(d)(5)(A), made

technical amendment to Pub. L. 101-508, Sec. 4207(a)(1)(A). See

1990 Amendment note below.

1990 - Subsec. (c)(2)(C). Pub. L. 101-508, Sec.

4008(b)(3)(A)(iii), substituted "subsection (d)(1)(C)" for

"subsection (d)(2)(C)".

Subsec. (d)(1). Pub. L. 101-508, Sec. 4008(b)(3)(A)(i), (ii),

redesignated par. (2) as (1) and struck out former par. (1) which

read as follows: "If a hospital knowingly and willfully, or

negligently, fails to meet the requirements of this section, such

hospital is subject to -

"(A) termination of its provider agreement under this

subchapter in accordance with section 1395cc(b) of this title, or

"(B) at the option of the Secretary, suspension of such

agreement for such period of time as the Secretary determines to

be appropriate, upon reasonable notice to the hospital and to the

public."

Subsec. (d)(1)(B). Pub. L. 101-508, Sec. 4207(a)(2), (3),

formerly Sec. 4027(a)(2), (3), as renumbered by Pub. L. 103-432,

Sec. 160(d)(4), which directed amendment of par. (2)(B) by

substituting "negligently" for "knowingly" and "is gross and

flagrant or is repeated" for "knowing and willful or negligent",

was executed by making the substitutions in par. (1)(B) to reflect

the probable intent of Congress and the intervening redesignation

of par. (2) as (1) by Pub. L. 101-508, Sec. 4008(b)(3)(A)(ii). See

above.

Subsec. (d)(2). Pub. L. 101-508, Sec. 4008(b)(3)(A)(ii),

redesignated par. (3) as (2). Former par. (2) redesignated (1).

Subsec. (d)(2)(A). Pub. L. 101-508, Sec. 4008(b)(1), (2),

substituted "negligently" for "knowingly" and inserted "(or not

more than $25,000 in the case of a hospital with less than 100

beds)" after "$50,000".

Subsec. (d)(3). Pub. L. 101-508, Sec. 4207(a)(1)(A), formerly

Sec. 4027(a)(1)(A), as renumbered and amended by Pub. L. 103-432,

Sec. 160(d)(4), (5)(A), added par. (3). Former par. (3)

redesignated (2).

Subsec. (i). Pub. L. 101-508, Sec. 4207(k)(3), formerly Sec.

4027(k)(3), as renumbered by Pub. L. 103-432, Sec. 160(d)(4),

amended subsec. (i) generally. Prior to amendment, subsec. (i) read

as follows: "A participating hospital may not penalize or take

adverse action against a physician because the physician refuses to

authorize the transfer of an individual with an emergency medical

condition that has not been stabilized."

1989 - Pub. L. 101-239, Sec. 6211(h)(2)(A), struck out "active"

before "labor" in section catchline.

Subsec. (a). Pub. L. 101-239, Sec. 6211(h)(2)(B), which directed

the amendment of subsec. (a) by striking out "or to determine if

the individual is in active labor (within the meaning of section

(e)(2) of this section)" was executed by striking out "or to

determine if the individual is in active labor (within the meaning

of subsection (e)(2) of this section)" after "exists".

Pub. L. 101-239, Sec. 6211(a), substituted "hospital's emergency

department, including ancillary services routinely available to the

emergency department," for "hospital's emergency department".

Subsec. (b). Pub. L. 101-239, Sec. 6211(h)(2)(C), struck out

"active" before "labor" in heading.

Subsec. (b)(1). Pub. L. 101-239, Sec. 6211(h)(2)(D)(i), struck

out "or is in active labor" after "emergency medical condition" in

introductory provisions.

Subsec. (b)(1)(A). Pub. L. 101-239, Sec. 6211(h)(2)(D)(ii),

struck out "or to provide for treatment of the labor" after

"stabilize the medical condition".

Subsec. (b)(2). Pub. L. 101-239, Sec. 6211(b)(1), inserted "and

informs the individual (or a person acting on the individual's

behalf) of the risks and benefits to the individual of such

examination and treatment," after "in that paragraph", substituted

"and treatment." for "or treatment.", and inserted at end "The

hospital shall take all reasonable steps to secure the individual's

(or person's) written informed consent to refuse such examination

and treatment."

Subsec. (b)(3). Pub. L. 101-239, Sec. 6211(b)(2), inserted "and

informs the individual (or a person acting on the individual's

behalf) of the risks and benefits to the individual of such

transfer," after "subsection (c) of this section" and inserted at

end "The hospital shall take all reasonable steps to secure the

individual's (or person's) written informed consent to refuse such

transfer."

Subsec. (c). Pub. L. 101-239, Sec. 6211(g)(1)(A), substituted

"individual" for "patient" in heading.

Subsec. (c)(1). Pub. L. 101-239, Sec. 6211(c)(4), (g)(1)(B),

(h)(2)(E), in introductory provisions, substituted "an individual"

for "a patient", "subsection (e)(3)(B) of this section)" for

"subsection (e)(4)(B) of this section) or is in active labor", and

"the individual" for "the patient", and inserted at end "A

certification described in clause (ii) or (iii) of subparagraph (A)

shall include a summary of the risks and benefits upon which the

certification is based."

Subsec. (c)(1)(A)(i). Pub. L. 101-239, Sec. 6211(c)(1),

(g)(1)(B), substituted "the individual" for "the patient", "the

individual's behalf" for "the patient's behalf", and "after being

informed of the hospital's obligations under this section and of

the risk of transfer, in writing requests transfer to another

medical facility" for "requests that the transfer be effected".

Subsec. (c)(1)(A)(ii). Pub. L. 101-239, Sec. 6211(c)(2)(B), (3),

(g)(1)(B), substituted "has signed a certification that based upon

the information available at the time of transfer" for ", or other

qualified medical personnel when a physician is not readily

available in the emergency department, has signed a certification

that, based upon the reasonable risks and benefits to the patient,

and based upon the information available at the time" and

"individual and, in the case of labor, to the unborn child" for

"individual's medical condition".

Subsec. (c)(1)(A)(iii). Pub. L. 101-239, Sec. 6211(c)(2)(A), (C),

(D), added cl. (iii).

Subsec. (c)(2)(A). Pub. L. 101-239, Sec. 6211(c)(5), added

subpar. (A). Former subpar. (A) redesignated (B).

Subsec. (c)(2)(B). Pub. L. 101-239, Sec. 6211(c)(5)(A),

(g)(1)(B), redesignated subpar. (A) as (B) and substituted "the

individual" for "the patient" in cls. (i) and (ii). Former subpar.

(B) redesignated (C).

Subsec. (c)(2)(C). Pub. L. 101-239, Sec. 6211(c)(5)(A), (d),

redesignated subpar. (B) as (C) and substituted "sends to" for

"provides" and "all medical records (or copies thereof), related to

the emergency condition for which the individual has presented,

available at the time of the transfer, including records related to

the individual's emergency medical condition, observations of signs

or symptoms, preliminary diagnosis, treatment provided, results of

any tests and the informed written consent or certification (or

copy thereof) provided under paragraph (1)(A), and the name and

address of any on-call physician (described in subsection (d)(2)(C)

of this section) who has refused or failed to appear within a

reasonable time to provide necessary stabilizing treatment" for

"with appropriate medical records (or copies thereof) of the

examination and treatment effected at the transferring hospital".

Former subpar. (C) redesignated (D).

Subsec. (c)(2)(D). Pub. L. 101-239, Sec. 6211(c)(5)(A),

redesignated subpar. (C) as (D). Former subpar. (D) redesignated

(E).

Subsec. (c)(2)(E). Pub. L. 101-239, Sec. 6211(c)(5)(A),

(g)(1)(B), redesignated subpar. (D) as (E) and substituted

"individuals" for "patients".

Subsec. (d)(2)(B). Pub. L. 101-239, Sec. 6211(e)(1), amended

subpar. (B) generally. Prior to amendment, subpar. (B) read as

follows: "The responsible physician in a participating hospital

with respect to the hospital's violation of a requirement of this

subsection is subject to the sanctions described in section

1395u(j)(2) of this title, except that, for purposes of this

subparagraph, the civil money penalty with respect to each

violation may not exceed $50,000, rather than $2,000."

Subsec. (d)(2)(C). Pub. L. 101-239, Sec. 6211(e)(2), added

subpar. (C) and struck out former subpar. (C) which read as

follows: "As used in this paragraph, the term 'responsible

physician' means, with respect to a hospital's violation of a

requirement of this section, a physician who -

"(i) is employed by, or under contract with, the participating

hospital, and

"(ii) acting as such an employee or under such a contract, has

professional responsibility for the provision of examinations or

treatments for the individual, or transfers of the individual,

with respect to which the violation occurred."

Subsec. (e)(1). Pub. L. 101-239, Sec. 6211(h)(1)(A), substituted

"means - " and subpars. (A) and (B) for "means a medical condition

manifesting itself by acute symptoms of sufficient severity

(including severe pain) such that the absence of immediate medical

attention could reasonably be expected to result in -

"(A) placing the patient's health in serious jeopardy,

"(B) serious impairment to bodily functions, or

"(C) serious dysfunction of any bodily organ or part."

Subsec. (e)(2). Pub. L. 101-239, Sec. 6211(h)(1)(B), (E),

redesignated par. (3) as (2) and struck out former par. (2) which

defined "active labor".

Subsec. (e)(3). Pub. L. 101-239, Sec. 6211(h)(1)(E), redesignated

par. (4) as (3). Former par. (3) redesignated (2).

Subsec. (e)(4). Pub. L. 101-239, Sec. 6211(h)(1)(E), redesignated

par. (5) as (4). Former par. (4) redesignated (3).

Subsec. (e)(4)(A). Pub. L. 101-239, Sec. 6211(h)(1)(C),

substituted "emergency medical condition described in paragraph

(1)(A)" for "emergency medical condition", "likely to result from

or occur during" for "likely to result from", and "from a facility,

or, with respect to an emergency medical condition described in

paragraph (1)(B), to deliver (including the placenta)" for "from a

facility".

Subsec. (e)(4)(B). Pub. L. 101-239, Sec. 6211(h)(1)(D), inserted

"described in paragraph (1)(A)" after "emergency medical

condition", "or occur during" after "to result from", and ", or,

with respect to an emergency medical condition described in

paragraph (1)(B), that the woman has delivered (including the

placenta)" after "from a facility".

Subsec. (e)(5). Pub. L. 101-239, Sec. 6211(h)(1)(E), redesignated

par. (6) as (5). Former par. (5) redesignated (4).

Pub. L. 101-239, Sec. 6211(g)(2), substituted "an individual" for

"a patient" in two places.

Subsec. (e)(6). Pub. L. 101-239, Sec. 6211(h)(1)(E), redesignated

par. (6) as (5).

Pub. L. 101-239, Sec. 6003(g)(3)(D)(xiv), added par. (6).

Subsecs. (g) to (i). Pub. L. 101-239, Sec. 6211(f), added

subsecs. (g) to (i).

1988 - Subsec. (d)(1). Pub. L. 100-360, Sec. 411(b)(8)(A)(i),

amended Pub. L. 100-203, Sec. 4009(a)(2), see 1987 Amendment note

below.

Subsec. (d)(2). Pub. L. 100-360, Sec. 411(b)(8)(A)(i), as amended

by Pub. L. 100-485, Sec. 608(d)(18)(E), amended Pub. L. 100-203,

Sec. 4009(a)(1), see 1987 Amendment note below.

1987 - Subsec. (d)(1). Pub. L. 100-203, Sec. 4009(a)(2), which

directed insertion of a provision related to imposing the sanction

described in section 1395u(j)(2)(A) of this title, was amended

generally by Pub. L. 100-360, Sec. 411(b)(8)(A)(i), so that it does

not amend par. (1).

Subsec. (d)(2). Pub. L. 100-203, Sec. 4009(a)(1), as amended by

Pub. L. 100-360, Sec. 411(b)(8)(A)(i), as amended by Pub. L.

100-485, Sec. 608(d)(18)(E), substituted subpars. (A) and (B) for

"In addition to the other grounds for imposition of a civil money

penalty under section 1320a-7a(a) of this title, a participating

hospital that knowingly violates a requirement of this section and

the responsible physician in the hospital with respect to such a

violation are each subject, under that section, to a civil money

penalty of not more than $25,000 for each such violation.",

designated second sentence as subpar. (C), substituted "this

paragraph" for "the previous sentence", and redesignated former

subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar.

(C).

1986 - Subsec. (b)(2), (3). Pub. L. 99-509 struck out "legally

responsible" after "individual (or a".

Subsec. (e)(3). Pub. L. 99-514 struck out "and has, under the

agreement, obligated itself to comply with the requirements of this

section" after "section 1395cc of this title".

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-33 applicable to services furnished on

or after Oct. 1, 1997, see section 4201(d) of Pub. L. 105-33, set

out as a note under section 1395f of this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by section 4008(b)(1)-(3)(A) of Pub. L. 101-508

applicable to actions occurring on or after the first day of the

sixth month beginning after Nov. 5, 1990, see section 4008(b)(4) of

Pub. L. 101-508, set out as a note under section 1395cc of this

title.

Amendment by section 4207(a)(1)(A) of Pub. L. 101-508 effective

on the first day of the first month beginning more than 60 days

after Nov. 5, 1990, see section 4207(a)(1)(C) of Pub. L. 101-508,

as amended, set out as a note under section 1320c-3 of this title.

Section 4207(a)(4), formerly 4027(a)(4), of Pub. L. 101-508, as

renumbered and amended by Pub. L. 103-432, title I, Sec. 160(d)(4),

(5)(B), Oct. 31, 1994, 108 Stat. 4444, provided that: "The

amendments made by paragraphs (2) and (3) [amending this section]

shall apply to actions occurring on or after the first day of the

sixth month beginning after the date of the enactment of this Act

[Nov. 5, 1990]."

EFFECTIVE DATE OF 1989 AMENDMENT

Section 6211(i) of Pub. L. 101-239 provided that: "The amendments

made by this section [amending this section] shall take effect on

the first day of the first month that begins more than 180 days

after the date of the enactment of this Act [Dec. 19, 1989],

without regard to whether regulations to carry out such amendments

have been promulgated by such date."

EFFECTIVE DATE OF 1988 AMENDMENTS

Amendment by Pub. L. 100-485 effective as if included in the

enactment of the Medicare Catastrophic Coverage Act of 1988, Pub.

L. 100-360, see section 608(g)(1) of Pub. L. 100-485, set out as a

note under section 704 of this title.

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by Pub. L. 100-360, as it relates to a provision

in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203,

effective as if included in the enactment of that provision in Pub.

L. 100-203, see section 411(a) of Pub. L. 100-360, set out as a

Reference to OBRA; Effective Date note under section 106 of Title

1, General Provisions.

EFFECTIVE DATE OF 1987 AMENDMENT

Section 4009(a)(2), formerly Sec. 4009(a)(3), of Pub. L. 100-203,

as redesignated by Pub. L. 100-360, title IV, Sec.

411(b)(8)(A)(ii), July 1, 1988, 102 Stat. 772, provided that: "The

amendments made by this subsection [amending this section] shall

apply to actions occurring on or after the date of the enactment of

this Act [Dec. 22, 1987]."

EFFECTIVE DATE OF 1986 AMENDMENT

Amendment by Pub. L. 99-514 effective, except as otherwise

provided, as if included in enactment of the Consolidated Omnibus

Budget Reconciliation Act of 1985, Pub. L. 99-272, see section

1895(e) of Pub. L. 99-514, set out as a note under section 162 of

Title 26, Internal Revenue Code.

EFFECTIVE DATE

Section 9121(c) of Pub. L. 99-272 provided that: "The amendments

made by this section [enacting this section and amending section

1395cc of this title] shall take effect on the first day of the

first month that begins at least 90 days after the date of the

enactment of this Act [Apr. 7, 1986]."

INSPECTOR GENERAL STUDY OF PROHIBITION ON HOSPITAL EMPLOYMENT OF

PHYSICIANS

Section 4008(c) of Pub. L. 101-508 directed Secretary of Health

and Human Services (acting through Inspector General of Department

of Health and Human Services) to conduct a study of the effect of

State laws prohibiting the employment of physicians by hospitals on

the availability and accessibility of trauma and emergency care

services, and include in such study an analysis of the effect of

such laws on the ability of hospitals to meet the requirements of

section 1867 of the Social Security Act (this section) relating to

the examination and treatment of individuals with an emergency

medical condition and women in labor, with Secretary to submit a

report to Congress on the study not later than 1 year after Nov. 5,

1990.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300d-13, 1320b-5,

1320c-3, 1395w-22, 1395cc of this title.

-FOOTNOTE-

(!1) So in original. Probably should be followed by a comma.

(!2) So in original.

(!3) So in original. Probably should be "woman".

-End-

-CITE-

42 USC Sec. 1395ee 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395ee. Practicing Physicians Advisory Council

-STATUTE-

(a) Appointment

The Secretary shall appoint, based upon nominations submitted by

medical organizations representing physicians, a Practicing

Physicians Advisory Council (in this section referred to as the

"Council") to be composed of 15 physicians, each of whom has

submitted at least 250 claims for physicians' services under this

subchapter in the previous year. At least 11 of the members of the

Council shall be physicians described in section 1395x(r)(1) of

this title and the members of the Council shall include both

participating and nonparticipating physicians and physicians

practicing in rural areas and underserved urban areas.

(b) Meetings

The Council shall meet once during each calendar quarter to

discuss certain proposed changes in regulations and carrier manual

instructions related to physician services identified by the

Secretary. To the extent feasible and consistent with statutory

deadlines, such consultation shall occur before the publication of

such proposed changes.

(c) Reimbursement of expenses

Members of the Council shall be entitled to receive reimbursement

of expenses and per diem in lieu of subsistence in the same manner

as other members of advisory councils appointed by the Secretary

are provided such reimbursement and per diem under this subchapter.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1868, as added Pub. L.

101-508, title IV, Sec. 4112, Nov. 5, 1990, 104 Stat. 1388-64.)

-MISC1-

PRIOR PROVISIONS

A prior section 1395ee, act Aug. 14, 1935, ch. 531, title XVIII,

Sec. 1868, as added July 30, 1965, Pub. L. 89-97, title I, Sec.

102(a), 79 Stat. 329, provided for creation of a National Medical

Review Committee, functions of such Committee, including submission

of annual reports to the Secretary and Congress, employment of

technical assistance, and for availability of assistance and data,

prior to repeal by Pub. L. 90-248, title I, Sec. 164(c), Jan. 2,

1968, 81 Stat. 874.

TERMINATION OF ADVISORY COUNCILS

Advisory councils established after Jan. 5, 1973, to terminate

not later than the expiration of the 2-year period beginning on the

date of their establishment, unless, in the case of a council

established by the President or an officer of the Federal

Government, such council is renewed by appropriate action prior to

the expiration of such 2-year period, or in the case of a council

established by Congress, its duration is otherwise provided by law.

See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86 Stat.

770, 776, set out in the Appendix to Title 5, Government

Organization and Employees.

-End-

-CITE-

42 USC Sec. 1395ff 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395ff. Determinations; appeals

-STATUTE-

(a) Initial determinations

(1) Promulgations of regulations

The Secretary shall promulgate regulations and make initial

determinations with respect to benefits under part A of this

subchapter or part B of this subchapter in accordance with those

regulations for the following:

(A) The initial determination of whether an individual is

entitled to benefits under such parts.

(B) The initial determination of the amount of benefits

available to the individual under such parts.

(C) Any other initial determination with respect to a claim

for benefits under such parts, including an initial

determination by the Secretary that payment may not be made, or

may no longer be made, for an item or service under such parts,

an initial determination made by a utilization and quality

control peer review organization under section 1320c-3(a)(2) of

this title, and an initial determination made by an entity

pursuant to a contract (other than a contract under section

1395w-22 of this title) with the Secretary to administer

provisions of this subchapter or subchapter XI of this chapter.

(2) Deadlines for making initial determinations

(A) In general

Subject to subparagraph (B), in promulgating regulations

under paragraph (1), initial determinations shall be concluded

by not later than the 45-day period beginning on the date the

fiscal intermediary or the carrier, as the case may be,

receives a claim for benefits from an individual as described

in paragraph (1). Notice of such determination shall be mailed

to the individual filing the claim before the conclusion of

such 45-day period.

(B) Clean claims

Subparagraph (A) shall not apply with respect to any claim

that is subject to the requirements of section 1395h(c)(2) or

1395u(c)(2) of this title.

(3) Redeterminations

(A) In general

In promulgating regulations under paragraph (1) with respect

to initial determinations, such regulations shall provide for a

fiscal intermediary or a carrier to make a redetermination with

respect to a claim for benefits that is denied in whole or in

part.

(B) Limitations

(i) Appeal rights

No initial determination may be reconsidered or appealed

under subsection (b) of this section unless the fiscal

intermediary or carrier has made a redetermination of that

initial determination under this paragraph.

(ii) Decisionmaker

No redetermination may be made by any individual involved

in the initial determination.

(C) Deadlines

(i) Filing for redetermination

A redetermination under subparagraph (A) shall be available

only if notice is filed with the Secretary to request the

redetermination by not later than the end of the 120-day

period beginning on the date the individual receives notice

of the initial determination under paragraph (2).

(ii) Concluding redeterminations

Redeterminations shall be concluded by not later than the

30-day period beginning on the date the fiscal intermediary

or the carrier, as the case may be, receives a request for a

redetermination. Notice of such determination shall be mailed

to the individual filing the claim before the conclusion of

such 30-day period.

(D) Construction

For purposes of the succeeding provisions of this section a

redetermination under this paragraph shall be considered to be

part of the initial determination.

(b) Appeal rights

(1) (!1) In general

(A) Reconsideration of initial determination

Subject to subparagraph (D), any individual dissatisfied with

any initial determination under subsection (a)(1) of this

section shall be entitled to reconsideration of the

determination, and, subject to subparagraphs (D) and (E), a

hearing thereon by the Secretary to the same extent as is

provided in section 405(b) of this title and to judicial review

of the Secretary's final decision after such hearing as is

provided in section 405(g) of this title. For purposes of the

preceding sentence, any reference to the "Commissioner of

Social Security" or the "Social Security Administration" in

subsection (g) or (l) of section 405 of this title shall be

considered a reference to the "Secretary" or the "Department of

Health and Human Services", respectively.

(B) Representation by provider or supplier

(i) In general

Sections 406(a), 1302, and 1395hh of this title shall not

be construed as authorizing the Secretary to prohibit an

individual from being represented under this section by a

person that furnishes or supplies the individual, directly or

indirectly, with services or items, solely on the basis that

the person furnishes or supplies the individual with such a

service or item.

(ii) Mandatory waiver of right to payment from beneficiary

Any person that furnishes services or items to an

individual may not represent an individual under this section

with respect to the issue described in section 1395pp(a)(2)

of this title unless the person has waived any rights for

payment from the beneficiary with respect to the services or

items involved in the appeal.

(iii) Prohibition on payment for representation

If a person furnishes services or items to an individual

and represents the individual under this section, the person

may not impose any financial liability on such individual in

connection with such representation.

(iv) Requirements for representatives of a beneficiary

The provisions of section 405(j) of this title and of

section 406 of this title (other than subsection (a)(4) of

such section) regarding representation of claimants shall

apply to representation of an individual with respect to

appeals under this section in the same manner as they apply

to representation of an individual under those sections.

(C) Succession of rights in cases of assignment

The right of an individual to an appeal under this section

with respect to an item or service may be assigned to the

provider of services or supplier of the item or service upon

the written consent of such individual using a standard form

established by the Secretary for such an assignment.

(D) Time limits for filing appeals

(i) Reconsiderations

Reconsideration under subparagraph (A) shall be available

only if the individual described in subparagraph (A) files

notice with the Secretary to request reconsideration by not

later than the end of the 180-day period beginning on the

date the individual receives notice of the redetermination

under subsection (a)(3) of this section, or within such

additional time as the Secretary may allow.

(ii) Hearings conducted by the Secretary

The Secretary shall establish in regulations time limits

for the filing of a request for a hearing by the Secretary in

accordance with provisions in sections 405 and 406 of this

title.

(E) Amounts in controversy

(i) In general

A hearing (by the Secretary) shall not be available to an

individual under this section if the amount in controversy is

less than $100, and judicial review shall not be available to

the individual if the amount in controversy is less than

$1,000.

(ii) Aggregation of claims

In determining the amount in controversy, the Secretary,

under regulations, shall allow two or more appeals to be

aggregated if the appeals involve -

(I) the delivery of similar or related services to the

same individual by one or more providers of services or

suppliers, or

(II) common issues of law and fact arising from services

furnished to two or more individuals by one or more

providers of services or suppliers.

(F) Expedited proceedings

(i) Expedited determination

In the case of an individual who has received notice from a

provider of services that such provider plans -

(I) to terminate services provided to an individual and a

physician certifies that failure to continue the provision

of such services is likely to place the individual's health

at significant risk, or

(II) to discharge the individual from the provider of

services,

the individual may request, in writing or orally, an

expedited determination or an expedited reconsideration of an

initial determination made under subsection (a)(1) of this

section, as the case may be, and the Secretary shall provide

such expedited determination or expedited reconsideration.

(ii) Expedited hearing

In a hearing by the Secretary under this section, in which

the moving party alleges that no material issues of fact are

in dispute, the Secretary shall make an expedited

determination as to whether any such facts are in dispute

and, if not, shall render a decision expeditiously.

(G) Reopening and revision of determinations

The Secretary may reopen or revise any initial determination

or reconsidered determination described in this subsection

under guidelines established by the Secretary in regulations.

(c) Conduct of reconsiderations by independent contractors

(1) In general

The Secretary shall enter into contracts with qualified

independent contractors to conduct reconsiderations of initial

determinations made under subparagraphs (B) and (C) of subsection

(a)(1) of this section. Contracts shall be for an initial term of

three years and shall be renewable on a triennial basis

thereafter.

(2) Qualified independent contractor

For purposes of this subsection, the term "qualified

independent contractor" means an entity or organization that is

independent of any organization under contract with the Secretary

that makes initial determinations under subsection (a)(1) of this

section, and that meets the requirements established by the

Secretary consistent with paragraph (3).

(3) Requirements

Any qualified independent contractor entering into a contract

with the Secretary under this subsection shall meet all of the

following requirements:

(A) In general

The qualified independent contractor shall perform such

duties and functions and assume such responsibilities as may be

required by the Secretary to carry out the provisions of this

subsection, and shall have sufficient training and expertise in

medical science and legal matters to make reconsiderations

under this subsection.

(B) Reconsiderations

(i) In general

The qualified independent contractor shall review initial

determinations. Where an initial determination is made with

respect to whether an item or service is reasonable and

necessary for the diagnosis or treatment of illness or injury

(under section 1395y(a)(1)(A) of this title), such review

shall include consideration of the facts and circumstances of

the initial determination by a panel of physicians or other

appropriate health care professionals and any decisions with

respect to the reconsideration shall be based on applicable

information, including clinical experience and medical,

technical, and scientific evidence.

(ii) Effect of national and local coverage determinations

(I) National coverage determinations

If the Secretary has made a national coverage

determination pursuant to the requirements established

under the third sentence of section 1395y(a) of this title,

such determination shall be binding on the qualified

independent contractor in making a decision with respect to

a reconsideration under this section.

(II) Local coverage determinations

If the Secretary has made a local coverage determination,

such determination shall not be binding on the qualified

independent contractor in making a decision with respect to

a reconsideration under this section. Notwithstanding the

previous sentence, the qualified independent contractor

shall consider the local coverage determination in making

such decision.

(III) Absence of national or local coverage determination

In the absence of such a national coverage determination

or local coverage determination, the qualified independent

contractor shall make a decision with respect to the

reconsideration based on applicable information, including

clinical experience and medical, technical, and scientific

evidence.

(C) Deadlines for decisions

(i) Reconsiderations

Except as provided in clauses (iii) and (iv), the qualified

independent contractor shall conduct and conclude a

reconsideration under subparagraph (B), and mail the notice

of the decision with respect to the reconsideration by not

later than the end of the 30-day period beginning on the date

a request for reconsideration has been timely filed.

(ii) Consequences of failure to meet deadline

In the case of a failure by the qualified independent

contractor to mail the notice of the decision by the end of

the period described in clause (i) or to provide notice by

the end of the period described in clause (iii), as the case

may be, the party requesting the reconsideration or appeal

may request a hearing before the Secretary, notwithstanding

any requirements for a reconsidered determination for

purposes of the party's right to such hearing.

(iii) Expedited reconsiderations

The qualified independent contractor shall perform an

expedited reconsideration under subsection (b)(1)(F) of this

section as follows:

(I) Deadline for decision

Notwithstanding section 416(j) of this title and subject

to clause (iv), not later than the end of the 72-hour

period beginning on the date the qualified independent

contractor has received a request for such reconsideration

and has received such medical or other records needed for

such reconsideration, the qualified independent contractor

shall provide notice (by telephone and in writing) to the

individual and the provider of services and attending

physician of the individual of the results of the

reconsideration. Such reconsideration shall be conducted

regardless of whether the provider of services or supplier

will charge the individual for continued services or

whether the individual will be liable for payment for such

continued services.

(II) Consultation with beneficiary

In such reconsideration, the qualified independent

contractor shall solicit the views of the individual

involved.

(III) Special rule for hospital discharges

A reconsideration of a discharge from a hospital shall be

conducted under this clause in accordance with the

provisions of paragraphs (2), (3), and (4) of section

1320c-3(e) of this title as in effect on the date that

precedes December 21, 2000.

(iv) Extension

An individual requesting a reconsideration under this

subparagraph may be granted such additional time as the

individual specifies (not to exceed 14 days) for the

qualified independent contractor to conclude the

reconsideration. The individual may request such additional

time orally or in writing.

(D) Limitation on individual reviewing determinations

(i) Physicians and health care professional

No physician or health care professional under the employ

of a qualified independent contractor may review -

(I) determinations regarding health care services

furnished to a patient if the physician or health care

professional was directly responsible for furnishing such

services; or

(II) determinations regarding health care services

provided in or by an institution, organization, or agency,

if the physician or any member of the family of the

physician or health care professional has, directly or

indirectly, a significant financial interest in such

institution, organization, or agency.

(ii) Family described

For purposes of this paragraph, the family of a physician

or health care professional includes the spouse (other than a

spouse who is legally separated from the physician or health

care professional under a decree of divorce or separate

maintenance), children (including stepchildren and legally

adopted children), grandchildren, parents, and grandparents

of the physician or health care professional.

(E) Explanation of decision

Any decision with respect to a reconsideration of a qualified

independent contractor shall be in writing, and shall include a

detailed explanation of the decision as well as a discussion of

the pertinent facts and applicable regulations applied in

making such decision, and in the case of a determination of

whether an item or service is reasonable and necessary for the

diagnosis or treatment of illness or injury (under section

1395y(a)(1)(A) of this title) an explanation of the medical and

scientific rationale for the decision.

(F) Notice requirements

Whenever a qualified independent contractor makes a decision

with respect to a reconsideration under this subsection, the

qualified independent contractor shall promptly notify the

entity responsible for the payment of claims under part A of

this subchapter or part B of this subchapter of such decision.

(G) Dissemination of decisions on reconsiderations

Each qualified independent contractor shall make available

all decisions with respect to reconsiderations of such

qualified independent contractors to fiscal intermediaries

(under section 1395h of this title), carriers (under section

1395u of this title), peer review organizations (under part B

of subchapter XI of this chapter), Medicare+Choice

organizations offering Medicare+Choice plans under part C of

this subchapter, other entities under contract with the

Secretary to make initial determinations under part A of this

subchapter or part B of this subchapter or subchapter XI of

this chapter, and to the public. The Secretary shall establish

a methodology under which qualified independent contractors

shall carry out this subparagraph.

(H) Ensuring consistency in decisions

Each qualified independent contractor shall monitor its

decisions with respect to reconsiderations to ensure the

consistency of such decisions with respect to requests for

reconsideration of similar or related matters.

(I) Data collection

(i) In general

Consistent with the requirements of clause (ii), a

qualified independent contractor shall collect such

information relevant to its functions, and keep and maintain

such records in such form and manner as the Secretary may

require to carry out the purposes of this section and shall

permit access to and use of any such information and records

as the Secretary may require for such purposes.

(ii) Type of data collected

Each qualified independent contractor shall keep accurate

records of each decision made, consistent with standards

established by the Secretary for such purpose. Such records

shall be maintained in an electronic database in a manner

that provides for identification of the following:

(I) Specific claims that give rise to appeals.

(II) Situations suggesting the need for increased

education for providers of services, physicians, or

suppliers.

(III) Situations suggesting the need for changes in

national or local coverage policy.

(IV) Situations suggesting the need for changes in local

medical review policies.

(iii) Annual reporting

Each qualified independent contractor shall submit annually

to the Secretary (or otherwise as the Secretary may request)

records maintained under this paragraph for the previous

year.

(J) Hearings by the Secretary

The qualified independent contractor shall (i) prepare such

information as is required for an appeal of a decision of the

contractor with respect to a reconsideration to the Secretary

for a hearing, including as necessary, explanations of issues

involved in the decision and relevant policies, and (ii)

participate in such hearings as required by the Secretary.

(4) Number of qualified independent contractors

The Secretary shall enter into contracts with not fewer than 12

qualified independent contractors under this subsection.

(5) Limitation on qualified independent contractor liability

No qualified independent contractor having a contract with the

Secretary under this subsection and no person who is employed by,

or who has a fiduciary relationship with, any such qualified

independent contractor or who furnishes professional services to

such qualified independent contractor, shall be held by reason of

the performance of any duty, function, or activity required or

authorized pursuant to this subsection or to a valid contract

entered into under this subsection, to have violated any criminal

law, or to be civilly liable under any law of the United States

or of any State (or political subdivision thereof) provided due

care was exercised in the performance of such duty, function, or

activity.

(d) Deadlines for hearings by the Secretary

(1) Hearing by administrative law judge

(A) In general

Except as provided in subparagraph (B), an administrative law

judge shall conduct and conclude a hearing on a decision of a

qualified independent contractor under subsection (c) of this

section and render a decision on such hearing by not later than

the end of the 90-day period beginning on the date a request

for hearing has been timely filed.

(B) Waiver of deadline by party seeking hearing

The 90-day period under subparagraph (A) shall not apply in

the case of a motion or stipulation by the party requesting the

hearing to waive such period.

(2) Departmental Appeals Board review

(A) In general

The Departmental Appeals Board of the Department of Health

and Human Services shall conduct and conclude a review of the

decision on a hearing described in paragraph (1) and make a

decision or remand the case to the administrative law judge for

reconsideration by not later than the end of the 90-day period

beginning on the date a request for review has been timely

filed.

(B) DAB hearing procedure

In reviewing a decision on a hearing under this paragraph,

the Departmental Appeals Board shall review the case de novo.

(3) Consequences of failure to meet deadlines

(A) Hearing by administrative law judge

In the case of a failure by an administrative law judge to

render a decision by the end of the period described in

paragraph (1), the party requesting the hearing may request a

review by the Departmental Appeals Board of the Department of

Health and Human Services, notwithstanding any requirements for

a hearing for purposes of the party's right to such a review.

(B) Departmental Appeals Board review

In the case of a failure by the Departmental Appeals Board to

render a decision by the end of the period described in

paragraph (2), the party requesting the hearing may seek

judicial review, notwithstanding any requirements for a hearing

for purposes of the party's right to such judicial review.

(e) Administrative provisions

(1) Limitation on review of certain regulations

A regulation or instruction that relates to a method for

determining the amount of payment under part B of this subchapter

and that was initially issued before January 1, 1981, shall not

be subject to judicial review.

(2) Outreach

The Secretary shall perform such outreach activities as are

necessary to inform individuals entitled to benefits under this

subchapter and providers of services and suppliers with respect

to their rights of, and the process for, appeals made under this

section. The Secretary shall use the toll-free telephone number

maintained by the Secretary under section 1395b-2(b) of this

title to provide information regarding appeal rights and respond

to inquiries regarding the status of appeals.

(3) Continuing education requirement for qualified independent

contractors and administrative law judges

The Secretary shall provide to each qualified independent

contractor, and, in consultation with the Commissioner of Social

Security, to administrative law judges that decide appeals of

reconsiderations of initial determinations or other decisions or

determinations under this section, such continuing education with

respect to coverage of items and services under this subchapter

or policies of the Secretary with respect to part B of subchapter

XI of this chapter as is necessary for such qualified independent

contractors and administrative law judges to make informed

decisions with respect to appeals.

(4) Reports

(A) Annual report to Congress

The Secretary shall submit to Congress an annual report

describing the number of appeals for the previous year,

identifying issues that require administrative or legislative

actions, and including any recommendations of the Secretary

with respect to such actions. The Secretary shall include in

such report an analysis of determinations by qualified

independent contractors with respect to inconsistent decisions

and an analysis of the causes of any such inconsistencies.

(B) Survey

Not less frequently than every 5 years, the Secretary shall

conduct a survey of a valid sample of individuals entitled to

benefits under this subchapter who have filed appeals of

determinations under this section, providers of services, and

suppliers to determine the satisfaction of such individuals or

entities with the process for appeals of determinations

provided for under this section and education and training

provided by the Secretary with respect to that process. The

Secretary shall submit to Congress a report describing the

results of the survey, and shall include any recommendations

for administrative or legislative actions that the Secretary

determines appropriate.

(f) Review of coverage determinations

(1) National coverage determinations

(A) In general

Review of any national coverage determination shall be

subject to the following limitations:

(i) Such a determination shall not be reviewed by any

administrative law judge.

(ii) Such a determination shall not be held unlawful or set

aside on the ground that a requirement of section 553 of

title 5 or section 1395hh(b) of this title, relating to

publication in the Federal Register or opportunity for public

comment, was not satisfied.

(iii) Upon the filing of a complaint by an aggrieved party,

such a determination shall be reviewed by the Departmental

Appeals Board of the Department of Health and Human Services.

In conducting such a review, the Departmental Appeals Board -

(I) shall review the record and shall permit discovery

and the taking of evidence to evaluate the reasonableness

of the determination, if the Board determines that the

record is incomplete or lacks adequate information to

support the validity of the determination;

(II) may, as appropriate, consult with appropriate

scientific and clinical experts; and

(III) shall defer only to the reasonable findings of

fact, reasonable interpretations of law, and reasonable

applications of fact to law by the Secretary.

(iv) The Secretary shall implement a decision of the

Departmental Appeals Board within 30 days of receipt of such

decision.

(v) A decision of the Departmental Appeals Board

constitutes a final agency action and is subject to judicial

review.

(B) Definition of national coverage determination

For purposes of this section, the term "national coverage

determination" means a determination by the Secretary with

respect to whether or not a particular item or service is

covered nationally under this subchapter, but does not include

a determination of what code, if any, is assigned to a

particular item or service covered under this subchapter or a

determination with respect to the amount of payment made for a

particular item or service so covered.

(2) Local coverage determination

(A) In general

Review of any local coverage determination shall be subject

to the following limitations:

(i) Upon the filing of a complaint by an aggrieved party,

such a determination shall be reviewed by an administrative

law judge of the Social Security Administration. The

administrative law judge -

(I) shall review the record and shall permit discovery

and the taking of evidence to evaluate the reasonableness

of the determination, if the administrative law judge

determines that the record is incomplete or lacks adequate

information to support the validity of the determination;

(II) may, as appropriate, consult with appropriate

scientific and clinical experts; and

(III) shall defer only to the reasonable findings of

fact, reasonable interpretations of law, and reasonable

applications of fact to law by the Secretary.

(ii) Upon the filing of a complaint by an aggrieved party,

a decision of an administrative law judge under clause (i)

shall be reviewed by the Departmental Appeals Board of the

Department of Health and Human Services.

(iii) The Secretary shall implement a decision of the

administrative law judge or the Departmental Appeals Board

within 30 days of receipt of such decision.

(iv) A decision of the Departmental Appeals Board

constitutes a final agency action and is subject to judicial

review.

(B) Definition of local coverage determination

For purposes of this section, the term "local coverage

determination" means a determination by a fiscal intermediary

or a carrier under part A of this subchapter or part B of this

subchapter, as applicable, respecting whether or not a

particular item or service is covered on an intermediary- or

carrier-wide basis under such parts, in accordance with section

1395y(a)(1)(A) of this title.

(3) No material issues of fact in dispute

In the case of a determination that may otherwise be subject to

review under paragraph (1)(A)(iii) or paragraph (2)(A)(i), where

the moving party alleges that -

(A) there are no material issues of fact in dispute, and

(B) the only issue of law is the constitutionality of a

provision of this subchapter, or that a regulation,

determination, or ruling by the Secretary is invalid,

the moving party may seek review by a court of competent

jurisdiction without filing a complaint under such paragraph and

without otherwise exhausting other administrative remedies.

(4) Pending national coverage determinations

(A) In general

In the event the Secretary has not issued a national coverage

or noncoverage determination with respect to a particular type

or class of items or services, an aggrieved person (as

described in paragraph (5)) may submit to the Secretary a

request to make such a determination with respect to such items

or services. By not later than the end of the 90-day period

beginning on the date the Secretary receives such a request

(notwithstanding the receipt by the Secretary of new evidence

(if any) during such 90-day period), the Secretary shall take

one of the following actions:

(i) Issue a national coverage determination, with or

without limitations.

(ii) Issue a national noncoverage determination.

(iii) Issue a determination that no national coverage or

noncoverage determination is appropriate as of the end of

such 90-day period with respect to national coverage of such

items or services.

(iv) Issue a notice that states that the Secretary has not

completed a review of the request for a national coverage

determination and that includes an identification of the

remaining steps in the Secretary's review process and a

deadline by which the Secretary will complete the review and

take an action described in subclause (I), (II), or (III).

(B) Deemed action by the Secretary

In the case of an action described in clause (i)(IV), if the

Secretary fails to take an action referred to in such clause by

the deadline specified by the Secretary under such clause, then

the Secretary is deemed to have taken an action described in

clause (i)(III) as of the deadline.

(C) Explanation of determination

When issuing a determination under clause (i), the Secretary

shall include an explanation of the basis for the

determination. An action taken under clause (i) (other than

subclause (IV)) is deemed to be a national coverage

determination for purposes of review under subparagraph (A).

(5) Standing

An action under this subsection seeking review of a national

coverage determination or local coverage determination may be

initiated only by individuals entitled to benefits under part A

of this subchapter, or enrolled under part B of this subchapter,

or both, who are in need of the items or services that are the

subject of the coverage determination.

(6) Publication on the Internet of decisions of hearings of the

Secretary

Each decision of a hearing by the Secretary with respect to a

national coverage determination shall be made public, and the

Secretary shall publish each decision on the Medicare (!2)

Internet site of the Department of Health and Human Services. The

Secretary shall remove from such decision any information that

would identify any individual, provider of services, or supplier.

(7) Annual report on national coverage determinations

(A) In general

Not later than December 1 of each year, beginning in 2001,

the Secretary shall submit to Congress a report that sets forth

a detailed compilation of the actual time periods that were

necessary to complete and fully implement national coverage

determinations that were made in the previous fiscal year for

items, services, or medical devices not previously covered as a

benefit under this subchapter, including, with respect to each

new item, service, or medical device, a statement of the time

taken by the Secretary to make and implement the necessary

coverage, coding, and payment determinations, including the

time taken to complete each significant step in the process of

making and implementing such determinations.

(B) Publication of reports on the Internet

The Secretary shall publish each report submitted under

clause (i) on the medicare Internet site of the Department of

Health and Human Services.

(8) Construction

Nothing in this subsection shall be construed as permitting

administrative or judicial review pursuant to this section

insofar as such review is explicitly prohibited or restricted

under another provision of law.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1869, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 330; amended

Pub. L. 92-603, title II, Sec. 299O(a), Oct. 30, 1972, 86 Stat.

1464; Pub. L. 98-369, div. B, title III, Sec. 2354(b)(35), July 18,

1984, 98 Stat. 1102; Pub. L. 99-509, title IX, Secs. 9313(a)(1),

(b)(1), 9341(a)(1), Oct. 21, 1986, 100 Stat. 2002, 2037; Pub. L.

100-93, Sec. 8(e), Aug. 18, 1987, 101 Stat. 694; Pub. L. 100-203,

title IV, Secs. 4082(a), (b), 4085(i)(18), (19), Dec. 22, 1987, 101

Stat. 1330-128, 1330-133; Pub. L. 103-296, title I, Sec. 108(c)(5),

Aug. 15, 1994, 108 Stat. 1485; Pub. L. 105-33, title IV, Sec.

4611(c), Aug. 5, 1997, 111 Stat. 473; Pub. L. 106-554, Sec. 1(a)(6)

[title V, Secs. 521(a), 522(a)], Dec. 21, 2000, 114 Stat. 2763,

2763A-534, 2763A-543.)

-REFTEXT-

REFERENCES IN TEXT

Parts A, B, and C of this subchapter, referred to in subsecs.

(a)(1), (c)(3)(F), (G), (e)(1), and (f)(2)(B), (5), are classified

to sections 1395c et seq., 1395j et seq., and 1395w-21 et seq.,

respectively, of this title.

Part B of subchapter XI of this chapter, referred to in subsecs.

(c)(3)(G) and (e)(3), is classified to section 1320c et seq. of

this title.

-MISC1-

AMENDMENTS

2000 - Pub. L. 106-554, Sec. 1(a)(6) [title V, Sec. 521(a)],

amended section generally, completely revising and expanding

provisions relating to determinations with respect to benefits

under part A or part B of this subchapter, changing the structure

of the section from two subsecs. lettered (a) and (b) to five

subsecs. lettered (a) to (e).

Subsec. (f). Pub. L. 106-554, Sec. 1(a)(6) [title V, Sec.

522(a)], added subsec. (f).

1997 - Subsec. (b)(2)(B). Pub. L. 105-33 inserted "(or $100 in

the case of home health services)" after "$500".

1994 - Subsec. (b)(1). Pub. L. 103-296 inserted ", except that,

in so applying such sections and in applying section 405(l) of this

title thereto, any reference therein to the Commissioner of Social

Security or the Social Security Administration shall be considered

a reference to the Secretary or the Department of Health and Human

Services, respectively" after "section 405(g) of this title" in

closing provisions.

1987 - Subsec. (a). Pub. L. 100-203, Sec. 4085(i)(18), inserted

"or a claim for benefits with respect to home health services under

part B of this subchapter" before "shall".

Subsec. (b)(2). Pub. L. 100-203, Sec. 4085(i)(19), inserted "and

(1)(D)" after "paragraph (1)(C)" in two places.

Subsec. (b)(3)(B). Pub. L. 100-203, Sec. 4082(a), substituted

"section 553" for "chapter 5".

Subsec. (b)(5). Pub. L. 100-203, Sec. 4082(b), added par. (5).

Subsec. (c). Pub. L. 100-93 struck out subsec. (c) which read as

follows: "Any institution or agency dissatisfied with any

determination by the Secretary that it is not a provider of

services, or with any determination described in section

1395cc(b)(2) of this title, shall be entitled to a hearing thereon

by the Secretary (after reasonable notice and opportunity for

hearing) to the same extent as is provided in section 405(b) of

this title, and to judicial review of the Secretary's final

decision after such hearing as is provided in section 405(g) of

this title."

1986 - Subsec. (a). Pub. L. 99-509, Sec. 9341(a)(1)(A), inserted

"or part B" after "amount of benefits under part A".

Pub. L. 99-509, Sec. 9313(b)(1)(A), inserted "and any other

determination with respect to a claim for benefits under part A of

this subchapter" before "shall".

Subsec. (b)(1). Pub. L. 99-509, Sec. 9313(a)(1), in concluding

provisions, inserted at end "Sections 406(a), 1302, and 1395hh of

this title shall not be construed as authorizing the Secretary to

prohibit an individual from being represented under this subsection

by a person that furnishes or supplies the individual, directly or

indirectly, with services or items solely on the basis that the

person furnishes or supplies the individual with such a service or

item. Any person that furnishes services or items to an individual

may not represent an individual under this subsection with respect

to the issue described in section 1395pp(a)(2) of this title unless

the person has waived any rights for payment from the beneficiary

with respect to the services or items involved in the appeal. If a

person furnishes services or items to an individual and represents

the individual under this subsection, the person may not impose any

financial liability on such individual in connection with such

representation."

Subsec. (b)(1)(C). Pub. L. 99-509, Sec. 9341(a)(1)(B), inserted

"or part B".

Subsec. (b)(1)(D). Pub. L. 99-509, Sec. 9313(b)(1)(B), added

subpar. (D).

Subsec. (b)(2). Pub. L. 99-509, Sec. 9341(a)(1)(C), amended par.

(2) generally. Prior to amendment, par. (2) read as follows:

"Notwithstanding the provisions of subparagraph (C) of paragraph

(1) of this subsection, a hearing shall not be available to an

individual by reason of such subparagraph (C) if the amount in

controversy is less than $100; nor shall judicial review be

available to an individual by reason of such subparagraph (C) if

the amount in controversy is less than $1,000."

Subsec. (b)(3), (4). Pub. L. 99-509, Sec. 9341(a)(1)(D), added

pars. (3) and (4).

1984 - Subsec. (b)(1)(B). Pub. L. 98-369 struck out the comma

before "or section 1395i-2" and struck out ", or section 1819"

after "section 1395i-2 of this title".

1972 - Subsec. (b). Pub. L. 92-603 redesignated existing

provisions as par. (1), generally amended conditions under which a

dissatisfied individual shall be entitled to a hearing by Secretary

and to judicial review of final decision of Secretary after such

hearing, and added par. (2).

EFFECTIVE DATE OF 2000 AMENDMENT

Amendment by section Sec. 1(a)(6) [title V, Sec. 521(a)] of Pub.

L. 106-554 applicable with respect to initial determinations made

on or after Oct. 1, 2002, see section 1(a)(6) [title V, Sec.

521(d)] of Pub. L. 106-554, set out as a note under section 1320c-3

of this title.

Amendment by section 1(a)(6) [title V, Sec. 522(a)] of Pub. L.

106-554 applicable with respect to a review of any national or

local coverage determination filed, a request to make such a

determination made, and a national coverage determination made, on

or after Oct. 1, 2001, see section 1(a)(6) [title V, Sec. 522(d)]

of Pub. L. 106-554, set out as a note under section 1314 of this

title.

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-33 applicable to services furnished on

or after Jan. 1, 1998, and for purposes of applying such amendment,

any home health spell of illness that began, but did not end,

before such date, to be considered to have begun as of such date,

see section 4611(f) of Pub. L. 105-33, set out as a note under

section 1395d of this title.

EFFECTIVE DATE OF 1994 AMENDMENT

Amendment by Pub. L. 103-296 effective Mar. 31, 1995, see section

110(a) of Pub. L. 103-296, set out as a note under section 401 of

this title.

EFFECTIVE DATE OF 1987 AMENDMENTS

Section 4082(e)(1), (2) of Pub. L. 100-203 provided that:

"(1) The amendment made by subsection (a) [amending this section]

shall take effect on the date of the enactment of this Act [Dec.

22, 1987].

"(2) The amendment made by subsection (b) [amending this section]

shall apply to requests for hearings filed after the end of the

60-day period beginning on the date of the enactment of this Act."

Amendment by Pub. L. 100-93 effective at end of fourteen-day

period beginning Aug. 18, 1987, and inapplicable to administrative

proceedings commenced before end of such period, see section 15(a)

of Pub. L. 100-93, set out as a note under section 1320a-7 of this

title.

EFFECTIVE DATE OF 1986 AMENDMENT

Section 9313(b)(2) of Pub. L. 99-509 provided that: "The

amendments made by this subsection [amending this section] take

effect on the date of the enactment of this Act [Oct. 21, 1986]."

Section 9341(b) of Pub. L. 99-509 provided that: "The amendments

made by subsection (a) [amending this section and sections 1395u

and 1395pp of this title] shall apply to items and services

furnished on or after January 1, 1987."

EFFECTIVE DATE OF 1984 AMENDMENT

Amendment by Pub. L. 98-369 effective July 18, 1984, but not to

be construed as changing or affecting any right, liability, status,

or interpretation which existed (under the provisions of law

involved) before that date, see section 2354(e)(1) of Pub. L.

98-369, set out as a note under section 1320a-1 of this title.

EFFECTIVE DATE OF 1972 AMENDMENT

Section 299O(b) of Pub. L. 92-603 provided that:

"(1) The provisions of subparagraphs (A) and (B) of section

1869(b)(1) of the Social Security Act [subsec. (b)(1)(A), (B) of

this section], as amended by subsection (a) of this section, shall

be effective on the date of enactment of this Act [Oct. 30, 1972].

"(2) The provisions of paragraph (2) and subparagraph (C) of

paragraph (1) of section 1869(b) of the Social Security Act

[subsec. (b)(1)(C) and (b)(2) of this section], as amended by

subsection (a) of this section, shall be effective with respect to

any claims under part A of title XVIII of such Act [part A of this

subchapter], filed -

"(A) in or after the month in which this Act is enacted [Oct.

1972], or

"(B) before the month in which this Act is enacted [Oct. 1972],

but only if a civil action with respect to a final decision of

the Secretary of Health, Education, and Welfare on such claim has

not been commenced under such section 1869(b) [subsec. (b) of

this section] before such month."

STUDY OF AGGREGATION RULE FOR CLAIMS FOR SIMILAR PHYSICIANS'

SERVICES

Pub. L. 101-508, title IV, Sec. 4113, Nov. 5, 1990, 104 Stat.

1388-64, directed Secretary of Health and Human Services to carry

out a study of the effects of permitting the aggregation of claims

that involve common issues of law and fact furnished in the same

carrier area to two or more individuals by two or more physicians

within the same 12-month period for purposes of appeals provided

for under subsec. (b)(2) of this section, and to report on the

results of such study and any recommendations to Congress by Dec.

31, 1992.

MEDICARE HEARINGS AND APPEALS

Section 4037 of Pub. L. 100-203 provided that:

"(a) Maintaining Current System for Hearings and Appeals. - Any

hearing conducted under section 1869(b)(1) of the Social Security

Act [subsec. (b)(1) of this section] prior to the earliest of the

date on which the Secretary of Health and Human Services submits

the report required to be submitted by the Secretary under

subsection (b)(1) or September 1 shall be conducted by

Administrative Law Judges of the Office of Hearings and Appeals of

the Social Security Administration in the same manner as are

hearings conducted under section 205(b)(1) of such Act [section

405(b)(1) of this title].

"(b) Study and Report on Use of Telephone Hearings. -

"(1) The Secretary of Health and Human Services and the

Comptroller General of the United States shall each conduct a

study on holding hearings under section 1869(b)(1) of the Social

Security Act [subsec. (b)(1) of this section] by telephone and

shall each report the results of the study not later than 6

months after the date of enactment of this Act [Dec. 22, 1987].

"(2) The studies under paragraph (1) shall focus on whether

telephone hearings allow for a full and fair evidentiary hearing,

in general, or with respect to any particular category of claims

and shall examine the possible improvements to the hearing

process (such as cost-effectiveness, convenience to the claimant,

and reduction in time under the process) resulting from the use

of such hearings as compared to the adoption of other changes to

the process (such as expansions in staff and resources)."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1395i-5, 1395l, 1395m,

1395u, 1395x, 1395w-4, 1395w-22, 1395y, 1395pp, 1395ww, 1395yy,

1395fff of this title; title 45 section 231f.

-FOOTNOTE-

(!1) So in original. No par. (2) has been enacted.

(!2) So in original. Probably should not be capitalized.

-End-

-CITE-

42 USC Sec. 1395gg 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395gg. Overpayment on behalf of individuals and settlement of

claims for benefits on behalf of deceased individuals

-STATUTE-

(a) Payments to providers of services or other person regarded as

payment to individuals

Any payment under this subchapter to any provider of services or

other person with respect to any items or services furnished any

individual shall be regarded as a payment to such individual.

(b) Incorrect payments on behalf of individuals; payment adjustment

Where -

(1) more than the correct amount is paid under this subchapter

to a provider of services or other person for items or services

furnished an individual and the Secretary determines (A) that,

within such period as he may specify, the excess over the correct

amount cannot be recouped from such provider of services or other

person, or (B) that such provider of services or other person was

without fault with respect to the payment of such excess over the

correct amount, or

(2) any payment has been made under section 1395f(e) of this

title to a provider of services or other person for items or

services furnished an individual,

proper adjustments shall be made, under regulations prescribed

(after consultation with the Railroad Retirement Board) by the

Secretary, by decreasing subsequent payments -

(3) to which such individual is entitled under subchapter II of

this chapter or under the Railroad Retirement Act of 1974 [45

U.S.C. 231 et seq.], as the case may be, or

(4) if such individual dies before such adjustment has been

completed, to which any other individual is entitled under

subchapter II of this chapter or under the Railroad Retirement

Act of 1974 [45 U.S.C. 231 et seq.], as the case may be, with

respect to the wages and self-employment income or the

compensation constituting the basis of the benefits of such

deceased individual under subchapter II of this chapter.

As soon as practicable after any adjustment under paragraph (3) or

(4) is determined to be necessary, the Secretary, for purposes of

this section, section 1395i(g) of this title, and section 1395t(f)

of this title, shall certify (to the Railroad Retirement Board if

the adjustment is to be made by decreasing subsequent payments

under the Railroad Retirement Act of 1974 [45 U.S.C. 231 et seq.])

the amount of the overpayment as to which the adjustment is to be

made. For purposes of clause (B) of paragraph (1), such provider of

services or such other person shall, in the absence of evidence to

the contrary, be deemed to be without fault if the Secretary's

determination that more than such correct amount was paid was made

subsequent to the third year following the year in which notice was

sent to such individual that such amount had been paid; except that

the Secretary may reduce such three-year period to not less than

one year if he finds such reduction is consistent with the

objectives of this subchapter.

(c) Exception to subsection (b) payment adjustment

There shall be no adjustment as provided in subsection (b) of

this section (nor shall there be recovery) in any case where the

incorrect payment has been made (including payments under section

1395f(e) of this title) with respect to an individual who is

without fault or where the adjustment (or recovery) would be made

by decreasing payments to which another person who is without fault

is entitled as provided in subsection (b)(4) of this section, if

such adjustment (or recovery) would defeat the purposes of

subchapter II or subchapter XVIII of this chapter or would be

against equity and good conscience. Adjustment or recovery of an

incorrect payment (or only such part of an incorrect payment as the

Secretary determines to be inconsistent with the purposes of this

subchapter) against an individual who is without fault shall be

deemed to be against equity and good conscience if (A) the

incorrect payment was made for expenses incurred for items or

services for which payment may not be made under this subchapter by

reason of the provisions of paragraph (1) or (9) of section

1395y(a) of this title and (B) if the Secretary's determination

that such payment was incorrect was made subsequent to the third

year following the year in which notice of such payment was sent to

such individual; except that the Secretary may reduce such

three-year period to not less than one year if he finds such

reduction is consistent with the objectives of this subchapter.

(d) Liability of certifying or disbursing officer for failure to

recoup

No certifying or disbursing officer shall be held liable for any

amount certified or paid by him to any provider of services or

other person where the adjustment or recovery of such amount is

waived under subsection (c) of this section or where adjustment

under subsection (b) of this section is not completed prior to the

death of all persons against whose benefits such adjustment is

authorized.

(e) Settlement of claims for benefits under this subchapter on

behalf of deceased individuals

If an individual, who received services for which payment may be

made to such individual under this subchapter, dies, and payment

for such services was made (other than under this subchapter), and

the individual died before any payment due him under this

subchapter with respect to such services was completed, payment of

the amount due (including the amount of any unnegotiated checks)

shall be made -

(1) if the payment for such services was made (before or after

such individual's death) by a person other than the deceased

individual, to the person or persons determined by the Secretary

under regulations to have paid for such services, or if the

payment for such services was made by the deceased individual

before his death, to the legal representative of the estate of

such deceased individual, if any;

(2) if there is no person who meets the requirements of

paragraph (1), to the person, if any, who is determined by the

Secretary to be the surviving spouse of the deceased individual

and who was either living in the same household with the deceased

at the time of his death or was, for the month in which the

deceased individual died, entitled to a monthly benefit on the

basis of the same wages and self-employment income as was the

deceased individual;

(3) if there is no person who meets the requirements of

paragraph (1) or (2), or if the person who meets such

requirements dies before the payment due him under this

subchapter is completed, to the child or children, if any, of the

deceased individual who were, for the month in which the deceased

individual died, entitled to monthly benefits on the basis of the

same wages and self-employment income as was the deceased

individual (and, in case there is more than one such child, in

equal parts to each such child);

(4) if there is no person who meets the requirements of

paragraph (1), (2), or (3), or if each person who meets such

requirements dies before the payment due him under this

subchapter is completed, to the parent or parents, if any, of the

deceased individual who were, for the month in which the deceased

individual died, entitled to monthly benefits on the basis of the

same wages and self-employment income as was the deceased

individual (and, in case there is more than one such parent, in

equal parts to each such parent);

(5) if there is no person who meets the requirements of

paragraph (1), (2), (3), or (4), or if each person who meets such

requirements dies before the payment due him under this

subchapter is completed, to the person, if any, determined by the

Secretary to be the surviving spouse of the deceased individual;

(6) if there is no person who meets the requirements of

paragraph (1), (2), (3), (4), or (5), or if each person who meets

such requirements dies before the payment due him under this

subchapter is completed, to the person or persons, if any,

determined by the Secretary to be the child or children of the

deceased individual (and, in case there is more than one such

child, in equal parts to each such child);

(7) if there is no person who meets the requirements of

paragraph (1), (2), (3), (4), (5), or (6), or if each person who

meets such requirements dies before the payment due him under

this subchapter is completed, to the parent or parents, if any,

of the deceased individual (and, in case there is more than one

such parent, in equal parts to each such parent); or

(8) if there is no person who meets the requirements of

paragraph (1), (2), (3), (4), (5), (6), or (7), or if each person

who meets such requirements dies before the payment due him under

this subchapter is completed, to the legal representatives of the

estate of the deceased individual, if any.

(f) Settlement of claims for section 1395k benefits on behalf of

deceased individuals

If an individual who received medical and other health services

for which payment may be made under section 1395k(a)(1) of this

title dies, and no assignment of the right to payment for such

services was made by such individual before his death, and payment

for such services has not been made -

(1) if the person or persons who furnished the services agree

to the terms of assignment specified in section

1395u(b)(3)(B)(ii) of this title with respect to the services,

payment for such services shall be made to such person or

persons, and

(2) if the person or persons who furnished the services do not

agree to the terms of assignment specified in section

1395u(b)(3)(B)(ii) of this title with respect to the services,

payment for such services shall be made on the basis of an

itemized bill to the person who has agreed to assume the legal

obligation to make payment for such services and files a request

for payment (with such accompanying evidence of such legal

obligation as may be required in regulations),

but only in such amount and subject to such conditions as would be

applicable if the individual who received the services had not

died.

(g) Refund of premiums for deceased individuals

If an individual, who is enrolled under section 1395i-2(c) of

this title or under section 1395p of this title, dies, and premiums

with respect to such enrollment have been received with respect to

such individual for any month after the month of his death, such

premiums shall be refunded to the person or persons determined by

the Secretary under regulations to have paid such premiums or if

payment for such premiums was made by the deceased individual

before his death, to the legal representative of the estate of such

deceased individual, if any. If there is no person who meets the

requirements of the preceding sentence such premiums shall be

refunded to the person or persons in the priorities specified in

paragraphs (2) through (7) of subsection (e) of this section.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1870, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 331; amended

Pub. L. 90-248, title I, Sec. 154(b), (c), Jan. 2, 1968, 81 Stat.

862; Pub. L. 92-603, title II, Secs. 261(a), 266, 281(a), (b), Oct.

30, 1972, 86 Stat. 1448, 1450, 1454, 1455; Pub. L. 93-445, title

III, Sec. 309, Oct. 16, 1974, 88 Stat. 1358; Pub. L. 96-499, title

IX, Sec. 954(a), Dec. 5, 1980, 94 Stat. 2647; Pub. L. 97-248, title

I, Sec. 128(d)(1), Sept. 3, 1982, 96 Stat. 367; Pub. L. 100-203,

title IV, Secs. 4039(h)(7), 4096(a)(2), Dec, 22, 1987, 101 Stat.

1330-139, as amended Pub. L. 100-360, title IV, Sec. 411(e)(3),

July 1, 1988, 102 Stat. 776; Pub. L. 100-360, title IV, Sec.

411(j)(4)(B), July 1, 1988, 102 Stat. 791.)

-REFTEXT-

REFERENCES IN TEXT

The Railroad Retirement Act of 1974, referred to in subsec. (b),

is act Aug. 29, 1935, ch. 812, as amended generally by Pub. L.

93-445, title I, Sec. 101, Oct. 16, 1974, 88 Stat. 1305, which is

classified generally to subchapter IV (Sec. 231 et seq.) of chapter

9 of Title 45, Railroads. For further details and complete

classification of this Act to the Code, see Codification note set

out preceding section 231 of Title 45, section 231t of Title 45,

and Tables.

-MISC1-

AMENDMENTS

1988 - Pub. L. 100-360, Sec. 411(e)(3), added Pub. L. 100-203,

Sec. 4039(h)(7), see 1987 Amendment note below.

Subsec. (f)(1), (2). Pub. L. 100-360, Sec. 411(j)(4)(B),

substituted "of assignment specified in" for "specified in

subclauses (I) and (II) of".

1987 - Pub. L. 100-203, Sec. 4039(h)(7), as added by Pub. L.

100-360, Sec. 411(e)(3), amended section catchline generally.

Subsec. (f)(1), (2). Pub. L. 100-203, Sec. 4096(a)(2),

substituted "to the terms specified in subclauses (I) and (II) of

section 1395u(b)(3)(B)(ii) of this title with respect to the

services" for "that the reasonable charge is the full charge for

the services".

1982 - Subsec. (c). Pub. L. 97-248 substituted "section 1395y(a)"

for "section 1395y".

1980 - Subsec. (f). Pub. L. 96-499 amended subsec. (f) generally,

inserting provision for payments to providers of medical and other

health services where the person or persons furnishing the services

did not agree that the reasonable charge was the full charge for

such services.

1974 - Subsec. (b). Pub. L. 93-445 substituted "Railroad

Retirement Act of 1974" for "Railroad Retirement Act of 1937",

wherever appearing.

1972 - Subsec. (b). Pub. L. 92-603, Sec. 281(a), required that

provider of services or other person be without fault with respect

to payment of excess over correct amount as prerequisite to

adjustment or recovery of incorrect payments.

Subsec. (c). Pub. L. 92-603, Secs. 261(a), 281(b), substituted

"or where the adjustment (or recovery) would be made by decreasing

payments to which another person who is without fault is entitled

as provided in subsection (b)(4) of this section, if" for "and

where", inserted reference to subchapter XVIII of this chapter, and

inserted provisions covering the adjustment or recovery of

incorrect payments against individuals who are without fault.

Subsec. (g). Pub. L. 92-603, Sec. 266, added subsec. (g).

1968 - Pub. L. 90-248, Sec. 154(b), provided for settlement of

claims for benefits on behalf of deceased individuals in section

catchline.

Subsecs. (e), (f). Pub. L. 90-248, Sec. 154(c), added subsecs.

(e) and (f).

EFFECTIVE DATE OF 1988 AMENDMENT

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by Pub. L. 100-360, as it relates to a provision

in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203,

effective as if included in the enactment of that provision in Pub.

L. 100-203, see section 411(a) of Pub. L. 100-360, set out as a

Reference to OBRA; Effective Date note under section 106 of Title

1, General Provisions.

EFFECTIVE DATE OF 1987 AMENDMENT

Amendment by section 4096(a)(2) of Pub. L. 100-203 applicable to

services furnished on or after Jan. 1, 1988, see section 4096(d) of

Pub. L. 100-203, set out as a note under section 1320c-3 of this

title.

EFFECTIVE DATE OF 1982 AMENDMENT

Amendment by Pub. L. 97-248 effective Sept. 3, 1982, see section

128(e)(3) of Pub. L. 97-248, set out as a note under section 1395x

of this title.

EFFECTIVE DATE OF 1980 AMENDMENT

Section 954(b) of Pub. L. 96-499 provided that: "The amendment

made by this section [amending this section] shall apply only to

claims filed on or after January 1, 1981."

EFFECTIVE DATE OF 1974 AMENDMENT

Amendment by Pub. L. 93-445 effective Jan. 1, 1975, see section

603 of Pub. L. 93-445, set out as a note under section 402 of this

title.

EFFECTIVE DATE OF 1972 AMENDMENT

Section 261(b) of Pub. L. 92-603 provided that: "The amendment

made by subsection (a) [amending this section] shall apply with

respect to waiver actions considered after the date of the

enactment of this Act [Oct. 30, 1972]."

Section 281(g) of Pub. L. 92-603 provided that: "The provisions

of subsection (a)(1) [amending this section] shall apply with

respect to notices of payment sent to individuals after the date of

enactment of this Act [Oct. 30, 1972]. The provisions of

subsections (a)(2), (b), (c), and (d) [amending this section and

sections 1395u and 1395cc of this title] shall apply in the case of

notices sent to individuals after 1968. The provisions of

subsections (e) and (f) [amending sections 1395f and 1395n of this

title] shall apply in the case of services furnished (or deemed to

have been furnished) after 1970."

WAIVER OF LIABILITY LIMITING RECOUPMENT IN CERTAIN CASES

Pub. L. 101-239, title VI, Sec. 6109, Dec. 19, 1989, 103 Stat.

2213, provided that: "In the case where more than the correct

amount may have been paid to a physician or individual under part B

of title XVIII of the Social Security Act [part B of this

subchapter] with respect to services furnished during the period

beginning on July 1, 1985, and ending on March 31, 1986, as a

result of a carrier's establishing statewide fees for certain

procedure codes while the carrier was in the process of

implementing the national common procedure coding system of the

Health Care Financing Administration, the provisions of section

1870(c) of the Social Security Act [subsec. (c) of this section]

shall apply, without the need for affirmative action by such a

physician or individual, so as to prevent any recoupment, or other

decrease in subsequent payments, to the physician or individual.

The previous sentence shall apply to claims for items and services

which were reopened by carriers on or after July 31, 1987."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1395i, 1395t, 1395u of

this title; title 2 section 906.

-End-

-CITE-

42 USC Sec. 1395hh 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395hh. Regulations

-STATUTE-

(a) Authority to prescribe regulations; ineffectiveness of

substantive rules not promulgated by regulation

(1) The Secretary shall prescribe such regulations as may be

necessary to carry out the administration of the insurance programs

under this subchapter. When used in this subchapter, the term

"regulations" means, unless the context otherwise requires,

regulations prescribed by the Secretary.

(2) No rule, requirement, or other statement of policy (other

than a national coverage determination) that establishes or changes

a substantive legal standard governing the scope of benefits, the

payment for services, or the eligibility of individuals, entities,

or organizations to furnish or receive services or benefits under

this subchapter shall take effect unless it is promulgated by the

Secretary by regulation under paragraph (1).

(b) Notice of proposed regulations; public comment

(1) Except as provided in paragraph (2), before issuing in final

form any regulation under subsection (a) of this section, the

Secretary shall provide for notice of the proposed regulation in

the Federal Register and a period of not less than 60 days for

public comment thereon.

(2) Paragraph (1) shall not apply where -

(A) a statute specifically permits a regulation to be issued in

interim final form or otherwise with a shorter period for public

comment,

(B) a statute establishes a specific deadline for the

implementation of a provision and the deadline is less than 150

days after the date of the enactment of the statute in which the

deadline is contained, or

(C) subsection (b) of section 553 of title 5 does not apply

pursuant to subparagraph (B) of such subsection.

(c) Publication of certain rules; public inspection; changes in

data collection and retrieval

(1) The Secretary shall publish in the Federal Register, not less

frequently than every 3 months, a list of all manual instructions,

interpretative rules, statements of policy, and guidelines of

general applicability which -

(A) are promulgated to carry out this subchapter, but

(B) are not published pursuant to subsection (a)(1) of this

section and have not been previously published in a list under

this subsection.

(2) Effective June 1, 1988, each fiscal intermediary and carrier

administering claims for extended care, post-hospital extended

care, home health care, and durable medical equipment benefits

under this subchapter shall make available to the public all

interpretative materials, guidelines, and clarifications of

policies which relate to payments for such benefits.

(3) The Secretary shall to the extent feasible make such changes

in automated data collection and retrieval by the Secretary and

fiscal intermediaries with agreements under section 1395h of this

title as are necessary to make easily accessible for the Secretary

and other appropriate parties a data base which fairly and

accurately reflects the provision of extended care, post-hospital

extended care and home health care benefits pursuant to this

subchapter, including such categories as benefit denials, results

of appeals, and other relevant factors, and selectable by such

categories and by fiscal intermediary, service provider, and

region.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1871, as added Pub. L.

89-97, title I, Sec. 102(a) July 30, 1965, 79 Stat. 331; amended

Pub. L. 99-509, title IX, Sec. 9321(e)(1), Oct. 21, 1986, 100 Stat.

2017; Pub. L. 100-203, title IV, Sec. 4035(b), (c), Dec. 22, 1987,

101 Stat. 1330-78.)

-MISC1-

AMENDMENTS

1987 - Subsec. (a). Pub. L. 100-203, Sec. 4035(b), designated

existing provisions as par. (1) and added par. (2).

Subsec. (c). Pub. L. 100-203, Sec. 4035(c), added subsec. (c).

1986 - Pub. L. 99-509 designated existing provisions as subsec.

(a) and added subsec. (b).

EFFECTIVE DATE OF 1987 AMENDMENT

Amendment by Pub. L. 100-203 effective Dec. 22, 1987, and

applicable to budgets for fiscal years beginning with fiscal year

1989, see section 4035(a)(3) of Pub. L. 100-203, set out as a note

under section 1395h of this title.

EFFECTIVE DATE OF 1986 AMENDMENT

Section 9321(e)(3)(A) of Pub. L. 99-509 provided that: "The

amendments made by paragraph (1) [amending this section] shall

apply to notices of proposed rulemaking issued after the date of

the enactment of this Act [Oct. 21, 1986]."

REGULATIONS

Pub. L. 101-508, title IV, Sec. 4207(j), formerly Sec. 4027(j),

Nov. 5, 1990, 104 Stat. 1388-124, as renumbered and amended by Pub.

L. 103-432, title I, Sec. 160(d)(4), (12), Oct. 31, 1994, 108 Stat.

4444, provided that: "The Secretary of Health and Human Services

shall issue such regulations (on an interim or other basis) as may

be necessary to implement this subtitle [subtitle A (Secs.

4000-4361) of title IV of Pub. L. 101-508, see Tables for

classification] and the amendments made by this subtitle."

Section 4039(g) of title IV of Pub. L. 100-203 provided that:

"The Secretary of Health and Human Services shall issue such

regulations (on an interim or other basis) as may be necessary to

implement this subtitle and the amendments made by this subtitle

[subtitle A (Secs. 4001-4097) of title IV of Pub. L. 100-203, see

Tables for classification]."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1395h, 1395u, 1395ff of

this title.

-End-

-CITE-

42 USC Sec. 1395ii 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395ii. Application of certain provisions of subchapter II

-STATUTE-

The provisions of sections 406 and 416(j) of this title, and of

subsections (a), (d), (e), (h), (i), (j), (k), and (l) of section

405 of this title, shall also apply with respect to this subchapter

to the same extent as they are applicable with respect to

subchapter II of this chapter, except that, in applying such

provisions with respect to this subchapter, any reference therein

to the Commissioner of Social Security or the Social Security

Administration shall be considered a reference to the Secretary or

the Department of Health and Human Services, respectively.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1872, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 332; amended

Pub. L. 92-603, title II, Sec. 242(a), Oct. 30, 1972, 86 Stat.

1419; Pub. L. 98-369, div. B, title III, Sec. 2354(b)(36), July 18,

1984, 98 Stat. 1102; Pub. L. 103-296, title I, Sec. 108(c)(4), Aug.

15, 1994, 108 Stat. 1485.)

-MISC1-

AMENDMENTS

1994 - Pub. L. 103-296 inserted before period at end ", except

that, in applying such provisions with respect to this subchapter,

any reference therein to the Commissioner of Social Security or the

Social Security Administration shall be considered a reference to

the Secretary or the Department of Health and Human Services,

respectively".

1984 - Pub. L. 98-369 struck out the comma after "406" and struck

out reference to subsec. (f) of section 405 of this title.

1972 - Pub. L. 92-603 struck out reference to provisions of

section 408 of this title.

EFFECTIVE DATE OF 1994 AMENDMENT

Amendment by Pub. L. 103-296 effective Mar. 31, 1995, see section

110(a) of Pub. L. 103-296, set out as a note under section 401 of

this title.

EFFECTIVE DATE OF 1984 AMENDMENT

Amendment by Pub. L. 98-369 effective July 18, 1984, but not to

be construed as changing or affecting any right, liability, status,

or interpretation which existed (under the provisions of law

involved) before that date, see section 2354(e)(1) of Pub. L.

98-369, set out as a note under section 1320a-1 of this title.

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by Pub. L. 92-603 not applicable to any acts,

statements, or representations made or committed prior to Oct. 30,

1972, see section 242(d) of Pub. L. 92-603, set out as an Effective

Date note under section 1320a-7b of this title.

-End-

-CITE-

42 USC Sec. 1395jj 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395jj. Designation of organization or publication by name

-STATUTE-

Designation in this subchapter, by name, of any nongovernmental

organization or publication shall not be affected by change of name

of such organization or publication, and shall apply to any

successor organization or publication which the Secretary finds

serves the purpose for which such designation is made.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1873, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 332.)

-End-

-CITE-

42 USC Sec. 1395kk 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395kk. Administration of insurance programs

-STATUTE-

(a) Functions of Secretary; performance directly or by contract

Except as otherwise provided in this subchapter and in the

Railroad Retirement Act of 1974 [45 U.S.C. 231 et seq.], the

insurance programs established by this subchapter shall be

administered by the Secretary. The Secretary may perform any of his

functions under this subchapter directly, or by contract providing

for payment in advance or by way of reimbursement, and in such

installments, as the Secretary may deem necessary.

(b) Contracts to secure special data, actuarial information, etc.

The Secretary may contract with any person, agency, or

institution to secure on a reimbursable basis such special data,

actuarial information, and other information as may be necessary in

the carrying out of his functions under this subchapter.

(c) Oaths and affirmations

In the course of any hearing, investigation, or other proceeding

that he is authorized to conduct under this subchapter, the

Secretary may administer oaths and affirmations.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1874, as added and

amended Pub. L. 89-97, title I, Secs. 102(a), 111(a), July 30,

1965, 79 Stat. 332, 340; Pub. L. 92-603, title II, Sec. 289, Oct.

30, 1972, 86 Stat. 1457; Pub. L. 93-445, title III, Sec. 310, Oct.

16, 1974, 88 Stat. 1359.)

-REFTEXT-

REFERENCES IN TEXT

The Railroad Retirement Act of 1974, referred to in subsec. (a),

is act Aug. 29, 1935, ch. 812, as amended generally by Pub. L.

93-445, title I, Sec. 101, Oct. 16, 1974, 88 Stat. 1305, which is

classified generally to subchapter IV (Sec. 231 et seq.) of chapter

9 of Title 45, Railroads. For further details and complete

classification of this Act to the Code, see Codification note set

out preceding section 231 of Title 45, section 231t of Title 45,

and Tables.

-MISC1-

AMENDMENTS

1974 - Subsec. (a). Pub. L. 93-445 substituted "Railroad

Retirement Act of 1974" for "Railroad Retirement Act of 1937".

1972 - Subsec. (c). Pub. L. 92-603 added subsec. (c).

1965 - Subsec. (a). Pub. L. 89-97 inserted reference to Railroad

Retirement Act of 1937 in first sentence.

EFFECTIVE DATE OF 1974 AMENDMENT

Amendment by Pub. L. 93-445 effective Jan. 1, 1975, see section

603 of Pub. L. 93-445, set out as a note under section 402 of this

title.

EFFECTIVE DATE OF 1965 AMENDMENT

Amendment by Pub. L. 89-97 applicable to calendar year 1966 or to

any subsequent calendar year but only if by October 1 immediately

preceding such calendar year the Railroad Retirement Tax Act

provides for a maximum amount of monthly compensation taxable under

such Act during all months of such calendar year equal to

one-twelfth of maximum wages which Federal Insurance Contributions

Act provides may be counted for such calendar year, see section

111(e) of Pub. L. 89-97.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in title 45 section 231f.

-End-

-CITE-

42 USC Sec. 1395ll 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395ll. Studies and recommendations

-STATUTE-

(a) Health care of the aged and disabled

The Secretary shall carry on studies and develop recommendations

to be submitted from time to time to the Congress relating to

health care of the aged and the disabled, including studies and

recommendations concerning (1) the adequacy of existing personnel

and facilities for health care for purposes of the programs under

parts A and B of this subchapter; (2) methods for encouraging the

further development of efficient and economical forms of health

care which are a constructive alternative to inpatient hospital

care; and (3) the effects of the deductibles and coinsurance

provisions upon beneficiaries, persons who provide health services,

and the financing of the program.

(b) Operation and administration of insurance programs

The Secretary shall make a continuing study of the operation and

administration of the insurance programs under parts A and B of

this subchapter (including a validation of the accreditation

process of the Joint Commission on Accreditation of Hospitals, the

operation and administration of health maintenance organizations

authorized by section 226 of the Social Security Amendments of 1972

[42 U.S.C. 1395mm], the experiments and demonstration projects

authorized by section 402 of the Social Security Amendments of 1967

[42 U.S.C. 1395b-1] and the experiments and demonstration projects

authorized by section 222(a) of the Social Security Amendments of

1972 [42 U.S.C. 1395b-1 note]), and shall transmit to the Congress

annually a report concerning the operation of such programs.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1875, as added Pub. L.

89-97, title I, Sec. 102(a), July 30, 1965, 79 Stat. 332; amended

Pub. L. 90-248, title IV, Sec. 402(c), Jan. 2, 1968, 81 Stat. 931;

Pub. L. 92-603, title II, Secs. 201(c)(7), 222(c), 226(d), 244(d),

Oct. 30, 1972, 86 Stat. 1373, 1393, 1404, 1423; Pub. L. 98-369,

div. B, title III, Sec. 2354(b)(17), July 18, 1984, 98 Stat. 1101;

Pub. L. 99-509, title IX, Sec. 9316(a), Oct. 21, 1986, 100 Stat.

2006; Pub. L. 100-203, title IV, Sec. 4085(i)(20), Dec. 22, 1987,

101 Stat. 1330-133; Pub. L. 100-647, title VIII, Sec. 8413, Nov.

10, 1988, 102 Stat. 3801; Pub. L. 101-234, title III, Sec.

301(b)(5), (d)(2), Dec. 13, 1989, 103 Stat. 1985, 1986; Pub. L.

101-239, title VI, Sec. 6103(b)(3)(A), Dec. 19, 1989, 103 Stat.

2199.)

-REFTEXT-

REFERENCES IN TEXT

Parts A and B of this subchapter, referred to in text, are

classified to sections 1395c et seq. and 1395j et seq.,

respectively, of this title.

Section 226 of the Social Security Amendments of 1972, referred

to in subsec. (b), is section 226 of Pub. L. 92-603, which enacted

section 1395mm of this title and provisions set out as notes under

that section and amended this section and sections 1395f, 1395l,

and 1396b of this title.

Section 402 of the Social Security Amendments of 1967, referred

to in subsec. (b), is section 402 of Pub. L. 90-248, which enacted

section 1395b-1 of this title and amended this section.

Section 222(a) of the Social Security Amendments of 1972,

referred to in subsec. (b), is section 222(a) of Pub. L. 92-603,

which enacted provisions set out as note under section 1395b-1 of

this title.

-MISC1-

AMENDMENTS

1989 - Subsec. (c). Pub. L. 101-239 struck out subsec. (c) which

related to patient outcome assessment research program.

Subsec. (c)(7). Pub. L. 101-234, Sec. 301(b)(5), (d)(2), amended

par. (7) identically, substituting "date of the enactment of this

section" for "date of the enactment of this Act".

1988 - Subsec. (c)(3). Pub. L. 100-647 amended par. (3)

generally. Prior to amendment, par. (3) read as follows: "For

purposes of carrying out the research program, there are authorized

to be appropriated -

"(A) from the Federal Hospital Insurance Trust Fund $4,000,000

for fiscal year 1987 and $5,000,000 for each of fiscal years 1988

and 1989, and

"(B) from the Federal Supplementary Medical Insurance Trust

Fund $2,000,000 for fiscal year 1987 and $2,500,000 for each of

fiscal years 1988 and 1989."

1987 - Subsec. (c)(3)(B). Pub. L. 100-203 substituted "fiscal

year 1987" for "fiscal years 1987".

1986 - Subsec. (c). Pub. L. 99-509 added subsec. (c).

1984 - Subsec. (b). Pub. L. 98-369 struck out "the" after "Joint

Commission on".

1972 - Subsec. (a). Pub. L. 92-603, Sec. 201(c)(7), inserted "and

the disabled" after "aged".

Subsec. (b). Pub. L. 92-603, Secs. 222(c), 226(d)(1), 244(d),

substituted "(including a validation of the accreditation process

of the Joint Commission on the Accreditation of Hospitals, the

operation and administration of health maintenance organizations

authorized by section 226 of the Social Security Amendments of

1972, the experiments and demonstration projects authorized by

section 402 of the Social Security Amendments of 1967 and the

experiments and demonstration projects authorized by section 222(a)

of the Social Security Amendments of 1972)" for "(including the

experimentation authorized by section 402 of the Social Security

Amendments of 1967)". Pub. L. 92-603, Sec. 226(d)(2), which

directed the substitution of "1972" for "1971", could not be

executed because "1971" did not appear.

1968 - Subsec. (b). Pub. L. 90-248 inserted "(including the

experimentation authorized by section 402 of the Social Security

Amendments of 1967" after "under parts A and B of this subchapter".

EFFECTIVE DATE OF 1989 AMENDMENT

Section 6103(b)(3)(A) of Pub. L. 101-239 provided that the

amendment made by that section is effective for fiscal years

beginning after fiscal year 1990.

EFFECTIVE DATE OF 1984 AMENDMENT

Amendment by Pub. L. 98-369 effective July 18, 1984, but not to

be construed as changing or affecting any right, liability, status,

or interpretation which existed (under the provisions of law

involved) before that date, see section 2354(e)(1) of Pub. L.

98-369, set out as a note under section 1320a-1 of this title.

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by section 226(d) of Pub. L. 92-603 effective with

respect to services provided on or after July 1, 1973, see section

226(f) of Pub. L. 92-603, set out as an Effective Date note under

section 1395mm of this title.

STUDY ON ENROLLMENT PROCEDURES FOR GROUPS THAT RETAIN INDEPENDENT

CONTRACTOR PHYSICIANS

Pub. L. 106-554, Sec. 1(a)(6) [title IV, Sec. 413], Dec. 21,

2000, 114 Stat. 2763, 2763A-515, provided that:

"(a) In General. - The Comptroller General of the United States

shall conduct a study of the current medicare enrollment process

for groups that retain independent contractor physicians with

particular emphasis on hospital-based physicians, such as emergency

department staffing groups. In conducting the evaluation, the

Comptroller General shall consult with groups that retain

independent contractor physicians and shall -

"(1) review the issuance of individual medicare provider

numbers and the possible medicare program integrity

vulnerabilities of the current process;

"(2) review direct and indirect costs associated with the

current process incurred by the medicare program and groups that

retain independent contractor physicians;

"(3) assess the effect on program integrity by the enrollment

of groups that retain independent contractor hospital-based

physicians; and

"(4) develop suggested procedures for the enrollment of these

groups.

"(b) Report. - Not later than 1 year after the date of the

enactment of this Act [Dec. 21, 2000], the Comptroller General

shall submit to Congress a report on the study conducted under

subsection (a)."

GAO STUDIES AND REPORTS ON MEDICARE PAYMENTS

Pub. L. 106-554, Sec. 1(a)(6) [title IV, Sec. 437], Dec. 21,

2000, 114 Stat. 2763, 2763A-527, provided that:

"(a) GAO Study on HCFA Post-Payment Audit Process. -

"(1) Study. - The Comptroller General of the United States

shall conduct a study on the post-payment audit process under the

medicare program under title XVIII of the Social Security Act

[this subchapter] as such process applies to physicians,

including the proper level of resources that the Health Care

Financing Administration should devote to educating physicians

regarding -

"(A) coding and billing;

"(B) documentation requirements; and

"(C) the calculation of overpayments.

"(2) Report. - Not later than 18 months after the date of the

enactment of this Act [Dec. 21, 2000], the Comptroller General

shall submit to Congress a report on the study conducted under

paragraph (1) together with specific recommendations for changes

or improvements in the post-payment audit process described in

such paragraph.

"(b) GAO Study on Administration and Oversight. -

"(1) Study. - The Comptroller General of the United States

shall conduct a study on the aggregate effects of regulatory,

audit, oversight, and paperwork burdens on physicians and other

health care providers participating in the medicare program under

title XVIII of the Social Security Act [this subchapter].

"(2) Report. - Not later than 18 months after the date of the

enactment of this Act [Dec. 21, 2000], the Comptroller General

shall submit to Congress a report on the study conducted under

paragraph (1) together with recommendations regarding any area in

which -

"(A) a reduction in paperwork, an ease of administration, or

an appropriate change in oversight and review may be

accomplished; or

"(B) additional payments or education are needed to assist

physicians and other health care providers in understanding and

complying with any legal or regulatory requirements."

STUDY AND REPORT REGARDING UTILIZATION OF PHYSICIANS' SERVICES BY

MEDICARE BENEFICIARIES

Pub. L. 106-113, div. B, Sec. 1000(a)(6) [title II, Sec. 211(c)],

Nov. 29, 1999, 113 Stat. 1536, 1501A-349, provided that:

"(1) Study by secretary. - The Secretary of Health and Human

Services, acting through the Administrator of the Agency for Health

Care Policy and Research, shall conduct a study of the issues

specified in paragraph (2).

"(2) Issues to be studied. - The issues specified in this

paragraph are the following:

"(A) The various methods for accurately estimating the economic

impact on expenditures for physicians' services under the

original medicare fee-for-service program under parts A and B of

title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.)

[parts A and B of this subchapter] resulting from -

"(i) improvements in medical capabilities;

"(ii) advancements in scientific technology;

"(iii) demographic changes in the types of medicare

beneficiaries that receive benefits under such program; and

"(iv) geographic changes in locations where medicare

beneficiaries receive benefits under such program.

"(B) The rate of usage of physicians' services under the

original medicare fee-for-service program under parts A and B of

title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.)

among beneficiaries between ages 65 and 74, 75 and 84, 85 and

over, and disabled beneficiaries under age 65.

"(C) Other factors that may be reliable predictors of

beneficiary utilization of physicians' services under the

original medicare fee-for-service program under parts A and B of

title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).

"(3) Report to congress. - Not later than 3 years after the date

of the enactment of this Act [Nov. 29, 1999], the Secretary of

Health and Human Services shall submit a report to Congress setting

forth the results of the study conducted pursuant to paragraph (1),

together with any recommendations the Secretary determines are

appropriate.

"(4) Medpac report to congress. - Not later than 180 days after

the date of submission of the report under paragraph (3), the

Medicare Payment Advisory Commission shall submit a report to

Congress that includes -

"(A) an analysis and evaluation of the report submitted under

paragraph (3); and

"(B) such recommendations as it determines are appropriate."

STUDY OF ADULT DAY CARE SERVICES

Pub. L. 100-360, title II, Sec. 208, July 1, 1988, 102 Stat. 732,

as amended by Pub. L. 100-485, title VI, Sec. 608(d)(8), Oct. 13,

1988, 102 Stat. 2415, directed Secretary of Health and Human

Services to conduct a survey of adult day care services in United

States and to report to Congress, by not later than 1 year after

July 1, 1988, on the information collected in the survey, prior to

repeal by Pub. L. 101-234, title II, Sec. 201(a), Dec. 13, 1989,

103 Stat. 1981.

STUDY TO DEVELOP A STRATEGY FOR QUALITY REVIEW AND ASSURANCE

Section 9313(d) of Pub. L. 99-509, as amended by Pub. L. 100-203,

title IV, Sec. 4085(i)(21)(A), Dec. 22, 1987, 101 Stat. 1330-133,

directed Secretary of Health and Human Services to arrange, with

the National Academy of Sciences or other appropriate nonprofit

private entity, for a study to design a strategy for reviewing and

assuring the quality of care for which payment may be made under

this subchapter, specified items to be included in the study, and

directed Secretary to submit to Congress, not later than Jan. 1,

1990, a report on the study with recommendations with respect to

strengthening quality assurancees and review activities for

services furnished under the medicare program.

SPECIAL TREATMENT OF STATES FORMERLY UNDER WAIVER

For treatment of hospitals in States which have had a waiver

approved under this section, upon termination of waiver, see

section 9202(j) of Pub. L. 99-272, as amended, set out as a note

under section 1395ww of this title.

DRUG DETOXIFICATION MEDICARE COVERAGE AND FACILITY INCENTIVES

Pub. L. 96-499, title IX, Sec. 931(f), Dec. 5, 1980, 94 Stat.

2634, which related to a study of medicare coverage of certain

additional detoxification-related services, was repealed by Pub. L.

97-35, title XXI, Sec. 2121(h), Aug. 13, 1981, 95 Stat. 796.

LEGISLATIVE RECOMMENDATIONS REGARDING REIMBURSEMENT FOR

OPTOMETRISTS' SERVICES

Pub. L. 96-499, title IX, Sec. 937(b), Dec. 5, 1980, 94 Stat.

2640, provided that the Secretary of Health and Human Services

submit to the Congress by Jan. 1, 1982, legislative recommendations

with respect to reimbursement under title XVIII of the Social

Security Act [this subchapter] for services furnished by

optometrists in connection with cataracts and such other services

which they are legally authorized to perform.

DEMONSTRATION PROJECTS, STUDIES, AND REPORTS: NUTRITIONAL THERAPY,

SECOND OPINION COST-SHARING, SERVICES OF REGISTERED DIETITIANS,

SERVICES OF CLINICAL SOCIAL WORKERS, ORTHOPEDIC SHOES, RESPIRATORY

THERAPY SERVICES, AND FOOT CONDITIONS; GRANTS, PAYMENTS, AND

EXPENDITURES

Pub. L. 96-499, title IX, Sec. 958, Dec. 5, 1980, 94 Stat. 2648,

directed Secretary of Health and Human Services to carry out

certain demonstration projects and conduct certain studies as

follows: (a) a demonstration project to determine extent to which

nutritional therapy in early renal failure could retard the disease

with resultant substantive deferment of dialysis, and aspects of

making such therapy available under this subchapter, report to

Congress to be submitted within twenty-four months of Dec. 5, 1980;

(b) demonstration projects with respect to waiving the applicable

cost sharing amounts which beneficiaries under this subchapter had

to pay for obtaining a second opinion on having surgery, report to

be submitted within one year after Dec. 5, 1980; (c) a study of

conditions under which services of registered dietitians could be

covered as a home health benefit under this subchapter, report to

be submitted within twenty-four months of Dec. 5, 1980; (d)

demonstration projects to determine aspects of making services of

clinical social workers more generally available under this

subchapter, report to be submitted within twenty-four months of

Dec. 5, 1980; (e) a study of methods for providing coverage under

part B of this subchapter for orthopedic shoes for individuals with

disabling or deforming conditions requiring special fitting

considerations, or requiring special shoes in conjunction with the

use of an orthosis or foot support, report to be submitted no later

than July 1, 1981; (f) a study of conditions under which services

with respect to respiratory therapy could be covered as a home

health benefit under this subchapter, report to be submitted within

twenty-four months of Dec. 5, 1980; and (g) a study analyzing cost

effects of alternative approaches to improving coverage under this

subchapter for treatment of various types of foot conditions,

report to be submitted within twenty-four months of Dec. 5, 1980.

Payments and expenditures for such studies and projects were to be

made in appropriate part from the Federal Hospital Insurance Trust

Fund established by section 1395i of this title, and the Federal

Supplemental Medical Insurance Trust Fund established by section

1395t of this title.

DEMONSTRATION PROJECT RELATING TO THE TERMINALLY ILL

Pub. L. 96-265, title V, Sec. 506, June 9, 1980, 94 Stat. 475,

authorized Secretary of Health and Human Services to provide for

participation, by Social Security Administration, in a

demonstration project relating to the terminally ill then being

conducted within the Department of Health and Human Services, the

purpose of such participation to be to study impact on terminally

ill of provisions of disability programs administered by Social

Security Administration and to determine how best to provide

services needed by persons who were terminally ill through programs

over which the Social Security Administration had administrative

responsibility, and authorized to be appropriated necessary sums

not in excess of $2,000,000 for any fiscal year.

REPORT TO CONGRESS WITH RESPECT TO URBAN OR RURAL COMPREHENSIVE

MENTAL HEALTH CENTERS AND CENTERS FOR TREATMENT OF ALCOHOLISM AND

DRUG ABUSE; SUBMISSION NO LATER THAN JUNE 13, 1978

Pub. L. 95-210, Sec. 4, Dec. 13, 1977, 91 Stat. 1490, directed

Secretary of Health, Education, and Welfare to submit to Congress,

no later than six months after Dec. 13, 1977, a report on the

advantages and disadvantages of extending coverage under this

subchapter to urban or rural comprehensive mental health centers

and to centers for treatment of alcoholism and drug abuse.

STUDY AND REVIEW BY COMPTROLLER GENERAL OF ADMINISTRATIVE STRUCTURE

FOR PROCESSING MEDICARE CLAIMS; REPORT TO CONGRESS

Pub. L. 95-142, Sec. 12, Oct. 25, 1977, 91 Stat. 1197, directed

Comptroller General to conduct a comprehensive study and review of

administrative structure established for processing of claims under

this subchapter for purpose of determining whether and to what

extent more efficient claims administration under this subchapter

could be achieved and directed Comptroller General to submit to

Congress no later than July 1, 1979, a complete report with respect

to such study and review.

REPORT BY SECRETARY OF HEALTH, EDUCATION, AND WELFARE ON DELIVERY

OF HOME HEALTH AND OTHER IN-HOME SERVICES; CONTENTS; CONSULTATION

REQUIREMENTS; SUBMISSION TO CONGRESS

Pub. L. 95-142, Sec. 18, Oct. 25, 1977, 91 Stat. 1202, directed

Secretary of Health, Education, and Welfare, not later than one

year after Oct. 25, 1977, to submit to appropriate committees of

Congress a report analyzing, evaluating, and making recommendations

with respect to all aspects of delivery of home health and other

in-home services authorized to be provided under subchapters XVIII,

XIX, and XX of this chapter.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in title 45 section 231f.

-End-

-CITE-

42 USC Sec. 1395mm 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 7 - SOCIAL SECURITY

SUBCHAPTER XVIII - HEALTH INSURANCE FOR AGED AND DISABLED

Part D - Miscellaneous Provisions

-HEAD-

Sec. 1395mm. Payments to health maintenance organizations and

competitive medical plans

-STATUTE-

(a) Rates and adjustments

(1)(A) The Secretary shall annually determine, and shall announce

(in a manner intended to provide notice to interested parties) not

later than September 7 before the calendar year concerned -

(i) a per capita rate of payment for each class of individuals

who are enrolled under this section with an eligible organization

which has entered into a risk-sharing contract and who are

entitled to benefits under part A of this subchapter and enrolled

under part B of this subchapter, and

(ii) a per capita rate of payment for each class of individuals

who are so enrolled with such an organization and who are

enrolled under part B of this subchapter only.

For purposes of this section, the term "risk-sharing contract"

means a contract entered into under subsection (g) of this section

and the term "reasonable cost reimbursement contract" means a

contract entered into under subsection (h) of this section.

(B) The Secretary shall define appropriate classes of members,

based on age, disability status, and such other factors as the

Secretary determines to be appropriate, so as to ensure actuarial

equivalence. The Secretary may add to, modify, or substitute for

such classes, if such changes will improve the determination of

actuarial equivalence.

(C) The annual per capita rate of payment for each such class

shall be equal to 95 percent of the adjusted average per capita

cost (as defined in paragraph (4)) for that class.

(D) In the case of an eligible organization with a risk-sharing

contract, the Secretary shall make monthly payments in advance and

in accordance with the rate determined under subparagraph (C) and

except as provided in subsection (g)(2) of this section, to the

organization for each individual enrolled with the organization

under this section.

(E)(i) The amount of payment under this paragraph may be

retroactively adjusted to take into account any difference between

the actual number of individuals enrolled in the plan under this

section and the number of such individuals estimated to be so

enrolled in determining the amount of the advance payment.

(ii)(I) Subject to subclause (II), the Secretary may make

retroactive adjustments under clause (i) to take into account

individuals enrolled during the period beginning on the date on

which the individual enrolls with an eligible organization (which

has a risk-sharing contract under this section) under a health

benefit plan operated, sponsored, or contributed to by the

individual's employer or former employer (or the employer or former

employer of the individual's spouse) and ending on the date on

which the individual is enrolled in the plan under this section,

except that for purposes of making such retroactive adjustments

under this clause, such period may not exceed 90 days.

(II) No adjustment may be made under subclause (I) with respect

to any individual who does not certify that the organization

provided the individual with the explanation described in

subsection (c)(3)(E) of this section at the time the individual

enrolled with the organization.

(F)(i) At least 45 days before making the announcement under

subparagraph (A) for a year (beginning with the announcement for

1991), the Secretary shall provide for notice to eligible

organizations of proposed changes to be made in the methodology or

benefit coverage assumptions from the methodology and assumptions

used in the previous announcement and shall provide such

organizations an opportunity to comment on such proposed changes.

(ii) In each announcement made under subparagraph (A) for a year

(beginning with the announcement for 1991), the Secretary shall

include an explanation of the assumptions (including any benefit

coverage assumptions) and changes in methodology used in the

announcement in sufficient detail so that eligible organizations

can compute per capita rates of payment for classes of individuals

located in each county (or equivalent area) which is in whole or in

part within the service area of such an organization.

(2) With respect to any eligible organization which has entered

into a reasonable cost reimbursement contract, payments shall be

made to such plan in accordance with subsection (h)(2) of this

section rather than paragraph (1).

(3) Subject to subsections (c)(2)(B)(ii) and (c)(7) of this

section, payments under a contract to an eligible organization

under paragraph (1) or (2) shall be instead of the amounts which

(in the absence of the contract) would be otherwise payable,

pursuant to sections 1395f(b) and 1395l(a) of this title, for

services furnished by or through the organization to individuals

enrolled with the organization under this section.

(4) For purposes of this section, the term "adjusted average per

capita cost" means the average per capita amount that the Secretary

estimates in advance (on the basis of actual experience, or

retrospective actuarial equivalent based upon an adequate sample

and other information and data, in a geographic area served by an

eligible organization or in a similar area, with appropriate

adjustments to assure actuarial equivalence) would be payable in

any contract year for services covered under parts A and B of this

subchapter, or part B only, and types of expenses otherwise

reimbursable under parts A and B of this subchapter, or part B only

(including administrative costs incurred by organizations described

in sections 1395h and 1395u of this title), if the services were to

be furnished by other than an eligible organization or, in the case

of services covered only under section 1395x(s)(2)(H) of this

title, if the services were to be furnished by a physician or as an

incident to a physician's service.

(5) The payment to an eligible organization under this section

for individuals enrolled under this section with the organization

and entitled to benefits under part A of this subchapter and

enrolled under part B of this subchapter shall be made from the

Federal Hospital Insurance Trust Fund and the Federal Supplementary

Medical Insurance Trust Fund. The portion of that payment to the

organization for a month to be paid by each trust fund shall be

determined as follows:

(A) In regard to expenditures by eligible organizations having

risk-sharing contracts, the allocation shall be determined each

year by the Secretary based on the relative weight that benefits

from each fund contribute to the adjusted average per capita

cost.

(B) In regard to expenditures by eligible organizations

operating under a reasonable cost reimbursement contract, the

initial allocation shall be based on the plan's most recent

budget, such allocation to be adjusted, as needed, after cost

settlement to reflect the distribution of actual expenditures.

The remainder of that payment shall be paid by the former trust

fund.

(6) Subject to subsections (c)(2)(B)(ii) and (c)(7) of this

section, if an individual is enrolled under this section with an

eligible organization having a risk-sharing contract, only the

eligible organization shall be entitled to receive payments from

the Secretary under this subchapter for services furnished to the

individual.

(b) Definitions; requirements

For purposes of this section, the term "eligible organization"

means a public or private entity (which may be a health maintenance

organization or a competitive medical plan), organized under the

laws of any State, which -

(1) is a qualified health maintenance organization (as defined

in section 300e-9(d) (!1) of this title), or

(2) meets the following requirements:

(A) The entity provides to enrolled members at least the

following health care services:

(i) Physicians' services performed by physicians (as

defined in section 1395x(r)(1) of this title).

(ii) Inpatient hospital services.

(iii) Laboratory, X-ray, emergency, and preventive

services.

(iv) Out-of-area coverage.

(B) The entity is compensated (except for deductibles,

coinsurance, and copayments) for the provision of health care

services to enrolled members by a payment which is paid on a

periodic basis without regard to the date the health care

services are provided and which is fixed without regard to the

frequency, extent, or kind of health care service actually

provided to a member.

(C) The entity provides physicians' services primarily (i)

directly through physicians who are either employees or

partners of such organization, or (ii) through contracts with

individual physicians or one or more groups of physicians

(organized on a group practice or individual practice basis).

(D) The entity assumes full financial risk on a prospective

basis for the provision of the health care services listed in

subparagraph (A), except that such entity may -

(i) obtain insurance or make other arrangements for the

cost of providing to any enrolled member health care services

listed in subparagraph (A) the aggregate value of which

exceeds $5,000 in any year,

(ii) obtain insurance or make other arrangements for the

cost of health care service listed in subparagraph (A)

provided to its enrolled members other than through the

entity because medical necessity required their provision

before they could be secured through the entity,

(iii) obtain insurance or make other arrangements for not

more than 90 percent of the amount by which its costs for any

of its fiscal years exceed 115 percent of its income for such

fiscal year, and

(iv) make arrangements with physicians or other health

professionals, health care institutions, or any combination

of such individuals or institutions to assume all or part of

the financial risk on a prospective basis for the provision

of basic health services by the physicians or other health

professionals or through the institutions.

(E) The entity has made adequate provision against the risk

of insolvency, which provision is satisfactory to the

Secretary.

Paragraph (2)(A)(ii) shall not apply to an entity which had

contracted with a single State agency administering a State plan

approved under subchapter XIX of this chapter for the provision of

services (other than inpatient hospital services) to individuals

eligible for such services under such State plan on a prepaid risk

basis prior to 1970.

(c) Enrollment in plan; duties of organization to enrollees

(1) The Secretary may not enter into a contract under this

section with an eligible organization unless it meets the

requirements of this subsection and subsection (e) of this section

with respect to members enrolled under this section.

(2)(A) The organization must provide to members enrolled under

this section, through providers and other persons that meet the

applicable requirements of this subchapter and part A of subchapter

XI of this chapter -

(i) only those services covered under parts A and B of this

subchapter, for those members entitled to benefits under part A

of this subchapter and enrolled under part B of this subchapter,

or

(ii) only those services covered under part B of this

subchapter, for those members enrolled only under such part,

which are available to individuals residing in the geographic area

served by the organization, except that (I) the organization may

provide such members with such additional health care services as

the members may elect, at their option, to have covered, and (II)

in the case of an organization with a risk-sharing contract, the

organization may provide such members with such additional health

care services as the Secretary may approve. The Secretary shall

approve any such additional health care services which the

organization proposes to offer to such members, unless the

Secretary determines that including such additional services will

substantially discourage enrollment by covered individuals with the

organization.

(B) If there is a national coverage determination made in the

period beginning on the date of an announcement under subsection

(a)(1)(A) of this section and ending on the date of the next

announcement under such subsection that the Secretary projects will

result in a signifcant (!2) change in the costs to the organization

of providing the benefits that are the subject of such national

coverage determination and that was not incorporated in the

determination of the per capita rate of payment included in the

announcement made at the beginning of such period -

(i) such determination shall not apply to risk-sharing

contracts under this section until the first contract year that

begins after the end of such period; and

(ii) if such coverage determination provides for coverage of

additional benefits or under additional circumstances, subsection

(a)(3) of this section shall not apply to payment for such

additional benefits or benefits provided under such additional

circumstances until the first contract year that begins after the

end of such period,

unless otherwise required by law.

(3)(A)(i) Each eligible organization must have an open enrollment

period, for the enrollment of individuals under this section, of at

least 30 days duration every year and including the period or

periods specified under clause (ii), and must provide that at any

time during which enrollments are accepted, the organization will

accept up to the limits of its capacity (as determined by the

Secretary) and without restrictions, except as may be authorized in

regulations, individuals who are eligible to enroll under

subsection (d) of this section in the order in which they apply for

enrollment, unless to do so would result in failure to meet the

requirements of subsection (f) of this section or would result in

the enrollment of enrollees substantially nonrepresentative, as

determined in accordance with regulations of the Secretary, of the

population in the geographic area served by the organization.

(ii)(I) If a risk-sharing contract under this section is not

renewed or is otherwise terminated, eligible organizations with

risk-sharing contracts under this section and serving a part of the

same service area as under the terminated contract are required to

have an open enrollment period for individuals who were enrolled

under the terminated contract as of the date of notice of such

termination. If a risk-sharing contract under this section is

renewed in a manner that discontinues coverage for individuals

residing in part of the service area, eligible organizations with

risk-sharing contracts under this section and enrolling individuals

residing in that part of the service area are required to have an

open enrollment period for individuals residing in the part of the

service area who were enrolled under the contract as of the date of

notice of such discontinued coverage.

(II) The open enrollment periods required under subclause (I)

shall be for 30 days and shall begin 30 days after the date that

the Secretary provides notice of such requirement.

(III) Enrollment under this clause shall be effective 30 days

after the end of the open enrollment period, or, if the Secretary

determines that such date is not feasible, such other date as the

Secretary specifies.

(B) An individual may enroll under this section with an eligible

organization in such manner as may be prescribed in regulations and

may terminate his enrollment with the eligible organization as of

the beginning of the first calendar month following the date on

which the request is made for such termination (or, in the case of

financial insolvency of the organization, as may be prescribed by

regulations) or, in the case of such an organization with a

reasonable cost reimbursement contract, as may be prescribed by

regulations. In the case of an individual's termination of

enrollment, the organization shall provide the individual with a

copy of the written request for termination of enrollment and a

written explanation of the period (ending on the effective date of

the termination) during which the individual continues to be

enrolled with the organization and may not receive benefits under

this subchapter other than through the organization.

(C) The Secretary may prescribe the procedures and conditions

under which an eligible organization that has entered into a

contract with the Secretary under this subsection may inform

individuals eligible to enroll under this section with the

organization about the organization, or may enroll such individuals

with the organization. No brochures, application forms, or other

promotional or informational material may be distributed by an

organization to (or for the use of) individuals eligible to enroll

with the organization under this section unless (i) at least 45

days before its distribution, the organization has submitted the

material to the Secretary for review and (ii) the Secretary has not

disapproved the distribution of the material. The Secretary shall

review all such material submitted and shall disapprove such

material if the Secretary determines, in the Secretary's

discretion, that the material is materially inaccurate or

misleading or otherwise makes a material misrepresentation.

(D) The organization must provide assurances to the Secretary

that it will not expel or refuse to re-enroll any such individual

because of the individual's health status or requirements for

health care services, and that it will notify each such individual

of such fact at the time of the individual's enrollment.

(E) Each eligible organization shall provide each enrollee, at

the time of enrollment and not less frequently than annually

thereafter, an explanation of the enrollee's rights under this

section, including an explanation of -

(i) the enrollee's rights to benefits from the organization,

(ii) the restrictions on payments under this subchapter for

services furnished other than by or through the organization,

(iii) out-of-area coverage provided by the organization,

(iv) the organization's coverage of emergency services and

urgently needed care, and

(v) appeal rights of enrollees.

(F) Each eligible organization that provides items and services

pursuant to a contract under this section shall provide assurances

to the Secretary that in the event the organization ceases to

provide such items and services, the organization shall provide or

arrange for supplemental coverage of benefits under this subchapter

related to a pre-existing condition with respect to any exclusion

period, to all individuals enrolled with the entity who receive

benefits under this subchapter, for the lesser of six months or the

duration of such period.

(G)(i) Each eligible organization having a risk-sharing contract

under this section shall notify individuals eligible to enroll with

the organization under this section and individuals enrolled with

the organization under this section that -

(I) the organization is authorized by law to terminate or

refuse to renew the contract, and

(II) termination or nonrenewal of the contract may result in

termination of the enrollments of individuals enrolled with the

organization under this section.

(ii) The notice required by clause (i) shall be included in -

(I) any marketing materials described in subparagraph (C) that

are distributed by an eligible organization to individuals

eligible to enroll under this section with the organization, and

(II) any explanation provided to enrollees by the organization

pursuant to subparagraph (E).

(4) The organization must -

(A) make the services described in paragraph (2) (and such

other health care services as such individuals have contracted

for) (i) available and accessible to each such individual, within

the area served by the organization, with reasonable promptness

and in a manner which assures continuity, and (ii) when medically

necessary, available and accessible twenty-four hours a day and

seven days a week, and

(B) provide for reimbursement with respect to services which

are described in subparagraph (A) and which are provided to such

an individual other than through the organization, if (i) the

services were medically necessary and immediately required

because of an unforeseen illness, injury, or condition and (ii)

it was not reasonable given the circumstances to obtain the

services through the organization.

(5)(A) The organization must provide meaningful procedures for

hearing and resolving grievances between the organization

(including any entity or individual through which the organization

provides health care services) and members enrolled with the

organization under this section.

(B) A member enrolled with an eligible organization under this

section who is dissatisfied by reason of his failure to receive any

health service to which he believes he is entitled and at no

greater charge than he believes he is required to pay is entitled,

if the amount in controversy is $100 or more, to a hearing before

the Secretary to the same extent as is provided in section 405(b)

of this title, and in any such hearing the Secretary shall make the

eligible organization a party. If the amount in controversy is

$1,000 or more, the individual or eligible organization shall, upon

notifying the other party, be entitled to judicial review of the

Secretary's final decision as provided in section 405(g) of this

title, and both the individual and the eligible organization shall

be entitled to be parties to that judicial review. In applying

sections 405(b) and 405(g) of this title as provided in this

subparagraph, and in applying section 405(l) of this title thereto,

any reference therein to the Commissioner of Social Security or the

Social Security Administration shall be considered a reference to

the Secretary or the Department of Health and Human Services,

respectively.

(6) The organization must have arrangements, established in

accordance with regulations of the Secretary, for an ongoing

quality assurance program for health care services it provides to

such individuals, which program (A) stresses health outcomes and

(B) provides review by physicians and other health care

professionals of the process followed in the provision of such

health care services.

(7) A risk-sharing contract under this section shall provide that

in the case of an individual who is receiving inpatient hospital

services from a subsection (d) hospital (as defined in section

1395ww(d)(1)(B) of this title) as of the effective date of the

individual's -

(A) enrollment with an eligible organization under this section

-

(i) payment for such services until the date of the

individual's discharge shall be made under this subchapter as

if the individual were not enrolled with the organization,

(ii) the organization shall not be financially responsible

for payment for such services until the date after the date of

the individual's discharge, and

(iii) the organization shall nonetheless be paid the full

amount otherwise payable to the organization under this

section; or

(B) termination of enrollment with an eligible organization

under this section -

(i) the organization shall be financially responsible for

payment for such services after such date and until the date of

the individual's discharge,

(ii) payment for such services during the stay shall not be

made under section 1395ww(d) of this title, and

(iii) the organization shall not receive any payment with

respect to the individual under this section during the period

the individual is not enrolled.

(8) A contract under this section shall provide that the eligible

organization shall meet the requirement of section 1395cc(f) of

this title (relating to maintaining written policies and procedures

respecting advance directives).

(d) Right to enroll with contracting organization in geographic

area

Subject to the provisions of subsection (c)(3) of this section,

every individual entitled to benefits under part A of this

subchapter and enrolled under part B of this subchapter or enrolled

under part B of this subchapter only (other than an individual

medically determined to have end-stage renal disease) shall be

eligible to enroll under this section with any eligible

organization with which the Secretary has entered into a contract

under this section and which serves the geographic area in which

the individual resides.

(e) Limitation on charges; election of coverage; "adjusted

community rate" defined; workmen's compensation and insurance

benefits

(1) In no case may -

(A) the portion of an eligible organization's premium rate and

the actuarial value of its deductibles, coinsurance, and

copayments charged (with respect to services covered under parts

A and B of this subchapter) to individuals who are enrolled under

this section with the organization and who are entitled to

benefits under part A of this subchapter and enrolled under part

B of this subchapter, or

(B) the portion of its premium rate and the actuarial value of

its deductibles, coinsurance, and copayments charged (with

respect to services covered under part B of this subchapter) to

individuals who are enrolled under this section with the

organization and enrolled under part B of this subchapter only

exceed the actuarial value of the coinsurance and deductibles that

would be applicable on the average to individuals enrolled under

this section with the organization (or, if the Secretary finds that

adequate data are not available to determine that actuarial value,

the actuarial value of the coinsurance and deductibles applicable

on the average to individuals in the area, in the State, or in the

United States, eligible to enroll under this section with the

organization, or other appropriate data) and entitled to benefits

under part A of this subchapter and enrolled under part B of this

subchapter, or enrolled under part B only, respectively, if they

were not members of an eligible organization.

(2) If the eligible organization provides to its members enrolled

under this section services in addition to services covered under

parts A and B of this subchapter, election of coverage for such

additional services (unless such services have been approved by the

Secretary under subsection (c)(2) of this section) shall be

optional for such members and such organization shall furnish such

members with information on the portion of its premium rate or

other charges applicable to such additional services. In no case

may the sum of -

(A) the portion of such organization's premium rate charged,

with respect to such additional services, to members enrolled

under this section, and

(B) the actuarial value of its deductibles, coinsurance, and

copayments charged, with respect to such services to such members

exceed the adjusted community rate for such services.

(3) For purposes of this section, the term "adjusted community

rate" for a service or services means, at the election of an

eligible organization, either -

(A) the rate of payment for that service or services which the

Secretary annually determines would apply to a member enrolled

under this section with an eligible organization if the rate of

payment were determined under a "community rating system" (as

defined in section 300e-1(8) of this title, other than

subparagraph (C)), or

(B) such portion of the weighted aggregate premium, which the

Secretary annually estimates would apply to a member enrolled

under this section with the eligible organization, as the

Secretary annually estimates is attributable to that service or

services,

but adjusted for differences between the utilization

characteristics of the members enrolled with the eligible

organization under this section and the utilization characteristics

of the other members of the organization (or, if the Secretary

finds that adequate data are not available to adjust for those

differences, the differences between the utilization

characteristics of members in other eligible organizations, or

individuals in the area, in the State, or in the United States,

eligible to enroll under this section with an eligible organization

and the utilization characteristics of the rest of the population

in the area, in the State, or in the United States, respectively).

(4) Notwithstanding any other provision of law, the eligible

organization may (in the case of the provision of services to a

member enrolled under this section for an illness or injury for

which the member is entitled to benefits under a workmen's

compensation law or plan of the United States or a State, under an

automobile or liability insurance policy or plan, including a

self-insured plan, or under no fault insurance) charge or authorize

the provider of such services to charge, in accordance with the

charges allowed under such law or policy -

(A) the insurance carrier, employer, or other entity which

under such law, plan, or policy is to pay for the provision of

such services, or

(B) such member to the extent that the member has been paid

under such law, plan, or policy for such services.

(f) Membership requirements

(1) For contract periods beginning before January 1, 1999, each

eligible organization with which the Secretary enters into a

contract under this section shall have, for the duration of such

contract, an enrolled membership at least one-half of which

consists of individuals who are not entitled to benefits under this

subchapter.

(2) Subject to paragraph (4), the Secretary may modify or waive

the requirement imposed by paragraph (1) only -

(A) to the extent that more than 50 percent of the population

of the area served by the organization consists of individuals

who are entitled to benefits under this subchapter or under a

State plan approved under subchapter XIX of this chapter, or

(B) in the case of an eligible organization that is owned and

operated by a governmental entity, only with respect to a period

of three years beginning on the date the organization first

enters into a contract under this section, and only if the

organization has taken and is making reasonable efforts to enroll

individuals who are not entitled to benefits under this

subchapter or under a State plan approved under subchapter XIX of

this chapter.

(3) If the Secretary determines that an eligible organization has

failed to comply with the requirements of this subsection, the

Secretary may provide for the suspension of enrollment of

individuals under this section or of payment to the organization

under this section for individuals newly enrolled with the

organization, after the date the Secretary notifies the

organization of such noncompliance.

(4) Effective for contract periods beginning after December 31,

1996, the Secretary may waive or modify the requirement imposed by

paragraph (1) to the extent the Secretary finds that it is in the

public interest.

(g) Risk-sharing contract

(1) The Secretary may enter a risk-sharing contract with any

eligible organization, as defined in subsection (b) of this

section, which has at least 5,000 members, except that the

Secretary may enter into such a contract with an eligible

organization that has fewer members if the organization primarily

serves members residing outside of urbanized areas.

(2) Each risk-sharing contract shall provide that -

(A) if the adjusted community rate, as defined in subsection

(e)(3) of this section, for services under parts A and B of this

subchapter (as reduced for the actuarial value of the coinsurance

and deductibles under those parts) for members enrolled under

this section with the organization and entitled to benefits under

part A of this subchapter and enrolled in part B of this

subchapter, or

(B) if the adjusted community rate for services under part B of

this subchapter (as reduced for the actuarial value of the

coinsurance and deductibles under that part) for members enrolled

under this section with the organization and entitled to benefits

under part B of this subchapter only

is less than the average of the per capita rates of payment to be

made under subsection (a)(1) of this section at the beginning of an

annual contract period for members enrolled under this section with

the organization and entitled to benefits under part A of this

subchapter and enrolled in part B of this subchapter, or enrolled

in part B of this subchapter only, respectively, the eligible

organization shall provide to members enrolled under a risk-sharing

contract under this section with the organization and entitled to

benefits under part A of this subchapter and enrolled in part B of

this subchapter, or enrolled in part B of this subchapter only,

respectively, the additional benefits described in paragraph (3)

which are selected by the eligible organization and which the

Secretary finds are at least equal in value to the difference

between that average per capita payment and the adjusted community

rate (as so reduced); except that this paragraph shall not apply

with respect to any organization which elects to receive a lesser

payment to the extent that there is no longer a difference between

the average per capita payment and adjusted community rate (as so

reduced) and except that an organization (with the approval of the

Secretary) may provide that a part of the value of such additional

benefits be withheld and reserved by the Secretary as provided in

paragraph (5). If the Secretary finds that there is insufficient

enrollment experience to determine an average of the per capita

rates of payment to be made under subsection (a)(1) of this section

at the beginning of a contract period, the Secretary may determine

such an average based on the enrollment experience of other

contracts entered into under this section.

(3) The additional benefits referred to in paragraph (2) are -

(A) the reduction of the premium rate or other charges made

with respect to services furnished by the organization to members

enrolled under this section, or

(B) the provision of additional health benefits,

or both.

(4) Repealed. Pub. L. 100-203, title IV, Sec. 4012(b), Dec. 22,

1987, 101 Stat. 1330-61.

(5) An organization having a risk-sharing contract under this

section may (with the approval of the Secretary) provide that a

part of the value of additional benefits otherwise required to be

provided by reason of paragraph (2) be withheld and reserved in the

Federal Hospital Insurance Trust Fund and in the Federal

Supplementary Medical Insurance Trust Fund (in such proportions as

the Secretary determines to be appropriate) by the Secretary for

subsequent annual contract periods, to the extent required to

stabilize and prevent undue fluctuations in the additional benefits

offered in those subsequent periods by the organization in

accordance with paragraph (3). Any of such value of additional

benefits which is not provided to members of the organization in

accordance with paragraph (3) prior to the end of such period,

shall revert for the use of such trust funds.

(6)(A) A risk-sharing contract under this section shall require

the eligible organization to provide prompt payment (consistent

with the provisions of sections 1395h(c)(2) and 1395u(c)(2) of this

title) of claims submitted for services and supplies furnished to

individuals pursuant to such contract, if the services or supplies

are not furnished under a contract between the organization and the

provider or supplier.

(B) In the case of an eligible organization which the Secretary

determines, after notice and opportunity for a hearing, has failed

to make payments of amounts in compliance with subparagraph (A),

the Secretary may provide for direct payment of the amounts owed to

providers and suppliers for such covered services furnished to

individuals enrolled under this section under the contract. If the

Secretary provides for such direct payments, the Secretary shall

provide for an appropriate reduction in the amount of payments

otherwise made to the organization under this section to reflect

the amount of the Secretary's payments (and costs incurred by the

Secretary in making such payments).

(h) Reasonable cost reimbursement contract; requirements

(1) If -

(A) the Secretary is not satisfied that an eligible

organization has the capacity to bear the risk of potential

losses under a risk-sharing contract under this section, or

(B) the eligible organization so elects or has an insufficient

number of members to be eligible to enter into a risk-sharing

contract under subsection (g)(1) of this section,

the Secretary may, if he is otherwise satisfied that the eligible

organization is able to perform its contractual obligations

effectively and efficiently, enter into a contract with such

organization pursuant to which such organization is reimbursed on

the basis of its reasonable cost (as defined in section 1395x(v) of

this title) in the manner prescribed in paragraph (3).

(2) A reasonable cost reimbursement contract under this

subsection may, at the option of such organization, provide that

the Secretary -

(A) will reimburse hospitals and skilled nursing facilities

either for the reasonable cost (as determined under section

1395x(v) of this title) or for payment amounts determined in

accordance with section 1395ww of this title, as applicable, of

services furnished to individuals enrolled with such organization

pursuant to subsection (d) of this section, and

(B) will deduct the amount of such reimbursement from payment

which would otherwise be made to such organization.

If such an eligible organization pays a hospital or skilled nursing

facility directly, the amount paid shall not exceed the reasonable

cost of the services (as determined under section 1395x(v) of this

title) or the amount determined under section 1395ww of this title,

as applicable, unless such organization demonstrates to the

satisfaction of the Secretary that such excess payments are

justified on the basis of advantages gained by the organization.

(3) Payments made to an organization with a reasonable cost

reimbursement contract shall be subject to appropriate retroactive

corrective adjustment at the end of each contract year so as to

assure that such organization is paid for the reasonable cost

actually incurred (excluding any part of incurred cost found to be

unnecessary in the efficient delivery of health services) or the

amounts otherwise determined under section 1395ww of this title for

the types of expenses otherwise reimbursable under this subchapter

for providing services covered under this subchapter to individuals

described in subsection (a)(1) of this section.

(4) Any reasonable cost reimbursement contract with an eligible

organization under this subsection shall provide that the Secretary

shall require, at such time following the expiration of each

accounting period of the eligible organization (and in such form

and in such detail) as he may prescribe -

(A) that the organization report to him in an independently

certified financial statement its per capita incurred cost based

on the types of components of expenses otherwise reimbursable

under this subchapter for providing services described in

subsection (a)(1) of this section, including therein, in

accordance with accounting procedures prescribed by the

Secretary, its methods of allocating costs between individuals

enrolled under this section and other individuals enrolled with

such organization;

(B) that failure to report such information as may be required

may be deemed to constitute evidence of likely overpayment on the

basis of which appropriate collection action may be taken;

(C) that in any case in which an eligible organization is

related to another organization by common ownership or control, a

consolidated financial statement shall be filed and that the

allowable costs for such organization may not include costs for

the types of expense otherwise reimbursable under this

subchapter, in excess of those which would be determined to be

reasonable in accordance with regulations (providing for limiting

reimbursement to costs rather than charges to the eligible

organization by related organizations and owners) issued by the

Secretary; and

(D) that in any case in which compensation is paid by an

eligible organization substantially in excess of what is normally

paid for similar services by similar practitioners (regardless of

method of compensation), such compensation may as appropriate be

considered to constitute a distribution of profits.

(5)(A) After August 5, 1997, the Secretary may not enter into a

reasonable cost reimbursement contract under this subsection (if

the contract is not in effect as of August 5, 1997), except for a

contract with an eligible organization which, immediately previous

to entering into such contract, had an agreement in effect under

section 1395l(a)(1)(A) of this title.

(B) Subject to subparagraph (C), the Secretary shall approve an

application for a modification to a reasonable cost contract under

this section in order to expand the service area of such contract

if -

(i) such application is submitted to the Secretary on or before

September 1, 2003; and

(ii) the Secretary determines that the organization with the

contract continues to meet the requirements applicable to such

organizations and contracts under this section.

(C) The Secretary may not extend or renew a reasonable cost

reimbursement contract under this subsection for any period beyond

December 31, 2004.

(i) Duration, termination, effective date, and terms of contract;

powers and duties of Secretary

(1) Each contract under this section shall be for a term of at

least one year, as determined by the Secretary, and may be made

automatically renewable from term to term in the absence of notice

by either party of intention to terminate at the end of the current

term; except that in accordance with procedures established under

paragraph (9), the Secretary may at any time terminate any such

contract or may impose the intermediate sanctions described in

paragraph (6)(B) or (6)(C) (whichever is applicable) on the

eligible organization if the Secretary determines that the

organization -

(A) has failed substantially to carry out the contract;

(B) is carrying out the contract in a manner substantially

inconsistent with the efficient and effective administration of

this section; or

(C) no longer substantially meets the applicable conditions of

subsections (b), (c), (e), and (f) of this section.

(2) The effective date of any contract executed pursuant to this

section shall be specified in the contract.

(3) Each contract under this section -

(A) shall provide that the Secretary, or any person or

organization designated by him -

(i) shall have the right to inspect or otherwise evaluate (I)

the quality, appropriateness, and timeliness of services

performed under the contract and (II) the facilities of the

organization when there is reasonable evidence of some need for

such inspection, and

(ii) shall have the right to audit and inspect any books and

records of the eligible organization that pertain (I) to the

ability of the organization to bear the risk of potential

financial losses, or (II) to services performed or

determinations of amounts payable under the contract;

(B) shall require the organization with a risk-sharing contract

to provide (and pay for) written notice in advance of the

contract's termination, as well as a description of alternatives

for obtaining benefits under this subchapter, to each individual

enrolled under this section with the organization; and

(C)(i) shall require the organization to comply with

subsections (a) and (c) of section 300e-17 of this title

(relating to disclosure of certain financial information) and

with the requirement of section 300e(c)(8) (!3) of this title

(relating to liability arrangements to protect members);

(ii) shall require the organization to provide and supply

information (described in section 1395cc(b)(2)(C)(ii) of this

title) in the manner such information is required to be provided

or supplied under that section;

(iii) shall require the organization to notify the Secretary of

loans and other special financial arrangements which are made

between the organization and subcontractors, affiliates, and

related parties; and

(D) shall contain such other terms and conditions not

inconsistent with this section (including requiring the

organization to provide the Secretary with such information) as

the Secretary may find necessary and appropriate.

(4) The Secretary may not enter into a risk-sharing contract with

an eligible organization if a previous risk-sharing contract with

that organization under this section was terminated at the request

of the organization within the preceding five-year period, except

in circumstances which warrant special consideration, as determined

by the Secretary.

(5) The authority vested in the Secretary by this section may be

performed without regard to such provisions of law or regulations

relating to the making, performance, amendment, or modification of

contracts of the United States as the Secretary may determine to be

inconsistent with the furtherance of the purpose of this

subchapter.

(6)(A) If the Secretary determines that an eligible organization

with a contract under this section -

(i) fails substantially to provide medically necessary items

and services that are required (under law or under the contract)

to be provided to an individual covered under the contract, if

the failure has adversely affected (or has substantial likelihood

of adversely affecting) the individual;

(ii) imposes premiums on individuals enrolled under this

section in excess of the premiums permitted;

(iii) acts to expel or to refuse to re-enroll an individual in

violation of the provisions of this section;

(iv) engages in any practice that would reasonably be expected

to have the effect of denying or discouraging enrollment (except

as permitted by this section) by eligible individuals with the

organization whose medical condition or history indicates a need

for substantial future medical services;

(v) misrepresents or falsifies information that is furnished -

(I) to the Secretary under this section, or

(II) to an individual or to any other entity under this

section;

(vi) fails to comply with the requirements of subsection

(g)(6)(A) of this section or paragraph (8); or

(vii) in the case of a risk-sharing contract, employs or

contracts with any individual or entity that is excluded from

participation under this subchapter under section 1320a-7 or

1320a-7a of this title for the provision of health care,

utilization review, medical social work, or administrative

services or employs or contracts with any entity for the

provision (directly or indirectly) through such an excluded

individual or entity of such services;

the Secretary may provide, in addition to any other remedies

authorized by law, for any of the remedies described in

subparagraph (B).

(B) The remedies described in this subparagraph are -

(i) civil money penalties of not more than $25,000 for each

determination under subparagraph (A) or, with respect to a

determination under clause (iv) or (v)(I) of such subparagraph,

of not more than $100,000 for each such determination, plus, with

respect to a determination under subparagraph (A)(ii), double the

excess amount charged in violation of such subparagraph (and the

excess amount charged shall be deducted from the penalty and

returned to the individual concerned), and plus, with respect to

a determination under subparagraph (A)(iv), $15,000 for each

individual not enrolled as a result of the practice involved,

(ii) suspension of enrollment of individuals under this section

after the date the Secretary notifies the organization of a

determination under subparagraph (A) and until the Secretary is

satisfied that the basis for such determination has been

corrected and is not likely to recur, or

(iii) suspension of payment to the organization under this

section for individuals enrolled after the date the Secretary

notifies the organization of a determination under subparagraph

(A) and until the Secretary is satisfied that the basis for such

determination has been corrected and is not likely to recur.

(C) In the case of an eligible organization for which the

Secretary makes a determination under paragraph (1), the basis of

which is not described in subparagraph (A), the Secretary may apply

the following intermediate sanctions:

(i) Civil money penalties of not more than $25,000 for each

determination under paragraph (1) if the deficiency that is the

basis of the determination has directly adversely affected (or

has the substantial likelihood of adversely affecting) an

individual covered under the organization's contract.

(ii) Civil money penalties of not more than $10,000 for each

week beginning after the initiation of procedures by the

Secretary under paragraph (9) during which the deficiency that is

the basis of a determination under paragraph (1) exists.

(iii) Suspension of enrollment of individuals under this

section after the date the Secretary notifies the organization of

a determination under paragraph (1) and until the Secretary is

satisfied that the deficiency that is the basis for the

determination has been corrected and is not likely to recur.

(D) The provisions of section 1320a-7a of this title (other than

subsections (a) and (b)) shall apply to a civil money penalty under

subparagraph (B)(i) or (C)(i) in the same manner as such provisions

apply to a civil money penalty or proceeding under section

1320a-7a(a) of this title.

(7)(A) Each risk-sharing contract with an eligible organization

under this section shall provide that the organization will

maintain a written agreement with a utilization and quality control

peer review organization (which has a contract with the Secretary

under part B of subchapter XI of this chapter for the area in which

the eligible organization is located) or with an entity selected by

the Secretary under section 1320c-3(a)(4)(C) of this title under

which the review organization will perform functions under section

1320c-3(a)(4)(B) of this title and section 1320c-3(a)(14) of this

title (other than those performed under contracts described in

section 1395cc(a)(1)(F) of this title) with respect to services,

furnished by the eligible organization, for which payment may be

made under this subchapter.

(B) For purposes of payment under this subchapter, the cost of

such agreement to the eligible organization shall be considered a

cost incurred by a provider of services in providing covered

services under this subchapter and shall be paid directly by the

Secretary to the review organization on behalf of such eligible

organization in accordance with a schedule established by the

Secretary.

(C) Such payments -

(i) shall be transferred in appropriate proportions from the

Federal Hospital Insurance Trust Fund and from the Supplementary

Medical Insurance Trust Fund, without regard to amounts

appropriated in advance in appropriation Acts, in the same manner

as transfers are made for payment for services provided directly

to beneficiaries, and

(ii) shall not be less in the aggregate for such organizations

for a fiscal year than the amounts the Secretary determines to be

sufficient to cover the costs of such organizations' conducting

activities described in subparagraph (A) with respect to such

eligible organizations under part B of subchapter XI of this

chapter.

(8)(A) Each contract with an eligible organization under this

section shall provide that the organization may not operate any

physician incentive plan (as defined in subparagraph (B)) unless

the following requirements are met:

(i) No specific payment is made directly or indirectly under

the plan to a physician or physician group as an inducement to

reduce or limit medically necessary services provided with

respect to a specific individual enrolled with the organization.

(ii) If the plan places a physician or physician group at

substantial financial risk (as determined by the Secretary) for

services not provided by the physician or physician group, the

organization -

(I) provides stop-loss protection for the physician or group

that is adequate and appropriate, based on standards developed

by the Secretary that take into account the number of

physicians placed at such substantial financial risk in the

group or under the plan and the number of individuals enrolled

with the organization who receive services from the physician

or the physician group, and

(II) conducts periodic surveys of both individuals enrolled

and individuals previously enrolled with the organization to

determine the degree of access of such individuals to services

provided by the organization and satisfaction with the quality

of such services.

(iii) The organization provides the Secretary with descriptive

information regarding the plan, sufficient to permit the

Secretary to determine whether the plan is in compliance with the

requirements of this subparagraph.

(B) In this paragraph, the term "physician incentive plan" means

any compensation arrangement between an eligible organization and a

physician or physician group that may directly or indirectly have

the effect of reducing or limiting services provided with respect

to individuals enrolled with the organization.

(9) The Secretary may terminate a contract with an eligible

organization under this section or may impose the intermediate

sanctions described in paragraph (6) on the organization in

accordance with formal investigation and compliance procedures

established by the Secretary under which -

(A) the Secretary first provides the organization with the

reasonable opportunity to develop and implement a corrective

action plan to correct the deficiencies that were the basis of

the Secretary's determination under paragraph (1) and the

organization fails to develop or implement such a plan;

(B) in deciding whether to impose sanctions, the Secretary

considers aggravating factors such as whether an organization has

a history of deficiencies or has not taken action to correct

deficiencies the Secretary has brought to the organization's

attention;

(C) there are no unreasonable or unnecessary delays between the

finding of a deficiency and the imposition of sanctions; and

(D) the Secretary provides the organization with reasonable

notice and opportunity for hearing (including the right to appeal

an initial decision) before imposing any sanction or terminating

the contract.

(j) Payment in full and limitation on actual charges; physicians,

providers of services, or renal dialysis facilities not under

contract with organization

(1)(A) In the case of physicians' services or renal dialysis

services described in paragraph (2) which are furnished by a

participating physician or provider of services or renal dialysis

facility to an individual enrolled with an eligible organization

under this section and enrolled under part B of this subchapter,

the applicable participation agreement is deemed to provide that

the physician or provider of services or renal dialysis facility

will accept as payment in full from the eligible organization the

amount that would be payable to the physician or provider of

services or renal dialysis facility under part B of this subchapter

and from the individual under such part, if the individual were not

enrolled with an eligible organization under this section.

(B) In the case of physicians' services described in paragraph

(2) which are furnished by a nonparticipating physician, the

limitations on actual charges for such services otherwise

applicable under part B of this subchapter (to services furnished

by individuals not enrolled with an eligible organization under

this section) shall apply in the same manner as such limitations

apply to services furnished to individuals not enrolled with such

an organization.

(2) The physicians' services or renal dialysis services described

in this paragraph are physicians' services or renal dialysis

services which are furnished to an enrollee of an eligible

organization under this setion (!4) by a physician, provider of

services, or renal dialysis facility who is not under a contract

with the organization.

(k) Risk-sharing contracts

(1) Except as provided in paragraph (2) -

(A) on or after the date standards for Medicare+Choice

organizations and plans are first established under section

1395w-26(b)(1) of this title, the Secretary shall not enter into

any risk-sharing contract under this section with an eligible

organization; and

(B) for any contract year beginning on or after January 1,

1999, the Secretary shall not renew any such contract.

(2) An individual who is enrolled in part B of this subchapter

only and is enrolled in an eligible organization with a

risk-sharing contract under this section on December 31, 1998, may

continue enrollment in such organization in accordance with

regulations described in section 1395w-26(b)(1) of this title.

(3) Notwithstanding subsection (a) of this section, the Secretary

shall provide that payment amounts under risk-sharing contracts

under this section for months in a year (beginning with January

1998) shall be computed -

(A) with respect to individuals entitled to benefits under both

parts A and B of this subchapter, by substituting payment rates

under section 1395w-23(a) of this title for the payment rates

otherwise established under subsection (a) of this section, and

(B) with respect to individuals only entitled to benefits under

part B of this subchapter, by substituting an appropriate

proportion of such rates (reflecting the relative proportion of

payments under this subchapter attributable to such part) for the

payment rates otherwise established under subsection (a) of this

section.

(4) The following requirements shall apply to eligible

organizations with risk-sharing contracts under this section in the

same manner as they apply to Medicare+Choice organizations under

part C of this subchapter:

(A) Data collection requirements under section

1395w-23(a)(3)(B) of this title.

(B) Restrictions on imposition of premium taxes under section

1395w-24(g) of this title in relating to payments to such

organizations under this section.

(C) The requirement to accept enrollment of new enrollees

during November 1998 under section 1395w-21(e)(6) of this title.

(D) Payments under section 1395w-27(e)(2) of this title.

-SOURCE-

(Aug. 14, 1935, ch. 531, title XVIII, Sec. 1876, as added and

amended Pub. L. 92-603, title II, Secs. 226(a), 278(b)(3), Oct. 30,

1972, 86 Stat. 1396, 1453; Pub. L. 93-233, Sec. 18(m), (n), Dec.

31, 1973, 87 Stat. 970, 971; Pub. L. 94-460, title II, Sec.

201(a)-(d), Oct. 8, 1976, 90 Stat. 1956, 1957; Pub. L. 95-292, Sec.

5, June 13, 1978, 92 Stat. 315; Pub. L. 97-248, title I, Sec.

114(a), Sept. 3, 1982, 96 Stat. 341; Pub. L. 97-448, title III,

Sec. 309(b)(12), Jan. 12, 1983, 96 Stat. 2409; Pub. L. 98-21, title

VI, Secs. 602(g), 606(a)(3)(H), Apr. 20, 1983, 97 Stat. 164, 171;

Pub. L. 98-369, div. B, title III, Secs. 2350(a)(1), (b)(1), (2),

(c), 2354(b)(37), (38), July 18, 1984, 98 Stat. 1097, 1098, 1102;

Pub. L. 99-272, title IX, Sec. 9211(a)-(d), Apr. 7, 1986, 100 Stat.

178, 179; Pub. L. 99-509, title IX, Secs. 9312(b)(1), (c)(1), (2),

(d)(1), (e)(1), (f), 9353(e)(2), Oct. 21, 1986, 100 Stat.

1999-2001, 2048; Pub. L. 99-514, title XVIII, Sec. 1895(b)(11)(A),

Oct. 22, 1986, 100 Stat. 2934; Pub. L. 100-203, title IV, Secs.

4011(a)(1), (b)(1), 4012(b), 4013(a), 4014, 4018(a), 4039(h)(8),

Dec. 22, 1987, 101 Stat. 1330-60, 1330-61, 1330-65, as amended Pub.

L. 100-360, title IV, Sec. 411(c)(3), (e)(3), July 1, 1988, 102

Stat. 773, 776; Pub. L. 100-360, title II, Secs. 202(f), 211(c)(3),

224, title IV, Sec. 411(c)(1), (4), (6), formerly (5), July 1,

1988, 102 Stat. 717, 738, 748, 772, 773, as amended Pub. L.

100-485, title VI, Sec. 608(d)(19)(B), (C), Oct. 13, 1988, 102

Stat. 2419; Pub. L. 100-647, title VIII, Sec. 8412(a)(1), Nov. 10,

1988, 102 Stat. 3801; Pub. L. 101-234, title II, Secs. 201(a),

202(a), Dec. 13, 1989, 103 Stat. 1981; Pub. L. 101-239, title VI,

Secs. 6206(a)(1), (b)(1), 6212(b)(1), (c)(2), 6411(d)(3)(A), Dec.

19, 1989, 103 Stat. 2244, 2250, 2271; Pub. L. 101-508, title IV,

Secs. 4204(a)(1), (2), (c)(1), (2), (d)(1), (e)(1), 4206(b)(1),

Nov. 5, 1990, 104 Stat. 1388-108 to 1388-111, 1388-116; Pub. L.

103-296, title I, Sec. 108(c)(6), Aug. 15, 1994, 108 Stat. 1486;

Pub. L. 103-432, title I, Sec. 157(b)(1), (4), Oct. 31, 1994, 108

Stat. 4442; Pub. L. 104-191, title II, Secs. 215(a), (b), 231(g),

Aug. 21, 1996, 110 Stat. 2005-2007, 2014; Pub. L. 105-33, title IV,

Sec. 4002(a)-(b)(2)(A), Aug. 5, 1997, 111 Stat. 328, 329; Pub. L.

106-113, div. B, 1000(a)(6) [title V, Sec. 503], Nov. 29, 1999, 113

Stat. 1536, 1501A-380; Pub. L. 106-554, Sec. 1(a)(6) [title VI,

Sec. 634], Dec. 21, 2000, 114 Stat. 2763, 2763A-568.)

-REFTEXT-

REFERENCES IN TEXT

Parts A and B of this subchapter, referred to in text, are

classified to sections 1395c et seq. and 1395j et seq.,

respectively, of this title.

Section 300e-9(d) of this title, referred to in subsec. (b)(1),

was redesignated section 300e-9(c) of this title by Pub. L.

100-517, Sec. 7(b), Oct. 24, 1988, 102 Stat. 2580.

Parts A and B of subchapter XI of this chapter, referred to in

subsecs. (c)(2) and (i)(7)(A), (B)(ii), are classified to sections

1301 et seq. and 1320c et seq., respectively, of this title.

Section 300e(c)(8) of this title, referred to in subsec.

(i)(3)(C)(i), was redesignated section 300e(c)(7) of this title by

Pub. L. 100-517, Sec. 5(b), Oct. 24, 1988, 102 Stat. 2579.

Part C of this subchapter, referred to in subsec. (k)(4), is

classified to section 1395w-21 et seq. of this title.

-MISC1-

AMENDMENTS

2000 - Subsec. (h)(5)(B), (C). Pub. L. 106-554 added subpar. (B)

and redesignated former subpar. (B) as (C).

1999 - Subsec. (h)(5)(B). Pub. L. 106-113 substituted "2004" for

"2002".

1997 - Subsec. (f)(1). Pub. L. 105-33, Sec. 4002(a)(1),

substituted "For contract periods beginning before January 1, 1999,

each" for "Each" and struck out "or under a State plan approved

under subchapter XIX of this chapter" before period at end.

Subsec. (f)(2). Pub. L. 105-33, Sec. 4002(a)(2), substituted

"Subject to paragraph (4), the Secretary" for "The Secretary".

Subsec. (f)(4). Pub. L. 105-33, Sec. 4002(a)(3), added par. (4).

Subsec. (h)(5). Pub. L. 105-33, Sec. 4002(b)(2)(A), added par.

(5).

Subsec. (k). Pub. L. 105-33, Sec. 4002(b)(1), added subsec. (k).

1996 - Subsec. (i)(1). Pub. L. 104-191, Sec. 215(a)(1),

substituted "in accordance with procedures established under

paragraph (9), the Secretary may at any time terminate any such

contract or may impose the intermediate sanctions described in

paragraph (6)(B) or (6)(C) (whichever is applicable) on the

eligible organization if the Secretary determines that the

organization - " for "the Secretary may terminate any such contract

at any time (after such reasonable notice and opportunity for

hearing to the eligible organization involved as he may provide in

regulations), if he finds that the organization - " in introductory

provisions, added subpars. (A) to (C), and struck out former

subpars. (A) to (C) which read as follows:

"(A) has failed substantially to carry out the contract,

"(B) is carrying out the contract in a manner inconsistent with

the efficient and effective administration of this section, or

"(C) no longer substantially meets the applicable conditions of

subsections (b), (c), (e), and (f) of this section."

Subsec. (i)(6)(B). Pub. L. 104-191, Sec. 215(a)(4), struck out

concluding provisions which read as follows: "The provisions of

section 1320a-7a of this title (other than subsections (a) and (b))

shall apply to a civil money penalty under clause (i) in the same

manner as they apply to a civil money penalty or proceeding under

section 1320a-7a(a) of this title."

Subsec. (i)(6)(C). Pub. L. 104-191, Sec. 215(a)(2), added subpar.

(C).

Subsec. (i)(6)(D). Pub. L. 104-191, Sec. 231(g), added subpar.

(D).

Subsec. (i)(7)(A). Pub. L. 104-191, Sec. 215(b), substituted "a

written agreement" for "an agreement".

Subsec. (i)(9). Pub. L. 104-191, Sec. 215(a)(3), added par. (9).

1994 - Subsec. (a)(1)(E)(ii)(I). Pub. L. 103-432, Sec. 157(b)(4),

struck out comma after "contributed to".

Subsec. (a)(3). Pub. L. 103-432, Sec. 157(b)(1), substituted

"subsections (c)(2)(B)(ii) and (c)(7) of this section" for

"subsection (c)(7) of this section".

Subsec. (c)(5)(B). Pub. L. 103-296 inserted at end "In applying

sections 405(b) and 405(g) of this title as provided in this

subparagraph, and in applying section 405(l) of this title thereto,

any reference therein to the Commissioner of Social Security or the

Social Security Administration shall be considered a reference to

the Secretary or the Department of Health and Human Services,

respectively."

1990 - Subsec. (a)(1)(E). Pub. L. 101-508, Sec. 4204(e)(1),

designated existing provisions as cl. (i) and added cl. (ii).

Subsec. (a)(6). Pub. L. 101-508, Sec. 4204(c)(2), substituted

"subsections (c)(2)(B)(ii) and (c)(7)" for "subsection (c)(7)".

Subsec. (c)(2). Pub. L. 101-508, Sec. 4204(c)(1), designated

existing provisions as subpar. (A), redesignated former subpars.

(A) and (B) and former cls. (i) and (ii) as cls. (i) and (ii) and

subcls. (I) and (II), respectively, and added subpar. (B).

Subsec. (c)(8). Pub. L. 101-508, Sec. 4206(b)(1), added par. (8).

Subsec. (i)(6)(A)(vi). Pub. L. 101-508, Sec. 4204(a)(2), inserted

"or paragraph (8)" after "(g)(6)(A) of this section".

Subsec. (i)(8). Pub. L. 101-508, Sec. 4204(a)(1), added par. (8).

Subsec. (j)(1)(A). Pub. L. 101-508, Sec. 4204(d)(1)(A),

substituted "physicians' services or renal dialysis services" for

"physicians' services", "physician or provider of services or renal

dialysis facility" for "physician" in three places, and "applicable

participation agreement" for "participation agreement under section

1395u(h)(1) of this title".

Subsec. (j)(2). Pub. L. 101-508, Sec. 4204(d)(1)(B), substituted

"physicians' services or renal dialysis services" for "physicians'

services" in two places and "which are furnished to an enrollee of

an eligible organization under this setion [sic] by a physician,

provider of services, or renal dialysis facility who is not under a

contract with the organization." for "which - " and subpars. (A)

and (B) which read as follows:

"(A) are emergency services or out-of-area coverage (described

in clauses (iii) and (iv) of subsection (b)(2)(A) of this

section), and

"(B) are furnished to an enrollee of an eligible organization

under this section by a person who is not under a contract with

the organization."

1989 - Subsec. (a)(1)(F). Pub. L. 101-239, Sec. 6206(a)(1), added

subpar. (F).

Subsec. (a)(5). Pub. L. 101-234, Sec. 202(a), repealed Pub. L.

100-360, Sec. 211(c)(3)(A), and provided that the provisions of law

amended or repealed by such section are restored or revised as if

such section had not been enacted, see 1988 Amendment note below.

Subsec. (c)(3)(A)(i). Pub. L. 101-239, Sec. 6206(b)(1)(A),

substituted "period or periods" for "30-day period".

Subsec. (c)(3)(A)(ii). Pub. L. 101-239, Sec. 6206(b)(1)(B), added

cl. (ii) and struck out former cl. (ii) which read as follows: "For

each area served by more than one eligible organization under this

section, the Secretary (after consultation with such organizations)

shall establish a single 30-day period each year during which all

eligible organizations serving the area must provide for open

enrollment under this section. The Secretary shall determine annual

per capita rates under subsection (a)(1)(A) of this section in a

manner that assures that individuals enrolling during such a 30-day

period will not have premium charges increased or any additional

benefits decreased for 12 months beginning on the date the

individual's enrollment becomes effective. An eligible organization

may provide for such other open enrollment period or periods as it

deems appropriate consistent with this section."

Subsecs. (e)(1), (g)(3)(A). Pub. L. 101-234, Sec. 201(a),

repealed Pub. L. 100-360, Sec. 202(f), and provided that the

provisions of law amended or repealed by such section are restored

or revived as if such section had not been enacted, see 1988

Amendment notes below.

Subsec. (g)(5). Pub. L. 101-239, Sec. 6212(c)(2), struck out "and

during a period of not longer than four years" after first

reference to "Secretary".

Subsec. (i)(6)(A)(vii). Pub. L. 101-239, Sec. 6411(d)(3)(A),

added cl. (vii).

Subsec. (j). Pub. L. 101-239, Sec. 6212(b)(1), added subsec. (j).

1988 - Subsec. (a)(5). Pub. L. 100-360, Sec. 211(c)(3)(B),

amended second sentence generally. Prior to amendment, second

sentence read as follows: "The portion of that payment to the

organization for a month to be paid by the latter trust fund shall

be equal to 200 percent of the sum of -

"(A) the product of (i) the number of such individuals for the

month who have attained age 65, and (ii) the monthly actuarial

rate for supplementary medical insurance for the month as

determined under section 1395r(a)(1) of this title, and

"(B) the product of (i) the number of such individuals for the

month who have not attained age 65, and (ii) the monthly

actuarial rate for supplementary medical insurance for the month

as determined under section 1395r(a)(4) of this title."

Pub. L. 100-360, Sec. 211(c)(3)(A), substituted ", the Federal

Supplementary Medical Insurance Trust Fund, and the Federal

Catastrophic Drug Insurance Trust Fund" for "and the Federal

Supplementary Medical Insurance Trust Fund" in first sentence.

Subsec. (c)(3)(F). Pub. L. 100-360, Sec. 411(c)(1), realigned

margin with left margin of subpar. (G).

Subsec. (e)(1). Pub. L. 100-360, Sec. 202(f)(1), inserted at end

"The preceding sentence shall be applied separately with respect to

covered outpatient drugs."

Subsec. (f)(3). Pub. L. 100-647 redesignated par. (4) as (3) and

struck out former par. (3) which read as follows:

"(A) An eligible organization described in subparagraph (B) may

elect, for purposes of enrollment and residency requirements under

this section and for determining the compliance of a subdivision,

subsidiary, or affiliate described in subparagraph (B)(iii) with

the requirement of paragraph (1) for the period before October 1,

1992, to have members described in subparagraph (B)(iii) who

receive services through the subdivision, subsidiary, or affiliate

considered to be members of the parent organization.

"(B) An eligible organization described in this subparagraph is

an eligible organization which -

"(i) is described in section 1396b(m)(2)(B)(iii) of this title;

"(ii) has members who have a collectively bargained contractual

right to obtain health benefits from the organization;

"(iii) elects to provide benefits under a risk-sharing contract

to individuals residing in a service area, who have a

collectively bargained contractual right to obtain benefits from

the organization, through a subdivision, subsidiary, or affiliate

which itself is an eligible organization serving the area and

which is owned or controlled by the parent eligible organization;

and

"(iv) has assumed any risk of insolvency and quality assurance

with respect to individuals receiving benefits through such a

subdivision, subsidiary, or affiliate."

Subsec. (f)(3)(A). Pub. L. 100-360, Sec. 411(c)(6), formerly Sec.

411(c)(5), as redesignated by Pub. L. 100-485, Sec. 608(d)(19)(C),

inserted "enrollment and residency requirements under this section

and for" after "for purposes of" and substituted "described in

subparagraph (B)(iii) who receives services through the

subdivision" for "of the subdivision".

Subsec. (f)(4). Pub. L. 100-647 redesignated par. (4) as (3).

Subsec. (g)(3)(A). Pub. L. 100-360, Sec. 202(f)(2), substituted

"rates" for "rate".

Subsec. (g)(5). Pub. L. 100-360, Sec. 411(c)(3), amended Pub. L.

100-203, Sec. 4013, see 1987 Amendment note below.

Subsec. (i)(6)(A). Pub. L. 100-360, Sec. 411(c)(4)(A), inserted

", in addition to any other remedies authorized by law," after "the

Secretary may provide" in concluding provisions.

Subsec. (i)(6)(B). Pub. L. 100-360, Sec. 411(c)(4)(C), formerly

Sec. 411(c)(4)(B), as redesignated by Pub. L. 100-485, Sec.

608(d)(19)(B)(ii), substituted "or proceeding under section

1320a-7a(a) of this title" for "under that section" in last

sentence.

Subsec. (i)(6)(B)(i). Pub. L. 100-360, Sec. 411(c)(4)(B), as

added by Pub. L. 100-485, Sec. 608(d)(19)(B)(i), (iii), inserted

"of such subparagraph" after "(v)(I)".

Pub. L. 100-360, Sec. 224, inserted at end "plus, with respect to

a determination under subparagraph (A)(ii), double the excess

amount charged in violation of such subparagraph (and the excess

amount charged shall be deducted from the penalty and returned to

the individual concerned), and plus, with respect to a

determination under subparagraph (A)(iv), $15,000 for each

individual not enrolled as a result of the practice involved,".

Subsec. (i)(7)(A). Pub. L. 100-360, Sec. 411(e)(3), added Pub. L.

100-203, Sec. 4039(h)(8)(A), (B), see 1987 Amendment note below.

Subsec. (i)(7)(B). Pub. L. 100-360, Sec. 411(e)(3), added Pub. L.

100-203, Sec. 4039(h)(8)(C), see 1987 Amendment note below.

1987 - Subsec. (c)(3)(F). Pub. L. 100-203, Sec. 4011(a)(1), added

subpar. (F).

Subsec. (c)(3)(G). Pub. L. 100-203, Sec. 4011(b)(1), added

subpar. (G).

Subsec. (f)(3), (4). Pub. L. 100-203, Sec. 4018(a), added par.

(3) and redesignated former par. (3) as (4).

Subsec. (g)(4). Pub. L. 100-203, Sec. 4012(b), struck out par.

(4) which read as follows: "A risk-sharing contract under this

subsection may, at the option of an eligible organization, provide

that the Secretary -

"(A) will reimburse hospitals and skilled nursing facilities

either for payment amounts determined in accordance with section

1395ww of this title, or, if applicable, for the reasonable cost

(as determined under section 1395x(v) of this title) or other

appropriate basis for payment established under this subchapter,

of inpatient services furnished to individuals enrolled with such

organization pursuant to subsection (d) of this section, and

"(B) will deduct the amount of such reimbursement for payment

which would otherwise be made to such organization."

Subsec. (g)(5). Pub. L. 100-203, Sec. 4013, which directed

amendment of par. (5) by substituting "six years" for "four years",

was amended generally by Pub. L. 100-360, Sec. 411(c)(3), so that

it does not amend this section.

Subsec. (i)(6). Pub. L. 100-203, Sec. 4014, amended par. (6)

generally. Prior to amendment, par. (6) read as follows:

"(6)(A) Any eligible organization with a risk-sharing contract

under this section that fails substantially to provide medically

necessary items and services that are required (under law or such

contract) to be provided to individuals covered under such

contract, if the failure has adversely affected (or has a

substantial likelihood of adversely affecting) these individuals,

is subject to a civil money penalty of not more than $10,000 for

each such failure.

"(B) The provisions of section 1320a-7a of this title (other than

subsection (a)) shall apply to a civil money penalty under

subparagraph (A) in the same manner as they apply to a civil money

penalty under that section."

Subsec. (i)(7)(A). Pub. L. 100-203, Sec. 4039(h)(8)(A), (B), as

added by Pub. L. 100-360, Sec. 411(e)(3), substituted "Each" for

"Except as provided under section 1320c-3(a)(4)(C) of this title,

each", inserted "or with an entity selected by the Secretary under

section 1320c-3(a)(4)(C) of this title" after "located)", and

substituted "which the review organization" for "which the peer

review organization".

Subsec. (i)(7)(B). Pub. L. 100-203, Sec. 4039(h)(8)(C), as added

by Pub. L. 100-360, Sec. 411(e)(3), substituted "the review

organization" for "the peer review organization".

1986 - Subsec. (a)(1)(A). Pub. L. 99-514 substituted "announce

(in a manner intended to provide notice to interested parties)" for

"publish" in introductory provisions.

Pub. L. 99-272, Sec. 9211(d), inserted ", and shall publish not

later than September 7 before the calendar year concerned" after

"The Secretary shall annually determine" in introductory

provisions.

Subsec. (a)(3). Pub. L. 99-272, Sec. 9211(a)(2), substituted

"Subject to subsection (c)(7) of this section, payments" for

"Payments".

Subsec. (a)(6). Pub. L. 99-272, Sec. 9211(a)(3), substituted

"Subject to subsection (c)(7) of this section, if" for "If".

Subsec. (c)(3)(B). Pub. L. 99-272, Sec. 9211(b), substituted "the

date on which" for "a full calendar month after", and inserted

provision at end that in the case of an individual's termination of

enrollment, the organization shall provide the individual with a

copy of the written request for termination of enrollment and a

written explanation of the period (ending on the effective date of

the termination) during which the individual continues to be

enrolled with the organization and may not receive benefits under

this subchapter other than through the organization.

Subsec. (c)(3)(C). Pub. L. 99-272, Sec. 9211(c), inserted

provisions at end that no brochures, application forms, or other

promotional or informational material may be distributed by an

organization to (or for the use of) individuals eligible to enroll

with the organization under this section unless at least 45 days

before its distribution, the organization has submitted the

material to the Secretary for review and the Secretary has not

disapproved the distribution of the material, and that Secretary

shall review all such material submitted and shall disapprove such

material if the Secretary determines, in the Secretary's

discretion, that the material is materially inaccurate or

misleading or otherwise makes a material misrepresentation.

Subsec. (c)(7). Pub. L. 99-272, Sec. 9211(a)(1), added par. (7).

Subsec. (c)(3)(E). Pub. L. 99-509, Sec. 9312(b)(1), added subpar.

(E).

Subsec. (f)(2). Pub. L. 99-509, Sec. 9312(c)(1), struck out "if

the Secretary determines that" after "imposed by paragraph (1)

only", added new subpars. (A) and (B), and struck out former

subpars. (A) and (B) which read as follows:

"(A) special circumstances warrant such modification or waiver,

and

"(B) the eligible organization has taken and is making reasonable

efforts to enroll individuals who are not entitled to benefits

under this subchapter or under a State plan approved under

subchapter XIX of this chapter."

Subsec. (f)(3). Pub. L. 99-509, Sec. 9312(c)(2)(A), added par.

(3).

Subsec. (g)(6). Pub. L. 99-509, Sec. 9312(d)(1), added par. (6).

Subsec. (i)(1)(C). Pub. L. 99-509, Sec. 9312(c)(3)(B),

substituted "(e), and (f)" for "and (e)".

Subsec. (i)(3)(C). Pub. L. 99-509, Sec. 9312(e)(1), designated

existing provisions as cl. (i) and added cls. (ii) and (iii).

Subsec. (i)(6). Pub. L. 99-509, Sec. 9312(f), added par. (6).

Subsec. (i)(7). Pub. L. 99-509, Sec. 9353(e)(2), added par. (7).

1984 - Subsec. (b)(2)(D). Pub. L. 98-369, Sec. 2354(b)(37),

substituted "subparagraph (A)" for "paragraph (1)".

Subsec. (c)(3)(A). Pub. L. 98-369, Sec. 2350(a)(1), designated

existing provisions as cl. (i), inserted "and including the 30-day

period specified under clause (ii)" after "30 days duration every

year", and added cl. (ii).

Subsec. (c)(4)(A)(i). Pub. L. 98-369, Sec. 2354(b)(38),

substituted "with reasonable promptness" for "promptly as

appropriate".

Subsec. (g)(2). Pub. L. 98-369, Sec. 2350(b)(1), inserted "and

except that an organization (with the approval of the Secretary)

may provide that a part of the value of such additional benefits be

withheld and reserved by the Secretary as provided in paragraph

(5)" at end of first sentence.

Subsec. (g)(4)(A). Pub. L. 98-369, Sec. 2350(c), inserted "and

skilled nursing facilities" after "hospitals", inserted "or the

appropriate basis for payment established under this subchapter"

after "section 1395x(v) of this title)", and struck out "hospital"

before "services furnished to individuals".

Subsec. (g)(5). Pub. L. 98-369, Sec. 2350(b)(2), added par. (5).

1983 - Subsec. (a)(5)(A)(ii), (B)(ii). Pub. L. 98-21, Sec.

606(a)(3)(H), substituted "1395r(a)(1)" for "1395r(c)(1)".

Subsec. (g)(1). Pub. L. 97-448 substituted "subsection (b)" for

"subsection (b)(1)".

Subsec. (g)(4). Pub. L. 98-21, Sec. 602(g), added par. (4).

1982 - Pub. L. 97-248 completely revised section, expanding its

coverage to permit payments to both health maintenance

organizations and competitive medical plans.

1978 - Subsec. (b)(2)(B). Pub. L. 95-292 substituted

"Administrator of the Health Care Financing Administration" for

"Commissioner of Social Security".

1976 - Subsec. (b). Pub. L. 94-460, Sec. 201(a), struck out

provisions defining a health maintenance organization as a public

or private organization which provides physicians' services and a

sufficient number of primary care and specialty care physicians,

assures its members access to qualified practitioners in

specialties available in area served by such organization,

demonstrates financial responsibility and means to provide

comprehensive health care services, has at least half of its

enrolled members under age 65, assures prompt and qualified health

service, and has an open enrollment period at least every year, and

revised the definition and requirements of an health maintenance

organization to conform to those set forth in the Public Health

Service Act, except that the services which such an organization

must provide are those covered in parts A and B of this subchapter

rather than the basic health services defined in the Public Health

Service Act, and inserted provisions requiring Secretary to

administer determinations of whether an organization is a health

maintenance organization through and in the office of the Assistant

Secretary for Health, to integrate the administration of such

functions and duties with the administration of provisions

requiring the continued regulation of health maintenance

organizations under the Public Health Service Act, and to

administer other provisions of this section through the

Commissioner of Social Security.

Subsec. (h). Pub. L. 94-460, Sec. 201(b), substituted provisions

that each health maintenance organization with which the Secretary

enters into a contract under this section have an enrolled

membership at least half of which consists of individuals who have

not attained age 65, with the Secretary empowered to waive that

requirement for a period of not more than three years from the date

a health maintenance organization first enters into an agreement

with the Secretary pursuant to subsection (i) of this section for

provisions that such requirement not apply with respect to any

health maintenance organization for such period not to exceed three

years from the date such organization enters into an agreement with

the Secretary pursuant to subsection (i) of this section, as the

Secretary might permit.

Subsec. (i)(6)(B). Pub. L. 94-460, Sec. 201(c), substituted

"(other than costs with respect to out-of-area services and, in the

case of an organization which has entered into a risk-sharing

contract with the Secretary pursuant to paragraph (2)(A), the cost

of providing any member with basic health services the aggregate

value of which exceeds $5,000 in any year)" for "(Other than those

with respect to out-of-area services)".

Subsec. (k). Pub. L. 94-460, Sec. 201(d), added subsec. (k).

1973 - Subsec. (a)(3)(A)(ii). Pub. L. 93-233, Sec. 18(m), struck

out ", with the apportionment of savings being proportional to the

losses absorbed and not yet offset" at end.

Subsec. (g)(2). Pub. L. 93-233, Sec. 18(n), substituted "portion

of its premium rate or other charges" for "portion" and "shall not

exceed" for "may not exceed", and struck out cl. (i) designation

preceding "the actuarial value" and provisions reading "less (ii)

the actuarial value of other charges made in lieu of such

deductible and coinsurance", respectively.

1972 - Subsec. (i). Pub. L. 92-603, Sec. 278(b)(3), substituted

"skilled nursing facility" for "extended care facility" and

"skilled nursing facilities" for "extended care facilities".

EFFECTIVE DATE OF 1996 AMENDMENT

Section 215(c) of Pub. L. 104-191 provided that: "The amendments

made by this section [amending this section] shall apply with

respect to contract years beginning on or after January 1, 1997."

Amendment by section 231(g) of Pub. L. 104-191 applicable to acts

or omissions occurring on or after Jan. 1, 1997, see section 231(i)

of Pub. L. 104-191, set out as a note under section 1320a-7a of

this title.

EFFECTIVE DATE OF 1994 AMENDMENTS

Amendment by Pub. L. 103-432 effective as if included in the

enactment of Pub. L. 101-508, see section 157(b)(8) of Pub. L.

103-432, set out as a note under section 1395y of this title.

Amendment by Pub. L. 103-296 effective Mar. 31, 1995, see section

110(a) of Pub. L. 103-296, set out as a note under section 401 of

this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Section 4204(a)(4) of Pub. L. 101-508 provided that: "The

amendments made by paragraphs (1) and (2) [amending this section]

shall apply with respect to contract years beginning on or after

January 1, 1992, and the amendments made by paragraph (3) [amending

section 1320a-7a of this title] shall take effect on the date of

the enactment of this Act [Nov. 5, 1990]."

Section 4204(c)(3) of Pub. L. 101-508, as amended by Pub. L.

103-432, title I, Sec. 157(b)(2), Oct. 31, 1994, 108 Stat. 4442,

provided that: "The amendments made by this subsection [amending

this section] shall apply with respect to national coverage

determinations that are not incorporated in the determination of

the per capita rate of payment for individuals enrolled for years

beginning with 1991 with an eligible organization which has entered

into a risk-sharing contract under section 1876 of the Social

Security Act [this section]."

Section 4204(d)(2) of Pub. L. 101-508, as amended by Pub. L.

103-432, title I, Sec. 157(b)(3), Oct. 31, 1994, 108 Stat. 4442,

provided that: "The amendments made by paragraph (1) [amending this

section] shall apply with respect to items and services furnished

on or after January 1, 1991."

Section 4204(e)(2) of Pub. L. 101-508, as amended by Pub. L.

103-432, title I, Sec. 157(b)(5), Oct. 31, 1994, 108 Stat. 4442,

provided that: "The amendments made by paragraph (1) [amending this

section] shall apply with respect to individuals enrolling with an

eligible organization under a health benefit plan operated,

sponsored, or contributed to, by the individual's employer or

former employer (or the employer or former employer of the

individual's spouse) on or after January 1, 1991."

Amendment by section 4206(b)(1) of Pub. L. 101-508 applicable to

contracts under this section and payments under section

1395l(a)(1)(A) of this title as of the first day of the first month

beginning more than 1 year after Nov. 5, 1990, see section

4206(e)(2) of Pub. L. 101-508, set out as a note under section

1395l of this title.

EFFECTIVE DATE OF 1989 AMENDMENTS

Section 6206(b)(2) of Pub. L. 101-239 provided that: "The

amendments made by paragraph (1) [amending this section] shall take

effect 60 days after the date of the enactment of this Act [Dec.

19, 1989]."

Section 6212(b)(2) of Pub. L. 101-239 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to services furnished on or after April 1, 1990."

Section 6212(c)(3) of Pub. L. 101-239 provided that: "The

amendments made by this subsection [amending this section and

repealing provisions set out as notes below] shall take effect on

the date of the enactment of this Act [Dec. 19, 1989]."

Section 6411(d)(4)(B) of Pub. L. 101-239 provided that: "The

amendments made by paragraph (3) [amending this section and section

1396a of this title] shall apply to employment and contracts as of

90 days after the date of the enactment of this Act [Dec. 19,

1989]."

Amendment by section 201(a) of Pub. L. 101-234 effective Jan. 1,

1990, see section 201(c) of Pub. L. 101-234, set out as a note

under section 1320a-7a of this title.

Amendment by section 202(a) of Pub. L. 101-234 effective Jan. 1,

1990, and applicable to premiums for months beginning after Dec.

31, 1989, see section 202(b) of Pub. L. 101-234, set out as a note

under section 401 of this title.

EFFECTIVE DATE OF 1988 AMENDMENTS

Section 8412(b) of Pub. L. 100-647 provided that: "The amendments

made by subsection (a) [amending this section] shall not apply to

contracts in effect on the date of the enactment of this Act [Nov.

10, 1988] or extensions (not exceeding 90 days) thereof."

Amendment by Pub. L. 100-485 effective as if included in the

enactment of the Medicare Catastrophic Coverage Act of 1988, Pub.

L. 100-360, see section 608(g)(1) of Pub. L. 100-485, set out as a

note under section 704 of this title.

Amendment by section 202(f) of Pub. L. 100-360 applicable to

enrollments effected on or after Jan. 1, 1990, see section

202(m)(3) of Pub. L. 100-360, set out as a note under section 1395u

of this title.

Amendment by section 211(c)(3) of Pub. L. 100-360 applicable,

except as specified in such amendment, to monthly premiums for

months beginning with January 1989, see section 211(d) of Pub. L.

100-360, set out as a note under section 1395r of this title.

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by section 411(c)(1), (3), (4), (6), (e)(3) of

Pub. L. 100-360, as it relates to a provision in the Omnibus Budget

Reconciliation Act of 1987, Pub. L. 100-203, effective as if

included in the enactment of that provision in Pub. L. 100-203, see

section 411(a) of Pub. L. 100-360, set out as a Reference to OBRA;

Effective Date note under section 106 of Title 1, General

Provisions.

EFFECTIVE DATE OF 1987 AMENDMENT

Section 4011(a)(2) of Pub. L. 100-203 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

with respect to contracts entered into or renewed on or after the

date of enactment of this Act [Dec. 22, 1987]."

Section 4011(b)(2) of Pub. L. 100-203 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to contracts entered into or renewed on or after the date of the

enactment of this Act [Dec. 22, 1987]."

Section 4012(d) of Pub. L. 100-203 provided that: "The amendments

made by subsections (a) and (b) [amending this section and section

1395cc this title] shall apply to admissions occurring on or after

April 1, 1988, or, if later, the earliest date the Secretary can

provide the information required under subsection (c) [set out as a

note below] in machine readable form."

Section 4013(b) of Pub. L. 100-203, which provided the effective

date for amendment made by section 4013(a) of Pub. L. 100-203, was

omitted in the general amendment of section 4013 of Pub. L. 100-203

by Pub. L. 100-360, title IV, Sec. 411(c)(3), July 1, 1988, 102

Stat. 773.

EFFECTIVE DATE OF 1986 AMENDMENTS

Section 1895(b)(11)(B) of Pub. L. 99-514 provided that: "The

amendment made by subparagraph (A) [amending this section] shall

apply to determinations of per capita payment rates for 1987 and

subsequent years."

Section 9312(b)(2) of Pub. L. 99-509 provided that: "The

amendment made by paragraph (1) [amending this section] shall take

effect on January 1, 1987, and shall apply to enrollments effected

on or after such date."

Section 9312(c)(3) of Pub. L. 99-509, as amended by Pub. L.

100-203, title IV, Sec. 4018(d), Dec. 22, 1987, 101 Stat. 1330-66;

Pub. L. 101-239, title VI, Sec. 6212(a), Dec. 19, 1989, 103 Stat.

2249; Pub. L. 103-66, title XIII, Sec. 13569, Aug. 10, 1993, 107

Stat. 608, provided that:

"(A) New restriction. - The amendment made by paragraph (1)

[amending this section] shall apply to modifications and waivers

granted after the date of the enactment of this Act [Oct. 21,

1986].

"(B) Sanctions for noncompliance. - The amendments made by

paragraph (2) [amending this section] shall take effect on the date

of the enactment of this Act.

"(C) Treatment of current waivers. - In the case of an eligible

organization (or successor organization) that -

"(i) as of the date of the enactment of this Act, has been

granted, under paragraph (2) of section 1876(f) of the Social

Security Act [subsec. (f)(2) of this section], a modification or

waiver of the requirement imposed by paragraph (1) of that

section, but

"(ii) does not meet the requirement for such modification or

waiver under the amendment made by paragraph (1) of this

subsection,

the organization shall make, and continue to make, reasonable

efforts to meet scheduled enrollment goals, consistent with a

schedule of compliance approved by the Secretary of Health and

Human Services. If the Secretary determines that the organization

has complied, or made significant progress towards compliance, with

such schedule of compliance, the Secretary may extend such waiver.

If the Secretary determines that the organization has not complied

with such schedule, the Secretary may provide for a sanction

described in section 1876(f)(3) of the Social Security Act [subsec.

(f)(3) of this section] (as amended by this section) effective with

respect to individuals enrolling with the organization after the

date the Secretary notifies the organization of such noncompliance.

"(D) Treatment of certain waivers. - In the case of an eligible

organization (or successor organization) that is described in

clauses (i) and (ii) of subparagraph (C) and that received a grant

or grants totaling at least $3,000,000 in fiscal year 1987 under

section 329(d)(1)(A) or 330(d)(1) of the Public Health Service Act

[42 U.S.C. 254b(d)(1)(A), 254c(d)(1)] -

"(i) before January 1, 1996, section 1876(f) of the Social

Security Act [subsec. (f) of this section] shall not apply to the

organization;

"(ii) beginning on January 1, 1990, the Secretary of Health and

Human Services shall conduct an annual review of the organization

to determine the organization's compliance with the quality

assurance requirements of section 1876(c)(6) of such Act [subsec.

(c)(6) of this section]; and

"(iii) after January 1, 1990, if the organization receives an

unfavorable review under clause (ii), the Secretary, after notice

to the organization of the unfavorable review and an opportunity

to correct any deficiencies identified during the review, may

provide for the sanction described in section 1876(f)(3) of such

Act [subsec. (f)(3) of this section] effective with respect to

individuals enrolling with the organization after the date the

Secretary notifies the organization that the organization is not

in compliance with the requirements of section 1876(c)(6) of such

Act."

Section 9312(d)(2) of Pub. L. 99-509 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to risk-sharing contracts under section 1876 of the Social Security

Act [this section] with respect to services furnished on or after

January 1, 1987."

Section 9312(e)(2) of Pub. L. 99-509 provided that: "The

amendments made by paragraph (1) [amending this section] shall

apply to contracts as of January 1, 1987."

Section 9353(e)(3)(B) of Pub. L. 99-509, as amended by Pub. L.

100-203, title IV, Sec. 4039(h)(9)(C), as added by Pub. L. 100-360,

title IV, Sec. 411(e)(3), July 1, 1988, 102 Stat. 776, provided

that: "The amendment made by paragraph (2) [amending this section]

shall apply to risk-sharing contracts with eligible organizations,

under section 1876 of the Social Security Act [this section], as of

April 1, 1987. The provisions of section 1876(i)(7) of the Social

Security Act [subsec. (i)(7) of this section] (added by such

amendment) shall apply to health maintenance organizations with

contracts in effect under section 1876 of such Act (as in effect

before the date of the enactment of Public Law 97-248 [Sept. 3,

1982]) in the same manner as it applies to eligible organizations

with risk-sharing contracts in effect under section 1876 of such

Act (as in effect on the date of the enactment of this Act [Dec.

22, 1987])."

Section 9211(e) of Pub. L. 99-272 provided that:

"(1) Financial responsibility. - The amendments made by

subsection (a) [amending this section] shall apply to enrollments

and disenrollments that become effective on or after the date of

the enactment of this Act [Apr. 7, 1986].

"(2) Disenrollments. - The amendments made by subsection (b)

[amending this section] shall apply to requests for termination of

enrollment submitted on or after May 1, 1986.

"(3) Material review. - (A) The amendment made by subsection (c)

[amending this section] shall not apply to material which has been

distributed before July 1, 1986.

"(B) Such amendment also shall not apply so as to require the

submission of material which is distributed before July 1, 1986.

"(C) Such amendment shall also not apply to material which the

Secretary determines has been prepared before the date of the

enactment of this Act [Apr. 7, 1986] and for which a commitment for

distribution has been made, if the application of such amendment

would constitute a hardship for the organization involved.

"(4) Publication. - The amendment made by subsection (d)

[amending this section] shall apply to determinations of per capita

rates of payment for 1987 and subsequent years.

"(5) Necessary modification of contracts. - The Secretary of

Health and Human Services shall provide for such changes in the

risk-sharing contracts which have been entered into under section

1876 of the Social Security Act [this section] as may be necessary

to conform to the requirements imposed by the amendments made by

this section [amending this section] on a timely basis."

EFFECTIVE DATE OF 1984 AMENDMENT

Section 2350(d) of Pub. L. 98-369 provided that: "The amendments

made by this section [amending this section and enacting provisions

set out as notes under this section] shall become effective on the

date of the enactment of this Act [July 18, 1984]."

Amendment by section 2354(b)(37), (38) of Pub. L. 98-369

effective July 18, 1984, but not to be construed as changing or

affecting any right, liability, status, or interpretation which

existed (under the provisions of law involved) before that date,

see section 2354(e)(1) of Pub. L. 98-369, set out as a note under

section 1320a-1 of this title.

EFFECTIVE DATE OF 1983 AMENDMENTS; TRANSITIONAL RULE

Amendment by section 602(g) of Pub. L. 98-21 applicable to items

and services furnished by or under arrangement with a hospital

beginning with its first cost reporting period that begins on or

after Oct. 1, 1983, any change in a hospital's cost reporting

period made after November 1982 to be recognized for such purposes

only if the Secretary finds good cause therefor, see section

604(a)(1) of Pub. L. 98-21, set out as a note under section 1395ww

of this title.

Amendment by section 606(a)(3)(H) of Pub. L. 98-21 applicable to

premiums for months beginning with January 1984, but for months

after June 1983 and before January 1984, the monthly premium for

June 1983 shall apply to individuals enrolled under parts A and B

of this subchapter, see section 606(c) of Pub. L. 98-21, set out as

a note under section 1395r of this title.

Amendment by section 309(b)(12) of Pub. L. 97-448 effective as if

originally included as a part of this section as this section was

amended by the Tax Equity and Fiscal Responsibility Act of 1982,

Pub. L. 97-248, see section 309(c)(2) of Pub. L. 97-448, set out as

a note under section 426-1 of this title.

EFFECTIVE DATE OF 1982 AMENDMENT

Section 114(c) of Pub. L. 97-248, as amended by Pub. L. 98-369,

div. B, title III, Sec. 2354(c)(3)(A), (B), July 18, 1984, 98 Stat.

1102; Pub. L. 98-617, Sec. 3(a)(5), Nov. 8, 1984, 98 Stat. 3295;

Pub. L. 99-509, title IX, Sec. 9312(a), Oct. 21, 1986, 100 Stat.

1999, provided that:

"(1) Subject to paragraph (2), the amendment made by subsection

(a) [amending this section] shall apply with respect to services

furnished on or after the initial effective date (as defined in

paragraph (4)), except that such amendment shall not apply -

"(A) with respect to services furnished by an eligible

organization to any individual who is enrolled with that

organization under an existing cost contract (as defined in

paragraph (3)(A)) and entitled to benefits under part A, or

enrolled in part B, of title XVIII of the Social Security Act

[this subchapter] at the time the organization first enters into

a new risk-sharing contract (as defined in paragraph (3)(D))

unless -

"(i) the individual requests at any time that the amendment

apply, or

"(ii) the Secretary determines at any time that the amendment

should apply to all members of the organization because of

administrative costs or other administrative burdens involved

and so informs in advance each affected member of the eligible

organization;

"(B) with respect to services furnished by an eligible

organization during the five-year period beginning on the initial

effective date, if -

"(i) the organization has an existing risk-sharing contract

(as defined in paragraph (3)(B)) on the initial effective date,

or

"(ii) on the date of the enactment of this Act [Sept. 3,

1982] the organization was furnishing services pursuant to an

existing demonstration project (as defined in paragraph

(3)(C)), such demonstration project is concluded before the

initial effective date, and before such initial effective date

the organization enters into an existing risk-sharing contract,

unless the organization requests that the amendment apply

earlier; or

"(C) with respect to services furnished by an eligible

organization during the period of an existing demonstration

project if on the initial effective date the organization was

furnishing services pursuant to the project and if the project

concludes after such date.

"(2)(A) In the case of an eligible organization which has in

effect an existing cost contract (as defined in paragraph (3)(A))

on the initial effective date, the organization may receive payment

under a new risk-sharing contract with respect to a current,

nonrisk medicare enrollee (as defined in subparagraph (C)) only to

the extent that the organization enrolls, for each such enrollee,

two new medicare enrollees (as defined in subparagraph (D)). The

selection of those current nonrisk medicare enrollees with respect

to whom payment may be so received under a new risk-sharing

contract shall be made in a nonbiased manner.

"(B) Subparagraph (A) shall not be construed to prevent an

eligible organization from providing for enrollment, on a basis

described in subsection (a)(6) of section 1876 of the Social

Security Act [subsec. (a)(6) of this section] (as amended by this

Act [Pub. L. 97-248], other than under a reasonable cost

reimbursement contract), of current, nonrisk medicare enrollees and

from providing such enrollees with some or all of the additional

benefits described in section 1876(g)(2) of the Social Security Act

[subsec. (g)(2) of this section] (as amended by this Act [Pub. L.

97-248]), but (except as provided in subparagraph (A)) -

"(i) payment to the organization with respect to such enrollees

shall only be made in accordance with the terms of a reasonable

cost reimbursement contract, and

"(ii) no payment may be made under section 1876 of such Act

[this section] with respect to such enrollees for any such

additional benefits.

Individuals enrolled with the organization under this subparagraph

shall be considered to be individuals enrolled with the

organization for the purpose of meeting the requirement of section

1876(g)(2) of the Social Security Act [subsec. (g)(2) of this

section] (as amended by this Act [Pub. L. 97-248]).

"(C) For purposes of this paragraph, the term 'current, nonrisk

medicare enrollee' means, with respect to an organization, an

individual who on the initial effective date -

"(i) is enrolled with that organization under an existing cost

contract, and

"(ii) is entitled to benefits under part A and enrolled under

part B, or enrolled in part B, of title XVIII of the Social

Security Act [this subchapter].

"(D) For purposes of this paragraph, the term 'new medicare

enrollee' means, with respect to an organization, an individual who

-

"(i) is enrolled with the organization after the date the

organization first enters into a new risk-sharing contract,

"(ii) at the time of such enrollment is entitled to benefits

under part A, or enrolled in part B, of title XVIII of the Social

Security Act [this subchapter], and

"(iii) was not enrolled with the organization at the time the

individual became entitled to benefits under part A, or to enroll

in part B, of such title [this subchapter].

"(E) The preceding provisions of this paragraph shall not to

[sic] apply to payments made for current, nonrisk medicare

enrollees for months beginning with April 1987.

"(3) For purposes of this subsection:

"(A) The term 'existing cost contract' means a contract which

is entered into under section 1876 of the Social Security Act

[this section], as in effect before the initial effective date,

or reimbursement on a reasonable cost basis under section

1833(a)(1)(A) of such Act [section 1395l(a)(1)(A) of this title],

and which is not an existing risk-sharing contract or an existing

demonstration project.

"(B) The term 'existing risk-sharing contract' means a contract

entered into under section 1876(i)(2)(A) of the Social Security

Act [subsec. (i)(2)(A) of this section], as in effect before the

initial effective date.

"(C) The term 'existing demonstration project' means a

demonstration project under section 402(a) of the Social Security

Amendments of 1967 [section 1395b-1(a) of this title] or under

section 222(a) of the Social Security Amendments of 1972 [section

222(a) of Pub. L. 92-603, set out as a note under section 1395b-1

of this title], relating to the provision of services for which

payment may be made under title XVIII of the Social Security Act

[this subchapter].

"(D) The term 'new risk-sharing contract' means a contract

entered into under section 1876(g) of the Social Security Act

[subsec. (g) of this section], as amended by this Act [Pub. L.

97-248].

"(E) The term 'reasonable cost reimbursement contract' means a

contract entered into under section 1876(h) of such Act [subsec.

(h) of this section], as amended by this Act, or reimbursement on

a reasonable cost basis under section 1833(a)(1)(A) of such Act

[section 1395l(a)(1)(A) of this title].

"(4) As used in this section, the term 'initial effective date'

means -

"(A) the first day of the thirteenth month which begins after

the date of the enactment of this Act [Sept. 3, 1982], or

"(B) the first day of the first month [Feb. 1, 1985] after the

month in which the Secretary of Health and Human Services

notifies the Committee on Finance of the Senate and the

Committees on Ways and Means and on Energy and Commerce of the

House of Representatives that he is reasonably certain that the

methodology to make appropriate adjustments (referred to in

section 1876(a)(4) of the Social Security Act [subsec. (a)(4) of

this section], as amended by this Act [Pub. L. 97-248]) has been

developed and can be implemented to assure actuarial equivalence

in the estimation of adjusted average per capita costs under that

section,

whichever is later."

EFFECTIVE DATE OF 1978 AMENDMENT

Amendment by Pub. L. 95-292 effective with respect to services,

supplies, and equipment furnished after the third calendar month

beginning after June 13, 1978, except that provisions for the

implementation of an incentive reimbursement system for dialysis

services furnished in facilities and providers to become effective

with respect to a facility's or provider's first accounting period

beginning after the last day of the twelfth month following the

month of June 1978, and except that provisions for reimbursement

rates for home dialysis to become effective on Apr. 1, 1979, see

section 6 of Pub. L. 95-292, set out as a note under section 426 of

this title.

EFFECTIVE DATE OF 1976 AMENDMENT

Section 201(e) of Pub. L. 94-460 provided that: "The amendments

made by this section [amending this section] shall be effective

with respect to contracts entered into between the Secretary and

health maintenance organizations under section 1876 of the Social

Security Act [this section] on and after the first day of the first

calendar month which begins more than 30 days after the date of

enactment of this Act [Oct. 8, 1976]."

EFFECTIVE DATE OF 1973 AMENDMENT

Section 18(z-3)(3) of Pub. L. 93-233 provided that: "The

amendments made by subsections (m) and (n) [amending this section]

shall be effective with respect to services provided after June 30,

1973."

EFFECTIVE DATE

Section 226(f) of Pub. L. 92-603 provided that: "The amendments

made by this section [enacting this section, amending sections

1395f, 1395l, 1395ll, and 1396b of this title, and enacting

provisions set out as notes under this section] shall be effective

with respect to services provided on or after July 1, 1973."

REPORT ON IMPACT

Section 4002(b)(2)(B) of Pub. L. 105-33 provided that: "By not

later than January 1, 2001, the Secretary of Health and Human

Services shall submit to Congress a report that analyzes the

potential impact of termination of reasonable cost reimbursement

contracts, pursuant to the amendment made by subparagraph (A), on

medicare beneficiaries enrolled under such contracts and on the

medicare program. The report shall include such recommendations

regarding any extension or transition with respect to such

contracts as the Secretary deems appropriate."

TRANSITION RULE FOR PSO ENROLLMENT

Section 4002(h) of Pub. L. 105-33 provided that: "In applying

subsection (g)(1) of section 1876 of the Social Security Act (42

U.S.C. 1395mm) to a risk-sharing contract entered into with an

eligible organization that is a provider-sponsored organization (as

defined in section 1855(d)(1) of such Act [section 1395w-25(d)(1)

of this title], as inserted by section 5001 [4001]) for a contract

year beginning on or after January 1, 1998, there shall be

substituted for the minimum number of enrollees provided under such

section the minimum number of enrollees permitted under section

1857(b)(1) of such Act [1395w-27(b)(1) of this title] (as so

inserted)."

REQUIREMENTS WITH RESPECT TO ACTUARIAL EQUIVALENCE OF AAPCC

Section 4204(b) of Pub. L. 101-508, as amended by Pub. L.

103-432, title I, Sec. 157(a), Oct. 31, 1994, 108 Stat. 4441; Pub.

L. 104-316, title I, Sec. 122(g), Oct. 19, 1996, 110 Stat. 3837,

provided that:

"(1)(A) Not later than October 1, 1995, the Secretary of Health

and Human Services (in this subsection referred to as the

'Secretary') shall submit a proposal to the Congress that provides

for revisions to the payment method to be applied in years

beginning with 1997 for organizations with a risk-sharing contract

under section 1876(g) of the Social Security Act [subsec. (g) of

this section].

"(B) In proposing the revisions required under subparagraph (A),

the Secretary shall consider -

"(i) the difference in costs associated with medicare

beneficiaries with differing health status and demographic

characteristics; and

"(ii) the effects of using alternative geographic

classifications on the determinations of costs associated with

beneficiaries residing in different areas.

"(2) Not later than 3 months after the date of submittal of the

proposal under paragraph (1), the Comptroller General shall review

the proposal and shall report to Congress on the appropriateness of

the proposed modifications."

[Amendment by section 122(g) of Pub. L. 104-316 to section

4204(b)(4), (5) of Pub. L. 101-508, set out above, could not be

executed, because section 4204(b) of Pub. L. 101-508 did not

contain pars. (4) and (5) subsequent to amendment by Pub. L.

103-432.]

STUDY OF CHIROPRACTIC SERVICES

Section 4204(f) of Pub. L. 101-508, as amended by Pub. L.

103-432, title I, Sec. 157(b)(6), Oct. 31, 1994, 108 Stat. 4442,

directed Secretary to conduct a study of the extent to which health

maintenance organizations with contracts under section 1876 of the

Social Security Act (this section) make available to enrollees

entitled to benefits under title XVIII of such Act (this

subchapter) chiropractic services that are covered under such

title, such study to examine the arrangements under which such

services are made available and the types of practitioners

furnishing such services to such enrollees and to be based on

contracts entered into or renewed on or after Jan. 1, 1991, and

before Jan. 1, 1993, with Secretary to issue a report to Congress

on results of the study not later than Jan. 1, 1993, including

recommendations with respect to any legislative and regulatory

changes determined necessary by Secretary to ensure access to such

services.

EFFECT ON STATE LAW

Conscientious objections of health care provider under State law

unaffected by enactment of subsec. (c)(8) of this section, see

section 4206(c) of Pub. L. 101-508, set out as a note under section

1395cc of this title.

NOTICE OF METHODOLOGY USED IN MAKING ANNOUNCEMENTS UNDER SUBSECTION

(A)(1)(A)

Section 6206(a)(2) of Pub. L. 101-239 provided that: "Before July

1, 1990, the Secretary of Health and Human Services shall provide

for notice to eligible organizations of the methodology used in

making the announcement under section 1876(a)(1)(A) of the Social

Security Act [subsec. (a)(1)(A) of this section] for 1990."

ADJUSTMENT OF CONTRACTS WITH PREPAID HEALTH PLANS

Section 203(b) of Pub. L. 101-234 provided that: "Notwithstanding

any other provision of this Act [see Tables for classification],

the amendments made by this Act (other than the repeal of sections

1833(c)(5) and 1834(c)(6) of the Social Security Act [sections

1395l(c)(5) and 1395m(c)(6) of this title]) shall not apply to

risk-sharing contracts, for contract year 1990 -

"(1) with eligible organizations under section 1876 of the

Social Security Act [this section], or

"(2) with health maintenance organizations under section

1876(i)(2)(A) of such Act [subsec. (i)(2)(A) of this section] (as

in effect before February 1, 1985), under section 402(a) of the

Social Security Amendments of 1967 [section 1395b-1(a) of this

title], or under section 222(a) of the Social Security Amendments

of 1972 [Pub. L. 92-603, set out as a note under section 1395b-1

of this title]."

ADJUSTMENT OF CONTRACTS WITH PREPAID HEALTH PLANS

Section 222 of Pub. L. 100-360, as amended by Pub. L. 100-485,

title VI, Sec. 608(d)(13), Oct. 13, 1988, 102 Stat. 2415, provided

that: "The Secretary of Health and Human Services shall -

"(1) modify contracts under section 1876 of the Social Security

Act [this section], for portions of contract years occurring

after December 31, 1988, to take into account the amendments made

by this Act [see Short Title of 1988 Amendment note under section

1305 of this title]; and

"(2) require such organizations and organizations paid under

section 1833(a)(1)(A) of such Act [section 1395l(a)(1)(A) of this

title] to make appropriate adjustments (including adjustments in

premiums and benefits) in the terms of their agreements with

medicare beneficiaries to take into account such amendments.

The Secretary shall also provide for appropriate modifications of

contracts with health maintenance organizations under section

1876(i)(2)(A) of the Social Security Act [subsec. (i)(2)(A) of this

section] (as in effect before February 1, 1985), under section

402(a) of the Social Security Amendments of 1967 [section

1395b-1(a) of this title], or under section 222(a) of the Social

Security Amendments of 1972 [42 U.S.C. 1395b-1 note], for portions

of contract years occurring after December 31, 1988, so as to apply

to such organizations and contracts the requirements imposed by the

amendments made by this Act upon an organization with a

risk-sharing contract under section 1876 of the Social Security

Act."

PROVISION OF MEDICARE DRG RATES FOR CERTAIN PAYMENTS AND DATA ON

INPATIENT COST PASS-THROUGH ITEMS

Section 4012(c) of Pub. L. 100-203, as amended by Pub. L.

100-360, title IV, Sec. 411(c)(2)(B), July 1, 1988, 102 Stat. 773,

provided that: "The Secretary of Health and Human Services shall

provide (in machine readable form) to eligible organizations under

section 1876 of the Social Security Act [this section] medicare DRG

rates for payments required by the amendment made by subsection (a)

[amending section 1395cc of this title] and data on cost

pass-through items for all inpatient services provided to medicare

beneficiaries enrolled with such organizations."

MEDICARE PAYMENT DEMONSTRATION PROJECTS

Section 4015 of Pub. L. 100-203, as amended by Pub. L. 100-360,

title IV, Sec. 411(c)(5), as added by Pub. L. 100-485, title VI,

Sec. 608(d)(19)(C), Oct. 13, 1988, 102 Stat. 2419, provided that:

"(a) Medicare Insured Group Demonstration Projects. -

"(1) The Secretary of Health and Human Services (in this

subsection referred to as the 'Secretary') may provide for

capitation demonstration projects (in this subsection referred to

as 'projects') with an entity which is an eligible organization

with a contract with the Secretary under section 1876 of the

Social Security Act [this section] or which meets the

restrictions and requirements of this subsection. The Secretary

may not approve a project unless it meets the requirements of

this subsection.

"(2) The Secretary may not conduct more than 3 projects and may

not expend, from funds under title XVIII of the Social Security

Act [this subchapter], more than $600,000,000 in any fiscal year

for all such projects.

"(3) The per capita rate of payment under a project -

"(A) may be based on the adjusted average per capita cost (as

defined in section 1876(a)(4) of the Social Security Act

[subsec. (a)(4) of this section]) determined only with respect

to the group of individuals involved (rather than with respect

to medicare beneficiaries generally), but

"(B) the rate of payment may not exceed the lesser of -

"(i) 95 percent of the adjusted average per capita cost

described in subparagraph (A), or

"(ii)(I) in the 4th year or 5th year of a project, 115

percent of the adjusted average per capita cost (as defined

in section 1876(a)(4) of such Act [subsec. (a)(4) of this

section]) for classes of individuals described in section

1876(a)(1)(B) of that Act [subsec. (a)(1)(B) of this

section], or

"(II) in any subsequent year of a project, 95 percent of

the adjusted average per capita cost (as defined in section

1876(a)(4) [subsec. (a)(4) of this section]) for such

classes.

"(4) If the payment amounts made to a project are greater than

the costs of the project (as determined by the Secretary or, if

applicable, on the basis of adjusted community rates described in

section 1876(e)(3) of the Social Security Act [subsec. (e)(3) of

this section]), the project -

"(A) may retain the surplus, but not to exceed 5 percent of

the average adjusted per capita cost determined in accordance

with paragraph (3)(A), and

"(B) with respect to any additional surplus not retained by

the project, shall apply such surplus to additional benefits

for individuals served by the project or return such surplus to

the Secretary.

"(5) Enrollment under the project shall be voluntary.

Individuals enrolled with the project may terminate such

enrollment as of the beginning of the first calendar month

following the date on which the request is made for such

termination. Upon such termination, such individuals shall retain

the same rights to other health benefits that such individuals

would have had if they had never enrolled with the project

without any exclusion or waiting period for pre-existing

conditions.

"(6) The requirements of -

"(A) subsection (c)(3)(C) (relating to dissemination of

information),

"(B) subsection (c)(3)(E) (annual statement of rights),

"(C) subsection (c)(5) (grievance procedures),

"(D) subsection (c)(6) (on-going quality),

"(E) subsection (g)(6) (relating to prompt payment of

claims),

"(F) subsection (i)(3)(A) and (B) (relating to access to

information and termination notices),

"(G) subsection (i)(6) (relating to providing necessary

services), and

"(H) subsection (i)(7) (relating to agreements with peer

review organizations),

of section 1876 of the Social Security Act [this section] shall

apply to a project in the same manner as they apply to eligible

organizations with risk-sharing contracts under such section.

"(7) The benefits provided under a project must be at least

actuarially equivalent to the combination of the benefits

available under title XVIII of the Social Security Act [this

subchapter] and the benefits available through any alternative

plans in which the individual can enroll through the employer.

The project shall guarantee the actuarial value of benefits

available under the employer plan for the duration of the

project.

"(8) A project shall comply with all applicable State laws.

"(9) The Secretary may not authorize a project unless the

entity offering the project demonstrates to the satisfaction of

the Secretary that it has the necessary financial reserves to pay

for any liability for benefits under the project (including those

liabilities for health benefits under medicare and any

supplemental benefits).

"(10) The Comptroller General shall monitor projects under this

subsection and shall report periodically (not less often than

once every year) to the Committee on Finance of the Senate and

the Committee on Energy and Commerce and Committee on Ways and

Means of the House of Representatives on the status of such

projects and the effect on such projects of the requirements of

this section and shall submit a final report to each such

committee on the results of such projects.

"(b) Payment Methodology Reform Demonstrations Projects. -

"(1) The Secretary of Health and Human Services (in this

subsection referred to as the 'Secretary') is specifically

authorized to conduct demonstration projects under this

subsection for the purpose of testing alternative payment

methodologies pertaining to capitation payments under title XVIII

of the Social Security Act [this subchapter], including -

"(A) computing adjustments to the average per capita cost

under section 1876 of such Act [this section] on the basis of

health status or prior utilization of services, and

"(B) accounting for geographic variations in cost in the

adjusted average per capita costs applicable to an eligible

organization under such section which differs from payments

currently provided on a county-by-county basis.

"(2) No project may be conducted under this subsection -

"(A) with an entity which is not an eligible organization (as

defined in section 1876(b) of the Social Security Act [subsec.

(b) of this section]), and

"(B) unless the project meets all the requirements of

subsections (c) and (i)(3) of section 1876 of such Act

[subsecs. (c) and (i)(3) of this section].

"(3) There are authorized to be appropriated to carry out

projects under this subsection $5,000,000 in each of fiscal years

1989 and 1990.

"(c) Application of Provisions. - The provisions of subsection

(a)(2) and the first sentence of subsection (b) of section 402 of

the Social Security Amendments of 1967 [section 1395b-1(a)(2), (b)

of this title] shall apply to the demonstration projects under this

section in the same manner as they apply to experiments under

subsection (a)(1) of that section."

[For termination, effective May 15, 2000, of provisions of law

requiring submittal to Congress of any annual, semiannual, or other

regular periodic report listed in House Document No. 103-7 (in

which the requirement to report not less than once every year to

certain committees of Congress under section 4015(a)(10) of Pub. L.

100-203, set out above, is listed on page 9), see section 3003 of

Pub. L. 104-66, as amended, set out as a note under section 1113 of

Title 31, Money and Finance.]

GAO STUDY AND REPORTS ON MEDICARE CAPITATION

Section 4017 of Pub. L. 100-203 directed Comptroller General to

conduct a study on medicare capitation rates that would include an

analysis and assessment of the current method for computing per

capita rates of payment under section 1876 of the Social Security

Act (this section), including the method for determining the United

States per capita cost; the method for establishing relative costs

for geographic areas and the data used to establish age, sex, and

other weighting factors; ways to refine the calculation of adjusted

average per capita costs under section 1876 of such Act, including

making adjustments for health status or prior utilization of

services and improvements in the definition of geographic areas;

the extent to which individuals enrolled with organizations with a

risk-sharing contract with the Secretary under section 1876 of such

Act differ in utilization and cost from fee-for-service

beneficiaries and ways for modifying enrollment patterns through

program changes or for reflecting the differences in rates through

group experience rating or other means; approaches for limiting the

liability of the contracting organization under section 1876 of

such Act in catastrophic cases; ways of establishing capitation

rates on a basis other than fee-for-service experience in areas

with high prepaid market penetration; and methods for providing the

rate levels necessary to maintain access to quality prepaid

services in rural or medically underserved areas, while maintaining

cost savings; and directed Comptroller General, not later than

January 1 of 1989 and 1990, to submit to Congress interim reports

on the progress of the study and, not later than Jan. 1, 1991, a

final report on the results of such study.

DEMONSTRATION PROJECTS TO PROVIDE PAYMENT ON A PREPAID, CAPITATED

BASIS FOR COMMUNITY NURSING AND AMBULATORY CARE FURNISHED TO

MEDICARE BENEFICIARIES

Pub. L. 106-113, div. B, Sec. 1000(a)(6) [title V, Sec. 532],

Nov. 29, 1999, 113 Stat. 1536, 1501A-388, as amended by Pub. L.

106-554, Sec. 1(a)(6) [title VI, Sec. 632(a)], Dec. 21, 2000, 114

Stat. 2763, 2763A-566, provided that:

"(a) Extension. - Notwithstanding any other provision of law, any

demonstration project conducted under section 4079 of the Omnibus

Budget Reconciliation Act of 1987 (Public Law 100-123 [Pub. L.

100-203]; 42 U.S.C. 1395mm note) and conducted for the additional

period of 2 years as provided for under section 4019 of BBA [Pub.

L. 105-33, set out as a note below], shall be conducted for an

additional period of 2 years.

"(b) Terms and Conditions. -

"(1) January through september 2000. - For the 9-month period

beginning with January 2000, any such demonstration project shall

be conducted under the same terms and conditions as applied to

such demonstration during 1999.

"(2) October 2000 through december 2001. - For the 15-month

period beginning with October 2000, any such demonstration

project shall be conducted under the same terms and conditions as

applied to such demonstration during 1999, except that the

following modifications shall apply:

"(A) Basic capitation rate. - The basic capitation rate paid

for services covered under the project (other than case

management services) per enrollee per month and furnished

during -

"(i) the period beginning with October 1, 2000, and ending

with December 31, 2000, shall be determined by actuarially

adjusting the actual capitation rate paid for such services

in 1999 for inflation, utilization, and other changes to the

CNO service package, and by reducing such adjusted capitation

rate by 10 percent in the case of the demonstration sites

located in Arizona, Minnesota, and Illinois, and 15 percent

for the demonstration site located in New York; and

"(ii) 2001 shall be determined by actuarially adjusting the

capitation rate determined under clause (i) for inflation,

utilization, and other changes to the CNO service package.

"(B) Targeted case management fee. - Effective October 1,

2000 -

"(i) the case management fee per enrollee per month for -

"(I) the period described in subparagraph (A)(i) shall be

determined by actuarially adjusting the case management fee

for 1999 for inflation; and

"(II) 2001 shall be determined by actuarially adjusting the

amount determined under subclause (I) for inflation; and

"(ii) such case management fee shall be paid only for

enrollees who are classified as moderately frail or frail

pursuant to criteria established by the Secretary.

"(C) Greater uniformity in clinical features among sites. -

Each project shall implement for each site -

"(i) protocols for periodic telephonic contact with

enrollees based on -

"(I) the results of such standardized written health

assessment; and

"(II) the application of appropriate care planning approaches;

"(ii) disease management programs for targeted diseases

(such as congestive heart failure, arthritis, diabetes, and

hypertension) that are highly prevalent in the enrolled

populations;

"(iii) systems and protocols to track enrollees through

hospitalizations, including pre-admission planning,

concurrent management during inpatient hospital stays, and

post-discharge assessment, planning, and follow-up; and

"(iv) standardized patient educational materials for

specified diseases and health conditions.

"(D) Quality improvement. - Each project shall implement at

each site once during the 15-month period -

"(i) enrollee satisfaction surveys; and

"(ii) reporting on specified quality indicators for the

enrolled population.

"(c) Evaluation. -

"(1) Preliminary report. - Not later than July 1, 2001, the

Secretary of Health and Human Services shall submit to the

Committees on Ways and Means and Commerce [now Energy and

Commerce] of the House of Representatives and the Committee on

Finance of the Senate a preliminary report that -

"(A) evaluates such demonstration projects for the period

beginning July 1, 1997, and ending December 31, 1999, on a

site-specific basis with respect to the impact on per

beneficiary spending, specific health utilization measures, and

enrollee satisfaction; and

"(B) includes a similar evaluation of such projects for the

portion of the extension period that occurs after September 30,

2000.

"(2) Final report. - The Secretary shall submit a final report

to such Committees on such demonstration projects not later than

July 1, 2002. Such report shall include the same elements as the

preliminary report required by paragraph (1), but for the period

after December 31, 1999.

"(3) Methodology for spending comparisons. - Any evaluation of

the impact of the demonstration projects on per beneficiary

spending included in such reports shall include a comparison of -

"(A) data for all individuals who -

"(i) were enrolled in such demonstration projects as of the

first day of the period under evaluation; and

"(ii) were enrolled for a minimum of 6 months thereafter;

with

"(B) data for a matched sample of individuals who are

enrolled under part B of title XVIII of the Social Security Act

[part B of this subchapter] and are not enrolled in such a

project, or in a Medicare+Choice plan under part C of such

title [part C of this subchapter], a plan offered by an

eligible organization under section 1876 of such Act [this

section], or a health care prepayment plan under section

1833(a)(1)(A) of such Act [section 1395l(a)(1)(A) of this

title]."

[Pub. L. 106-554, Sec. 1(a)(6) [title VI, Sec. 632(b)], Dec. 21,

2000, 114 Stat. 2763, 2763A-568, provided that: "The amendments

made by subsection (a) [amending section 1000(a)(6) [title V, Sec.

532] of Pub. L. 106-113, set out above] shall be effective as if

included in the enactment of section 532 of BBRA [Pub. L. 106-113,

Sec. 1000(a)(6) [title V, Sec. 532] (113 Stat. 1501A-388)."]

Section 4019 of Pub. L. 105-33 provided that: "Notwithstanding

any other provision of law, demonstration projects conducted under

section 4079 of the Omnibus Budget Reconciliation Act of 1987 [Pub.

L. 100-203, set out as a note below] may be conducted for an

additional period of 2 years, and the deadline for any report

required relating to the results of such projects shall be not

later than 6 months before the end of such additional period."

Section 4079 of Pub. L. 100-203, as amended by Pub. L. 100-360,

title IV, Sec. 411(h)(8), July 1, 1988, 102 Stat. 787, provided

that:

"(a) In General. - The Secretary of Health and Human Services (in

this section referred to as the 'Secretary') shall enter into an

agreement with not less than four eligible organizations submitting

applications under this section to conduct demonstration projects

to provide payment on a prepaid, capitated basis for community

nursing and ambulatory care furnished to any individual entitled to

benefits under part A and enrolled under part B of title XVIII of

the Social Security Act [part A and part B of this subchapter]

(other than an individual medically determined to have end-stage

renal disease) who resides in the geographic area served by the

organization and enrolls with such organization (in accordance with

subsection (c)(2)).

"(b) Definitions of Community Nursing and Ambulatory Care and

Eligible Organization. - As used in this section:

"(1) The term 'community nursing and ambulatory care' means the

following services:

"(A) Part-time or intermittent nursing care furnished by or

under the supervision of registered professional nurses.

"(B) Physical, occupational, or speech therapy.

"(C) Social and related services supportive of a plan of

ambulatory care.

"(D) Part-time or intermittent services of a home health

aide.

"(E) Medical supplies (other than drugs and biologicals) and

durable medical equipment while under a plan of care.

"(F) Medical and other health services described in

paragraphs (2)(H)(ii) and (5) through (9) of section 1861(s) of

the Social Security Act [section 1395x(s)(2)(H)(ii), (5)-(9) of

this title].

"(G) Rural health clinic services described in section

1861(aa)(1)(C) of such Act [section 1395x(aa)(1)(C) of this

title].

"(H) Certain other related services listed in section

1915(c)(4)(B) of such Act [section 1396n(c)(4)(B) of this

title] to the extent the Secretary finds such services are

appropriate to prevent the need for institutionalization of a

patient.

"(2) The term 'eligible organization' means a public or private

entity, organized under the laws of any State, which meets the

following requirements:

"(A) The entity (or a division or part of such entity) is

primarily engaged in the direct provision of community nursing

and ambulatory care.

"(B) The entity provides directly, or through arrangements

with other qualified personnel, the services described in

paragraph (1).

"(C) The entity provides that all nursing care (including

services of home health aids) is furnished by or under the

supervision of a registered nurse.

"(D) The entity provides that all services are furnished by

qualified staff and are coordinated by a registered

professional nurse.

"(E) The entity has policies governing the furnishing of

community nursing and ambulatory care that are developed by

registered professional nurses in cooperation with (as

appropriate) other professionals.

"(F) The entity maintains clinical records on all patients.

"(G) The entity has protocols and procedures to assure, when

appropriate, timely referral to or consultation with other

health care providers or professionals.

"(H) The entity complies with applicable State and local laws

governing the provision of community nursing and ambulatory

care to patients.

"(I) The requirements of subparagraphs (B), (D), and (E) of

section 1876(b)(2) of the Social Security Act [42 U.S.C.

1395mm(b)(2)(B), (D), (E)].

"(c) Agreements With Eligible Organizations To Conduct

Demonstration Projects. -

"(1) The Secretary may not enter into an agreement with an

eligible organization to conduct a demonstration project under

this section unless the organization meets the requirements of

this subsection and subsection (e) with respect to members

enrolled with the organization under this section.

"(2) The organization shall have an open enrollment period for

the enrollment of individuals under this section. The duration of

such period of enrollment and any other requirement pertaining to

enrollment or termination of enrollment shall be specified in the

agreement with the organization.

"(3) The organization must provide to members enrolled with the

organization under this section, through providers and other

persons that meet the applicable requirements of titles XVIII and

XIX of the Social Security Act [this subchapter and subchapter

XIX of this chapter], community nursing and ambulatory care (as

defined in subsection (b)(1)) which is generally available to

individuals residing in the geographic area served by the

organization, except that the organization may provide such

members with such additional health care services as the members

may elect, at their option, to have covered.

"(4) The organization must make community nursing and

ambulatory care (and such other health care services as such

individuals have contracted for) available and accessible to each

individual enrolled with the organization under this section,

within the area served by the organization, with reasonable

promptness and in a manner which assures continuity.

"(5) Section 1876(c)(5) of the Social Security Act [subsec.

(c)(5) of this section] shall apply to organizations under this

section in the same manner as it applies to organizations under

section 1876 of such Act.

"(6) The organization must have arrangements, established in

accordance with regulations of the Secretary, for an ongoing

quality assurance program for health care services it provides to

such individuals under the demonstration project conducted under

this section, which program (A) stresses health outcomes and (B)

provides review by health care professionals of the process

followed in the provision of such health care services.

"(7) Under a demonstration project under this section -

"(A) the Secretary could require the organization to provide

financial or other assurances (including financial

risk-sharing) that minimize the inappropriate substitution of

other services under title XVIII of such Act [this subchapter]

for community nursing services; and

"(B) if the Secretary determines that the organization has

failed to perform in accordance with the requirements of the

project (including meeting financial responsibility

requirements under the project, any pattern of disproportionate

or inappropriate institutionalization) the Secretary shall,

after notice, terminate the project.

"(d) Determination of Per Capita Payment Rates. -

"(1) The Secretary shall determine for each 12-month period in

which a demonstration project is conducted under this section,

and shall announce (in a manner intended to provide notice to

interested parties) not later than three months before the

beginning of such period, with respect to each eligible

organization conducting a demonstration project under this

section, a per capita rate of payment for each class of

individuals who are enrolled with such organization who are

entitled to benefits under part A and enrolled under part B of

title XVIII of the Social Security Act [part A and part B of this

subchapter].

"(2)(A) Except as provided in paragraph (3), the per capita

rate of payment under paragraph (1) shall be determined in

accordance with this paragraph.

"(B) The Secretary shall define appropriate classes of members,

based on age, disability status, and such other factors as the

Secretary determines to be appropriate, so as to ensure actuarial

equivalence. The Secretary may add to, modify, or substitute for

such classes, if such changes will improve the determination of

actuarial equivalence.

"(C) The per capita rate of payment under paragraph (1) for

each such class shall be equal to 95 percent of the adjusted

average per capita cost (as defined in subparagraph (D)) for that

class.

"(D) For purposes of subparagraph (C), the term 'adjusted

average per capita cost' means the average per capita amount that

the Secretary estimates in advance (on the basis of actual

experience, or retrospective actuarial equivalent based upon an

adequate sample and other information and data, in a geographic

area served by an eligible organization or in a similar area,

with appropriate adjustments to assure actuarial equivalence)

would be payable in any contract year for those services covered

under parts A and B of title XVIII of the Social Security Act

[parts A and B of this subchapter] and types of expenses

otherwise reimbursable under such parts A and B which are

described in subparagraphs (A) through (G) of subsection (b)(1)

(including administrative costs incurred by organizations

described in sections 1816 and 1842 of such Act [sections 1395h

and 1395u of this title]), if the services were to be furnished

by other than an eligible organization.

"(3) The Secretary shall, in consultation with providers,

health policy experts, and consumer groups develop

capitation-based reimbursement rates for such classes of

individuals entitled to benefits under part A and enrolled under

part B of the Social Security Act [probably means parts A and B

of title XVIII of that Act, this subchapter] as the Secretary

shall determine. Such rates shall be applied in determining per

capita rates of payment under paragraph (1) with respect to at

least one eligible organization conducting a demonstration

project under this section.

"(4)(A) In the case of an eligible organization conducting a

demonstration project under this section, the Secretary shall

make monthly payments in advance and in accordance with the rate

determined under paragraph (2) or (3), except as provided in

subsection (e)(3)(B), to the organization for each individual

enrolled with the organization.

"(B) The amount of payment under paragraph (2) or (3) may be

retroactively adjusted to take into account any difference

between the actual number of individuals enrolled in the plan

under this section and the number of such individuals estimated

to be so enrolled in determining the amount of the advance

payment.

"(5) The payment to an eligible organization under this section

for individuals enrolled under this section with the organization

and entitled to benefits under part A and enrolled under part B

of the Social Security Act shall be made from the Federal

Hospital Insurance Trust Fund and the Federal Supplementary

Medical Insurance Trust Fund established under such Act [this

chapter] in such proportions from each such trust fund as the

Secretary deems to be fair and equitable taking into

consideration benefits attributable to such parts A and B,

respectively.

"(6) During any period in which an individual is enrolled with

an eligible organization conducting a demonstration project under

this section, only the eligible organization (and no other

individual or person) shall be entitled to receive payments from

the Secretary under this title [probably means title XVIII of the

Social Security Act, this subchapter] for community nursing and

ambulatory care (as defined in subsection (b)(1)) furnished to

the individual.

"(e) Restriction on Premiums, Deductibles, Copayments, and

Coinsurance. -

"(1) In no case may the portion of an eligible organization's

premium rate and the actuarial value of its deductibles,

coinsurance, and copayments charged (with respect to community

nursing and ambulatory care) to individuals who are enrolled

under this section with the organization, exceed the actuarial

value of the coinsurance and deductibles that would be applicable

on the average to individuals enrolled under this section with

the organization (or, if the Secretary finds that adequate data

are not available to determine that actuarial value, the

actuarial value of the coinsurance and deductibles applicable on

the average to individuals in the area, in the State, or in the

United States, eligible to enroll under this section with the

organization, or other appropriate data) and entitled to benefits

under part A and enrolled under part B of the Social Security Act

[probably means parts A and B of title XVIII of that Act, this

subchapter], if they were not members of an eligible

organization.

"(2) If the eligible organization provides to its members

enrolled under this section services in addition to community

nursing and ambulatory care, election of coverage for such

additional services shall be optional for such members and such

organization shall furnish such members with information on the

portion of its premium rate or other charges applicable to such

additional services. In no case may the sum of -

"(A) the portion of such organization's premium rate charged,

with respect to such additional services, to members enrolled

under this section, and

"(B) the actuarial value of its deductibles, coinsurance, and

copayments charged, with respect to such services to such

members

exceed the adjusted community rate for such services (as defined

in section 1876(e)(3) of the Social Security Act [subsec. (e)(3)

of this section]).

"(3)(A) Subject to subparagraphs (B) and (C), each agreement to

conduct a demonstration project under this section shall provide

that if -

"(i) the adjusted community rate, referred to in paragraph

(2), for community nursing and ambulatory care covered under

parts A and B of title XVIII of the Social Security Act [parts

A and B of this subchapter] (as reduced for the actuarial value

of the coinsurance and deductibles under those parts) for

members enrolled under this section with the organization,

is less than

"(ii) the average of the per capita rates of payment to be

made under subsection (d)(1) at the beginning of the 12-month

period (as determined on such basis as the Secretary determines

appropriate) described in such subsection for members enrolled

under this section with the organization,

the eligible organization shall provide to such members the

additional benefits described in section 1876(g)(3) of the Social

Security Act [subsec. (g)(3) of this section] which are selected

by the eligible organization and which the Secretary finds are at

least equal in value to the difference between that average per

capita payment and the adjusted community rate (as so reduced).

"(B) Subparagraph (A) shall not apply with respect to any

organization which elects to receive a lesser payment to the

extent that there is no longer a difference between the average

per capita payment and adjusted community rate (as so reduced).

"(C) An organization conducting a demonstration project under

this section may provide (with the approval of the Secretary)

that a part of the value of such additional benefits under

subparagraph (A) be withheld and reserved by the Secretary as

provided in section 1876(g)(5) of the Social Security Act

[subsec. (g)(5) of this section].

"(4) The provisions of paragraphs (3), (5), and (6) of section

1876(g) of the Social Security Act [subsec. (g)(3), (5), and (6)

of this section] shall apply in the same manner to agreements

under this section as they apply to risk-sharing contracts under

section 1876 of such Act, and, for this purpose, any reference in

such paragraphs to paragraph (2) is deemed a reference to

paragraph (3) of this subsection.

"(5) Section 1876(e)(4) of the Social Security Act [subsec.

(e)(4) of this section] shall apply to eligible organizations

under this section in the same manner as it applies to eligible

organizations under section 1876 of such Act.

"(f) Commencement and Duration of Projects. - Each demonstration

project under this section shall begin not later than July 1, 1989,

and shall be conducted for a period of three years.

"(g) Report. - Not later than January 1, 1992, the Secretary

shall submit to the Congress a report on the results of the

demonstration projects conducted under this section."

STUDY OF AAPCC AND ACR

Section 9312(g) of Pub. L. 99-509 directed Secretary of Health

and Human Services to provide, through contract with an appropriate

organization, for a study of the methods by which the adjusted

average per capita cost ("AAPCC", as defined in subsec. (a)(4) of

this section) can be refined to more accurately reflect the average

cost of providing care to different classes of patients, and the

adjusted community rate ("ACR", as defined in subsec. (e)(3) of

this section) can be refined, with Secretary to submit to Congress,

by not later than Jan. 1, 1988, specific legislative

recommendations concerning methods by which the calculation of the

AAPCC and the ACR could be refined.

ALLOWING MEDICARE BENEFICIARIES TO DISENROLL AT LOCAL SOCIAL

SECURITY OFFICES

Section 9312(h) of Pub. L. 99-509 provided that: "The Secretary

of Health and Human Services shall provide that individuals

enrolled with an eligible organization under section 1876 of the

Social Security Act [this section] may disenroll, on and after June

1, 1987, at any local office of the Social Security

Administration."

USE OF RESERVE FUNDS

Section 9312(i) of Pub. L. 99-509 provided that: "Notwithstanding

any provision of section 1876(g)(5) of the Social Security Act (42

U.S.C. 1395mm(g)(5)) to the contrary, funds reserved by an eligible

organization under such section before the date of the enactment of

this Act [Oct. 21, 1986] may be applied, at the organization's

option, to offset the amount of any reduction in payment amounts to

the organization effected under Public Law 99-177 [Dec. 12, 1985,

99 Stat. 1037, see Tables for classification] during fiscal year

1986."

PHASE-IN OF ENROLLMENT PERIOD BY SECRETARY

Section 2350(a)(2) of Pub. L. 98-369 provided that: "The

Secretary of Health and Human Services may phase in, over a period

of not longer than three years, the application of the amendments

made by paragraph (1) [amending this section] to all applicable

areas in the United States if the Secretary determines that it is

not administratively feasible to establish a single 30-day open

enrollment period for all such applicable areas before the end of the period."

STABILIZATION FUND; ESTABLISHMENT LIMITATION; USES; REPORT TO

CONGRESS

Section 2350(b)(3), (4) of Pub. L. 98-369, as amended by Pub. L.

100-203, title IV, Sec. 4013, Dec. 22, 1987, 101 Stat. 1330-61;

Pub. L. 100-360, title IV, Sec. 411(c)(3), July 1, 1988, 102 Stat. 773, prohibited Secretary of Health and Human Services from

approving the establishment of a stabilization fund by an eligible

organization under subsec. (g)(5) of this section for any contract

period beginning later than Sept. 30, 1990, and directed Secretary

to report to Congress with respect to use of stabilization funds by

eligible organizations under subsec. (g)(5) of this section and to

assess the need for such funds not later than 54 months after July

1984, prior to repeal by Pub. L. 101-239, title VI, Sec.

6212(c)(1), Dec. 19, 1989, 103 Stat. 2250.

STUDY OF ADDITIONAL BENEFITS SELECTED BY ELIGIBLE ORGANIZATIONS

Section 114(d) of Pub. L. 97-248 directed Secretary of Health and

Human Services to conduct a study of the additional benefits

selected by eligible organizations pursuant to subsec. (g)(2) of

this section, with Secretary to report to Congress within 24 months

of the initial effective date (as defined in subsec. (c)(4) of

section 114 of Pub. L. 97-248) with respect to the findings and

conclusions made as a result of such study.

STUDY EVALUATING THE EXTENT OF, AND REASONS FOR, TERMINATION BY

MEDICARE BENEFICIARIES OF MEMBERSHIP IN ORGANIZATIONS WITH

CONTRACTS UNDER THIS SECTION

Section 114(e) of Pub. L. 97-248 directed Secretary of Health and

Human Services to conduct a study evaluating the extent of, and

reasons for, the termination by medicare beneficiaries of their

memberships in organizations with contracts under section 1876 of

the Social Security Act (this section), with Secretary to submit an

interim report to Congress, within two years after the initial

effective date (as defined in subsec. (c)(4) of section 114 of Pub.

L. 97-248), and a final report within five years after such date

containing the respective interim and final findings and

conclusions made as a result of such study.

REIMBURSEMENT FOR SERVICES

Section 226(b) of Pub. L. 92-603 provided that:

"(1) Notwithstanding the provisions of section 1814 and section

1833 of the Social Security Act [sections 1395f and 1395l of this

title], any health maintenance organization which has entered into

a contract with the Secretary pursuant to section 1876 of such Act

[this section] shall, for the duration of such contract, (except as

provided in paragraph (2)) be entitled to reimbursement only as

provided in section 1876 of such Act [this section] for individuals

who are members of such organizations.

"(2) With respect to individuals who are members of organizations

which have entered into a risk-sharing contract with the Secretary

pursuant to subsection (i)(2)(A) [of this section] prior to July 1,

1973, and who, although eligible to have payment made pursuant to

section 1876 of such Act [this section] for services rendered to

them, chose (in accordance with regulations) not to have such

payment made pursuant to such section, the Secretary shall, for a

period not to exceed three years commencing on July 1, 1973, pay to

such organization on the basis of an interim per capita rate,

determined in accordance with the provisions of section 1876(a)(2)

of such Act [subsec. (a)(2) of this section], with appropriate

actuarial adjustments to reflect the difference in utilization of

out-of-plan services, which would have been considered sufficiently

reasonable and necessary under the rules of the health maintenance

organization to be provided by that organization, between such

individuals and individuals who are enrolled with such organization

pursuant to section 1876 of such Act [this section]. Payments under

this paragraph shall be subject to retroactive adjustment at the

end of each contract year as provided in paragraph (3).

"(3) If the Secretary determines that the per capita cost of any

such organization in any contract year for providing services to

individuals described in paragraph (2), when combined with the cost of the Federal Hospital Insurance Trust Fund and the Federal

Supplementary Medical Insurance Trust Fund in such year for

providing out-of-plan services to such individuals, is less than or

greater than the adjusted average per capita cost (as defined in

section 1876(a)(3) of such Act) [subsec. (a)(3) of this section] of

providing such services, the resulting savings shall be apportioned

between such organization and such Trust Funds, or the resulting

losses shall be absorbed by such organization, in the manner

prescribed in section 1876(a)(3) of such Act [subsec. (a)(3) of

this section]."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1320a-1, 1320a-7,

1320a-7b, 1320c-2, 1320c-3, 1395f, 1395i-2, 1395l, 1395u, 1395w-4,

1395w-21, 1395w-23, 1395w-26, 1395x, 1395cc, 1395cc-2, 1395ll, 1395nn, 1395ss, 1395ww, 1395ccc, 1395eee, 1396a, 1396b, 1396d,

1396u-2, 1396u-4 of this title; title 2 section 906.

-FOOTNOTE-

(!1) See References in Text note below.

(!2) So in original. Probably should be "significant".

(!3) See References in Text note below.

(!4) So in original. Probably should be "section".

-End-

-CITE-

42 USC Sec. 1395nn 01/06/03