Page:United States Statutes at Large Volume 95.djvu/813

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PUBLIC LAW 97-000—MMMM. DD, 1981

PUBLIC LAW 97-35—AUG. 13, 1981

95 STAT. 787

(c) The amendment made by subsection (a) shall apply only to services furnished by a hospital during any accounting year beginning on or after October 1, 1981.

Effective date. 42 USC 1395UU note.

ADJUSTMENT IN PAYMENT FOR INAPPROPRIATE HOSPITAL SERVICES

SEC. 2102. (a)(1) Section 1861(v)(l)(G)(i) of the Social Security Act is 42 USC I395x. amended by striking out "the hospital had (during the immediately preceding calendar year) an average daily occupancy rate of 80 percent or more" and inserting in lieu thereof "there is not an excess of hospital beds in such hospital and (subject to clause (iv)) there is not an excess of hospital beds in the area of such hospital". (2) Clause (iv) of section 1861(v)(l)(G) of such Act is amended to read as follows: "(iv) In determining under clause (i), in the case of a public hospital, whether or not there is an excess of hospital beds in the area of such hospital, such determination shall be made on the basis of only the public hospitals (including the hospital) which are in the area of the hospital and which are under common ownership with that hospital.". (b)(1) The amendments made by subsection (a) shall apply to Effective date. services provided on or after the first day of the first month beginning 42 USC 1395x note. after the date of the enactment of this Act. (2) For amendments respecting reimbursement for inappropriate hospital services under medicaid, see section 2173 of this subtitle. LIMITATION ON MEDICARE AND MEDICAID PAYMENTS FOR CERTAIN DRUGS

SEC 2103. (a)(1) Section 1862 of the Social Security Act is amended by inserting after subsection (b) the following new subsection: "(c) No payment may be made under part B 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 505 of the Federal Food, Drug, and Cosmetic Act 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.". (2) The amendment made by paragraph (1) shall apply with respect to expenses incurred on or after October 1, 1981.

42 USC I395y.

21 USC 321 note.

2i use 355.

Effective date. 42 USC I395y note.