Page:United States Statutes at Large Volume 106 Part 6.djvu/412

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106 STAT. 4970 PUBLIC LAW 102-585 —NOV. 4, 1992 described in subparagraphs (J) and (K) of paragraph (4) that are located in the State.

    • (E) RECERTIFICATION.—The Secretary shall require

the recertification of entities certified pursuant to this paragraph on a not more frequent than annual basis, and shall require that such entities submit information to the Secretary to permit the Secretary to evaluate the vsdidity of subsequent purchases by such entities in the same manner as that required under subparagraph (B). "(8) DEVELOPMENT OF PRIME VENDOR PROGRAM.— The Secretary shall establish a prime vendor program under which covered entities may enter into contracts with prime vendors for the distribution of covered outpatient drugs. If a covered entity obtains drugs directly from a manufacturer, the manufacturer shall be responsible for the costs of distribution. "(9) NOTICE TO MANUFACTURERS. — The Secretary shall notify manufacturers of covered outpatient drugs and single State agencies under section 1902(a)(5) of the Social Security Act of me identities of covered entities under this paragraph, and of entities that no longer meet the requirements of paragraph (5) or that are no longer certified pursuant to paragraph (7). "(10) No PROHIBITION ON LARGER DISCOUNT. — Nothing in this subsection shall prohibit a manufacturer from charging a price for a drug that is lower than the maximum price that may be charged under paragraph (1). "(b) OTHER DEFINITIONS. —In this section, the terms 'average manufacturer price*, 'covered outpatient drug*, and 'manufacturer^ have the meaning given such terms in section 1927(k) of the Social Security Act. "(c) REFERENCES TO SOCIAL SECURITY ACT.— Any reference in this section to a provision of the Social Security Act shall be deemed to be a reference to the provision as in effect on the date of the enactment of this section. "(d) COMPLIANCE WITH REQUIREMENTS.—A manufacturer is deemed to meet the requirements of subsection (a) if the manufacturer establishes to the satisfaction of the Secretary that the manufacturer would comply (and has offered to comply) with the provisions of this section (as in effect immediately after the enactment of the Veterans Health Care Act of 1992), as applied by the Secretary, and would have entered into an agreement under this section (as such section was in effect at such time), but for a legislative change in this section (or the application of this section) after the date of the enactment of such Act.". 42 USC 256b (b) STUDY OF TREATMENT OF CERTAIN CLINICS AS COVERED ^o ^- ENTITIES ELIGIBLE FOR PRESCRIPTION DRUG DISCOUNTS.— (1) STUDY.—The Secretary of Health and Human Services shall conduct a study of the feasibility and desirability of including entities described in paragraph (3) as covered entities eligible for limitations on the prices of covered outpatient drugs under section 340B(a) of the Public Health Service Act (as added by subsection (a)). (2) REPORT.— Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit a report to Congress on the study conducted under paragraph (1), and shall include in the report—