Sec. 101. Establishment of part B payment rules for negotiation-eligible drugs and biologicals
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Section 1847A of the Social Security Act ( 42 U.S.C. 1395w–3a ) is amended— in paragraph (1)— in the matter preceding subparagraph (A), by striking Subject to paragraph
(7)and inserting Subject to paragraphs
(7)and
(9); in subparagraph (B), by striking at the end or ; in subparagraph (C), by striking the period at the end and inserting ; or ; and by adding at the end the following new subparagraph: in the case of a negotiation-eligible drug or biological, the maximum allowable cost determined under paragraph (9). ; and by adding at the end the following new paragraph: Not later than 180 days after the date of the enactment of this paragraph, the Secretary shall notify each manufacturer of each negotiation-eligible drug or biological that is subject to negotiation for payment under this part. In this paragraph, the term negotiation-eligible drug or biological means a single source drug or biological (as defined in subparagraph (C)) for which each of the following have expired: The period of regulatory data protections or exclusivity granted for such drug or biological (including for new chemical entities, biologics, orphan drugs, pediatric formulations, and clinical trials). Subject to the succeeding sentence, the period of any patents issued for such drug or biological up to 1 year after the approval of such drug or biological. In the case of small molecule product that is a such a drug or biological, the period of any patents listed in the publication, Approved Drug Products With Therapeutic Equivalence Evaluations (referred to as the Orange Book ). The Secretary and the manufacturer of a negotiation-eligible drug or biological shall during the negotiation period negotiate a maximum allowable cost for such drug or biological. In the case that the Secretary and the manufacturer do not determine a maximum allowable cost for such drug or biological, the Secretary shall determine the maximum allowable cost for such drug or biological at an amount that is at least 65 percent and not more than 75 percent of the average sales price of such drug or biological. In this subparagraph, the term maximum allowable cost means the amount agreed to by the Secretary and the manufacturer of a negotiation-eligible drug or biological for a unit of such drug or biological that is not less than 65 percent and not more than 75 percent of the lowest average sales price of such drug or biological for the preceding 1-year period. For purposes of this paragraph, the term single source drug or biological means— a drug or drug product that— is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act and is marketed pursuant to such approval; and is not the listed drug for any drug that is approved under section 505(j) and is marketed pursuant to such approval; or a biological product that— is licensed under section 351(a) of the Public Health Service Act, including any product deemed to be licensed under such section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act and is marketed pursuant to section 351 of the Public Health Service Act; and is not the reference product for any biological product that is licensed and is marketed pursuant to such section of such Act. .
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- 42 USC 1395w–3a
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Sec. 101
Establishment of part B payment rules for negotiation-eligible drugs and biologicals
Cite42 USC 1395w–3a
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