Sec. 5. Authority to use alternative payment under the Medicare program for drugs and biologicals to prevent potential drug shortages
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Section 1847A(e) of the Social Security Act (42 U.S.C. 1395w–3a(e)) is amended— by striking and inserting “ Payment in Response to Public Health Emergency.— In the case Payments.— In the case ; and by adding at the end the following new paragraph: In the case of a drug or biological described in subparagraph (B), the Secretary may use the wholesale acquisition cost (or other reasonable measure of a drug or biological price) instead of the manufacturer’s average sales price for quarters beginning on or after the date on which the Secretary determines the drug or biological is described in such subparagraph and for subsequent quarters until the end of the quarter in which such drug or biological is removed from the drug shortage list under section 506E of the Federal Food, Drug, and Cosmetic Act, or in the case of a drug or biological described in subparagraph (B)(ii)(II), the date on which the Secretary determines the manufacturing capacity or the number of manufacturers of such drug or biological is sufficient to prevent a potential shortage of the drug or biological.
For purposes of subparagraph (A), a drug or biological described in this subparagraph is a drug or biological— that is life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition (as those terms are defined for purposes of section 506C of the Federal Food, Drug, and Cosmetic Act and is subject to the reporting requirements under section 506C(b) of such Act), including any such drug or biological that is used in emergency medical care or during surgery; and that is listed on the drug and biological shortage list maintained by the Food and Drug Administration pursuant to section 506E of the Federal Food, Drug, and Cosmetic Act, and for which the manufacturer of such drug or biological notifies the Secretary of a permanent discontinuance or an interruption that is likely to lead to a meaningful disruption in the manufacturer’s supply of that drug or biological pursuant to section 506C(b)(1) of such Act; or that was listed on such drug and biological shortage list within the preceding 5 years and for which the manufacturing capacity of manufacturers with an approved application for such drug or biological, or the number of manufacturers with an approved application for such drug or biological, declines during a 6-month period, as determined by the Secretary.
For each quarter in which the amount of payment for a drug or biological described in subparagraph
(B)pursuant to subparagraph
(A)exceeds the amount of payment for the drug or biological otherwise applicable under this section, the manufacturer of such drug or biological shall provide to the Secretary information related to the potential cause or causes of the shortage and the expected length of the shortage with respect to such drug. . Section 1886(d)(5) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5) ) is amended by adding at the end the following new subparagraph: The Secretary shall establish a modifier or other mechanism for purposes of tracking utilization of drugs on the shortage list pursuant to section 506E of the Federal Food, Drug, and Cosmetic Act, and update the modifier to reflect the drugs on such list each calendar year. . Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall— conduct a study on— drugs and biologicals for which payment is made under the inpatient prospective payment system
(IPPS)under section 1886 of the Social Security Act ( 42 U.S.C. 1395ww ) and the hospital outpatient prospective payment system
(OPPS)under section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t) ) that have been on the shortage list under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e(c)(2) ) in the last 5 years; and whether any changes to payment under such payment systems would decrease— the number of drugs and biologicals on such shortage list; or the frequency with which the drugs and biologicals appear on such shortage list; and submit to Congress recommendations for legislation and administrative actions with respect to the matters described in subparagraphs
(A)and
(B)of paragraph (1).
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- 42 USC 1395w–3a(e)
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Sec. 5
Authority to use alternative payment under the Medicare program for drugs and biologicals to prevent potential drug shortages
Cite42 USC 1395w–3a(e)
Cites 4Cited by 0 across 0 sources