Sec. 617. Payments for prescription drugs and approved devices and equipment
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The prices to be paid for covered pharmaceuticals, medical supplies, medical technologies, and medically necessary equipment covered under this Act shall be negotiated annually by the Secretary. Notwithstanding any other provision of law, the Secretary shall, for fiscal years beginning on or after the date of the enactment of this subsection, negotiate with pharmaceutical manufacturers the prices (including discounts, rebates, and other price concessions) that may be charged to the Medicare for All Program during a negotiated price period (as specified by the Secretary) for covered drugs for eligible individuals under the Medicare for All Program.
In negotiating such prices under this section, the Secretary shall take into account the following factors: The comparative clinical effectiveness and cost effectiveness, when available from an impartial source, of such drug. The budgetary impact of providing coverage of such drug. The number of similarly effective drugs or alternative treatment regimens for each approved use of such drug. The total revenues from global sales obtained by the manufacturer for such drug and the associated investment in research and development of such drug by the manufacturer.
The negotiated price of each covered drug for a negotiated price period shall be finalized not later than 30 days before the first fiscal year in such negotiated price period. Notwithstanding any exclusivity under clause
(iii)or
(iv)of section 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic Act, clause
(iii)or
(iv)of section 505(c)(3)(E) of such Act, section 351(k)(7)(A) of the Public Health Service Act, or section 527(a) of the Federal Food, Drug, and Cosmetic Act, or by an extension of such exclusivity under section 505A of such Act or section 505E of such Act, and any other provision of law that provides for market exclusivity (or extension of market exclusivity) with respect to a drug, in the case that the Secretary is unable to success fully negotiate an appropriate price for a covered drug for a negotiated price period, the Secretary shall authorize the use of any patent, clinical trial data, or other exclusivity granted by the Federal Government with respect to such drug as the Secretary determines appropriate for purposes of manufacturing such drug for sale under Medicare for All Program. Any entity making use of a competitive license to use patent, clinical trial data, or other exclusivity under this section shall provide to the manufacturer holding such exclusivity reasonable compensation, as determined by the Secretary based on the following factors: The risk-adjusted value of any Federal Government subsidies and investments in research and development used to support the development of such drug. The risk-adjusted value of any investment made by such manufacturer in the research and development of such drug. The impact of the price, including license compensation payments, on meeting the medical need of all patients at a reasonable cost. The relationship between the price of such drug, including compensation payments, and the health benefits of such drug. Other relevant factors determined appropriate by the Secretary to provide reasonable compensation. The manufacturer described in subparagraph
(A)may seek recovery against the United States in the United States Court of Federal Claims. Until 1 year after a drug described in subparagraph
(A)is approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act or section 351(k) of the Public Health Service Act and is provided under license issued by the Secretary under such subparagraph, the Medicare for All Program shall not pay more for such drug than the average of the prices available, during the most recent 12-month period for which data is available prior to the beginning of such negotiated price period, from the manufacturer to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity in the ten OECD (Organization for Economic Cooperation and Development) countries that have the largest gross domestic product with a per capita income that is not less than half the per capita income of the United States. The Secretary may procure a drug manufactured pursuant to a competitive license under subparagraph
(A)for purposes of this Act. The Secretary shall prioritize review of applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act for drugs licensed under paragraph (3)(A). No drug manufacturer may engage in anticompetitive behavior with another manufacturer that may interfere with the issuance and implementation of a competitive license or run contrary to public policy. The Secretary may require pharmaceutical manufacturers to disclose to the Secretary such information that the Secretary determines necessary for purposes of carrying out this subsection.