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July 3 -- The Centers for Medicare & Medicaid Services (CMS) invites comment to OMB by August 2, 2023 regarding the proposed Negotiation Data Elements under Sections 11001 and 11002 of the Inflation Reduction Act.

Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (Pub. L. 117–169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price Negotiation Program (the “Negotiation Program”), codified in sections 1191 through 1198 of the Social Security Act (“the Act”). The Act establishes the Negotiation Program to negotiate maximum fair prices (“MFPs”), defined at 1191(c)(3) of the Act, for certain high expenditure, single source selected drugs covered under Medicare Part B and Part D. For the first year of the Negotiation Program, the Secretary of Health and Human Services (the “Secretary”) will select 10 Part D high expenditure, single source drugs for negotiation. The Secretary is required to negotiate maximum fair prices (MFPs) with drug manufacturers for 10 qualifying Part D drugs for 2026, 15 Part D drugs for 2027, 15 Part B and Part D drugs in 2028, and 20 Part B and Part D drugs for 2029 and each following year.

The statute requires that CMS consider certain data from Primary Manufacturers as part of the negotiation process. These data include the data required to calculate non-FAMP for selected drugs for the purpose of establishing a ceiling price, as outlined in section 1193(a)(4)(A), and the negotiation factors outlined in section 1194(e)(1) for the purpose of formulating offers and counteroffers process pursuant to section 1193(a)(4)(B). Some of these data are held by the Primary Manufacturer and are not currently available to CMS. Data described in section 1194(e)(1) and 1193(a)(4) must be submitted by the Primary Manufacturer.

Section 1194(e)(2) requires CMS to consider certain data on alternative treatments to the selected drug. Because the statute does not specify where these data come from, CMS will allow for optional submission from Primary Manufacturers and the public. CMS will additionally review existing literature, conduct internal analyses, and consult subject matter and clinical experts on the factors listed in 1194(e)(2) to ensure consideration of such factors. Manufacturers may optionally submit this information as part of their Negotiation Data Elements Information Collection Request Form. The public may optionally submit evidence about alternative treatments.
Medicare Drug Price Negotiation: https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation  
CMS submission to OMB: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202306-0938-013 Click IC List for information collection instrument, View Supporting Statement for technical documentation. Submit comments through this webpage.
FRN: https://www.federalregister.gov/d/2023-14176

For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at https://www.aeaweb.org/content/file?id=5806

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