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July 25 -- The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment to OMB by August 24, 2023 on CMS' intention to collect information on Drug Price Negotiation Counteroffers.

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 a maximum fair price (“MFP”) with manufacturers, defined at section 1191(c)(3) of the Act, for certain high expenditure, single source drugs covered under Medicare Part B and Part D (“selected drugs”). For the first year of the Negotiation Program, CMS will select up to 10 high expenditure, single source drugs covered by Medicare Part D for negotiation, which will be published September 1, 2023. The MFPs that are negotiated for these drugs will apply beginning in initial price applicability year 2026. The negotiation period begins on the earlier of the date that the Primary Manufacturer enters into a Medicare Drug Price Negotiation Program Agreement or, for initial price applicability year 2026, October 1, 2023.

The statute provides that, after receiving CMS' written initial offer, the Primary Manufacturer may, in accordance with section 1194(b)(2)(C) of the Act, submit an optional written counteroffer (if CMS' written initial offer is not accepted by the Primary Manufacturer) that must be submitted no later than 30 days after the date of receipt of the written initial offer. If the Primary Manufacturer chooses to develop and submit a written counteroffer to CMS' written initial offer during the drug price negotiation process for initial price applicability year 2026, the Primary Manufacturer must submit the Counteroffer Form.

Every offer and counteroffer will include an Addendum populated with the offered/counteroffered MFP. If an agreement is reached at any point during the negotiation process by the Primary Manufacturer accepting CMS’ written initial offer or final offer (as described in section 60.4.4 of the revised guidance), CMS accepting the Primary Manufacturer’s counteroffer, or an agreement being reached in association with the negotiation meetings, the Addendum to the Agreement, as described in section 40.3 of the revised guidance, will be executed by both parties and will constitute agreement on the MFP. Section 60.4.4 of the revised guidance describes how and when the Addendum will be created and signed. The MFP included in the executed Addendum will apply for the selected drug for initial price applicability year 2026 and will be updated according to section 1195(b)(1)(A) of the Act for subsequent years in the price applicability period, as applicable. CMS is requesting OMB approval for this New Collection that focuses on information required for the submission of counteroffers during the drug price negotiation process for initial price applicability year 2026. The Counteroffer Form will collect the name of the drug, the Primary Manufacturer’s counteroffer for the MFP, the justification for the counteroffer, attestations on the use of cost-effectiveness measures in data submitted, and certification by authorized representatives of the Primary Manufacturer.   
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=202307-0938-009 Click IC List for information collection instrument, View Supporting Statement for technical documentation. Submit comments through this webpage.
FRN: https://www.federalregister.gov/d/2023-15713

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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