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CMS Releases Proposed Forms to Effectuate Medicare MFP Under the IRA of IPAY 2026 and IPAY 2027

Health Highlights
November 07, 2024

Erin Estey Hertzog

Manatt Health

Ross Margulies

Manatt Health

This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. For more information on how to subscribe and to activate a complimentary one week trial to Manatt on Health, please reach out to Barret Jefferds.     
On October 28, CMS requested public comment​ on four proposed information collections (ICRs) it intends to impose on drug manufacturers and pharmacies in order to effectuate maximum fair prices (MFP) under the Inflation Reduction Act (IRA's) Medicare Drug Price Negotiation Program for initial price applicability year (IPAY) 2026 and IPAY 2027. CMS had previously announced its intention to establish a Medicare Transaction Facilitator (MTF) to exchange data and potentially payments necessary to ensure manufacturers are providing access to MFP-priced drugs.

CMS is requesting comment on four ICRs:
  1. Manufacturer and dispensing entity enrollment in the MTF;
  2. Manufacturer and dispensing entity complaints and disputes related to their participation in the MTF;
  3. Manufacturer MFP effectuation plans; and
  4. Manufacturer payment elements.
The proposed forms are available here. Public comments are due December 27. A second, 30-day comment period will occur in early 2025.

CMS is required to request comments on these forms under the Paperwork Reduction Act, and the purpose of this comment period is primarily to evaluate the burden on the public of the forms themselves. As such, CMS is not expected to make new policy in these draft information collections, and the forms in fact provide fairly technical guidance on how information will be collected in connection with the MTF.
For more information on how to subscribe and to activate a complimentary one week trial to Manatt on Health, please reach out to Barret Jefferds.     
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