On April 18, 2023, the Centers for Medicare & Medicaid Services (CMS) issued an Information Collection Request (ICR) addressing the “Drug Price Negotiation Process” for the Medicare Drug Price Negotiation Program, including the “Counteroffer Form” manufacturers must use to submit a counteroffer to CMS’s proposed maximum fair price (MFP).

CMS cannot offer or agree to any manufacturer counteroffer that exceeds the statutorily determined ceiling price.

The following outlines the negotiation process for the 2026 price applicability year (PAY):

Key Considerations

  • The Counteroffer Form imposes a 1,500-word limit for the manufacturer’s response to the justifications in CMS’s initial offer and its reasons why the manufacturer believes that the manufacturer-specific data and data related to the selected drug’s therapeutic alternatives do not support CMS’s initial offer and better supports the manufacturer’s counteroffer.
  • The Counteroffer Form includes a manufacturer certification to timely notify CMS of any changes to information submitted and to reflect its understanding that “any misrepresentations may give rise to liability, including under the False Claims Act.”

Next Steps for Stakeholders

Submit comments to https://www.regulations.gov or via regular mail:

  • Comments to the Negotiation Data Elements ICR are due by May 22, 2023
  • Comments to the Drug Price Negotiation Process ICR are due by June 20, 2023

Related Documents

Drug Price Negotiation Process Information Collection Request | Supporting Statement and Forms

Data Negotiation Elements Information Collection Request | Supporting Statement and Forms

Date of Issuance: April 18, 2023

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