Negotiation Program Drug Selection for Initial Price Applicability Year 2028 (CMS-10844) - IRA

In accordance with section 1192(d)(2) of the Act, the term “negotiation-eligible drug” excludes, with respect to the initial price applicability years 2026, 2027, and 2028, a qualifying single source drug that meets the requirements for the exception for small biotech drugs (the “Small Biotech Exception,” or “SBE”). This information is required in order for CMS to accurately identify whether a given drug meets the criteria for the Small Biotech Exception in accordance with section 1192(d)(2) of the Act. To ensure that drugs covered under Part B and/or Part D that meet the requirements for the SBE are excluded from the term “negotiation-eligible drug,” a manufacturer that seeks the SBE for its drug covered under Part B and/or Part D (“Submitting Manufacturer”) must submit information to CMS about the company and its products in order for the drug to be considered for the exception. If the Submitting Manufacturer seeks the SBE for a drug covered under Part B and/or Part D it acquired after December 31, 2021, the Submitting Manufacturer must also submit information related to the separate entity that had the Medicare Coverage Gap Discount Program agreement for the drug on December 31, 2021 for drugs covered under Part D and information related to the holder of the New Drug Application(s) (NDA)(s) or Biologics License Applications(s) (BLA)(s) as of December 31, 2021 for drugs covered under Part B. If the Submitting Manufacturer was acquired by another entity after December 31, 2021, the Submitting Manufacturer must provide information regarding that acquiring entity for CMS to assess whether the acquisition triggers the limitation at section 1192(d)(2)(B)(ii) of the Act. Under section 1192(f)(1)(B) of the Act, the manufacturer of a biosimilar biological product (“Biosimilar Manufacturer” of a “Biosimilar”) may submit a request, prior to the selected drug publication date, for CMS’ consideration to delay the inclusion of a negotiation-eligible drug that includes the reference product for the Biosimilar (such a negotiation-eligible drug is herein referred to as a “Reference Drug”) on the selected drug list for a given initial price applicability year. CMS needs to collect information to identify the Biosimilar Drug, the Reference Drug, the Biosimilar Manufacturer and the Section 1194(f) of the Act establishes the requirements governing the identification of renegotiation-eligible drugs and selection of drugs for renegotiation. CMS must collect information from Primary Manufacturers to determine which selected drugs qualify as a renegotiation-eligible drug and may be selected for renegotiation in accordance with section 1194(f)(3) of the Act. Specifically, section 1194(f)(2)(D) of the Act instructs CMS to identify whether a selected drug is eligible for renegotiation based on a material change to any of the factors listed in section 1194(e) of the Act, which include the data in section 1194(e)(1) that must be submitted by the Primary Manufacturer of a selected drug. Additionally, once a drug has been selected for renegotiation, CMS must also consider section 1194(e)(1) data during the renegotiation period in the development of offers and consideration of counteroffers.

The latest form for Negotiation Program Drug Selection for Initial Price Applicability Year 2028 (CMS-10844) - IRA expires 2028-11-30 and can be found here.

Small Biotech Exception

Federal Enterprise Architecture: Health - Health Care Services

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