CMS announces the approval of the Negotiation Program Drug Selection for Initial Price Applicability Year 2028 under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request (hereinafter, the “Drug Selection ICR”) (CMS-10844, OMB 0938-1443) by the Office of Management and Budget (OMB) on November 10, 2025 (available at: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202509-0938-014).

The approved Drug Selection ICR package contains three parts:

• the Small Biotech Exception, which includes the information necessary for CMS to determine if a qualifying single source drug meets the requirements to be excluded as a negotiation-eligible drug upon request by the manufacturer of the drug,
• the Biosimilar Delay, which includes the information necessary for CMS to determine if the reference product of a biosimilar biological product (the “biosimilar”) qualifies for a delay of inclusion as a negotiation-eligible drug upon a request by the manufacturer of such a biosimilar, and
• the Identification and Selection of Renegotiation-Eligible Drugs, which includes a voluntary submission of data from Primary Manufacturers of selected drugs to inform CMS’ determinations of which selected drugs qualify as a renegotiation-eligible drug and may be selected for renegotiation for initial price applicability year 2028.

All responses to the Drug Selection ICR must be submitted to CMS by 11:59 p.m. PT on December 12, 2025. Additional information about the specific submission method for each part of the Drug Selection ICR is included below.

For questions, please contact IRARebateandNegotiation@cms.hhs.gov.

(1) Requesting a Small Biotech Exception in the CMS Health Plan Management System (CMS HPMS)

On November 12, 2025, CMS will release the functionality for manufacturers to request a Small Biotech Exception in the CMS HPMS for initial price applicability year 2028. Manufacturers seeking a Small Biotech Exception must submit a Small Biotech Exception request in the CMS HPMS by 11:59 p.m. PT on December 12, 2025.

Instructions for manufacturers to gain access to the CMS HPMS are available at: https://www.cms.gov/about-cms/information-systems/hpms/user-id-process. Manufacturers with access to the CMS HPMS will be able to access the functionality within the CMS HPMS to complete and submit a Small Biotech Exception request within the CMS HPMS no later than 12:00 a.m. PT on November 12, 2025: https://hpms.cms.gov/app/ng/home/.

Additional Information: Section 1192 of the Social Security Act (the “Act”) provides certain exceptions and exclusions for otherwise negotiation-eligible drugs. The submission of a request for a Small Biotech Exception provides the information necessary for CMS to determine the applicability of a potential circumstance provided under the Act where certain drugs may be removed from negotiation eligibility if certain statutory requirements are met. Specifically, in accordance with section 1192(d)(2) of the Act, the term “negotiation-eligible drug” excludes, with respect to 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”). The CMS HPMS functionality described above is the mechanism by which a manufacturer may request a Small Biotech Exception.

(2) Requesting a Biosimilar Delay in the CMS HPMS

On November 12, 2025, CMS will release the functionality for manufacturers to request a Biosimilar Delay in the CMS HPMS for initial price applicability year 2028. Manufacturers seeking a Biosimilar Delay must submit a Biosimilar Delay request in the CMS HPMS by 11:59 p.m. PT on December 12, 2025.

Instructions for manufacturers to gain access to the CMS HPMS are available at: https://www.cms.gov/about-cms/information-systems/hpms/user-id-process. Manufacturers with access to the CMS HPMS will be able to access the functionality within the CMS HPMS to complete and submit a request for a Biosimilar Delay within the CMS HPMS no later than 12:00 a.m. PT on November 12, 2025: https://hpms.cms.gov/app/ng/home/.

Additional Information: Section 1192 of the Act provides certain exceptions and exclusions for otherwise negotiation-eligible drugs. A Biosimilar Delay provides the information necessary for CMS to determine the applicability of a potential circumstance provided under the Act where certain drugs may be removed from negotiation eligibility if certain statutory requirements are met. In accordance with section 1192(f)(1)(B) of the Act, CMS may delay the inclusion of a negotiation-eligible drug that includes the reference product for a biosimilar biological product on the selected drug list for a given initial price applicability year if certain statutory requirements are met regarding the biosimilar’s status of licensure and marketing (the “Biosimilar Delay”) in accordance with section 1192(f) of the Act. The CMS HPMS functionality described above is the mechanism by which a manufacturer may request a Biosimilar Delay.

(3) Voluntary Submission of Information from Primary Manufacturers to Inform Renegotiation Drug Eligibility and Selection for Initial Price Applicability Year 2028

Primary Manufacturers of drugs originally selected for negotiation for initial price applicability years 2026 and 2027 may voluntarily submit information to CMS to inform renegotiation drug eligibility and selection for initial price applicability year 2028.

To provide CMS with the voluntary information, a Primary Manufacturer must first email CMS by 11:59 p.m. PT on November 28, 2025 at IRARebateandNegotiation@cms.hhs.gov to indicate its intention to submit the information. Primary Manufacturers are encouraged to use the email template included in the Drug Selection ICR (CMS-10844, OMB 0938-1443) available at: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202509-0938-014) to indicate their submission intent.

Once CMS receives notification of the Primary Manufacturer’s intent to provide the information, CMS will then provide the Primary Manufacturer with access to a specific Box folder and a template of the ICR questions for submission. To voluntarily provide CMS with information prior to renegotiation eligibility determination and selection, the Primary Manufacturer must have uploaded its submission to the Box folder by 11:59 p.m. PT on December 12, 2025.

Additional Information: Section 1194(f)(2) of the Act instructs CMS to identify whether a selected drug is eligible for renegotiation because a new indication has been added to the selected drug (per section 1194(f)(2)(A)) or because there has been a material change to any of the factors listed in section 1194(e) of the Act (per section 1194(f)(2)(D)). In accordance with section 1194(f)(3)(C) of the Act, CMS will select drugs for renegotiation from among these renegotiation-eligible drugs if CMS expects renegotiation is “likely to result in a significant change” in the maximum fair price (MFP). This applies to renegotiation-eligible drugs that are not automatically selected for renegotiation due to a change in monopoly status.