Drug Price Negotiation Process under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849) - (IRA)
Revision of a currently approved collection
No
Regular
Approved without change
01/08/2025
11/25/2024
Prior to the submission of the information collection request (ICR) for Drug Price Negotiation Process under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849), CMS will provide an analysis of the 2027 negotiation data submissions from manufacturers including, but not limited to, a meta-analysis of data from sections C: Research and Development Costs, Recoupment and D: Current Unit Costs of Production and Distribution, and E: Prior Federal Financial Support. Also, in its 2028 ICR submission, CMS will address (1) improvements to the agencyâs ability to audit manufacturersâ data, (2) revisions to ensure high quality and more consistent data across manufacturers, and (3) reporting burden reductions for manufacturers based on the agency's experience and analysis of the Initial Price Applicability Year 2027 data submissions.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
01/31/2026
36 Months From Approved
09/30/2025
355
0
10
23,764
0
2,043
0
0
0
Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117-169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price Negotiation Program (the âNegotiation Programâ), codified in sections 1191 through 1198 of the Social Security Act (âthe Actâ). Section 1193(a)(1) of the Act establishes that CMS will negotiate an MFP with âthe manufacturerâ of the selected drug. In section 1191(c)(1) of the Act, the Negotiation Program statute adopts the definition of manufacturer established in section 1847A(c)(6)(A) of the Act. To the extent that more than one entity meets the statutory definition of manufacturer for a selected drug for purposes of initial price applicability year 2027.
The statute provides that, after receiving CMSâ written initial offer for a selected drug, the Primary Manufacturer may, in accordance with section 1194(b)(2)(C) of the Act, submit an optional written counteroffer (if CMSâ 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 CMSâ written initial offer during the drug price negotiation process for initial price applicability year 2027, the Primary Manufacturer must submit the Counteroffer Form.
Burden has increased due to the merger of the "Written Counteroffer" (CMS-10849) ICR and the "Negotiation Data Elements" (CMS-10847) ICR into this existing ICR package for the Drug Price Negotiation Process that was developed to streamline the review process for the pharmaceutical industry and other interested parties when reviewing Paperwork Reduction Act (PRA) renewals for this notice.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Negotiation Data Elements ICR Form