Medicare Transaction Facilitator for 2026 and 2027 under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) (CMS-10912)
New collection (Request for a new OMB Control Number)
No
Regular
Approved with change
05/09/2025
04/01/2025
Prior to the submission of the information collection request (ICR) âMedicare Transaction Facilitator for 2026 and 2027 under Sections 11001 and 11002 of the Inflation Reduction Act (IRA),â CMS will provide analysis of the MTF data submissions from manufacturers and dispending entities including the Maximum Fair Price (MFP) effectuation plans and the complaints and disputes form. Also, for the 2028 ICR submission, CMS will address how it made improvements, simplified, and reduced burden on manufacturers and dispending entities.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2027
36 Months From Approved
93,375
0
0
877,960
0
0
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 (âthe Negotiation Programâ), codified in sections 1191 through 1198 of the Social Security Act (âthe Actâ). The Act establishes the Negotiation Program to negotiate a maximum fair price (âMFPâ), defined at section 1191(c)(3) of the Act, for certain high expenditure, single source drugs covered under Medicare Part B and Part D (âselected drugsâ). In accordance with section 1193(a) of the Act, any Primary Manufacturer of a selected drug that continues to participate in the Negotiation Program and reaches agreement upon an MFP must provide access to the MFP to MFP-eligible individuals, defined in section 1191(c)(2)(A) of the Act, and to pharmacies, mail order services, other dispensing entities, providers and suppliers with respect to such MFP-eligible individuals who are dispensed that selected drug during a price applicability period.
The purpose of this information collection request (ICR) is for CMS to collect information from manufacturers of drugs covered under Part D selected for negotiation under the Inflation Reduction Act for the initial price applicability years 2026 and 2027 and the dispensing entities that dispense the selected drugs to MFP-eligible individuals. To facilitate the effectuation of the MFP, CMS will engage a Medicare Transaction Facilitator (âMTFâ). The MTF system will be comprised of two modules: the MTF Data Module (MTF DM), and the MTF Payment Module (MTF PM). Primary Manufacturers participating in the Negotiation Program are required to participate in the MTF DM.
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.
Non-MTF User to Complete Drug Price Negotiation Program MTF DM Complaint Intake Form