Prior to the re-submission of the information collection âMedicare Prescription Drug Inflation Rebate Program: Sections 11101 and 11102 of the Inflation Reduction Act (IRA) (CMS-10930)â 0938-1485), the agency will assess its respondent burden, utility, and if the collection is duplicative with other collections in HHS for implementing the 340B and other drug programs. This assessment will be guided by the principles and priorities set forth in the Executive Order 14192 title "Unleashing Prosperity Through Deregulation" (January 21, 2025) https://www.whitehouse.gov/presidential-actions/2025/01/unleashing-prosperity-through-deregulation/. The assessment will inform and be integrated in the agencyâs next extension or revision of this information collection.
Inventory as of this Action
Requested
Previously Approved
11/30/2028
36 Months From Approved
10,400
0
0
83,200
0
0
0
0
0
The purpose of this ICR is for the Centers for Medicare & Medicaid Services (CMS) to collect information to implement the Medicare Part D Drug Inflation Rebate Program as proposed in CY 2026 Physician Fee Schedule (PFS) proposed rule. Specifically, section 1860D 14B(b)(1)(B) of the Act requires that beginning with plan year 2026, CMS shall exclude from the total number of units for a Part D rebatable drug, with respect to an applicable period, those units for which a manufacturer provides a discount under the 340B Program. In the CY 2026 PFS proposed rule, CMS proposed to establish a 340B repository to receive voluntary submissions from covered entities of certain data elements from Part D 340B claims to allow CMS to assess such data for use in identifying units of Part D rebatable drugs for which a manufacturer provides a discount under the 340B Program in a future applicable period. CMS proposed to allow covered entities to submit data on units of Part D rebatable drugs for which a manufacturer provides a discount under the 340B Program beginning in 2026 to begin testing the usability of the 340B repository. This ICR will enable CMS to collect information to implement this voluntary collection.
This is a new collection that is associated with our CY 2026 Physician Fee Schedule (PFS) final rule. The rule establishes a 340B repository to receive voluntary submissions from covered entities. Overall it sets out a burden of 10,400 responses (2,600 covered entities x 4 quarterly responses) and 83,200 total hours.
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.
Form CMS-10930 340B Repository Data Elements Reporting Example Form
RWC Comments on OMB IRA Collection 4904-4505-7155 v.3.pdf
CMS-10930- Supporting Statement A_(CMS-1832-F version 14).docx
Voluntary 340B Repository Data Element Reporting Requirements