Medicare Prescription Drug Inflation Rebate Program: Sections 11101 and 11102 of the Inflation Reduction Act (IRA) (CMS-10930)
New collection (Request for a new OMB Control Number)
No
Regular
07/24/2025
Requested
Previously Approved
36 Months From Approved
26,000
0
208,000
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.
We estimate that approximately 6,500 covered entities will respond and submit data to the 340B Repository Data Elements Reporting Form for CY 2026 based on internal CMS analyses of the unique 340B ID numbers in the HRSA OPAIS database that are active (that is, not terminated) with at least one contract pharmacy association listed and based on comments received on the CY 2025 PFS proposed rule from interested parties, including covered entities, requesting and expressing support for the establishment of a 340B repository.
We expect that each submission would take 6 hours at $106.02/hr for a Software Quality Assurance Analyst and Tester and 2 hours at $128.00/hr for a General and Operations Manager. In aggregate, we estimate an annual burden of 208,000 hours (6,500 covered entities x 8 hr/response x 4 responses/year) at a cost of $23,195,120 (26,000 responses x [(2 hr x $128.00/hr) + (6 hr x $106.02/hr)]).
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 Voluntary 340B Repository Data Element Reporting Requirements
CMS-10930 - Supporting Statement A (CMS-1832-P version 1+).docx
Voluntary 340B Repository Data Element Reporting Requirements