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| TREAS/IRS | RIN: 1545-BR16 | Publication ID: 2026 |
| Title: Branded Prescription Drug Fee Discounts | |
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Abstract:
The proposed regulation updates 51.4(b)(2)(i)(B) and (iv) of the Branded Prescription Drug Fee Regulations, which currently cite to the Coverage Gap Discount Program described in section 1860D-14A of the SSA (42 U.S.C.1395w-114a), to reflect that the Inflation Reduction Act terminated this program and replaced it with the Manufacturer Discount Program described in section 1860D-14C of the SSA (42 U.S.C. 1395w-114c). The proposed regulations would also update 51.11 to reflect the applicability date for proposed 51.4(b)(2)(i)(B) and (iv). This regulatory action is aligned with Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First (Apr. 15, 2025). Additionally, updating the regulations to conform with recent statutory changes reduces the compliance burden for feepayers. |
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| Agency: Department of the Treasury(TREAS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: No | Unfunded Mandates: No |
| EO 14192 Designation: Deregulatory | |
| CFR Citation: 26 CFR part 51 (Revision) (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: Pub. L. 117-169, sec. 11201 26 U.S.C. 7805 | |
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Legal Deadline:
None |
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Timetable:
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| Additional Information: REG-103430-24 Drafting attorney: Julia Barlow, (202) 317-3305 Reviewing attorney: Charles Langley, (202) 317-5274 Treasury attorney: Shelley Leonard, (202) 622-2172 CC: ECE | |
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Small Entities Affected: No | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
| Related RINs: Related to 1545-BJ39 | |
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Agency Contact: Julia Barlow Attorney Department of the Treasury Internal Revenue Service 1111 Constitution Avenue NW, Room 5316, Washington, DC 20224 Phone:202 317-3305 Email: julia.c.barlow@irscounsel.treas.gov |
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