# 2025-24153: New Rules Tweak Drug Fees: Rebates Get a Regulatory Remix

2025-24153, Statutory Updates to Branded Prescription Drug Fee Regulations, is a Federal Register proposed rule from Treasury Department, Internal Revenue Service published 2026-01-02, effective 2025-01-01 (as of 2026-06-11).

- Canonical: https://policyrisk.com/federal-register/2025-24153
- As of: 2026-06-11
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-24153
- Title: Statutory Updates to Branded Prescription Drug Fee Regulations
- Type: Proposed Rule
- Agencies: Treasury Department; Internal Revenue Service
- Citation: 91 FR 93
- Published: 2026-01-02
- Effective: 2025-01-01
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: 1545-BR16
- Last updated: 2026-06-11

## In one line

New Rules Tweak Drug Fees: Rebates Get a Regulatory Remix

## Summary

If you make or import certain branded prescription drugs, new rules are coming your way! These updates change how discounts and rebates count toward fees you pay each year, thanks to a new law swapping out an old discount program. You’ve got until March 3, 2026, to share your thoughts before these changes take effect.

## Abstract

This document proposes amendments to regulations regarding the annual fee imposed on covered entities engaged in the business of manufacturing or importing certain branded prescription drugs. In response to the replacement of the Coverage Gap Discount Program with the new Manufacturer Discount Program by the Inflation Reduction Act of 2022, the proposed regulations would make updates regarding the discounts, rebates, and other price concessions used to determine branded prescription drug sales under Medicare Part D and would update for prior statutory changes. These proposed regulations would affect persons engaged in the business of manufacturing or importing certain branded prescription drugs.

## Effects PRIA read

- Manufacturer Discount Program Included: benefit, low. If you make or import certain branded prescription drugs, CMS will start counting discounts from the new Manufacturer Discount Program when it calculates Medicare Part D sales used to allocate the annual branded prescription drug fee. This change applies for sales years beginning on or after Januar…
- Coverage Gap Discount Updated to 70%: benefit, low. If you make or import certain branded drugs, the rules update the Coverage Gap Discount Program discount to 70 percent (instead of 50 percent) for plan years after plan year 2018 and correct the term to "manufacturer-paid." Discounts from the Coverage Gap Discount Program through December 31, 2024…
- Who Is Affected—and Small Business Exclusions: benefit, low. The proposed rule affects manufacturers and importers with branded prescription drug sales to specified government programs; Treasury and the IRS estimate roughly 300 affected entities based on tax year 2024. Entities with aggregate branded drug sales not more than $5 million will not be impacted,…
- No New Reporting Requirements Imposed: benefit, low. If you manufacture or import covered branded drugs, these proposed regulations do not create new reporting requirements for you. The changes apply to how Federal agencies (like CMS) compile and transmit data to the IRS, and Treasury and IRS expect minimal additional compliance costs for covered ent…

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## Sources
- [2025-24153 on federalregister.gov](https://www.federalregister.gov/documents/2026/01/02/2025-24153/statutory-updates-to-branded-prescription-drug-fee-regulations)
- [2025-24153 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-01-02/pdf/2025-24153.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-24153 (as of 2026-06-11).