New Rules Tweak Drug Fees: Rebates Get a Regulatory Remix
Published Date: 1/2/2026
Proposed Rule
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.
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
Manufacturer Discount Program Included
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 January 1, 2025 and affects how the $2.8 billion annual fee is apportioned.
Coverage Gap Discount Updated to 70%
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 may still be used to calculate fees for sales that occurred while that program was effective; no Coverage Gap discounts are expected to be taken into account beginning in the 2027 fee year.
Who Is Affected—and Small Business Exclusions
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, and the fee calculation excludes the first $5 million in sales and excludes 90 percent of sales that are over $5 million and not more than $125 million.
No New Reporting Requirements Imposed
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 entities.
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Key Dates
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