Earlier this year, the Health Resources & Services Administration (HRSA) announced a pilot program which allows 340B discounts for certain drugs to be provided as a rebate after the purchase rather than an upfront discount. At this time, the program is limited to the ten drugs on the Centers for Medicare & Medicaid Services (CMS) Medicare Drug Price Negotiation Selected Drug List for year 2026.
HRSA recently approved nine manufacturer rebate plans which cover all ten eligible drugs. Eight of the plans will go into effect for all covered entities beginning on January 1, 2026, while Novartis’ plan will go into effect on April 1, 2026. The pilot will operate for a minimum of one year. While only a summary of the manufacturers’ approved plans is public, the manufacturers’ full notices to covered entities are available for review.
The pilot program will be operated through the Beacon technology platform. Both HRSA and Beacon have published FAQs about the pilot program.
Claims Submission
Covered entities must submit claims on Beacon within 45 days of dispensing the drug; although, some manufacturers may consider exceptions and extenuating circumstances for claims submitted later. The claim submission must contain the HRSA-approved pharmacy or medical data fields in order for a rebate to be approved.
Rebates will be processed and paid within 10 days of claim submission. The amount paid will be the difference between the Wholesale Acquisition Cost (WAC) price and 340B price for the product on the date of dispense regardless of the WAC price actually paid by a covered entity.
Denials
Denials will also be processed within 10 days of claim submission. Manufacturers noted in their letters that claims may be denied due to missing data fields or submission of the same claim by multiple covered entities. HRSA requires manufacturers to provide a rationale and supporting documentation for denials.
Alternatively, rebate requests under the pilot program may not be “denied based on compliance concerns with diversion or Medicaid duplicate discounts.” But, according to Beacon’s FAQs, 340B claims data may be used to (1) identify instances of duplication in Medicare, Medicaid, and commercial channels and (2) reduce or deny duplicate claims within such channels.
Agency Oversight
Manufacturers must submit periodic reports to HRSA. The agency will also review compliance with the rebate model when auditing covered entities and manufacturers.
HRSA has reserved the right to revoke rebate model approval if a manufacturer “trends toward” not paying rebates within 10 days of claim submissions. HRSA has also indicated that it will provide a mechanism in the future for stakeholders to provide feedback on the program.
If you have any questions about how the pilot program may impact you, please reach out to any Eyman Partners attorney to discuss.