HRSA approves 8 drug company plans for participation in 340B Rebate Model Pilot Program

The Health Resources and Services Administration posted on its website that it had approved eight drug company plans for participation in the 340B Rebate Model Pilot Program with a start date of Jan. 1. 

The updated website includes a listing of the drug companies and drugs approved by HRSA for the pilot program. The bottom of the webpage also includes some updated FAQs related to the pilot program.

“Under the 340B Rebate Model Pilot Program, covered entities must continue to make purchases through their 340B wholesaler account and must ensure they are only requesting rebates on the above drugs dispensed to 340B eligible patients after a purchase is made,” HRSA said. “Manufacturers should work with their distributor partners to ensure the [wholesale acquisition cost] price is loaded in the 340B wholesaler account where purchases will be made by covered entities to then obtain a rebate.” 

“Manufacturers should subsequently work with their distributors to obtain necessary data from the 340B wholesaler account to monitor purchases in that account,” HRSA said. “Covered entities and manufacturers should maintain auditable records for puchases [sic] made subject to the 340B Rebate Model Pilot Program. HRSA will continue to audit both covered entities and manufacturers to ensure compliance with statutory requirements. All approved manufacturer plans will issue rebates based at the unit level.” 

The program, which HRSA announced July 31, will provide certain drugmakers the option to give access to 340B discounted pricing for certain drugs under a rebate model. The voluntary rebate program will be piloted for at least one year, which will allow HRSA to understand the “merits and shortcomings” of a rebate model in the 340B Drug Pricing Program. See the Aug. 1 AHA Regulatory Advisory for more details on the program.

In a Sept. 30 letter, AHA told HRSA that the agency vastly underestimated the costs the 340B Rebate Model Pilot Program will inflict on hospitals and asked the agency to delay implementation.