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The 340b rebate model pilot program consists of a selected group of drugs of manufacturers who have submitted plans meeting specific criteria that hrsa has approved. On august 1, 2025, the health resources and services administration (hrsa), administrator of the 340b drug pricing program, announced its voluntary 340b rebate model pilot program in a notice and set forth next steps for drug manufacturers to apply to participate in the program. Manufacturer plans for participation in the 340b rebate model pilot program should be submitted to 340bpricing@hrsa.gov no later than september 15, 2025
Approvals will be made by october 15, 2025, for a january 1, 2026, effective date. Under the program, 340b covered entities will be required to initially purchase drugs above the 340b ceiling price and later receive. As evidenced by manufacturer contract pharmacy restrictions, being complicit could be detrimental to the intent of the 340b program
Comments are due by september 2, 2025.
The pilot program, effective january 1, 2026, offers a new path for drug manufacturers to provide 340b discounts via rebates, but only with prior hrsa approval and under strict parameters. 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 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.
Manufacturers that wish to apply must submit plans for participation to the agency no later than september 15, 2025, with agency approvals to be made by october 15, 2025 for an effective date of january 1, 2026 Overview of 340b rebate pilot. Plan should include assurances that all costs for data submission through an information technology (it) platform be borne by the manufacturer and no additional administrative costs of running the rebate model shall be passed onto the covered entities. The health resources and services administration (hrsa) has approved a 340b rebate model pilot program that will significantly change how 340b discounts are accessed for covered entities for certain medications
The rebate model pilot program is voluntary for manufacturers, but if a manufacturer chooses to participate, covered entities will be required to participate for those specific drugs.
The health resources and services administration (hrsa) announced, on oct 30 which products will be included in the upcoming 340b rebate model pilot program Hrsa approved eight manufacturers’ plans, covering nine of the ten products eligible for the pilot
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