The Health Resources and Services Administration has approved eight manufacturer rebate plans under a new 340B pilot program set to launch Jan. 1. The initiative will replace upfront drug discounts with post-sale rebates and comes amid heightened tension between hospitals and federal regulators over changes to the 340B program.
Here are five things to know:
- Eight manufacturers, 9 drugs, one platform: Participating drugmakers include Bristol Myers Squibb, Immunex Corp., AstraZeneca AB, Pharmacyclics, Merck Sharp & Dohme, Boehringer Ingelheim, Novo Nordisk, Janssen Biotech and Janssen Pharmaceuticals. All plans apply to all covered entity types and use the Beacon platform. Covered drugs include Eliquis, Enbrel, Farxiga, Imbruvica, Januvia, Jardiance, multiple NovoLog and Fiasp products, Stelara and Xarelto.
- Rebates to replace upfront discounts: Manufacturers will issue post-sale rebates instead of upfront 340B discounts. Covered entities must purchase through their 340B wholesaler accounts and submit pharmacy and medical claims data to obtain unit-level rebates.
- Administrative burden is expected to grow: Hospital and pharmacy leaders have warned the model could strain safety-net providers by creating cash flow gaps and adding paperwork. A 340B Health analysis found that disproportionate-share hospitals could face average upfront costs of more than $72 million if the model expands.
- Lawmakers seek postponement: A bipartisan group of 162 lawmakers has urged HHS to pause the pilot, citing concerns about its fast-tracked timeline and potential legal overreach.
- Hospitals criticize rebate model: America’s Essential Hospitals called the pilot “a clear case of the fox guarding the hen house” in an Oct. 30 statement. President and CEO Jennifer DeCubellis said the model offers “no benefit to patients’ ability to access discounted drugs” and would harm hospitals that rely on 340B to serve vulnerable populations.
