The American Hospital Association has filed a friend-of-the-court brief supporting HHS’ motion to dismiss AbbVie’s lawsuit challenging the agency’s longstanding definition of “patient” under the 340B Drug Pricing Program.
The brief, filed July 14, argues AbbVie is attempting to bypass the program’s required audit and administrative dispute resolution process by asking a federal court to rewrite established program rules. America’s Essential Hospitals, the Children’s Hospital Association, the Association of American Medical Colleges and the American Society of Health-System Pharmacists also joined the AHA’s filing.
Here are four things to know:
- The AHA said AbbVie’s claims are premature. The association argued the drugmaker has not completed the 340B program’s required audit and administrative review process before seeking judicial intervention.
- The AHA said the HHS’ definition of “patient” is consistent with the 340B statute and warned that allowing the case to proceed could deprive hospitals of due process protections guaranteed under the law.
- AbbVie filed suit in April, arguing HHS’ 1996 guidance allows covered entities to claim 340B discounts for prescriptions tied to minimal or unrelated patient interactions. The company is seeking a narrower definition requiring prescriptions to be connected to care provided at the qualifying facility.
- AbbVie’s lawsuit follows a series of legal disputes over the 340B program, including litigation over state contract pharmacy laws and the company’s unsuccessful challenge to Tennessee’s Hospital Protection Act.
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