340B Action Heats Up: New Developments From the Courts, Administration and Drug Makers

In the courts, in the Administration and in drug maker initiatives, action on the Section 340B prescription drug discount program has heated up this summer. The program, known by its section number of the federal Public Health Service Act, has been the subject of a D.C. District Court of Appeals decision upholding a reduction in Medicare reimbursement for certain 340B-purchased drugs, a regulatory proposal to reduce such reimbursement even further, steps by pharmaceutical manufacturers to address perceived compliance issues in the 340B contract pharmacy context, and an agency notice imposing additional 340B registration requirements for nonprofit hospitals. This article provides details on these issues, as well as on President Trump’s recent executive order regarding federally qualified health center prices for insulin and injectable epinephrine.

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