The Biden administration recently proposed revising the process behind an outlet for pharmaceutical companies to resolve price fights for those participating in the 340B drug discount program. According to this Bloomberg article, disputes between providers and pharmaceutical companies were in limbo as the industry waited for the Biden administration to replace an administrative dispute resolution (ADR) board. McDermott Partner Emily J. Cook said the proposed US Department of Health and Human Services rule ushers in “some significant changes” from the prior ADR process.
340B hospitals should not expect to receive withheld program funds anytime soon despite a recent US Supreme Court ruling. According to this Becker’s Hospital Review article, the Court reversed a 2020 federal appeals court ruling that found that the US Department of Health and Human Services (HHS) had the authority to make a $1.6 billion annual reimbursement cut to the program under its Medicare Outpatient Prospective Payment System (OPPS). McDermott Partner Emily J. Cook said that the ruling will not result in any immediate changes to Medicare payments for 340B drugs nor require that HHS restore the full payment rates for the drugs.
The US District Court for the District of Columbia recently held that the Centers for Medicare and Medicaid Services (CMS) exceeded its authority by reducing Medicare payment rates for 340B drugs, but, because of the budget-neutral nature of the cuts, the court left implementation details of its order temporarily unresolved to avoid disrupting administration of the Medicare Hospital Outpatient Prospective Payment System. It remains to be seen what remedies the court will ultimately order and whether CMS will appeal the decision.
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