340B Dispute Resolution Rule Likely Violated Proper Regulatory Procedures – Court
Ruling halts the 340B rule, and may have relevance in a suit brought by PBMs challenging the ‘rebate rule,’ which was issued in final form after HHS had suspended action on the reg.
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340B Fight Escalates As Biden Administration Seeks Refunds From Manufacturers, Threatens Them With Fines
Lilly, AstraZeneca, Novartis, Sanofi, Novo Nordisk and United Therapeutics ordered by HRSA to resume discounts to 340B contract pharmacies and refund past 'overcharges.'
HHS initially postponed only those provisions of the final regulation that were scheduled to go into effect 29 January, but Biden Administration now faces April deadline from court to determine how to proceed with the rest of the rule.
Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?