Lexology December 7, 2022
Citing “policy and operational challenges” with the current 340B Administrative Dispute Resolution (ADR) Process, the US Department of Health and Human Services (HHS) has issued a new Proposed Rule to modify the current ADR Process. The Proposed Rule would materially simplify and speed up the ADR Process, but leaves open questions as to the specific nature and scope of disputes that can be brought to the ADR Panel for review. Further, like the current ADR Process, the proposed process will likely only serve as the starting point of a formal litigation process to resolve disputes between 340B Covered Entities and drug manufacturers. The Proposed Rule is available here. Our prior analysis of the rule implementing the current ADR Process is...
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