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HRSA Publishes 340B Program Dispute Resolution - Vimarsana News

HRSA Publishes 340B Program Dispute Resolution

Friday, December 11, 2020 On Thursday, 10 December 2020, the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) issued a pre-publication copy of the long-awaited 340B Drug Pricing Program Alternative Dispute Resolution (ADR) Final Rule. 1 The Final Rule was issued more than 10 years after the Affordable Care Act (ACA) amended the 340B statute to require the Secretary of HHS to promulgate regulations establishing and implementing a binding ADR process to resolve certain disputes between covered entities and manufacturers. 2 The ADR Fi...

HHS signs off on 340B dispute resolution rule - Vimarsana News

HHS signs off on 340B dispute resolution rule

HHS signs off on 340B dispute resolution rule Modern Healthcare Illustration / Getty Images The dispute resolution process proposed in 2016 allows covered entities to force drugmakers into a process that would result in final, binding decisions by the agency. The policy is a win for safety-net providers. But it's unlikely to put to bed the heated conflict between providers and drugmakers over providers' use of contract pharmacies. The administrative dispute resolution plan "is not an appropriate or timely solution for refusals by Eli Lilly, AstraZeneca, Sanofi, Novartis, United Therapeutics a...