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...