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Dispute Resolution HRSA Federal Rules of Civil Procedure

Mintz - Health Care Viewpoints

340B Program Administrative Dispute Resolution Final Rule: Key Takeaways

On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR)...more

ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

ArentFox Schiff on

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more

King & Spalding

HRSA Proposes Changes to ADR Procedures for 340B Disputes

King & Spalding on

On November 29, 2022, the Health Resources and Services Administration (HRSA) issued a proposed rule (Proposed Rule) to revise the alternative dispute resolution (ADR) procedures for disputes arising under the 340B drug...more

King & Spalding

HRSA Implements Administrative Dispute Resolution Process for 340B Program

King & Spalding on

On December 10, 2020, HRSA issued a final rule (the Final Rule) implementing the 340B Drug Pricing Program administrative dispute resolution (ADR) process–an overdue mandate from the Affordable Care Act. Under the Final...more

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