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Dispute Resolution Manufacturers Department of Health and Human Services (HHS)

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...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

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

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On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

Foley Hoag LLP

HRSA ADR Panel Dismisses NACHC's 340B Complaint Against Two Drug Manufacturers

Foley Hoag LLP on

The 340B program requires drug manufacturers to offer outpatient pharmaceuticals to statutorily defined covered entities (including certain hospitals and certain federal grantees, such as federally qualified health centers)...more

King & Spalding

Federal Judge Blocks Implementation of 340B ADR Final Rule

King & Spalding on

On March 16, 2021, a federal judge issued a preliminary injunction blocking HHS from implementing the 340B administrative dispute resolution final rule (the Final Rule) released in December 2020. The blocked Final Rule would...more

Hinshaw & Culbertson - Health Care

Change is on the Horizon for 340B Pharmacy Program's Administrative Dispute Resolution Process

The U.S. Health Resources and Services Administration (HRSA) published a final rule (the Rule) on December 14, 2020, which outlined the requirements and procedures for the 340B pharmacy program's administrative dispute...more

Verrill

340B Providers Get Partial Relief from New Dispute Resolution Regulation

Verrill on

1. 340B ADR Process Established - At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical...more

McDermott Will & Emery

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

McDermott Will & Emery on

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

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