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Department of Health and Human Services (HHS) 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

Davis Wright Tremaine LLP

Litigation Preparedness Following a Data Breach: Three Tips to Consider During the Incident Response Period

Data breaches come in many different forms, sizes, and levels of complexity, but they tend to share certain key facts: A third-party bad actor—whether through a phishing attack, a ransomware attack, exploitation of a zero-day...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - July 2023

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...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

McDermott Will & Emery

HHS Goes Back to the Drawing Board on the 340B ADR Process

McDermott Will & Emery on

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...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

Holland & Hart - Health Law Blog

Utah Care-Review Privilege

Utah adopted a care-review privilege “to improve medical care by allowing health-care personnel to reduce morbidity or mortality and to provide information to evaluate and improve hospital and health care.” In January, the...more

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