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Section 340B HRSA Enforcement Actions

McDermott Will & Emery

This Week in 340B: February 18 – 24, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Emery

This Week in 340B: February 4 – 10, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Emery

This Week in 340B: January 28 – February 3, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Emery

This Week in 340B: December 17, 2024 – January 6, 2025

Find updates on 340B litigation from December 17, 2024 – January 6, 2025 to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to...more

McDermott Will & Emery

What Makes a Patient a “Patient”? Court Rejects Restrictive 340B Definition

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On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more

Bass, Berry & Sims PLC

Third Circuit Ruling Allows Restrictions on 340B Contract Pharmacies

On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more

Robinson+Cole Health Law Diagnosis

Delaware District Court Determines that HRSA Enforcement Letter Targeting 340B Program Restrictions Violates the APA

A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the...more

ArentFox Schiff

340B “Saga” Works Its Way Through the Courts: What Manufacturers Need to Know

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A handful of recent court decisions have brought a small degree of resolution and simultaneously a large degree of uncertainty to what we at Arent Fox affectionately refer to as the “340B Saga.” It’s a dispute lasting...more

Foley Hoag LLP - Medicaid and the Law

District Courts Issue Key Decisions in 340B Contract Pharmacy Cases

Over the last two weeks we have seen a flurry of activity from U.S. District Courts across the country in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and HRSA, the agency responsible for...more

Foley & Lardner LLP

Court Sides with Drug Manufacturers in Ongoing 340B Litigation

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Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more

Sheppard Mullin Richter & Hampton LLP

Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the...

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...more

Foley & Lardner LLP

New HHS Board Will Hear 340B Drug Pricing Disputes

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On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing...more

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

Baker Donelson on

Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

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