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Covered Entities Pharmacies Manufacturers

McDermott Will & Emery

This Week in 340B: July 2 – 8, 2024

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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

Foley Hoag LLP

D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions

Foley Hoag LLP on

On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more

Bass, Berry & Sims PLC

D.C. Circuit Becomes Second Federal Appeals Court to Allow Restrictions on 340B Contract Pharmacies

Bass, Berry & Sims PLC on

On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...more

Polsinelli

HRSA Aims for Swift Dispute Resolution with new 340B ADR Final Rule

Polsinelli on

On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers....more

McDermott Will & Emery

This Week in 340B: January 2023 #5

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Foley Hoag LLP

HRSA Proposes to Overhaul 340B Dispute Process

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On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more

Manatt, Phelps & Phillips, LLP

[Ongoing Program] Understanding the 340B Program: A Guide to the Newest Developments - November 9th, 3:00 pm - 4:00 pm ET

Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - The 340B discount program—which requires manufacturers to provide outpatient drugs to...more

Husch Blackwell LLP

340B Update: HRSA Notifies Six Manufacturers That They Are In Violation Of The 340B Statute

Husch Blackwell LLP on

Since mid-2020, many pharmaceutical manufacturers have introduced policies that scope their offering of 340B pricing, including limiting contract pharmacy arrangements and requiring covered entities to submit claims data....more

McDermott Will & Emery

340B in 2021: What Covered Entities and Their Partners Need to Know Now

McDermott Will & Emery on

Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of...more

Bricker Graydon LLP

Federal court sides with Eli Lilly challenge to HHS expansion of 340B discounts

Bricker Graydon LLP on

On March 16, 2021, the United States District Court in Indiana granted plaintiff Eli Lilly’s request for a preliminary injunction to halt implementation of a Department of Health and Human Services (HHS) rule published in...more

McDermott Will & Emery

[Webinar] 340B in 2021: What Covered Entities and Their Partners Need to Know Now - March 18th, 2:00 pm - 3:00 pm ET

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This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow. Our...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

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

K&L Gates LLP

340B Update: HRSA Moves Forward with 340B ADR Rule as Covered Entities Challenge Contract Pharmacy Actions

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In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more

K&L Gates LLP

340B Update: Congress and the Administration Respond to Drug Manufacturers' 340B Contract Pharmacy Actions

K&L Gates LLP on

In recent weeks, several drug manufacturers have taken actions that impact covered entities participating in the 340B Drug Pricing Program (340B Program) and their contract pharmacies....more

Baker Donelson

HRSA Guidance Updates Suggest Tightening of 340B Covered Entity Repayment Rules

Baker Donelson on

Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency's expectations for health care providers participating in the 340B drug...more

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