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Healthcare Reform HRSA Section 340B

Mintz - Health Care Viewpoints

Will Sustained Pressure on the 340B Program Finally Lead to Much Needed Reform?

As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s...more

Foley Hoag LLP

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

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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

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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

McDermott+

McDermottPlus Check-Up: April 26, 2024

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A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...more

McDermott Will & Emery

This Week in 340B: April 16 – April 22, 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

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

McDermott Will & Emery

This Week in 340B: December 21, 2023 – January 8, 2024

McDermott Will & Emery on

We’re back from the holidays with updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country as we move into 2024. Each week we comb through the dockets of more than 50 340B...more

McDermott Will & Emery

New HRSA 340B Program Resource Asserts Agency’s Position on “Patient” Definition

McDermott Will & Emery on

On December 14, 2023, Health Resources & Services Administration (HRSA) announced a new resource on the 340B Program website compiling resources associated with the 340B Program definition of “patient.” The website is...more

McDermott Will & Emery

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

McDermott Will & Emery on

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

Foley Hoag LLP

District Court Invalidates 340B Patient Definition in Genesis Case, Raising Questions About Program Scope

Foley Hoag LLP on

On Friday, November 3, 2023, the U.S. District Court for the District of South Carolina issued a long-awaited decision in Genesis Health Care, Inc. v. Becerra—a case dating back to 2017 contesting HRSA’s definition of...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

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On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

Manatt, Phelps & Phillips, LLP

340B Roundup: Trump-Era Rule Rescinded, Motion to Dismiss Denied & HRSA Advisory Opinion Withdrawn

The last two weeks of June saw several key developments affecting the 340B Drug Pricing Program—a federal government program created in 1992 that requires pharmaceutical manufacturers to provide outpatient drugs to eligible...more

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – July 2017 #2

Welcome back everybody. The absence of Senator John McCain (AZ) – who is recovering at home from a craniotomy – has caused Senate Republicans to delay consideration of the Better Care Reconciliation Act (BCRA) previously...more

Polsinelli

Health Reform + Related Health Policy News - December 2014, Issue 1

Polsinelli on

In This Issue: - Top News ..Congress Passes Omnibus Spending Package ..HRSA Cancels Plan for 340B ‘Mega Reg’; Congress Weighs Options ..Supreme Court to Hear Challenge to ACA Subsidies ...more

Mintz - Health Care Viewpoints

Health Update - June 2014

In This Issue: - Judge Rules Against 340B Drug Authority - FDA Approves Skin Infection Drug - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

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