Category Archives: Litigation

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340B Program Alert: Federal District Court Pauses Scheduled Implementation of Rebate Pilot Program

By Brenda Maloney Shafer, Richard Davis, Michael French and Jake Pallotta on Posted in Covered Entities, Litigation
Mere days before the Health Resources and Services Administration’s (HRSA) 340B Rebate Model Pilot Program’s (“Pilot”) scheduled January 1, 2026 effective date, a federal district court granted a preliminary injunction that temporarily halts the scheduled implementation of the Pilot approved rebate models. The decision, citing significant deficiencies in HRSA’s administrative processes when developing and implementing … Continue Reading

340B Developments in 2024 – Litigation and Legislation

By Richard Davis, Brenda Maloney Shafer, Madison Hartman and Michael French on Posted in Legislation, Litigation
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts. Litigation Update Although 340B stakeholders still await the 7th Circuit and the DC Court of appeals to weigh in on the permissibility of manufacturer contract pharmacy restrictions, another … Continue Reading

The Current State of 340B and What to Expect in 2023

By Brenda Maloney Shafer, Richard Davis, Michael French and Madison Hartman on Posted in Legislation, Litigation
2022 was an eventful year on the 340B front, packed with updates to consequential litigation, proposed new rules, ongoing uncertainty into the Health Resources and Services Administration’s (HRSA) underlying enforcement authority, and changes to 340B-related laws on the state level. We saw the Supreme Court side with 340B hospitals in a significant $1.6 billion Medicare … Continue Reading

Brenda Shafer, Michael French and Richard Davis Author Law360 Article on Questions Related to Section 340B Drug Pricing

By Brenda Maloney Shafer, Michael French and Richard Davis on Posted in Contract Pharmacies, Legislation, Litigation
Quarles Health & Life Sciences attorneys Brenda Shafer, Michael French and Richard Davis recently wrote an article for Law360 about questions surrounding the ability of the Health Resources and Services Administration’s ability to enforce key requirements related to the Section 340B drug pricing program. In the article, Shafer, French and Davis address aspects of the 340B program … Continue Reading

340B Program Changes on the Horizon? Start Planning Now for Potentially Seismic Impact of Upcoming Genesis Decision

By Michael French, Brenda Maloney Shafer and Richard Davis on Posted in Covered Entities, Guidance, Litigation
As the extensively covered Genesis Healthcare, Inc. v. Azar case continues to proceed, 340B covered entities expect to soon receive much-anticipated clarification on what can reasonably constitute a 340B eligible patient. In the meantime, covered entities should begin planning and strategizing now for how such a significant change to the 340B Program would impact its 340B services … Continue Reading
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