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Federal Court Strikes Down HRSA’s Offsite Registration Policy

Mar 3, 2026 | 340B, Litigation, News and Updates

On March 3, 2026, the U.S. District Court for the District of Columbia struck down the Health Resources & Services Administration’s (HRSA’s) requirement that for new offsite outpatient facilities to be eligible to use 340B discounted drugs they must...

Texas District Court Sets Aside 2024 CMS Hold Harmless Rule & Related Bulletins

Sep 24, 2025 | Litigation, Medicaid

A Texas District Court judge granted Texas’ motion for summary judgment in the state’s lawsuit challenging two CMS Informational Bulletins and provisions in CMS’ 2024 Medicaid managed care rule that prohibit certain voluntary redistribution agreements among private...

HRSA Notifies Six Drug Manufacturers of Referral to OIG for Possible Penalties

Sep 22, 2021 | 340B, Litigation, News and Updates

The Health Resources and Services Administration (HRSA) has taken additional steps to require 340B drug discounts when drugs are dispensed through contract pharmacies. On September 22, HRSA followed up on earlier letters to six manufacturers refusing contract pharmacy...

HRSA Withdraws Contract Pharmacy Advisory Opinion But Will Continue Enforcement of Statute, Including Pursuant to May 17 Letters

Jun 18, 2021 | 340B, Litigation

The Health and Resource Service Administration (HRSA) announced June 18, in connection with the ongoing AstraZeneca case, that is withdrawing its December 2020 contract pharmacy Advisory Opinion “to avoid confusion and unnecessary litigation.” Despite withdrawal of...

Judge in AstraZeneca Lawsuit Denies Government’s Motion to Dismiss

Jun 16, 2021 | 340B, Litigation, News and Updates

A district court judge in Delaware issued an opinion denying the government’s motion to dismiss a lawsuit regarding a December 2020 Advisory Opinion issued by the Health and Resource Service Administration (HRSA). The judge concluded that the 340B statute is silent as...

Manufacturers Respond to HRSA 340B Cease and Desist Letter

Jun 10, 2021 | 340B, Litigation, News and Updates

On June 10, 2021, Eli Lilly became the third manufacturer to response to HRSA’s May 17th Cease and Desist letter on 340B drug pricing. The response details Eli Lilly’s rejection of HRSA’s reasoning in its Cease and Desist letter, arguing that the agency’s reasoning is...
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