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 the informal guidance, HRSA […]
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 […]
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 […]
On May 17, 2021, the Health and Resource Service Administration (HRSA) issued letters to six pharmaceutical manufacturers requiring the entities to immediately cease an ongoing practice of withholding 340B pricing to covered entities utilizing contract pharmacies. Manufacturers have defended these […]
A district court judge in Indiana today issued a narrow ruling enjoining the Department of Health and Human Services (HHS) from implementing a rule issued in December finalizing administrative dispute resolution (ADR) procedures for the 340B program. Eli Lilly argued […]
A district court judge in California today dismissed a lawsuit filed by several hospital associations seeking to ensure enforcement of 340B discounts when drugs are dispensed through contract pharmacies. The judge concluded that the lawsuit was premature, as no final […]
Six national associations representing hospitals and pharmacists, and three individual hospitals participating in the 340B drug discount program, filed a lawsuit in the Northern District of California asking the court to order the Health and Resource Service Administration (HRSA) to […]
On April 20, The U.S. Court of Appeals for the Fifth Circuit became the third appeals to court to reinstate CMS’ 2017 final rule requiring states to include Medicare and commercial payments in their Medicaid DSH limit calculations. The rule […]
On April 6, 2020, a petition for writ of certiorari was filed in the DSH litigation case of Children’s Hospital Association of Texas v. Azar.
After the Health and Resource Service Administration (HRSA) issued a December Advisory Opinion requiring 340B discounts for drugs dispensed through contract pharmacies, four drug manufacturers—Eli Lilly, AstraZeneca, Sanofi, and Novo Nordisk—have now filed four separate lawsuits in three jurisdictions challenging […]
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