Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more
On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more
In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and...more
On June 21, 2024, a three-judge panel of the United States Court of Appeals for the Fifth Circuit issued an opinion in Braidwood Management Inc. et al. v. Xavier Becerra et al. reversing an injunction entered by the lower...more
On June 21, 2024, the United States Court of Appeals for the Fifth Circuit (“Fifth Circuit”) issued its ruling in Braidwood v. Becerra. The court determined that the Affordable Care Act’s (“ACA”) requirement that group...more
On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo. In a 6-3 decision, the Court held that Chevron’s rule that courts must defer...more
A federal appeals court panel in New Orleans is poised to uphold a lower court ruling enjoining the enforcement of the Affordable Care Act's (ACA) requirement that most private health insurance cover recommendations of the...more
A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the...more
On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more
Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more
On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...more
Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more
On July 8, 2020, the United States Supreme Court decided two cases addressing employers’ religious freedoms in very different contexts: one concerning whether religious school teachers could challenge adverse employment...more
On July 8, 2020, in the consolidated cases of Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania et al. and Donald J. Trump, President of the United States, et al. v. Pennsylvania et al., the U.S. Supreme...more
The Supreme Court just upheld two Trump-era rules expanding religious and moral exemptions to the Affordable Care Act’s (ACA) contraceptive mandate. The July 8 decision in Little Sisters of the Poor v. Pennsylvania is just...more
In Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania, the Supreme Court this week upheld regulations issued by the U.S. Departments of Treasury, Labor, and Health and Human Services (the Departments) that...more
On July 8, the U.S. Supreme Court issued two 7-2 decisions involving religious exemptions to federal employment and benefits laws....more
This week, the Supreme Court ruled that employers may exclude coverage for birth control from their health plans based upon moral or religious objections to contraception. ...more
Until this week, federal law required most insurance plans to cover the cost of birth control without a copay. However, the history behind this issue can be traced back much further....more
On July 8, 2020, the U.S. Supreme Court decided Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania and Trump v. Pennsylvania, holding that the Department of Health and Human Services validly created...more
The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more
In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more
In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more