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Administrative Procedure Act HRSA

McDermott Will & Emery

Loper Bright and the 340B Statute

McDermott Will & Emery on

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

King & Spalding

Fifth Circuit Reverses District Court’s Nationwide Injunction on ACA’s Preventive Care Coverage Mandates

King & Spalding on

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

Groom Law Group, Chartered

Latest Update to the Ongoing Challenge to the ACA’s Preventive Services Mandate

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

Foley & Lardner LLP

What Does the End of Chevron Deference Mean for Federal Health Care Programs?

Foley & Lardner LLP on

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

Epstein Becker & Green

Fifth Circuit Poised to Uphold Ruling Striking Down Preventive Coverage Requirement

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

Robinson+Cole Health Law Diagnosis

Delaware District Court Determines that HRSA Enforcement Letter Targeting 340B Program Restrictions Violates the APA

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

Bass, Berry & Sims PLC

Government Appeals Decisions in 340B Contract Pharmacy Litigation

Bass, Berry & Sims PLC on

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

Foley & Lardner LLP

Court Sides with Drug Manufacturers in Ongoing 340B Litigation

Foley & Lardner LLP on

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

Sheppard Mullin Richter & Hampton LLP

Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the...

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

ArentFox Schiff

340B Entities Sue HHS Over Lack of Dispute Resolution Process

ArentFox Schiff on

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

Hogan Lovells

United States Supreme Court recognizes employer religious freedoms in two recent decisions

Hogan Lovells on

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

McNees Wallace & Nurick LLC

Supreme Court Rules that Employers May Use Religious and Moral Exemptions for Requirement to Provide Health Plan Coverage for...

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

Fisher Phillips

Supreme Court Upholds Rules Expanding Exemptions To ACA’s Contraceptive Mandate

Fisher Phillips on

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

Ballard Spahr LLP

Supreme Court Upholds Exemption to ACA’s Contraceptive Mandate

Ballard Spahr LLP on

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

Franczek P.C.

SCOTUS Gives Religious Exemptions Wide Berth in Two Key Employment Rulings

Franczek P.C. on

On July 8, the U.S. Supreme Court issued two 7-2 decisions involving religious exemptions to federal employment and benefits laws....more

Burr & Forman

New Supreme Court Ruling Allows Religious Employers to Exempt Birth Control from Health Care Coverage

Burr & Forman on

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

Bricker Graydon LLP

Religious exemption carries in U.S. Supreme Court decision on preventive reproductive care

Bricker Graydon LLP on

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

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania and Trump v. Pennsylvania

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

Jones Day

Legislation, Lawsuit Cloud Future of 340B Program Payment Rate Reductions

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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

Arnall Golden Gregory LLP

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

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

K&L Gates LLP

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

K&L Gates LLP on

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

Foley & Lardner LLP

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

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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

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