News & Analysis as of

Final Rules PHRMA

Bass, Berry & Sims PLC

Federal District Court Vacates Copay Accumulator Adjustment Rule: Programs Remain the Same for Now

Bass, Berry & Sims PLC on

On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more

Hogan Lovells

D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

Hogan Lovells on

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s motion for summary judgment and vacating (i.e.,...more

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

King & Spalding

D.C. District Court Rules Drug Manufacturer Group Must File New Lawsuit To Challenge HHS Interpretive Rule on 340B Orphan Drug...

King & Spalding on

On August 27, 2014, the United States District Court for the District of Columbia rejected Plaintiff Pharmaceutical Research and Manufacturers of America’s (PhRMA) request to invalidate HHS’s recent interpretive rule...more

BakerHostetler

The Orphan Drug Wars: HHS’s Rebuttal to Its Recent Loss to PhRMA

BakerHostetler on

On June 18, 2014, the U.S. Department of Health and Human Services (HHS) publicly stated that the recent decision of the U.S. District Court for the District of Columbia to vacate HHS’s regulation covering orphan drugs and...more

BakerHostetler

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

BakerHostetler on

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

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