Legal Opinion
Pharmaessentia USA Corporation v. United States Department of Health and Human Services
District Court, District of Columbia
Decided September 29, 2025No. Civil Action No. 2024-3346Published
1Opinion of the Court
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA PHARMAESSENTIA USA CORP., Plaintiff, v. Case No. 1:24-cv-03346 (TNM) DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants. MEMORANDUM OPINION PharmaEssentia USA, a drug manufacturer, challenges the Centers for Medicare and Medicaid Services’ (CMS) conclusion that it did not qualify as a “Specified Small Manufacturer.” That decision denied PharmaEssentia the ability to gradually phase in drug discounts the Inflation Reduction Act (IRA) mandates. The governing statutory scheme is complex, but the dispute is not. The parties agree…
2Cases cited28 opinions
- Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc.Supreme Court of the United States · 1975
- Thomas Jefferson University v. ShalalaSupreme Court of the United States · 1994
- Kisor v. WilkieSupreme Court of the United States · 2019
- Amer Bioscience Inc v. Thompson, Tommy G.Court of Appeals for the D.C. Circuit · 2001
- Public Citizen, Inc., Aviation Consumer Action Project, and Families of Pan-Am 103/lockerbie v. Federal Aviation AdministrationCourt of Appeals for the D.C. Circuit · 1993
23 more not listed; retrieve them via the Exa API.