On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more
8/4/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Covered Entities ,
Drug Pricing ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Pilot Programs ,
Public Comment ,
Rebates ,
Reporting Requirements ,
Section 340B
Two recent federal court cases signal new significant developments with respect to the 340B Drug Pricing Program. Specifically: (1) new federal district court litigation challenging a recent HRSA Notice involving 340B Program...more
On January 30, 2023, the Court of Appeals for the Third Circuit issued a precedential decision rejecting a policy of the Department of Health and Human Services (HHS) in implementing the 340B Program. Under that policy, HHS...more
In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more
10/4/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Co-payments ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Dismissals ,
Drug Pricing ,
Fraud and Abuse ,
Healthcare Fraud ,
Medicare Beneficiaries ,
OIG ,
Pfizer ,
Prescription Drugs ,
Ripeness