Welcome to the August issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more
9/2/2025
/ Affordable Care Act ,
Appeals ,
Article II ,
Constitutional Challenges ,
Employee Retirement Income Security Act (ERISA) ,
False Claims Act (FCA) ,
HRSA ,
Medicaid ,
Medicare ,
New Legislation ,
Pharmacy Benefit Manager (PBM) ,
Pilot Programs ,
Qui Tam ,
Section 340B ,
Tax Credits ,
Whistleblowers
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
In a May 15, 2025, opinion, Judge Dabney Friedrich of the US District Court for the District of Columbia denied drugmakers’ motions for summary judgment against the US Department of Health and Human Services and the Health...more
5/30/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
HRSA ,
Judicial Authority ,
Manufacturers ,
Medicaid ,
Motion for Judgment ,
Pharmaceutical Industry ,
Pre-approval ,
Prescription Drugs ,
Rebates ,
Regulatory Authority ,
Sanofi ,
Section 340B