On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more
8/4/2025
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
HRSA ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicare ,
Pharmaceutical Industry ,
Pilot Programs ,
Prescription Drugs ,
Public Comment ,
Section 340B
The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more
On May 12, 2025, President Trump issued an executive order (the “Executive Order”) directing executive agencies and, imminently, pharmaceutical manufacturers to take steps to deliver most-favored-nation (“MFN”) prescription...more
More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more
1/10/2025
/ Biotechnology ,
Business Strategies ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Investigational New Drug Application (IND) ,
Licensing Rules ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Pricing ,
Regulatory Reform ,
Regulatory Requirements ,
Variable Rates
Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more
11/5/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fixed Price ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Inpatient Prospective Payment System (IPPS) ,
Loper Bright Enterprises v Raimondo ,
Medicaid Drug Rebate Program ,
Medicare ,
ONC ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Prescription Drugs ,
Public Health Emergency ,
Reimbursements ,
SEC v Jarkesy ,
Statutory Interpretation ,
Telehealth