On January 23, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed a federal district court’s ruling against the Pharmaceutical Coalition for Patient Access (“Coalition”), rejecting its challenge to an unfavorable...more
On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more
8/1/2024
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Fertility Treatments ,
Financial Aid ,
Life Sciences ,
Manufacturers ,
OIG ,
Patient Assistance Programs ,
Patients ,
Pharmaceutical Industry ,
Travel Expenses
On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more
7/11/2024
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Life Sciences ,
Manufacturers ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Refunds ,
Risk Mitigation
On September 25, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued an unfavorable Advisory Opinion No. 23-06 related to a proposed arrangement involving purchasing the technical...more