On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more
4/8/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Manufacturers ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
REMS ,
Specialty Healthcare
In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final rules to modernize regulations implementing the federal...more
12/22/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Final Rules ,
Health Care Providers ,
New Value Exception ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Rebates ,
Safe Harbors ,
Stark Law ,
Technology Sector