On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more
6/28/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Fraud and Abuse ,
Health Insurance ,
Healthcare ,
Life Sciences ,
Medicaid ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs
Bass, Berry & Sims attorney Shannon Wiley, with Carine Leslie and Katie Garmon of PYA, P.C., recently discussed the complexities associated with billing, coding, and collecting for infusion services as part of the Infusion...more
In January, a federal jury in the Northern District of Illinois convicted Mark Sorenson, owner of durable medical equipment (DME) pharmacy Symed Inc., for participating in a conspiracy to obtain $24.8 million in illegal...more
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
On November 16, the Department of Health and Human Services Office of Inspector General (OIG) took a shot across the bow of the healthcare industry when it published a Special Fraud Alert highlighting some of the fraud and...more
In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more
2/5/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Flat Fees ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Rebates ,
Safe Harbors ,
Trump Administration