A recent settlement involving a Medicare Advantage plan should serve as a reminder that the federal Anti-Kickback Statute (AKS) is broad and far-reaching, both on its face and in practice. On July 1, 2022, the U.S. Department...more
7/12/2022
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Incentives ,
Medicare ,
Medicare Advantage ,
OIG ,
Patient Referrals ,
Settlement
The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently published Advisory Opinion 22-14, in which it analyzed an ophthalmology practice's proposal to offer continuing education (CE)...more
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
4/28/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Jury Verdicts ,
Medicaid ,
Medical Devices ,
Medicare ,
Medtronic ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Stark Law ,
TRICARE
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
4/15/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Appeals ,
Criminal Conspiracy ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Jury Trial ,
Jury Verdicts ,
Kickbacks ,
Laboratories ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reversal ,
TRICARE
The Centers for Medicare & Medicaid Services (CMS) on March 30, 2020, issued blanket waivers of sanctions under the physician self-referral law (Stark Law), retroactive to March 1, 2020, in response to the COVID-19 pandemic...more
• The OIG issued an unfavorable advisory opinion on a proposed program by which a marketer would provide free drugs to hospitals to utilize in an inpatient setting to treat infantile epilepsy.
• Contrary to the typical...more
11/28/2018
/ Advisory Opinions ,
Anti-Kickback Statute ,
Drug Pricing ,
Fraud and Abuse ,
Free-Drug Programs ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
OIG ,
Pharmaceutical Industry ,
Prescription Drug Coverage
OIG Advisory Opinions -
Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized -
On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
9/6/2017
/ Anti-Kickback Statute ,
Anti-Steering Rules ,
Appeals ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EMTs ,
Expert Testimony ,
False Claims Act (FCA) ,
False Statements ,
Food and Drug Administration (FDA) ,
FRCP 9(b) ,
Health Care Providers ,
Health Insurance ,
Hip Replacement ,
Hospitals ,
Litigation Strategies ,
Manufacturers ,
Medicaid Reimbursements ,
Medicare ,
Medicare Part D ,
Misrepresentation ,
OIG ,
Patient Safety ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Defects ,
Qui Tam ,
Retaliation ,
Reversal ,
Witness Preparation
Enforcement -
OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals -
On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more
3/27/2017
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Centers for Medicare & Medicaid Services (CMS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Free Health-Related Services ,
Health Care Providers ,
Health Insurance ,
Hospital Mergers ,
Hospitals ,
Market Allocation Scheme ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Safe Harbors ,
Sherman Act ,
Unfair or Deceptive Trade Practices ,
Value-Based Purchasing