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
In Ruan v. United States, the U.S. Supreme Court on June 27, 2022, dealt a blow to the U.S. Department of Justice by vacating convictions of two physicians convicted of violating 21 U.S.C. §841(a) of the Controlled Substances...more
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
A recent U.S. Department of Justice (DOJ) settlement should serve as a reminder that pharmaceutical manufacturers are not the only entity in the drug supply chain that are susceptible to enforcement actions with respect to...more
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
On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing...more
4/6/2018
/ Bulk Purchasing ,
Draft Guidance ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Manufacturers ,
Outsourcing Facilities ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
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