Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more
The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals”...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.
...more
3/3/2021
/ 21st Century Cures Act ,
Anti-Kickback Statute ,
Bonuses ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Commercially Reasonable Efforts ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Fair Market Value ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Profit Sharing ,
Safe Harbors ,
Stark Law ,
Value-Based Care
Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute.
The Department of Health and Human Services Office of...more
The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more
11/18/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Fraud ,
Health Care Providers ,
Medicaid ,
Medical Devices ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Remuneration ,
Speaker Programs ,
TRICARE
The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more
7/31/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
FQHC ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Public Safety ,
Safe Harbors
In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more
2/3/2020
/ Anti-Kickback Statute ,
Criminal Penalties ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Electronic Medical Records ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare Fraud ,
Investigations ,
Kickbacks ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Software ,
Whistleblowers
Home Health Care Employees Plead Guilty in Multi-Million Dollar Medicaid Fraud Scheme -
Two individuals pled guilty in Pennsylvania federal court to conspiracy to defraud the Pennsylvania Medicaid program and commit...more
1/24/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Home Health Agencies ,
OIG ,
Whistleblowers
DOJ News -
Manufacturer to Pay Over $37.5 Million to Resolve False Claims Act Allegations -
On January 15, 2015, the DOJ announced that ResMed Corp., a manufacturer of durable medical equipment, agreed to pay over...more
1/20/2020
/ Anti-Kickback Statute ,
Clinical Trials ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Indictments ,
Misrepresentation ,
Physicians ,
Qui Tam ,
Settlement ,
Tax Deductions ,
Tax Fraud ,
Tax Returns ,
Whistleblowers
Defense Vehicle Manufacturer Accused of Defrauding the Government by $1.2 Billion -
On Tuesday, December 3, the United States District Court for the District of Columbia unsealed a six-year-old False Claims Act complaint...more
12/9/2019
/ Anti-Kickback Statute ,
Clinical Laboratory Testing ,
Criminal Prosecution ,
Defense Sector ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Guilty Pleas ,
Healthcare Fraud ,
Manufacturers ,
Medicaid ,
Medicare ,
Settlement ,
Stark Law ,
TRICARE ,
United Auto Workers
Headlines that Matter for Companies and Executives in Regulated Industries -
Kentucky Hospital Agrees to Pay $10 Million to Resolve False Claims Act Allegations -
Jewish Hospital & St. Mary’s Healthcare Inc. d/b/a...more
11/25/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Compounding ,
Drug Testing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Laboratories ,
Medicaid ,
Medicare ,
Pharmacies ,
Prescription Drugs ,
Settlement
Nissan and its Former CEO Settle Charges for Fraudulently Concealing More than $140 Million in Compensation and Retirement Benefits -
This week, the Securities and Exchange Commission (SEC) announced a settlement with...more
9/30/2019
/ Anti-Kickback Statute ,
Bribery ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Insider Trading ,
Opioid ,
Patient Referrals ,
Securities and Exchange Commission (SEC) ,
Settlement ,
Stark Law ,
Travel Act
34 Individuals Charged in $258 Million Medicare and Medicaid Fraud Schemes -
Twenty-six individuals in the state of California, fourteen of whom were doctors or medical professionals, and eight individuals in Arizona and...more
9/23/2019
/ Anti-Kickback Statute ,
Controlled Substances ,
Criminal Conspiracy ,
Criminal Convictions ,
Criminal Prosecution ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Facilities ,
Hospitals ,
Kickbacks ,
Medicaid ,
Medicare ,
Pharmacies ,
Prescription Drugs ,
Private Equity Firms ,
Stark Law
NY Ambulette Owners Plead Guilty to $8.6 Million Health Care Kickback Scheme -
On September 5, the Department of Justice announced that two New York ambulette owners pleaded guilty to one count of conspiracy to offer and...more
9/13/2019
/ Anti-Kickback Statute ,
Deferred Prosecution Agreements ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Guilty Pleas ,
Insider Trading ,
Kickbacks ,
Medicare ,
Securities and Exchange Commission (SEC) ,
Whistleblowers
Medical Device Exec Sentenced to 42 Months in Prison for $4.6 Million Kickback Scheme, Co-Conspirator Awaits Sentencing -
On August 29, the Department of Justice announced that a Tennessee health care executive, Brenda...more
9/9/2019
/ Anti-Kickback Statute ,
Bribery ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Contractors ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Pharmacies ,
Prison ,
SBA ,
TRICARE
Doctors and Alabama Cardiac Center to Pay $1.1 Million to Resolve Kickback Allegations -
On August 27, the US Attorney’s Office for the Western District of Washington announced a $1.1 million settlement with three...more
8/30/2019
/ Anti-Kickback Statute ,
Debtors ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
OIG ,
Qui Tam ,
Safe Harbors
Podiatrist Sentenced to Prison for Fraudulent Billing Scheme -
On July 19, 2019, a New York podiatrist was sentenced to 366 days in prison, assessed a $50,000 fine, ordered to pay $869,651 in restitution and forfeit...more
7/29/2019
/ Anti-Kickback Statute ,
Criminal Convictions ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmacies ,
Physicians ,
Prescription Drugs