The government has announced a renewed and expanded focus on False Claims Act (FCA) enforcement, doubling down on traditional health care priorities like kickbacks and drug pricing while signaling increased scrutiny of...more
With the new year underway, the ArentFox Schiff Health Care team highlights 10 of the most pressing legal issues facing the industry in 2023.
End of the COVID-19 Public Health Emergency. After being in effect for more than...more
2/17/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Inflation Reduction Act (IRA) ,
No Surprises Act (NSA) ,
Popular ,
Proposed Rules ,
Public Health Emergency ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Telehealth
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
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
Headlines that Matter for Companies and Executives in Regulated Industries -
DOJ News -
Government Intervenes Against Integrated Health Care System in False Claims Act Suit-
The Department of Justice (the DOJ)...more
Omnicare and CVS Face Fraudulent Billing Lawsuit -
On Tuesday, the US Attorney’s Office for the Southern District of New York announced a False Claims Act lawsuit against Omnicare, Inc. and its parent company, CVS Health...more
12/20/2019
/ CVS ,
Department of Justice (DOJ) ,
Dismissals ,
False Claims Act (FCA) ,
Government Investigations ,
Medicaid ,
Medicare ,
Medicare Part D ,
Omnicare ,
Pharmacies ,
Prescription Drugs ,
Rite Aid ,
State Attorneys General ,
TRICARE ,
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
Compound Ingredient Supplier to Pay Over $22 Million to Resolve Allegations Brought Under Qui Tam Provisions of FCA -
On November 7, 2019, the Department of Justice (DOJ) announced that Fagron Holding USA LLC (Fagron) had...more
11/18/2019
/ Alstom ,
Civil Monetary Penalty ,
Corporate Officers ,
Criminal Convictions ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Healthcare Fraud ,
Insider Trading ,
Medicare ,
Qui Tam ,
TRICARE ,
Whistleblowers
Third Circuit Holds False Claims Act Relator Lacks Standing and Right to Intervene in Related Criminal Case -
In a matter of first impression, the Third Circuit held last week that a relator who filed an action under the...more
11/8/2019
/ Alternate Remedy ,
Annual Reports ,
Antitrust Violations ,
Criminal Antitrust Litigation ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
DOJ Strike Force ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Motion to Dismiss ,
Motion To Intervene ,
Public Procurement Policies ,
Qui Tam ,
Relators ,
Securities and Exchange Commission (SEC) ,
Standing ,
Subsequent Litigation ,
Tax Crimes
Kickback Allegations Settled for $20.25 Million -
Sanford Health, Sanford Medical Center, and Sanford Clinic (collectively, Sanford), a South Dakota health system, will pay $20.25 million to settle allegations that they...more
Former Drugstore Executive Receives Two-Year Sentence, Ordered to Pay $6.3 Million for Kickback Scheme -
A Pennsylvania federal judge sentenced a former Rite-Aid advertising executive to two-years imprisonment and ordered...more
10/29/2019
/ Criminal Convictions ,
Criminal Prosecution ,
False Claims Act (FCA) ,
HUBZone ,
Indictments ,
Insider Trading ,
JPMorgan Chase ,
Kickbacks ,
Market Manipulation ,
Rare Earth Metals ,
Restitution ,
Rite Aid ,
SBA ,
Securities and Exchange Commission (SEC) ,
State Contractors ,
Wire Fraud
DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases -
On October 8, 2019, Assistant Attorney General Brian Benczkowski announced new guidance for federal prosecutors evaluating whether a corporation is unable...more
10/21/2019
/ Corporate Criminal Fines ,
Corporate Misconduct ,
Criminal Investigations ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Sentencing Guidelines ,
Healthcare Facilities ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
New Guidance ,
Prescription Drugs
Genetic Testing Company and Three Principals Settle FCA Allegations for $42.6 Million -
On October 9, 2019, New Orleans-based laboratory company UTC Laboratories Inc. (RenRX) agreed to pay $41.6 million, and its three...more
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
Former CEO of Virginia-Based Contractor to Pay $20M to Settle False Claims Act Allegations -
On August 20, 2019, the majority owner and former Chief Executive Officer of Virginia-based defense contractor ADS, Inc. –...more
Whistleblower Collects on Cybersecurity FCA Case -
On July 31, 2019, Cisco Systems agreed to pay $8.6 million in civil damages to settle claims that it sold video surveillance technology with known security flaws to several...more
Telemarketing Business Agrees to Pay $2.5 Million to Settle FCA Allegations of Telemedicine Scheme -
The US Attorney’s Office for the Middle District of Florida, in collaboration with the US Attorney’s Office for the...more
8/12/2019
/ Department of Justice (DOJ) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Indictments ,
Kickbacks ,
Medicare ,
Physicians ,
Settlement ,
Telemarketing
Patient Recruiter Convicted in $1.3 Million Kickback Conspiracy Scheme -
After a six-day trial, a federal jury in Detroit found a patient recruiter guilty of one count of conspiracy to pay and receive health care...more
8/5/2019
/ Aiding and Abetting ,
Blue Book ,
Civil Monetary Penalty ,
Criminal Conspiracy ,
Criminal Convictions ,
Criminal Prosecution ,
False Claims Act (FCA) ,
Federal Contractors ,
Foreclosure Sales ,
Health Care Providers ,
Healthcare Fraud ,
Home Health Agencies ,
Kickbacks ,
Medicare ,
Mortgage Lenders ,
Public Contracts ,
Settlement ,
Wire Fraud
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