Congress recently passed two bills that are designed to educate patients and prescribers about biosimilars and thereby encourage their use and to close a loophole in existing law that allows certain branded drugs to retain...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.
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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
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
On March 11, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a voluntary model within the Medicare Part D program that would allow certain Part D plans to cap Medicare beneficiaries’ out-of-pocket costs for...more
The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more
3/9/2020
/ Call Letter ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Cost-Sharing ,
Health Care Providers ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Reporting Requirements
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 -
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
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
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
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
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
On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed update to the hospital outpatient prospective payment system (Proposed Rule)....more
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
DOJ News -
Inpatient Rehabilitation Company Agrees to Pay $48 Million to Resolve FCA Allegations -
DOJ announced that Encompass Health Corporation (f/k/a HealthSouth Corporation), the nation’s largest operator of...more
7/17/2019
/ Criminal Conspiracy ,
Department of Justice (DOJ) ,
Disgorgement ,
False Claims Act (FCA) ,
Guilty Pleas ,
Health Care Providers ,
Healthcare Facilities ,
Insider Trading ,
Laboratories ,
Medicare ,
Most-Favored Nations ,
OIG ,
Permanent Injunctions ,
Pre-Judgment Interest ,
Qui Tam ,
Relators ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
Securities Violations ,
Settlement ,
State False Claims Acts ,
Wire Fraud