On March 12, 2024, the U.S. Court of Appeals for the Second Circuit issued an important decision interpreting the “willfulness” standard necessary to find a violation of the federal Anti-Kickback Statute (AKS). The decision...more
On November 15, 2023, the U.S Department of Justice (DOJ) announced a $45.6 million consent judgment (Settlement) with six skilled nursing facilities (SNFs), as well as the owner of the SNFs and its management company which...more
12/13/2023
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Settlement ,
Skilled Nursing Facility ,
Statutory Violations
On March 29, 2023, the Department of Justice’s (DOJ) Office for the Eastern District of Michigan announced a notable set of three settlements (collectively, the Settlement) in excess of $69 million dollars total with a...more
On March 29, 2023, the Department of Justice’s (DOJ) Office for the Eastern District of Michigan announced a notable set of three settlements (collectively, the Settlement) in excess of $69 million dollars total with a...more
4/5/2023
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Physicians ,
Self-Referral ,
Self-Referral Disclosure Protocol ,
Settlement Agreements ,
Stark Law
On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the...more
On September 26, 2022, the United States Department of Justice (DOJ) announced a $900 million settlement with pharmaceutical company Biogen Inc., which arose from alleged violations of the federal False Claims Act (FCA) and...more
HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations -
On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector...more
The Robinson+Cole Health Law Group is committed to examining and reporting on issues important to the health care and life sciences industries. Below are excerpts from our Health Law Diagnosis blog, where we post on fraud and...more
On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the...more
On August 24, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an “extension of the timeline” for publication of a final rule addressing changes to the Physician Self-Referral Law (or Stark Law) regulations....more
Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services...more
5/6/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Physicians ,
Self-Referral ,
Stark Law ,
Waivers
On April 3, 2020 the Office of Inspector General (OIG) issued a Policy Statement to notify health care providers and other parties subject to the Anti-Kickback Statute (AKS) that the OIG will not impose administrative...more
On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...more
1/31/2020
/ Anti-Kickback Statute ,
Criminal Prosecution ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
EHR ,
Electronic Medical Records ,
Enforcement Actions ,
Failure to Comply ,
False Claims Act (FCA) ,
Fines ,
Forfeiture ,
Health Care Providers ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs
On October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) formally published its proposed rule (the PSR Rule) to update exceptions to the Physician Self-Referral Law (PSR Law, also known as the Stark Law). For...more
10/31/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Commercial Reasonableness ,
Fair Market Value ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
Patient Referrals ,
Physicians ,
Proposed Rules ,
Rulemaking Process ,
Self-Referral ,
Stark Law ,
Value-Based Care
On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions to the federal Physician Self-Referral Law (the Stark Law), the...more
On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more
9/18/2019
/ Anti-Kickback Statute ,
Co-payments ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Marketing ,
Meals-Gifts-and Entertainment Rules ,
Medicare ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Qui Tam ,
Remuneration ,
Settlement Agreements ,
Whistleblowers
In a complaint filed on July 22, 2019, the U.S. Attorney’s Office for the Southern District of New York (DOJ) intervened in a qui tam False Claims Act (FCA) suit against Life Spine Inc. (Life Spine), and senior executives of...more
On March 6, 2019, the U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a favorable advisory opinion that allows a nonprofit medical center (“Center”) to offer free, in-home follow-up care...more
The Department of Justice (DOJ) recently announced two high-dollar False Claims Act (FCA) enforcement actions involving allegedly fraudulent arrangements tied to the implementation and use of electronic health record systems...more
2/21/2019
/ Anti-Kickback Statute ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
EHR ,
Electronic Health Record Incentives ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare Fraud ,
Settlement Agreements ,
Stark Law ,
White Collar Crimes
On February 19, 2019, the Department of Justice (DOJ) announced that it had intervened in a False Claims Act (FCA) whistleblower suit filed against Arriva Medical LLC (Arriva) and its parent that allegedly involves the...more
On February 6, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a proposed rule (Proposed Rule) that would amend the safe harbor regulations under the Federal Anti-Kickback...more
2/7/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Rebates ,
Safe Harbors
On January 24, 2019, the Office of Inspector General (“OIG”) issued a favorable advisory opinion allowing a pharmaceutical manufacturer (“Manufacturer”) to temporarily loan limited-functionality smartphones to financially...more
On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a...more
9/20/2018
/ Advisory Opinions ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Hospitals ,
Manufacturers ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Product Defects ,
Warranties ,
Written Agreements
The Department of Justice (DOJ) announced two significant False Claims Act (FCA) settlements in recent days that signal continued close government scrutiny of billing, coding and referral practices at hospitals....more
8/9/2018
/ Anti-Kickback Statute ,
Coding ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Kickbacks ,
Medicare ,
Patient Referrals ,
Stark Law
The Department of Justice (DOJ), recently intervened in a civil False Claims Act (FCA) case filed against Insys Therapeutics, Inc. (Insys) in the Central District of California that alleges FCA violations arising from the...more