Under a new 2025 law, Massachusetts is one of the first in the nation to broaden its state False Claims Act (FCA) to require disclosures by investors and owners of health care entities. On January 8, 2025, Governor Maura...more
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 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 3, 2020, a Massachusetts Federal District Court issued a notable decision on the applicability of the state’s medical peer review privilege in a federal proceeding, determining that the privilege does not apply to...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 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
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 June 5, 2019, the Department of Justice (DOJ) announced a global settlement with Insys Therapeutics (Insys) that preliminarily resolves criminal and civil cases against the opioid manufacturer in a number of jurisdictions....more
6/26/2019
/ Chapter 11 ,
Commercial Bankruptcy ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Drug & Alcohol Abuse ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Mail Fraud ,
Manufacturers ,
Marketing ,
Opioid ,
Pain Management ,
Pharmaceutical Industry ,
Prescription Drugs ,
Settlement Agreements
On May 7, 2019, the U.S. Department of Justice (DOJ) provided important new guidance addressing cooperation credit that may be available to defendants in False Claims Act (FCA) investigations (Guidance)....more
On April 30, 2019, the Office of the Attorney General of Massachusetts (AG) announced that it had entered into two settlements totaling over $10 million with home health care companies to resolve allegations of submission of...more
Since the beginning of 2019, federal and state authorities in Connecticut have announced a number of enforcement actions targeting alleged health care fraud in the state. ...more
On February 25, 2019, the U.S. Department of Justice (DOJ) announced a settlement with a urology group practice to settle allegations of False Claims Act (FCA) violations tied to the alleged submission of improperly unbundled...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
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
On April 30, 2018 a Massachusetts physician was convicted of a criminal violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as one count of obstruction of a criminal health care...more
A series of criminal and civil enforcement actions announced in recent weeks demonstrate the continued attention that state regulators throughout the Northeast are placing on health care fraud. ...more
4/2/2018
/ Criminal Prosecution ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
Healthcare Fraud ,
Identity Theft ,
Medicaid ,
Medicare ,
Opioid ,
Pain Management ,
Whistleblowers ,
White Collar Crimes
The Department of Justice (DOJ) recently resolved two health care fraud cases – one criminal and one civil – that demonstrate the government’s continued scrutiny of lavish meals and “speaker’s bureaus” sponsored by...more
Last month, a U.S. District Court in the Middle District of Florida overturned judgments totaling $347,864,285 returned by a jury under the federal False Claims Act (FCA) and Florida’s state equivalent against the owners and...more