The Eliminating Kickbacks in Recovery Act (EKRA), enacted in 2018 as part of the SUPPORT Act, established a criminal statute prohibiting payments for patient referrals related to recovery homes, clinical treatment facilities, and laboratories. EKRA mostly mirrors the Anti-Kickback Statute (AKS) but extends its reach to commercial health insurance as well as federal programs like
False Claims Act
South Carolina Lab Settles False Claim Act Case – A Study on Commercial Reasonableness and Disguised Kickbacks
By Danielle Tangorre on
A clinical lab in Anderson, South Carolina, and its founder and CEO have agreed to pay a minimum of $6.8 million to settle a federal qui tam case based on allegations for paying illegal kickbacks to physicians in exchange for referrals of laboratory tests. Under the settlement agreement, this figure may increase to approximately…
False Claims Act Enforcement of Pharmacy Pricing & Prescribing Practices: The Walgreens Cases
By Yelena Greenberg, Danielle Tangorre & Guest Contributor on
This post was co-authored with Ivy Miller, legal intern at Robinson+Cole. Ivy is admitted to practice law in Massachusetts.
The Department of Justice has launched a number of enforcement actions targeting pharmacies for alleged violations of the False Claims Act (FCA). Recently, Walgreens has been the subject of two noteworthy government settlements related to alleged…
Massachusetts Enhances Regulatory Oversight of Health Care Transactions on For-Profit and Private Equity Investments
By Yelena Greenberg, Danielle Tangorre, Conor Duffy, Leslie Levinson & Guest Contributor on
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.
Massachusetts has expanded regulatory oversight of health care transactions by imposing False Claims Act liability on health care owners and investors for changes including failure to disclose violations. On January 8, 2025, Governor Maura Healey signed…
Massachusetts Expands FCA Liability To Owners and Private Equity Investors
By Danielle Tangorre, Conor Duffy, Leslie Levinson & Guest Contributor on
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.
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…
CMS Finalizes Standard for Identifying Overpayments and Grace Period for Investigations of Related Overpayments
By Conor Duffy & Leslie Levinson on
Posted in Academic Medical Centers, Ambulatory Surgical Centers (ASC), Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Health Policy, Home Health/ Home Care, Hospice, Hospitals and Health Systems, Laboratories, Long Term Care and Nursing Homes, Pharmaceuticals and Biologics, Pharmacy Law, Physicians and Allied Health Professionals, Private Equity, Reimbursement, Stark Law, Telehealth, Telemedicine
As part of its 2025 Physician Fee Schedule Final Rule (PFS Rule), the Centers for Medicare & Medicaid Services (CMS) finalized two crucial updates to federal Medicare overpayments regulations (sometimes referred to as the “60-Day Rule”) that (1) align the standard for when an overpayment is identified with the applicable standard under the…
Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision Unconstitutional
By Danielle Tangorre, Michael Lisitano & Guest Contributor on
*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
On September 30, 2024, Judge Kathryn Kimball Mizelle of the U.S. District Court for the Middle District of Florida issued an order in United States ex rel. Clarissa Zafirov v. Florida Medical Associates, LLC, holding that the…
South Dakota Hospital Settles False Claims Act Allegations for Over $14 Million Following Self-Disclosure
By Conor Duffy, Michael Lisitano & Guest Contributor on
*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
On September 18, 2024, the Department of Justice (DOJ) announced a settlement with Dunes Surgical Hospital and United Surgical Partners International, Inc. (USPI), an entity holding a partial ownership interest in Dunes, in connection with alleged violations…
DOJ Announces $1.3 Million Settlement Involving a Laboratory Marketer, Physicians, and the Physicians’ Medical Practices
By Danielle Tangorre & Robinson+Cole's Health Law Group on
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.
On April 29, 2024, the Department of Justice (DOJ) announced a $1.3 million settlement (Settlement) with a South Carolina clinical laboratory marketer and his marketing company, and three physicians and their medical practices in North Carolina…
Key Second Circuit Decision Defines AKS Willfulness Standard
By Conor Duffy & Leslie Levinson on
Posted in Academic Medical Centers, Ambulance, Ambulatory Surgical Centers (ASC), Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Home Health/ Home Care, Hospice, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals
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 provides important guidance for health care and pharmaceutical organizations on what constitutes a knowing violation of the AKS and for counsel…