On December 31, 2025, the federal Drug Enforcement Administration (DEA) extended current regulatory flexibilities related to tele-prescribing of controlled substances for another year. The DEA issued a fourth temporary extension (2026 Extension) of its pandemic-era telehealth flexibilities, which are now scheduled to end on December 31, 2026. The DEA explained that another extension
Department of Justice
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…
Clean Slate: San Antonio Lab Executives Exonerated in Health Care Fraud Case
By Danielle Tangorre & Guest Contributor on
This post is co-authored by Julianna M. Charpentier, a member of Robinson+Cole’s Enforcement, Investigations + Litigation in Health Care team.
Earlier this year, a Florida jury fully acquitted two owners of an independent clinical laboratory located in San Antonio, Texas accused of conspiring to commit health care fraud and wire fraud. Defendants Diego Sanchez…
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…
DEA Extends Telehealth Lifeline for Patients
By Conor Duffy & Guest Contributor on
*This post was co-authored by Paul Palma, legal intern at Robinson+Cole. Paul is not admitted to practice law.
On November 15, 2024, the Drug Enforcement Administration (DEA) and the Department of Health & Human Services (HHS) jointly announced an extension of current COVID-era tele-prescribing flexibilities for another year – through December 31, 2025 – via…
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 Charges 36 Defendants in Connection with Telemedicine and Clinical Laboratory Fraud and Abuse Schemes
By Danielle Tangorre & Guest Contributor on
*This post was co-authored by Lily Denslow, legal intern at Robinson+Cole. Lily is not admitted to practice law.
On June 27, 2024, the Department of Justice (DOJ) announced its 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants for alleged participation in various health care fraud schemes alleged to…
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…