On March 14, 2025, as part of a spending bill to avert a federal government shutdown, Congress extended COVID-era telehealth “waivers” applicable to Medicare until September 30, 2025. These were originally scheduled to end...more
In a much-anticipated decision, the First Circuit unanimously ruled the government and relators must prove that a violation of the federal Anti-Kickback Statute (AKS) was the “but-for” cause of a false claim under the False...more
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,...more
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
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more
On December 6, 2024, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) released the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2023 (the Report). The Report...more
12/18/2024
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Investigations ,
Medicaid ,
Medicare ,
OIG ,
Private Equity ,
Telemedicine
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...more
On September 28, 2024, California Governor Gavin Newsom vetoed California Assembly Bill 3129 (the Bill). The Bill, if enacted, would have imposed new notice and consent requirements for private equity investors involved in...more
On August 20, 2024, the United States District Court for the Northern District of Texas (Dallas Division) struck down the Federal Trade Commission’s (FTC) non-compete rule, 16 CFR § 910.1-6, that was set to take effect...more
8/22/2024
/ Administrative Procedure Act ,
Competition ,
Confidential Information ,
Employer Liability Issues ,
Employment Contract ,
Federal Trade Commission (FTC) ,
Final Rules ,
Healthcare ,
Hiring & Firing ,
Injunctive Relief ,
Intellectual Property Protection ,
Non-Compete Agreements ,
Restrictive Covenants
On August 1, 2024, the Department of Justice (DOJ) issued final guidance on its Corporate Whistleblower Awards Pilot Program (Program), offering financial incentives to qualifying individuals who report certain criminal...more
8/8/2024
/ Corporate Misconduct ,
Corruption ,
Department of Justice (DOJ) ,
Internal Investigations ,
New Guidance ,
Pilot Programs ,
Qui Tam ,
Voluntary Disclosure ,
Whistleblower Awards ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes
In April, the Federal Trade Commission (FTC) promulgated a new rule banning non-competes (the Rule); The FTC adopted the Rule to prohibit employers from entering into or enforcing non-compete clauses with workers and senior...more
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...more
7/2/2024
/ Anti-Kickback Statute ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Telemedicine
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...more
Last week, the Department of Justice (DOJ) announced the Criminal Division’s Pilot Program on Voluntary Self-Disclosures for Individuals (the Program). Pursuant to the Program, “an individual who voluntarily self-discloses...more
Additional States Implement Notice Requirements for Healthcare Transactions -
In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions....more
In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions. On March 13, 2024, Indiana joined this trend as Indiana Governor Eric Holcomb...more
On March 7, 2024, Deputy Attorney General (DAG) Lisa Monaco announced the contours of a new Department of Justice (DOJ) pilot program (Pilot) offering financial incentives to individual whistleblowers who report certain...more
On June 22, 2023, New York State Public Health Law § 2802-b, added a Health Equity Impact Assessment (HEIA) to the Certificate of Need (CON) process for certain health care facilities. The new requirement comes as part of...more
On Wednesday, November 1, the Center for Medicare & Medicaid Services (CMS) released its Home Health Prospective Payment System Rate Update final rule for CY 2024 (the Final Rule). The Rule estimates that the aggregate...more
On Monday, October 2, 2023, the New York Office of the Medicaid Inspector General (OMIG) published its Annual Report for 2022. The Report details the various efforts that New York’s Medicaid program undertook in 2022 to...more
On Monday, October 2, 2023, the New York Office of the Medicaid Inspector General (OMIG) published its Annual Report for 2022. The Report details the various efforts that New York’s Medicaid program undertook in 2022 to...more
On August 18, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-05 (Advisory Opinion), in which the OIG warned that it would likely issue sanctions under the Federal anti-kickback statute (AKS) if a...more
On August 18, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-05 (Advisory Opinion), in which the OIG warned that it would likely issue sanctions under the Federal anti-kickback statute (AKS) if a...more
The New York Office of the Medicaid Inspector General (OMIG) recently announced updates to its Self-Disclosure Program in response to feedback from Medicaid stakeholders after its revised posting in January 2023. OMIG revised...more
On May 2, 2023, legislators approved the $229 billion New York State FY 2023-2024 Budget Bill (“the Budget”), which was signed by Governor Hochul on May 3, 2023. Article VII of the Budget touches almost every aspect of the...more
5/8/2023
/ Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Home Health Care ,
Hospitals ,
Life Sciences ,
New York ,
Patient Privacy Rights ,
Reproductive Healthcare Issues ,
State Budgets