The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the DOJ-HHS False Claims...more
7/22/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Medicare Advantage ,
Trump Administration ,
Whistleblowers ,
Working Groups
On May 6, 2025, with almost no discernible press or public announcements, the Dental Trade Alliance (DTA) – a trade association of dental suppliers and service providers – issued a revised and restated U.S. Code of Ethics...more
Welcome to the third issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more
2/28/2025
/ California ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Practice of Medicine ,
Data Privacy ,
Medicaid ,
Medicare ,
New Legislation ,
Popular ,
Private Equity ,
Reproductive Healthcare Issues ,
Telehealth
In a unanimous panel opinion filed on February 18, 2025, the First Circuit held that False Claims Act cases predicated on violations of the Anti-Kickback Statute (“AKS”), require proof that alleged kickbacks were the...more
2/21/2025
/ Anti-Kickback Statute ,
Appeals ,
But For Causation ,
Causation ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Judicial Authority ,
Litigation Strategies ,
Medicare ,
Pharmaceutical Industry ,
Regeneron ,
Statutory Interpretation
2023 was another record year for False Claims Act enforcement. On February 22, 2024, the U.S. Department of Justice (DOJ) announced that the federal government and whistleblowers were party to a record number of FCA...more
2/27/2024
/ Artificial Intelligence ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Due Diligence ,
Enforcement Actions ,
Enforcement Priorities ,
Enforcement Statistics ,
False Claims Act (FCA) ,
Health Care Providers ,
Investors ,
Life Sciences ,
Medicare ,
Medicare Advantage ,
Medicare Part C ,
Portfolio Companies ,
Private Equity ,
Private Equity Firms ,
Self-Disclosure Requirements ,
Voluntary Disclosure ,
Whistleblowers
On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more
11/27/2023
/ Anti-Kickback Statute ,
Board of Directors ,
Compliance ,
Department of Health and Human Services (HHS) ,
Employee Training ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
New Guidance ,
OIG ,
Policies and Procedures ,
Stark Law ,
Voluntary Correction Program ,
Voluntary Participation
The Supreme Court recently issued a significant decision clarifying what it means to “knowingly” submit a false claim under the False Claims Act. At issue in United States ex rel. Schutte v. SuperValu Inc. were allegations...more
6/6/2023
/ Discount Pricing ,
Drug Pricing ,
False Claims Act (FCA) ,
Federal Contractors ,
Fraud ,
Medicaid ,
Medicare ,
Mens Rea ,
Objective Standard ,
Petition for Writ of Certiorari ,
Pharmacies ,
Prescription Drugs ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
Subjective Standard ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Willful Violations
For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance...more