Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more
7/17/2025
/ Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Funding ,
Gender Identity ,
Healthcare ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Whistleblowers
The Department of Justice’s (“DOJ”) May 19, 2025 “Civil Rights Fraud Initiative” memorandum, issued by Deputy Attorney General Todd Blanche (the “Initiative”), marks a consequential policy shift for False Claims Act (“FCA”)...more
The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”)...more
The standard for an “identified overpayment” under Medicare Parts A–D now aligns with section 1128J(d)(4)(A) of the Social Security Act, which incorporates by reference the Federal False Claim Act’s (the “FCA”) “knowledge”...more
1/28/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Overpayment ,
Reporting Requirements ,
Risk Management
On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and...more
12/18/2024
/ Anti-Kickback Statute ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud Alerts ,
Health Care Providers ,
Marketing ,
Medicare Advantage ,
OIG ,
Telemedicine ,
Third-Party
On June 16, 2023, the Supreme Court (the “Court”) in United States ex rel. Polansky v. Executive Health Resources affirmed the federal government’s power to dismiss a False Claims Act (“FCA”) action brought under the qui tam...more
7/19/2023
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Fraud and Abuse ,
FRCP 41 ,
Healthcare ,
Motion To Intervene ,
Qui Tam ,
Regulatory Authority ,
Relators ,
SCOTUS ,
United States ex rel Polansky v Executive Health Resources Inc ,
Whistleblowers
We previously wrote about the United States Department of Justice’s (“DOJ”) Civil Cyber-Fraud Initiative (“CCFI”), which “aims to hold accountable entities or individuals that put U.S. information or systems at risk by...more
In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more
4/7/2023
/ Anti-Kickback Statute ,
Appeals ,
But For Causation ,
Causation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare ,
OIG ,
Regulatory Standards ,
Remuneration
In recent years, there have been only a handful of corporate integrity agreements (“CIAs”) and integrity agreements (“IAs”) that have included a “conditional exclusion release” of the Office of the Inspector General for the...more
On July 20, 2022, the Office of Inspector General for the Department of Health and Human Services (“OIG”) issued a special fraud alert (“Alert”) advising “practitioners to exercise caution when entering into arrangements with...more
Last fall, the United States Department of Justice (“DOJ”) launched its Civil Cyber-Fraud Initiative (“CCFI”) as part of its effort to “combat new and emerging cyber threats to the security of sensitive information and...more
7/21/2022
/ Audits ,
Cybersecurity ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
DFARS ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Fraud ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Settlement Agreements ,
US State Departments