On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more
6/30/2025
/ Advisory Opinions ,
Anti-Kickback Statute ,
Compliance ,
Contract Terms ,
Department of Health and Human Services (HHS) ,
Documentation ,
Fair Market Value ,
Fees ,
Health Care Providers ,
Medicaid ,
Medicare ,
OIG ,
Professional Corporation ,
Reimbursements ,
Safe Harbors ,
Telehealth ,
Written Agreements
Welcome to the Summer 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more
Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
Welcome to the Winter 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more
First Circuit Joins Sixth and Eighth Circuits in Adopting Heightened, But-For Causation Standard for AKS-Based FCA Claims -
On February 18, the US Court of Appeals for the First Circuit became the latest court to agree...more
2/24/2025
/ Anti-Kickback Statute ,
But For Causation ,
Causation ,
Compliance ,
Cybersecurity ,
DCIS ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare ,
Overpayment ,
Paycheck Protection Program (PPP) ,
Pharmaceutical Industry ,
SBA ,
Settlement ,
TRICARE
President Trump Puts a “Pause” on FCPA Enforcement -
On Monday, President Donald Trump signed an executive order (EO) pausing the enforcement of the Foreign Corrupt Practices Act (FCPA). According to the EO, the pause will...more
2/17/2025
/ Bribery ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Executive Orders ,
Foreign Corrupt Practices Act (FCPA) ,
Fraud ,
Healthcare Fraud ,
Kickbacks ,
Medicare Fraud ,
Securities and Exchange Commission (SEC) ,
Significant Transnational Criminal Organization ,
Trump Administration ,
White Collar Crimes
Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case -
On January 6, a District Court of Massachusetts judge granted summary judgment for defendants on allegations of violating the...more
1/27/2025
/ Anti-Kickback Statute ,
Causation ,
Compliance ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Medicare Advantage ,
Opioid ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
SCOTUS ,
Settlement ,
Skilled Nursing Facility ,
Whistleblowers
Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more
12/10/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Florida ,
Fraud ,
Health Technology ,
Healthcare ,
Manufacturers ,
Medicare Part D ,
OIG ,
Qui Tam ,
Risk Assessment ,
Settlement ,
Whistleblowers ,
White Collar Crimes
San Diego Physician and Medical Practice Pay $3.8 Million to Resolve FCA Allegations-
San Diego-based physician Dr. Janette J. Gray and her former medical practice, The Center for Health & Wellbeing, agreed to pay $3.8...more
10/28/2024
/ CARES Act ,
Compliance ,
Contractors ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Home Health Agencies ,
Investigations ,
Medicare ,
Misrepresentation ,
NASA ,
Paycheck Protection Program (PPP) ,
Popular ,
SBA ,
Settlement ,
TRICARE
Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more
7/31/2024
/ Anti-Kickback Statute ,
Beneficiaries ,
Bring Your Own Device (BYOD) ,
But For Causation ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement ,
Fair Market Value ,
False Claims Act (FCA) ,
Health Insurance ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Oral Argument ,
Physician Compensation Arrangements ,
Policies and Procedures ,
Portability ,
Settlement ,
Stark Law ,
TRICARE ,
Valuation