In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more
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
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
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data.
Companies that once only developed hardware-based solutions for...more
5/26/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Information Blocking Rules ,
Intellectual Property Protection ,
Med Tech ,
Medical Devices ,
Patent-Eligible Subject Matter ,
Popular ,
Safe Harbors ,
Software
The July 20, 2022 Special Fraud Alert describes findings from what OIG describes as “dozens of investigations of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services”...more
7/29/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Liability ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Durable Medical Equipment ,
Enforcement Actions ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Risk Alert ,
Telehealth ,
Telemedicine
The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
3/8/2022
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Private Equity ,
Telehealth
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
11/5/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Failure to Report ,
False Claims Act (FCA) ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Physician-Owned Distributors ,
Physicians ,
Settlement Agreements ,
Sunshine Act
In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more
10/4/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Co-payments ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Dismissals ,
Drug Pricing ,
Fraud and Abuse ,
Healthcare Fraud ,
Medicare Beneficiaries ,
OIG ,
Pfizer ,
Prescription Drugs ,
Ripeness