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
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
On October 28, a majority of members on the Senate Judiciary Committee voted 15-7 to advance to the full Senate a bipartisan bill that would make a number of amendments to the False Claims Act (“FCA”), including one that...more
Telehealth’s exponential growth –in part due to the COVID-19 pandemic – has highlighted both its value in increasing access to care and the potential for misuse. The U.S. Department of Health and Human Services’ Office of...more
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
Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False...more
8/13/2021
/ Co-payments ,
Department of Justice (DOJ) ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medical Supplies ,
Medicare ,
Settlement Agreements
In recent months, the Kaiser Health Network (part of the Kaiser Family Foundation) has issued three reports scrutinizing the orthopedic industry and its practices. Each report articulates the stakeholder group’s concerns over...more
8/11/2021
/ Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Conflicts of Interest ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Physician Payments ,
Physicians ,
Policies and Procedures ,
Sunshine Act