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 (OIG), manufacturers have contested the OIG’s...more
Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme -
A Long Island, New York, businessman was arrested on conspiracy, kickback, and money laundering charges stemming from an alleged scheme to defraud...more
With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year....more
Pfizer Settles Its Subsidiary’s Kickback Allegations for Nearly $60 Million -
Pfizer Inc. agreed to pay over $59,746,277 to resolve allegations that its wholly owned subsidiary, Biohaven Pharmaceutical Holding Company...more
2/3/2025
/ Acquisitions ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare Part D ,
Mergers ,
Pharmaceutical Industry ,
Purdue Pharma ,
Sentencing ,
Settlement ,
Whistleblowers
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions -
In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
1/13/2025
/ Anti-Kickback Statute ,
Appeals ,
Appointments Clause ,
Article III ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Misrepresentation ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Qui Tam ,
SCOTUS ,
Settlement ,
Stark Law ,
Unconstitutional Condition ,
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
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional -
On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
10/7/2024
/ Anti-Kickback Statute ,
Appointments Clause ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Health Care Programs (FHCP) ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Misrepresentation ,
OIG ,
Qui Tam ,
Sentencing ,
Settlement ,
Unconstitutional Condition
Previously, we discussed how the US Supreme Court’s opinion in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce could create opportunities for private litigants to challenge health...more
7/30/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Loper Bright Enterprises v Raimondo ,
Payment Systems ,
Regulatory Agenda ,
SCOTUS ,
Secretary of HHS ,
Stark Law
With the approval of the modified mifepristone Risk Evaluation and Mitigation Strategy (REMS), it has been a momentous few weeks in the reproductive health legal space.
Modification to the REMS for Mifepristone...more
With the new year underway, the ArentFox Schiff Health Care team highlights 10 of the most pressing legal issues facing the industry in 2023.
End of the COVID-19 Public Health Emergency. After being in effect for more than...more
2/17/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Inflation Reduction Act (IRA) ,
No Surprises Act (NSA) ,
Popular ,
Proposed Rules ,
Public Health Emergency ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Telehealth
On November 18, 2022, a collection of organizations and providers that oppose abortion filed suit against the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS), seeking — among...more
Most violations of the Health Information Portability and Accountability Act (HIPAA) are addressed through administrative enforcement action. But, in some circumstances of improper conduct affecting the privacy or security of...more
A pair of reports recently issued by the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG) highlight the important role telehealth services have played in ensuring access to medical...more
9/21/2022
/ Beneficiaries ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Fee-for-Service ,
Fraud ,
Medicare ,
Medicare Advantage ,
OIG ,
Public Health Emergency ,
Telehealth
On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that...more
8/1/2022
/ Anti-Kickback Statute ,
Bribery ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement ,
False Claims Act (FCA) ,
Fraud ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare Fraud ,
OIG ,
Telehealth ,
Telemedicine
Beginning January 1, 2022, all state licensed or certified health care facilities and providers must follow extensive rules for providing a "good faith estimate" of health care charges to uninsured and self-pay patients prior...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers.
...more
3/3/2021
/ 21st Century Cures Act ,
Anti-Kickback Statute ,
Bonuses ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Commercially Reasonable Efforts ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Fair Market Value ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Profit Sharing ,
Safe Harbors ,
Stark Law ,
Value-Based Care
Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more
2/17/2021
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Digital Health ,
DMEPOS ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Manufacturers ,
Medical Devices ,
OIG ,
Safe Harbors ,
Stark Law ,
Technology ,
Value-Based Care
The Senate Health, Education, Labor, and Pensions Committee recently voted to advance bipartisan legislation, called the Lower Health Care Costs Act (the Act), aimed at, among other things, curbing surprise medical bills. ...more
7/13/2019
/ Bipartisan Agreement ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare Costs ,
Legislative Agendas ,
Out of Network Provider ,
Patient Rights ,
Prescription Drug Coverage ,
Proposed Legislation ,
Public Health ,
Surprise Medical Bills ,
Transparency