News & Analysis as of

Healthcare Fraud Department of Health and Human Services (HHS) Prescription Drugs

ArentFox Schiff

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

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Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...more

Dorsey & Whitney LLP

DOJ & HHS Announce Reinvigoration of False Claims Act Working Group and Healthcare Fraud Enforcement Priorities

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The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more

BakerHostetler

DOJ Announces Record-Breaking National Health Care Fraud Takedown Against 324 Defendants with Over $14.6 Billion in Alleged Fraud

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The DOJ announced on June 30 an unprecedented Health Care Fraud Takedown resulting in criminal charges against 324 defendants (including 96 doctors, nurse practitioners, pharmacists and other licensed providers), with an...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

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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

Alston & Bird

Health Care Week in Review | Congress Passes Government Funding Package; HHS Nominee Confirmation Process Heats Up

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Morgan Lewis - As Prescribed

FCA Enforcement Risk Remains for Rare Disease Stakeholders

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Arnall Golden Gregory LLP

Lowering the Bar: Second Circuit Finds “At-Least-One-Purpose” Sufficient for Proving Anti-Kickback Statute Violation

On December 27, 2024, the United States Court of Appeals for the Second Circuit joined other federal circuit courts in adopting the “at-least-one-purpose” rule (generally shortened to the “one purpose rule”)....more

Morgan Lewis - Health Law Scan

HHS OIG Sets Out Limited Guardrails for Patient Assistance Arrangements

In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community....more

Foley Hoag LLP - White Collar Law &...

False Claims Act in 2025: Looking Back and What’s Ahead

This is the fifth in our 2025 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more

Lathrop GPM

Nearly 200 Health Care Providers Charged in Aggressive Enforcement Action by DOJ Health Care Fraud Strike Force Alleging Schemes...

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The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

Sheppard Mullin Richter & Hampton LLP

HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment...

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting...more

Sheppard Mullin Richter & Hampton LLP

Recent Developments in Telehealth Enforcement

The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the...more

Goodwin

Judge Dismisses Pfizer’s Lawsuit Over HHS Limits on Drug Copay Assistance

Goodwin on

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

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

Hogan Lovells

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

Hogan Lovells on

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more

BakerHostetler

FDA and Pharmacy Weekly Digest - November 2020 #1

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Food - FDA Releases Resources on Food Traceability Proposed Rule – The FDA released a resource to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability...more

Polsinelli

OIG Issues Guidance on Speaker Programs By Drug and Device Companies

Polsinelli on

This week, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert providing insight into speaker programs put on by drug and medical device companies that the OIG considers signs of potential fraud. Generally,...more

Rivkin Radler LLP

Teva under Fire from DOJ

Rivkin Radler LLP on

Teva Pharmaceuticals USA Inc. is in the crosshairs of the U.S. Department of Justice (DOJ) on two separate matters. On August 18, the DOJ announced that it filed a lawsuit against Teva and an affiliate, Teva Neuroscience...more

Rivkin Radler LLP

HHS, DOJ Release Fraud and Abuse Report

Rivkin Radler LLP on

The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion,...more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

Mintz - Health Care Viewpoints

Health Care Enforcement Year-in-Review and 2020 Outlook: Criminal Case Developments

As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the...more

Foley Hoag LLP - White Collar Law &...

White Collar Year in Preview: Healthcare Fraud Trends in 2020

Editors’ Note: This is the second in our start-of-year series examining important trends in white collar law and investigations in the coming year. Our previous entry discussed SEC enforcement in 2020. Up next: a look at...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

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