News & Analysis as of

Department of Health and Human Services (HHS) Pharmaceutical Industry Kickbacks

Arnall Golden Gregory LLP

HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group

In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former acting general counsel and principal deputy general counsel of the U.S....more

Harris Beach Murtha PLLC

OIG January 2024 Enforcement Summary

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Harris Beach Murtha PLLC

HHS Office of Inspector General November 2023 Enforcement Activity

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Nelson Mullins Riley & Scarborough LLP

OIG Issues Unfavorable Opinion About Bundling Free Items with Reimbursable Services

On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more

Health Care Compliance Association (HCCA)

Rob DeConti on the Latest Guidance and Insights from the OIG at HHS

In this podcast Rob DeConti, Assistant Inspector General for Legal Affairs within the office of counsel to the Inspector General at HHS, was good enough to share a tremendous amount of insight into what the OIG is seeing,...more

Holland & Knight LLP

Healthcare Law Update: April 2021

Holland & Knight LLP on

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

Polsinelli

No Steak, No Wine? OIG Cautions Against Physician Speaker Programs

Polsinelli on

In a Special Fraud Alert issued on November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS-OIG) raised significant fraud and abuse concerns with companies offering or providing...more

Hogan Lovells

HHS OIG has “significant concerns” about company-sponsored speaker programs

Hogan Lovells on

On November 16, 2020, the U.S. Health & Human Services (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert – a type of guidance historically used to signal enforcement priorities – “to highlight certain...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

Blank Rome LLP

Recent and Possible Executive Orders on Drug Pricing: What You Need to Know

Blank Rome LLP on

On July 24, 2020, President Trump signed three Executive Orders aimed at lowering prescription drug costs and increasing patients’ access to life-saving medications. A fourth Executive Order was discussed, which could reduce...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

Bass, Berry & Sims PLC

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...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

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Bass, Berry & Sims PLC

Congress Takes Action to Curb the Opioid Crisis

Bass, Berry & Sims PLC on

In a bipartisan effort to combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the Act), was enacted on October 24,...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic: Laws Impacting Prescribers and Care Givers

K&L Gates LLP on

This is the first episode in a series focused on the legal issues surrounding the nationwide opioid crisis. To begin the series, Carla DewBerry discusses the laws and regulations impacting health care providers caring for...more

BakerHostetler

Doctors Corralled for Kickbacks

BakerHostetler on

The U.S. Department of Health and Human Services Office of Inspector General's (OIG) chief counsel indicated in 2007 that the government's fraud enforcement focus on large organizations was an "ineffective strategy" and that...more

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