News & Analysis as of

Fraud and Abuse Medical Devices

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Bass, Berry & Sims PLC

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

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We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Harris Beach PLLC

OIG December Enforcement Summary

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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

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

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Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

Foley & Lardner LLP

Software as a Medical Device (SaMD): Health Care Regulatory Considerations

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Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more

Epstein Becker & Green

Physicians Beware! Groups Providing DME, Prosthetic Devices, and Other Medical Supplies to Their Medicare Patients Risk Violating...

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When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q2 2023

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There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023.  Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more

ArentFox Schiff

Texas Lab Settles Unnecessary Drug Testing Allegations for $6 Million

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A laboratory company based in Texas, Genotox Laboratories Ltd., recently reached an agreement with the federal government to resolve False Claims Act and Anti-Kickback Statute violations, stemming from allegations related to...more

Bass, Berry & Sims PLC

[Webinar] Healthcare Fraud & Abuse Annual Review - February 22nd, 10:00 am - 12:00 pm CST

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Bass, Berry & Sims will release its 11th Annual Healthcare Fraud & Abuse Review in early February 2023. As a companion to the Review, we will host a complimentary webinar on Wednesday, February 22, 2023, from 10:00 a.m.-12:00...more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

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We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Sheppard Mullin Richter & Hampton LLP

OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company

On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving...more

Manatt, Phelps & Phillips, LLP

OIG Advisory Opinion Recognizes Legitimacy of Certain Physician-Owned Device Companies

After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion by the Office of Inspector General for the U.S. Department of Health &...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Mintz - Health Care Viewpoints

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more

Bass, Berry & Sims PLC

10th Annual Healthcare Fraud & Abuse Review

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Bass, Berry & Sims is pleased to announce the release of the 10th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2021. Compiled by the firm’s Healthcare Fraud & Abuse Task Force,...more

Goodwin

Patient Stakeholder Group Zeroes in on Medical Device Industry

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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

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

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2020

Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

Polsinelli

Special Fraud Alert from DHHS OIG Cautions Against Use of Health Care Speaker Programs

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The Department of Health and Human Services Office of Inspector General (“DHHS OIG”) recently issued a Special Fraud Alert regarding fraud and abuse concerns related to speaker programs offered by pharmaceutical and medical...more

Stinson LLP

Is Your Prior Authorization Program Demonstrably Compliant?

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A recent settlement announced by DOJ serves as a good reminder of the need for device and pharmaceutical manufacturers to periodically revisit their prior authorization assistance programs, to assure that the programs are...more

The Volkov Law Group

Drug and Medical Device Fraud Risks Increase in Pandemic Era

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The drug and medical device/testing industry is under significant pressure to develop new products to address the COVID-19 pandemic.  The federal government is increasing spending and support of drug and device companies in...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Annual Review 2019

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Bass, Berry & Sims is pleased to announce the release of the 2019 edition of its Healthcare Fraud & Abuse Annual Review. Compiled by the firm’s Healthcare Fraud Task Force, the Review is an in-depth and comprehensive analysis...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Robinson+Cole Health Law Diagnosis

Department of Justice Intervenes in False Claims Act Suit, Adding Reimbursement Consultant Defendant

On February 19, 2019, the Department of Justice (DOJ) announced that it had intervened in a False Claims Act (FCA) whistleblower suit filed against Arriva Medical LLC (Arriva) and its parent that allegedly involves the...more

K&L Gates LLP

K&L Gates Triage: Artificial Intelligence in Health Care

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Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more

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