News & Analysis as of

Office of the Inspector General Medical Devices Fraud and Abuse

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

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

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

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

Baker Donelson

OIG Advisory Opinion 18-02: Medical Device Distributor Can Provide Free Samples and Patient Surveys

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On May 7, 2018, the OIG issued a favorable advisory opinion, No. 18-02, regarding an arrangement that would allow a medical device distributor (Requestor) to provide free sample ostomy products to federal health care program...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Mintz - Health Care Viewpoints

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Parker Poe Adams & Bernstein LLP

The Game Plan for Health Care Enforcement: Office of Inspector General Releases 2015 Work Plan

The Office of Inspector General (“OIG”) within the federal Department of Health and Human Services (“HHS”) is charged with protecting the integrity of HHS programs by combating fraud, abuse and waste. On Halloween of 2014,...more

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