News & Analysis as of August 12, 2025

Medical Devices

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

Epstein Becker & Green on 8/5/2025

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more

Navigating OIG’s Advisory Opinion on Medical Device Billing Arrangements and Anti-Kickback Statute Risks

ArentFox Schiff on 7/22/2025

On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device...more

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

Epstein Becker & Green on 7/10/2025

On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....more

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Skadden, Arps, Slate, Meagher & Flom LLP on 7/8/2025

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

Gardner Law on 5/29/2025

Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

What Life Sciences Companies Need to Know in 2025

ArentFox Schiff on 4/29/2025

Key Insights for Pharma Manufacturers Regarding the AKS - 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...more

OIG December Enforcement Summary

Harris Beach Murtha PLLC on 1/12/2024

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

OIG Determines That Providing Free Hearing Aids to Bimodal-Hearing Candidates Implicates the Anti-Kickback Statute and Beneficiary...

Arnall Golden Gregory LLP on 11/3/2023

On October 20, 2023, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an unfavorable Advisory Opinion No. 23-08 to a supplier of cochlear implants coupled with external sound...more

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on 10/5/2023

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on 5/26/2023

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more

“Shotgun Pleadings” Ineffective for FCA Claims

Dorsey & Whitney LLP on 5/20/2022

On April 21, 2022, the Northern District of Georgia granted a motion to dismiss a False Claims Act (“FCA”) suit brought against ERMI LLC (“ERMI”), a medical device manufacturer, describing the complaint as a “shotgun...more

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

Health Care Compliance Association (HCCA) on 2/17/2022

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

Navigating Relationships With Practice Support and Other Tech Vendors

Skadden, Arps, Slate, Meagher & Flom LLP on 5/6/2021

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement

Skadden, Arps, Slate, Meagher & Flom LLP on 4/22/2021

Report on Medicare Compliance Volume 29, Number 39. News Briefs: November 2020

Health Care Compliance Association (HCCA) on 11/9/2020

Report on Medicare Compliance 29, no. 39 (November 2, 2020) - Medtronic USA Inc., a medical device maker, has agreed to pay $8.1 million to settle allegations it violated the False Claims Act by paying kickbacks to induce...more

Merit Medical Systems Settles False Claims Act Case for $18 Million (Part I of II)

The Volkov Law Group on 11/4/2020

Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...more

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

The Volkov Law Group on 10/23/2019

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

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

Skadden, Arps, Slate, Meagher & Flom LLP on 12/13/2018

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

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

Thomas Fox - Compliance Evangelist on 9/11/2015

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Doctors, Enforcement Risks And Compliance Programs

The Volkov Law Group on 7/4/2013

Doctors better get used to government regulation. The Affordable Healthcare Act contains a lengthy complement of new laws and regulations. ...more

Pharmaceutical And Medical Device Compliance: Domestic And Foreign Bribery

The Volkov Law Group on 6/3/2013

Pharmaceutical and medical device companies have a raw deal when it comes to domestic and foreign bribery. ...more

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