News & Analysis as of

Medical Devices Durable Medical Equipment Anti-Kickback Statute

Rivkin Radler LLP

Seventh Circuit Rejects Extension of AKS to Marketing Companies Without Evidence of Intent to Induce Referrals

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The U.S. Court of Appeals for the Seventh Circuit recently rejected an effort by the federal government to extend the federal Anti-Kickback Statute (AKS) to a marketing company in the absence of influence by the company over...more

King & Spalding

Seventh Circuit Reverses AKS Conviction Involving Payments to Marketers and DME Manufacturer

King & Spalding on

On April 14, 2025, the U.S. Court of Appeals for the Seventh Circuit issued its opinion in United States v. Sorensen, No. 24-1557, reversing the criminal conviction of Mark Sorensen, the owner of SyMed Inc., a...more

BakerHostetler

The Seventh Circuit Narrows AKS Scope for 1099 Marketers and Advertisers

BakerHostetler on

On April 14, the Seventh Circuit in United States v. Sorensen issued a decision reversing a jury conviction and narrowing the scope of the Anti-Kickback Statute (AKS) as applied to marketers and advertisers....more

Stevens & Lee

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

Gardner Law

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

Gardner Law on

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

King & Spalding

DOJ Announces False Claims Act Recoveries for FY 2022

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On February 7, 2023, the Department of Justice (DOJ) announced its annual False Claims Act (FCA) recoveries for fiscal year 2022. DOJ recovered $2.2 billion from a total of 351 settlements and judgments—the second-highest...more

Dorsey & Whitney LLP

Recent DOJ Settlements Involving DME Manufacturers Highlight Important Anti-Kickback Considerations

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​​​​​​​The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more

Polsinelli

DOJ Telemedicine Offensive Pushes Forward with New Charges

Polsinelli on

For the past two years, telemedicine companies, durable medical equipment suppliers, pharmacies, and individuals and entities that market to such entities have been at the center of DOJ gunsights. In 2019, the Department...more

Holland & Knight LLP

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

Holland & Knight LLP on

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

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