News & Analysis as of August 16, 2025

Healthcare Fraud

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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 -

False Claims Act Settlements to Know from the First Half of 2025

Bass, Berry & Sims PLC on 8/12/2025

With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...more

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

“Longstanding and Clear”: OIG Continues Characteristic Close Scrutiny of Below-Market Benefits to Referral Sources

Arnall Golden Gregory LLP on 8/1/2025

The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...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

OIG Declines to Approve Medical Device Company's Proposal to Subsidize Screening Costs

Bass, Berry & Sims PLC on 7/3/2025

On June 20, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-04, in which it declined to approve a proposal by a medical device company (Requestor) to pay the...more

OIG Says Medical Device Company's Proposal to Pay for Exclusion Screening for Customers May Violate the Anti-Kickback Statute

Epstein Becker & Green on 6/24/2025

On June 20, 2025, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion - OIG Advisory Opinion 25-04 (“AO 25-04”)....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

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

Rivkin Radler LLP on 5/21/2025

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

Speaker Programs: Two Recent Enforcement Actions Serve as a Reminder of the Government's Longstanding Scrutiny

Mintz - Health Care Viewpoints on 5/19/2025

The pharmaceutical and medical device industries have long utilized speaker programs, which typically involve retaining health care professionals to speak or present on the companies’ products to educate their peers. Speaker...more

Limitations to the Anti-Kickback Statute? Seventh Circuit Reverses Conviction Finding “Aggressive” Marketing Tactics Insufficient...

Arnall Golden Gregory LLP on 5/13/2025

On April 14, 2025, the United States Court of Appeals for the Seventh Circuit reversed the conviction of the owner of a durable medical equipment (“DME”) distributor, ruling that there was insufficient evidence to support a...more

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

King & Spalding on 5/8/2025

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

Seventh Circuit Decision Clarifies Distinction Between Face-to-Face Sales and Advertising Under the Anti-Kickback Statute

Blank Rome LLP on 4/22/2025

Overview - In a significant decision, United States v. Sorensen, --- F.4th ----, 2025 WL 1099080 (7th Cir. Apr. 14, 2025), the United States Court of Appeals for the Seventh Circuit reversed the conviction of Mark...more

New Seventh Circuit Decision Signals Greater Flexibility for Healthcare Marketing Services

Epstein Becker & Green on 4/21/2025

On April 14, 2025, the United States Court of Appeals for the Seventh Circuit issued a decision in a case involving the federal Anti-Kickback Statute (“AKS”) and marketing services that the court framed as an appeal...more

Investigations Newsletter: Seventh Circuit Reverses AKS Conviction Involving Allegations of Illegal Marketing and Advertising

ArentFox Schiff on 4/21/2025

Seventh Circuit Reverses AKS Conviction Involving Allegations of Illegal Marketing and Advertising - On April 14, the US Court of Appeals for the Seventh Circuit reversed the criminal conviction of Mark Sorensen after a...more

13th Annual Healthcare Fraud & Abuse Review - 2024

Bass, Berry & Sims PLC on 3/7/2025

Bass, Berry & Sims is pleased to announce the release of the 13th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2024. Compiled by the firm's Healthcare Fraud & Abuse Task Force,...more

Legal Marketing Tactics or an Illegal Kickback Scheme? The Seventh Circuit’s Impending Decision on the Expansiveness of the...

Quarles & Brady LLP on 12/18/2024

On December 4, the U.S. Court of Appeals for the Seventh Circuit heard oral arguments in USA v. Mark Sorensen, case number 24-1557, and it is now taking under advisement a case that could have widespread effects as to what...more

The State AG Report – 10.10.2024

Cozen O'Connor on 10/11/2024

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •GOP AGs Urge Congress to Tune In and Support AM Radio in...more

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

Gardner Law on 4/2/2024

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

Second Circuit: Whistleblower Must Adequately Allege Willfulness to Assert FCA Claims Based on AKS Violations

ArentFox Schiff on 3/19/2024

On March 12, the Second Circuit affirmed in part and reversed in part a district court dismissal of False Claims Act (FCA) claims predicated on alleged Anti-Kickback Statute (AKS) violations. Adam Hart brought the claims...more

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

Bass, Berry & Sims PLC on 2/27/2024

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

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

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

Morrison & Foerster LLP on 1/10/2024

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

McDermott Will & Schulte on 9/26/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

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

Epstein Becker & Green on 8/14/2023

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

False Claims Act Settlements to Know from Q2 2023

Bass, Berry & Sims PLC on 7/18/2023

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

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