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Anti-Kickback Statute

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... more +
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 -
Goodwin

Health Headlines: May 2025

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On May 14, 2025, Pennsylvania State Sen. Tim Kearney and State Rep. Lisa Borowski introduced legislation addressing private equity and corporate interests in healthcare. Pennsylvania Gov. Josh Shapiro is touting the companion...more

Dinsmore & Shohl LLP

First Circuit Requires But-for Causation for AKS-Based FCA Liability, Bolsters Majority View

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What is the proper causation standard for an Anti-Kickback Statute violation to trigger liability under the False Claims Act? The First Circuit has answered that question in a much anticipated interlocutory decision in...more

Gardner Law

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

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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

Arnall Golden Gregory LLP

Government Investigations Team Insights - May 2025

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AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors, SEC enforcement attorneys, and federal agency attorneys, has...more

Dentons

Ep. 63 – Speaking Fees and Safe Harbors: Lessons from a $202M AKS Settlement

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In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

ArentFox Schiff

Investigations Newsletter: DOJ Plans to Use the FCA to Attack DEI Initiatives

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DOJ Plans to Use the FCA to Attack DEI Initiatives - On May 19, the US Department of Justice (DOJ) announced a novel use of the False Claims Act (FCA) to enforce Trump Administration policies against antisemitism, gender...more

Troutman Pepper Locke

Connecticut Dentists Bite Off More Than They Can Chew; Settle False Claims Allegations for Nearly $500,000

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On May 9, Connecticut Attorney General (AG) William Tong, in collaboration with the U.S. Attorney’s Office for the District of Connecticut, announced a $495,721 false claims settlement with Advanced Dental Center PC (Advanced...more

Foley & Lardner LLP

Unpacking the Federal Anti-Kickback Statute’s Application to Payments to Medicare Advantage Agents and Brokers

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On December 11, 2024, the U.S. Department of Health & Human Services’ Office of Inspector General (OIG), issued a Special Fraud Alert (Alert) focusing on financial arrangements involving Medicare Advantage (MA) Organizations...more

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

Hinshaw & Culbertson - Health Care

OIG Advisory Opinion 25-02 Integrates Community Health Center Social Support Services with Primary Care Referral Programs

Hinshaw & Culbertson - Health Care on

The U.S. Department of Health and Human Services (HHS) Office of Inspector General ("OIG") issued Advisory Opinion No. 25-02 ("Opinion") on April 4, 2025, regarding a Health Center proposal to link social support services to...more

Morgan Lewis - Health Law Scan

Mass. USAO Focuses on Healthcare Fraud in Private Equity Investments, Broker Arrangements at Annual Conference

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On May 8, 2025, the Boston Bar Association hosted its annual White Collar Crime Conference, a reoccurring theme of which was the recognition of changing times, while also maintaining that the core principles of criminal and...more

Mintz - Health Care Viewpoints

Noteworthy False Claims Act Settlement Demonstrates DOJ’s Continued Scrutiny of Arrangements Between Hospitals and Physician...

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On May 14, 2025, Fresno Community Hospital and Medical Center d/b/a Community Health System (CHS) and its technology partner, Physicians Network Advantage, Inc. (PNA), agreed to pay $31.5 million (the Settlement Agreement)...more

ArentFox Schiff

Investigations Newsletter: DOJ Announces Updated White-Collar Enforcement Priorities and Revised Policies

ArentFox Schiff on

DOJ Announces Updated White-Collar Enforcement Priorities and Revised Policies - Earlier this week, the Criminal Division of the US Department of Justice (DOJ) introduced a new white-collar enforcement plan, which sets...more

Mintz - Health Care Viewpoints

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

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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

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Health Care Compliance Association (HCCA) on

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Cozen O'Connor

Justice Department Continues Pattern of False Claims Act Suits Due to Alleged Kickbacks

Cozen O'Connor on

On May 1, the federal government brought a False Claims Act (“FCA”) suit against three health insurers, as well as three insurance brokers. The Justice Department’s suit alleges that the insurers paid millions of dollars in...more

Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

Rivkin Radler LLP

Genetic Testing Marketing Companies and Executives Settle Medicare Fraud Allegations for $6 Million

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The U.S. Attorney’s Office for the Eastern District of Pennsylvania announced on April 23 that Genexe, LLC (doing business as Genexe Health) and its parent company, Immerge, Inc., along with two of their executive...more

Lowenstein Sandler LLP

Two False Claims Act Cases From SDNY Highlight Continuing Bite of Aggressive Healthcare Enforcement

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The U.S. Attorney’s Office for the Southern District of New York last week announced the resolution of two significant False Claims Act (FCA) cases—one from a large settlement and the other the result of a jury verdict after...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

Venable LLP

Defense-Friendly Anti-Kickback Statute and False Claims Act Marketing and Advertising Decisions

Venable LLP on

On April 14, 2025, the Seventh and Second Circuits each issued opinions narrowing the scope of advertising, marketing, and booking fee activities that run afoul of the federal Anti-Kickback Statute (AKS). See United States v....more

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

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On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Foley & Lardner LLP

The Northern District of Illinois Endorses “But For” Causation Standard for AKS-Premised False Claims Act Cases

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A circuit split over the causation standard under the federal Anti-Kickback Statute (AKS) could grow wider after a recent Northern District of Illinois (NDIL) decision. In United States ex rel. Jeffrey Wilkerson & Larry...more

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