News & Analysis as of August 18, 2025

Health Care Providers

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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 -

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

ArentFox Schiff on 6/30/2025

On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more

FMV for Provider Contracts: Regulatory Standards

Holland & Hart LLP on 8/22/2024

As a general rule, healthcare employers are required to pay employed physicians and other contracted providers fair market value (FMV) for their services, but many employers do not understand relevant regulatory standards. ...more

How to Wear the Investor Hat When Physicians Are the Revenue Generators

Husch Blackwell LLP on 8/20/2024

Engaging in management and investor conversations about maintaining and growing a business is critical, no matter the industry. Whether you’re discussing normal business sustainability, organic growth, or contemplating a...more

Now is Not the Time to Relax: Record Settlements in Stark Law and False Claims Cases

Lathrop GPM on 6/4/2024

In early May 2024, the University of Pittsburgh Medical Center (UPMC) agreed to pay $38 million to resolve a False Claims Act case based on alleged Stark Law violations. The size of the settlement in United States ex rel. J....more

Ep. 12 - Working with Valuation Experts to Substantiate Fair Market Value Compensation

Dentons on 4/26/2024

We often work with valuation experts to ensure compensation payments between healthcare organizations and physicians are fair market value and commercially reasonable for purposes of compliance with the Stark Law and the...more

Labs Take Note: In a New Opinion, OIG Reminds Us that Fair Market Value Payments Can Still Violate the Anti-Kickback Statute

Bass, Berry & Sims PLC on 10/9/2023

On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more

Defensibility of a fair market value analysis

Health Care Compliance Association (HCCA) on 8/3/2023

Fair market value (FMV) is a pinnacle issue with respect to healthcare regulatory compliance and compensation agreements. This article will analyze the issues related to an FMV defensibility analysis of compensation...more

Is Fair Market Value Dispositive in an Anti-Kickback Statute Case?

Stevens & Lee on 6/22/2023

On the heels of the Sixth Circuit’s recent decision in Martin v. Hathaway, previously discussed on Health Law Observer, a critical issue in that case, i.e., the meaning of the term “remuneration” for purposes of the federal...more

Fair Market Value Defensibility Analysis: Why is It Different from a Fair Market Value Opinion?

Nelson Mullins Riley & Scarborough LLP on 10/20/2022

Fair market value is a pinnacle issue for compliance under the Stark Law and Anti-Kickback Statute. Compensation arrangements that are required to be representative of fair market value under Stark/AKS include employment,...more

The Tale of Two CE Programs: OIG Compares Healthcare Provider and Third-Party Continuing Education in Recent Advisory Opinion

McDermott Will & Schulte on 8/4/2022

The Office of Inspector General of the US Department of Health and Human Services (OIG) issued Advisory Opinion 22-14 (AO 22-14) on June 29, 2022, concerning continuing education (CE) programs to be offered by an...more

OIG: Continuing Education Programs Have Independent Value Under AKS

Troutman Pepper Locke on 7/19/2022

In the wake of the global pandemic, which forced manufacturers, trade organizations, and all other players in the health care industry to rethink how to provide medical education and communication on new product offerings to...more

Sponsoring Continuing Education Programs—OIG Weighs in with Advisory Opinion 22-14

Bass, Berry & Sims PLC on 7/6/2022

On June 29, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-14, approving in part, and denying in part, a request from an ophthalmology practice...more

[Webinar] Updates on Stark Regulations and Impacts on Fair Market Value/Commercial Reasonableness - June 28th, 12:00 pm - 1:30 pm...

Health Care Compliance Association (HCCA) on 6/3/2022

Learning Objectives: - Impact 2021 Physician Fee Schedule has had/will have on Physician Compensation and Benchmark Data - Impact COVID has had/will have on Physician Compensation - Evolution of Use of Benchmark Data,...more

California Court: Fair Market Value Payments May Not Avert Anti-Kickback Liability

McGuireWoods LLP on 5/4/2022

In February 2022, the U.S. District Court for the Central District of California denied a defendant’s motion to dismiss a qui tam action alleging that the defendant had violated the federal Anti-Kickback Statute (AKS). In its...more

Arent Fox's Stark & Anti-Kickback Statute Final Rules Analysis

ArentFox Schiff on 3/3/2021

Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more

Fraud and abuse risks in digital health: What tech companies need to know about healthcare enforcement – Part II

White & Case LLP on 2/10/2021

For companies looking to monetize their hard-earned innovations in digital health, there is a minefield of potential healthcare enforcement to avoid. As discussed in Part I of this alert, such healthcare enforcement can lead...more

CMS Finalizes and Clarifies Key Valuation Terms in the Stark Law

Jones Day on 1/20/2021

The Situation: Under the federal Physician Self-Referral Law ("Stark Law"), many physician arrangements must meet one or more of the so-called "big three" requirements: that the arrangement be "commercially reasonable," that...more

[Webinar] What Compliance Professionals Need to Know About the New Stark and Anti-Kickback Regulations - January 29th, 12:00 pm -...

Health Care Compliance Association (HCCA) on 1/14/2021

Learning Objectives: - Explain changes to existing concepts including fair market value, commercial reasonableness, and volume or value - Examine the new definitions, exceptions, and safe harbors and their impact on...more

CMS Finalizes New Limitations to the Isolated Transactions Exception to the Stark Law

Jones Day on 1/13/2021

The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or fair market value...more

The Regulatory Sprint is Over – What’s at the Finish Line Under the New Stark and AKS Final Rules?

Verrill on 1/8/2021

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare &...more

New Stark Regulations Further Clarify Definitions of Fair Market Value and General Market Value

Hinshaw & Culbertson - Health Care on 12/14/2020

The Department of Health and Human Services (HHS), on November 20, 2020, released final rules for the federal physician self-referral law (Stark) and the anti-kickback statute (AKS). The Centers for Medicare & Medicaid...more

CMS Sprints to Overhaul Stark

Davis Wright Tremaine LLP on 12/4/2020

With the benefit of more than three decades of rulemaking and hundreds of submissions under the Self-Referral Disclosure Protocol, CMS has seized the opportunity in the final Sprint Regulations to adopt a number of...more

Special Fraud Alert: Speaker Programs – If It's Too Good to Be True, It Probably Is

Bass, Berry & Sims PLC on 11/25/2020

On November 16, the Department of Health and Human Services Office of Inspector General (OIG) took a shot across the bow of the healthcare industry when it published a Special Fraud Alert highlighting some of the fraud and...more

OIG Takes Aim at Speaker Programs in Special Fraud Alert

Bradley Arant Boult Cummings LLP on 11/20/2020

On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the...more

OIG Releases Policy Statement Extending HHS Blanket Waiver Protection to Certain Federal Anti-Kickback Statute Violations During...

Seyfarth Shaw LLP on 4/7/2020

On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a policy statement of enforcement discretion (the “Policy Statement”) regarding sanctions under the Federal...more

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