News & Analysis as of August 14, 2025

Advisory Opinions

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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 -

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

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

ArentFox Schiff on 12/10/2024

Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Office of Inspector Warns Against Proposed Surgeon-owned Turnkey Intraoperative Neuromonitoring Business

Harris Beach Murtha PLLC on 8/23/2023

In a rarely seen “unfavorable” advisory opinion, the United States Department of Health and Human Services Office of Inspector General (“OIG”) recently warned that an entity’s (“Requestor”) proposal to assist surgeons in...more

OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company

Sheppard Mullin Richter & Hampton LLP on 6/28/2022

On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving...more

Physician Ownership in Medical Device Company Will Not Trigger Anti-Kickback Statute Enforcement Action, OIG Concludes in Advisory...

ArentFox Schiff on 5/23/2022

Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more

OIG Declines to Approve Lab’s Payment of Specimen Collection Fees to Hospitals

Bass, Berry & Sims PLC on 5/6/2022

On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more

OIG Issues Advisory Opinion Regarding Physician-Owned Device Company

King & Spalding on 5/4/2022

On April 20, 2022, OIG issued an advisory opinion regarding an arrangement involving a family of physicians having an ownership interest in a medical device company that manufactures products that the physicians also order. ...more

OIG Publishes New Procedural Process for Advisory Opinions

King & Spalding on 1/17/2022

On January 6, 2022, OIG issued a final rule (Final Rule) that will update the process and procedures that govern advisory opinions in early 2022. The Final Rule will be effective 30 days after its publication in the Federal...more

New Advisory Opinion on ASCs: New Flexibilities (Or Not?)

Foley & Lardner LLP on 7/6/2021

A recent advisory opinion issued by the Office of the Inspector General (OIG) has generated a great deal of buzz in the ambulatory surgery center (ASC) world. However, in some ways, the buzz is overstated and does not...more

Healthcare Law Update: April 2021

Holland & Knight LLP on 4/15/2021

William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

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Anti-Kickback Statute › Fraud › Advisory Opinions

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