News & Analysis as of August 20, 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 -

“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’s Advisory Opinion No. 25-08: Negative Opinion Highlights Potential Broad Reach of AKS

Morgan Lewis - Health Law Scan on 8/1/2025

In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more

OIG Advisory Opinion 25-03: Navigating Anti-Kickback Rules and Safe Harbors in Telehealth Contractual Arrangements

Hinshaw & Culbertson - Health Care on 7/3/2025

On June 6, 2025, the Office of Inspector General (OIG) issued Advisory Opinion 25-03 (the “Opinion”), offering guidance for structuring telehealth collaborations in a manner that complies with the federal Anti-Kickback...more

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

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on 6/25/2025

On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...more

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

Hinshaw & Culbertson - Health Care on 5/20/2025

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

Second Circuit Holds No FCA Violation Where Defendant Relied on Favorable OIG Advisory Opinions

King & Spalding on 5/2/2025

On April 14, 2025, the Second Circuit issued a summary order holding that the relator failed to plead scienter, a necessary element under the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), where the defendant...more

OIG Issues Favorable Advisory Opinion Permitting a Community Health Center to Refer Primary Care Services During Provision of...

King & Spalding on 4/30/2025

On April 9, 2025, OIG posted Advisory Opinion No. 25-02, a favorable advisory opinion allowing a community health center operating under Section 330 of the Public Health Service Act (the Requestor) to ask individuals, to whom...more

OIG Issues Another Favorable Advisory Opinion on Patient Recruitment Efforts by Community Health Centers

Mintz - Health Care Viewpoints on 4/24/2025

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

McDermott Will & Schulte on 9/6/2024

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

New Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers

Foley & Lardner LLP on 4/26/2024

The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for...more

[Webinar] Lunch and Learn Series: Prohibitions on Provider Inducements - February 27th, 12:00 pm - 1:00 pm ET

Rivkin Radler LLP on 2/16/2024

On Tuesday, February 27, the next installment of Rivkin Radler’s Healthcare Compliance Lunch & Learn series, will be presented by Rivkin Radler Partners, Geoffrey Kaiser and Benjamin Malerba. The program, “Prohibitions on...more

New Marketing Possibilities for Vendors Contracted with Medicare Providers and Suppliers Following OIG’s Favorable Advisory...

Sheppard Mullin Richter & Hampton LLP on 1/18/2024

On December 28, 2023, the Office of Inspector General (the “OIG”) issued a favorable Advisory Opinion (No. 23-15) (the “Opinion”) to a consulting vendor (the “Requestor”) that wanted to provide up to $75 in gift cards to...more

OIG Approves the Use of Gift Cards to Reward Customers' Marketing Efforts

Bass, Berry & Sims PLC on 1/17/2024

On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 23-15, approving a physician practice consultant’s proposal to offer gift cards to its customers when...more

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

McDermott Will & Schulte on 11/30/2023

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

OIG Issues New Advisory Opinion on Federal Anti-Kickback Statute

WilmerHale on 11/14/2023

The Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion that explored the limits of a relatively new safe harbor to the federal Anti-Kickback Statute (AKS) that aims...more

OIG Provides Guidance on Physician Bonus Compensation

Venable LLP on 11/9/2023

On October 13, 2023, the Department of Health and Human Services Office of Inspector General (the OIG) released an advisory opinion regarding a multi-specialty physician practice's (the Practice) proposed plan to pay bonuses...more

Cochlear Implant Manufacturer Proposes to Provide Free Compatible Hearing Aids

Harris Beach Murtha PLLC on 11/2/2023

This opinion addresses a proposed arrangement (“Proposed Arrangement”) by the manufacturer of cochlear implants (“Requestor”), where the Requestor would provide certain patients who receive one of their implants with a free...more

OIG Issues Unfavorable Advisory Opinion on Free Items to Patients Tied to Reimbursable Services

Mintz - Health Care Viewpoints on 11/2/2023

Perhaps unsurprisingly, the Office of Inspector General for the Department of Health and Human Services (OIG) rejected a manufacturer’s proposal to provide free hearing aids to certain patients if they receive one of the...more

OIG Issues Advisory Opinion on Federal Anti-Kickback Statute

WilmerHale on 10/26/2023

The Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion highlighting two important—if easy to overlook—areas that health care companies and providers should remain...more

OIG Issues Favorable Opinion Concerning Bonus Payments to Employed Physicians

Stevens & Lee on 10/26/2023

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently considered the question whether an employed physician can be paid bonus compensation relating to procedures performed by the...more

OIG Pathology Lab: Don't Pay for Services You Don't Need

McDermott Will & Schulte on 10/25/2023

In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services arrangement with referring...more

OIG Issues Favorable Opinion Regarding Physician Group’s Proposal to Pay Bonuses to its Employed Physicians Based on Net Profits

Robinson+Cole Health Law Diagnosis on 10/20/2023

On October 13, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-07 (Advisory Opinion), in which the OIG issued a favorable opinion regarding a physician group employer’s proposal to pay bonuses to its...more

OIG Confirms the Broad Protection of Employee Safe Harbor

Sheppard Mullin Richter & Hampton LLP on 10/17/2023

Late last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) posted Advisory Opinion No. 23-07 affirming the broad protection available for compensation to employed physicians under the...more

Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint Venture

Robinson+Cole Health Law Diagnosis on 9/25/2023

On August 18, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-05 (Advisory Opinion), in which the OIG warned that it would likely issue sanctions under the Federal anti-kickback statute (AKS) if a...more

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Anti-Kickback Statute › Health Care Providers › Advisory Opinions

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