News & Analysis as of

Medicare Anti-Kickback Statute Advisory Opinions

Venable LLP

OIG Issues Favorable Advisory Opinion on Physician-Telehealth Arrangement

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On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-03 (Opinion), which provided favorable guidance for physician practices seeking to contract with...more

Hinshaw & Culbertson - Health Care

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

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

ArentFox Schiff

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

ArentFox Schiff on

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

DLA Piper

OIG Issues Favorable Advisory Opinion on Telehealth Marketplace MSO-PC Arrangement

DLA Piper on

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion under the federal Anti-Kickback Statute (AKS), wading into the world of not only telehealth but also...more

Robinson+Cole Health Law Diagnosis

OIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory Opinion

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management...more

King & Spalding

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

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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

King & Spalding

OIG Issues a Favorable Advisory Opinion to a Pharmaceutical Manufacturer Regarding Free Transportation, Lodging and Support for...

King & Spalding on

On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more

Bass, Berry & Sims PLC

More Losses than Gains? OIG Declines to Approve Certain Medicare Advantage Gainsharing Arrangements in Advisory Opinion 24-08

Bass, Berry & Sims PLC on

On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

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

Bass, Berry & Sims PLC

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

Bass, Berry & Sims PLC on

On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

Sheppard Mullin Richter & Hampton LLP

District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more

Foley & Lardner LLP

OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials

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In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Sheppard Mullin Richter & Hampton LLP

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

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

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding the Subsidization of Certain Medicare Cost-Sharing Obligations in the Context of a...

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On December 21, 2023, the OIG issued a favorable advisory opinion (Advisory Opinion 23-11) regarding the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial. The...more

Harris Beach Murtha PLLC

OIG Opinion: DME Supplier Subsidy of Medicare Cost-Sharing in Cardiac Trial OK

This favorable OIG opinion concludes that although the proposed arrangement (“Proposed Arrangement”) to subsidize Medicare cost-sharing obligations for Medicare patients in a cardiac clinical trial (“Study”) would constitute...more

WilmerHale

OIG Issues New Advisory Opinion on Federal Anti-Kickback Statute

WilmerHale on

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

Bass, Berry & Sims PLC

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

Bass, Berry & Sims PLC on

On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

King & Spalding

OIG Issues Advisory Opinion Rejecting Proposal to Offer Free Compatible Hearing Aids to Certain Patients

King & Spalding on

On October 20, 2023, OIG issued a negative Advisory Opinion in response to a proposal from a cochlear implant manufacturer (Requestor) to offer and provide free compatible hearing aids to certain patients (Proposed...more

Stevens & Lee

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

Holland & Knight LLP

OIG Looks at How Employed Physicians Bonuses Are Paid from ASC Profits

Holland & Knight LLP on

The U.S. Department of Health & Human Services Office of the Inspector General (OIG) on Oct. 13, 2023, posted Advisory Opinion No. 23-07 detailing a favorable response to a proposal by a Requestor to pay bonuses to its...more

Harris Beach Murtha PLLC

OIG’s Favorable Opinion: Employed Physicians Paid Bonuses Based on ASCs’ Net Profits

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This opinion addresses a proposed arrangement (“Proposed Arrangement”) between a multi-specialty physician practice (“Requestor”) that employs approximately 11 physician employees (“Physician Employees”). In addition to base...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

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

Mintz - Health Care Viewpoints

OIG Issues Unfavorable Advisory Opinion on Common Arrangements between Physician Practices and Health Care Providers

On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider...more

Rivkin Radler LLP

OIG Advisory Opinion Warns on IONM Company “Surgeon Deals”

Rivkin Radler LLP on

On August 18, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published an Advisory Opinion warning that a common arrangement under which surgeons profit from referrals of their patients...more

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