News & Analysis as of August 24, 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 -

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Skadden, Arps, Slate, Meagher & Flom LLP on 7/8/2025

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more

OIG Declines to Approve Medical Device Company's Proposal to Subsidize Screening Costs

Bass, Berry & Sims PLC on 7/3/2025

On June 20, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-04, in which it declined to approve a proposal by a medical device company (Requestor) to pay the...more

OIG Says Medical Device Company's Proposal to Pay for Exclusion Screening for Customers May Violate the Anti-Kickback Statute

Epstein Becker & Green on 6/24/2025

On June 20, 2025, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion - OIG Advisory Opinion 25-04 (“AO 25-04”)....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

OIG Approves Hospital’s Redemption Offer to Retiring Physician-Owners

Bass, Berry & Sims PLC on 1/10/2024

On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 23-12, approving a physician-owned hospital’s offer to redeem over a two-year period the...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 Approves Physician-Owned Medical Device Company

Mintz - Health Care Viewpoints on 4/28/2022

On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more

OIG Permits Physician-Employer to Retain Profits from Anesthesia Services Provided by CRNA in Physician Office and ASC

Bass, Berry & Sims PLC on 11/19/2021

A pain management practice that employs a certified registered nurse anesthetist (CRNA) to provide anesthesia services in both an office location and an ambulatory surgery center (ASC) owned, in part, by the physician-owner...more

OIG Issues Favorable Advisory Opinion (No. 21-01) on Free Drug Program

Bass, Berry & Sims PLC on 4/8/2021

On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more

OIG Approves of Free In-Home Follow-Up Care Program Targeting High Risk CHF and COPD Patients in Advisory Opinion

Robinson+Cole Health Law Diagnosis on 4/16/2019

On March 6, 2019, the U.S. Department of Health & Human Services Office of Inspector General (OIG) issued a favorable advisory opinion that allows a nonprofit medical center (“Center”) to offer free, in-home follow-up care...more

OIG Advisory Opinion Allows Routine Waiver of Federal Cost-Sharing Obligations

Mintz - Health Care Viewpoints on 1/21/2019

In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts. The OIG’s analysis hinged on several factors that, taken...more

OIG Advisory Opinion Allows Charitable Pediatric Clinic to Provide Routine Cost-Sharing Waivers

Robinson+Cole Health Law Diagnosis on 1/16/2019

On January 14, 2019, the Health and Human Services Office of Inspector General (OIG) published a favorable Advisory Opinion allowing a charitable pediatric clinic (Clinic) to routinely waive cost-sharing amounts for patients...more

OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System...

Robinson+Cole Health Law Diagnosis on 11/14/2018

On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were...more

Advisory Opinion: Free van shuttle services to medical facilities

Tucker Arensberg, P.C. on 11/5/2015

On October 21, 2015 the Department of Health and Human Services Office of Inspector General posted Advisory Opinion No. 15-13. This Opinion relates to a request for Advisory Opinion about a plan to offer free van shuttle...more

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