News & Analysis as of August 15, 2025

Healthcare Facilities

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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 Advisory Opinion 25-08: Unfavorable DME – Vendor Payment Arrangement

Baker Donelson on 7/24/2025

On July 1, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 25-08, an unfavorable opinion discussing a proposed arrangement in which a medical device company...more

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

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Health Care Compliance Association (HCCA) on 5/15/2025

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

AGG Talks: Home Health & Hospice Podcast - Episode 10: Anti-Kickback Compliance for Hospice and Skilled Nursing Providers

Arnall Golden Gregory LLP on 4/3/2025

In this episode, AGG Healthcare attorneys Bill Dombi and Jason Bring discuss recent OIG guidance on hospice and skilled nursing facility relationships, focusing on anti-kickback risks and fraud concerns. They cover key issues...more

Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)

Health Care Compliance Association (HCCA) on 4/3/2025

In addition to releasing its General Compliance Program Guidance, the OIG at HHS announced plans to publish a series of Industry Segment-Specific Compliance Program Guidances (ICPG). The first of these, addressing nursing...more

OIG Approves Municipality’s Plan to Bill Insurance and Waive Co-Pays for Treatment-in-Place Emergency Medical Services

Arnall Golden Gregory LLP on 12/9/2024

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-09 (the “Opinion”) to a municipal corporation (the “Requestor” or...more

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on 4/2/2024

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

OIG Approves Arrangement Incentivizing Medigap Policyholders to Seek Treatment From PHO Network Hospitals

Arnall Golden Gregory LLP on 3/14/2024

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-01 (the “Opinion”), to a Medicare Supplemental Health Insurance...more

Key Value-Based Care Developments to Watch in 2024

Holland & Knight LLP on 3/5/2024

The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...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 Advisory Opinion: Free Hearing Aids from Cochlear Implant Maker Could Violate Fraud and Abuse Laws

Morgan Lewis - Health Law Scan on 11/22/2023

The US Department of Health and Human Services Office of Inspector General (OIG) posted on October 25, 2023 Advisory Opinion No. 23-08, in which OIG rejected a proposed arrangement from a cochlear implant device manufacturer...more

HHS OIG Posts Comprehensive Health Care Compliance Program Guidance

Saul Ewing LLP on 11/16/2023

In early November, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released its General Compliance Program Guidance (the Guidance). This was HHS OIG’s first update since 2008....more

OIG Issues Unfavorable Advisory Opinion for Proposed IONM Joint Venture

Saul Ewing LLP on 9/1/2023

The HHS Office of Inspector General issued an 'unfavorable' advisory opinion in August with respect to a proposed joint venture relating to interoperative neuro monitoring. Parties considering joint ventures and those in...more

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

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

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

OIG Permits FQHC to Loan Smartphones to Patients to Receive Telehealth Services

Saul Ewing LLP on 5/9/2022

On April 28, 2022, the Office of Inspector General (“OIG”) published Advisory Opinion 22-08 in which the OIG declined to impose sanctions against a federally qualified health center (“Requestor”). The Requestor proposed an...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

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on 2/17/2021

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

Healthcare Fraud & Abuse Review 2020

Bass, Berry & Sims PLC on 2/4/2021

Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

Stark Law and Anti-Kickback Statute Waivers Prove to be Useful Measures During the COVID-19 Pandemic … But, Will They Last?

Butler Snow LLP on 9/4/2020

The novel Coronavirus (“COVID-19”) pandemic has brought about unprecedented applications of certain federal healthcare laws and regulations, including the federal physician self-referral law (the “Stark Law”) and the federal...more

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Anti-Kickback Statute › Office of the Inspector General › Healthcare Facilities

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