Articles and Blogs

Anti-Kickback Statute

Court Confirms Value in Obtaining Advisory Opinion from OIG

[04/28/25]

Posted on April 28, 2025 in Health Law News

Published by: Hall Render

Three recent cases out of New York show the value in obtaining Advisory Opinions from the Office of Inspector General (“OIG”) when considering the risk of certain arrangements under the Anti-Kickback Statute (“AKS”). Background In 2022, a whistleblower who was also a physician (“Relator”) filed a False Claims Act Complaint against Platform, an online... READ MORE

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Seventh Circuit Narrows Scope of Anti-Kickback Statute in United States v. Sorensen

[04/28/25]

Posted on April 28, 2025 in Litigation Analysis

Published by: Hall Render

On April 14, 2025, the U.S. Court of Appeals for the Seventh Circuit (the “Court”) reversed the conviction of Mark Sorensen under the federal Anti-Kickback Statute (“AKS”), holding that payments to marketing firms and manufacturers – absent influence over health care decisions – do not constitute illegal kickbacks. Notably, this marks the Seventh Circuit’s... READ MORE

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Supreme Court Rejects Expansive “Willfulness” Application in AKS Case

[11/25/24]

Posted on November 25, 2024 in Health Law News, Long-Term Care, Home Health & Hospice

Published by: Hall Render

On October 7, 2024, the United States Supreme Court denied review of a Second Circuit decision limiting the “willfulness” requirement for liability under the federal Anti-Kickback Statute (“AKS”) to knowledge that one’s actions are unlawful. The Second Circuit rejected the argument made by the plaintiff relators in U.S. ex rel. Hart v. McKesson (“Hart“)... READ MORE

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Minnesota District Court Cites Excessive Fines Clause to Limit FCA Penalties

[10/22/24]

Posted on October 22, 2024 in False Claims Act Defense, Health Law News, Litigation Analysis

Published by: Hall Render

The government lawsuit against defendants Precision Lens and its founder Paul Ehlen, United States ex rel. Fesenmaier v. Cameron-Ehlen Group, Inc. (“Fesenmaier”), has garnered substantial media attention. This is due in part to juicy facts (kickbacks to physicians in such forms as fancy meals and exclusive vacations for which physicians were invoiced at below... READ MORE

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OIG Greenlights Specific Arrangement Involving Gift Cards Offered by Consulting Firm to Physician Practices in New Advisory Opinion

[04/04/24]

Posted on April 4, 2024 in Health Law News

Published by: Hall Render

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently issued Advisory Opinion No. 23-15 (“Advisory Opinion”), a favorable opinion involving a consulting firm’s (“Requestor”) proposal to offer gift cards to its existing physician practice customers for referring potential new customers. The OIG approved the Proposed Arrangement (defined below), noting... READ MORE

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Mixed Signals? Compliance Considerations for the Provision of Free Advanced Practice Provider Support

[07/25/23]

Posted on July 25, 2023 in Health Law News

Published by: Hall Render

On December 14, 2022, the Office of Inspector General (“OIG”) issued an advisory opinion which approved a hospital program (“Arrangement”) to provide advanced practice provider (“APP”) support for inpatients being cared for by primary care physicians (“Participating Physicians”). Several months later, in May 2023, the Department of Justice (“DOJ”) reached a settlement of $29,744,065... READ MORE

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OIG Greenlights Smartphone Loaner Program for Telehealth Access

[05/09/22]

Posted on May 9, 2022 in Health Law News

Published by: Hall Render

Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-08 (the “Advisory Opinion”), approving a federally qualified health center’s (“FQHC’s”) provision of “locked” smartphones and chargers to existing patients in order to promote access to telehealth services (the “Arrangement”). Background The FQHC primarily serves low-income individuals,... READ MORE

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Higher Minimum Penalties and Other Important Updates to the OIG’s Health Care Fraud Self-Disclosure Protocol

[11/12/21]

Posted on November 12, 2021 in Health Law News

Published by: Hall Render

On November 8, 2021, the U.S. Department of Health & Human Services Office of Inspector General (“OIG”) revised its Self-Disclosure Protocol (“SDP”) for health care providers for the first time since 2013. OIG’s revisions brought the SDP in line with the current statutory penalties under the Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law... READ MORE

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OIG Provides Favorable Opinion and Roadmap for ASC Joint Ventures

[07/29/21]

Posted on July 29, 2021 in Health Law News

Published by: Hall Render

On April 29, 2021, the U.S. Department of Health and Human Services’s Office of Inspector General (“OIG”) posted Advisory Opinion No. 21-02 (“Advisory Opinion”), a favorable opinion involving an ambulatory surgery center (“ASC”) joint venture and related safe harbors to the Anti-Kickback Statute (“AKS”). This opinion is significant for many reasons, including: It is... READ MORE

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The Sprint to Value: CMS Transforms the Stark Law

[12/04/20]

Posted on December 4, 2020 in COVID-19 Daily Updates, Health Law News

Published by: Hall Render

On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a much anticipated final rule (“Final Rule”) aimed at modernizing and streamlining key regulations under the federal Stark Law. As anticipated, the Final Rule included some major changes to the Stark regulations that will drive physician contracting, compensation models and compliance... READ MORE

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