Articles and Blogs

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

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

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

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

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

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

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

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

On November 16, 2020, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a Special Fraud Alert (the “Alert”) addressing speaker program payments made by pharmaceutical and medical device companies to health care professionals (“HCPs”). Specifically, the Alert focuses on company-sponsored events at which the HCP makes a speech... READ MORE

On July 24, 2020, President Trump announced four Executive Orders (“Executive Orders”) characterized as focusing on lowering drug prices via various mechanisms. These Executive Orders, described in more detail below, include: (1) Executive Order on Access to Affordable Life-saving Medications; (2) Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen; (3)... READ MORE