Articles and Blogs

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

On July 8, 2020, the Department of Justice announced it settled a qui tam action[1] involving alleged violations of the federal and state False Claims Act (“FCA”) for $72.3 million against an Oklahoma surgical specialty hospital, its managers, a physician group and two individual physicians. Part of the factual allegations underpinning the FCA claims... READ MORE

As COVID-19-related testing capabilities increase along with other kinds of desired laboratory tests, clinical laboratories are encountering heightened volumes resulting from rising demand for services. Recovery homes and clinical treatment facilities may also see heightened demand for services stemming from the COVID-19 fall-out. In addition to this demand, these entities may wish to promote... READ MORE

Talk Is Cheap: Funding Negotiations Stall as Spending Deadline Approaches This week, the Senate had planned to begin deliberations on a legislative package that includes funding for the Department of Health and Human Services for fiscal year (“FY”) 2020. However, when Senate Majority Leader Mitch McConnell (R-KY) offered the motion needed to begin the debate,... READ MORE

The Eastern District of Texas affirmed the Government’s right to dismiss FCA actions over a whistleblower’s objections. The Court held that the Government may dismiss claims to avoid the costs of extended litigation. The United States Declined to Intervene Health Choice Alliance, LLC filed an FCA action alleging that the defendants defrauded the United... READ MORE