Articles and Blogs

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

The Office of the Inspector General (“OIG”) and Department of Justice (“DOJ”) often release information about compliance settlements under the Anti-Kickback Statute (“AKS”), including both the settlement value and the subject arrangement. The most recent data from 2018 shows several of these settlements arose from real estate arrangements and some involved millions of dollars... READ MORE

Recently, Lyft announced that its ridesharing service is now considered a covered benefit under the Arizona Medicaid program. This announcement follows implementation of new Arizona Medicaid regulations allowing ‘”rideshare”‘ companies to enroll as non-emergency medical transportation providers. Under the policy, participating Medicaid patients can request to schedule non-emergency medical transportation to ensure access to... READ MORE

On January 29, 2019, the Department of Health and Human Services Office of Inspector General (“OIG”) published Advisory Opinion 19-02, which approved an arrangement allowing a pharmaceutical manufacturer to loan smartphones to financially needy patients in order to assist with medication adherence. OIG stated that it would not impose sanctions against the parties for... READ MORE

Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a favorable advisory opinion, Advisory Opinion 19-01, concerning a charitable pediatric clinic (the “Clinic”)’s arrangement under which the Clinic waives cost-sharing amounts for a small percentage of TRICARE and Medicare beneficiaries not covered by a state insurance program (the “Arrangement”). After... READ MORE