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 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 April 3, 2020, OIG released a Policy Statement indicating OIG will exercise its enforcement discretion not to impose administrative sanctions under the federal Anti-Kickback Statute (“AKS”) for certain financial arrangements related to a COVID-19 purpose that are covered under the Blanket Stark waivers issued by the Secretary of the U.S. Department of Health... 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

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

The Fifth Circuit ruled that a whistleblower’s voluntary dismissal with prejudice cannot affect the Government’s ability to pursue related litigation. When the Government has not yet intervened, and thus is not a yet a party, a case cannot be dismissed with prejudice as to the Government by a whistleblower. Background In Vaughn, ex rel.... READ MORE