Articles and Blogs

On January 31, 2019, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a proposed rule that, if finalized, would eliminate Anti-Kickback Statute (“AKS”) safe harbor protection for prescription drug rebates paid by manufacturers to pharmacy benefit managers (“PBMs”), Medicare Part D plans and Medicaid managed care organizations (“Proposed Rule”).... READ MORE

On October 24, 2018, Congress enacted a new law titled the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”) as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (“SUPPORT Act”). The SUPPORT Act is a comprehensive law that seeks to combat the opioid... 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

In the era of value-based care, health care providers and manufacturers are increasingly examining risk sharing opportunities in the treatment of patients. On September 17, the Department of Health and Human Services Office of Inspector General (“OIG”) published Advisory Opinion 18-10 whereby it approved a proposed risk sharing initiative with defined guardrails. Advisory Opinion... READ MORE

On August 27, 2018, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a Request for Information (“RFI”) regarding the Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law (“CMP”). The RFI, published as a result of HHS’s desire to transition the current health care system to one that pays... READ MORE

On May 7, 2018, the Department of Health and Human Services Office of Inspector General (“OIG”) published Advisory Opinion 18-02, which approved an arrangement allowing a durable medical equipment (“DME”) distributor to provide patients with product samples at no cost to the patient. OIG stated that it would not impose sanctions against the parties... READ MORE

In a new case from the Southern District of Ohio, US_v_MillenniumRadiology, the court denied a motion to dismiss a False Claims Act suit, finding that compliance with a safe harbor could only be raised on summary judgment. The court also found that uncompensated service as a medical director could form the basis for a False Claims... READ MORE