Allison W. Shuren

Allison Shuren co-chairs the Life Sciences & Healthcare Regulatory practice and advises a wide range of healthcare and life science clients on regulatory, compliance, and enforcement. She is a trusted advisor for international manufacturers of medical devices, pharmaceuticals, biologics and diagnostics as well as emerging companies with early-stage innovations, developers of virtual and digital health technology, private equity funds and the their portfolio companies, and broad range of providers of healthcare services, including ambulatory surgery centers, remote monitoring and diagnostic testing facilities, clinical laboratories, dialysis centers, physician group practices, virtual health networks, and physician practice management companies. A primary focus of Allison’s practice is compliance with health regulatory requirements, especially the healthcare fraud and abuse laws. She counsels on complex referral arrangements as well as sales and marketing programs, including discounts and rebates. She also represents clients in government investigations and qui tam actions involving False Claims Act, Anti-Kickback Statute, Stark Law, and health care fraud allegations. She regularly interacts with the U.S. Department of Health and Human Services Office of Inspector General, the U.S. Department of Justice, and the Centers for Medicare & Medicaid Services. She also leads internal compliance investigations and regulatory due diligence related acquisitions and investments.