Allison W. Shuren

Allison Shuren co-chairs the Life Sciences & Healthcare Regulatory practice and is a recognized leader in healthcare, advising a wide range of healthcare and life science clients on regulatory, compliance, and enforcement. Recognized for more than a decade by both Chambers and Legal 500 United States, including as Leading Lawyer for Healthcare Service Providers, Allison is a trusted advisor for provider and suppliers of health care services including hospitals and health systems, hospice providers, ambulatory surgery centers, remote monitoring and diagnostic testing facilities, clinical laboratories, dialysis centers, physician group practices, virtual and digital health networks, and physician practice management companies; developers and manufacturers of innovative medical products across medical technology, pharmaceuticals and biotechnology; and investors in the healthcare sector. 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, joint venture, and co-management 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, Physician Self-Referral 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.

Before she began her legal career, Allison was a practicing critical care pediatric nurse practitioner concentrating in pediatric cardiovascular disease and neonatal pediatric surgery. She has served as a principal investigator as well as a research coordinator for clinical trials involving pharmaceutical and medical device products. During her clinical career, she helped spearhead the development of an outcomes management and clinical pathway program.