Kelly Cleary

Kelly M. Cleary represents clients on a diverse range of health care regulatory and policy matters, helping clients understand and navigate an increasingly complex and often changing regulatory code. She provides strategic advice and counsel to the full range of health care and life sciences participants—including hospitals, academic medical centers, cancer centers, health IT companies, and pharmaceutical and device manufacturers—on health care policy, regulatory and enforcement matters. As an advisor to health industry participants, she supports in-house legal and business teams in structuring complex transactions and other strategic initiatives in a manner that minimizes regulatory risk.

Kelly has particular experience in matters involving state and federal fraud and abuse laws, including the federal Stark Law and Anti-Kickback Statute and their state analogs, and the Patient Protection and Affordable Care Act marketplace regulations. She also has successfully represented clients before administrative and judicial tribunals on matters relating to Medicare and Medicaid enrollment and reimbursement, as well as in lawsuits arising under the False Claims Act. In addition, Kelly advises clients on privacy, security and breach notification issues arising under state and federal laws.