Katherine S. Makielski

Kat Makielski focuses on representing clients in the health care and life sciences industries, including hospitals, health systems, pharmaceutical and medical device manufacturers, laboratory service providers, and other health care providers. She advises on health care regulatory and compliance issues for matters spanning corporate counseling, government investigations, False Claims Act and other civil litigation, and transactions involving health care professionals and entities.

Kat has advised hospitals and medical device manufacturers on potential Stark Law, federal Anti-Kickback Statute, and federal tax exemption implications for significant physician compensation arrangements and discount practices. She also has counseled clients on Medicare billing and reimbursement requirements and recommended policies to promote compliance with the Two-Midnight Rule. Additionally, Kat has advised on various health care regulatory matters, including HIPAA and state data privacy rules, the Sunshine Act (Open Payments Program), and FDA regulations. Furthermore, she has experience advising strategic health care transactions, focusing on fraud and abuse and other health care compliance concerns. [1]