2021 +Dx Diagnostics Forum

James A. Cannatti III advises healthcare, technology, and life sciences organizations on complex regulatory, compliance, and enforcement matters at the forefront of the evolving healthcare ecosystem. His practice spans digital health and health information technology (IT) policy, fraud and abuse compliance, and emerging regulatory risk areas, including in the diagnostics, life sciences services, research, pharmacy, and distribution space.

James counsels healthcare providers, diagnostics companies, health IT developers, and life sciences services and research companies on compliance with federal healthcare requirements, including the Anti-Kickback Statute, Stark Law, and EKRA. He also represents clients in internal investigations and enforcement matters, drawing on his deep experience with government expectations and enforcement priorities to provide practical, regulator-informed guidance on navigating enforcement risk and regulatory change.

James’s advisory work frequently addresses cutting-edge regulatory topics and developments, including:

• Fraud and abuse risk and enforcement trends involving healthcare providers, diagnostics, laboratory services, and life sciences companies
• Internal investigations and responses to government inquiries involving the US Department of Justice and the US Department of Health and Human Services’ Office of Inspector General (OIG)
• Compliance with the Anti-Kickback Statute, Stark Law, and the Eliminating Kickbacks in Recovery Act of 2018 in complex commercial arrangements
• Digital health enforcement and compliance risks, including remote patient monitoring and telehealth
• Information blocking and interoperability requirements under the 21st Century Cures Act
• Health IT certification, APIs, and data-sharing obligations

Before entering private practice, James spent more than a decade at the OIG, where he held a range of roles, including serving as its first Senior Counselor for Health Information Technology. In that role, he worked on the development, interpretation, and enforcement of federal healthcare policy affecting providers, health IT developers, and other industry stakeholders.

While in law school, James served as a managing editor of the Ohio State Journal on Dispute Resolution.

Counsels healthcare and life sciences clients on government investigations, regulatory compliance, and compliance program development  

Represents clients in False Claims Act qui tam matters, government audits, civil monetary penalty and exclusion investigations, and CMS suspension and revocation actions  

Advises on the Anti-Kickback Statute and Stark Law, and on Medicare and Medicaid coverage and payment rules  

Negotiates and implements corporate integrity agreements and makes government self-disclosures 

Michael (Mike) Ryan advises manufacturers, healthcare providers, and investors on the legal, regulatory, and reimbursement/market access issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products, and drugs. He helps clinical laboratories and life sciences companies maintain regulatory compliance and evaluate, develop, and implement strategies to optimize coding, coverage, and payment for novel technologies.

Additionally, Mike helps innovative companies identify and navigate applicable Food and Drug Administration (FDA) regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. He regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and reviews promotional and marketing materials for FDA-regulated medical products.

Mike also counsels clinical laboratories on state and federal compliance issues, including those under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), state laboratory licensure laws, and billing and reimbursement rules.