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.

Tony Maida counsels health care and life sciences clients on government investigations, regulatory compliance and compliance program development. Having served as a government official, Tony has extensive experience in health care fraud and abuse and compliance issues, including the federal and state Anti-Kickback and Stark Laws and Medicare and Medicaid coverage and payment rules. Tony is a practice area leader for the Healthcare Regulatory & Compliance practice.

He represents clients in False Claims Act (FCA) qui tam matters, government audits, civil monetary penalty and exclusion investigations, and Centers for Medicare and Medicaid Services (CMS) suspension, and revocation actions, negotiating and implementing corporate integrity agreements, and making government self-disclosures. Tony also draws on his background in government investigations to assist clients in evaluating, developing and implementing corporate compliance programs.

Tony previously served as deputy chief of the Administrative and Civil Remedies Branch of the US Department of Health and Human Services (HHS) Office of Inspector General (OIG), where he represented the agency on investigating FCA and civil monetary penalty cases, negotiating and monitoring corporate integrity agreements, and defending exclusion appeals. While serving at HHS, Tony was a principal author of the OIG's current Self-Disclosure Protocol. He also has advised CMS on policy issues, including the Medicare Overpayment Rule and the creation of the Self-Referral Disclosure Protocol.

Tony represents a wide variety of clients, including

• Hospitals and health systems
• Professional services organizations and physician practice management companies, such as anesthesia, dentistry, dermatology, emergency medicine, oncology, primary care, radiology and wellness practices
• Pharmaceutical and medical device manufacturers and distributors
• Long-term care, home health, hospice and other post/sub-acute providers
• Pharmacies and pharmacy benefit managers
• Dialysis providers
• Laboratories
• Ambulance companies
• Health plans
• Electronic health records and revenue cycle management vendors
• Investors and other financial institutions that invest in and/or support the health care and life science industries

Tony writes and speaks frequently on health care regulatory topics and has lectured on health care fraud and abuse issues at Boston University School of Law and American University Washington College of Law.

Prior to his government service, Tony represented hospitals and physician practices on health care regulatory and corporate compliance issues. During law school, Tony was the editor of the 2001 Symposium issues of the American Journal of Law and Medicine.

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.