McDermott Will & Schulte, a global law firm

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.

Steven J. Schnelle is a trusted advisor to investors, executives, general counsel, and business operators in the healthcare and life sciences sectors, delivering actionable strategies to help them achieve market leadership, drive transformative growth, and navigate complex regulatory landscapes. With a national reputation for his transactional acumen and regulatory insights, Steven brings clarity and alignment to multifaceted arrangements, empowering organizations to excel in today’s dynamic healthcare environment.

Steven is a recognized authority in national reimbursement strategy, enabling clients to maximize the value of healthcare services and products. His counsel is particularly sought after by executive leadership teams and general counsel in hospital systems, as well as by professional groups; pharmacy service providers; clinical laboratories; and manufacturers of pharmaceuticals, medical devices, and durable medical equipment. He has extensive experience in advising on cutting-edge regulatory developments and innovative business models, ensuring his clients remain competitive and compliant.

Core Areas of Experience:

• Healthcare Mergers and Acquisitions (M&A). Guiding transactions involving changes of ownership and control with a focus on seamless regulatory coordination
• Federal Healthcare Oversight. Managing audits, investigations, and compliance with federal programs
• Third-Party Payer and Reimbursement. Addressing challenges and opportunities in payer participation and payment structures
• Medicare Administrative Appeals. Driving favorable outcomes in high-stakes appeals
• Sector-Specific Regulations. Navigating the nuanced regulatory requirements of health facilities, corporate practice, pharmacy, clinical laboratories, hospice care, and pharmaceutical/device manufacturing
• Pharmacy Matters. Counseling pharmacies on state and federal regulatory frameworks, Medicare enrollment disputes, and revocations

Steven has also cultivated a niche practice in navigating the complexities of the 340B Drug Pricing Program, providing tailored guidance on program development, audit response, manufacturer repayments, and litigation. His ability to resolve intricate issues relating to duplicate discounts and alleged diversion has earned him accolades from healthcare providers and pharmacy services providers alike.

Thought Leadership

Steven’s thought leadership has been widely recognized, with accolades from Chambers USA and other prestigious legal directories. He is a sought-after speaker at industry conferences, addressing topics ranging from healthcare M&A trends to reimbursement innovation. His insights have also been featured in leading publications, and he frequently mentors the next generation of legal talent in the healthcare sector.

Deborah advises clients on reimbursement and policy strategy for medical devices, diagnostics, biologics and health services by public and private payers. With more than 25 years of health industry experience, Deborah leverages her deep knowledge and strong industry relationships to deliver strategic, operational and policy consultative services to companies of all sizes, from start-ups to Fortune 100 companies. Due to her deep background in working with clients across the healthcare services spectrum, Deborah has a detailed understanding of the market access process and the historical successes to help healthcare clients with emerging and innovative technologies achieve their goals.

For the past decade, Deborah has worked alongside healthcare innovators to advance their market access goals, including:

• Navigating the complex Centers for Medicare and Medicaid Services (CMS) landscape;
• Addressing the challenges and opportunities of bringing e-products to market; and
• Providing insight on the US healthcare system and the health industry.

Deborah also collaborates with clients pursuing Medicare coding, coverage and payment of their groundbreaking, digitally-enabled healthcare solutions and services, including diagnostic tests and medical devices, artificial intelligence (AI)-powered technologies, remote monitoring tools, and other innovative health services. Her work encompasses assessing the various pathways in federal testing and the requirements needed to obtain additional or incremental payment. Deborah has been successful in obtaining favorable payment rates under the Medicare Clinical Laboratory Fee Schedule, incremental payment in the hospital inpatient and outpatient setting, and procedure, product and diagnosis codes.

Prior to joining McDermott+, Deborah was a senior leader at a health technology company focused on the healthcare benefits industry. She also held roles at several consulting firms where she focused on corporate and product strategy for health plans launching new products in the private sector, built health economic models, and analyzed data to assess the effectiveness of federal and state health programs.