Monica A. Wallace focuses her practice on complex regulatory and transactional counseling to healthcare organizations, including health systems, hospitals, ambulatory surgery centers, physician groups, dental providers, behavioral health clients, integrated delivery systems, academic medical centers, DMEPOS and pharmaceutical manufacturers and suppliers, home health agencies, and venture capital and private equity firms and their health-related portfolio companies. Monica is a practice area leader for the Healthcare Regulatory & Compliance practice.

Monica concentrates her regulatory practice on healthcare fraud and abuse, Medicare and Medicaid enrollment, reimbursement and billing, legal assessments and audits, compliance programs, and other general regulatory matters including licensure, survey/certification and accreditation. Her transactional practice includes mergers, acquisitions and affiliations, divestitures, hospital/physician joint ventures and corporate reorganization.

Previously, Monica worked with hospital executive management at the University of Iowa Hospitals and Clinics on strategic academic medical center issues.

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 

Drew Elizabeth McCormick is a seasoned healthcare regulatory lawyer whose practice spans the full spectrum of federal and state regulatory oversight of the health industry. She is particularly known for her sophisticated command of fraud and abuse laws — including the Anti-Kickback Statute, the Stark Law, the False Claims Act, and state fraud and abuse analogues — as well as Medicare and Medicaid program rules, reimbursement rules and policy, and enrollment, licensing, and certification requirements. She also has extensive experience in various emerging areas of healthcare regulation, including surprise billing regulation and state transaction notice laws.

Drew regularly leverages this deep regulatory knowledge in government audits, civil investigative demands, and internal investigations, helping clients assess exposure, craft defensible responses, and navigate complex interactions with enforcement agencies. Her work also extends to the transactional arena, where she identifies regulatory risks, structures compliant arrangements, and supports diligence and post-closing integration for strategic transactions.

In addition, Drew provides strategic, day-to-day counseling to healthcare providers, payors, and emerging companies, guiding them through operational questions, policy changes, and compliance program design to support both business objectives and regulatory integrity.

Caroline Reignley provides strategic legal, regulatory and compliance counsel to for-profit and nonprofit hospitals, health systems, other healthcare providers, life sciences and technology companies.

Fraud and Abuse

Caroline counsels clients on interpretation and risk mitigation under the Anti-Kickback Statute, Stark Law and EKRA. She also advises on internal and government investigations related to the False Claims Act, Stark Law and Anti-Kickback Statute. Her extensive experience navigating civil and criminal investigations within the healthcare space informs her strategic approach to risk management in transactions and the development of robust compliance programs.

Digital Health

Caroline advises clients involved in digital health—the intersection of health software applications, analytical tools, medical technology and electronic data assets enabled by the internet and mobile devices—on the applicable legal and regulatory infrastructure, with a particular focus on remote patient monitoring programs. She offers nuanced insights into fraud and abuse issues that arise in novel partnerships and other relationships between digital health companies and established healthcare providers. Her broad experience allows her to deliver practical, forward-thinking compliance and revenue strategies that help her clients thrive in today’s complex and still-evolving digital health regulatory landscape.

Medicare Reimbursement and Healthcare Compliance Matters

Caroline advises Medicare providers, consultants and vendors on a wide range of business, legal and regulatory issues. Caroline has extensive experience advising clients on Medicare and Medicaid fee-for-service reimbursement, billing and coding. She also advises clients on professional licensure, scope of practice, physician and health care professional clinician relationships and supervision, together with overall corporate compliance.

Prior to joining the Firm, Caroline served as a health law fellow for a regional nonprofit health system and as a law clerk at the US Department of Health and Human Services. Her background gives her a deep understanding of legal issues from both the regulator and provider perspectives.

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 

Monica A. Wallace focuses her practice on complex regulatory and transactional counseling to healthcare organizations, including health systems, hospitals, ambulatory surgery centers, physician groups, dental providers, behavioral health clients, integrated delivery systems, academic medical centers, DMEPOS and pharmaceutical manufacturers and suppliers, home health agencies, and venture capital and private equity firms and their health-related portfolio companies. Monica is a practice area leader for the Healthcare Regulatory & Compliance practice.

Monica concentrates her regulatory practice on healthcare fraud and abuse, Medicare and Medicaid enrollment, reimbursement and billing, legal assessments and audits, compliance programs, and other general regulatory matters including licensure, survey/certification and accreditation. Her transactional practice includes mergers, acquisitions and affiliations, divestitures, hospital/physician joint ventures and corporate reorganization.

Previously, Monica worked with hospital executive management at the University of Iowa Hospitals and Clinics on strategic academic medical center issues.