DONIELLE MCCUTCHEON is an experienced strategic regulatory counselor for life sciences, healthcare, and health technology companies, including both emerging and established medical device, pharmaceutical, and biotech manufacturers, as well as clinical laboratories, telehealth companies, and private equity firms focused on life sciences and healthcare. Donielle is recognized in Chambers USA in the area of Healthcare – Illinois (2024). Crain’s Chicago Business named Donielle to their 2024 “Notable Nonprofit Board Leaders” list as a result of her work for Uniting Voices Chicago.
Offers a Practical Perspective. Donielle’s clients depend on her to provide practical and thoughtful solutions to their most challenging regulatory and compliance problems and she is highly regarded by clients and colleagues for her responsiveness and dedication to client service. Her client base includes medical device and pharmaceutical manufacturers, small biotech companies, genetic and early cancer detection screening companies, dental labs and dental product manufacturers, large healthcare providers, telehealth companies, and private equity firms and strategics focused on life sciences investments. For this broad range of clients, Donielle is often advising company boards of directors, c-suite personnel, and in-house counsel. Her ability to provide nuanced counsel in a business-forward manner distinguishes her from other outside counsel.
De-Risks Novel and Complex Arrangements. Donielle helps clients design and implement financial arrangements with customers and potential referral sources, sales and marketing offerings, value-based arrangements, discount and rebate offers, market access strategies, and patient support programs in compliance with the federal Anti-Kickback Statute (AKS), the Eliminating Kickbacks in Recovery Act (EKRA), the Stark Law, Medicare and Medicaid coverage and reimbursement rules, healthcare compliance program guidance, the Sunshine Act, government price reporting rules, and other state and federal fraud and abuse and compliance laws. She is the go-to healthcare lawyer for emerging and early-stage life sciences companies on these issues.
Leads Compliance Audits and Designs Compliance Programs. Donielle is routinely engaged to lead sensitive internal investigations and risk assessments focused on regulatory topics where she leverages her broad perspective and deep industry experience. She has also assisted numerous companies in designing right-sized compliance programs to align with government guidance and effectively prevent, identify and address instances of non-compliance, including drafting policies and procedures, counseling on implementation issues, and training company personnel.
Leads Life Sciences and Healthcare Transactions. Donielle regularly advises private equity firms and corporate clients on the wide variety of complex issues that arise in the context of mergers, acquisitions, and investments involving life sciences and healthcare companies.
Government Investigations and Enforcement Matters. Donielle defends clients in civil healthcare fraud investigations brought by the U.S. Department of Justice and the Office of Inspector General. Most recently, she has been involved in defending two medical device companies in separate qui tam whistleblower matters alleging violations of the False Claims Act and the AKS relating to various marketing practices.
Donielle regularly speaks and writes on topics that affect her clients’ businesses, such as navigating the telehealth boom, mitigating enterprise fraud and abuse and compliance risks, strategic approaches to Sunshine Act compliance, and securing coverage and reimbursement for novel healthcare items and services. She has also lectured for a healthcare management course at Loyola University’s Chicago Quinlan School of Business.
Donielle received her B.A. in political science from the University of Michigan and her J.D. from The University of Chicago Law School. She is a proud member, secretary, and chair of the Nominating & Governance Committee of the board of directors for Uniting Voices Chicago (formerly Chicago Children’s Choir), the nation’s preeminent youth choral and leadership organization.