Donielle McCutcheon

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.

Examples of Donielle’s recent engagements include:

Medical Device Counseling

• Conducted focused internal compliance audit of implantable device unit of large medical device manufacturer on healthcare professional and patient engagement issues, including conducting over 25 personnel interviews.
• Served as day-to-day fraud and abuse counsel to numerous emerging and established medical device manufacturers by providing practical advice on discount and rebate arrangements with customers, financial arrangements with healthcare professionals, sales and marketing practices, and compliance matters.
• Analyzed the potential applicability of the Sunshine Act and state financial transparency reporting laws on behalf of an international digital health company with a complex corporate structure.
• Developed sophisticated safeguards for complementary clinical services offering on behalf of medical technology company.
• Designed critical safeguards for clinical services offering on behalf of medical technology company.
• Provided strategic advice to medical device manufacturers who are considering and/or implementing novel value- and outcomes-based contracting models, including risk-share proposals, with customers.
• Advised a pre-commercial medical device manufacturer on considerations related to compensating healthcare professionals in equity and commission fair market value determination under privilege on behalf of client to support the same.

Pharmaceutical/Biotech Counseling

• Counseled a clinical-stage oncology company with respect to patient support programs, including free drug patient assistance programs (PAPs), co-payment support, reimbursement advice, insurance bridge program, and donations to third-party patient assistance foundations in advance of product launch.
• Prepared comment letters to the Centers for Medicare & Medicaid Services (CMS) and other agencies to advance client policy positions on important fraud and abuse proposals on behalf of a number of pharmaceutical manufacturers.
• Conducted an internal review of a pharmaceutical company’s managed care contracting practices to advise on strategies to mitigate potential fraud and abuse risk and impact on government price reporting.
• Conducted a privileged review of a biologics company’s compliance program effectiveness and advised on resourcing and staffing needs and policy and process enhancements to reduce risk in the growing business area.
• Advised an established pharmaceutical manufacturer on fraud and abuse considerations for proposed financial arrangements with telehealth providers.

Clinical Laboratory Counseling

• Supported a diagnostic clinical laboratory’s compliance department in developing compliance safeguards for a growing company and presented compliance updates and developments to c-suite and board of directors.
• Provided critical counsel to an early-commercial stage diagnostic laboratory company with an early cancer detection test on federal and state fraud and abuse and CLIA issues.

Healthcare Provider Counseling

• Advised a national retailer on AKS considerations in connection with the client’s lease arrangements with independent doctors of optometry, including securing a fair market value opinion from a third-party valuation expert.
• Advised a national telehealth company on healthcare compliance considerations and assisted with the development of key compliance policies in advance of the company’s SPAC merger.
• Provided regulatory counseling to a nationwide physician medical practice group with respect to physician compensation, profit sharing, relationships with referring physicians, and potential overpayment disclosures under the healthcare fraud and abuse laws.

Healthcare and Life Sciences Transactions

• Represented Stryker in its US$4.9 billion acquisition of Inari Medical, Inc. (pending).
• Represented Carlin Consumer Health in its acquisition of Penetrex from Wellbeam Consumer Health.
• Led regulatory due diligence reviews for numerous life sciences transactions, including mergers and acquisitions on behalf of private equity firms, joint venture arrangements, and in connection with IPOs and SPACs, and advised clients on fraud and abuse, compliance, corporate practice of medicine, regulatory obligations, and change of ownership issues in the context of the same.

• Donielle is passionate about the firm’s recruiting and retention efforts.
  • She is co-chair of The University of Chicago recruiting team, and plays an active role in the firm’s Summer Associate Program.
  • In addition, she is a member of the Chicago office’s Committee for the Evaluation and Compensation of Associates.
• Donielle is dedicated to inclusion both within and outside the firm.
  • She is a member of the Chicago office’s Inclusion Committee.
  • She is secretary and chair of the Nominating & Governance Committee of the board of directors for Uniting Voices Chicago (formerly the Chicago Children’s Choir), the nation’s preeminent youth choral and leadership organization that inspires and unites thousands of youth from diverse backgrounds to become global ambassadors through high-caliber musical education.