Donielle McCutcheon is an experienced strategic regulatory counselor for global life sciences companies, including both prominent and emerging pharmaceutical, biotech, and medical device manufacturers, as well as healthcare providers, telehealth companies, and private equity firms focused on healthcare.
Donielle’s clients depend on her to provide practical and thoughtful solutions to their most challenging regulatory problems and she is highly regarded by clients and colleagues for her responsiveness and dedication to client service. Donielle counsels on healthcare fraud and abuse, including nuanced issues under the federal Anti-Kickback Statute and Stark Law; managed care contracting; Medicare and Medicaid coverage and reimbursement; drug pricing; transparency reporting, or other issues. Donielle has extensive experience in advising companies on all aspects of healthcare compliance programs, including drafting policies and procedures, counseling on implementation issues and leading audits and internal reviews. In addition to her regulatory counseling, Donielle regularly advises private equity firms and corporate clients on the wide variety of complex issues that arise in the context of mergers and acquisitions involving life sciences companies. 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 Graduate School of Business.
Donielle is actively involved in 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 firm’s Committee on Retention and Promotion of Women and Committee on Compensation of Associates.
Donielle is committed to promoting diversity and inclusion within the firm and the legal profession. She previously served as co-chair of the Chicago office’s Associates Diversity Council and is now a member of the firm’s Diversity Committee.
Donielle holds a Bachelor of Arts in political science from the University of Michigan and is a graduate of University of Chicago Law School. She lives in Chicago with her husband and two children.