DONIELLE MCCUTCHEON is an experienced strategic regulatory counselor for healthcare and 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 received her B.A. in Political Science from the University of Michigan and her J.D. from the University of Chicago Law School. Donielle is a proud member of the Board of Directors for the Chicago Children’s Choir, the nation’s preeminent youth choral and leadership organization.
Examples of Donielle’s recent engagements include:
- Advise national retailer on federal Anti-Kickback Statute 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;
- Counsel clinical-stage oncology company with respect to patient support programs, including 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;
- Serve as day-to-day fraud and abuse counsel to a number of 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;
- Prepare comment letters to the Centers for Medicare and Medicaid Services (CMS) and other agencies to advance client policy positions on important regulatory proposals;
- Advise national telehealth company on healthcare compliance considerations and assist with the development of key compliance policies in advance of the company’s SPAC merger;
- Provide strategic advice to pharmaceutical and medical device manufacturers who are considering and/or implementing novel value- and outcomes-based contracting models, including risk-share proposals, with customers;
- Provide regulatory counseling to 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;
- Conduct 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;
- Analyze the potential applicability of the Sunshine Act to various pharmaceutical and medical device manufacturers, including those with ex-U.S. entities and complex corporate structures; and
- Conduct regulatory due diligence reviews for numerous life sciences transactions, including mergers and acquisitions on behalf of private equity firms, and in connection with IPOs and SPACs, and advise clients on fraud and abuse, compliance, corporate practice of medicine, and change of ownership issues in the context of the same.