DONIELLE MCCUTCHEON is an experienced strategic regulatory counselor for global life sciences companies, including many of the world’s most prominent pharmaceutical, biotech, and medical device manufacturers, as well as health insurers, healthcare providers and private equity firms focused on healthcare. Donielle advises clients on critical business solutions for their most challenging regulatory problems, whether they involve healthcare fraud and abuse, including 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.
Examples of Donielle’s recent engagements include:
- 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 medical device manufacturers by providing practical advice on discount and rebate arrangements with customers, engagement of 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;
- 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;
- Counsel medical device company on compliance program considerations and draft full set of compliance policies;
- 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;
- Manage comprehensive analysis of state health insurance laws on behalf of a health insurance company in connection with the company’s implementation of innovative collaboration arrangements with providers;
- 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 on behalf of private equity firms, and advised clients on fraud and abuse, compliance, healthcare licensure and change of ownership issues in the context of the same.
Donielle received her B.A. in Political Science from the University of Michigan and her J.D. from the University of Chicago.