Donielle McCutcheon

Examples of Donielle’s recent engagements include:

Pharmaceutical/Biotech Counseling

• Counsel 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.
• Prepare comment letters to the Centers for Medicare and 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.
• 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.
• Conduct privileged review of a biologics company’s compliance program effectiveness and advise on resourcing and staffing needs and policy and process enhancements to reduce risk in the growing business area.
• Advise established pharmaceutical manufacturer on fraud and abuse considerations for proposed financial arrangements with telehealth providers.

Medical Device Counseling

• 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.
• Analyze 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 .
• Develop sophisticated safeguards for complementary clinical services offering on behalf of medical technology company.
• Provide 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.
• Assist early-commercial implantable medical device manufacturer in standing up a healthcare compliance program that aligns with the Department of Health and Human Services, Office of Inspector General’s Seven Elements of an Effective Compliance Program, including conducting compliance training for the company’s Board of Directors and Executive teams, preparing policies, and conducting coaching-sessions with newly appointed Chief Compliance Officer.
• Advise 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.

Clinical Laboratory Counseling

• Support diagnostic clinical laboratory’s Compliance Department in developing compliance safeguards for growing company and presenting compliance updates and developments to leadership and Board of Directors.
• Provide critical counsel to pre-launch stage diagnostic lab company on federal and state fraud and abuse and CLIA issues in anticipation of launch of company’s first lab developed cancer screening test.

Healthcare Provider Counseling 

• 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.
• 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 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.

Healthcare and Life Sciences Transactions

• Lead 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 advise 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, Donielle is a member of the firm’s Chicago Office Committee on Associate Compensation.

Donielle is dedicated to promoting diversity and inclusion both within and outside the firm.

• She is a member of the Chicago office Diversity, Equity & Inclusion Committee and previously served as co-chair of the Chicago office’s Associates Diversity Council.
• She is an active member of the Board of Directors for Uniting Voices Chicago (formerly the Chicago Children’s Choir), the nation’s preeminent youth choral and leadership organization and leads the organization’s Anti-Racism Task Force.