Donielle McCutcheon

About Donielle McCutcheon

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.

Experience

1. Partner

   Sidley Austin LLP

   Jan 2019 — Present

   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 is a proud member of the Board of Directors for the Chicago Children’s Choir, the nation’s preeminent youth choral and leadership organization.

Education

• University of Chicago Law School

  Law

  2006 — 2009

• University of Michigan

  B.A>, Political Science

  2000 — 2004

Skills

• Healthcare
• Class Actions
• Intellectual Property
• Medical Devices
• Courts
• Legislative Relations
• Medicaid
• Legal Research
• Corporate Law
• Legal Writing
• Litigation
• Mediation
• Civil Litigation