Advises clients in the health care sector on food and drug law and health care regulatory and reimbursement matters, with a focus on the laws and regulations implemented by the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS).
Helps life sciences companies optimize the value of their innovations by developing tailored regulatory strategies and navigating complex coding, coverage and reimbursement challenges.

Marlee is a consultant in the health care and life sciences practice. She focuses on food and drug law and health care compliance, reimbursement and regulatory matters. Marlee represents pharmaceutical and medical device manufacturers, technology companies, laboratories, hospitals and health systems, major academic medical centers, non-profit research foundations and a variety of other health care entities.

Marlee’s work includes advising such clients on U.S. and international laws and regulations related to the commercialization of and post-marketing compliance for pharmaceutical products, medical devices and other health technologies, including developing FDA regulatory strategies and navigating complex coding, coverage and reimbursement challenges. She counsels pharmaceutical clients on a variety of market access matters, including implications of Medicare payment rules, drug utilization management, biosimilar policies and continuity of care laws and regulations.

She assists medical device and biotechnology firms in obtaining favorable regulatory treatment, including De Novo clearances and combination product reviews. Marlee also counsels clients regarding FDA and Federal Trade Commission (FTC) advertising and promotion matters, including refining promotional and educational communications and developing compliance policies.

Marlee provides advice related to clinical trials, including negotiating clinical trial agreements, both with parties in the United States and internationally; assessing compliance issues; structuring trials from FDA and CMS perspectives; and providing guidance on FDA and Office of Human Research Protections requirements. She spent time on a secondment with a leading academic medical center, where she negotiated clinical trial agreements and supported technology development.

She conducts due diligence and provides strategic analysis related to transactions across the health care industry, including acquisitions of entities and products, mergers and joint ventures, and a variety of loan agreements, licensing arrangements and investments. Her work includes advising health care clients on compliance with federal and state fraud and abuse laws, including the federal anti-kickback statute, the Stark Law and the False Claims Act.

Marlee was named “One to Watch in America” for Health Care Law in 2023 by Best Lawyers.

Marlee was awarded a fellowship by Loyola’s Beazley Institute for Health Law and Policy and earned a Certificate in Health Law. She was also a fellow of the Loyola Institute for Consumer Antitrust Studies.

During law school, Marlee was a judicial intern for a magistrate judge in the U.S. District Court for the Northern District of Illinois and a legal intern at the American Medical Association, headquartered in Chicago, Illinois.

Representative Work

Advising on the FDA submission process for a next-generation sequencing test and CMS coverage and coding strategy for an academic medical center.
Assisting in an advocacy effort before Congress and federal agencies to obtain Medicare coverage for comprehensive genomic profiling tests.
Counseling a pharmaceutical company regarding the implications of Medicare payment policies and state laws affecting patient access to pharmaceutical products, including laws and policies relating to biosimilars, the 340B program and continuity of care.
Advising numerous early-stage digital-health companies on FDA regulatory strategy and engagement.
Developing legal training materials on FDA rules on promotion and communication for products both pre- and post-commercialization, and advising clients on promotional activities and communications for both “consumer” technologies positioned as not FDA-regulated and marketed, cleared or approved medical devices.

Performing due diligence analysis in connection with a hospital system acquisition for compliance with federal and state fraud and abuse provisions, privacy laws and other statutory and regulatory restrictions.
Counseling an academic medical center with respect to the compliance risks associated with a joint venture affiliation involving analysis of federal and state fraud and abuse laws, state corporate practice of medicine, fee-splitting and certificate-of-need laws, and requirements associated with the 340B program.
Negotiating sophisticated clinical trial agreements and other agreements relating to technology development on behalf of pharmaceutical companies, medical device manufacturers and academic medical centers.
Engaging the FDA on development of cybersecurity standards on behalf of a medical device cybersecurity company.
Advising a health technology company on the application of FDA device regulations to its products.
Advising a biomedical company on FDA classification of a combination product.
Producing global, U.S. and U.K. compliance handbooks for a pharmaceutical company based in India.
Advising a dialysis company on Medicare and Medicaid regulatory issues impacting its business.
Engaging stakeholders (patients and physicians) to educate FDA and federal policy-makers on issues relating to osteoarthritis.

Education
J.D., Loyola University Chicago School of Law, magna cum laude, 2014
B.A., Tufts University, 2009

Bar Admissions
District of Columbia
Illinois

Speeches and Publications

Panelist, “Understanding and Applying Ethics and Confidentiality Rules in the MLP Context,” webinar hosted by the National Center for Medical-Legal Partnerships, July 9, 2015.