Monique Nolan, M.D., J.D. | People

Dr. Monique Nolan is an attorney with 20 years of health regulatory experience in the government, private, and nonprofit sectors, including more than a decade in the U.S. Department of Health and Human Services (HHS) Office of the General Counsel, where she focused on the Medicare and Medicaid programs administered by the Centers for Medicare & Medicaid Services (CMS). Highly skilled at analyzing complex issues that intersect the legal, policy, and legislative realms, Monique develops practical solutions and strategies to further client objectives in rapidly changing environments. She advises on a range of healthcare regulatory and legislative matters affecting healthcare providers, suppliers, and pharmaceutical and medical device manufacturers. Monique focuses on Medicare and Medicaid policy, coverage, coding, and reimbursement across the spectrum of healthcare products and clinical services, helping clients to develop strategies for improving market access for innovative technologies and services and to advocate their positions before administrative agencies.

Prior to joining the firm, Monique was a member of the health leadership team for The MITRE Corporation's health program and its operation of the CMS and HHS-sponsored Alliance to Modernize Healthcare, a Federally Funded Research & Development Center. While there, she served previously as Chief of Health Strategy and subsequently as Senior Principal in the Division of Healthcare Payment, Innovation, & Quality, where she supported CMS on a range of policy and strategic matters, including Hospital Inpatient Prospective Payment System (IPPS) New Technology Add-on Payments and enforcement of hospital price transparency requirements. During her time as an attorney with the CMS Division of HHS Office of the General Counsel from 2006–2019, she concentrated on legal issues concerning Medicare disproportionate share hospital (DSH) adjustments, Hospital IPPS Direct and Indirect Graduate Medical Education (DGME and IME) payments, Medicare national coverage and benefit category determinations, physician quality programs, durable medical equipment and end-stage renal disease payment systems, Medicare claims appeals, and the Medicaid drug rebate program.

Monique began her legal career as an associate in the health practice group of a large D.C. law firm, where she focused on a wide range of health regulatory matters. She holds a law degree from the Georgetown University Law Center. Prior to practicing law, she earned her medical degree from the University of Maryland School of Medicine and completed her medical internship in the Johns Hopkins University/Sinai Hospital Residency Training Program in Internal Medicine.

Focus Areas

Experience

Advised large hospital system on regulatory issues, including hospital billing for ambulance transports, hospital services related to non-covered/experimental services, and post-hospital extended care services.
Counseled a Children’s Hospital on 340B eligibility in connection to a corporate transaction/campus expansion.
Advises clients and develops rulemaking comments on the hospital IPPS and OPPS payment systems, with emphasis new technology and pass-through payments, MS-DRG and APC assignments, coding, and item/procedure coverage and payment.
Assists several physician specialty societies and biotechnology companies in developing strategic positions regarding Medicare policies and rulemakings.
Prepares comment letters on Centers for Medicare & Medicaid Services proposed rules regarding Medicare programs and reimbursement issues.

Represents individual clients and coalitions in meetings with the Centers for Medicare & Medicaid Services on coding, coverage, and reimbursement matters.
Advises clients on the Medicare End-stage Renal Dialysis Prospective Payment System, including transitional drug add-on payment adjustments and the bundling of new services.
Analyzes and drafts legislative language for biotechnology companies and pharmaceutical manufacturers related to diagnostic test coverage, prescription drug pricing and payment reforms, pharmacy benefit managers, and the 340B Drug Pricing Program.