Marc Samuels, JD, MPH

Marc Samuels is the CEO of ADVI Health and one of the most consequential advisors in the life sciences, market access, and healthcare policy sectors. Over a career spanning more than two decades, he has played a direct role in more than 200 product launches and nearly every seminal coverage and payment decision made by The Centers for Medicare and Medicaid, from cell and gene therapy to oncology, rare disease, medical devices, diagnostics, and digital therapeutics.

He is not a consultant who studies the system from the outside. He helped build it.

The Work That Defines Him

Marc’s advisory practice sits at the intersection of healthcare policy, market access, reimbursement strategy, and real-world evidence, the four disciplines that determine whether a breakthrough therapy reaches the patients who need it, and at what price. His clients include life sciences companies, managed services organizations, providers, trade and patient associations, and digital health companies navigating the most complex access and reimbursement environments in modern medicine.

He is widely regarded as one of the foremost authorities on CMS coverage and payment decision-making, coding and reimbursement strategy for cell and gene therapy, IRA and MFN drug pricing negotiation, and the evolving regulatory relationship between CMS and FDA. He has been called one of the best-kept secrets in healthcare for those seeking to work with CMS and payers — and recognized as one of the most influential Medicare lobbyists in the country by The Boston Globe.

Under Marc’s leadership, ADVI Health has grown from a four-person firm to a 60-person organization with offices in Austin, Chicago, and Washington, DC, serving more than 150 clients worldwide across three integrated practice areas: Market Access Policy Strategy, Reimbursement, and Strategic Analytics and Value Evidence. His first acquisition, PHAR, positioned ADVI at the forefront of HTA and HEOR economic modeling, real-world evidence, and value economics for the biopharma sector.

ADVI Health and Marc have been finalists in Washington Business Journal’s Best Places to Work and Austin Business Journal Best CEO. 

Before ADVI

Marc’s public sector career is the credential behind the credential. He spent a decade in state and federal government, most recently as Chief of Staff to Texas Medicaid — at the time, a $24.5 billion program representing more than 25 percent of the Texas state budget. He implemented Texas’ first Medicaid managed care plan law and led the enactment and operation of S-CHIP.

Earlier in his career, Marc advised both President George Herbert Walker Bush and then-Governor George W. Bush on healthcare policy, serving in the White House Office of Policy Development and the Texas Governor’s Office of Policy. He was involved in the directive to improve the nation’s drug and device approval process while serving on the President’s Council on Competitiveness under Vice President Dan Quayle. He also published a body of research on the neuropsychological signature of the AIDS virus through the Midwest AIDS Behavioral Research Institute.

The people who shaped American healthcare policy over the last three decades are Marc’s professional peers, not his references.

Thought Leadership and Affiliations

Marc is a board member at the Duke Margolis Institute for Health Policy, where his work focuses on the evolving roles of CMS and FDA in a changing healthcare ecosystem and solutions to the coding and reimbursement challenges facing cell and gene therapies. He serves as Policy Counsel to the National Comprehensive Cancer Network (NCCN) and as a board member of the ADAPT and RISE programs at the UCSF Rosenman Institute, where he also championed the BUILD program supporting women and minority entrepreneurs and the NCCN Foundation’s first Young Investigator Award focused on health equity.

His analysis and commentary appear regularly in STAT News, The Pink Sheet, Fierce Healthcare, In Vivo, Managed Care Executive, the Journal of Oncology Practice, Medical Economics, and major regional publications. He is a published contributor to the Managed Care Answer Book and HMO and Capitation Answer Book (Panel Publishers, New York). Marc also publishes his own byline on Linked In which is widely read and re-shared. 

Marc speaks frequently on healthcare transformation, business strategy, regulatory and policy change, the future of healthcare innovation, and the American Ingenuity argument for the life sciences sector.

Education

Yale Medical School, School of Public Health · University of Texas School of Law · University of Michigan (Neuroscience)