FDA approval alone is no longer sufficient for patients to have access to innovative new diagnostic tests. Now more than ever, test developers also need to achieve positive reimbursement decisions by payers, and to address regulations or policies that determine if or how new tests can be used in patient care.
Every patient deserves the same access to solutions for today’s expanding healthcare challenges. But how do you overcome the hurdles associated with bringing new diagnostic tests to market?
Market Access
To avoid pitfalls associated with non-coverage, lack of adequate billing/reporting codes, or suboptimal payment for new tests, developers need to identify, understand, and have a plan to address any potential reimbursement barriers early, before a test is marketed. Because payer policies can change rapidly in response to external factors – including the introduction of a new diagnostic test – the landscape may shift in the time it takes for the developer to meet regulatory requirements. In that case, the developer should also have a post-market plan to support customers in overturning negative coverage determinations or denied claims.
Policy
Test developers should be aware of any new or modified laws, rules, or guidances that can impact how their test may be reimbursed, regulated, or used. By staying on top of proposed introductions or changes, test developers can help shape the environment they do business in, and more importantly, potentially prevent any additional onerous or costly requirements from being imposed.
Strategy
Applies expertise analyzing trends in market access and policy development to create a comprehensive roadmap of what developers need to be aware of and/or do at each stage of a product lifecycle in order to achieve a successful product launch by forging a seamless transition from regulatory authorization to positive coverage from payers.
Consulting Services
Leadership
Michele M. Schoonmaker, Ph.D.
Owner/Principal Consultant
Michele Schoonmaker LLC is a consulting company focused on providing strategic solutions to complex market access and/or government affairs problems facing companies or laboratories. Michele spent 17 years with Cepheid, a leading molecular diagnostics company, where her primary responsibilities were to develop and implement global strategic reimbursement plans for Cepheid’s molecular diagnostic product. Prior, Michele was a Specialist in Genetics for the Congressional Research Service (CRS), a division of the Library of Congress.
As a senior advisor, she analyzed trends in clinical, social, and legal issues in genetic medicine and wrote detailed prospective reports and provided reference material upon request to Members of Congress and their staff. Michele also has experience working for the U.S. Food and Drug Administration (FDA) as a regulatory policy analyst and reviewer of diagnostic tests and with the National Institute of Aging/National Institutes of Health in the Immunology Laboratory as a Biologist. She holds a Ph.D. in Health Services Research, Genetics and Public Policy from Johns Hopkins University School of Hygiene and Public Health.
