Current Reimbursement and Regulatory Roadblocks Inhibit the
While effective coverage determination methodologies have been developed for many areas in healthcare, they are insufficient for the needs of the dynamic molecular diagnostic environment. Molecular diagnostics present new challenges for coverage that are so different from other medical services and devices that neither the “gold standard” randomized control trial, nor Coverage with Evidence Determination (CED), works well as a coverage determination methodology. The possibility of restricted access to potentially life-saving medical research is very real, as are restricted coverage-caused delays in the development and clinical use of laboratory tests needed to drive new patient therapies.
The white paper, “A Pay-for-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests,” co-authored by
Co-author Ding stated, “The explosion of genetic testing is completely transforming how many life-threatening health conditions are being treated today, dramatically increasing longevity and quality of life for many patients. It is imperative that the cost and value of these tests be factored into payor reimbursement to encourage appropriate use of diagnostics and to support the growth of personalized medicine.”
The proposed value-based model outlined in the white paper advances a coverage determination process that encourages innovation in the agile molecular diagnostics environment. The technology-enabled coverage determination process presents a unique opportunity for a self-regulating system that inherently optimizes patient outcomes, payor cost containment and developer recovery on investment.