Reimbursement and coverage challenges associated with bringing emerging molecular diagnostics into the personalized...

A simple search of the US FDA and the Centers for Medicare and Medicaid Services (CMS) websites demonstrates that the science of personalized medicine is far more advanced than current coverage and reimbursement policies. When one searches the websites of the FDA and CMS for pharmagenomics, personalized medicine and genetic testing, over 1800 hits come up on the US FDA website, and 52 hits come up on the CMS website. Although this is no surprise to those involved in the field of personalized medicine, it does illustrate the uphill battle that we face in educating policy makers on the need to appropriately cover and reimburse molecular diagnostics for use in a personalized medicine paradigm. A fully integrated personalized medicine paradigm will be driven by the ability to eliminate the reimbursement and coverage barriers that impact a patient's ability to access technological innovations in molecular diagnostic testing. For the purpose of this discussion, molecular diagnostic tests will be defined as a clinical diagnostic test performed on DNA, RNA or protein.