PDX coverage gap

The future of the U.S. diagnostics industry, and hopes that personalized medicine can be transformed from a slogan into reality, hinge in large measure on payers learning to discern which genetic tests provide clinically valuable information, and then reimbursing at levels commensurate with that value.

But when it comes to genetic screening tests intended to predict an individual's response to treatment or risk of developing a disease, different parts ofHHS have acted at cross purposes. While NIH has been funding research to develop genetic screening technologies and FDA has been promoting their application to personalized medicine, the Centers for Medicare and Medicaid Services (CMS) has interpreted the law in a way that precludes reimbursement for most screening tests...