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.

The policy effectively precludes the prescription of a genetic test based on a family history of a condition.

This could change - a little, and slowly - in the future. Provisions of the Medicare Improvements for Patients and Providers Act (MIPPA) crack the door open for coverage of some screening tests. MIPPA, which came into effect in January, requires CMS to cover some preventive services, such as screening tests. But it creates a lengthy, convoluted process that gives the agency a great deal of latitude to decline coverage.

CMS issued a final rule in October 2008 describing how it will implement the preventive services provisions. As it puts these into effect, the agency will shape a large segment of the U.S. diagnostics marketplace.

There is no timeline for the agency to begin making coverage decisions. But given that preventive medicine is at the heart of congressional healthcare reform proposals, it is possible that CMS and private insurance companies will be given new mandates or incentives for covering genetic screening in the coming months. Unless or until that happens, manufacturers will have to run a complex and as yet untested bureaucratic maze to gain approval to sell genetic screening tests to the Medicare population.

Interpretation is everything

When

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