groups? “Is the relevance of a particular biomarker or a particular genetic test the same thing when you’re 70 years old and you’ve already expressed certain diseases as it is when you’re much younger?”

Factors in Coverage Decisions

Age is also a factor in assessing the value of genetic tests. Young people have a lifetime to manage their risks but may have little personal incentive to do so. Genomic testing may not be as relevant for a person who joins the Medicare program at 65 as it is when he or she is 2 years old, said Jacques. “Why shouldn’t people arrive … in the Medicare program with whatever predictive genetic factors that may be brought to bear, in fact, already done?”

Another factor Jacques cited is that genetic tests can have multiple platforms, multiple vendors, and multiple indications. In such a setting, reference standards can be critical. Several years ago, Jacques attended a meeting in which test developers could not agree on the definition of the colors used in their test. “I told them at that meeting that they had absolutely no chance of Medicare reimbursement unless they could at least agree on standards,” he said. “Sure enough, by the next year they had collaborated with NIST and actually developed standards.” Evaluating a product without knowing the starting reference point is a real difficulty, said Jacques.

Finally, a major challenge within CMS, as with FDA, is that payment decisions are binary. Statutes dictate how CMS must pay for covered health care practices. For example, congressional mandates delineate coverage for screening tests versus diagnostic tests, with screening tests tied to the findings of the USPSTF recommendations.

In contemplating the evaluation of tests, Jacques wondered if granting full reimbursement for a covered test would act as a disincentive to the development of further evidence. Jacques questioned whether it might make sense to pay initially at a lower level—say at 75 percent. Then, as the evidence base matured and if evidence demonstrated clinical benefit, a payment premium could be awarded—say 135 percent. Such a system could support future innovation and the development of “the next big thing.”

Innovation in Review

Several initiatives have been developed to enable collaboration between CMS and FDA, including the parallel review process and CMS representation on FDA’s Council for Medical Device Innovation. CMS has been open to accompanying test developers and others if they choose to meet with FDA for initial feedback, Jacques said.

CMS also has been doing coverage with evidence development for sev-



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