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Medicare Reviewing Potential Coverage of Genetic Tests

NEW YORK (GenomeWeb News) – The Center for Medicare Services is beginning to take a closer look at genetic tests and will consider if some of these molecular tests should be approved for coverage under the program.

CMS will review evidence on genetic tests, assess their preventive value, and will consider gene expression and pharmagoconemic tests for coverage decisions, according to CMS's Chief Medical Officer, Barry Straube, who spoke recently at a Department of Health and Human Services meeting in Washington, DC.

The CMS group that advises on coverage issues, the Medical Evidence Development and Coverage Advisory Committee (MEDCAC), will meet in early May for a discussion on genetic testing that could inform Medicare's future policy. The group of advisers will focus on what types of evidence will be needed to evaluate screening genetic tests for Medicare coverage.

MEDCAC plans to determine whether genetic testing as a lab screening service improves health outcomes, and if it can change or reduce disease complications or morbidity. The group also will aim to identify current data deficiencies on genetic testing that warrant further research.

MEDCAC uses evidence from medical literature, technology assessments, and it examines data and information on the effectiveness and appropriations of medical items and services covered under Medicare.

CMS also is looking into the value of preventive services, which were not originally provided through Medicare, but which over the past 10 or 15 years have been added to Medicare coverage through statutes, Straube explained to the Secretary's Advisory Committee on Genetics, Health and Society's quarterly meeting. That statutory authority is not there yet for genetic tests, but under last year's Medicare Improvement for Patients and Providers Act CMS gained the authority to consider adding preventive service benefits, Straube added.

Straube currently serves as an ex officio advisor for the SACGHS committee.

That bill enables CMS to consider preventive services "that identify medical conditions or risk factors" that the Secretary of Health deems "reasonable and necessary for the prevention or early detection of an illness or disability," and those recommended by the US Preventive Services Task Force.

"This is a very important modality that may allow us to start addressing genetic testing issues without waiting for Congress to actually give us this specific mandate," Straube told the committee.

CMS also has been considering how the Clinical Laboratory Improvements Amendments regulations apply to genetic tests.

"There have been discussions about whether genetic testing should be separated out into a specific… high-complexity laboratory testing," Straube added. "So far our policy has been that whatever applies to other high complexity testing should apply to genetic testing... but we have not found a reason yet to separate genetic testing" into a separate area, he said.

Speaking more broadly about work that may be on the way for CMS, Straube said that gene-expression profiling tests and pharmacogenomic testing have been identified along with 20 other medical topics that the group will consider for coverage.

He said that gene expression in oncology and pharmacogenomics testing are "ripe" with potential as topics for national coverage decisions.

In its announcement on the most recent NCD topics list, released in December, CMS said that it currently is "unclear if the widespread addition of [gene-expression oncology] testing to the evaluation of patients" would cause a "meaningful change in disease management and improved health outcomes."

CMS also noted in that listing that pharmacogenomic tests for DNA variants are used to "improve effectiveness and/or to avoid adverse drug events," but added that "there is a relative scarcity of high-quality published evidence from outcome-related clinical trials about the clinical utility due to pharmacogenetic testing at the time."

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