Time to Act on Genetic Testing? 

Jan 03 2019

A question I’m hearing more and more often from employers is, “Should we cover genetic testing?” My answer to that very broad question is that the employer undoubtedly already is covering genetic or genomic testing to some extent and likely has been for many years. Health plans monitor the research literature and cover tests in situations where there is evidence that they make a difference in the clinical outcome of the patient. The most exciting breakthroughs have come in testing the genomics of cancer cells and using that information to choose the most effective treatment. We’re seeing a true explosion of progress in this area. For some cancers there is no evidence that a specific genomic profile indicates a specific treatment; in these cases, testing would not be covered. But I’m told that about 500 research articles on cancer are being published each week, and while not all of them are game changers, it’s a measure of how quickly the field is evolving.

The area of personalized medicine where the genomic profile of the individual guides the selection of medication for other conditions, such as high blood pressure or depression, is developing more slowly. The research so far is not yielding guidance as clear-cut as for cancer genomics and chemotherapy selection. A few drugs require genomic testing; for example, a specific HIV drug that is dangerous in certain people and effective in others. The plans cover and indeed require this test to approve the medication.

Prenatal genetic testing has been available and covered for years. Many states have coverage mandates, and I have not yet heard of case in which testing that is recommended by national organizations (such as the American College of Obstetrics and Gynecology) is not covered. Some of the tests are changing as the technology evolves. I recently reviewed a case in which a member requested coverage for a new type of test because it was more accurate. In fact, it is more accurate only for people in a particular age group (for whom it was in fact covered); for the member requesting it, it would have been much less accurate than other kinds of testing. The take-away is that testing was covered for the condition, just not the new method in this particular case.

As I discussed in an earlier blog post, there is no evidence to support the efficacy of genomic testing (available direct to consumer) without a specific clinical question other than “I wonder if I am at risk for something?” This article in the New York Times gives a sense how little agreement there is about assessing clinical risk based on an individual’s genomic profile. Practical issues remain to be solved as well. Currently there is no good way to follow up with (for example) a person who was tested two years ago and told that they had a particular risk to see if their status has changed. There is also concern about the validity of the test results. When tests are done for clinical reasons (not a fishing expedition) the labs have to be certified by CLIA. Direct-to-consumer products may not have this requirement for quality and oversight. You may want to share this link to consumer information on genetic testing with your plan members.

Bottom line for employers: Genetic/genomic testing is a very technical and rapidly changing area of medicine that holds great promise. Right now it is providing better diagnostics and treatment selection for some patients – but that’s mixed with a considerable amount of over-promise and hype. Coverage positions should evolve as rapidly as the science evolves and employers need to have trusted clinical partners to help evaluate new tests as they come along. Employers also may benefit from having help communicating about this very complex issue with their members.

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