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Healthcare Opinion Science

Insurance Roadblocks Threaten to Limit Use of Genomic Tests

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Genomics has been a hotbed of new ideas for medical tests that could change the face of healthcare. But even as these tests reach the clinic, many insurance companies are refusing to cover them—in part because of antiquated views of what diagnostics should do. This resistance threatens to quell innovation that would dramatically improve patient outcomes.

The divide comes from the radically different approach to diagnosing patients taken by many genome-based tests. Consider first how conventional diagnostic testing works. A patient shows up at the ER complaining of diarrhea and several other non-specific symptoms, for example. Physicians make an educated guess about the source of the problem—say, norovirus. Off in the hospital’s clinical laboratory, technicians get to work running a test for norovirus. This is a tedious and time-consuming process, but ultimately, the results come back negative. Now the physicians make another guess, and technicians run a new test. This cycle can go on and on, stretching from days to even weeks.

Genomics upends this trial-and-error process. For the patient above, a genomic test would cover all of the common causes of gastrointestinal infections in one shot, getting answers simultaneously from a single biological sample. In patients with cancer, genome sequencing of tumors lets physicians choose the most appropriate therapy based on key genetic markers, rather than guessing based on where the cancer originated. Perhaps most transformative of all: sequencing the DNA of babies born with mysterious diseases pinpoints the diagnosis in a remarkable proportion of cases. That diagnosis would otherwise take years and countless appointments with a host of specialists to achieve.

Scientists refer to this approach as “hypothesis-free testing,” but don’t let the bland phrasing fool you. Being able to trace the source of a person’s health problem with limited or even no useful clinical information up front could usher in a totally new era of medicine.

You might think this would be welcomed by insurance companies because genome-based tests offer healthcare providers a significantly higher chance of finding the answer on the first try, allowing them to get patients on the right treatment sooner, minimizing long-term damage and unnecessary use of medications. But you’d be mistaken.

Instead, some insurance companies and other coverage-deciding organizations have determined that tests reporting broad results like this can’t be considered true diagnostic tests since they screen for many different things at once. Some companies have declined to reimburse for these tests while others have provided only limited coverage, setting a massive obstacle in the way of clinical adoption. Still other insurers have agreed to cover these tests, but only in very specific situations. The lack of coverage agreement confounds physicians and clinical lab technicians, who are unable to set clear expectations with patients about how much they’ll owe.

Some major insurers such as Anthem and UnitedHealthcare have moved toward requiring pre-authorization for genetic tests, setting up automated systems to streamline new requests. While this process helps to get patients and providers on the same page before the expenses are incurred, it isn’t a realistic approach for situations requiring urgent medical care.

Some of the current arguments against covering genome-based tests are fair. Scientists do not yet understand the clinical implications of all possible DNA variants, so not even experts can say with certainty what the clinical utility of certain elements included in these tests will be. Also, these broader tests tend to be more expensive than a single conventional clinical test.

But these are rapidly changing conditions. Our understanding of DNA is improving all the time, and more and more genome-based tests are being brought to market. Questions about clinical utility will be answered authoritatively in the not-too-distant future. Meanwhile, the cost of genomic technologies is falling fast. Before long, it may very well be cheaper to run some of these broad tests than to use conventional ones.

What matters most now is that healthcare organizations—hospitals and insurance companies alike—treat decisions to decline or limit coverage of genome-based tests as transitional. In order to prevent long-term technological stagnation, these reimbursement questions should be revisited frequently because changing landscapes of cost and information will rapidly alter the calculations about when and what should be covered. If these decisions are made permanent, we face the scary possibility that genomic innovation could be kept away from the medical institutions and patients who need it most.

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