Coverage policy for genetic tests should reflect clinical utility

Key Points

MEDICAL SCIENCE has progressed exponentially in recent years, but the challenge for insurers continues to be determining coverage policies. Adding to the complexity is the emerging science of smart medicine, that is, the delivery of effective care based on personal attributes of the patient, such as genetic markers, for example.

Peter Dehnel, MD, medical director at Blue Cross and Blue Shield of Minnesota, says that an increasing number of medical tests have been developed to aid in the diagnosis, treatment or identification of risk for a variety of conditions. However, once these costly tests are conducted, the findings won't always have practical treatment implications.

"I think that technology has exceeded our ability to use the information in a timely and effective manner," he says.

"There's not a well-defined evidence base in which to make recommendations because it's so new," he says.

INFLUENCE TREATMENT

SelectHealth, the health insurance arm of Intermountain Healthcare, covers genetic testing and diagnostics that are deemed medically necessary through its major diagnostic benefit. They determine which tests qualify for coverage through a multistep review process that evaluates the statistical and clinical validity of the test.

"Probably the most common reason that we either choose to cover or not cover a genetic test is clinical utility," says Kenneth Schaecher, MD, FACP, the medical director for Select Health.

For instance, the company does provide coverage for a gene-expression test that helps identify the primary tumor in cancer cases that have been difficult to diagnose. The decision to cover the test was made because it met the three elements of the review process and provided clinically meaningful data about a patient's care that could allow for a more tailored therapy.

"It helps avoid the use of medicines that wouldn't work that are quite expensive, so there's the effectiveness side to it also," Schaecher says.

Clay Marsh, MD, executive director of the Center for Personalized Health Care at The Ohio State University, says some forms of genetic tests are more commonly accepted than others such as the test that looks for BRCA1 or BRCA2 genes in women who have breast cancer.

Marsh says some of the earliest research in genetic testing has been done in the area of pharmacogenomics to identify how patients with certain genetic profiles will respond to a drug.

For example, the anti-clotting drug clopidogrel has been found to poorly metabolize in patients who carry a variant CYP2C19 gene. A genetic test can be used to identify these patients. Marsh says that insurers are more likely to pay for this type of genetic testing because it provides specific data about treatment effectiveness and could help minimize overall medical costs.

Coverage for testing that identifies a person's risk factor of developing a disease is more variable because there are not always clear treatment implications associated with the findings.

Even though coverage is more likely for pharmacogenomic tests, these tests are rarely ordered.