NEW YORK (GenomeWeb) – National health plan Cigna has published a new coverage policy outlining its conditions for covering whole-exome sequencing (WES) and whole-genome sequencing (WGS).
The policy, which Cigna developed in collaboration with a network of genetics experts from InformedDNA, represents the first time a national health plan has laid out coverage criteria for WES.
Cigna said it would cover WES when a patient meets all the criteria on a detailed list. For example, a board-certified geneticist or physician specialist must determine that testing will impact a patient's clinical decisions and outcomes; that the illness is likely due to genetics and not environmental exposures, injury, or infection; that the features of the disease suggest that single-gene testing or panel testing wouldn't be sufficient, and that WES would avoid multiple, invasive workups.
According to Cigna, the payor won't cover WES for prenatal diagnosis or preimplantation testing of an embryo. Cigna also said it doesn't consider WES in the general population medically necessary.
Meanwhile, Cigna said it wouldn't cover WGS for any condition, and characterized this type of testing as experimental, investigational, and unproven.
"Not all genetic tests have clinical value, nor are they appropriate for the entire population, just like a new medication wouldn't be right for everybody," Jeffrey Hankoff, Cigna's medical officer for clinical performance and quality, said in a statement." By issuing this policy, Cigna is hoping to provide an "appropriate clinical structure" that healthcare providers can reference as they consider and order WES in specific clinical contexts.
Most payors consider WGS and WES experimental, and only cover WES after case-by-case evaluation of the clinical context in which a test was performed. Regardless, requests for WES is increasing at a rate of 10 percent per quarter, InformedDNA and Cigna estimated in a joint statement. WES doesn't provide answers for the majority of complex medical scenarios, and often yields variants of unknown significance "that can raise troubling concerns among individuals and their healthcare providers," the two groups stated.
Cigna and InformedDNA attempted to further clarify earlier WGS/WES guidelines from the American College of Medical Genetics and Genomics. "The [ACMG] guidelines did not provide specific testing criteria," Cigna and InformedDNA wrote. "As a result, it hasn't been clear to healthcare providers when WES is considered a useful diagnostic test that health plans will cover."
Cigna has been working with InformedDNA for several years to provide online and telephonic genetic counseling. Under the latest policy, Cigna said it also covers pre- and post-test genetic counseling for individuals who have received testing or are candidates for testing, from board-certified geneticists, a certified and credentialed counselor, or a nurse not employed by a commercial testing firm.