By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Cigna became the first national health insurance plan to publish a coverage policy on whole exome sequencing (WES). The insurer defined coverage criteria for WES, but still will not cover WGS for any indication, considering it “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," said Jeffrey F. Hankoff, M.D., Cigna’s medical officer for clinical performance and quality, in a statement. "This coverage policy provides the clarity that health care professionals need and will help them and their patients make informed decisions to drive improved clinical outcomes."
Cigna’s coverage of WES (CPT code 81415) requires evaluation by a genetics specialist and comes with an expectation that WES will impact clinical decision making and outcomes in order to meet the "medically necessary" criteria.
While Cigna details the phenotypic conditions for which a genetic etiology is the "most likely explanation," some of the considerations in the coverage decision boil down to practicality and cost. For instance, WES is covered in situations where the clinical presentation does not fit a well-described syndrome for which single-gene or targeted panel testing is available; where WES is more practical than the separate single gene tests or panels that would be recommended based on the differential diagnosis; and when WES results would eliminate the need for multiple and/or invasive procedures, follow-up, or screening that would be recommended in the absence of testing.
In a statement Cigna said that targeted genetic testing is typically a more cost-effective approach with a lower risk of incidental findings, but recognizes that WES may be "useful" in diagnosing complex phenotypes.
"In addition to the diagnostic power of WES, the cost-effectiveness of such testing is a compelling reason to consider its use in clinical practice," the company writes in the coverage decision. "However, WES is only cost effective if it replaces the need for multiple individual gene tests, and it is not as cost-effective when it is utilized after performing and receiving uninformative results from multiple other genetic tests. For this reason, genetics providers should consider when WES should be performed prior to more traditional testing, such as chromosome microarray or targeted panels."
Cigna added that it would not cover prenatal diagnosis or preimplantation testing of an embryo using WES because it is "considered experimental, investigational, and unproven."
Cigna has been working with InformedDNA, which provides online and telephone genetic counseling to Cigna enrollees. In a joint statement, the companies say that requests for WES have been growing by 10 percent per quarter, but until now WES was only approved on a case-by-case basis. They say that this coverage decision helps provide a "clinical structure" to guide providers with specific criteria for appropriate ordering. The decision calls for pre- and post-test genetic counseling by medical geneticists, as well as credentialed genetic nurses and certified genetic counselors (not employed by a commercial genetic testing laboratory, unless part of an integrated health system which delivers services besides laboratory testing).