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Genetic testing to determine the KIF6 Trp719Arg variant status is being evaluated as a prognostic test to predict risk of future cardiovascular events and/or as a pharmacogenetic test to predict response to statin therapy, particularly in high-risk patients.
Analysis of prospective observational studies of cardiovascular health, and of the placebo arm of randomized controlled trials of statin intervention in at-risk populations have suggested a significant association between the Trp719Arg single nucleotide polymorphism (SNP; rs20455) in kinesin-like protein 6 (KIF6) and the development of clinical coronary artery disease (CAD). Approximately 60 percent of the population carries the putative KIF6 high-risk 719Arg allele. Moreover, carriers of the 719Arg allele in the treatment arms of the statin trials appeared to be at no increased risk, or at decreased risk of CAD or recurrent myocardial infarction (MI), depending on the intensity of the statin therapy. These results supported the development of a KIF6 Trp719Arg genotyping test for use as a predictor of CAD risk and of the likely effectiveness of statin therapy.
Celera Corporation, now a wholly owned subsidiary of Quest Diagnostics, holds a U.S. patent related to methods of determining heart attack risk by detecting the KIF6 gene variant and reduction of such increased risk by statin therapy, and offers the “Cardio IQ™ KIF6 Genotype.” Celera's Berkeley HeartLab subsidiary has been offering KIF6 genotyping (KIF6-StatinCheck™ Genotype Test) since July 2008, and now offers it as part of a comprehensive cardiovascular risk screening program with other serum-based tests. San Francisco General Hospital’s Clinical Chemistry Laboratory (University of California, San Francisco, CA), is the only non-Celera lab to obtain a license to develop a KIF6 LTD; a small number of clinical labs/health care groups have negotiated with Celera to offer the test by sending it to BHL (e.g., Aurora Health Care of Milwaukee, WI).
POLICYKIF6 Genotyping is considered investigational for predicting cardiovascular risk and/or the effectiveness of statin therapy.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY03/31/2011: Approved by Medical Policy Advisory Committee.
03/27/2012: Policy reviewed; no changes.
01/14/2013: Added the following new 2013 CPT codes to the Code Reference section: 81479.
03/14/2014: Policy reviewed; no changes to policy statement. Removed deleted CPT codes 83890-83894, 83896-83898, 83900-83909, and 83912 from the Code Reference section.
03/17/2015: Policy description updated with information regarding the KIF6 protein and tests. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.67
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.