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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 (RCTs) of statin intervention in at-risk populations have suggested a significant association between the arginine-to-tryptophan substitution at position 719 (Trp719Arg) single nucleotide polymorphism (rs20455) in kinesin-like protein 6 (KIF6) and the development of clinical coronary artery disease (CAD). Approximately 60% 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 through detection of 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, is the only non-Celera lab to obtain a license to develop a KIF6 laboratory-developed test; 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).
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests (LDTs) must meet the general regulatory standards of the Clinical Laboratory Improvement Act (CLIA). Laboratories that offer LDTs must be licensed by CLIA for high-complexity testing. To date, the U.S. Food and Drug Administration (FDA) has chosen not to require any regulatory review of this test.
POLICYKIF6 genotyping is considered investigational for predicting cardiovascular risk and/or the effectiveness of statin therapy.
Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
07/30/2015: Code Reference section updated for ICD-10.
03/30/2016: Policy description updated regarding laboratory-developed tests. Policy statement unchanged. Policy guidelines updated to add genetic counseling information. Investigative definition updated.
06/06/2016: Policy number added.
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.