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MP 2.04.98

Genetic Testing


Medical Policy
Section
Medicine

Original Policy Date
08/2007

Last Review Status/Date
Created Local Policy/8:2007
Issue
5:2007
Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

Genetic molecular testing is the analysis of human DNA, RNA, chromosomes, certain metabolites and proteins to detect heritable disease-related genotypes, mutations, phenotypes or karyotypes for clinical purposes.  Certain genetic molecular tests have been demonstrated to be of significant value in providing information with regard to diagnosis and treatment of a given condition.  However, clinical usefulness of any genetic molecular test is dependent on the availability of specific, effective interventions to reduce risk or treat disease.
Commercial availability in and of itself does not ensure that a genetic molecular test is indicated for clinical application.  Genetic molecular testing is a rapidly evolving science in which the significance of detecting specific germ-like mutations has yet to be clarified, especially in individuals with no known family history of a given disease.
There are a number of independent laboratories promoting genetic testing to identify patients with genetic predisposition for many disease states.  Although this is exciting technology, the presence of a particular genotype does not always have a high positive or negative predictive value that the disease will or will not be expressed.  In addition, there is little information to suggest that knowledge will impact the outcome of that particular disease, i.e. there may be no treatment, as in Huntington's Chorea.
Additional concerns arise because tests promoted by individual laboratories, do not have to meet any quality standard and there is no requirement of proof of efficacy.  Only tests that are produced as "kits" to be sold to other commercial laboratories require clearance through the FDA.  For example, if Roche Laboratories creates a genetic test kit to be sold to laboratories, such as ©LabCorp®, the kit must meet scrutiny of the FDA.  On the other hand, a test created by a company such as Prometheus Laboratories®, which is performed only by that lab, and marketed to others, requires no scrutiny.

Policy

In order to provide effective care for our members it will be necessary to consider each test on an individual basis.  This policy applies to tests not otherwise described in other medical policies.


Policy Guidelines

Genetic testing is considered medically necessary to establish a molecular diagnosis of an inheritable disease when all of the following are met:

  • The member displays clinical features, or is at direct risk of inheriting the mutation in question (pre-symptomatic); and
  • The result of the test will be used specifically for diagnosis or the result of the test will directly affect the treatment being delivered to the member; and
  • After history, physical examination, pedigree analysis, genetic counseling and completion of conventional diagnostic studies, a definitive diagnosis remains uncertain; and
  • The providing laboratory must be approved by the FDA or other governmental agency; and
  • Peer-reviewed literature is available that provides evidence for the indications and performance of the test or the indication for the test is in accordance with the guidelines of the American College of Medical Genetics.

Occasionally, genetic testing of tissue samples from other family members who are not covered by Blue Cross of Idaho may be required to provide the medical information necessary for the proper medical care of a Blue Cross of Idaho member.  Blue Cross of Idaho covers genetic testing for heritable disorders in non-members when all of the following conditions are met:

  • The information is needed to adequately assess risk in the Blue Cross of Idaho member; and
  • The information will be used in the immediate care plan of the Blue Cross of Idaho member; and
  • The non-member's benefit plan, if any, will not cover the test (a copy of the denial letter from the non-member's benefit plan must be provided).
  • Blue Cross of Idaho may also request a copy of the certificate of coverage from the non-member's health insurance plan if: 1) the denial letter from the non-member's insurance carrier fails to specify the basis for non-coverage; 2) the denial is based on a specific plan exclusion; or 3) the genetic test is denied by the non-member's insurance carrier as not medically necessary and the medical information provided does not clarify why testing would not be of significant medical benefit to the non-member.

Any decision to cover a test under this policy will be considered medically necessary for the individual in question and not a precedent for general coverage under the member contract.  Coverage will be under the sole discretion of the plan as defined under individual benefits management.

Molecular diagnostic testing in many clinical situations is considered investigational and may be denied as an exclusion of the member contract.


 

Codes

Number

Description

CPT 83890 Molecular diagnostics (DNA) testing often done as part of genetic testing, each nucleic acid type (ie. DNA or RNA)
83891 Molecular diagnostics; isolation or extraction of highly purified nucleic acid, each nucleic acid type (ie, DNA or RNA)
83892 Molecular diagnostics;enzymatic digestion, each enzyme treatment
83893 Molecular diagnostics; dot/slot blot production, each nucleic acid preparation
83894 Molecular diagnostics; separation by gel electrophoresis (eg, agarose, polyacrylamide, each nucleic acid preparation
83896 Molecular diagnostics; nucleic acid probe, each
83897 Molecular diagnostics; nucleic acid transfer (eg, Souther, Northern), each nucleic acid preparation
83898 Molecular diagnostics; amplification, target, each nucleic acid sequence
83900 Molecular diagnostics; amplification, target, multiplex, first two nucleic acid sequences
83901 Molecular diagnostics; amplification, target, multiplex, each additional nucleic acid sequence beyond 2 (listed separately in addition to code for primary procedure)
83902 Molecular diagnostics; reverse transcription
83903 Molecular diagnostics; mutation scanning, by physical properties (eg, single strand conformational polymorphisms (SSCP), heteroduplex, denaturing gradient gel electrophoresis (DGGE), RNA'ase A), single segment,each
83904 Molecular diagnostics; mutation identification by sequencing, single segment, each segment
83905 Molecular diagnostics; mutation identification by allele specific transciption, single segment, each segment
83906 Molecular diagnostics; mutation identification by allele specific translation, sigle segment, each segment
83907 Molecular diagnostics; lysis of cells prior to nucleic acid extraction (eg, stool specimens, paraffin embedded tissue), each specimen
83908 Molecular diagnostics; amplification, signal, each nucleic acid sequence
83909 Molecular diagnostics; separation and identification by high resolution technique (eg, capillary electrophoresis), each nucleic acid preparation
83912 Molecular diagnostics; interpretation and report
83913 Molecular diagnostics; RNA stabilization
83914 Mutation identification by enzymatic ligation or primer extension, single segment, each segment (eg, oligonucleotide ligation assay )OLA), single base chain extension (SBCE), or allele-specific primer extension (ASPE))
88291 Cytogenetics and molecular cytogenetics, interpretation and report
88245 Genetic Testing; chromosome analysis for breakage syndromes; baseline Sister Chromatid Exchange (SCE), 20-25 cells
88248 Chromosome analysis for breakage syndromes; baseline breakage, score 50-100 cells, count 20 cells, 2 karyotypes (eg, for ataxia telangiectasia, Fanconi anemia, fragile X)
88249 Chromosome analysis for breakage syndromes; score 100 cells, clastogen stress (eg, diepoxybutane, mitomycin C, ionizing radiation, UV radiation)
88261 Chromosome analysis; count 5 cells, 1 karyotype, with banding
88263 Chromosome analysis; count 45 celss for mosaicism, 2 karotypes, with banding
88264 Chrmosome analysis; anayze 20-25 cells
88267 Chromosome analysis, amniotic fluid or chorionic villus, count 15 cells, 1 karyotype, with banding
88269 Chromosome analysis, in situ for amniotic fluid cells, count cells from 6-12 colonies, 1 karyotype, with banding
88271 Molecular cytogenetics; DNA probe, each (eg, FISH)
88272 Molecular cytogenetics; chromosomal in situ hybridization, analyze 3-5 cells (eg, for derivatives and markers)
88273 Molecular cytogenetics; chromosomal in situ hybridization, analyze 10-30 cells (eg, for microdeletions)
88274 Molecular cytogenetics; interphase in situ hybridization, analyze 25-99 cells
88275 Molecular cytogenetics; interphase in situ hybridization, analyze 100-300 cells
88280 Chromosome analysis; additional karyotypes, each study
88283 Chromosome analysis; additional specialized banding technique (eg, NOR, C-banding)
88285 Chromosome analysis; additional cells counted, each study
88289 Chromosome analysis; additional high resolution study
88291 Cytogenetics and molecular cytogenetics, interpretation and report
S3800 Genetic testing for amyotrophic lateral sclerosis (ALS)
S3818 Genetic testing; Complete gene sequence analysis; BRCA 1 gene
S3819 Complete gene sequence analysis; BRCA 2 gene
S3820 Complete analysis BRCA 1 and BRCA 2 gene sequence analysis for susceptibility to breast and ovarian cancer
S3822 Single mutation analysis (in individual with a known BRCA1 of BRCA2 mutation in the family) for susceptibility to breast and ovarian cancer
S3823 Three-mutation BRCA1 and BRCA2 analysis for susceptibility to breast and ovarian cancer in Ashkenazi individuals
S3828 Complete gene sequence analysis; MLH1 gene
S3829 Complete gene sequence analysis; MLH2 gene
S3830 Complete MLH1 and MLH2 gene sequence analysis for hereditary nonpolyposis colorectal cancer (HNPCC) genetic testing
S3831 Single-mutation analysis (in individual with a known MLH1 and MLH2 mutation in the family) for hereditary nonpolyposis colorectal cancer (HNPCC) genetic testing
S3833 Complete APC gene sequence analysis for susceptibility to familial adenomatous polyposis (FAP) and attenuated fap
S3834 Single-mutation analysis (in individual with a known APC mutation in the family) for susceptibility to familial adenomatous polyposis (FAP) and attenuated FAP
S3835 Complete gene sequence analysis for cystic fibrosis genetic testing
S3837 Complete gene sequence analysis for hemochromatosis genetic testing
S3840 DNA analysis for germline mutations of the RET proto-oncogene for susceptibility to multiple endocrine neoplasia type 2
S3841 Genetic testing for retinoblastoma
S3842 Genetic testing for Von Hippel-Lindau disease
S3843 DNA analysis of the F5 gene for susceptibility to factor V Leiden thrombophilia
S3844 DNA analysis of the connexin 26 gene (GJB2) for susceptibility to congenital, profound deafness
S3845 Genetic testing for alpha-thalassemia
S3846 Genetic testing for hemoglobin E beta-thalassemia
S3847 Genetic testing for Tay-Sachs disease
S3848 Genetic testing for Gaucher disease
S3849 Genetic testing for Neimann-Pick disease
S3850 Genetic testing for sickle cell anemia
S3851 Genetic testing for Canavan disease
S3852 DNA analysis for  APOE epilson 4 allele for susceptibility to Alzheimer's disease
S3853 Genetic testing for myotonic muscular dystrophy
S3854 Gene expression profiling panel for use in the management of breast cancer treatment
S3855 Genetic testing for detection of mutations in the presenilin-1 gene
ICD-9 Diagnosis multiple codes  


Index

Genetic testing


Policy History

Date Action Reason
08/01/07 Add policy to Medicine section, Pathology, Laboratory subsection Local Policy
03/17/08 Update policy  Code update only, added CPT codes for genteic testing 


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