Notification



Notification Issue Date:



Policy Attachment


Attachment to Policy # 06.02.35w


Attachment:B

Policy #:06.02.35w

Description:Services that are Considered Medically Necessary with Criteria

Title:Genetic Testing (Independence Administrators)


Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.



Attachment B lists procedure codes that may represent medically necessary genetic testing and may be covered for an individual when the testing has a direct effect on the management and clinical care of the individual being tested and if test-specific criteria are met.

Ashkenazi Jewish Genetic Carrier Screening Panel

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes: 81200, 81209, 81242, 81250, 81251, 81255, and 81260 when any of the following indications are met:
  • Reproductive partners who are planning pregnancy or are pregnant, where at least one partner is a member of Ashkenazi Jewish heritage
  • High-risk individuals with a positive family history of the disease

Services represented by the CPT codes 81200, 81209, 81242, 81250, 81251, 81255 and 81260 are considered not medically necessary and, therefore, not covered for general population screening.

Genetic testing is considered medically necessary and, therefore, covered for the service represented by CPT code 81205 in high-risk individuals with Ashkenazi Jewish heritage for diagnostic purposes only.
Code
81200
81205
81209
81242
81250
81251
81255
81260
81290
81330

BRCA Testing

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81212, 81215, 81216, and 81217 when the criteria in the Genetic Testing for Inherited Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Mutations policy are met.

See the current version of Genetic Testing for Inherited Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Mutations policy 06.02.06 for medically necessary criteria.
Code
81212
81215
81216
81217


Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Testing:
Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT code 81220 when any of the following indications are met:

  • Reproductive partners who are planning pregnancy or are pregnant
  • High-risk individuals with a positive family history of the disease OR individuals suspected of the disease
  • Individuals with a congenital absence of vas deferens
Code
81220

Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT code 81221 when the following indication is met:
  • Presence of mutations or variants that are not a part of ACMG mutation panels and have been identified in a family member
Code
81221

Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT code 81222 when any of the following indications are met:
  • Individuals with relatives with known deletion/duplication variants
  • Individuals suspected of the disease when none of the common mutations are identified using ACMG mutation panels or sequencing
Code
81222

Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT code 81223 when the results from the CPT code 81220 genetic test are negative or inconclusive.
Code
81223

Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT code 81224 for individuals suspected of cystic fibrosis transmembrane conductance regulator (CFTR)--related male infertility or males with the absence of a vas deferens.
Code
81224


CYP450 Genotyping for CYP2C19

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 81225 for genotyping of CYP2C19 *2 and *3 alleles in individuals with cardiovascular disease undergoing treatment with clopidogrel (Plavix®) to identify poor metabolizers of the drug.

Repeat CYP2C19 genotyping is NOT medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis OR treatment of illness or injury.

Code
81225

EGFR

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 81235 when the criteria in the current version of the Pharmacogenetic Testing for Drug Sensitivity policy 06.02.30 attachments H (Genetic testing for epidermal growth factor receptor (EGFR) mutation in individuals with non-small cell lung cancer (NSCLC) as a technique to predict treatment response to erlotinib (Tarceva®)) are met.
Code
81235

Hereditary Hypercoagulability

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81240 and 81241 when any of the following indications are met:

  • Individuals under age <50 with any venous thrombosis
  • Relatives of individuals with a positive family history of venous thrombosis
  • Venous thrombosis in pregnant women or women taking oral contraceptives
  • Myocardial infarction in female smokers under age 50
  • Females with recurrent pregnancy loss, or second trimester miscarriage, intrauterine fetal growth retardation, or stillbirth
  • Individuals with venous thrombosis, age >50, except when active malignancy is present

Services represented by the CPT codes 81240 and 81241 are considered not medically necessary and, therefore, not covered for general population screening.
Code
81240
81241

MEDICALLY NECESSARY

Whole-Genome Chromosomal Microarray Analysis for the Evaluation of Developmental Delay/Intellectual Disability, Autism Spectrum Disorder, and/or Congenital Anomalies

Whole-genome chromosomal microarray analysis (CMA) is considered medically necessary and, therefore, covered as first-line testing in individuals with any of the following:
  • Apparently nonsyndromic developmental delay/intellectual disability
  • In the presence of ASD according to accepted Diagnostic and Statistical Manual of Mental Disorder (DSM-5) criteria, even in the absence of any other stigmata of other genetic syndromes
  • Multiple congenital anomalies not specific to a well-delineated genetic syndrome

Whole-Genome Chromosomal Microarray Analysis for Prenatal (Fetal) Diagnostic Testing

In individuals who are undergoing invasive diagnostic prenatal (fetal) testing, whole-genome chromosome microarray (CMA) testing is considered medically necessary and, therefore, covered as an alternative to karyotyping.

Whole-genome Chromosomal Microarray Testing for the Evaluation of Pregnancy Loss

Whole-genome chromosomal microarray analysis (CMA) of fetal tissue for evaluation of pregnancy loss is considered medically necessary and, therefore, covered.

NOT MEDICALLY NECESSARY

Chromosomal microarray analysis (CMA) is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in confirming the diagnosis of a well delineated disorder or syndrome that is clinically recognized without specialized testing (e.g., Down syndrome, neural tube defects, achondroplasia).

EXPERIMENTAL/INVESTIGATIONAL

All other uses for whole-genome chromosomal microarray analysis are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.
Code
81228
81229
S3870

Fragile X

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81243 and 81244 when any of the following indications are met:

  • Individuals with intellectual disability or developmental delay, autism, undiagnosed history of intellectual disability, or who are exhibiting clinical symptoms of Fragile X syndrome
  • Reproductive partners who are planning pregnancy or are pregnant and who have a family history of the disease or an undiagnosed history of intellectual disability
  • Fetuses of mothers who are known carriers of Fragile X syndrome

Services represented by the CPT codes 81243 and 81244 are considered not medically necessary and, therefore, not covered for general population screening.
Code
81243
81244

GJB2 and GJB6

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81252, 81253, and 81254, and HCPCS code S3844 for the following:

  • For the diagnosis of DFNB1 or DFNA3 in individuals with nonsyndromic hearing loss.
Code
81252
81253
81254
S3844

Hereditary Hemochromatosis

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 81256 when any of the following indications are met:

  • Individual with clinical symptoms of iron overload and serum transferrin saturation ≥45%, and /or ferritin above the upper limit of normal
  • Individual with a family history of hemochromatosis
Code
81256

JAK2

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 81270 for any of the following:

  • For qualitative assessment of JAK2-V617F sequence variant using methods with detection thresholds of up to 5% for initial diagnostic assessment of adults presenting with symptoms of CMPD
  • For diagnostic assessment of polycythemia vera in adults
Code
0027U
81270

KRAS

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 81275 for KRAS sequence variant testing to predict response to treatment with anti-EGFR monoclonal antibodies (ie, testing for cetuximab and panitumumab monotherapy and for combination therapy of cetuximab with irinotecan or oxaliplatin) in individuals with metastatic colorectal cancer who have failed or are refractory to first- or second-line chemotherapy.

For more information see the current version of Pharmacogenetic Testing for Drug Sensitivity policy 06.02.30 attachments E (Genetic testing for BRAF mutation analysis in metastatic colorectal cancer to predict nonresponse to anti-EGFR monoclonal antibodies, cetuximab and pantimumab) and G (Genetic testing for somatic mutations by KRAS mutation analysis in non-small cell lung cancer technique to predict treatment response to erlotinib (Tarceva®)).

Code
81275

Long QT syndrome

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81413 and 81414 when the criteria in the Genetic Testing for Congenital Long QT Syndrome policy are met.

See the current version of the Genetic Testing for Congenital Long QT Syndrome policy 06.02.31 for medically necessary criteria.

Code
81413
81414

MLH1 and MSH2

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81292, 81293 and 81294, 81295, 81296 and 81297 when the criteria in Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) policy are met.

See the current version of Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) policy #06.02.10 for medically necessary criteria.

Code
81292
81293
81294
81295
81296
81297

MSH6

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81298, 81299, and 81300 when the criteria in Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) policy are met.

See the current version of Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) policy #06.02.10 for medically necessary criteria.

Code
81298
81299
81300

PMS2

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81317, 81318, and 81319 when the criteria in Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) policy are met.

See the current version of Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) policy #06.02.10 for medically necessary criteria.

Code
81317
81318
81319

Microsatellite instability analysis

Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT code 81301 for microsatellite instability testing as an initial screening for Lynch syndrome prior to testing for sequence variants in the mismatch repair genes.

For more information and medical necessity criteria, see the current version of the Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) policy #06.02.10.
Code
81301

APC Mutational Analysis

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81201, 81202, and 81203 when the criteria in Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) policy are met.

See the current version of the Genetic Testing for Inherited Susceptibility to Colon Cancer and Microsatellite Instability Testing (Familial Adenomatous Polyposis and Lynch Syndrome) policy #06.02.10 for medically necessary criteria.
Code
81201
81202
81203

MECP2

Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT codes 81302, 81303, and 81304 in either of the following scenarios:

  • For testing for MECP2 sequence variants in patients who have some symptoms of Rett syndrome but do not meet established clinical diagnostic criteria
  • For prenatal testing for MECP2 sequence variants in the parents of children with Rett syndrome who meet the established clinical diagnostic criteria and for whom there is evidence that Rett syndrome was inherited rather than occurred sporadically
Code
81302
81303
81304

PMP22

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81324, 81325, and 81326 for the following:

  • For an individual with an oncology inidication with unexplained or preexisting familial neuropathy consistent with Charcot-Marie-Tooth disease.
  • For prenatal or preimplantation genetic diagnosis of Charcot-Marie-Tooth disease Type 1A.
Code
81324
81325
81326

PTEN

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81324, 81325, and 81326 for the following:
  • To confirm the diagnosis when a patient has clinical signs of a PTEN hamartoma tumor syndrome.
  • Genetic testing for a PTEN mutation may be considered medically necessary in a first -degree relative* of a proband with a known PTEN mutation.

Genetic testing for a PTEN mutation is considered experimental/investigational and, therefore, not coveredfor all other indications, including, but not limited to, prenatal testing.

* Testing a first-degree relative

When a deleterious familial PTEN mutation is known, testing for the specific familial mutation should be performed.

If there is no known familial PTEN mutation, comprehensive testing includes full sequence analysis and deletion/duplication analyses. The order of testing to optimize yield would be 1) Sequencing of PTEN exons 1-9 and flanking intron regions. If no mutation is identified, perform 2) deletion/duplication analysis. If no mutation is identified, consider, 3) Promoter analysis (research). Promoter analysis detects mutations in ~10% of individuals with CS who do not have an identifiable mutation in the PTEN coding region.
Code
81321
81322
81323

SNRPN/UBE3A

Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT code 81331 for either of the following indications:

  • Diagnosis of Prader-Willi syndrome (PWS) in symptomatic neonates, infants, children, or adults
  • In symptomatic children for diagnosis of Angelman Syndrome (AS)
Code
81331

Genetic Testing for Alpha-1 Antitrypsin Deficiency

Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT code 81332 when both of the following conditions are met:
  • Patient is suspected of having alpha-1 antitrypsin deficiency because of clinical factors and/or because the patient may be at high risk of having alpha-1 antitrypsin deficiency due to a first-degree relative with AAT deficiency; AND
  • Patient has a serum alpha-1 antitrypsin level in the range of severe deficiency
Code
81332

T cell antigen beta and gamma

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT codes 81340, 81341, and 81342 when results from these tests are interpreted in the context of clinical, histologic, and immunophenotypic data concerning leukemia and lymphoma, especially when monitoring minimal residual disease.

Code
81340
81341
81342

Fetal Fibronectin

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 82731 when the criteria in the current version of the Fetal Fibronectin Enzyme (fFN) Immunoassay policy 06.02.04 are met.
Code
82731

AlloMap™ Molecular Expression Testing for Heart Transplant Rejection

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 81595 when the criteria in the current version of the AlloMap™ Molecular Expression Testing for Heart Transplant Rejection policy 06.02.29 are met.
Code
81595

Human Immunodeficiency Virus (HIV) Genotyping and Phenotyping

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 87900, 87901, 87903, 87904, and 87906 when the criteria in the current version of Human Immunodeficiency Virus (HIV) Genotyping and Phenotyping policy 06.02.09 are met.
Code
87900
87901
87903
87904
87906

Preimplantation Genetic Diagnosis (PGD) Testing

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 88271, 888272, 88273, 88274, 88275, 88291, and 88365 when the criteria in the current version of the Preimplantation Genetic Diagnosis (PGD) Testing policy 06.02.24 are met.
Code
88271
88272
88273
88274
88275
88291
88365

In Vitro Chemosensitivity and Chemoresistance Assays

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 89240 when the criteria in the current version of the In Vitro Chemosensitivity and Chemoresistance Assays policy 06.02.14 are met.
Code
89240

Assays of Genetic Expression in Tumor Tissue for Breast Cancer Prognosis

Genetic testing is considered medically necessary and, therefore, covered for services represented by the HCPCS code S3854 when the criteria in the current version of the Assays of Genetic Expression in Tumor Tissue for Breast Cancer Prognosis policy 06.02.27 are met.
Code
S3854

In Vitro Chemosensitivity and Chemoresistance Assays

Genetic testing is considered medically necessary and, therefore, covered for services represented by the CPT code 89240 when the criteria in the current version of the In Vitro Chemosensitivity and Chemoresistance Assays policy 06.02.14 are met.
Code
89240

Nucleic acid sequencing-based testing of maternal plasma
Genetic testing is considered medically necessary and, therefore, covered for services represented by CPT code 81507 when the following criteria are met:
  • In women with high-risk singleton pregnancies undergoing screening for fetal aneuploidy.
  • Karyotyping would be necessary to exclude the possibility of a false positive nucleic acid sequencing–based test.
  • Before testing, women should be counseled about the risk of a false positive test.

Nucleic acid sequencing-based testing of maternal plasma for fetal aneuploidy is considered not medically necessary and, therefore, not covered in women with low- or average-risk singleton pregnancies.

Nucleic acid sequencing-based testing of maternal plasma for fetal aneuploidy is considered experimental/investigational in women with twin or multiple pregnancies.
Code
81507

Physician Interpretation and Report

HCPCS code G0452 is considered medically necessary and, therefore, covered when performed for services that are considered medically necessary by the Company.
Code
G0452


Miscellaneous
Code
0001U
0008M
0012U
0016U
0017U
0022U
0040U
0046U
0049U
0070U
0071U
0072U
0073U
0074U
0075U
0076U
0084U
0096U
0098U
0154U
0155U
0500T
81105
81106
81107
81108
81109
81110
81111
81112
81120
81121
81161
81175
81176
81232
81238
81247
81248
81249
81258
81259
81269
81277
81287
81288
81307
81308
81309
81334
81335
81361
81362
81363
81364
81420
81519
81520
81521
81522
81551
81552
87563
87624
87625
87634
87662
88364
88366
81162
81170
81218
81219
81272
81273
81276
81311
81314
81412
81439
81528
81545
81595
G0476
G0464
81226
81310
81350
81246
81313
87483
S3854
87505
81163
81164
81165
81166
81167
81171
81172
81173
81174
81177
81178
81179
81180
81181
81182
81183
81184
81185
81186
81187
81188
81189
81190
81204
81233
81234
81236
81237
81239
81271
81274
81284
81285
81286
81289
81305
81306
81312
81320
81329
81333
81336
81337
81343
81344
81345
81443
81518



Version Effective Date: 01/01/2020
Version Issued Date: 12/31/2019
Version Reissued Date: N/A

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