Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

c)    Genetic testing must be performed by in-network providers, unless otherwise stated in your plan documents.

1)    Preauthorization is required for genetic and genomic testing and chromosome analysis, except as specifically noted below in the Medical Policy.

2)    Genetic Testing and Chromosome Analysis are covered only when:

a)    There is documented evidence that a genetic anomaly or defect may be present which could threaten the life or health of the member being tested; AND

b)    There is credible research showing there are treatments available for that genetic anomaly or defect that will significantly prolong the life or improve the health of the member being tested; AND

c)    Decisions about treatment will be made based on the results of the genetic testing. 

3)    Companion diagnostic testing (identifying a genetic variant that would qualify a patient for personalized treatment with a specific medication) will only be covered when there is research demonstrating improved outcomes. While companion diagnostic testing holds great promise for personalized medicine, this is an area where medical practice is still evolving. Despite FDA approval of companion testing, there are instances where the theoretic benefits are not yet supported by research showing improved outcomes. As described above in 2) b), there needs to be evidence the associated treatment will make a difference in outcomes.

4)    Mutation testing of tumor tissue is covered when there is documented evidence that the mutation testing will determine appropriate treatment.

5)    QualChoice follows NCCN Guidelines and DNA Direct for genetic testing. When NCCN guidelines or DNA Direct indicate that multiple testing options exist for the same clinical scenario, we will only cover the test(s) that meet medical necessity criteria (see BI024).

6)    Normally, broad genetic panels are not covered because their usefulness for informing clinical management decisions and changing outcomes is unproven. However, NCCN and DNA Direct are now recommending the use of genetic panel screening for women who qualify for BRCA screening and either men or women who qualify for Lynch Syndrome screening. QualChoice will follow this recommendation—only for specific genetic panels that have been shown to be cost effective. The reason for the change in position by NCCN and DNA Direct is that BRCA mutations and Lynch Syndrome mutations account for only about 50% of the cancers in these two high risk groups. The Myriad myRisk screening panel (which includes additional clinically relevant mutations for patients at high risk for breast/ovarian/peritoneal cancer or Lynch Syndrome) will be covered in this situation.

7)    Please see BI205 for fetal genetic testing.  

8)    Red cell antigen genotyping requires prior-authorization and is not medically indicated for routine blood transfusions.

9)    In order to avoid inaccurate, incomplete or untimely requests, all prior-authorization requests for blood genetic tests require the following:

a)    The request is submitted by the ordering provider office, AND

b)    Submitted clinical is from patient medical records such as provider clinic progress notes. Information on lab request forms is not accepted, AND

c)    The request is submitted before testing and not more than 14 days after the collection of blood specimen.

1)    Preauthorization is not required for the following specific circumstances:

a)    Bone marrow biopsy chromosome analysis for patients with:

i)   Lymphoma

ii)    Acute or chronic myeloid and lymphoid leukemia

iii)     Multiple Myeloma

iv)     Polycythemia Vera

v)      Myelodysplastic syndromes

b)    BCR-ABL gene testing in patients with Chronic Myelogenous Leukemia (CML)

c)    Protease Inhibitor typing or SERPINA1 Targeted Mutation Analysis for suspected alpha-1-antitrypsin deficiency

d)    Chromosome analysis for suspected Down’s Syndrome

e)    Prenatal detection of chromosomal abnormalities in the babies of pregnant women over age 35 (see policies BI017: Amniocentesis, BI072: Chorionic Villus Sampling, and BI205: Prenatal Testing).

f)     Afirma genomic testing in members with thyroid nodules.

g)    The following tumor marker testing on solid tumors:

i)   BRAF V600E targeted analysis (note that full BRAF sequencing still requires pre-authorization)

ii)    EGFR targeted mutation analysis

iii)     KIT targeted sequence analysis

iv)     KIT D816 targeted mutation analysis

v)      KRAS exon 2 targeted mutation analysis

vi)     KRAS additional codon targeted mutation analysis

vii)      MGMT promoter methylation analysis

viii)      NRAS exon 2 and exon 3 analysis

ix)       Oncotype DX breast cancer test for women with breast cancer – see BI129: Tumor Markers for specific indications (once per lifetime).

2)    Prolaris (81541) requires prior authorization to ensure it is being used according to NCCN guidelines (post biopsy for NCCN low or favorable intermediate risk prostate cancer in patients with at least 10 years life expectancy who have not yet received treatment for prostate cancer and are candidates for active surveillance or definitive therapy). Although NCCN guidelines indicate OncotypeDx Prostate or ProMark may be used in this same clinical scenario, these tests offer no advantage over Prolaris and will not be covered.

Decipher Prostate CA Classifier (81542) requires prior authorization to ensure it is being used according to NCCN guidelines.

3)    MyPath Melanoma requires preauthorization. This is used when a skin lesion is not clearly benign or malignant based on histopathological features. The sample is derived from primary excision of a non-metastatic, melanocytic lesion that has not been previously treated, and the results will be used in conjunction with other information from clinical evaluation, histopathological features, and other diagnostic procedures to determine whether the lesion is benign or malignant.

DecisionDx Uveal Melanoma (81552) also requires prior authorization.

4)    Companion diagnostic testing (identifying a genetic variant that would qualify a patient for personalized treatment with a specific medication) will only be covered when there is research demonstrating improved outcomes. While companion diagnostic testing holds great promise for personalized medicine, this is an area where medical practice is still evolving. Despite FDA approval of companion testing, there are instances where the theoretic benefits are not yet supported by research showing improved outcomes. As described above in the Public Statement, there needs to be evidence the associated treatment will make a difference in outcomes.

5)    Normally, broad genetic panels are not covered because their usefulness for informing clinical management decisions and changing outcomes is unproven. However, NCCN and DNA Direct are now recommending the use of genetic panel screening for women who qualify for BRCA screening and either men or women who qualify for Lynch Syndrome screening. QualChoice will follow this recommendation—only for specific genetic panels that have been shown to be cost effective. The reason for the change in position by NCCN and DNA Direct is that BRCA mutations and Lynch Syndrome mutations account for only about 50% of the cancers in these two high risk groups. The Myriad myRisk screening panel (which includes additional clinically relevant mutations for patients at high risk for breast/ovarian/peritoneal cancer or Lynch Syndrome) will be covered in this situation.   

6)            A broad genetic panel is now also indicated for patients with certain advanced stage cancers, such as non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, breast cancer or  ovarian cancerQualChoice specifically covers the Foundation1CDx panel (CPT 0037U) based on NCCN and DNA Direct criteria.

7)    Red cell antigen genotyping (0180U – 201U) requires prior authorization.  It is not medically necessary for routine transfusions.  Red cell antigen genotyping is only indicated when there is a high risk of alloimmunization—as in transfusion-dependent sickle cell patients.

8)    The following tests are considered experimental or investigational, and are not covered (this list is not exhaustive):

a)    Corus CAD gene expression test

b)    CYP2C9 or VKORC1 testing for warfarin response

c)    CYP2D6 testing for Tamoxifen response

d)    CDKN2A or CDK4 testing for familial malignant melanoma

e)    The use of cell free circulating tumor DNA to identify genetic mutations present in a tumor (also known as a liquid biopsy)

f)     Mammaprint and Mammostrat for breast cancer prognosis

g)    Oncotype DX colon cancer assay

h)    Cancer of Unknown Primary testing, such as (but not limited to) CancerTYPE ID, Cancer Origin Test, and ResponseDX Tissue of Origin Test

i)     UroVysion FISH testing for bladder cancer

9)    All other genetic, genomic, and pharmacogenetic tests and chromosome analyses require pre-authorization. Since the development and clinical use of these types of tests is continually evolving and changing rapidly (based on new research), it is not practical to continually maintain a current list of all the relevant tests. Any such list quickly becomes out of date. For any tests not specifically mentioned, the medical necessity criteria for preauthorization will be determined by referring to the most current recommendations from DNA Direct or other sources of evidence-based guidelines considered by QualChoice to be credible and unbiased. This will ensure the use of the tests is clinically relevant and medically necessary rather than letting the marketing get ahead of the science.  See BI205 for fetal genetic testing.

Codes Used In This BI: