Description

Genetic testing can be utilized to diagnose and monitor cancer indications including, but may not be limited to, glioblastoma, leukemia, lymphoma, myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPNs) and thyroid cancer. This type of testing is indicated for an individual who exhibits disease symptoms and may be necessary to diagnose or rule out suspected cancer or monitor known cancer.

For information regarding JAK2, CALR or MPL genetic testing, please refer to Janus Kinase 2 (JAK2), Calreticulin (CALR) and Myeloproliferative Leukemia (MPL) Variant Analysis Medical Coverage Policy.

Genetic Testing for Diagnosis and Monitoring of Cancer

• Effective Date: 05/25/2023
• Revision Date: 05/25/2023
• Review Date: 05/25/2023
• Policy Number: HUM-0561-018

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

DNA Specimen Provenance Assignment (DSPA) Testing

(eg, know error System) is a molecular diagnostic test intended for the protection and control of tissue samples to purportedly decrease the incidence of diagnostic mistakes due to the misidentification, specimen transposition or cell contamination of samples, also known as specimen provenance complications (SPCs). Breast and prostate tissues are most often tested but other tissue types, such as bone marrow, may also be examined.

Multigene (or expanded) Panels

Analyze a broad set of genes simultaneously (as opposed to single gene testing that searches for variants in 1 specific gene) and have been proposed to evaluate the DNA of an individual with a personal and/or family history of more than 1 hereditary condition or syndrome. Panels often include medically actionable genes but may also include those with unclear medical management. Targeted (or focused) multigene panels analyze a limited number of genes targeted to a specific condition. An example of a multigene panel includes, but may not be limited to, myAML NGS Panel.

For information regarding genetic testing for the following, please refer to Genetic Testing Medical Coverage Policy:

• DNA banking or preservation
• General population screening
• Individual 17 years of age or younger for adult-onset conditions
• Interpretation and reporting for molecular pathology procedure
• Polygenic risk score (PRS) and single nucleotide polymorphisms (SNPs)
• Repeat germline or somatic genetic testing
• Retrieved archival tissue

Humana recognizes that the field of genetic testing is rapidly changing and that other tests may become available.

Coverage Determination

Any state mandates for genetic testing for diagnosis and monitoring of cancer take precedence over this medical coverage policy.

Genetic testing may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage.

Genetic Testing for Diagnosis and Monitoring of Cancer

• Effective Date: 05/25/2023
• Revision Date: 05/25/2023
• Review Date: 05/25/2023
• Policy Number: HUM-0561-018

Apply General Criteria for Genetic and Pharmacogenomics Tests when disease- or gene-specific criteria are not available on a medical coverage policy.

For information regarding general criteria for genetic tests, please refer to Genetic Testing Medical Coverage Policy.

ASXL1 Full Gene Sequencing or Targeted Sequence Analysis

Humana members may be eligible under the Plan for ASXL1 full gene sequencing (81175) or targeted sequence analysis (81176) for the following indications:

• Acute myeloid leukemia (AML); OR
• Chronic myeloid leukemia (CML); OR
• Myelodysplastic syndrome (MDS); OR
• Myeloproliferative neoplasms (MPNs) when JAK2, CALR and MPL analyses are negative and diagnosis is still suspected; OR
• Systemic mastocytosis; OR
• Unexplained cytopenia* and MDS is suspected

CCND1::IGH t(11;14) Translocation Analysis

Humana members may be eligible under the Plan for CCND1::IGH t(11;14) (81168) translocation analysis for mantle cell lymphoma.

IDH1/IDH2 Mutation Testing

Humana members may be eligible under the Plan for IDH1 (81120) and/or IDH2 (81121) mutation testing for the following indications:

• AML; OR
• Cholangiocarcinoma that is locally advanced, metastatic or unresectable disease (eg, Oncomine Dx Target Test) (IDH1 only); OR
• CML; OR
• Gallbladder cancer that is metastatic or unresectable disease (IDH1 only); OR
• Glioblastoma/glioma; OR
• MDS; OR
• MPNs when JAK2, CALR and MPL analyses are negative and diagnosis is still suspected; OR
• Unexplained cytopenia* and MDS is suspected

IGH@::BCL2 t(14;18) Testing

Humana members may be eligible under the Plan for IGH@::BCL2 t(14;18) testing (81278) for follicular lymphoma.

KIT (c-KIT) Gene Analysis

Humana members may be eligible under the Plan for KIT (c-KIT) gene analysis when the following indications:

• AML (81272); OR
• CML; OR
• Gastrointestinal stromal tumor (GIST) (81272); OR
• Melanoma, metastatic or unresectable (81272)
• Systemic mastocytosis (81273)

MGMT Promoter Methylation Testing

Humana members may be eligible under the Plan for MGMT promoter methylation testing (81287) for the following indications:

• Glioblastoma and high-grade gliomas (grade 3 and 4); OR
• Determine eligibility for participation in a clinical trial for an individual with glioblastoma

MYD88 Gene Testing

Humana members may be eligible under the Plan for MYD88 gene testing (81305) for Waldenstrom’s macroglobulinemia (lymphoplasmacytic lymphoma).

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

PDGFRA Gene Testing

Humana members may be eligible under the Plan for PDGFRA gene analysis (81314) when an individual presents with a mass known or clinically suspected to be GIST.

PML::RARalpha t(15;17) Gene Testing

Humana members may be eligible under the Plan for PML::RARalpha t(15;17) gene testing (common [81315] and single [81316] breakpoints) for promyelocytic leukemia (PML) (includes AML).

RUNX1 Mutation Testing

Humana members may be eligible under the Plan for RUNX1 mutation testing (81334) for the following indications:

• AML; OR
• CML; OR
• MDS; OR
• MPNs when JAK2, CALR and MPL analyses are negative and diagnosis is still suspected; OR
• Systemic mastocytosis; OR
• Unexplained cytopenia* and MDS is suspected

SF3B1 Somatic Mutation Testing

Refer to Coverage Limitations section for SF3B1 somatic mutation testing for AML.

Humana members may be eligible under the Plan for SF3B1 somatic mutation testing (81347) for the following indications:

• Anemia** related to MDS or MDS/MPNs with ring sideroblasts; OR
• CML; OR
• MDS; OR
• MPNs when JAK2, CALR and MPL analyses are negative and diagnosis is still suspected; OR
• Unexplained cytopenia* and MDS is suspected

SRSF2 Somatic Mutation Testing

Refer to Coverage Limitations section for SRSF2 somatic mutation testing for AML.

Humana members may be eligible under the Plan for SRSF2 somatic mutation testing (81348) for the following indications:

• CML; OR
• MDS; OR
• MPNs when JAK2, CALR and MPL analyses are negative and diagnosis is still suspected; OR
• Systemic mastocytosis; OR
• Unexplained cytopenia* and MDS is suspected

TERT Mutation Testing

Refer to Coverage Limitations section for TERT mutation testing for thyroid carcinoma.

Humana members may be eligible under the Plan for TERT mutation testing (81345) for glioblastoma.

U2AF1 Somatic Mutation Testing

Refer to Coverage Limitations section for U2AF1 somatic mutation testing for AML.

Humana members may be eligible under the Plan for U2AF1 somatic mutation testing (81357) for the following indications:

• CML; OR

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• MDS; OR
• MPNs when JAK2, CALR and MPL analyses are negative and diagnosis is still suspected; OR
• Unexplained cytopenia* and MDS is suspected

ZRSR2 Somatic Mutation Testing

Refer to Coverage Limitations section for ZRSR2 somatic mutation testing for AML.

Humana members may be eligible under the Plan for ZRSR2 somatic mutation testing (81360) for the following indications:

• CML; OR
• MDS; OR
• Unexplained cytopenia* and MDS is suspected

Multigene Panels for Hematologic Malignancies

Humana members may be eligible under the Plan for multigene panel testing when the following criteria are met:

• Previous testing on bone marrow biopsies, bone marrow aspirates, bone marrow clots, peripheral blood samples or extramedullary sites suspected of harboring a myeloid malignancy has failed to provide definitive diagnosis, prognosis or therapeutic impact; AND
• For the evaluation of any of the following:
  • AML and panel testing includes core genes (e.g., myAML NGS Panel); OR
  • CML for either of the following
    • Advanced phase, accelerated phase or blast phase; OR
    • No identifiable BCR::ABL1 mutations; OR
  • MDS and testing includes core genes;
  • MPNs when JAK2, MPL and CALR analyses are negative and panel testing includes core genes; OR
  • Systemic mastocytosis and panel testing includes core genes; OR
  • Unexplained cytopenia* when MDS is suspected and testing includes core genes

*Results of conventional tests cannot establish the source of cytopenia and concomitant conditions including, but not limited to, infection, nutritional deficiencies, medication use and alcohol consumption, have been eliminated as the cause. **Pretreatment or pretransfusion Hgb level less than or equal to 11 grams per deciliter.

Coverage Limitations

Humana members may NOT be eligible under the Plan for genetic testing for cancer indications for any indications or tests other than those listed above including:

• AMBLor Melanoma Prognostic Test (0387U)
• Any of the following genes for AML:
  • SF3B1 (81347)
  • SRSF2 (81348)
  • U2AF1 (81357)
  • ZRSR2 (81360)
• Copy number by FISH, using image-based dielectrophoresis (DEP) sorting (DEPArray HER2 test) (0009U)
• Multigene panels unless specifically outlined in a medical coverage policy and meets disease- or gene-specific criteria including, but not limited to, GlioSeq
• Quantitative protein-based HER2 testing (eg, HERMark Breast Cancer Assay)

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Serum HER2 protein extracellular domain (c-ECD) levels
• TERT (81345) for thyroid carcinoma

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Laboratory quality control, including DNA Specimen Provenance Assignment (DSPA) testing to decrease specimen provenance complications (SPC) (eg, know error System) (81265) is considered integral to the primary procedure and not separately reimbursable.

Additional information about genetic testing or cancer may be found from the following websites:

Background

• American Cancer Society
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.