This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This policy applies to all molecular tumor marker testing intended for use in solid tumors. This policy does not apply to tumor marker testing for hematologic malignancies. This policy also does not apply to tumor markers found by liquid biopsy. Please see Liquid Biopsy Testing – Solid Tumors. This policy also does not apply when testing for germline (inherited) mutations in genes related to hereditary cancer syndromes (e.g., Hereditary Breast and Ovarian Cancer, Lynch syndrome, etc.). Although some of the same genes may be tested for inherited or acquired mutations, this policy addresses only testing for acquired mutations from tumor tissue.

Coverage criteria differ based on the type of testing being performed (i.e., individual tumor markers separately chosen based on the cancer type versus pre-defined panels of tumor markers) and how that testing will be billed (one or more individual tumor marker-specific procedure codes, specific panel procedure codes, or unlisted procedure codes).

When separate procedure codes will be billed for individual tumor markers (e.g., Tier 1 MoPath codes 81200-81355 or Tier 2 MoPath codes 81400-81408), each individually billed tumor marker test will be evaluated separately.

The following criteria will be applied:

• The member has a tumor type that will benefit from information provided by the requested tumor marker test based on at least ONE of the following:
  • All criteria are met from a test-specific policy if one is available (See Table 1 for tumor marker tests that have separate test-specific policies.); or
  • An oncology therapy Food and Drug Administration (FDA) label requires results from the tumor marker test to effectively or safely use the therapy for the member’s cancer type (See Table 1 for examples of currently recognized companion diagnostics); or
  • NCCN guidelines include the tumor marker test in the management algorithm for that particular cancer type and all other requirements are met (specific pathology findings, staging, etc.); however, the tumor marker must be explicitly included in the guidelines and not simply included in a footnote as an intervention that may be considered; or
  • The NCCN Biomarker Compendium has a level of evidence of at least 2A for the tumor marker’s application to the member’s specific cancer type; or

NOTE: If five (5) or more individually billed tumor marker tests are under review together (a panel) and the member either has non-small cell lung cancer (NSCLC) or meets criteria for five (5) or more individual tumor markers, the panel will be approved. However, the laboratory will be redirected to use a panel CPT code for billing purposes (e.g. 81445 or 81455).

When a multi-gene panel is being requested and will be billed with a single panel CPT code (e.g. 81445 or 81455), the panel may be considered medically necessary when the following criteria are met:

• The member has a diagnosis of NSCLC; or
• At least five (5) tumor markers included in the panel individually meet criteria for the member’s tumor type based on one of the following:
  • All criteria are met from a test-specific policy if ONE is available (See Table 1 for tumor marker tests that have separate test-specific policies.); or
  • An oncology therapy FDA label requires results from the tumor marker test to effectively or safely use the therapy for the member’s cancer type (See Table 1 for examples of currently recognized companion diagnostics for available therapies.); or
  • National Comprehensive Cancer Network (NCCN) guidelines include the tumor marker test in the management algorithm for that particular cancer type and all other requirements are met (specific pathology findings, staging, etc.); however, the tumor marker must be explicitly included in the guidelines and not simply included in a footnote as an intervention that may be considered; or
  • The NCCN Biomarker Compendium has a level of evidence of at least 2A for the tumor marker’s application to the member’s specific cancer type.

NOTE: If the member meets criteria for less than five (5) of the individual tumor markers in the panel, the panel will not be covered. The laboratory will be redirected to billing for individual tests for which the member meets criteria.

Table 1: Common cancer types and associated tumor markers. This list not all inclusive.

* In general, when there is an associated treatment, results from the referenced tumor marker are necessary for the safe or effective use of that therapy (companion diagnostics). The therapies and tumor markers are only included for cancer types approved for treatment according to FDA labeling.

Tumor marker testing-solid tumors is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

A network provider can bill the member for the non-covered service.

• Link to Provider Resource Center for the Medical Policy Update

05/2018, REMINDER: Molecular and Genomic Testing

• Link to References