Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: L-124-007
Topic: Tumor Marker Testing-Solid Tumors
Section: Laboratory
Effective Date: July 1, 2018
Issue Date: July 2, 2018
Last Reviewed: March 2018

Tumor markers refer to substances in the body that are altered in the presence of cancer. The alterations may be used to diagnose and subtype cancer, predict prognosis, make therapeutic decisions, and monitor disease progression. Tumor markers may be detected as abnormal protein levels, gene expression (RNA) patterns, chromosome abnormalities, or deoxyribonucleic acid (DNA) changes.

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.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

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:

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:

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.

CANCER TYPE

TUMOR MARKER

CPT

ASSOCIATED TREATMENTS *

APPLICABLE POLICY

Colerectal (Metastatic,
stage IV. Prognostic
purposes only)

BRAF

81210

N/A

L-141

Colorectal
(Metastatic)

KRAS

81275

cetuximab,  panitumumab

L-104

Colorectal
(Metastatic)

NRAS

81311

N/A

See this policy

Melanoma
(Metastatic)

BRAF

81210

vemurafenib, dabrafenib,trametinib/dabrafenib, vemurafenib/cobimentinib

L-171

Non-small cell lung

EGFR

81235

erlotinib, afatinib, gefitinib, osimertinib (T790M)

L-164

Non-small cell lung

ALK

81401

crizotinib, ceritinib, alectinib

See this policy

Non-small cell lung

ALK

81479

crizotinib, ceritinib, alectinib

See this policy

* 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.

Procedure Codes
81201, 81210, 81211, 81235, 81272, 81273, 81275, 81276, 81287, 81292, 81295, 81298, 81311, 81314, 81317, 81321, 81445, 81455, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81479, , 88271, 0048U


Refer to medical policy L-123 Liquid Biopsy Testing – Solid Tumors for additional information.


Professional Statements and Societal Positions

The National Comprehensive Cancer Network (NCCN) provides the following types of guidance.

  • NCCN Guidelines for Treatment of Cancer by Site provide detailed guidelines on the use of individual tumor markers for each cancer type addressed.
  • NCCN also makes the following recommendations specifically for using multi-gene panels in the evaluation of non-small cell lung cancer (NSCLC): The NCCN NSCLC Guidelines Panel strongly endorses broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with NSCLC.
  • NCCN has not recommended a panel approach for any other cancer types as of mid-2017.
  • NCCN also maintains a biomarker compendium stating the goal of the NCCN Biomarkers Compendium is to provide essential details for those tests which have been approved by NCCN Guideline Panels and are recommended by the NCCN Guidelines. Biomarkers for specific cancer types that are listed in the NCCN Biomarker Compendium have a level of evidence associated with their clinical utility.

The National Academy of Clinical Biochemistry (NACB, 2009) issued general tumor marker quality practice guidelines to encourage more appropriate use of tumor marker tests. They provide the following guidelines to determine if a tumor marker is useful:

  • The marker results are appropriate precisely for the required application (i.e., risk assessment, screening, diagnosis, prognosis, prediction, or post-treatment monitoring).
  • The marker results separate patients into two (2) or more populations whose outcomes differ so strikingly that they and their caregiver would treat one group differently than another.
  • The estimate of the separation in outcomes for marker positive and negative is reliable.

Some FDA labels require results from tumor marker tests to effectively or safely use the therapy for a specific cancer type.


Place of Service: Outpatient

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.


The policy position applies to all commercial lines of business


Denial Statements

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.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

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U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

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