Highmark Commercial Medical Policy - Pennsylvania

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Medical Policy: L-123-007
Topic: Liquid Biopsy Testing – Solid Tumors
Section: Laboratory
Effective Date: August 1, 2018
Issue Date: July 30, 2018
Last Reviewed: March 2018

The National Cancer Institute defines a liquid biopsy as a test done on a sample of blood to look for cancer cells from a tumor that are circulating in the blood or for pieces of deoxyribonucleic acid (DNA) from tumor cells that are in the blood. A liquid biopsy may be used to help find cancer at an early stage. It may also be used to help plan treatment or to find out how well treatment is working or if cancer has come back. Being able to take multiple samples of blood over time may also help doctors understand what kind of molecular changes are taking place in a tumor.

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.

Liquid Biopsy Testing – Solid Tumors is considered experimental/investigational (E/I) and therefore, non-covered.

  • E/I molecular and genomic (MolGen) tests refer to assays involving chromosomes, DNA, ribonucleic acid (RNA), or gene products that have insufficient data to determine the net health impact, which typically means there is insufficient data to support that a test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinical utility), and/or performs better than an existing standard of care medical management option. Such tests are also not generally accepted as standard of care in the evaluation or management of a particular condition.
  • In the case of MolGen testing, Food and Drug Administration (FDA) clearance is not a reliable standard given the number of laboratory developed tests that currently fall outside of FDA oversight and FDA clearance often does not assess clinical utility.

Test-specific Policies

  • Test-specific policies may be available for certain liquid biopsy tests. Please see the individual medical policy for specific information. For tests without a specific medical policy, use this policy for guidance.
Procedure Codes
0011M, 81201, 81210, 81211, 81235, 81270, 81272, 81273, 81275, 81276, 81287, 81292, 81295, 81298, 81310, 81311, 81314, 81317, 81321, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81445, 81455, 81479, 88271

Professional Statements and Societal Positions

The National Comprehensive Cancer Network (NCCN, 2017) states the following in regards to liquid biopsies for epidermal growth factor receptor (EGFR) T790M testing in patients with non-small cell lung cancer (NSCLC):

  • In patients with a sensitizing EGFR mutation at progression, tissue biopsy testing for EGFR T790M testing should be performed.
  • Recent data suggest that plasma genotyping (also known as liquid biopsy or plasma biopsy) may be considered instead of tissue biopsy to detect whether patients have T790M; however, if the plasma biopsy is negative, then tissue biopsy is recommended if feasible.

Many laboratories are developing liquid biopsies assays. For many of these assays, analytical validity studies have been performed; however, data regarding the clinical validity and clinical utility of these tests is still emerging.

The TRACERx study (Tracking Non-small cell lung cancer evolution through therapy (Rx)) is a large, prospective clinical trial being conducted to evaluate the relationship between intra-tumor heterogeneity and clinical outcome following surgery and adjuvant therapy. Researchers plan to analyze patient’s tumors before surgery and multiple times after surgery during their treatment regimen. Tumor tissue and circulating tumor DNA (ctDNA) in patient’s blood will be examined in approximately 840 patients with NSCLC. This trial is expected to continue until 2023.

Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Liquid biopsy 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 be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.


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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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages
If you need these services, contact the Civil Rights Coordinator.

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.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

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)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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