||Liquid Biopsy Testing – Solid Tumors
||August 1, 2018
||July 30, 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 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.
|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|
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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