Medical Policy: 02.04.60
Original Effective Date: August 2016
Reviewed: August 2017
Revised: August 2017
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Plasma based proteomic screening is a molecular diagnostic test available in the diagnostic workup of pulmonary nodules. To rule out malignancy, invasive diagnostic procedures such as CT-guided biopsies, bronchoscopies or video assisted thoracoscopy are often required but each carry procedure related complications ranging from post procedure pain to pneumothorax. Molecular diagnostic tests have been proposed to aid in risk-stratifying patients to eliminate or necessitate the need for subsequent invasive diagnostic procedures.
Pulmonary nodules are common clinical problem that may be found as an incidental finding on a chest x-ray or CT scan or in the context of lung cancer screening studies of smokers. The primary question following detection of pulmonary nodules is the probability of malignancy, with subsequent management based on various factors such as the radiographic characteristics of the pulmonary nodule (e.g. size, shape, density) and patient factors (e.g. age, smoking history, previous cancer history, family history, environmental/occupational exposures). The challenge in the diagnostic workup for pulmonary nodules is appropriately ruling-in patients for invasive diagnostic procedures and ruling-out patients who should forego invasive diagnostic procedures.
Proteomics is the study of the structure and function of proteins, including antibodies. The study of the concentration, structure and other characteristics of proteins, including antibodies contained in various bodily tissues, fluids and other materials has been proposed as a method of identifying and managing various diseases, including cancers. In proteomics, multiple test methods are used to study proteins. Immunoassays use antibodies to detect the concentration and/or structure of proteins. Mass spectrometry is an analytic technique that ionizes proteins into smaller fragments and determine mass and composition to identify and characterize proteins.
Plasma-based proteomic screening is a molecular test that may help physicians risk-stratify pulmonary nodules as likely benign, thereby increasing the number of patients who can confidently choose serial CT scans of their nodules (“active surveillance”), instead of invasive procedures like surgery and biopsy, that carry significant risks and costs. Additionally, plasma-based proteomic screening may also determine a likely malignancy in clinically low risk or intermediate risk pulmonary nodules thereby allowing for earlier detection in a subset of patients.
Xpresys Lung is plasma-based proteomic screening test that measures the relative abundance of 11 proteins across multiple disease pathways associated with lung cancer using an analytic technique called multiple reaction monitoring mass spectroscopy (MRM-mass spec). The role of this test is to aid physicians in differentiating likely benign, versus likely malignant nodules in patients. If the test yields a “likely benign” result, patients may choose active surveillance via serial CT scans to monitor the pulmonary nodule(s). If the test yields a “likely malignant” result, invasive diagnostic procedure would be indicated. The test is therefore only used in the management of pulmonary nodules to rule-in or rule-out invasive diagnostic procedures and does not provide a diagnosis of lung cancer.
Based on review of the peer reviewed medical literature for individuals with pulmonary nodules discovered by imaging who receive plasma-based proteomic screening, the evidence includes an analytic validity study, prospective cohort and prospective-retrospective studies. Direct evidence of clinical utility is limited. Additional randomized controlled studies are necessary to establish the impact of this testing in decreasing unnecessary invasive procedures or surgeries and concurrently decreasing cancer related deaths and other positive outcomes. Also, no professional society guidelines indicate the utilization of plasma-based proteomic screening (Xpresys Lung) for risk assessment and early screening for lung cancer in patients with pulmonary nodules. The evidence is insufficient to determine the effects of this testing on net health outcomes.
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory developed tests (LDTs) must meet general regulatory standards of the Clinical Laboratory Improvement Amendments (CLIA). Xpresys Lung test is available under the auspices of CLIA. Laboratories that offer LDTs must be licensed by CLIA for high complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test.
No practice guidelines and position statements were identified.
Not applicable
See also medical policy 02.04.55 Epidermal Growth Factor Receptor (EGFR) Testing
Plasma-based proteomic screening testing, including but not limited to the following, for risk assessment and early screening for lung cancer in patients with pulmonary is considered investigational:
Based on review of the peer reviewed medical literature for individuals with pulmonary nodules discovered by imaging who receive plasma-based proteomic screening, the evidence includes an analytic validity study, prospective cohort and prospective-retrospective studies. Direct evidence of clinical utility is limited. Additional randomized controlled studies are necessary to establish the impact of this testing in decreasing unnecessary invasive procedures or surgeries and concurrently decreasing cancer related deaths and other positive outcomes. Also, no professional society guidelines indicate the utilization of plasma-based proteomic screening (Xpresys Lung) for risk assessment and early screening for lung cancer in patients with pulmonary nodules. The evidence is insufficient to determine the effects of this testing on net health outcomes.
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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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