Proposed LCD - MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers (DL39648)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary.42 CFR 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityThis is a coverage policy for gene expression profile tests that assess risk or predict therapeutic response in men who have an established diagnosis of castration resistant or metastatic prostate cancer.Such testing is considered reasonable and necessary to help guide treatment decisions in men with prostate cancer and a life expectancy such that they are candidates for prostate cancer treatment according to the most recent nationally recognized guidelines at the time of testing or based on FDA labelling of drugs and biologics available as potential treatment options.The scope of this policy includes gene expression profile tests regardless of methodology. It is exclusive of targeted and comprehensive genomic profiles (CGP) by next generation sequencing (NGS) and single biomarker expression analyses.Coverage criteria:1. BOTH of the following criteria must be met:The beneficiary is being actively managed for castration resistant or metastatic (hormone sensitive or castration resistant) prostate cancer.The beneficiary is within the population and has the indication for which the test was developed and validated.2. At least 1 of the following criteria are met:The patient is a candidate for more than one management option, which could be considered to have varied, or increasing/decreasing levels of intensity based on a nationally recognized consensus guideline, and the physician and patient must decide among these treatments ORThe patient is a candidate for more than one management option, and the test has shown that it predicts response to a specific therapy among accepted therapy options based on nationally recognized consensus guidelines and/or FDA labelling.3. The patient has not been tested with the same or similar test for prostate cancer.4. The patient has not received pelvic radiation or androgen deprivation therapy (ADT) prior to the biopsy or prostate resection specimen on which the test will be performed.The only exception to this is for men who are nave to secondary systemic therapies (that could be given after ADT monotherapy) AND at least 1 of the following is true:a. They do not have other standard-of-care drug-targetable gene alterations to guide systemic therapy, as defined in nationally recognized guidelines ORb. They have other standard-of-care drug-targetable gene alterations to guide systemic therapy, as defined in nationally recognized guidelines but they are not eligible for those therapies for another reason.The test demonstrates analytical validity (AV), clinical validity (CV) and clinical utility (CU), establishing a clear and significant biological/ molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management in a clearly defined population.Clinical validity of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population.If the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm.Testing must be performed according to Clinical Laboratory Improvement Amendments (CLIA) and/or Food and Drug Administration (FDA) regulations in an accredited laboratory.The lab providing the test is responsible for clearly indicating to treating physicians the population and indication(s) for test use.The test successfully completes a Molecular Diagnostic Services Program (MolDX) Technical Assessment that ensures that AV, CV, and CU criteria set in this policy are met to establish the test as Reasonable and Necessary.Genomic expression profile tests that demonstrate equivalent or superior analytical and clinical validity to those covered by this contractor will be considered reasonable and necessary for the same indications.General InformationAssociated InformationN/ASources of InformationN/ABibliography