Extract of MOLDX coverage for LBX / MRD, released as proposal on 9/24/2020.

https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=38778&ver=7&SearchType=Advanced&CoverageSelection=Local&PolicyType=Both&AdvSearchName=2&KeyWord=MolDX&KeyWordLookUp=Title&KeyWordSearchType=Exact&kq=true&bc=IAAAAAgAAAAA&

Coverage Indications, Limitations, and/or Medical Necessity

This Medicare contractor will provide limited coverage for molecular circulating tumor DNA (ctDNA) tests that detect minimum residual disease (MRD) in patients with a personal history of cancer.

This Contractor provides limited coverage for MRD testing in cancer when:

1. If Next-Generation Sequencing (NGS) methodology is used in testing, the conditions set by NCD90.2 are fulfilled (summarized: the patient has advanced cancer; plans on being treated for said cancer, and has not been previously tested with the same test for the same genetic content) or are not applicable (the patient does not have cancer as defined below)
2. The patient has a personal history of cancer, the type and staging of which is within the intended use of the MRD test
3. The identification of recurrence or progression of disease within the intended use population of the test is identified in the NCCN or other established guidelines as a condition that requires a definitive change in patient management
4. The test is demonstrated to identify molecular recurrence or progression before there is clinical or radiographical evidence of recurrence or progression; and demonstrates sensitivity and specificity of subsequent recurrence or progression comparable with radiographical evidence of recurrence or progression
5. The test is demonstrated to identify recurrence or progression with sensitivity and specificity that is considerably more accurate than other established (non-MRD) forms of surveillance or monitoring. To be reasonable and necessary, it must also be medically acceptable that the test being utilized precludes other surveillance or monitoring tests unless they are required to follow-up or confirm the findings of this test
6. If the test is to be used for monitoring therapeutic response, it must demonstrate the clinical validity of its results in published literature for the explicit therapy indicated
7. If similar MRD tests exist in the market and are covered by this contractor, test performance for the test must be comparable to existing tests
8. The test satisfactorily completes a technical assessment that will review and confirm the analytical and clinical validity of the test to ensure conditions 1-7 above are met

MRD testing often requires two types of assays to be performed as part of the service. First, a sample is taken from tumor diagnostic material to establish a baseline tumor signature as defined by the test methodology. This is followed by a series assays run on blood to detect the presence or recurrence of tumor based on the measured biomarkers, expression, or other analytes over various timepoints. This series of assays comprises a single test when the patient is known to have cancer. When the patient is NOT known to have cancer (specifically when there is no clinical, radiographical, or other biological evidence that tumor cells remain post treatment and subsequently the patient is no longer being subjected to therapeutic interventions for cancer), a second kind of test may exist wherein a single additional timepoint may constitute a single test.