NEW YORK – Medicare Administrative Contractor Palmetto GBA released on Thursday a finalized local coverage decision for minimal residual disease cancer testing.
The general decision could cover MRD tests from a variety of companies, including Natera, NeoGenomics, Exact Sciences, Invitae, and Guardant Health, as long as those tests meet the coverage criteria, Craig-Hallum analyst Alex Nowak said in a note discussing the decision.
Under the future LCD, which goes into effect Dec. 26, tests must be used to noninvasively monitor minimal residual disease; patients must have a personal history of cancer where the type and staging are within the intended use of the test; and identification and monitoring of recurrence must be identified in National Comprehensive Cancer Network or other established guidelines as a condition that would require a definitive change in treatment management.
If a test uses next-generation sequencing, criteria under the national coverage determination for NGS must be met, unless they're not applicable — namely, the patient must have advanced cancer, plan on being treated for said cancer, and hasn't been previously tested with the same test for the same genetic content.
Other criteria in the new decision are that the MRD test must demonstrate recurrence or progression before clinical, biological, or radiographical evidence is available; the test must show equal or superior sensitivity and specificity compared to other recurrence monitoring tools; and it must preclude other surveillance monitoring tests that provide similar clinical results unless it's used for confirmation or follow-up.
The test must be used in a patient who is part of the population that the test was analytically validated on and according to its intended use.
If the test is used to monitor a specific therapeutic response, it has to demonstrate clinical validity of its results in published literature for the explicit management of therapy indication, and the clinical validity of any analytes or expression profiles measured must be established in a study published in peer-reviewed literature.
Also, a technical assessment of the test must be completed to confirm the analytical and clinical validity criteria, as well as the clinical utility criteria, and to establish the test as reasonable and necessary.
If a test uses a similar method or evaluates a similar analyte as another, more generally accepted test — or a test with existing coverage — it must demonstrate equivalent or superior test performance when used for the same indication in the same intended-use population.
CGS Administrators and Wisconsin Physician Service Insurance Corporation have also released final coverage documents aligning with Palmetto's decision. Noridian Healthcare Solutions has not released its final coverage decision.
According to Craig-Hallum's Nowak, the LCD would apply to Natera's Signatera immune-oncology monitoring indication and can be expanded to its multiple myeloma, ovarian cancer, and other solid organ tumor indications when the criteria are met and the technical assessment is completed.
Natera previously received coverage for its Signatera MRD test for use in patients with colorectal cancer last year.
Nowak wrote in an analyst note that the announcement "is a significant positive for the burgeoning MRD testing space, as new tests/indications no longer need to apply for a separate LCD review, which takes years." He added that tests can now meet the criteria and file a technical assessment, receiving Medicare coverage within about six months.
As long as other companies' tests are as good or better than an incumbent assay, they can receive coverage, although Nowak noted that "exact rules for verifying superiority given study design mismatch is not exactly certain."