CMS Contractor Novitas Rescinds Coverage for Multiple Cancer Genetic Tests

NEW YORK – Medicare Administrative Contractor Novitas Solutions released a local coverage determination last week limiting coverage for multiple cancer genetic tests, including those from Castle Biosciences, Interpace Biosciences, and Pacific Edge Diagnostics.

The contractor reviewed and analyzed published literature for multiple genetic tests for oncology and rescinded coverage for Castle Bio's DecisionDx-Melanoma and DecisionDx-SCC tests, Pacific Edge Diagnostics' Cxbladder Detect, Enhanced Detect, Monitor, Enhanced Triage, and Resolve assays, Interpace's PancraGen, Clinical Genomics' Colvera, Abbott's UroVysion fluorescence in situ hybridization test, and the University of Pittsburgh Medical Center's ThyroSeq Cancer Risk Classifier and PancreaSeq Genomic Classifier.

The new coverage limitations take effect July 17.

The contractor also noted that tests are not medically reasonable and necessary if there are unestablished analytical or clinical validity or clinical utility levels of evidence, if the interventions are not identified by ClinGen, National Comprehensive Cancer Network, or OncoKB as demonstrating actionability in clinical decision-making, or if patients do not have either an established diagnosis of cancer or substantiated suspicion of cancer. Genetic testing of asymptomatic patients for screening purposes, as well as screening of their relatives and repetitions of the same genetic test on the same genetic material are also not considered medically reasonable or necessary.

According to Novitas, the Cxbladder portfolio of tests "all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract." The firm's evidence also demonstrates population biases, namely in early papers toward male patients with European ancestry. Novitas noted that most of the primary literature surrounding the tests is funded or directly written by Pacific Edge and that the conflict of interest must be considered when reviewing the papers. In addition, the tests have not been adequately vetted in the context of the Medicare population, Novitas said.

In a statement, Pacific Edge said it would explore all available legal options, including a potential appeal, with its lawyers, key opinion leaders, and other impacted companies and will continue to promote the tests and process all ordered tests. It added that the firm's revenue is expected to decrease substantially until the tests regain coverage, but that the company plans to bill and receive reimbursement from contracted US payors without interruption and from non-contracted private payors in line with current reimbursement rates.

Pacific Edge said that it will begin cost containment initiatives, including an immediate hiring freeze and halt on discretionary spending and new capital expenditure.

"Molecular diagnostics is a developing field, and this LCD has made an unprecedented move to change the threshold regarding what's acceptable evidence and what's not, by relying on third-party databases that do not adequately cover the current standard of care in bladder cancer diagnosis," Pacific Edge CEO Peter Meintjes said in the company's statement. "Consequently, Novitas does not appear to acknowledge that Pacific Edge's products improve the standard of care in bladder cancer diagnosis and does not appear to consider the benefits of noninvasive testing alternatives and may result in worse outcomes for patients."

UPMC's ThyroSeq test lost coverage due to the lack of evaluation of clinical utility in its published literature, the "inadequate quality" of the papers analyzed, and the insufficiency of its data, Novitas said. The PancreaSeq also lost coverage due to a lack of peer-reviewed literature and evidence.

For Castle Biosciences' tests, the MAC found that the body of peer-reviewed literature was insufficient to establish the analytic validity, clinical validity, and clinical utility of the assay in the Medicare population. The papers reviewed for Castle's tests left many questions related to the complexities of gene expression profiles unaddressed, Novitas said. The publications for the melanoma test also lacked consistent definitions across each study, while there were no significant studies determining patient outcomes or assessing clinician treatment decisions in a real-world setting after a DecisionDx-SCC test, making it impossible to determine clinical utility. The Castle Biosciences decision comes after fellow Medicare Administrative Contractor Wisconsin Physicians Service Insurance Corporation declined to cover the firm's DecisionDx-SCC test last week.

In a note to investors, BTIG analyst Mark Massaro said it is not yet clear whether Novitas' decision will affect the DecisionDx-Melanoma coverage from fellow Medicare Administrative Contractor Noridian. Novitas has never covered the test because Castle runs its tests in Arizona, which is under Noridian's jurisdiction. Massaro noted that management is "pursuing all avenues to reverse this decision."

A key issue with literature for Abbott's uFISH test was weakness in evaluating the test's ability to detect or predict recurrence, Novitas said. No studies were identified that established that uFISH was able to accurately distinguish between urothelial carcinoma and other cancers or other non-cancer urological conditions, the MAC added. As a result, like Castle Biosciences, the body of peer-reviewed literature was insufficient to establish the analytic validity, clinical validity, and clinical utility of the assay in the Medicare population.

Meantime, the evidence for assessing the Colvera test had "a number of shortcomings," including short follow-up time, insufficient longitudinal data, insufficient description of study methodology, and a failure to sufficiently address important pre-analytic variables, Novitas said. Also, there was no published paper addressing the clinical utility of the assay, it noted.

On Monday, Interpace Biosciences announced it would stop offering its PancraGen risk stratification test for pancreatic cancer once the Novitas final LCD goes into effect on July 17. Novitas said that there has been no proposed process for combining the test's results with consensus guidelines for decision-making and no prospective studies with a simultaneous control population to prove the test can affect patient-relevant outcomes.