Key takeaways:
- CMS will use newly defined criteria to qualify noninvasive biomarker CRC screening tests for coverage.
- Concerns remain that evidence for thresholds may be retrofitted to current test performance.
CMS established a new national framework setting performance thresholds to qualify noninvasive, biomarker-based colorectal cancer screening options — including FDA-approved stool- and blood-based tests — for coverage.
“The CMS coverage decision provides benchmarks for novel noninvasive tests to meet and exceed to gain coverage, and learn from the experience of currently approved tests,” Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman Professor of Medicine at NYU Grossman School of Medicine, told Healio. “It also allows newer test makers to understand the current performance standards and where improvements are needed.”
ColoSense (Geneoscopy), the first FDA-approved multitarget stool RNA test for CRC, is also the first test added to CMS’s national screening policy under the new standards.
Though CRC is the third-leading cause of cancer-related deaths in men and the fourth-leading cause in women, 1 in 3 eligible U.S. adults are not up to date on screening, a study in Preventing Chronic Disease found.
CMS’s decision to cover ColoSense expands the range of screening tools available to patients reluctant to undergo colonoscopy or traditional stool-based testing, adding an option that removes a common barrier to adherence, the need for patients to handle the stool sample.
Under the new decision, CMS will cover noninvasive biomarker-based CRC screening tests — that meet performance standards — every 3 years for adults aged 45 to 85 years at average risk.
To qualify for coverage, blood- and stool-based tests must be FDA-approved, processed in a Clinical Laboratory Improvement Amendments-approved lab and meet one of two performance criteria: have a sensitivity greater than or equal to 90% and a specificity greater than or equal to 87%, or a sensitivity greater than or equal to 79% and specificity greater than or equal to 90% in CRC detection compared with colonoscopy, the current standard.
Shaukat acknowledged that the new performance thresholds are an improvement over past requirements — CMS used to require a sensitivity of 74% for blood-based tests — but said it is unclear what evidence the new criteria are based on.
She expressed concern that the “criteria feel retrofitted to existing performance of stool and blood tests.”
“The criteria are missing mention of advanced precursor lesion sensitivity or sensitivity for stage I to II CRC, important measures of any test performance for CRC screening,” she continued.
Blood-based biomarker tests underperform other screening options in early detection, missing 1 in 3 early-stage cases of CRC, according to ACG.
CMS coverage criteria also stipulates that patients must not have CRC symptoms to qualify for a biomarker-based test, and must be informed about the test’s performance, as well as the need for a follow-up colonoscopy if test results are positive.
In a recent statement on updated CRC screening guidance from the American Cancer Society, ACG voiced concern that clinicians may not have the time to inform patients of the performance limitations of each screening test during visits.
For more information:
Aasma Shaukat, MD, MPH, is an ACG trustee and director of outcomes research in the division of gastroenterology and hepatology at NYU Grossman School of Medicine. She can be reached at gastroenterology@healio.com.
Sources/Disclosures
Source:
References:
Disclosures:
Shaukat reports consulting roles with Freenome, Geneoscopy and Universal Diagnostics.
Ask a clinical question and tap into Healio AI’s knowledge base.
- PubMed, enrolling/recruiting trials, guidelines
- Clinical Guidance, Healio CME, FDA news
- Healio’s exclusive daily news coverage of clinical data
