Medicaid Grants Coverage of Blood-Based Biomarker Testing in CRC Despite Lack of an Assay

February 25, 2021
Sara Karlovitch

The Centers for Medicare & Medicaid Services have found that there is sufficient evidence for the coverage of blood-based biomarker tests to be granted for patients with colorectal cancer once every 3 years or at a specific individual test interval labeled by the FDA.

The Centers for Medicare & Medicaid Services (CMS) have found that there is sufficient evidence for the coverage of blood-based biomarker tests to be granted for patients with colorectal cancer (CRC) once every 3 years or at a specific individual test interval labeled by the FDA. According to the memo from CMS, patients must first meet certain criteria before their blood-based biomarker testing can be covered.

Requirements for patients with CRC include being between, 50-85 years old, asymptomatic, and at an average risk of CRC. A blood test for CRC must have FDA market authorization with an indication for CRC screening, have a proven performance with both a sensitivity greater than or equal to 74% and specifically greater than or equal to 90% in the detection of CRC compared with the recognized standard, and it must be included as a recommended routine CRC screening test in at least one professional guidelines or censuses statement or United States Preventive Services Task Force (USPSPTF) recommendation.

The mSEPT9 (Epi proColon) test is the only FDA-approved blood-based assay for CRC. It is intended for adults of any sex, 50 years or older, and defined as average risk for CRC. The test is recommended in the 2008 United States Preventive Services Taskforce (USPSTF) CRC screening guidelines. The guidelines state that patients with a positive test should be referred for diagnostic coloscopy. Additionally, results should be used in combination with a physician’s assessment and individual risk factors in guiding patient management.

Despite being the only FDA-approved option for blood-based biomarker testing in the CRC space, CMS stated that mSEPT9 does not meet the proposed criteria to be an appropriate blood-based biomarker CRC screening test, meaning that it should not be covered by Medicaid or Medicare. This leaves no assay for Medicaid to cover.

According to CMS, clinical evidence observed with the use of mSEPT9 in CRC contradicts Medicaid coverage requirement in a few ways. First, the mSEPT9 test is not meant to replace CRC screening tests that are recommended by appropriate guidelines, such as a colonoscopy. Additionally, the test is not intended for patients who are will and able to undergo a routine CRC screening test that are recommended by the appropriate guidelines. Additionally, it is not for patients at an elevated risk of CRC and is not meant for patients who have been diagnosed with a relevant familial cancer syndrome

A meta-analysis of 19 studies totaling 7628 cases and controls found that its sensitivity to CRC was 69% and had a positive likelihood ratio of 9.1 and negative likelihood ratio of 0.34. In the average-risk population, the test had a positive predictive value of 2.6%. However, the negative predictive value was 99.8%.

"The mSEPT9 test has high specificity and moderate sensitivity for CRC and is therefore a potential alternative screening method for those declining fecal immunochemical test for occult blood (FIT) or other screening modalities. However, it is limited by its poor diagnostic performance for precancerous lesions (advanced adenomas and polyps) and its relatively high costs, and little is known about its acceptability to those declining to use the FIT," wrote the authors of the meta-analysis. Additionally, the study notes that while mSEPT9’s performance was similar to FIT, it is not currently a suitable replacement.

REFERENCE:
Proposed Decision Memo for Screening for Colorectal Cancer - Blood-Based Biomarker Tests (CAG-00454N) Accessed February 24, 2021. https://go.cms.gov/2ZXiFBP
Hariharan R, Jenkins M. Utility of the methylated SEPT9 test for the early detection of colorectal cancer: a systematic review and meta-analysis of diagnostic test accuracy. BMJ Open Gastroenterol. 2020;7(1):e000355. doi: 10.1136/bmjgast-2019-000355