Tests that the policy states current evidence does not support are effectively excluded from coverage for screening indications. Examples explicitly identified in this policy include urinary biomarker tests for precancerous colon polyps, blood-based biomarker tests for colorectal and lung cancer screening, and multi-cancer early detection assays; use of these tests for screening may be denied as not supported by evidence and not medically necessary for screening indications.

Providers should assume that, unless future high-quality evidence or guideline endorsements change the policy position, ordering these tests for routine screening will not meet coverage criteria and may trigger claim denials or prior authorization refusals.

Blood-based biomarker tests for lung cancer screening and multi-cancer early detection (MCD) tests lack endorsement by major guideline bodies referenced in this policy. The National Comprehensive Cancer Network (NCCN) does not include a recommendation for blood-based or micro-RNA–based lung cancer screening, and the National Cancer Institute (NCI) reports no large trials showing that MCD tests reduce cancer mortality.

Because guideline sources do not recommend these tests for population screening and evidence of clinical benefit is insufficient, routine screening with blood-based lung cancer biomarker tests or MCD tests is not supported under this policy and may be considered not medically necessary.

The policy states that urinary biomarker tests for precancerous colon polyps, blood-based biomarker tests for colorectal and lung cancer screening, and multi-cancer early detection tests are not supported by current evidence for screening indications. Concert’s evidence review found insufficient peer-reviewed data that blood-based colorectal tests improve health outcomes compared with the current standard of care.

As a result, these tests are treated as not medically necessary for screening in average-risk populations and are excluded from coverage for those indications unless future evidence or authoritative guideline changes justify reconsideration.

Routine use of blood-based lung cancer biomarker tests or multi-cancer detection tests for general population screening is not supported by current evidence or guideline recommendations. NCCN provides no recommendation for blood-based lung screening, and the NCI has found no large clinical trials demonstrating that MCD tests reduce cancer mortality.

Therefore, ordering these assays for routine screening is inconsistent with the policy’s evaluative criteria and may result in noncoverage; any use should be guided by evolving evidence and explicit guideline endorsement before coverage would be considered.

Summary of not-covered screening tests: urine-based colorectal precancerous polyp tests, most blood-based colorectal cancer screening tests, most blood-based lung cancer screening tests, and multi-cancer early detection (MCD) screening tests are not supported by current evidence for screening indications and are therefore not covered for routine screening under this policy.

This stance is based on the policy’s review of guideline positions and evidence summaries indicating insufficient data that these assays improve clinically meaningful outcomes such as cancer-specific mortality.

Blood-based biomarker lung cancer screening tests and multi-cancer detection tests for general population screening are not supported by guideline sources cited in this policy (for example, NCCN and NCI).

Because major professional societies have not endorsed these tests for screening and evidence of benefit is lacking, these tests are not covered for routine population screening and may be denied as not medically necessary.

Background: This policy covers genetic and biomarker screening tests intended to detect specific cancers in asymptomatic individuals or those at elevated risk. It distinguishes average-risk screening (for example, FIT-DNA stool DNA testing for colorectal cancer) from screening in higher-risk patients and summarizes guideline and FDA positions relevant to test use.

The policy aligns FIT-DNA screening criteria with guideline and regulatory guidance: FIT-DNA (stool DNA) testing is considered medically necessary only when the member is 45 years of age or older and is at average risk for colorectal cancer (no personal history of colorectal cancer or adenoma, no qualifying family history, no IBD, no cystic fibrosis, no hereditary CRC syndrome, no prior abdominal/pelvic radiation, and no symptoms suspicious for colorectal cancer).