Arizona Complete Health cancer biomarker coverage

Coverage Criteria

FIT-DNA Testing (Stool DNA Testing) - Medically Necessary

Covered when ALL of the following are met:

FIT-DNA criteria: Member is 45 years of age or older AND member is at average risk for colorectal cancer (does not have any of: personal history of colorectal cancer or adenoma or sessile serrated polyp; family history of colorectal cancer in close relatives; personal history of inflammatory bowel disease; personal history of cystic fibrosis; confirmed or suspected hereditary colorectal cancer syndrome such as familial adenomatous polyposis or Lynch syndrome; personal history of receiving abdominal or pelvic radiation; symptoms suspicious for an undiagnosed colorectal cancer such as rectal bleeding, iron deficiency anemia, abdominal pain, or weight loss).age >=45

Aligns with FDA label expansion and NCCN guidance; FIT alone is out of scope.

Urinary Biomarker Tests for Precancerous Colon Polyps

Urinary biomarker tests: Current evidence does not support the use of urinary biomarker tests for precancerous colon polyps for all indications.

Not supported for coverage per policy statement.

Blood-based Biomarker Colorectal Cancer Screening Tests

Blood-based colorectal biomarkers: Current evidence does not support the use of blood-based biomarkers to screen for colorectal cancer for all indications.

Specific tests listed include BeScreened-CRC, FirstSight CRC, ColonSentry, Epi proColon, ColoVantage, ColoScape, Guardant Shield, and others.

Blood-based Biomarker Lung Cancer Screening Tests

Blood-based lung biomarkers: Current evidence does not support the use of blood-based biomarker tests for lung cancer screening for all indications.

NCCN does not include a recommendation for blood-based or micro-RNA based lung cancer screening; examples include FirstLook (Delfi Diagnostics).

Multi-Cancer Early Detection Screening Tests

Multi-cancer early detection tests: Current evidence does not support multi-cancer early detection screening tests for all indications.

Examples include Galleri; NCI and major professional societies have not issued recommendations and there is no evidence from large trials showing mortality reduction.

Covered with criteria / informational

Coverage stance excerpts

Blood-based lung cancer screening: NCCN guidelines do not include a recommendation for lung cancer screening via blood-based or micro-RNA based screening; Concert notes insufficient evidence to support use.

See NCCN and Concert evidence summaries.

Multi-cancer early detection: NCI: no large clinical trials showing MCD tests reduce cancer mortality; no professional societies (including USPSTF) recommend MCD tests for screening.

See NCI and guideline summaries.

CA-125 testing context-specific consideration: NCCN recommends consideration of CA-125 testing in specific clinical contexts (eg, peritoneal mesothelioma with recurrent ascites/peritoneal thickening, initial evaluation of uterine neoplasms, appendiceal adenocarcinoma, occult primary with uterine/ovarian involvement) but not for general population screening.

Context-specific diagnostic use per NCCN; not recommended for routine screening.

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.

Covered Indications

FIT-DNA stool DNA testing for colorectal cancer screening in average-risk individuals aged 45 years or older

FIT-DNA average-risk and age requirement: FIT-DNA stool DNA testing for colorectal cancer screening is covered for average-risk individuals aged 45 years or older.age >=45

Member must be average risk (absence of personal history of CRC/adenoma, IBD, cystic fibrosis, hereditary CRC syndrome, prior abdominal/pelvic radiation, suspicious symptoms, or family history of CRC in close relatives).

Not Covered

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.

Coding

Referenced test CPT/HCPCS and diagnosis codesmixed

81528	Cologuard (stool DNA testing) example
0464U	ColoGuardPlus (Exact Sciences) example
0002U	PolypDx (Metabolomic Technologies) urinary biomarker test example
81327	Blood-based biomarker (listed as common billing)
81479	Unlisted molecular pathology procedure (used for several blood-based tests)
81599	Unlisted multianalyte assay with algorithmic analysis (listed)
0091U	FirstSight (CellMax Life) example
0163U	BeScreened-CRC (Beacon Biomedical) example
0368U	ColoScape Colorectal Cancer Detection example
0453U	ColonAiQ (Breakthrough Genomics) example

1–10 of 17

1/2

Coding updates mentionedmixed

No codes listed

FIT‑DNA age threshold

Age thresholdMember must be 45 years of age or older for FIT-DNA screening

Policy alignmentAge threshold aligns with FDA label expansion and NCCN guidance to include adults ages 45 years or older

ApplicabilityApplies to FIT-DNA (stool DNA) colorectal cancer screening — not to FIT alone

Provider Actions

Prior Authorization

Verify coding / prior auth

Verify coding and check payer prior authorization requirements before submitting claims. Common billing codes referenced in this policy include: FIT-DNA (81528, 0464U) with screening diagnosis Z12.10–Z12.13; blood-based and multi-cancer detection (e.g., 81327, 81479, 81599, 0091U, 0163U, 0368U, 0453U, G0327, C00–C96 as applicable); urinary biomarker example 0002U; and lung screening billing examples (81479, Z12.2). Providers should confirm the correct CPT/HCPCS/ICD-10 codes for the specific test performed and verify whether the plan requires prior authorization for that test or laboratory provider.

Affected example codes: 81528, 0464U, 0002U, 81327, 81479, 81599, 0091U, 0163U, 0368U, 0453U, G0327, Z12.10–Z12.13, 81479 (lung), Z12.2

Denial Risk

Denial triggers for unsupported screening tests

Use of tests for which the policy states current evidence does not support screening may result in claim denial. Examples specifically noted as not supported for screening include urinary biomarker tests for precancerous colon polyps, blood-based biomarker tests for colorectal cancer, blood-based biomarker lung cancer screening tests, and multi-cancer early detection (MCD) screening tests.

Background

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).

Definitions

Average risk (for colorectal cancer)

Definition (average risk)An individual without personal history of colorectal cancer or adenoma or sessile serrated polyp

Excluding conditions — personalNo personal history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or cystic fibrosis

Excluding conditions — familial/geneticNo confirmed or suspected hereditary colorectal cancer syndrome (e.g., FAP or Lynch syndrome) and no family history in close relatives

Excluding conditions — prior treatment/symptomsNo prior abdominal or pelvic radiation and no symptoms suspicious for undiagnosed colorectal cancer (e.g., rectal bleeding, iron deficiency anemia, abdominal pain, weight loss)

FIT‑DNA Testing

Test typeStool DNA testing (FIT‑DNA), example: Cologuard

Eligibility Requirements

No top-level eligibility requirement nodes are specified in this section of the policy.

Revision History

2023-10-23semi-annual_review

Semi-annual review updated title to V2.2024; minor rewording, coding and reference-table updates, and background/rationale edits including removal of older technical assessment and addition of May 2023 reference.

2024-04-24semi-annual_review

Semi-annual review for V2.2024 with minor wording clarifications and updates to coding, reference table, background, and references.

2024-11-24revision

OpenPayer

Cancer Screening and Surveillance: Genetic and Biomarker Tests