CurrentAmbetter NevadaPolicy N/A

Concert Genetic Testing — Cancer Screening and Surveillance

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Criteria and coverage stance for genetic and biomarker tests used to screen for various cancers (colorectal, lung, multi-cancer) in at-risk or average‑risk individuals; applies to Centene‑affiliated health plans.

Policy Summary

PayerAmbetter Nevada

PolicyConcert Genetic Testing — Cancer Screening and Surveillance

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionOrder FIT‑DNA (stool DNA) only for average‑risk individuals aged 45 and older; follow plan prior‑authorization processes for referenced test codes.

SourceLink

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CurrentAmbetter NevadaPolicy N/A

Concert Genetic Testing — Cancer Screening and Surveillance

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Policy Summary

PayerAmbetter Nevada

PolicyConcert Genetic Testing — Cancer Screening and Surveillance

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionOrder FIT‑DNA (stool DNA) only for average‑risk individuals aged 45 and older; follow plan prior‑authorization processes for referenced test codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

45+Minimum age for FIT‑DNA

InsufficientBlood/urinary biomarker stance

No recommendationMCED recommendation

NCCNGuideline cited

Coverage Criteria and Policy Stance

FIT-DNA Medical Necessity

FIT-DNA Testing (stool DNA testing) is considered medically necessary when ALL of the following are met:

FIT-DNA initial screening criteria: Member is 45 years of age or older AND member is average risk for colorectal cancer (does not have any of the listed high-risk conditions)age >=45

Average risk excludes: personal history of colorectal cancer, adenoma, or sessile serrated polyp; family history of colorectal cancer in close relatives; personal history of inflammatory bowel disease (ulcerative colitis or Crohn's disease); personal history of cystic fibrosis; confirmed or suspected hereditary colorectal cancer syndrome (e.g., FAP, Lynch syndrome); personal history of prior abdominal or pelvic radiation; or symptoms suspicious for colorectal cancer (e.g., rectal bleeding, iron deficiency anemia, abdominal pain, weight loss).

Urinary Biomarker Tests — Not Supported

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 indicationsN/A

Not supported by available evidence per policy.

Blood-based CRC Biomarker Tests — Not Supported

Blood-based biomarker colorectal cancer screening:

Blood-based CRC biomarkers: Current evidence does not support the use of blood-based biomarkers to screen for colorectal cancer for all indicationsN/A

Specific blood-based tests (e.g., BeScreened, FirstSight CRC, ColonSentry, Epi proColon, Colovantage, ColoScape, Guardant Shield) have insufficient evidence to demonstrate improved health outcomes compared to standard of care.

Blood-based Lung Cancer Biomarker Tests — Not Supported

Blood-based biomarker lung cancer screening:

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

NCCN (Lung Cancer Screening v1.2025) does not include a recommendation for blood-based or micro-RNA based lung cancer screening; evidence is insufficient.

Multi-Cancer Early Detection Tests — Not Supported

Multi-cancer early detection (MCED) tests:

MCED tests: Current evidence does not support multi-cancer early detection screening tests for all indicationsN/A

No large clinical trials demonstrate that MCD/MCED tests reduce cancer mortality; no professional societies (including USPSTF) currently recommend MCD tests for cancer screening.

Screening test coverage stance

Summary stance in this document portion

Blood-based lung cancer screening: NCCN (v1.2025) does not include a recommendation for lung cancer screening via blood-based or micro-RNA tests; evidence is insufficient to support use

See NCCN guidance and Concert evidence summary.

Multi-Cancer Early Detection (MCD) tests: NCI notes no large trials demonstrating reduction in cancer mortality and no professional societies (including USPSTF) recommend MCD tests for cancer screening

Policy stance: not supported for routine screening due to lack of evidence and guideline endorsement.

FIT-DNA (stool DNA) testing is specifically intended for screening average-risk individuals. It is not indicated for individuals who are not average risk — for example those with a personal history of colorectal cancer, adenoma, or sessile serrated polyp; a personal history of inflammatory bowel disease (ulcerative colitis or Crohn's disease); a personal history of cystic fibrosis; a confirmed or suspected hereditary colorectal cancer syndrome (e.g., FAP or Lynch syndrome); a personal history of prior abdominal or pelvic radiation; a family history of colorectal cancer in close relatives; or symptoms suspicious for colorectal cancer (e.g., rectal bleeding, iron deficiency anemia, abdominal pain, weight loss).

Blood-based biomarker tests for lung cancer and Multi-Cancer Early Detection (MCED) tests are not supported for routine population screening. Current NCCN guidance for lung cancer does not recommend blood-based or micro-RNA based screening, and the NCI reports no large trials showing MCED tests reduce cancer mortality; therefore these technologies are not supported for routine screening in this policy.

The policy does not support several emerging biomarker-based screening approaches due to insufficient evidence. Urinary biomarker tests for detection of precancerous colon polyps and blood-based colorectal cancer screening tests currently lack sufficient evidence to support screening use. Likewise, blood-based lung cancer biomarker tests (including micro-RNA approaches) and multi-cancer early detection (MCED) tests have not demonstrated mortality benefit in large trials and are not endorsed by professional societies; thus these test types are considered unsupported for routine screening.

Use of blood-based or micro‑RNA lung cancer screening tests, and multi‑cancer early detection (MCD/MCED) tests for routine cancer screening is not supported by this policy. NCCN lung screening guidance does not include blood‑based or micro‑RNA screening recommendations and evidence reviews identify insufficient peer‑reviewed data for several blood‑based assays; the NCI also reports no large trials showing MCED tests reduce cancer mortality, which informs the rationale for non‑coverage for routine screening.

Covered Indications

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

FIT-DNA screening indication: FIT-DNA stool DNA testing is indicated for colorectal cancer screening in average-risk individuals aged 45 years or olderage >=45

Member must be average risk as defined by absence of listed high-risk conditions (see exclusions).

No specific recommended indications for blood-based lung cancer screening or MCED tests due to insufficient evidence.

None specifically recommended in this portion of the document for blood-based lung cancer screening or MCED tests due to insufficient evidence.

Blood-based lung cancer screening and MCED tests: There are no recommended indications in this policy for blood-based lung cancer screening tests or multi-cancer early detection tests due to insufficient evidence and lack of professional society recommendations

NCCN and NCI citations indicate absence of endorsement for these screening tests.

Tests and Uses Not Covered

Not covered: Urinary biomarker tests for precancerous colon polyps, blood-based colorectal cancer screening tests, blood-based lung biomarker screening tests, and multi-cancer early detection screening tests are considered unsupported for screening indications due to insufficient evidence and lack of guideline endorsement; these tests are not covered for routine cancer screening under this policy.

Not covered: blood-based biomarker lung cancer screening tests and Multi-Cancer Early Detection (MCED) screening tests are not supported for routine cancer screening because current professional guidelines (e.g., NCCN) do not recommend blood‑based lung screening and authoritative reviews (including NCI) identify no evidence that MCED testing reduces cancer mortality.

Coding and Billing References

Referenced test CPT/HCPCS codesmixed

81528	FIT-DNA testing (example: Cologuard)
0464U	ColoGuardPlus
0002U	PolypDx (urinary biomarker)
0091U	FirstSight (CellMax Life) blood-based CRC
0163U	BeScreened-CRC
0368U	ColoScape Colorectal Cancer Detection
0453U	ColonAiQ
81327	Molecular pathology (used for some blood-based tests)
81479	Unlisted molecular pathology procedure
81599	Unlisted multianalyte assay with algorithmic analysis

1–10 of 11

1/2

Referenced screening diagnosis codesICD-10

Z12.10	Encounter for screening for malignant neoplasm of colon
Z12.11	Encounter for screening for malignant neoplasm of rectum
Z12.12	Encounter for screening for malignant neoplasm of colon and rectum
Z12.13	Encounter for screening for malignant neoplasm of large intestine
Z12.2	Encounter for screening for malignant neoplasm of respiratory organs

Cancer Screening Tests: policy reference additionsHCPCS

G0327	Added to Blood-based Biomarker Colorectal Cancer Screening Tests (policy reference)
G0328	Added to Blood-based Biomarker Colorectal Cancer Screening Tests (policy reference)

Age threshold for FIT-DNA

Age threshold>= 45 years

ApplicabilityApplies to FIT-DNA (stool DNA) colorectal cancer screening

Requirement contextMember must be 45 years of age or older AND average risk for colorectal cancer

Provider Actions, Authorization, and Documentation

Prior Authorization

Obtain prior authorization per plan rules for referenced test codes

Certain laboratory tests and their CPT/HCPCS codes referenced in this policy may require prior authorization under plan-specific rules; providers should obtain prior authorization per the member's Health Plan prior to submitting claims for these tests.

Examples of codes referenced: 81528, 0464U, 0002U, 0091U, 0163U, 0368U, 0453U, 81327, 81479, 81599, G0327

Prior Authorization

Note updates to G0327/G0328 coding — check PA requirements

The policy reference table and criteria were updated to add/clarify HCPCS codes G0327 and G0328 (and related G0326 mention) for blood‑based colorectal biomarker testing; prior authorization may be required per plan coding updates—confirm plan-specific PA requirements when ordering.

Codes specifically noted in revisions: G0327, G0328 (also G0326 referenced in update notes)

Definitions

Average risk for colorectal cancer

DefinitionAn individual without a personal history of colorectal cancer, adenoma, sessile serrated polyp, inflammatory bowel disease, cystic fibrosis, confirmed or suspected hereditary colorectal cancer syndrome, prior abdominal/pelvic radiation, or symptoms suspicious for colorectal cancer.

Disqualifying family historyA family history of colorectal cancer in close relatives disqualifies average-risk status

Use caseDefines eligibility for average-risk screening modalities such as FIT-DNA

FIT-DNA testing (stool DNA testing)

TermStool DNA testing combining FIT and DNA markers (example vendor: Cologuard)

PurposeUsed to screen for colorectal cancer in average-risk individuals

Background and Scope

Background: This policy addresses the use of genetic and biomarker screening tests intended to detect cancer in asymptomatic or at‑risk individuals and distinguishes average‑risk screening from high‑risk surveillance. It covers stool DNA testing (FIT‑DNA) for average‑risk colorectal cancer screening and evaluates other biomarker approaches (urinary, blood‑based colorectal and lung tests, and multi‑cancer early detection assays) against current evidence and guideline positions to determine whether screening indications are supported.

Revision History

2025-11annual_review

Annual review with minor rewording; FIT-DNA criteria updated to add requirement excluding individuals with symptoms suspicious for undiagnosed colorectal cancer, 'Urinary Biomarker Tests' name standardized, Multi-Cancer Early Detection section added, and coding table updated.

2024-04-24semi_annual_review

Semi-annual review: updated title to V2.2024, minor rewording for clarity, and coding, reference table, background and references updated.

2023-10revision

Policy Summary

PayerAmbetter Nevada

PolicyConcert Genetic Testing — Cancer Screening and Surveillance

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionOrder FIT‑DNA (stool DNA) only for average‑risk individuals aged 45 and older; follow plan prior‑authorization processes for referenced test codes.

SourceLink

On This Page

Note

Order tests only when policy criteria are met

Providers must follow the policy criteria when ordering screening tests: use FIT‑DNA only for average‑risk members aged ≥45 and avoid ordering urinary, blood‑based colorectal or lung biomarker tests and MCED tests for routine screening unless criteria are met.

FIT‑DNA medically necessary only if member is ≥45 and average risk (no listed high‑risk conditions).
Urinary, blood‑based CRC, blood‑based lung, and MCED tests are not supported for routine screening per policy.

Step Therapy

Step therapy not specified in this document portion

No step therapy requirements are specified in this portion of the document; providers should not assume any step therapy sequencing is mandated by this policy section.

Billing Rule

Use current CPT guidance and include appropriate screening diagnosis codes

Use current CPT coding guidance and include the appropriate colorectal or respiratory screening diagnosis codes when submitting claims (e.g., Z12.10–Z12.13 for colorectal cancer screening; Z12.2 for respiratory screening as applicable).

Common billing pairs shown: FIT‑DNA examples billed with 81528 or 0464U plus Z12.10–Z12.13.
Blood‑based CRC tests referenced with codes including 81327, 81479, 81599, 0091U, 0163U, 0368U, 0453U, G0327 and Z12.10–Z12.13.

Documentation Required

Ensure documentation supports medical necessity and aligns with plan terms

Coverage is subject to the member's Health Plan terms, exclusions, and applicable state/federal requirements; documentation submitted must support medical necessity consistent with the policy rationale and plan rules.

Documentation should align with the medical necessity rationale used by the Health Plan.
Policy is a guide and does not guarantee payment; follow plan-level administrative policies.

Denial Risk

Requests outside policy criteria are at risk for non‑coverage

Requests for screening tests that do not meet the policy criteria are at risk for non‑coverage; specifically, FIT‑DNA ordered for individuals under age 45 or for non‑average‑risk individuals, and urinary, blood‑based colorectal, blood‑based lung, or MCED screening tests ordered outside policy criteria should be handled per policy (likely not supported).

FIT‑DNA is only medically necessary for average‑risk individuals aged ≥45; ordering outside these criteria risks denial.
Urinary biomarker tests for precancerous polyps are not supported for all indications.
Blood‑based CRC and lung biomarker tests and MCED tests are not supported for routine screening per current evidence/guidelines.

Denial Risk

Unsupported blood‑based lung or MCED tests may lead to denial

Use of blood‑based biomarker lung cancer screening tests or multi‑cancer early detection (MCED/MCD) tests may be unsupported for coverage and subject to denial when professional society guidelines (e.g., NCCN, NCI, USPSTF) do not recommend them or evidence is insufficient.

NCCN (Lung Cancer Screening v1.2025) does not include a recommendation for blood‑based or micro‑RNA lung cancer screening.
NCI notes no large trials showing MCD tests reduce cancer mortality and no professional societies currently recommend MCD tests for screening.

Distinct from FIT aloneFIT-DNA includes DNA biomarker analysis in addition to fecal immunochemical testing

Fecal immunohistochemical testing (FIT)

DefinitionScreening test for colon cancer that detects human blood in the lower intestines (FIT testing alone does not involve genetic testing).

ScopeFIT alone is outside the scope of this policy

MethodUses antibodies to detect blood in the stool

FIT-DNA testing (combination definition)

DefinitionCombination of the fecal immunochemical test (FIT) with a test that detects abnormal DNA from cancer or polyp cells in the stool.

ComponentsIncludes both antibody-based blood detection (FIT) and stool DNA biomarker analysis

Intended useScreening for colorectal cancer in average-risk individuals aged >=45 years when other criteria are met

Close relatives (degree definitions)

First-degree relativesParents, siblings, and children

Second-degree relativesGrandparents, aunts, uncles, nieces, nephews, grandchildren, and half siblings

Third-degree relativesGreat grandparents, great aunts, great uncles, great grandchildren, and first cousins

Revision including addition of G0327 and G0328 to Blood-based Biomarker Colorectal Cancer Screening Tests in the policy reference table; updates to overview, coding, reference table, background and references; semi-annual review noted.

2023-03policy_developmentLatest

Policy developed and approved (Revision Date = 03/23; Approval Date = 03/23) with semi-annual review established and title updated to reflect V1.2024; overview, coding, reference-table, background and references updated.