CurrentCommunity Health Plan WashingtonPolicy N/A

CONCERT Genetic Testing Oncology: Cancer Screening and Surveillance

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This policy governs the medical necessity and coverage criteria for genetic and biomarker tests used to screen for specific cancers (including colorectal, lung, and multi-cancer early detection) for insured members, addressing average- and increased-risk individuals.

Policy Summary

PayerCommunity Health Plan Washington

PolicyCONCERT Genetic Testing Oncology: Cancer Screening and Surveillance

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionWhen ordering FIT‑DNA (Cologuard), document age ≥45 and average‑risk status consistent with FDA labeling and guidelines.

SourceLink

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CurrentCommunity Health Plan WashingtonPolicy N/A

CONCERT Genetic Testing Oncology: Cancer Screening and Surveillance

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Sign up for all Community Health Plan Washington policy alerts

Know when Community Health Plan Washington releases new policies or updates existing guidance.

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Policy Summary

PayerCommunity Health Plan Washington

PolicyCONCERT Genetic Testing Oncology: Cancer Screening and Surveillance

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionWhen ordering FIT‑DNA (Cologuard), document age ≥45 and average‑risk status consistent with FDA labeling and guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Covered with criteriaFIT‑DNA (stool DNA) screening stance

Insufficient evidenceBlood‑based CRC tests

Insufficient evidenceUrinary biomarker tests

Insufficient evidenceMulti‑cancer early detection

Codes listedCoding examples included

No recommendationNCCN lung screening stance

Coverage and Medical Necessity Criteria

FIT‑DNA Medical Necessity

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

Age requirement: Member is 45 years of age or olderage >=45

Per policy age criterion and FDA/NCCN-aligned labeling

Average-risk status (no disqualifying personal history): Member does NOT have any of the following personal history conditions: colorectal cancer, adenoma, sessile serrated polyp, inflammatory bowel disease (ulcerative colitis or Crohn's disease), cystic fibrosis, confirmed or suspected hereditary colorectal cancer syndrome (e.g., FAP, Lynch syndrome), or prior abdominal/pelvic radiationabsence of listed high-risk conditions

These personal-history conditions exclude FIT‑DNA screening; see policy list

Average-risk status (no disqualifying family history): Member does NOT have a family history of colorectal cancer in close relatives or close relatives with advanced precancerous polypsabsence of listed high-risk conditions

Family-history exclusions per policy

No symptoms suspicious for undiagnosed CRC: Member does NOT have symptoms suspicious for colorectal cancer (e.g., rectal bleeding, iron deficiency anemia, abdominal pain, weight loss)absence of listed symptoms

FIT‑DNA is for screening of asymptomatic, average-risk individuals; symptomatic patients require diagnostic evaluation

Urinary biomarker tests

Urinary biomarker tests for precancerous colon polyps:

Urinary biomarker stance: Current evidence does not support the use of urinary biomarker tests for precancerous colon polyps for any screening indicationsN/A

Considered unsupported by current evidence and not medically necessary for screening

Blood‑based CRC tests

Blood‑based biomarker colorectal cancer screening tests:

Blood-based CRC tests stance: Current evidence does not support the use of blood-based biomarker tests to screen for colorectal cancer for screening indicationsN/A

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

Blood‑based lung cancer tests

Blood‑based biomarker lung cancer screening tests:

Blood-based lung tests stance: Current evidence does not support use of blood-based biomarker tests (including micro‑RNA based assays) for lung cancer screening for any indicationsN/A

NCCN does not include a recommendation for blood-based or micro‑RNA lung cancer screening and Concert notes insufficient evidence; not recommended for screening

Multi‑Cancer Early Detection tests

Multi‑Cancer Early Detection (MCED) screening tests:

MCED stance: Current evidence does not support use of multi‑cancer early detection screening tests for screening indicationsN/A

No large clinical trials demonstrate that MCD/MCED tests reduce cancer mortality and no professional societies (including USPSTF) have issued recommendations for use in population screening

Screening and tumor marker testing coverage stance

Summary of coverage stance from cited guideline and evidence statements

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

See NCCN and Concert commentary on lung cancer screening tests

Multi-cancer early detection (MCD) tests: The National Cancer Institute states there are no large clinical trials showing that MCD/MCED tests reduce cancer mortality; no professional societies have issued recommendations for MCD tests for screening.

Evidence insufficiency supports non-coverage for routine screening

CA-125 tumor marker testing: NCCN recommends consideration of CA‑125 testing in specific diagnostic/evaluation contexts (peritoneal mesothelioma with signs/symptoms such as recurrent ascites or peritoneal thickening/masses; initial evaluation of uterine neoplasms; appendiceal adenocarcinoma evaluation; occult primary with peritoneal presentation or ascites).

These are diagnostic/evaluation indications rather than population screening

The policy identifies several tests as having insufficient evidence to support use for population screening and therefore not appropriate for coverage for screening indications. Specifically, urinary biomarker tests for precancerous colon polyps are stated as unsupported by current evidence (see policy statement). Similarly, blood-based colorectal cancer biomarker tests (examples named in the evidence review such as BeScreened, FirstSight CRC, ColonSentry, Epi proColon, Colovantage, ColoScape, and Guardant Shield) have been judged to have insufficient peer-reviewed evidence demonstrating improved health outcomes compared with standard of care. Multi-cancer early detection (MCED) assays are also noted as lacking evidence to support routine screening use. These tests are at risk for denial when submitted for routine screening because the available evidence does not demonstrate benefit for screening indications.

Multi-Cancer Early Detection (MCED) tests for routine population screening are not supported by evidence of mortality benefit; the National Cancer Institute reports no large clinical trials showing MCED tests reduce cancer mortality, and no major professional societies (including USPSTF) have issued recommendations for their use in screening. In parallel, NCCN guidance and Concert evidence reviews do not endorse blood-based microRNA or other blood-based approaches for lung cancer screening, citing insufficient evidence to recommend these modalities.

Summary of unsupported screening uses: urinary biomarker assays intended to detect precancerous colorectal polyps lack supportive evidence and are not recommended for screening; blood-based biomarkers for colorectal cancer similarly lack sufficient peer-reviewed data showing improved outcomes and are not supported for screening; blood-based tests proposed for lung cancer screening, including micro-RNA based assays, are not recommended by NCCN and lack adequate evidence; and multi-cancer early detection (MCED) tests have no demonstrated mortality benefit or professional society endorsement for population screening. Collectively, these uses are treated as not medically necessary for routine screening in asymptomatic individuals.

Guideline-based recommendations cited in the policy indicate NCCN does not include a recommendation for blood-based or micro-RNA based lung cancer screening in current lung screening guidance, and Concert notes insufficient evidence to support such testing. For multi-cancer early detection tests, the NCI states there are no large trials showing reduced cancer mortality, and no professional societies (including USPSTF) have issued recommendations endorsing MCED tests for screening; therefore routine use for population screening is not supported by guideline recommendations.

Indications Considered Covered

FIT‑DNA stool testing for average‑risk colorectal cancer screening in individuals aged 45 and older

FIT‑DNA stool testing for average‑risk colorectal cancer screening in individuals aged 45 and older — coverage conditions and exclusions:

Coverage indication: FIT‑DNA (stool DNA) may be used for colorectal cancer screening when the member is 45 years of age or older and is average risk for colorectal cancerage >=45; average risk

Coverage requires absence of listed high‑risk personal or family history conditions

Exclusion — personal history: Not covered for individuals with a personal history of colorectal cancer, adenoma, sessile serrated polyp, inflammatory bowel disease, cystic fibrosis, confirmed/suspected hereditary colorectal cancer syndrome, or prior abdominal/pelvic radiationpresence of any listed high-risk condition

These conditions disqualify average‑risk screening use

Services and Tests Not Covered

Not covered: The policy explicitly excludes coverage for screening indications of several tests due to insufficient evidence. Examples include urinary biomarker tests for precancerous colon polyps, which the document states are not supported for screening use; blood-based colorectal cancer biomarker screening tests, which the Concert evidence review found to have insufficient evidence of improved health outcomes; and blood-based lung cancer screening tests. In addition, multi-cancer early detection tests are not supported for routine population screening because there is no evidence from large clinical trials demonstrating a mortality benefit and no societal endorsements.

Not covered: The policy states that blood-based biomarker lung cancer screening tests are not supported by current guidelines (NCCN) and that evidence is insufficient to support their use for screening. Likewise, multi-cancer early detection (MCED) screening tests are not supported for routine population screening because the NCI has found no large trials demonstrating a reduction in cancer mortality and no professional society recommendations exist to endorse their use.

Example Codes and Coding Guidance

Example/Listed screening CPT/HCPCS and diagnosis codesmixed

81528	Cologuard (stool DNA test) example
0464U	ColoGuardPlus example
0002U	PolypDx (urinary biomarker) example
0091U	FirstSight (CellMax Life) example
0163U	BeScreened-CRC example
0368U	ColoScape Colorectal Cancer Detection example
0453U	ColonAiQ example
81327	Listed blood-based biomarker/common billing
81479	Unlisted molecular pathology/procedure code used for some tests
81599	Unlisted molecular pathology procedure code

1–10 of 13

1/2

Cancer Screening Tests: added codesHCPCS

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

inv-13: Age for FIT‑DNA screening — age threshold value

Age threshold>= 45 years

Policy citationFIT‑DNA medically necessary when member is 45 years of age or older

Alignment noteAge criterion aligns with FDA label expansion and NCCN guidance referenced in policy

inv-14: Symptoms suspicious for colorectal cancer — example presenting symptoms to guide diagnostic coding

Example presenting symptomsRectal bleeding

Additional examplesIron deficiency anemia; abdominal pain; weight loss

Provider Responsibilities and Prior Authorization

Prior Authorization

Follow payer prior authorization for listed CPT/HCPCS

Specified laboratory tests and example CPT/HCPCS codes (e.g., 81528, 0464U, 0002U, 0091U, 0163U, 0368U, 0453U, 81327, 81479, 81599, G0327) are listed in the policy; providers should follow the payer's prior authorization processes and obtain authorization when required before billing these codes.

Examples of listed codes include FIT‑DNA (Cologuard) 81528/0464U and various blood‑ and urine‑based test codes (0002U, 0091U, 0163U, 0368U, 0453U, 81327, 81479, 81599, G0327).
Follow payer-specific prior authorization rules before ordering or billing these tests.

Prior Authorization

Obtain prior authorization for added blood‑based CRC screening codes

Certain blood‑based colorectal biomarker screening codes added to the policy reference table (for example G0327, G0328) may require prior authorization; obtain authorization when billing these HCPCS codes.

Added/reference HCPCS codes include G0327 and G0328 for blood‑based biomarker CRC screening.

Member Eligibility and Policy Scope

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

Background and Policy Scope

Background: This policy addresses genetic and biomarker screening tests intended to detect cancer in asymptomatic individuals at average or increased risk. It distinguishes established screening modalities (for example, FIT-DNA stool testing when used in individuals aged ≥45 years who are average risk) from tests that lack sufficient evidence for screening use (including urinary biomarkers for precancerous polyps, many blood-based colorectal and lung biomarkers, and multi-cancer early detection assays). Professional guidance from NCCN, FDA approvals for specific products (e.g., Cologuard), and Concert/NCI evidence assessments inform the policy's coverage positions.

Definitions

inv-25: Average risk — definition for colorectal cancer average-risk

DefinitionAverage risk for colorectal cancer = absence of listed high‑risk personal or family history conditions (e.g., no personal history of colorectal cancer, adenoma/sessile serrated polyp, IBD, cystic fibrosis, hereditary CRC syndrome, prior abdominal/pelvic radiation, or family history in close relatives)

ImplicationOnly individuals meeting average‑risk definition are eligible for FIT‑DNA screening per policy

ExclusionsPresence of symptoms suspicious for CRC or documented high‑risk conditions disqualify average‑risk status

inv-26: FIT‑DNA — definition (stool DNA testing)

TermFIT‑DNA (stool DNA testing)

DescriptionStool DNA test used to screen for colorectal cancer; policy addresses use of FIT‑DNA for average‑risk individuals aged ≥45

Policy Revision History

04/24revision

Semi-annual review with minor rewording for clarity; updated title to reflect V1.2025 version and updated coding, reference table, background, and references.

11/24revision

Semi-annual review: updated Blood-based Biomarker Lung Cancer Screening Tests (NCCN version) and approval date recorded.

03/23creation

Policy developed and approved; semi-annual review noted with updates to title (V1.2024), overview, coding, reference table, background and references.

Policy Summary

PayerCommunity Health Plan Washington

PolicyCONCERT Genetic Testing Oncology: Cancer Screening and Surveillance

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionWhen ordering FIT‑DNA (Cologuard), document age ≥45 and average‑risk status consistent with FDA labeling and guidelines.

SourceLink

On This Page

Exclusion — family history: Not covered for individuals with a family history of colorectal cancer in close relatives or close relatives with advanced precancerous polypspresence of family-history risk

FIT‑DNA is intended for average‑risk individuals only

Exclusion — symptomatic individuals: Not covered for individuals with symptoms suspicious for undiagnosed colorectal cancer (e.g., rectal bleeding, iron deficiency anemia, abdominal pain, weight loss); symptomatic persons should undergo diagnostic evaluation rather than screening FIT‑DNApresence of symptoms

Policy distinguishes screening from diagnostic indications

Use of CA-125 testing in evaluation of suspected peritoneal mesothelioma, uterine neoplasms initial evaluation, appendiceal adenocarcinoma evaluation, and occult primary with peritoneal presentation or ascites

Use of CA‑125 testing — diagnostic/evaluation contexts (not routine population screening):

Peritoneal mesothelioma: Consider CA‑125 testing when there are signs or symptoms of peritoneal mesothelioma (e.g., recurrent ascites, peritoneal thickening or masses)

NCCN recommends consideration in symptomatic contexts

Uterine neoplasms initial evaluation: Consider CA‑125 testing during initial evaluation of uterine neoplasms

NCCN guidance supports consideration in this diagnostic context

Appendiceal adenocarcinoma evaluation: Consider CA‑125 testing in individuals with appendiceal adenocarcinoma, especially if CEA and CA‑19‑9 are normal

NCCN guidance cites CA‑125 usefulness in this setting

Occult primary with peritoneal presentation or ascites: Consider CA‑125 testing for adenocarcinoma or carcinoma not otherwise specified in patients with a uterus and/or ovaries presenting with peritoneal disease or ascites

NCCN recommends CA‑125 in this diagnostic scenario; documentation of clinical context is advised

UseSymptoms listed are considered suspicious for undiagnosed colorectal cancer and exclude average‑risk FIT‑DNA screening

Confirm prior authorization requirements for these specific codes with the payer prior to ordering.

Step Therapy

Step therapy not specified

Step therapy requirements are not specified in this section of the policy; there are no step‑therapy mandates described for the covered tests.

Policy text states step therapy is not specified for these screening tests.

Documentation Required

Document age and average‑risk status for FIT‑DNA

When ordering FIT‑DNA (Cologuard), documentation must support that the patient meets age and average‑risk criteria consistent with FDA labeling and NCCN guidance (e.g., age ≥45 and absence of listed high‑risk personal or family history).

Document patient age (≥45) consistent with FDA label expansion for Cologuard.
Document absence of high‑risk conditions (no personal history of CRC/advanced polyps, IBD, hereditary CRC syndrome, relevant family history) to establish average‑risk status.

Documentation Required

Document clinical signs/symptoms when ordering CA‑125

When ordering tumor marker testing such as CA‑125, document relevant signs, symptoms, and clinical context (for example recurrent ascites or peritoneal thickening/masses) to support use in the indicated diagnostic contexts.

Document specific signs/symptoms (e.g., recurrent ascites, peritoneal masses) when evaluating for peritoneal mesothelioma, uterine neoplasms, appendiceal adenocarcinoma, or occult primary with peritoneal presentation.
Record clinical rationale referencing guideline‑recommended diagnostic contexts rather than using CA‑125 for routine population screening.

Denial Risk

Unsupported tests may be denied

Tests that lack supporting evidence for screening indications (including urinary biomarkers for precancerous colon polyps; blood‑based colorectal and lung biomarker screening tests; and multi‑cancer early detection tests) are considered unsupported by current evidence and are at risk for denial.

Urinary biomarker tests for precancerous colon polyps: current evidence does not support use for screening.
Blood‑based biomarker colorectal and lung screening tests: current evidence does not support use for screening; NCCN does not recommend blood‑based lung screening.
Multi‑cancer early detection (MCD/MCED) tests: no large trials show mortality reduction; no professional society recommendations.

Denial Risk

MCED/MCD tests lack evidence — denial risk

Multi‑cancer detection (MCD/MCED) tests lack evidence of mortality benefit and have no professional society recommendations for routine screening; use for general cancer screening may be denied as not supported by evidence.

NCI reports there are no large clinical trials showing MCD tests reduce cancer mortality.
No professional medical societies (including USPSTF) have issued recommendations for MCD tests for screening.

Denial Risk

Blood‑based lung screening tests are at high denial risk

Blood‑based biomarker lung cancer screening tests are not recommended by NCCN and Concert notes insufficient evidence; ordering these blood‑based lung screening tests for routine screening may be denied.

NCCN lung cancer screening guidelines do not include a recommendation for blood‑based or micro‑RNA based screening.
Concert evidence review notes insufficient evidence to support use.

Prior Authorization

Ensure FIT‑DNA ordering aligns with FDA label and guidelines

Order and use of FIT‑DNA must align with FDA labeling and clinical guideline age/indication criteria; ensure documentation shows the patient is age ≥45 and meets average‑risk screening criteria before ordering or billing FIT‑DNA.

FDA approved Cologuard and expanded its label to include adults aged 45 and older; FIT‑DNA is not a substitute for diagnostic or surveillance colonoscopy in high‑risk individuals.
NCCN recommends FIT/FIT‑DNA for average‑risk individuals aged 45–75 and specifies symptoms that warrant diagnostic colonoscopy instead of screening.

Coverage noteFIT‑DNA covered when age and average‑risk criteria are met

inv-27: FIT — fecal immunohistochemical test definition and note

TermFIT (fecal immunohistochemical test)

DefinitionScreening test for colon cancer that detects human blood in the lower intestines

Policy scope noteFIT testing alone is outside the scope of this policy

inv-28: FIT-DNA — combined FIT and stool DNA testing definition

TermFIT‑DNA testing (combined FIT and stool DNA)

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

UsageDescribed in policy as the stool DNA modality considered for average‑risk screening when criteria are met

inv-29: Close relatives — definition including first-, second-, third-degree relatives and examples

DefinitionClose relatives include first‑, second‑, and third‑degree blood relatives

First‑degree examplesParents, siblings, and children

Second‑degree examplesGrandparents, aunts, uncles, nieces, nephews, grandchildren, half‑siblings

Third‑degree examplesGreat‑grandparents, great aunts/uncles, great grandchildren, first cousins

10/23revision

Semi-annual review: updated title to reflect V1.2024 version; added G0327 and G0328 to Blood-based Biomarker Colorectal Cancer Screening Tests in Policy Reference Table.

03/23revision

Semi-annual review and approval entries recorded (policy developed and approved in 03/23); updated overview, coding, reference table, background and references.

04/24approval

Approval recorded for updates made during 04/24 semi-annual review (title updated to V1.2025 version and minor rewording for clarity).

11/24approval

Approval recorded for updates to Blood-based Biomarker Lung Cancer Screening Tests and related sections (11/24 semi-annual review).

12/25approvalLatest

Approval recorded for annual review and updates including adding requirement that FIT-DNA criteria exclude individuals with symptoms suspicious for undiagnosed colorectal cancer and adding Multi-Cancer Early Detection section.