CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Serologic Genetic and Molecular Screening for Colorectal Cancer

Defines medical coverage and authorization requirements for blood-based (serologic) genetic and molecular screening tests for colorectal cancer for Blue Cross Blue Shield - Rhode Island products, distinguishing Medicare Advantage and Commercial product policies and coverage stances.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySerologic Genetic and Molecular Screening for Colorectal Cancer

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization for the BeScreened™-CRC test under Medicare Advantage Plans.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3named tests discussed

2product lines

3billing codes listed

1prior auth tests

Coverage Criteria

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Product-specific coverage decisions

Coverage determinations vary by product (Medicare Advantage vs Commercial).

Medicare Advantage - BeScreened™-CRC: BeScreened™-CRC test may be considered medically necessary when the Medicare Advantage Plans medical necessity criteria is used for review (see Medical Necessity policy). Prior authorization is required.see Medical Necessity policy

Refer to the Medical Necessity policy for specific clinical criteria and documentation requirements.

Medicare Advantage - Other blood-based tests: SEPT9 methylated DNA testing (eg, ColoVantage®, Epi proColon®) and other blood-based biomarker tests are covered and may be considered medically necessary when the medical criteria in the Medical Necessity policy are met. Some blood-based tests are covered without an authorization requirement.per Medical Necessity policy

Epi proColon has FDA approval; coverage may not require prior authorization for certain tests.

Commercial Products - Not medically necessary: For Commercial Products, SEPT9 methylated DNA testing (eg, ColoVantage®, Epi proColon®), gene expression profiling (eg, ColonSentry®), and BeScreened™-CRC are considered not medically necessary due to insufficient evidence of improvement in net health outcomes.not medically necessary

Benefits may vary by contract; refer to the Benefit Booklet or Evidence of Coverage.

For Commercial Products, the listed blood‑based colorectal cancer screening tests are considered not medically necessary. Benefits and coverage may vary by group contract; providers should refer to the member’s Benefit Booklet, Evidence of Coverage, or Subscriber Agreement for plan‑specific determinations.

Covered Indications

Average-risk adults for colorectal cancer screening who are non-compliant with standard screening

Covered indication for blood-based colorectal cancer screening tests (product-dependent):

Intended population: Average-risk adults for colorectal cancer screening who are non-compliant with standard screening modalities (eg, colonoscopy, sigmoidoscopy, fecal tests).

Medicare Advantage coverage: For Medicare Advantage Plans, blood-based tests (including BeScreened™-CRC when medical criteria are met) may be considered medically necessary per the Medical Necessity policy; SEPT9 methylated DNA testing and other blood-based biomarker tests are covered and some are covered without prior authorization.

Prior authorization is required for BeScreened™-CRC under Medicare Advantage.

Commercial Products - exclusion: For Commercial Products, blood-based tests listed (SEPT9 methylated DNA testing, gene expression profiling such as ColonSentry, and BeScreened™-CRC) are not covered as they are considered not medically necessary due to insufficient evidence.

Coding / Billing Codes

Covered CPT/HCPCS Codes (Medicare Advantage) / Not medically necessary for Commercial Productsmixed

81327	SEPT9 (Septin9) (eg, colorectal cancer) promoter methylation analysis
G0327	Colorectal cancer screening; blood-based biomarker

BeScreened™-CRC specific CPT (covered with criteria for Medicare Advantage; not medically necessary for Commercial)CPT

0163U

Oncology (colorectal) screening, biochemical ELISA of 3 plasma or serum proteins with demographic data using a proprietary algorithm, reported as likelihood of CRC or advanced adenomas (BeScreened™-CRC)

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for BeScreened™-CRC test under Medicare Advantage plans. Tests requiring prior authorization (e.g., BeScreened™-CRC) may be denied if prior authorization is not obtained.

Affected test: BeScreened™-CRC test

Documentation Required

Documentation Required for Medical Necessity

Medical necessity documentation per the Medical Necessity policy is required for Medicare Advantage coverage of BeScreened™-CRC and similar tests.

Follow Medical Necessity policy documentation requirements for BeScreened™-CRC

Step Therapy

No step therapy language specified.

Denial Risk

Denial Risk if Authorization Not Obtained

Tests requiring prior authorization for Medicare Advantage (BeScreened™-CRC) may be denied if prior authorization is not obtained; ensure authorization is obtained before performing or billing the test.

Potential denial condition: Lack of prior authorization for BeScreened™-CRC

Definitions

SEPT9 methylated DNA testing — PCR-based assays detecting methylated SEPT9 DNA (eg, ColoVantage, Epi proColon).

Test typePCR-based assays detecting methylated Septin9 (SEPT9) DNA in plasma/serum (eg, ColoVantage, Epi proColon)

Regulatory statusEpi proColon received FDA approval in April 2016

Performance notePerformance characteristics vary across assays due to methodological differences (DNA preparation, PCR primers/probes)

Examples / vendorsColoVantage (various laboratories such as ARUP, Quest, Clinical Genomics); Epi proColon (Epigenomics) — licensed to Polymedco and LabCorp

Gene expression profiling (ColonSentry) — PCR assay measuring expression of seven genes to stratify CRC risk.

Test typePCR assay measuring expression of seven genes to stratify colorectal cancer risk

Genes measuredANXA3, CLEC4D, TNFAIP6, LMNB1, PRRG4, VNN1, IL2RB

Intended useIntended to stratify average-risk adults who are non-compliant with colonoscopy and/or fecal occult blood testing

Clinical impact noteNot expected to alter care for patients who comply with recommended screening schedules due to narrow focus

BeScreened-CRC — PCR assay measuring expression of three protein biomarkers reported via a proprietary algorithm as likelihood of CRC.

Test typePCR assay detecting expression of three protein biomarkers reported via a proprietary algorithm

Biomarkers measuredTDGF-1 (Cripto-1), carcinoembryonic antigen (CEA), and an extracellular matrix protein involved in early tumor stroma changes

ReportingReported as likelihood of colorectal cancer or advanced adenomas using a proprietary algorithm (BeScreened™-CRC)

Coverage noteBeScreened™-CRC has specific CPT code (0163U) and coverage varies by product (covered with criteria for Medicare Advantage; not medically necessary for Commercial)

Background

Early detection of colorectal cancer reduces disease‑related mortality. Established screening modalities include colonoscopy, sigmoidoscopy, and fecal‑based tests; blood‑based assays (for example, SEPT9 methylated DNA tests, gene expression panels, and multivariate protein biomarker assays) have been proposed as simpler alternatives to improve screening uptake among average‑risk individuals who are non‑compliant with standard screening. Evidence and performance of these blood‑based assays vary by test and are insufficient to support coverage in Commercial Products.

Revision History

2022-01-01effective_date

Policy became effective.

2022-03-08last_review

Policy last reviewed on this date per internal records.

2022-08-03policy_updateLatest

Policy was updated (policy last updated date).