CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Blood-based colorectal cancer screening tests (SEPT9, gene expression, BeScreened, G0327)

Defines coverage and prior authorization expectations for blood-based colorectal cancer screening tests (including SEPT9 methylation assays, gene expression profiling, BeScreened-CRC, and HCPCS G0327) for BCBSRI Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBlood-based colorectal cancer screening tests (SEPT9, gene expression, BeScreened, G0327)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Unlisted CPT services and for tests billed to Medicare Advantage; verify member benefits before ordering.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1HCPCS covered (G0327)

3Tests not covered/NMN

Epi proColon 2016FDA/regulatory note

Sens 48% / Spec 92%Key performance

ListedRelated policies

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Coverage and Medical Necessity

Coverage stance by product

Coverage and medical necessity stance differs by product:

Medicare Advantage - Covered: HCPCS G0327 (colorectal cancer screening; blood-based biomarker) is covered as an appropriate colorectal cancer screening test for Medicare Advantage Plans.

See Preventive Services for Medicare Advantage Plans and related CMS guidance.

Medicare Advantage - Not covered tests: The currently available Epi proColon test and the following tests are not covered because evidence is insufficient to demonstrate improved net health outcomes: BeScreened-CRC (0163U); gene expression profiling tests (eg, ColonSentry; use Unlisted CPT); and SEPT9 promoter methylation analysis (eg, 81327/ColoVantage).

BCBSRI follows CMS national and local coverage determinations for Medicare Advantage Plans; specific Medicare guidance may supersede Commercial policy.

Commercial Products - Not medically necessary: For Commercial Products, blood-based colorectal cancer screening biomarker testing (G0327), gene expression profiling (Unlisted CPT), SEPT9 methylation assays (eg, 81327), and BeScreened-CRC (0163U) are considered not medically necessary due to insufficient evidence of improved net health outcomes.

Some genetic testing services may be contract exclusions for self-funded groups per the Biomarker Testing Mandate; verify member-specific benefits.

Some genetic testing services may be subject to contract exclusions for self-funded groups that have opted out of expanded biomarker coverage under the state Biomarker Testing Mandate. Providers should consult the member's benefit booklet or the related Genetic Services and Proprietary Laboratory Analyses policies to determine whether a specific test is a covered benefit, covered with authorization, not medically necessary, or excluded by contract.

Services determined to be not medically necessary or that are non-covered benefits are excluded from coverage. Providers may not bill members for such services unless the member has been informed and has provided written consent in advance. Verify benefits and eligibility using the member's subscriber agreement or employer agreement and contact the provider call center for member-specific determinations.

The policy identifies specific blood-based colorectal cancer tests that are considered not covered / not medically necessary for applicable products: BeScreened-CRC (CPT 0163U), gene expression profiling tests (Unlisted CPT codes, e.g., ColonSentry), and SEPT9 promoter methylation assays (CPT 81327 or vendor-specific assays). Additionally, HCPCS G0327 is handled differently by product (see coding); consult the Coding section for the Medicare Advantage coverage designation.

Services described in this policy as not medically necessary (NMN) are excluded from coverage and therefore will not be paid. The policy text lists specific tests as NMN/not covered where applicable; if no test-level NMN statement is present elsewhere in the policy for a given assay, providers must rely on the general NMN exclusion language and benefit verification to determine coverage for that service.

Billing Codes and Status

Covered HCPCS for Medicare AdvantageHCPCSCovered

G0327

Colorectal cancer screening; blood-based biomarker

BeScreened-CRCCPTNot Covered

0163U

BeScreenedTM_CRC test (Oncology (colorectal) screening, biochemical enzyme-linked immunosorbent assay (ELISA) of 3 plasma or serum proteins with proprietary algorithm)

SEPT9 / methylation analysisCPTNot Covered

81327

SEPT9 (Septin9) promoter methylation analysis

Unlisted CPT testsCPT

Unlisted CPT

Used for tests without assigned CPT codes (eg, gene expression profiling like ColonSentry)

Referenced CMS molecular pathology/LCD resourcesmixed

No codes listed

Authorization, Billing, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage members and for any services billed with an Unlisted CPT code so the rendered service can be identified and coverage determined. Participating providers should obtain prior authorization via the BCBSRI online tool (Medicare Advantage: required; Commercial: recommended).

Unlisted CPT codes always require authorization to determine medical necessity and coverage.
Medicare Advantage: prior authorization required.
Commercial products: prior authorization recommended; verify plan requirements.

Note

Prior Authorization and Benefit Verification

Providers must verify member-specific benefits and eligibility before providing services. Contact the BCBSRI provider call center or check the member’s subscriber agreement / certificate and employer agreement to confirm coverage, prior authorization requirements, and any member cost-sharing.

Verify benefits and eligibility for the specific plan and service.

Clinical Background and Test Context

Blood-based colorectal cancer screening tests detect tumor-derived DNA or measure gene/protein expression in blood and have been proposed as less invasive screening options to increase uptake. However, performance varies by assay and is generally considered inferior or insufficiently validated compared with established screening modalities (eg, fecal immunochemical testing and colonoscopy). For these reasons, current evidence has been judged insufficient to demonstrate improved net health outcomes for many of the commercially available blood-based assays, and coverage determinations differ by product type (Medicare Advantage versus Commercial).

Test Definitions and Abbreviations

SEPT9 (Septin9) methylated DNA — key details

Test typePCR-based blood tests that detect methylated Septin9 (SEPT9) DNA shed into the bloodstream by colorectal cancers (eg, ColoVantage, Epi proColon).

Regulatory statusEpi proColon (Epigenomics) received FDA approval in April 2016; Septin 9 technology has been licensed to other manufacturers (Polymedco, LabCorp).

Assay variabilityPerformance characteristics vary across commercially available SEPT9 assays likely due to methodological differences (DNA preparation, PCR primers, probes).

Gene expression profiling (ColonSentry, BeScreened-CRC) — key details

Assay descriptionsColonSentry: PCR-based blood test measuring expression of 7 genes (ANXA3, CLEC4D, TNFAIP6, LMNB1, PRRG4, VNN1, IL2RB); BeScreened-CRC: PCR assay detecting 3 protein biomarkers (TDGF-1/Cripto-1, carcinoembryonic antigen, and an extracellular matrix protein).

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBlood-based colorectal cancer screening tests (SEPT9, gene expression, BeScreened, G0327)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Unlisted CPT services and for tests billed to Medicare Advantage; verify member benefits before ordering.

SourceLink

On This Page

Confirm whether prior authorization was approved and document the authorization number before performing the service.

Documentation Required

Ordering Physician Must Obtain Authorization

The ordering physician is responsible for obtaining prior authorization. Laboratories, third parties, or other entities may not obtain authorizations or initiate appeals on behalf of the ordering physician. If a laboratory or third party is found to have supported any portion of the authorization process or appeal in violation of this requirement, BCBSRI may take actions up to termination from the provider network.

Only the ordering physician (or their authorized office staff acting under the physician) may request authorizations or submit appeals.
If a laboratory provides a service without required authorization, BCBSRI will deny the service and the laboratory may be held financially liable and may not bill the member.

Denial Risk

Member Billing and Denial Risk

If services are determined to be not medically necessary or are non-covered benefits, providers may not bill the member unless the member was informed in advance and provided written agreement to accept financial responsibility. Benefits and eligibility are determined by the member’s subscriber agreement, certificate, and/or employer agreement; those documents supersede this policy.

Do not charge members for services determined not medically necessary or non-covered unless there is prior written member consent.
Refer to the participation agreement for billing provisions and consult the member’s benefit documents for coverage determinations.

Designed to stratify average-risk adults who are non-compliant with colonoscopy or fecal testing to assess colorectal cancer risk.

Clinical impactBecause of their narrow target population (eg, screening non‑compliant patients), these assays are not expected to change management for patients already compliant with recommended screening.

methylated SEPT9 (mSEPT9) — definition and evaluation context

DefinitionA blood-based DNA methylation assay that detects methylation of the SEPT9 gene promoter region (mSEPT9) evaluated for colorectal cancer screening and detection.

Evidence baseMultiple prospective studies and meta-analyses have evaluated mSEPT9 diagnostic accuracy for colorectal cancer (see cited systematic reviews and prospective evaluations).

Performance considerationsQuantitative measurement and assay method influence detection performance; published studies report variable sensitivity and specificity across assays.

PLA / MAAA — definition

DefinitionProprietary Laboratory Analyses (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA) are laboratory tests that combine multiple analytes with an algorithm to generate a diagnostic or risk score.

CharacteristicsThese tests typically integrate results from several biomarkers (eg, proteins, gene expression, methylation) and apply an algorithmic model to produce a reportable result.

Policy contextPLA/MAAA tests are subject to evaluation of clinical validity and utility; coverage depends on evidence showing improvement in net health outcomes.