CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Serologic Genetic and Molecular Screening for Colorectal Cancer

Policy governs coverage and medical necessity determinations for blood-based serologic genetic and molecular tests for colorectal cancer screening for BCBSRI members, distinguishing Medicare Advantage and Commercial product stances.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySerologic Genetic and Molecular Screening for Colorectal Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective Date09|01 2023

Next Review DateN/A

Key ActionObtain prior authorization for Medicare Advantage and use an Unlisted CPT when no specific CPT exists; ordering physician must request authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3tests addressed

Medicare vs Commercialproduct stance

Covered G0327G0327 status

Not covered 8132781327 status

48%Epi proColon sensitivity

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage criteria and determinations

Coverage by product type

Coverage stance differs by product:

Medicare Advantage: HCPCS G0327 (Colorectal cancer screening; blood-based biomarker) is covered for Medicare Advantage Plans.

Medicare Advantage policies follow CMS NCD/LCD guidance; benefits may differ from Commercial products and may be greater than what is allowed by CMS.

Commercial Products: For Commercial Products, HCPCS G0327 (blood-based biomarker colorectal cancer screening) is stated as not medically necessary; specific tests listed as not medically necessary include BeScreened-CRC (CPT 0163U), SEPT9 methylated DNA testing (CPT 81327), and gene expression profiling (eg, ColonSentry — Unlisted CPT).

Prior authorization is recommended for Commercial Products.

The policy explicitly lists examples of tests that are not covered / not medically necessary in the provided excerpt. These include the BeScreenedTM_CRC test (CPT 0163U), SEPT9 methylated DNA testing (CPT 81327, e.g., ColoVantage or Epi proColon), and gene expression profiling tests (e.g., ColonSentry reported using an Unlisted CPT).

This excerpt does not present an exhaustive exclusions list. Coverage and benefit determinations are governed by the member’s subscriber agreement, member certificate, and/or employer agreement, which supersede this policy; providers should verify member-specific benefits with the provider call center.

Coverage varies by product. For Medicare Advantage Plans, HCPCS G0327 (colorectal cancer screening; blood-based biomarker) is listed as covered, while specific tests such as BeScreened (CPT 0163U), SEPT9 (CPT 81327), and gene expression profiling (Unlisted CPT) are called out as not covered where evidence is insufficient. For Commercial Products, the excerpt states that HCPCS G0327 and the same listed tests (CPT 0163U, CPT 81327, and gene expression profiling via Unlisted CPT) are considered not medically necessary due to insufficient evidence.

The policy notes that if services are determined to be not medically necessary (or are medically necessary but are non-covered benefits under the member agreement), such services may be treated as non-covered and may result in claim denial; members should not be billed unless they were informed and agreed in writing to assume financial responsibility in advance.

Covered indications

Blood-based biomarker colorectal cancer screening (HCPCS G0327) for Medicare Advantage enrollees

Covered as an appropriate colorectal cancer screening test for Medicare Advantage enrollees:

Required: Test is billed with HCPCS code G0327 (Colorectal cancer screening; blood-based biomarker).

No prior authorization is required for the covered G0327 test in Medicare Advantage Plans per policy statement.

Program alignment: Test use follows Medicare Advantage plan requirements and CMS national or local coverage determinations (NCD/LCD).

Refer to Preventive Services for Medicare Advantage Plans for screening schedule and eligibility.

Detection/screening using blood-based DNA methylation markers (mSEPT9)

Detection/screening using blood-based DNA methylation markers (mSEPT9) — references noted:

Not covered / not medically necessary services

Tests explicitly listed in the policy excerpt as not covered / not medically necessary include: BeScreenedTM_CRC (CPT 0163U), SEPT9 methylated DNA testing (CPT 81327), and gene expression profiling tests such as ColonSentry (billed with an Unlisted CPT). Additionally, the policy notes HCPCS G0327 as a covered code for Medicare Advantage but indicates differing stances for Commercial products.

An alternate excerpt of the policy indicates that this portion does not explicitly list tests or indications as not covered. Regardless, benefits and coverage remain subject to the member’s subscriber agreement or employer agreement, and providers should confirm eligibility and benefits for each member.

Coding and billing codes

Covered HCPCS (Medicare Advantage)HCPCSCovered

G0327

Colorectal cancer screening; blood-based biomarker

Not covered / not medically necessary CPTCPTNot Covered

81327

SEPT9 (Septin9) promoter methylation analysis

Not covered / not medically necessary CPT (BeScreened-CRC)CPTNot Covered

0163U

Oncology (colorectal) screening, biochemical ELISA of 3 plasma or serum proteins with demographic data using proprietary algorithm

Unlisted CPTsCPT

Unlisted CPT

Used for tests without assigned CPT codes (eg, ColonSentry)

Provider actions, authorizations, and billing rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage plans and recommended for Commercial products. Participating providers must obtain authorization via the online tool. Unlisted CPT codes require prior authorization so the plan can determine what specific service was rendered and whether it is a covered, medically necessary service. The ordering physician is responsible for initiating authorization; laboratories and laboratory representatives are not permitted to obtain authorization on behalf of the ordering physician.

Prior authorization required for Medicare Advantage; recommended for Commercial
Use of Unlisted CPT requires authorization to determine rendered service and coverage
Authorization must be obtained by the ordering physician via the provider online tool

Note

Verify Benefits and Eligibility

Verify member benefits and eligibility before providing services. For member-specific benefit information or questions about authorization status, contact the provider call center.

Background and rationale

Early detection of colorectal cancer (CRC) reduces mortality. Standard, accepted screening options include colonoscopy, sigmoidoscopy, and fecal-based tests. Blood-based molecular or serologic screening tests have been developed as potentially simpler alternatives to increase screening uptake, though clinical validity and impact on outcomes vary by test and are the basis for the differing coverage decisions noted in this policy.

Definitions and test descriptions

inv-19: SEPT9 methylated DNA — PCR-based assays detecting methylated SEPT9 in plasma/serum

DefinitionSEPT9 methylated DNA testing: PCR-based assays that detect methylated SEPT9 (Septin9) circulating DNA in plasma or serum (examples: Epi proColon, ColoVantage).

Typical methodAssay type: polymerase chain reaction (PCR); performance varies by laboratory and methodology (DNA preparation, primers, probes).

Manufacturers / labsOffered by multiple laboratories (ARUP Laboratories, Quest Diagnostics, Clinical Genomics); Epi proColon received FDA approval in April 2016.

CPT codingDocumented CPT code for SEPT9 promoter methylation analysis: 81327 (policy lists as not covered/not medically necessary for some product types).

inv-20: Gene expression profiling — tests (e.g., ColonSentry, BeScreened-CRC) measuring expression of selected genes/proteins

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySerologic Genetic and Molecular Screening for Colorectal Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective Date09|01 2023

Next Review DateN/A

Key ActionObtain prior authorization for Medicare Advantage and use an Unlisted CPT when no specific CPT exists; ordering physician must request authorization.

SourceLink

On This Page

Evidence base: Detection or screening for colorectal cancer using blood-based DNA methylation markers (eg, methylated SEPT9, mSEPT9) is referenced in multiple diagnostic performance studies, meta-analyses, and guideline documents cited by the policy (examples: Church et al. 2014; Li et al. 2016; NCCN; USPSTF).

This excerpt provides references only and does not specify detailed coverage criteria or an explicit coverage decision for mSEPT9-based tests.

Providers should contact the BCBSRI provider call center to confirm member benefits and eligibility prior to service

Benefits and eligibility are governed by the member's subscriber certificate or employer agreement

Denial Risk

Member Billing and Denial Risk

If services are not medically necessary or are non-covered benefits, the provider may not bill the member unless the provider has informed the member in advance and received written agreement to accept financial responsibility. Providers should refer to their participation agreement for applicable provisions.

Services determined not medically necessary or non-covered may be denied and could result in member billing only if advance written agreement exists
Providers remain responsible for following authorization and documentation requirements to avoid denials

Billing Rule

Unauthorized Laboratory Billing Prohibited

Laboratories are prohibited from obtaining authorization or participating in the authorization process on behalf of the ordering physician. If a laboratory provides a service that was not authorized, the service will be denied and the financial liability will be assigned to the participating laboratory; such charges may not be billed to the member. BCBSRI may take corrective action, up to termination from the provider network, if a laboratory or third party is found to have improperly supported the authorization process.

Laboratories must not obtain authorization or act on behalf of the ordering physician
Unauthorized laboratory services will be denied and billed to the laboratory, not the member
Improper authorization assistance by a lab or third party may lead to termination from the BCBSRI network

Documentation Required

Unlisted CPT and Authorization Process

For services described by an Unlisted CPT code, the ordering physician must request authorization and supply sufficient documentation to identify the specific service rendered so BCBSRI can determine coverage and medical necessity. Failure to obtain authorization for unlisted services may result in denial and financial liability.

Ordering physician is responsible for providing clinical documentation when requesting authorization for Unlisted CPT codes
Authorization is required to determine whether an unlisted service is covered or medically necessary

DefinitionGene expression profiling tests measure expression of selected genes or proteins in blood to stratify colorectal cancer (CRC) risk (examples: ColonSentry, BeScreened-CRC).

Assay formatsTypical methods include PCR-based assays (eg, ColonSentry) and ELISA-based protein assays (eg, BeScreened-CRC uses ELISA of 3 proteins with a proprietary algorithm).

Intended useDesigned to stratify average-risk adults who are non-compliant with colonoscopy or fecal testing; not intended to replace standard screening for compliant patients.

Coding guidanceSome gene expression tests lack specific CPT codes and may be billed with an Unlisted CPT code (policy references ColonSentry as Unlisted CPT).

inv-21: mSEPT9 marker referenced in diagnostic performance studies

Marker namemSEPT9: methylated SEPT9 circulating DNA marker referenced across multiple diagnostic performance studies and systematic reviews.

Evidence baseReferenced in meta-analyses and diagnostic studies (eg, Li et al. 2016 meta-analysis; Church et al. prospective evaluation).

Analytic noteQuantitative profiling of blood mSEPT9 can influence detection performance across colorectal tumor stages (study cited: Epigenomics Dec 2018).