DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Policy governs medical necessity, prior authorization, coding, and coverage stance for gene expression and protein biomarker tests used to risk-stratify and guide management of prostate cancer for Medicare Advantage and commercial products of BCBSRI.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Policy CodePolicy N/A

Change TypeMaterial updates to coverage, coding, and prior authorization

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization via the online tool for participating providers before ordering listed tests; only the ordering physician may complete authorization.

SourceLink

POLICY UPDATE CHANGES

Effective 9/1/2025, specified tests (Decipher, GPS, Oncotype DX AR-V7, Prolaris) may be considered medically necessary when online authorization criteria are met.

ProMark is listed as not covered / not medically necessary due to insufficient evidence.

Updated CPT coding effective 9/1/2025, mapping specific CPTs for Decipher, GPS (0047U), Oncotype DX AR-V7, and Prolaris; Unlisted molecular pathology code 81479 to be used for tests without specific CPT.

4Tests listed as may be medically necessary

1Test not covered / not medically necessary

81479Unlisted CPT to use

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09-01-2025Effective date

Coverage and Medical Necessity Criteria

Medically Necessary Tests (when authorization criteria met)

Covered when the online authorization tool medical criteria for participating providers are met (effective 9/1/2025).

Medicare Advantage and Commercial: Tests considered medically necessary when online authorization criteria are meteffective 2025-09-01

Applies to listed tests: Decipher, GPS, Oncotype DX AR-V7, Prolaris

ProMark (a protein biomarker test) is not covered for Medicare Advantage Plans and is considered not medically necessary for Commercial Products. The policy lists ProMark separately from tests that may be considered medically necessary when authorization criteria are met and specifies that the evidence is insufficient to demonstrate an improvement in net health outcome with ProMark.

Services determined to be not medically necessary or otherwise non-covered benefits are excluded from payment under the plan. Providers may not bill or collect payment from members for services denied as not medically necessary unless the member was informed and agreed in advance to self-pay; refer to the member's subscriber or employer agreement and your participation agreement for applicable provisions.

The rationale for deeming ProMark not medically necessary is limited and centers on insufficient evidence of clinical benefit. ProMark is a protein biomarker assay combining eight markers (DERL1, PDSS2, pS6, YB1L, HSPA9, FUS, SMAD4, CUL2) into a continuous risk score estimating probability of non–Gleason score 6 pathology. The published evidence consists primarily of retrospective clinical‑validity data from archived samples and there are no studies demonstrating clinical utility (for example, improved overall survival, disease‑specific survival, quality of life, or reduced treatment‑related morbidity). Because only a single clinical‑validity study is available and clinical‑utility data are absent, current evidence does not demonstrate that use of ProMark improves net health outcomes.

When services are determined to be not medically necessary under this policy, they may be denied and will not be payable by the plan.

Procedure and Billing Codes

Covered CPT CodesCPTCovered

81542

Decipher Prostate Genomic Classifier

Covered CPT CodesCPTCovered

0047U

Genomic Prostate Score (GPS) Test

Covered / Unlisted CPT CodesCPTCovered

81479

Oncotype DX AR-V7 Nuclear Detect; Unlisted molecular pathology procedure

Covered CPT CodesCPTCovered

81541

Prolaris

Unlisted CPTCPT

81479

Unlisted molecular pathology procedure — to be used for tests without a specific CPT (e.g., ProMark)

Biochemical recurrence PSA threshold

threshold>= 0.2 ng/mL confirmed

contextDefined by the American Urological Association as biochemical recurrence after radical prostatectomy

measurementSerum PSA level confirmed by a second determination at or above threshold

Provider Requirements, Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Decipher Prostate Genomic Classifier and for tests billed with CPT 81479 (Unlisted molecular pathology procedure) for Medicare Advantage Plans; prior authorization is recommended for Commercial Products. Participating providers must obtain authorization via the BCBSRI online authorization tool. Authorization determinations are made based on the clinical information submitted and the medical criteria in the online authorization tool.

Affected codes: CPT 81542 (Decipher Prostate Genomic Classifier), CPT 81541 (Prolaris), CPT 0047U (Genomic Prostate Score – GPS), CPT 81479 (Unlisted molecular pathology procedure) and other unlisted genetic testing CPT codes referenced in this policy.
Ordering physician must initiate and complete the authorization request using the online tool for participating providers.
Authorization is required to establish whether the service is covered or medically necessary prior to performing the test.

Note

Check Member-Specific Coverage

Providers must verify member benefits and eligibility and determine whether prior authorization is required for the specific member and product. Benefits and eligibility are governed by the member's subscriber certificate or employer agreement; those documents supersede this policy. For member-specific coverage questions, contact the BCBSRI provider call center or check eligibility through the payer portal before ordering testing.

Clinical Background and Scope

Prostate cancer is clinically heterogeneous and is managed according to individualized risk stratification that typically includes serum PSA level, clinical stage, and histologic grade (Gleason score). These factors guide decisions ranging from active surveillance to definitive local therapy and systemic treatment. Tissue‑based genomic classifiers, gene‑expression assays, and protein biomarker tests have been developed to refine prognostic estimates and help tailor management decisions. Post‑prostatectomy surveillance relies on serial PSA measurement to detect recurrence (biochemical recurrence generally defined as a PSA ≥ 0.2 ng/mL confirmed on a second determination). While some genomic classifiers have supporting validation and clinical‑utility evidence, assays such as ProMark currently have limited data (retrospective validity only) and lack demonstrated clinical utility, which informs the policy distinction between tests that may be authorized and those that are not covered.

Definitions and Test Descriptions

ProMark

assayProMark protein biomarker assay (8 biomarkers)

component biomarkersDERL1, PDSS2, pS6, YBXL, HSPA9, FUS, SMAD4, CUL2

scoringContinuous risk score (0–1) calculated from predefined logistic regression coefficients to estimate probability of non‑Gleason grade group 6 pathology

Biochemical recurrence after radical prostatectomy

definitionA serum PSA of 0.2 ng/mL or higher, confirmed by a second determination

clinical useUsed to identify biochemical recurrence after radical prostatectomy during post‑operative surveillance

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Policy CodePolicy N/A

Change TypeMaterial updates to coverage, coding, and prior authorization

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization via the online tool for participating providers before ordering listed tests; only the ordering physician may complete authorization.

SourceLink

On This Page

Do not assume coverage based on this policy alone — confirm the member's plan and benefit details.
If services are not covered or are denied as not medically necessary, providers may not bill members except as allowed by the provider participation agreement and after informed consent documented in advance.

Documentation Required

Authorization Process and Documentation

The ordering physician is responsible for submitting the authorization and all required documentation. Laboratories are not permitted to obtain authorization or act on behalf of the ordering physician. If a laboratory or third party assists or submits authorization information on behalf of the ordering physician, BCBSRI will consider that a violation and may take action up to termination from the provider network.

Required documentation includes clinical rationale, relevant medical records, pathology or diagnostic results, and any test-specific information requested in the online authorization tool.
Only the ordering physician may initiate appeals or administrative actions related to authorization or medical necessity determinations.

Denial Risk

Authorization and Laboratory Involvement

If a laboratory performs a test without required prior authorization, the service will be denied and the financial liability will fall to the performing laboratory or provider. Providers and laboratories should ensure authorization is obtained before testing to avoid claim denials and potential financial responsibility.

Unauthorized lab services will be denied and may not be billed to the member except as allowed by the participation agreement.
BCBSRI may deny payment for tests deemed not medically necessary or not covered under the member's benefit plan.

Billing Rule

Provider Action and Appeal Guidance

When an authorization is required, follow the online authorization tool instructions exactly and supply the clinical documentation requested. Incomplete or missing documentation may result in denial. If an authorization is denied for clinical appropriateness, appeals must be handled by the ordering physician and supported by appropriate clinical documentation.

For tests without a specific CPT (use of Unlisted CPT 81479), prior authorization is necessary to determine the specific service and coverage.
Providers should consult the Related Policies and coding section for guidance on applicable CPT codes and authorization requirements.

Note

Benefits & Eligibility

Benefits and eligibility are determined by the member's subscriber agreement, member certificate, and/or employer agreement. For questions about member-specific benefits or to confirm whether a service is covered, contact the provider call center or use the payer portal prior to ordering services.

This policy is informational and is not a guarantee of payment.
If services are determined not to be medically necessary or are non-covered benefits, providers may not charge the member unless the member has been informed and agreed in advance in accordance with the participation agreement.

monitoring intervalNCCN recommends PSA every 6–12 months for first 5 years and annually thereafter

Tissue-based genomic classifier / biopsy-based gene expression assay

termTissue‑based genomic classifier / biopsy‑based gene expression assay

descriptionA genomic classifier or gene expression assay uses tissue RNA expression patterns to generate a score that predicts prostate cancer outcomes (e.g., metastasis, recurrence)

evidence contextReferenced in multiple validation and clinical utility studies for post‑prostatectomy risk stratification

Cell cycle progression (CCP) score

definitionCell cycle progression (CCP) score is a prognostic RNA‑based score derived from expression of cell‑cycle genes to predict prostate cancer aggressiveness and outcomes

clinical roleUsed to inform risk stratification and treatment decisions in localized prostate cancer

supporting evidenceEvaluated in systematic reviews, registries, and validation studies cited in the literature