CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Defines medical necessity, prior authorization and coding for genomic and protein biomarker tests used to risk-stratify and guide treatment of prostate cancer for BCBSRI Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization via the online authorization tool (ordering physician only) for Decipher, GPS, Oncotype DX AR-V7, and Prolaris for Medicare Advantage and recommended for Commercial products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4Specific named tests considered medically necessary when criteria met

1Specific named test listed as not covered / not medically necessary

2025-09-01Effective date for medical criteria and coding

Medically Necessary and Not Covered Tests

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ALL of the following

Decipher Prostate Genomic Classifier (Veracyte, Inc), CPT 81542 is medically necessary when online authorization criteria are met
Oncotype DX AR-V7 Nuclear Detect (Genomic Health), CPT 81479 is medically necessary when online authorization criteria are met
Genomic Prostate Score (GPS) Test (MDxHealth), CPT 0047U is medically necessary when online authorization criteria are met
Prolaris (Myriad), CPT 81541 is medically necessary when online authorization criteria are met

Not Medically Necessary / Not Covered

The following test is considered not covered / not medically necessary due to insufficient evidence:

ALL of the following

ProMark (Metamark Genetics), protein biomarker test — considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products

CPT and Unlisted Codes

Medically Necessary CPT codes (when online authorization criteria met)CPTCovered

81542	Decipher Prostate Genomic Classifier
0047U	Genomic Prostate Score (GPS) Test (MDxHealth) — Test Name and Laboratory revised effective 7/1/2024
81479	Oncotype DX AR-V7 Nuclear Detect (also used as Unlisted molecular pathology when specific code not assigned)
81541	Prolaris (Myriad)

Unlisted molecular pathology requiring authorizationCPTCovered

81479

Unlisted molecular pathology procedure (to be used for tests without specific CPT such as ProMark) - requires authorization

Authorization and Documentation Requirements

Prior Authorization

Prior authorization required or recommended

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products and must be obtained via the online authorization tool for participating providers for the GPS Test, Decipher, Oncotype DX AR-V7, and Prolaris.

81542
0047U
81479
81541
81479 (unlisted)

Documentation Required

Ordering physician must obtain authorization

Only the ordering physician may obtain authorization, handle appeals, and prepare documentation of clinical appropriateness; laboratories or third parties are not allowed to obtain authorization or participate in the authorization process on behalf of the ordering physician.

Unauthorized lab-submitted services will be denied and financial liability rests with the laboratory.

Clinical Context

Gene expression profiling and protein biomarker assays have been proposed to improve risk stratification in prostate cancer to inform management decisions across the disease spectrum — for example, selection of active surveillance versus definitive therapy at diagnosis, decisions about post‑prostatectomy radiotherapy, and selection of systemic therapy in metastatic castration‑resistant prostate cancer. These tests are intended for use on prostate biopsy or surgical specimens to supplement clinical and pathologic risk factors when making treatment decisions. [See tests addressed in this policy.]

The evidence supporting clinical validity and clinical utility varies by test. Several genomic classifiers and cell‑cycle progression assays have published validation studies and have been used to refine postoperative risk estimates and influence recommendations for adjuvant or salvage radiotherapy. Genomic tests also have data informing their use in biopsy‑based risk assessment for active surveillance and in selecting systemic therapies in castration‑resistant disease where specific biomarkers (for example, nuclear AR‑V7 detection) may predict resistance to particular androgen‑targeted agents.

The ProMark protein biomarker assay (Metamark Genetics) is a CLIA‑regulated laboratory‑developed test that measures an 8‑biomarker panel and yields a continuous risk score between 0 and 1 estimating the probability of non‑Gleason‑score‑6 pathology. Available evidence for ProMark consists primarily of retrospective clinical‑validity studies using archived samples and there are no published studies demonstrating that ProMark testing improves patient‑centered outcomes. Therefore, current evidence is insufficient to demonstrate clinical utility for ProMark, and it is considered not covered / not medically necessary under this policy.

For administrative implementation, specific genomic tests that have supporting evidence are listed as medically necessary when the medical criteria in the payer's online authorization tool are met (including Decipher, Genomic Prostate Score [GPS], Oncotype DX AR‑V7 Nuclear Detect, and Prolaris). Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products. Some tests without an assigned CPT require use of an unlisted molecular pathology CPT and authorization to determine coverage and medical necessity.

Defined Terms

Definitions

ProMarkA CLIA-regulated protein biomarker assay (Metamark Genetics) producing a continuous risk score (0–1) to estimate probability of non-GS6 pathology; considered not covered due to insufficient evidence of clinical utility.

GPSGenomic Prostate Score (MDxHealth), CPT 0047U — a genomic test for prostate cancer risk stratification.

DecipherDecipher Prostate Genomic Classifier (Veracyte, Inc), CPT 81542 — a genomic classifier used for post-prostatectomy risk stratification and treatment decision support.

Oncotype DX AR-V7 Nuclear DetectA test to detect nuclear-localized AR-V7 protein (Genomic Health), CPT 81479; used in evaluation of castration-resistant prostate cancer to guide therapy selection.

ProlarisA cell cycle progression genomic test (Myriad), CPT 81541 used for prostate cancer prognostication.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Medically Necessary and Not Covered Tests

CPT and Unlisted Codes

Authorization and Documentation Requirements

Clinical Context

Defined Terms

Policy Dates

Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Medically Necessary and Not Covered Tests

CPT and Unlisted Codes

Authorization and Documentation Requirements

Clinical Context

Defined Terms

Also See

Policy Dates