CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 9, 2019

Next Review Date

Key ActionObtain prior authorization for Unlisted genetic testing CPT codes and the listed tests for BlueCHiP for Medicare (recommended for Commercial) via the online tool for participating providers.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update (has_material_change=false).

2Tests covered with criteria (Prolaris, Oncotype DX Prostate)

3Tests listed with insufficient evidence (ProMark, Decipher, Oncotype DX AR-V7)

1Unlisted CPT approach

Coverage Summary

Defines medical coverage criteria for specific gene expression and protein biomarker tests (Prolaris, Oncotype DX Prostate, ProMark, Decipher, Oncotype DX AR-V7) for prostate cancer management under BlueCHiP for Medicare and Commercial products, including prior authorization and coding guidance. Prolaris and Oncotype DX Prostate are covered for BlueCHiP for Medicare when their detailed clinical criteria are met; other listed tests (ProMark, Decipher, Oncotype DX AR-V7) have insufficient evidence to establish clinical utility. Prior authorization is required for BlueCHiP for Medicare (and recommended for Commercial), and specific CPT guidance is provided (eg, 81541 for Prolaris; 81479 for unlisted molecular pathology procedures).

Coverage stance: Mixed — Medicare: some tests covered with specific criteria; Commercial: considered not medically necessary.

Clinical thresholds

FFPE cancer length>= 0.5 mm

Estimated life expectancy>= 10 years

PSA<= 10 ng/mL (required in very low/low risk definitions)

PSA density< 0.15 ng/mL/g (required for very low risk)

Gleason Score<= 6 (or =6 as specified for Oncotype DX criteria)

Medical Necessity Criteria (by test and product)

Prolaris (BlueCHiP for Medicare)

Prolaris assay is covered only when ALL of the following clinical conditions are met:

ALL of the following

Needle biopsy with localized adenocarcinoma of prostate (no clinical evidence of metastasis or lymph node involvement)
FFPE prostate biopsy specimen with at least 0.5 mm of cancer length>= 0.5 mm
FFPE = formalin-fixed paraffin-embedded
Patient Stage (ONE of)
- Very Low Risk Disease: T1c AND Gleason Score ≤ 6 AND PSA ≤ 10 ng/mL AND <3 prostate cores with tumor AND ≤ 50% cancer in any core AND PSA density of < 0.15 ng/mL/gPSA ≤ 10 ng/mL; PSA density < 0.15 ng/mL/g; Gleason ≤ 6
- Low Risk Disease: T1-T2a AND Gleason Score ≤ 6 AND PSA ≤ 10 ng/mLPSA ≤ 10 ng/mL; Gleason ≤ 6
Patient has an estimated life expectancy of greater than or equal to 10 years>= 10 years
Patient is a candidate for and is considering conservative therapy and yet would be eligible for definitive therapy (radical prostatectomy, radiation therapy or brachytherapy)
Result will be used to determine treatment between definitive therapy and conservative management
Patient has not received pelvic radiation or androgen deprivation therapy prior to the biopsy
Test is ordered by a physician certified in the Myriad PROLARIS ™ Certification and Training Registry (CTR)
Patient is monitored for disease progression according to established standard of care

Oncotype DX® Prostate Cancer Assay (BlueCHiP for Medicare)

Oncotype DX Prostate is covered only when ALL of the following clinical conditions are met:

ALL of the following

Needle biopsy with localized adenocarcinoma of prostate (no clinical evidence of metastasis or lymph node involvement)
Patient Stage (ONE of)
- Very Low Risk Disease: T1c AND Gleason Score = 6 AND PSA = 10 ng/mLPSA = 10 ng/mL; Gleason = 6
- Low Risk Disease: T1-T2a AND Gleason Score = 6 AND PSA = 10 ng/mLPSA = 10 ng/mL; Gleason = 6

Other tests (ProMark, Decipher, Oncotype DX AR-V7) - BlueCHiP for Medicare

Coverage stance and evidence summary for other listed tests:

ALL of the following

ProMark protein biomarker test: evidence insufficient to determine effects on health outcomes (not established clinical utility)
Decipher prostate cancer classifier: evidence insufficient to determine effects on health outcomes (clinical validity evaluated but unclear clinical utility)
Oncotype DX AR-V7 Nuclear Detect for mCRPC: evidence insufficient to determine effects on health outcomes (no demonstrated clinical utility)

Commercial Products

Coverage stance for Commercial products:

Use of gene expression analysis and protein biomarkers to guide management of prostate cancer is considered not medically necessary in all situations due to insufficient evidence

Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization required (BlueCHiP for Medicare)

All Unlisted genetic testing CPT codes and the listed tests require prior authorization for BlueCHiP for Medicare to determine if the service is covered or medically necessary.

81479
81541

Prior Authorization

Prior authorization required/recommended for Commercial

Prior authorization is required for BlueCHiP for Medicare and recommended for Commercial products; obtained via online tool for participating providers.

81479
81541

Documentation Required

Ordering physician certification requirement

Test must be ordered by a physician certified in the applicable test Certification and Training Registry (Myriad PROLARIS CTR or Genomic Health Oncotype DX CTR).

Documentation Required

Clinical documentation and monitoring

Documentation must show localized adenocarcinoma on needle biopsy, life expectancy, candidacy for conservative vs definitive therapy, lack of prior pelvic radiation/ADT, and plans for monitoring per standard of care.

Background & Evidence Summary

These assays are intended to risk-stratify prostate cancer patients using gene expression profiling or protein biomarkers to guide decisions such as active surveillance versus definitive therapy, post-prostatectomy radiotherapy, or treatment selection in metastatic castration-resistant disease. Tests are performed on clinical specimens (eg, FFPE biopsy tissue or circulating tumor cells) and are offered as CLIA laboratory-developed tests.

The strength of evidence varies by assay: Prolaris and Oncotype DX Prostate have clinical validity data from retrospective and case-cohort studies suggesting prognostic signal but insufficient evidence of clinical utility to demonstrate improved health outcomes; ProMark, Decipher, and Oncotype DX AR-V7 have limited clinical validity data and no established clinical utility. Thus, evidence across assays is heterogeneous and generally insufficient for many indications.

Test / Evidence label	Summary
Prolaris evidence summary	Retrospective cohort studies show some improvement in prognostic accuracy; evidence insufficient to determine effects on health outcomes
Oncotype DX Prostate evidence summary	Case-cohort and retrospective studies with decision-curve analyses show clinical validity signals but insufficient evidence of clinical utility
ProMark/Decipher/Oncotype DX AR-V7 evidence summary	Limited clinical validity data; no established clinical utility; evidence insufficient

Name	Number	Type	Effective Date
MolDX: Genomic Health™ Oncotype DX® Prostate Cancer Assay	L36153	LCD

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 9, 2019

Next Review Date

SourceLink

On This Page

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Medical Coverage Policy | Gene Expression Profiling and Protein Biomarkers for Prostate Cancer Management

Coverage Summary

Medical Necessity Criteria (by test and product)

Coding

Provider Actions & Administrative Requirements

Background & Evidence Summary

Medicare Determinations

Definitions

Revision History