CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Gene Expression Profile Testing and Circulating Tumor DNA Testing for Predicting Recurrence in Colon Cancer

Defines medical necessity and coding for GEP and ctDNA prognostic tests (specifically Oncotype DX Colon Recurrence Score CPT 81525) to predict recurrence risk after surgery in stage II or III colon cancer for Medicare Advantage and commercial products; includes coverage notes, coding and related policy references.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Gene Expression Profile Testing and Circulating Tumor DNA Testing for Predicting Recurrence in Colon Cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/01/2024

Next Review Date

Key ActionOnly the ordering physician may be involved in authorization, appeal, or other administrative processes related to authorization/medical necessity; laboratories or third parties are prohibited from obtaining authorization on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

1Named covered test

81525Primary CPT code referenced

C18.0-C20, C21.1ICD-10 diagnosis range

Coverage Summary

Defines medical necessity and coding for GEP and ctDNA prognostic tests (specifically Oncotype DX Colon Recurrence Score CPT 81525) to predict recurrence risk after surgery in stage II or III colon cancer for Medicare Advantage and commercial products; includes coverage notes, coding and related policy references.

Surface headline policy facts

Effective Date2024-01-01

Last Review2025-10-01

StatusCURRENT

ScopeGene expression profile (GEP) and circulating tumor DNA (ctDNA) testing for predicting recurrence in stage II/III colon cancer

Medical-Necessity Criteria

Medically Necessary Tests

The following tests may be considered medically necessary for prognostic markers of stage II or III colon cancer following surgery:

Oncotype DX Colon Recurrence Score (Exact Sciences) CPT code 81525 for prognostic assessment in stage II or III colon cancer following surgery

Applicable for Medicare Advantage Plans and Commercial Products; laboratories are not permitted to obtain authorization on behalf of the ordering physician

GEP: Gene expression profile testing to assess recurrence risk using multigene assays (for example, the 12-gene recurrence score).

ctDNA: Circulating tumor DNA testing to detect tumor-derived DNA in blood as a marker of residual disease or recurrence.

Not Covered / Experimental

Coverage stance is mixed: the policy lists specific tests that may be considered medically necessary (for example, Oncotype DX Colon Recurrence Score CPT 81525), but notes variability across products and contracts and that some genetic testing services or laboratory-developed tests may be excluded or not covered. Some ctDNA assays and other laboratory-developed tests may be considered experimental or have insufficient evidence depending on contract terms, benefit booklets, or guideline interpretation.

Coding

Covered CPTCPTCovered

81525

Oncology (colon), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence score

Applicable ICD-10 Diagnosis CodesICD-10

C18.0-C20	Malignant neoplasm of colon (range)
C21.1	Malignant neoplasm of anal canal

Provider Actions

Documentation Required

Ordering physician must handle authorization and appeals

Only the ordering physician shall be involved in the authorization, appeal, or other administrative processes related to authorization/medical necessity. Laboratories or third parties are not allowed to obtain authorization or participate in the authorization process on behalf of the ordering physician, and use of a laboratory representative or related third party to obtain authorization or facilitate appeals is a violation of this policy.

Billing Rule

Unauthorized lab-performed services denied to laboratory

If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability will be the responsibility of the participating laboratory; the unauthorized service will not be billed to the member.

Documentation Required

Benefit verification required

Benefits may vary between groups and contracts. Providers must refer to the member's Benefit Booklet / Evidence of Coverage or Subscriber Agreement to determine applicable coverage and verify benefits for the member.

Background & Evidence

GEP and ctDNA tests are intended as prognostic markers to help identify stage II patients at higher risk of recurrence after surgery who may benefit from adjuvant chemotherapy. Tests include the Oncotype DX Colon Recurrence Score (CPT 81525) and various ctDNA assays; clinical and pathological high-risk features remain imperfect predictors, and laboratory-developed tests operate under CLIA oversight.

Key evidence and guideline citations include J Clin Oncol validation studies (Kennedy 2011; Yothers 2013; Venook 2013), the N Engl J Med ctDNA study (Tie 2022), and ASCO and NCCN guideline citations.

Type	Name	Number
LCD	MolDX: Molecular Diagnostic Tests (MDT)	L35160
Other	MolDX: Oncotype DX Colon Cancer billing and coding article	A54484