CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Next Generation Sequencing for Solid Tumors — Oncotype MAP Pan-Cancer Tissue Test

Defines medical coverage, prior authorization, and coding for the Oncotype MAP Pan-Cancer Tissue Test (a comprehensive genomic profiling NGS test) for Medicare Advantage and Commercial products offered by Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyNext Generation Sequencing for Solid Tumors — Oncotype MAP Pan-Cancer Tissue Test

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for Medicare Advantage members via the payer's online tool before ordering the Oncotype MAP Pan-Cancer Tissue Test.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0244UCPT/PLA code

257Genes interrogated

NCD 90.2Basis for necessity

RequiredPA status (MA)

Coverage Criteria for Oncotype MAP Pan‑Cancer Tissue Test

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Medical necessity criteria for Oncotype MAP Pan-Cancer Tissue Test

Covered when ALL of the following are met

Patient clinical status: Patient has relapsed, recurrent, refractory, metastatic, or advanced (stage III or IV) cancer.

based on NCD 90.2

Intent: Patient is seeking further treatment.

based on NCD 90.2

Previous testing: Test has not been previously performed on the patient for the same genetic content (same test).

Coverage denied if previously tested by same test for same genetic content

Coverage is denied when the test does not meet the Medicare NCD 90.2 criteria for next-generation sequencing in solid tumors, or when another comprehensive genomic profiling (CGP) test was performed on the same tumor specimen obtained on the same date of service. Commercial self‑funded groups may also have contract exclusions per the state Biomarker Mandate; providers must check the member's benefit booklet for customized coverage determinations.

The Oncotype MAP Pan‑Cancer Tissue Test is not covered if it does not fulfill all criteria set forth in NCD 90.2, including patient clinical status (relapsed, recurrent, refractory, metastatic, or advanced stage III/IV disease) and intent to seek further treatment, or if the test has previously been performed on the patient for the same genetic content.

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans (recommended for Commercial) for the Oncotype MAP Pan-Cancer Tissue Test.

Test: Oncotype MAP™ Pan-Cancer Tissue Test
Action: Prior authorization required for Medicare Advantage; recommended for Commercial products
How to obtain: Via the online provider tool for participating providers

Note

Commercial Contract Exclusions

Commercial self-funded groups may have contract exclusions related to biomarker testing. Providers must refer to the member's Benefit Booklet and the Coding sections of the Genetic Testing Services or Proprietary Laboratory Analyses policies to determine whether the member's plan has customized coverage or exclusions.

Reference: RI G.L. §27-19-81 (Biomarker Mandate) — some self-funded groups may have excluded expanded biomarker coverage
Action: Check member's Benefit Booklet and related policy coding sections for covered, not medically necessary, or excluded services

Prior Authorization

Prior Authorization Operational Note

Prior authorization is obtained via the online tool for participating providers. Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products. See Related Policies for additional details and for guidance on submitting authorization requests.

Test: Oncotype MAP™ Pan-Cancer Tissue Test
Authorization channel: online provider tool for participating providers
Operational note: Consult Related Policies for submission details and coding guidance

Denial Risk

Denial Conditions

Coverage is denied if the test does not fulfill all criteria set forth in NCD 90.2 or if another comprehensive genomic profiling (CGP) test was performed on the same tumor specimen (specimen obtained on the same date of service).

Denial condition: Failure to meet all NCD 90.2 criteria (e.g., relapsed, recurrent, refractory, metastatic, or advanced [stage III/IV] cancer AND seeking further treatment AND not previously tested by the same test for the same genetic content)
Denial condition: Another CGP test performed on the same tumor specimen (same date of service)

Biomarker and Result Requirements

Biomarker classes reported by the Oncotype MAP Pan-Cancer Tissue Test

Tumor mutational burden (TMB)Reported by the test and can inform targeted therapy decisions for solid tumors when medical necessity criteria are met.

Microsatellite instability (MSI)Reported by the test and can inform targeted therapy decisions for solid tumors when medical necessity criteria are met.

Single-nucleotide variants (SNVs)Interrogated by the test as part of comprehensive genomic profiling (NGS-based).

Insertions/deletions (INDELs)Interrogated by the test as part of comprehensive genomic profiling (NGS-based).

Copy number alterations (CNAs)Interrogated by the test as part of comprehensive genomic profiling (NGS-based).

Gene rearrangements (fusions/translocations)Interrogated by the test as part of comprehensive genomic profiling (NGS-based).

Definitions

Comprehensive Genomic Profiling (CGP)

DefinitionNGS assays that detect multiple variant classes (SNVs, INDELs, CNAs, gene fusions/translocations) and can calculate biomarkers such as TMB and MSI, typically larger panels designed for multiple tumor types.

Assay capabilitiesCan detect single-nucleotide variants, insertions/deletions, copy number alterations and gene rearrangements; can calculate tumor mutational burden and microsatellite instability.

Clinical useUsed to inform targeted therapies and precision medicine decisions in relapsed, recurrent, refractory, metastatic or advanced (stage III/IV) solid tumors when medical necessity criteria are met.

Example test/codeOncotype MAP Pan-Cancer Tissue Test — CPT/PLA 0244U: comprehensive genomic profiling, 257 genes, interrogates multiple variant classes and reports TMB and MSI.

Background

Next‑generation sequencing (NGS) is a massively parallel sequencing methodology used to detect multiple genomic alteration types — including single nucleotide variants (SNVs), insertions/deletions (indels), copy number alterations (CNAs), and rearrangements/fusions — and to derive biomarkers such as tumor mutational burden (TMB) and microsatellite instability (MSI). NGS‑based comprehensive genomic profiling (CGP) can inform targeted therapy and precision‑medicine decisions for relapsed, recurrent, refractory, metastatic or advanced (stage III/IV) solid tumors and is the clinical basis referenced by CMS NCD 90.2 for coverage decisions.