CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Envisia Genomic Classifier (CPT 81554) — Medical Necessity and Prior Authorization

Policy governs medical necessity and prior authorization for the Envisia genomic classifier (CPT 81554) to aid diagnosis of usual interstitial pneumonia (UIP) in patients with suspected interstitial lung disease when HRCT is nondefinitive; affects providers ordering the test for BCBSRI Medicare Advantage and Commercial members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyEnvisia Genomic Classifier (CPT 81554) — Medical Necessity and Prior Authorization

Policy CodePolicy N/A

Change TypeMaterial update: medical necessity + authorization

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization via the online tool (required for Medicare Advantage; recommended for Commercial) and ensure ordering physician performs authorization.

SourceLink

POLICY UPDATE CHANGES

Effective 9/1/2025 the Envisia Genomic Classifier (CPT 81554) is considered medically necessary when the medical criteria in the online authorization tool for participating providers is met.

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online tool for participating providers.

Laboratories are prohibited from obtaining authorization on behalf of the ordering physician; unauthorized lab-obtained services will be denied and billed to the laboratory.

81554Code

9/1/2025Effective

190

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Coverage Criteria for Envisia Genomic Classifier

Medical Necessity for Envisia

Covered when ALL of the following are met

Envisia medical necessity and authorization: Test is for patients with interstitial lung disease suspected of idiopathic pulmonary fibrosis who do not have a definitive usual interstitial pneumonia (UIP) pattern on high-resolution CT and no other known cause; the medical criteria in the online authorization tool for participating providers are met; prior authorization has been obtained per the online tool (required for Medicare Advantage, recommended for Commercial Products).N/A

Result is categorical UIP or Non-UIP to be interpreted with clinical and radiographic information to potentially avoid surgical lung biopsy.

Some genetic and biomarker testing may be restricted by contract for certain self‑funded groups under the state Biomarker Testing Mandate. For plans with such exclusions, coverage for genetic services—including whether a service requires authorization, is considered not medically necessary, or is not covered—is determined by the member’s specific benefit booklet and the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies.

Services that appear in the policies as not medically necessary or listed as not covered may reflect contract exclusions for self‑funded employer groups that have opted out of expanded biomarker testing coverage under the mandate. For members in those groups, those services are not payable regardless of clinical indication; always consult the member’s benefit booklet and the Coding/Related Policies lists to confirm applicability.

Indications When Test Is Covered

Patients with interstitial lung disease suspected of idiopathic pulmonary fibrosis who do not have a definitive UIP pattern on HRCT and no other known cause

Covered when ALL of the following are met

INDICATION: Patient has interstitial lung disease (ILD) suspected of idiopathic pulmonary fibrosis (IPF) and does not have a definitive UIP pattern on high-resolution computed tomography (HRCT) and no other known cause.N/A

AUTHORIZATION CRITERIA: The medical criteria in the online authorization tool for participating providers are met.N/A

Coverage is contingent on meeting the online tool criteria.

PRIOR AUTHORIZATION: Prior authorization has been obtained per the online authorization tool (required for Medicare Advantage Plans; recommended for Commercial Products).

Coding and Test Details

Covered CPT CodesCPTCovered

81554

Envisia Genomic Classifier

Genes analyzed — 190 genes

Number of genes analyzed190 genes

Assay typeMultianalyte gene expression classifier

Intended use contextAnalyzes expression across 190 genes to generate classifier result for ILD diagnosis

Provider Actions, Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans and is recommended for Commercial Products via the online authorization tool for participating providers.

Envisia Genomic Classifier (Veracyte) CPT Code 81554
Envisia Genomic Classifier

Documentation Required

Authorization Ownership and Documentation

Only the ordering physician shall be involved in the authorization, appeal, or other administrative processes related to authorization and medical necessity. Laboratories, laboratory representatives, or any third party with a relationship to a laboratory are not permitted to obtain authorization, initiate appeals, or participate in the authorization process on behalf of the ordering physician.

Ordering physician must use the online authorization tool.

Services Not Covered / Contract Exclusions

Certain genetic services may be not covered for self‑funded groups per contract exclusions under the Biomarker Testing Mandate. Determinations of which services are excluded and the distinction between services that require authorization versus those not covered are listed in the Coding sections of the Genetic Testing Services and Proprietary Laboratory Analyses policies; confirm coverage using the member’s Benefit Booklet and related policy lists.

Eligibility Requirements

There are no top‑level eligibility requirement nodes for this policy.

Definitions

Envisia genomic classifier definition

DefinitionEnvisia genomic classifier is a multianalyte assay analyzing expression of 190 genes to produce a categorical UIP or Non-UIP result to assist diagnosis of interstitial lung disease when HRCT is not definitive.

OutputCategorical result: UIP or Non-UIP

Clinical roleIntended to be interpreted with clinical and radiographic information and may reduce need for surgical lung biopsy

Idiopathic pulmonary fibrosis (IPF) definition

DefinitionIdiopathic pulmonary fibrosis (IPF) is a common form of interstitial lung disease characterized by progressive decline in pulmonary function, often leading to death from respiratory failure or related complications.

Typical onsetUsually presents in the sixth and seventh decades of life; rare under age 50

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyEnvisia Genomic Classifier (CPT 81554) — Medical Necessity and Prior Authorization

Policy CodePolicy N/A

Change TypeMaterial update: medical necessity + authorization

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization via the online tool (required for Medicare Advantage; recommended for Commercial) and ensure ordering physician performs authorization.

SourceLink

On This Page

Laboratories are prohibited from obtaining authorization on behalf of the ordering physician; services provided without proper authorization will be denied and billed to the laboratory.

Laboratories and their representatives are prohibited from obtaining authorizations or participating in appeals.

Denial Risk

Unauthorized Laboratory-Obtained Services Denied

If a laboratory obtains services without the required authorization or supports any portion of the authorization/appeal process on behalf of an ordering physician, those services will be denied and the participating laboratory will be financially liable. Such actions are violations of this policy and may result in severe actions up to termination from the BCBSRI provider network.

Services obtained by a laboratory without authorization will be denied and billed to the laboratory.
Violations may result in termination from the BCBSRI provider network.

Documentation Required

Provider Actions — Ordering Physician Responsibilities

The ordering physician must be the party responsible for initiating and maintaining documentation in the authorization process and for pursuing any necessary appeal. Laboratories or third parties must not prepare, submit, or otherwise facilitate authorization or appeal documentation on behalf of the ordering physician.

Ordering physician involvement is required for authorization and appeals.
Labs or representatives are prohibited from obtaining authorization or submitting appeal documentation.

PrognosisMean survival after diagnosis is approximately 2–5 years

Epidemiology noteEstimated incidence 8–17 per 100,000 person‑years in general population; higher in Medicare population

The Envisia genomic classifier is a multianalyte genomic expression assay that analyzes expression from 190 genes and provides a categorical UIP or Non‑UIP result to assist in the evaluation of patients with suspected interstitial lung disease when high‑resolution CT is not definitive. The result is intended to be interpreted alongside clinical and radiographic information and may reduce the need for surgical lung biopsy.