Medicare contractors cover Envisia to spare patients lung surgery

Four Medicare contractors cover the Envisia test for suspected idiopathic pulmonary fibrosis. In a cited interim analysis, diagnoses with it matched those with histopathology in 92% of 56 cases.

  • Not rated a person

    The contractors expect that patients will be spared surgical lung biopsy, but no cited study counted biopsies avoided or measured patient outcomes.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

Four independent assessment reports support the benefit.

Compared with

Diagnoses that expert multidisciplinary teams made from histopathology for the same patients. Measured.

The system’s part
In the cited clinical utility analysis, expert teams with the same clinical and CT information diagnosed each case twice, once with the classifier result and once with histopathology. That comparison isolates the classifier's part in the diagnosis. Its 92% agreement is an interim result on 56 cases. No cited study compares patient outcomes with and without the test. The determinations state that machine learning was used to train the algorithm on transbronchial biopsy samples.
Later
Persisted, 28 May 2026. CGS completed its annual review on 28 May 2026 with no changes, so coverage continued on the same evidence text.
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Benefit type
Improved Task Accuracy
System
Envisia Genomic Classifier
Made by
Veracyte, Inc.
Used by
Pulmonologists who order the test for Medicare patients with suspected idiopathic pulmonary fibrosis in the four contractors' jurisdictions
Where
United States (the Medicare jurisdictions of Palmetto GBA, CGS, Noridian and WPS)
Stage
In routine use
Date
Kind
Aggregate result
Broad benefit
Identifying Objects, Actions, and Events, Analyzing Data or Information
Collections
Scrutiny and findings
Last revised
1 November 2026

Sources

  1. Assessment report, by authors with no tie to the system.

    Palmetto GBA, Medicare Administrative Contractor for Jurisdictions J and M. Local Coverage Determination L37857: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test. Original effective date 1 April 2019, revision effective 29 June 2023. CMS Medicare Coverage Database, Summary of Evidence (Clinical Utility).

    These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology.

  2. Assessment report, by authors with no tie to the system.

    CGS Administrators, Medicare Administrative Contractor for Jurisdiction 15. Local Coverage Determination L37905: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test. Original effective date 20 May 2019, revision effective 28 May 2026. CMS Medicare Coverage Database, Analysis of Evidence (Rationale for Determination).

    The clinical utility of the Envisia™ Genomic Classifier to aid in the diagnosis of patients with an ILD of unknown cause and suspected of IPF, as defined in the intended use above, is quite promising.

  3. Assessment report, by authors with no tie to the system.

    Noridian Healthcare Solutions, Medicare Administrative Contractor for Jurisdictions E and F. Local Coverage Determination L37887: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test. Original effective date 27 May 2019, revision effective 22 January 2026. CMS Medicare Coverage Database, Summary of Evidence (Clinical Utility).

    These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology.

  4. Assessment report, by authors with no tie to the system.

    Wisconsin Physicians Service Insurance Corporation, Medicare Administrative Contractor for Jurisdictions 5 and 8. Local Coverage Determination L37919: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test. Original effective date 13 May 2019, revision effective 29 June 2023. CMS Medicare Coverage Database, Summary of Evidence (Clinical Utility).

    These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology.

Details

AI system

Workflow

The classifier analyzed the expression of 190 genes in 3 to 5 pooled transbronchial biopsy samples per patient. Machine learning trained the algorithm on biopsy samples from the BRAVE study, with diagnoses by expert lung pathologists as the reference. Multidisciplinary teams read the classifier result together with clinical information and CT findings.

Follow-up

Conditions for replication

The patient has interstitial lung disease suspected of IPF, with a probable or indeterminate pattern of usual interstitial pneumonia on high-resolution CT. Autoimmune disease and known occupational, environmental and medication causes have been excluded. The patient is healthy enough to undergo bronchoscopy with transbronchial biopsies.

Entry details

Sector

Healthcare (pulmonology).

Purpose

Veracyte built the Envisia Genomic Classifier to detect the usual interstitial pneumonia pattern, the hallmark of idiopathic pulmonary fibrosis, in transbronchial biopsy samples. The aim is a diagnosis without surgical lung biopsy.

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Cite this record

Peter H. Vartanian. (2026). Medicare contractors cover Envisia to spare patients lung surgery (AIBD-1007). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1007.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)

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