{"id":"AIBD-1007","title":"Four Medicare contractors cover Veracyte's Envisia classifier, finding that it can inform a lung fibrosis diagnosis without surgical lung biopsy","summary":"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.","date_observed":"2019-04-01","date_basis":"event","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Veracyte's Envisia Genomic Classifier reads the expression of 190 genes in tissue taken by bronchoscopy. It classifies the tissue as having the usual interstitial pneumonia pattern or not. That pattern marks idiopathic pulmonary fibrosis (IPF). Palmetto GBA's MolDX coverage determination took effect on 1 April 2019. The same text took effect for WPS, CGS and Noridian in May 2019. The contractors cite a 30-day mortality of 3-4% after surgical lung biopsy. In a blinded test set of 49 patients, the classifier had a specificity of 88% and a sensitivity of 70%. In an interim analysis of 56 cases, expert teams reached the same IPF or non-IPF diagnosis with the classifier as with histopathology in 92% of cases. The contractors cover the test when a CT scan has a probable or indeterminate pattern and known causes are excluded. They rated the evidence moderate in quality and limited in strength and weight. They judged its clinical utility “quite promising” and expect evidence of better patient outcomes from forthcoming studies. CGS completed an annual review with no changes on 28 May 2026.","category":"aggregate result","unexpected":false,"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.","system":"Envisia Genomic Classifier","model_version":null,"developer":"Veracyte, Inc.","deployer":"Pulmonologists who order the test for Medicare patients with suspected idiopathic pulmonary fibrosis in the four contractors' jurisdictions","location":"United States (the Medicare jurisdictions of Palmetto GBA, CGS, Noridian and WPS)","domain":"Healthcare (pulmonology)","segment":null,"benefit_type":"Improved Task Accuracy","work_activities":["4.A.1.b.1","4.A.2.a.4"],"taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"personal","depth":null,"reason":"The contractors expect that patients will be spared surgical lung biopsy, but no cited study counted biopsies avoided or measured patient outcomes."}],"ai_role":{"status":"assessed","statement":"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."},"evidence":[{"kind":"assessment report","citation":"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).","title":"LCD L37857: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37857","date":"2019-04-01","written_by":"independent","quote":"These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology."},{"kind":"assessment report","citation":"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).","title":"LCD L37905: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37905","date":"2019-05-20","written_by":"independent","quote":"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."},{"kind":"assessment report","citation":"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).","title":"LCD L37887: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37887","date":"2019-05-27","written_by":"independent","quote":"These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology."},{"kind":"assessment report","citation":"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).","title":"LCD L37919: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37919","date":"2019-05-13","written_by":"independent","quote":"These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology."}],"replication":{"produced_by":["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."],"must_hold":["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."],"echoes":[]},"paired_incident":null,"headline":"Medicare contractors cover *Envisia* to spare patients lung surgery","metric":"the same IPF or non-IPF diagnosis with the classifier as with histopathology in 92% of cases","comparator":{"against":"Diagnoses that expert multidisciplinary teams made from histopathology for the same patients","before":null,"after":"a 92% categorical agreement in IPF vs non-IPF diagnosis (interim results, n=56)","basis":"measured","quote":"Interim results for approximately half of cases (n=56) showed a 92% categorical agreement in IPF vs non-IPF diagnosis.","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37857"},"later":{"status":"persisted","date":"2026-05-28","note":"CGS completed its annual review on 28 May 2026 with no changes, so coverage continued on the same evidence text.","quote":"Revision Effective: 05/28/2026 Revision Explanation: Annual review, no changes made.","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37905"},"value":null,"developer_country":"United States","deployer_country":"United States","unrated_because":"The contractors relied on research studies of accuracy and agreement and on expected benefit, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-11-01","change":"Added the record from the finding of Palmetto GBA, CGS Administrators, Noridian Healthcare Solutions and Wisconsin Physicians Service Insurance Corporation.","source":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37857","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by an assessment body","claim_basis":"Sources: four independent assessment reports. The cited evidence includes no independent study or report.","case_jurisdictions":["United States"],"profile":{"case_id":"AIBD-1007","catalog_version":"1.0.0","source_fingerprint":"58bdf257e9a175264af8508afd85c3fb6ed2eee65644740dddd36ce30eda6f9f","collection_refs":[{"collection_id":"aibd","version":"2026-10-31"},{"collection_id":"querist","version":"2026-10-25"}],"source_ids":["AIBD-1007-source-0001","AIBD-1007-source-0002","AIBD-1007-source-0003","AIBD-1007-source-0004"],"families":{"strategic assessments":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"evaluations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"monetary observations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"institutional decisions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]}},"fields":{"actors[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"developer":"Veracyte, Inc.","deployer":"Pulmonologists who order the test for Medicare patients with suspected idiopathic pulmonary fibrosis in the four contractors' jurisdictions"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["developer","deployer"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"actors[].ownership_control":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"ai_contribution":{"state":"value_present","value":{"kind":"record_fields","fields":{"ai_role":{"status":"assessed","statement":"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."}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ai_role"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"ai_relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"category":"aggregate result","ai_role":{"status":"assessed","statement":"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."}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ai_role","category"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].alternatives":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].assessor_date":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].depth":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].display_confidence":{"state":"value_present","value":{"kind":"structured","data":{"confidence":"high","evidence_word":"found","claim_status":"Found by an assessment body","basis":"Sources: four independent assessment reports. The cited evidence includes no independent study or report.","interpretation":"Existing display rule preserved; the richer outcome-specific confidence question still needs review."}},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rationale":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"personal","reason":"The contractors expect that patients will be spared surgical lung biopsy, but no cited study counted biopsies avoided or measured patient outcomes."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rubric_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].status_basis":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].target":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"personal","reason":"The contractors expect that patients will be spared surgical lung biopsy, but no cited study counted biopsies avoided or measured patient outcomes."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"availability":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"brief":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"case_kind":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"case_links[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"claims[].evidence_links":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"claims[].evidence_strength":{"state":"value_present","value":{"kind":"structured","data":{"answer":"Found by an assessment body. Sources: four independent assessment reports. The cited evidence includes no independent study or report.","evidence_word":"found","claim_status":"Found by an assessment body"}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":["AIBD-1007-source-0001","AIBD-1007-source-0002","AIBD-1007-source-0003","AIBD-1007-source-0004"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Found by an assessment body. Sources: four independent assessment reports. The cited evidence includes no independent study or report.","inferred":false}},"claims[].missingness":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"claims[].proposition":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"cross_border_flows[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"decisions[].action_outcome":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].grounds":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].institution_task":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].success_criterion":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"deployment_stage":{"state":"value_present","value":{"kind":"structured","data":{"classification":"routine use","answer":"The system was in routine use. The four contractors have covered the test for Medicare patients since 2019.","scope":"The period and activity described in the case."}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["account","evidence"],"source_refs":["AIBD-1007-source-0001"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"The system was in routine use. The four contractors have covered the test for Medicare patients since 2019.","inferred":false}},"economics[].amount":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].costs[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].counterfactual":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].currency_price_basis":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].gross_net":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].measure_type":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].period_unit":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].realization":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].recipient_payer":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].return_payback":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].valuation_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"evaluations[].ai_uplift":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].comparator":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].design":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].effect":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].exposure":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].id":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].measurement_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].metric":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].reproduction_materials":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].setting_sample":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].uncertainty_limitations":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"external_references[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"follow_up[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"later":{"status":"persisted","date":"2026-05-28","note":"CGS completed its annual review on 28 May 2026 with no changes, so coverage continued on the same evidence text.","quote":"Revision Effective: 05/28/2026 Revision Explanation: Annual review, no changes made.","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37905"}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["later"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"human_oversight":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"id":{"state":"value_present","value":{"kind":"record_fields","fields":{"id":"AIBD-1007"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["id"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"infrastructure_dependencies[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].beneficiaries":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].beneficiary_count":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].benefit_type":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_type":"Improved Task Accuracy"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].claim":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Veracyte's Envisia Genomic Classifier reads the expression of 190 genes in tissue taken by bronchoscopy. It classifies the tissue as having the usual interstitial pneumonia pattern or not. That pattern marks idiopathic pulmonary fibrosis (IPF). Palmetto GBA's MolDX coverage determination took effect on 1 April 2019. The same text took effect for WPS, CGS and Noridian in May 2019. The contractors cite a 30-day mortality of 3-4% after surgical lung biopsy. In a blinded test set of 49 patients, the classifier had a specificity of 88% and a sensitivity of 70%. In an interim analysis of 56 cases, expert teams reached the same IPF or non-IPF diagnosis with the classifier as with histopathology in 92% of cases. The contractors cover the test when a CT scan has a probable or indeterminate pattern and known causes are excluded. They rated the evidence moderate in quality and limited in strength and weight. They judged its clinical utility “quite promising” and expect evidence of better patient outcomes from forthcoming studies. CGS completed an annual review with no changes on 28 May 2026.","benefit_type":"Improved Task Accuracy"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].distribution":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].duration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].id":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].stakeholder_group":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"personal","reason":"The contractors expect that patients will be spared surgical lung biopsy, but no cited study counted biopsies avoided or measured patient outcomes."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].status":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_status":"intended"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_status"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].tradeoffs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].unexpected":{"state":"value_present","value":{"kind":"record_fields","fields":{"unexpected":false,"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."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["unexpected","purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"places[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"location":"United States (the Medicare jurisdictions of Palmetto GBA, CGS, Noridian and WPS)","developer_country":"United States","deployer_country":"United States"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["location","developer_country","deployer_country"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"purpose":{"state":"value_present","value":{"kind":"record_fields","fields":{"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."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"record_dates":{"state":"value_present","value":{"kind":"record_fields","fields":{"date_observed":"2019-04-01","date_basis":"event","date_precision":"day","revisions":[{"date":"2026-11-01","change":"Added the record from the finding of Palmetto GBA, CGS Administrators, Noridian Healthcare Solutions and Wisconsin Physicians Service Insurance Corporation.","source":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37857","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["date_observed","date_basis","date_precision","revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"replication.attempts[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"replication.conditions":{"state":"value_present","value":{"kind":"record_fields","fields":{"replication":{"produced_by":["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."],"must_hold":["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."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"revision_history[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"revisions":[{"date":"2026-11-01","change":"Added the record from the finding of Palmetto GBA, CGS Administrators, Noridian Healthcare Solutions and Wisconsin Physicians Service Insurance Corporation.","source":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37857","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sector":{"state":"value_present","value":{"kind":"record_fields","fields":{"domain":"Healthcare (pulmonology)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["domain"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].access_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].citation_locator":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"assessment report","citation":"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).","title":"LCD L37857: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37857","date":"2019-04-01","written_by":"independent","quote":"These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology."},{"kind":"assessment report","citation":"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).","title":"LCD L37905: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37905","date":"2019-05-20","written_by":"independent","quote":"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."},{"kind":"assessment report","citation":"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).","title":"LCD L37887: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37887","date":"2019-05-27","written_by":"independent","quote":"These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology."},{"kind":"assessment report","citation":"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).","title":"LCD L37919: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37919","date":"2019-05-13","written_by":"independent","quote":"These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].id":{"state":"value_present","value":{"kind":"identifiers","identifiers":["AIBD-1007-source-0001","AIBD-1007-source-0002","AIBD-1007-source-0003","AIBD-1007-source-0004"],"role":"Existing evidence items, in their original order"},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"sources[].language":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"assessment report","citation":"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).","title":"LCD L37857: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37857","date":"2019-04-01","written_by":"independent","quote":"These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology."},{"kind":"assessment report","citation":"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).","title":"LCD L37905: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37905","date":"2019-05-20","written_by":"independent","quote":"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."},{"kind":"assessment report","citation":"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).","title":"LCD L37887: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37887","date":"2019-05-27","written_by":"independent","quote":"These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology."},{"kind":"assessment report","citation":"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).","title":"LCD L37919: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37919","date":"2019-05-13","written_by":"independent","quote":"These findings suggest that the Envisia™ classifier is capable of informing a clinical diagnosis without the need for surgical lung biopsy or expert pathology."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].upstream_sources":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"strategic_assessments[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"strategic assessments"},"summary":{"state":"value_present","value":{"kind":"record_fields","fields":{"summary":"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.","account":"Veracyte's Envisia Genomic Classifier reads the expression of 190 genes in tissue taken by bronchoscopy. It classifies the tissue as having the usual interstitial pneumonia pattern or not. That pattern marks idiopathic pulmonary fibrosis (IPF). Palmetto GBA's MolDX coverage determination took effect on 1 April 2019. The same text took effect for WPS, CGS and Noridian in May 2019. The contractors cite a 30-day mortality of 3-4% after surgical lung biopsy. In a blinded test set of 49 patients, the classifier had a specificity of 88% and a sensitivity of 70%. In an interim analysis of 56 cases, expert teams reached the same IPF or non-IPF diagnosis with the classifier as with histopathology in 92% of cases. The contractors cover the test when a CT scan has a probable or indeterminate pattern and known causes are excluded. They rated the evidence moderate in quality and limited in strength and weight. They judged its clinical utility “quite promising” and expect evidence of better patient outcomes from forthcoming studies. CGS completed an annual review with no changes on 28 May 2026."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"Envisia Genomic Classifier"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"Four Medicare contractors cover Veracyte's Envisia classifier, finding that it can inform a lung fibrosis diagnosis without surgical lung biopsy","headline":"Medicare contractors cover *Envisia* to spare patients lung surgery"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["fc338c1092a0b6f12094a8b75510c7660f4daecab7b78ad06a0463a0fae0ffc5"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Veracyte's Envisia Genomic Classifier reads the expression of 190 genes in tissue taken by bronchoscopy. It classifies the tissue as having the usual interstitial pneumonia pattern or not. That pattern marks idiopathic pulmonary fibrosis (IPF). Palmetto GBA's MolDX coverage determination took effect on 1 April 2019. The same text took effect for WPS, CGS and Noridian in May 2019. The contractors cite a 30-day mortality of 3-4% after surgical lung biopsy. In a blinded test set of 49 patients, the classifier had a specificity of 88% and a sensitivity of 70%. In an interim analysis of 56 cases, expert teams reached the same IPF or non-IPF diagnosis with the classifier as with histopathology in 92% of cases. The contractors cover the test when a CT scan has a probable or indeterminate pattern and known causes are excluded. They rated the evidence moderate in quality and limited in strength and weight. They judged its clinical utility “quite promising” and expect evidence of better patient outcomes from forthcoming studies. CGS completed an annual review with no changes on 28 May 2026.","replication":{"produced_by":["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."],"must_hold":["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."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":29,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":27,"review_not_assessed":62,"not_assessed":0,"complete":false,"by_state":{"value_present":29,"not_reported":0,"unresolved":62,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"36f4b953f2b9cb243c50d98c9d0149c9d9e97c4a4cda97fa46f210d3e219759b"}