Envisia for Idiopathic Pulmonary Fibrosis Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 09|01|2025 POLICY LAST REVIEWED: 05|21|2025 OVERVIEW
The Envisia genomic classifier is a multianalyte assay with algorithm analyses that analyzes gene expression of 190 genes to deliver a categorical UIP or Non-UIP result. The Envisia classifier is intended for patients with interstitial lung disease (ILD) suspected of idiopathic pulmonary fibrosis (IPF) and who do not have a definitive usual interstitial pneumonia (UIP) pattern by high resolution computed tomography (HRCT) or other known cause The Envisia genomic classifier is intended to provide a categorical UIP or Non-UIP result that along with clinical and radiographic information may guide treatment without the need for surgical lung biopsy reducing patient risk. MEDICAL CRITERIA Medicare Advantage Plans and Commercial Products Effective 9/1/2025, the following test(s) are considered medically necessary when the medical criteria in the online authorization tool for participating providers is met:
• Envisia Genomic Classifier (Veracyte) – CPT Code 81554 PRIOR AUTHORIZATION
Medicare Advantage Plans and Commercial Products Prior authorization is required for Medicare Advantage Plans and is recommended for Commercial Products via the online tool for participating providers for the following test(s):
• Envisia Genomic Classifier Note: Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. Only the ordering physician shall be involved in the authorization, appeal or other administrative processes related to prior authorization/medical necessity.
In no circumstance shall a laboratory or a physician/provider use a representative of a laboratory or anyone with a relationship to a laboratory and/or a third party to obtain authorization on behalf of the ordering physician, to facilitate any portion of the authorization process or any subsequent appeal of a claim where the authorization process was not followed and/or a denial for clinical appropriateness was issued, including any element of the preparation of necessary documentation of clinical appropriateness. If a laboratory or a third party is found to be supporting any portion of the authorization process, BCBSRI will deem the action a violation of this policy and severe action will be taken up to and including termination from the BCBSRI provider network. If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member. POLICY STATEMENT Medicare Advantage Plans and Commercial Products Effective 9/1/2025, the Envisia Genomic Classifier test may be considered medically necessary when the medical criteria in the online authorization tool for participating providers is met.
Commercial Products Some genetic testing services are not covered and a contract exclusion for any self-funded group that has excluded the expanded coverage of biomarker testing related to the state mandate, R.I.G.L. §27-19-81 described in the Biomarker Testing Mandate policy. For these groups, a list of which genetic testing services are covered with prior authorization, are not medically necessary or are not covered because they are a contract exclusion Medical Coverage Policy | Envisia for Idiopathic Pulmonary Fibrosis

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

can be found in the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies. Please refer to the appropriate Benefit Booklet to determine whether the member’s plan has customized benefit coverage. Please refer to the list of Related Policies for more information.

COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable laboratory benefits/coverage.

BACKGROUND Interstitial lung disease (ILD) is a heterogenous group of lung disorders, for which an accurate diagnosis is critical to determining appropriate intervention for a given patient. Idiopathic Pulmonary Fibrosis (IPF) is one the most common interstitial lung diseases and frequently implicated when there is no other known cause of ILD, and often necessitates surgical lung biopsy to obtain a diagnosis. The natural history of IPF is described as progressive decline in pulmonary function until eventual death from respiratory failure or complicating comorbidity. Patients with IPF under age 50 are rare, with disease typically presenting in the sixth and seventh decades of life and incidence increasing with older age. The incidence of IPF is estimated to be between 8-17 per 100,000 person-years in the general population, and mean survival after diagnosis is 2 to 5 years. A study evaluating Medicare claims data from 2000 to 2011 found that the incidence of IPF in the Medicare population is significantly higher, 93.7 per 100,000 person years, than observed in the general population.

CODING Medicare Advantage and Commercial Products
Effective 9/1/2025, the following CPT code is medically necessary for Medicare Advantage Plans and Commercial Products when medical criteria in the online authorization tool are met:
• Envisia Genomic Classifier – CPT Code 81554

RELATED POLICIES Biomarker Testing Mandate
Genetic Testing Services

PUBLISHED Provider Update, July 2025 Provider Update, September 2024 Provider Update, November 2023 Provider Update, May 2023 Provider Update, January 2021

REFERENCES Not applicable

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This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS