Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A57568 (Billing and Coding: MolDX: Envisia™, Veracyte™, Idiopathic Pulmonary Fibrosis Diagnostic Test) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A57568: Billing and Coding: MolDX: Envisia™, Veracyte™, Idiopathic Pulmonary Fibrosis Diagnostic Test (Billing and Coding, effective 2023-04-27)
- Covered ICD-10-CM codes
- 6
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 1
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| J84.10 | — |
| J84.111 | — |
| J84.112 | — |
| J84.113 | — |
| J84.116 | — |
| J84.9 | — |
Procedure codes: 81554.
Coverage indications, limitations and medical necessity
This is a laboratory test which will assist physicians caring for patients who have developed pulmonary (lung) scarring.
This policy provides limited coverage for the Envisia™ Genomic Classifier (Veracyte™, Inc., South San Francisco, CA), a tissue based multi-analyte assay with algorithm analysis test (hereafter called Envisia) for interstitial lung disease (ILD) patients who are suspected of having 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 of ILD. IPF suspicion increases significantly in patients greater than 60 years of age when HRCT is not definitive, and comorbidities in this population make clinicians reluctant to perform surgical lung biopsy to obtain a diagnosis due to significant procedure morbidity and mortality. Envisia™ testing is performed on less-invasive bronchoscopy transbronchial biopsy (TBB) samples, and is intended to provide a categorical UIP or non-UIP result, that along with clinical and radiographic information, may guide treatment without the need or risk of surgical lung biopsy.
Summary of evidence (opening)
ILD is a heterogenous group of lung disorders, for which an accurate diagnosis is critical to determining appropriate intervention for a given patient. 1 IPF is one of 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. 2 The incidence of IPF is estimated to be between 8-17 per 100,000 person years in the general population, 3 and mean survival after diagnosis is 2 to 5 years. 2 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. 4
Historically, lung transplantation has been the only proven treatment for IPF, but its use has been limited due to supply of donor organs and poor survival for IPF patients relative to other candidates. 5 Recent clinical trials evaluating the efficacy of anti-fibrotic therapy in patients diagnosed with IPF have demonstrated a 50% reduction in the proportion of patients that have absolute pulmonary function decline of 10% or greater, an increase in the rate of patients with no pulmonary function decline, and improved progression free survival. 6,7 These findings suggest an improvement in patient outcomes when IPF is accurately diagnosed and treated.
The pattern of UIP is the hallmark of an IPF diagnosis. The development of evidence based diagnostic criteria for IPF in 2011 by an international consortium of pulmonary societies, including the American Thoracic Society (ATS), requires exclusion of known causes of ILD, a definitive UIP pattern by HRCT, or specific combinations of UIP by HRCT and surgical pathology. 2 Despite efforts to standardize these criteria, interobserver agreement of categorical UIP diagnosis by HRCT following the ATS guideline is moderate (52%) among expert thoracic radiologists. 8 Recent studies suggest that a minority (13%) of patients being evaluated for IPF obtain a definitive UIP diagnosis by HRCT, necessitating surgical biopsy as the next diagnostic step. 9
Diagnosis of IPF by HRCT alone is challenging. As shown in Table 1, a diagnosis of UIP by HRCT requires the coexistence of multiple radiographic features of a UIP pattern and absence of features inconsistent with UIP. Those features consistent with IPF may also be found in patients with other common ILDs of known cause, such as chronic hypersensitivity pneumonitis (HP). 10 Although guidelines place significant importance upon a thorough clinical history to identify ILDs of known cause, up to 30% of patients with HP are ultimately diagnosed without identifying a known cause, further complicating clinician’s ability to distinguish these diseases. 11 Additional non-surgical biopsy approaches to diagnosing ILDs of known cause that may be utilized include bronchoalveolar lavage (BAL) for the identification of lymphocytosis which may suggest occult hypersensitivity pneumonitis, and TBB which is useful in diagnosing granulomatous disorders, such as sarcoidosis. 2 While highly specific for these indications and significantly less risk than a surgical biopsy, pathologic review of BAL and TBB specimens have not shown to be sensitive for detecting a UIP pattern. 12
The contractor cites 22 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2019-05-13
- Current revision effective
- 2023-06-29
- Last reviewed by the contractor
- 2023-05-23
- MCD version
- 12
Other related documents: A56402 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Wisconsin Physicians Service Insurance Corporation hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L37919 cover?
This policy provides limited coverage for the Envisia™ Genomic Classifier (Veracyte™, Inc., South San Francisco, CA), a tissue based multi-analyte assay with algorithm analysis test (hereafter called Envisia) for interstitial lung disease (ILD) patients who are suspected of having idiopathic pulmonary fibrosis (IPF), and who do not have a definitive usual interstitial pneumonia (UIP) pattern by high resolution… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L37919 apply to?
Wisconsin Physicians Service Insurance Corporation applies it to Medicare claims in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L37919?
The companion billing and coding article A57568 lists 6 ICD-10-CM codes in 1 group that support medical necessity; the first 6 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L37919?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.