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 A59505 (Billing and Coding: MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy) 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.
A59505: Billing and Coding: MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy (Billing and Coding, effective 2026-01-22)
- Covered ICD-10-CM codes
- 2
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 1
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| R91.1 | — |
| R91.8 | — |
Procedure codes: 81479.
Coverage indications, limitations and medical necessity
This contractor will provide limited coverage for molecular tests to aid in the diagnosis or exclusion of lung cancer in a patient with an indeterminate pulmonary nodule (IPN) following a non-diagnostic bronchoscopy when ALL of the following conditions are met:
• The beneficiary has undergone bronchoscopy for an indeterminate pulmonary nodule AND
• The bronchoscopy has failed to provide a specific histopathological diagnosis such that further diagnostic procedures would otherwise be considered necessary to pursue a specific diagnosis (non-diagnostic bronchoscopy); AND
• Test results will be used to meaningfully inform patient management within the framework of nationally recognized consensus guidelines.
• The nodule cannot or will not be evaluated by an alternate methodology (EBUS, FNA, etc.) for a specific diagnosis prior to receipt of molecular test results.
• The beneficiary does NOT have any of the following:
• Personal history of lung cancer
• Current diagnosis of cancer or high clinical suspicion for cancer
• An overall low risk for pulmonary malignancy such that test results would not meaningfully alter patient management and significantly improve patient outcomes.
• An overall high risk for pulmonary malignancy such that test results would not meaningfully alter patient management and significantly improve patient outcomes.
• The beneficiary has not been tested with the same or similar assay for the same clinical indication.
• The beneficiary is within the population and has the indication for which the test was developed and is covered. The lab providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use.
• The test has demonstrated clinical validity and utility, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision in a clearly defined population.
• Clinical validity of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population.
• Rule-out tests should have a high sensitivity and negative predictive value (NPV) such that patients can be safely selected for a less aggressive management strategy without delay to diagnosis due to false negative results.
• Rule-in tests should have a high specificity and positive predictive value (PPV) such that patients can be safely selected for more aggressive management without significantly increasing procedures in patients without cancer due to false positive results.
• The test demonstrates analytical validity including both analytical and clinical validations. If the test relies on an algorithm (which may range in complexity from a threshold determination of a single numeric value to a complex mathematical or computational function), the algorithm must be validated in a cohort that is not a development cohort for the algorithm.
• Tests utilizing a similar methodology or evaluating a similar molecular analyte to a test for which there is a generally accepted testing standard or for which existing coverage exists must demonstrate equivalent or superior test performance (i.e., sensitivity and/or specificity) when used for the same indication in the same intended-use population. New tests that become available with significantly improved performance may render older tests no longer compliant with this policy.
• The test successfully completes a Molecular Diagnostic Services Program (MolDX ® ) technical assessment that ensures the test is reasonable and necessary as described above.
NOTE: Next Generation Sequencing (NGS) performed to identify genetic variants in samples classified as malignant is not within the scope of this policy but may fall under other established policies.
Summary of evidence (opening)
Lung Cancer Screening
Lung cancer is the leading cause of cancer-related deaths in the United States. 1 It is estimated that 236,740 new cases of lung and bronchial cancer will have been diagnosed in the United States in 2022 (117,910 in men and 118,830 in women) with 130,180 anticipated deaths (68,820 in men and 61,360 in women). 1 Earlier diagnosis has significant impact on clinical outcome, as 5-year survival increases from 6%-9.5% for distant-stage disease, to 33-44% for regional disease, and 60-75% for localized disease, 1 although there have been recent improvements in non-small cell lung cancer outcomes across stages with the advent of targeted and molecular therapies. 2 Data from larger randomized control trials such as the National Lung Screening Trial (NLST) and the Dutch-Belgian Randomized Lung Cancer Screening Trial (Nederlands–Leuvens Longkanker Screenings Onderzoek [NELSON]) supports low-dose CT (LDCT) screening in high-risk individuals based on smoking criteria and age. 3-5 A noticeable decline in advanced-stage lung cancer diagnosis with a corresponding increase in incidence of localized stage disease was observed between 2013 and 2018 following recommendation for lung cancer screening by the United States Preventive Services Task Force (USPSTF). 6 Due to increased strength of evidence supporting annual screening with LDCT for high-risk individuals, USPSTF issued updated screening guidelines in March of 2021, expanding eligibility to adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. 6 The Centers for Medicare & Medicaid Services (CMS) covers annual LDCT screening for appropriate Medicare beneficiaries with significant smoking history up to 77 years of age if they participate in shared decision-making before their first screening LDCT. 7 LDCT screening is also recommended by the 2021 CHEST Guideline and Expert Panel Report on Screening for Lung Cancer. 8
Although there is consensus on the value of LDCT screening, uncertainty remains about the appropriate duration of screening and age of screening cessation, with NCCN recommending annual screening until the patient is no longer a candidate for definitive treatment. 9 There are also potential risks associated with LDCT screening including false negative as well as false positive results that can lead to unnecessary tests and invasive procedures, complications from the diagnostic workup, overdiagnosis of incidental findings, short-term anxiety due to indeterminate results, and radiation exposure. 9 As a result of increased implementation of screening guidelines, the incidence of nodules detected on CT continues to rise, and an estimated 1.5 million nodules are detected each year in the United States. 10 Most lung nodules found on LDCT are benign, 3 , 4 such that lung cancer prevalence in the screening setting is 0.8-2.2% and approximately 0.11% in nodules incidentally detected when imaging is performed for other reasons. 10 An LDCT screen is defined as “positive” if the size and morphologic features of the detected nodule results in a recommendation for follow-up testing in addition to recommended annual screening based on published guidelines. 8 Approximately 7% of patients with false positive results go on to an invasive procedure, most often bronchoscopy. 9,11,12
Indeterminate Pulmonary Nodules (IPN) Risk Assessment and Management Guidelines
The contractor cites 53 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2024-09-22
- Current revision effective
- 2026-01-22
- Last reviewed by the contractor
- 2024-06-20
- MCD version
- 5
Other related documents: A59854 (Response to Comments), A59855 (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 Noridian Healthcare Solutions, LLC 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 L39678 cover?
This contractor will provide limited coverage for molecular tests to aid in the diagnosis or exclusion of lung cancer in a patient with an indeterminate pulmonary nodule (IPN) following a non-diagnostic bronchoscopy when ALL of the following conditions are met: 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 L39678 apply to?
Noridian Healthcare Solutions, LLC applies it to Medicare claims in AK, AS, AZ, CA, CNMI, GU, HI, ID, MT, ND, NF, NV, OR, SD, SF, UT, WA, 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 L39678?
The companion billing and coding article A59505 lists 2 ICD-10-CM codes in 1 group that support medical necessity; the first 2 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L39678?
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.