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 A57901 (Billing and Coding: MolDX: Next-Generation Sequencing for Solid Tumors) 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.
A57901: Billing and Coding: MolDX: Next-Generation Sequencing for Solid Tumors (Billing and Coding, effective 2026-09-24)
- Covered ICD-10-CM codes
- 622
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 14
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C00.0 | — |
| C00.1 | — |
| C00.2 | — |
| C00.3 | — |
| C00.4 | — |
| C00.5 | — |
| C00.6 | — |
| C00.8 | — |
| C00.9 | — |
| C01 | Malignant neoplasm of base of tongue |
| C02.0 | — |
| C02.1 | — |
| C02.2 | — |
| C02.3 | — |
| C02.4 | — |
| C02.8 | — |
| C02.9 | — |
| C03.0 | — |
| C03.1 | — |
| C03.9 | — |
| C04.0 | — |
| C04.1 | — |
| C04.8 | — |
| C04.9 | — |
Procedure codes: 0244U, 0250U, 0329U, 0334U, 0379U, 0543U, 81445, 81449, 81455, 81456, 81457, 81458, 81459, 81479.
Coverage indications, limitations and medical necessity
This policy describes and clarifies coverage for Lab-Developed Tests (LDTs), Food and Drug Administration (FDA)-cleared, and FDA-approved clinical laboratory tests utilizing Next-Generation Sequencing (NGS) in cancer as allowable under the National Coverage Determination (NCD) 90.2, under section D describing Medicare Administrative Contractor (MAC) discretion for coverage. This policy’s scope is specific for solid tumor testing, and is exclusive of hematologic malignancies, circulating tumor DNA testing (ctDNA), and other cancer-related uses of NGS, such as germline testing in/for patients with cancer.
Summary of evidence (opening)
Summary of Evidence
NGS testing in solid tumors is becoming a routine component of the diagnostic process 1 ; the results can uncover the genomic mechanisms of cancer that have predictive, diagnostic, and prognostic utility to the patient and are used to better their management. 2 Understanding the mechanisms of disease and targeting treatment based on those aberrant processes (i.e., targeted therapies for biomarkers) has improved patient outcomes in many tumor types and is the basis of Precision Medicine. 3 Capturing mutations and other relevant genetic/genomic information is standard of care for determining clinical care for many tumor types, including the most common, such as melanoma, lung, colorectal, and breast carcinoma. 4-7 NGS adds the ability to capture abundant genomic data both efficiently, and relatively cheaply, and its use is showing to improve patient outcomes although studies in this regard are ongoing. 8 The established Centers for Medicare & Medicaid Services (CMS) National Coverage policy NCD 90.2 confirms these tests to be both reasonable and necessary in Medicare beneficiaries.
Professional Society Clinical Practice Guidelines
Guidelines for validating clinical NGS tests for use in cancer have been published in a joint effort by the Association for Molecular Pathology and the College of American Pathologists. 9 Guidelines for employing bioinformatics pipelines for NGS testing have also been published by these groups, 10 as well as guidelines for interpreting somatic variants in these panels (these same groups in collaboration with the American Society of Clinical Oncology). 11
The contractor cites 23 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2020-05-17
- Current revision effective
- 2026-02-05
- Last reviewed by the contractor
- 2023-04-20
- MCD version
- 11
The contractor lists one National Coverage Determination as related: NCD 90.2 Next Generation Sequencing (NGS). Where an NCD speaks, it controls; the LCD can only address what the NCD leaves open.
Other related documents: A55624 (Billing and Coding), A57904 (Response to Comments), A57906 (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 L38119 cover?
This policy describes and clarifies coverage for Lab-Developed Tests (LDTs), Food and Drug Administration (FDA)-cleared, and FDA-approved clinical laboratory tests utilizing Next-Generation Sequencing (NGS) in cancer as allowable under the National Coverage Determination (NCD) 90.2, under section D describing Medicare Administrative Contractor (MAC) discretion for coverage. This policy’s scope is specific for solid… 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 L38119 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 L38119?
The companion billing and coding article A57901 lists 622 ICD-10-CM codes in 1 group that support medical necessity; the first 24 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L38119?
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.