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 A58973 (Billing and Coding: MolDX: Plasma-Based Genomic Profiling in 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.
A58973: Billing and Coding: MolDX: Plasma-Based Genomic Profiling in Solid Tumors (Billing and Coding, effective 2026-02-05)
- Covered ICD-10-CM codes
- 622
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 10
- 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: 0179U, 0326U, 0485U, 0487U, 0571U, 81445, 81462, 81463, 81464, 81479.
Coverage indications, limitations and medical necessity
This is a limited coverage policy for next-generation sequencing (NGS) assays performed on solid tumor cell-free deoxyribonucleic acid (DNA) in plasma, from here on called “liquid biopsies.”
Criteria for Coverage
Guardant360 ® is covered only when all of the following conditions are met:
• Patient has been diagnosed with a recurrent, relapsed, refractory, metastatic, or advanced solid tumor that did not originate from the central nervous system. Patients who would meet all of the indications on the Food and Drug Administration (FDA) label for larotrectinib if they are found to have a neurotrophic receptor tyrosine kinase (NTRK) mutation may be considered to have advanced cancer, and
• Patient has not previously been tested with the Guardant360 ® test for the same genetic content. For a patient who has been tested previously using Guardant360 ® for cancer, that patient may not be tested again unless there is clinical evidence that the cancer has evolved wherein testing would be performed for different genetic content. Specifically, in patients with previously tested cancer, who have evidence of new malignant growth despite response to a prior targeted therapy, that growth may be considered to be sufficiently genetically different to require additional genetic testing, and
• Patient is untreated for the cancer being tested, or the patient is not responding to treatment (e.g., progression or new lesions on treatment), and
• The patient has decided to seek further cancer treatment with the following conditions:
• The patient is a candidate for further treatment with a drug that is either FDA-approved for that patient’s cancer, or has a National Comprehensive Cancer Network (NCCN) 1 or NCCN 2A recommendation for that patient’s cancer, and
• The FDA-approved indication or NCCN recommendation is based upon information about the presence or absence of a genetic biomarker tested for in the Guardant360 ® assay, and
• Tissue-based, comprehensive genomic profiling (CGP) is infeasible (e.g., quantity not sufficient for tissue-based CGP or invasive biopsy is medically contraindicated) or specifically in NSCLC Tissue-based CGP has shown no actionable mutations.
If no alteration is detected by Guardant360 ® or if circulating tumor deoxyribonucleic acid (ctDNA) is insufficient/not detected, tissue-based genotyping should be considered.
Other liquid biopsies will be covered for the same indications if they display similar performance in their intended used applications to Guardant360 ® .
A wide array of cancer treatments have developed ranging from surgery to medications. One of the newer approaches to the medical treatment of cancer has been to use drugs based on genetic features of a malignancy. While many patients will not benefit from genetic testing to select treatment, for those whose cancers have select biomarkers, the treatment of choice often includes therapy targeting that specific biomarker or therapy being avoided because of a biomarker. 1-13
In spite of the importance of actionable biomarker identification in cancer, research has shown that many patients do not receive genetic testing for the presence of actionable mutations in their cancers, and there are geographic disparities in testing with patients in rural areas and those receiving care at community treatment centers being less likely to receive testing. 14-16 In addition, logistical challenges to testing such as adequate tissue and the availability of any tissue have been identified as barriers to tissue-based genomic testing. 15 Additionally, even among patients whose cancers were genomically profiled at diagnosis and found to have a mutation for which they are receiving targeted treatment, resistance to the initial targeted treatment may emerge. For some patients, the identification of a new mutation, not present in the original tissue sample and found in the blood, may allow the selection of a new targeted life-prolonging therapy. 17
Summary of evidence (opening)
Clinical utility of comprehensive genomic profiling using plasma-based testing
Traditionally, tumor genotyping has been conducted by direct interrogation of tumor tissue obtained through invasive tissue sampling procedures. This diagnostic approach, however, is limited by the availability of sufficient tumor tissue and the ability of patients to undergo invasive procedures. In a recent study of over 100 community-based oncologists, nearly one-third of non-small cell lung cancer (NSCLC) patients were not tested for epidermal growth factor receptor (EGFR) or anaplastic large-cell lymphoma kinase (ALK), over 75% were not tested for ROS1 fusions, and fewer than 10% were tested for all guideline-recommended alterations. 15 These results were similar to a study in a single academic center where only 58% of non-squamous NSCLC were tested for EGFR and 40% for ALK fusions, despite 13% of patients undergoing repeat invasive biopsies to obtain sufficient tissue for genomic testing. 18 Tissue availability was similarly limited in several recent series, some of which reported that more than 50% of NSCLC patients had insufficient or unobtainable material for tissue-based CGP. 19-21
Even when successful, tissue acquisition procedures pose a significant morbidity and mortality risk to Medicare patients. In a recent report, 19% of all lung tissue acquisition procedures resulted in a serious adverse event, 22 while the National Lung Cancer Screening Trial reported 1-2% mortality rates in their cohorts. 23 The FDA has also specifically approved a medication for patients who have cancer (cancer type unspecified on the label) for which there is a high risk associated with surgical resection. 24 Given the high rates of inadequate genotyping described above, plasma-based CGP can provide an opportunity for non- and under-genotyped patients to benefit from therapy matched to a genetic biomarker. Early studies suggested that plasma-based CGP can identify potential genomic targets in both the first and second lines, with response rates similar to those of patients identified using tissue-based CGP and tissue-based CoDX. 20,21,25-27
It has been shown that the region of DNA sequenced is important, since alterations may occur outside the sequenced region or involve complex alterations (e.g., indels, copy number alterations, or rearrangements) that are not detectable by certain tests. 28 Newer techniques such as next-generation sequencing (NGS), offer the possibility of not only increased analytical sensitivity but also the ability to detect a broader range of genomic alterations. 29
The contractor cites 37 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2022-12-26
- Current revision effective
- 2026-02-05
- Last reviewed by the contractor
- 2025-01-14
- MCD version
- 7
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: A59278 (Response to Comments), A59279 (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 L39230 cover?
This is a limited coverage policy for next-generation sequencing (NGS) assays performed on solid tumor cell-free deoxyribonucleic acid (DNA) in plasma, from here on called “liquid biopsies.” 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 L39230 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 L39230?
The companion billing and coding article A58973 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 L39230?
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.