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 A58205 (Billing and Coding: MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells) 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.
A58205: Billing and Coding: MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells (Billing and Coding, effective 2026-05-28)
- Covered ICD-10-CM codes
- 85
- 2 groups
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 1
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C50.011 | — |
| C50.012 | — |
| C50.021 | — |
| C50.022 | — |
| C50.029 | — |
| C50.111 | — |
| C50.112 | — |
| C50.119 | — |
| C50.121 | — |
| C50.122 | — |
| C50.129 | — |
| C50.211 | — |
| C50.212 | — |
| C50.219 | — |
| C50.221 | — |
| C50.222 | — |
| C50.229 | — |
| C50.311 | — |
| C50.312 | — |
| C50.319 | — |
| C50.321 | — |
| C50.322 | — |
| C50.329 | — |
| C50.411 | — |
Procedure codes: 81479.
Coverage indications, limitations and medical necessity
This is a limited coverage policy for assays that detect biomarkers from circulating tumor cells (CTCs).
Criteria for Coverage
Cancers with established biomarker testing, as recommended by society or national guidelines
Assays that detect biomarkers from CTCs are covered when ALL of the following are met:
• The patient has been diagnosed with cancer
• The specific cancer type has an associated biomarker
• The associated biomarker has already established clinical utility (CU) in the peer-reviewed published literature for the intended cancer type and for the specific indication in the intended patient population
• The biomarker’s CU may include any of the following: it can be used to diagnose, risk-stratify, predict, or monitor response to therapy, as recommended by national or society guidelines (i.e., American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN))
• At least 1 of the following criteria are met AND there is clear documentation of at least 1 of these in the medical record:
• The patient’s cancer has not previously been tested for the specific biomarker, OR
• The patient has newly metastatic cancer, and a metastatic lesion has not been tested for the specific biomarker, OR
• The patient demonstrates signs of clinical, radiological or pathologic disease progression, OR
• There is concern for resistance to treatment based on specific and well-established clinical indications
• Testing for the biomarker can be performed using CTCs
• The CTC-based biomarker test successfully completes a comprehensive Technical Assessment (TA) by Molecular Diagnostic Services Program (MolDX ® ) that will ensure that Analytical Validity (AV) (including analytical and clinical validation), Clinical Validity (CV), and CU criteria are met to establish the test as Reasonable and Necessary.
• The clinical validation has demonstrated performance that is equivalent or superior to tissue-based testing or another already-accepted test for the same biomarker for the same intended use.
• CV (for new analytes) must be established through studies published in the peer-reviewed literature for the intended use of the test in the intended population.
• Tissue-based testing for the specific biomarker is infeasible (e.g., quantity not sufficient or invasive biopsy is medically contraindicated) OR will not provide sufficient information for subsequent medical management (e.g., in cases where human epidermal growth factor receptor 2 (HER2) overexpression is negative in a tissue biopsy but may be positive in the CTCs, due to tumor heterogeneity). There is clear documentation of at least 1 of these reasons for testing in the medical record.
• For a given patient encounter, only 1 test for assessing the biomarker may be performed UNLESS a second test, meeting all the criteria established herein, is reasonable and necessary as an adjunct to the first test.
• Duplicate testing of the same biomarker ( from the same sample type and for the same clinical indication ) using different methodologies is not covered. For example, testing for androgen receptor splice variant 7 (AR-V7) from CTCs by messenger RNA (mRNA) as well as immunohistochemistry (IHC)-based methodologies, for the same clinical indication, will not be covered.
Summary of evidence (opening)
Testing for biomarkers in cancer is often a routine part of medical care. 1 Biomarker testing can be performed from tissue samples, or from samples obtained using less-invasive means such as the liquid biopsy. In the liquid biopsy approach, testing is performed on cancer-derived components (including CTCs) found in peripheral blood or other body fluids. 2 Specifically, the testing of CTCs in liquid biopsy specimens involves cell capture, enrichment, and downstream molecular characterization, with the goal of impacting disease management in cancer. 3 Current technological approaches for identifying biomarkers from CTCs include distinguishing the comparatively rare tumor cells from among the large number of normal cells by image processing and/or direct capture techniques, along with staining for the biomarker of interest. 4-7
CTCs can be used to detect biomarkers important for prognosis, identifying treatment, and monitoring response to treatments in cancer. Biomarker detection from CTCs may therefore serve as a potential alternative to biomarker detection from biopsy specimens for certain cancers, including breast and prostate. 4-7
Breast Cancer
In 1998 the Food and Drug Administration (FDA) approved the drug Herceptin ® (trastuzumab) for the treatment of HER2 over-expressing breast cancer. Testing for HER2 has become 1 of the most important sources of information in making management decisions regarding systemic therapy in breast cancer. The NCCN guidelines on breast cancer recommend that all patients who have new primary or newly metastatic breast cancers be tested for HER2 using a methodology outlined in the ASCO/College of American Pathologists (CAP) guideline. 8,9 Traditionally, testing for HER2 was performed using tissue. Testing from tissue, however, can be associated with complications. For example, breast malignancies may metastasize to the brain, 10 and analyses of complications following brain biopsies have shown a wide array of complications ranging from neurologic complications to general surgical complications. 11,12
The contractor cites 68 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2021-07-25
- Current revision effective
- 2026-06-25
- Last reviewed by the contractor
- 2026-05-27
- MCD version
- 11
Other related documents: A58792 (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 L38678 cover?
• The CTC-based biomarker test successfully completes a comprehensive Technical Assessment (TA) by Molecular Diagnostic Services Program (MolDX ® ) that will ensure that Analytical Validity (AV) (including analytical and clinical validation), Clinical Validity (CV), and CU criteria are met to establish the test as Reasonable and Necessary. 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 L38678 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 L38678?
The companion billing and coding article A58205 lists 85 ICD-10-CM codes in 2 groups 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 L38678?
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.