Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
| Contract | Contractor | Type | States |
|---|---|---|---|
| 15102 | CGS Administrators, LLC | MAC - Part B | KY |
| 15202 | CGS Administrators, LLC | MAC - Part B | OH |
| 15101 | CGS Administrators, LLC | MAC - Part A | KY |
| 15201 | CGS Administrators, LLC | MAC - Part A | OH |
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A57165 (Billing and Coding: MolDX: Melanoma Risk Stratification Molecular Testing) 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.
A57165: Billing and Coding: MolDX: Melanoma Risk Stratification Molecular Testing (Billing and Coding, effective 2025-10-01)
- Covered ICD-10-CM codes
- 24
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 4
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C43.0 | — |
| C43.10 | — |
| C43.111 | — |
| C43.112 | — |
| C43.121 | — |
| C43.122 | — |
| C43.20 | — |
| C43.21 | — |
| C43.22 | — |
| C43.30 | — |
| C43.31 | — |
| C43.39 | — |
| C43.4 | — |
| C43.51 | — |
| C43.52 | — |
| C43.59 | — |
| C43.60 | — |
| C43.61 | — |
| C43.62 | — |
| C43.70 | — |
| C43.71 | — |
| C43.72 | — |
| C43.8 | — |
| C43.9 | — |
Procedure codes: 0578U, 81479, 81529, 81599.
Coverage indications, limitations and medical necessity
Molecular diagnostic tests used to assist in risk stratification of melanoma patients are covered when ALL of the following are true:
• The patient has a personal history of melanoma AND:
• Either
• Has Stage T1b and above OR
• Has T1a with documented concern about adequacy of microstaging
• Is undergoing workup or being evaluated for treatment, AND
• Does not have metastatic disease AND
• Presumed risk for a positive Sentinel Lymph Node Biopsy (SLNB) based on clinical, histological, or other information is >5% AND
• Has a disease stage, grade, and Breslow thickness (or other qualifying conditions) within the intended use of the test
2. The TEST has demonstrated, as part of a Technical Assessment:
• Clinical validity of analytes tested in predicting metastatic disease ( or absence of metastice disease) in peer-reviewed scientific literature
• Utility beyond clinical, histological, and radiographical factors in the ability to accurately stratify patients into risk groups to manage patient care, such by precluding unnecessary sentinel lymph node biopsies
• Appropriate analytical validity
• Performance characteristics equivalent or superior to other covered, similar tests
Summary of evidence (opening)
Cutaneous melanoma (CM) is increasing in incidence in the U.S., with an estimated 96,480 cases expected to be diagnosed in 2019 with 7,230 deaths. 1
In the treatment of CM, the risk that a patient has or will develop metastatic disease is central to many of the decision management choices in cutaneous melanoma, with more aggressive management or treatment strategies recommended for patients who are at a higher risk. 2 Per current national guidelines, a SLNB procedure is considered for all patients with melanoma pathologic Stage T1b and above, as well as those patients with T1a tumors in whom there is significant uncertainty about the adequacy of microstaging. 2,3 Patients with a positive SLN are at substantially increased risk for distant metastatic disease and death, 4 however, the procedure only provides prognostic information, and the MSLT-II study showed no survival benefit associated with completion lymphadenectomy in SLN positive patients. 5 Currently, the identification of SLN positive patients helps identify Stage III patients who can potentially benefit from targeted and immunotherapeutic agents in the adjuvant setting. 6-8 The procedure can be associated with complications in a substantial proportion of patients such as pain, seromas, nerve damage and edema, and requires a large team of dedicated personnel, including nuclear medicine physicians, surgeons, and pathologists. 9-11 It has been estimated that the cost of a SLNB can be 10 times that of a wide excision alone, and the cost per life saved in a patient population with low prevalence of positive SLN can approach 1 million dollars. 12 Overall, the likelihood of a positive SLN after the SLNB procedure is 16%, 4,13 but this is variable for specific populations. 13-16 Elderly patients account for a substantial proportion of CM patients, and 60% of melanoma-related deaths occur in patients ≥65 years-old. While older age is associated with a poor prognosis, fewer elderly patients are SLN positive, 14-18 which indicates that the prognostic value of SLNB is limited in this population.1 9,20 In general, a 5% likelihood for a positive SLN is recommended as a threshold for performing this procedure in a patient population. 13
Molecular diagnostic tests have been proposed to help managing clinicians risk stratify patients for selecting their most appropriate management based on their probability of developing metastatic disease; these tests may score patients’ probabilities of resultant metastatic disease by measuring tumor biomarkers such as relevant gene expression. 21-24 One gene expression profile (GEP) test (DecisionDx Melanoma, Castle Biosciences) was evaluated in a retrospective cohort (n=782) to evaluate its ability to predict metastasis and ability to predict SLNB status with tumors with a Breslow thickness 25
The ability of the test to identify a low- risk group was initially assessed and compared to SLNB in 2 contemporary, multi-center, prospective study cohorts: a 584 patient cohort from 2 published prospective studies (overall 14% SLN positive rate) 23,26 and a 837 patient cohort from prospectively tested patients at 5 large academic institutions (overall 12% SLN positive rate). 25 The rate of SLN positivity in both prospective study cohorts aligns with the SLN positivity rate in the general population of melanoma patients who have undergone SLNB. The results show that in patients from the Medicare-eligible population (65 years old and over) who were determined to be low-risk by this test, the concordance of a negative SLNB was 98.4%. These studies showed improved performance in other patient groups as well.
The contractor cites 49 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2019-06-24
- Current revision effective
- 2025-06-26
- Last reviewed by the contractor
- 2025-05-07
- MCD version
- 21
Other related documents: A59084 (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 CGS Administrators, 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 L38016 cover?
• Clinical validity of analytes tested in predicting metastatic disease ( or absence of metastice disease) in peer-reviewed scientific literature 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 L38016 apply to?
CGS Administrators, LLC applies it to Medicare claims in KY, OH. 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 L38016?
The companion billing and coding article A57165 lists 24 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 L38016?
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.