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 A57983 (Billing and Coding: MolDX: Pigmented Lesion Assay) 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.
A57983: Billing and Coding: MolDX: Pigmented Lesion Assay (Billing and Coding, effective 2023-12-28)
- Covered ICD-10-CM codes
- 1
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 1
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| D48.5 | — |
Procedure codes: 0089U.
Coverage indications, limitations and medical necessity
This Medicare contractor will provide limited coverage for the Pigmented Lesion Assay / PLA (DermTech, Inc., La Jolla, CA), a Ribonucleic Acid (RNA) gene expression test conducted on skin samples obtained noninvasively via adhesive patches.
The PLA is indicated only for use on pigmented skin lesions, for which a diagnosis of melanoma is being considered. The test may only be ordered by clinicians who evaluate pigmented skin lesions and perform biopsies. The test is covered for use as a source of information on whether or not to perform a biopsy.
The specific characteristics that the lesion must have are as follows:
• The lesion must meet 1 or more ABCDE criteria (Asymmetry, Border, Color, Diameter, Evolving)
• Primary melanocytic skin lesions between 5mm and 19mm
• Lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions)
• Lesions that do not contain a scar or were previously biopsied
• Lesions not located in areas of psoriasis, eczema or similar skin conditions
• Lesions not already clinically diagnosed as melanoma or for which the clinical suspicion is sufficiently high that the treating clinician believes melanoma is a more likely diagnosis than not
• Lesions in areas other than palms of hands, soles of feet, nails, mucous membranes, and hair covered areas that cannot be trimmed
Additional coverage requirements:
• The ordering clinician must also have a plan at the time of ordering the test to continue to monitor the skin lesion for changes if the test is negative. The record must also contain a photograph of the lesion at the time that the PLA is ordered to allow for appropriate evaluation in subsequent follow-up.
• Records must clearly support that the ordering clinician has the knowledge, skills, and experience to evaluate and biopsy pigmented skin lesions. If this information is not contained within the chart of the beneficiary to whom a service is being rendered, it must be supported by other readily available documentation, such as credentialing documentation, or documentation of training in the performance of such tasks. Such documentation should be provided if there are documentation requests.
• The ordering physician must clearly document the lesion site on the patient’s body.
• The test may not be ordered for the same lesion a second time.
• Only 1 test may be used per patient per clinical encounter, in most cases. In roughly 10% of patients, a second test may be indicated for the same clinical encounter. For rare cases where more than 2 tests are indicated in a single clinical encounter, an appeal with supporting documentation may be submitted for additional tests.
The PLA is not intended to be used as a screening test in patients without melanocytic skin lesions. It is also not covered as an adjunctive test in lesions that are considered to already warrant a biopsy. The PLA is a decision tool for atypical melanocytic lesions prior to the decision to biopsy.
Specific Coverage Criteria
The PLA is indicated for use on melanocytic skin lesions with 1 or more clinical or historical characteristics suggestive of melanoma, including 1 or more ABCDE criteria when a clinician trained in the clinical diagnosis of skin cancer is considering the need for biopsy to rule out melanoma. The PLA should not be used on clinically obvious melanoma. The PLA result is one element of the overall clinical assessment and should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy.
(PLA positive lesions [LINC (LINC00518) and/or PRAME (preferentially expressed antigen of melanoma) detected] should be considered for biopsy. The biopsy decision of a PLA negative lesion should be based on the remainder of the entire clinical context.)
The PLA is indicated only for use on:
• Primary melanocytic skin lesions between 5mm and 19mm
• Lesions where the skin is intact (i.e., non-ulcerated or non-bleeding lesions)
• Lesions that do not contain a scar or were previously biopsied
• Lesions not located in areas of psoriasis, eczema or similar skin conditions
• Lesions not clinically diagnosed as melanoma
• Lesions in areas other than palms of hands, soles of feet, nails, mucous membranes and hair covered areas that cannot be trimmed
The PLA is not intended to be used as a screening test in patients without melanocytic skin lesions. It is also not covered as an adjunctive test in lesions that are considered to already warrant a biopsy. The PLA is a decision tool for atypical melanocytic lesions prior to the decision to biopsy.
The evaluation with the PLA is limited to order by a physician or other qualified healthcare professional.
Summary of evidence (opening)
Background
Invasive and in situ cutaneous melanoma is a type of skin cancer that is diagnosed in over 178,000 patients annually in the United States. Over 9,300 people die from cutaneous melanoma in the US per year. 1 Detecting melanomas at their earliest stages (melanoma in situ (MIS) / Stage 1) impacts disease outcome and patient survival. The 5-year relative survival rate from diagnosis for localized, early melanoma is over 98%, but less than 20% for melanoma that has spread to distant sites. 2 The generally well accepted approach to assessing pigmented lesions includes visual inspection followed by surgical biopsy and histopathologic analysis of the biopsied tissue. 3-12 One large study assessing dermatologists’ biopsy decisions using existing decision making tools is approximately 25. 3 In another study, roughly 24 biopsies were needed to diagnose 1 invasive melanoma, and roughly 12 biopsies were needed to detect either invasive melanomas or MIS. 13 In summary, this approach results in many biopsies that do not lead to a melanoma diagnosis. Guidelines from the American Academy of Dermatology recommend that a prebiopsy photograph be taken to help with clinical / pathologic correlation. 14
Additionally, the diagnostic yield of early-stage melanoma on biopsied tissue is limited. Histopathologic assessment of early-stage biopsied melanoma tissue is challenging and has significant discordance between pathologists. 15-17 It also appears that under-interpretation is more common than over-interpretation of a patient who has had a biopsy, 16,17 which is tantamount to missed diagnoses. Additionally, while fellowship-trained or board-certified dermatopathologists tend to have a higher accuracy than other pathologists, even among this group, under-interpretation is highly prevalent. 16
In summary, conventional melanoma care may lead to both biopsies of non-malignant lesions, and even in those patients who do have a biopsy, the diagnosis of a malignancy may be missed. As such, there is potential clinical utility for a test that can spare a patient the need for a biopsy.
The contractor cites 33 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2020-04-12
- Current revision effective
- 2026-04-30
- Last reviewed by the contractor
- 2026-04-06
- MCD version
- 11
Other related documents: A57979 (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 L38178 cover?
This Medicare contractor will provide limited coverage for the Pigmented Lesion Assay / PLA (DermTech, Inc., La Jolla, CA), a Ribonucleic Acid (RNA) gene expression test conducted on skin samples obtained noninvasively via adhesive patches. 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 L38178 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 L38178?
The companion billing and coding article A57983 lists 1 ICD-10-CM codes in 1 group that support medical necessity; the first 1 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L38178?
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.