LCD L38051: MolDX: Pigmented Lesion Assay

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 ( A symmetry, B order, C olor, D iameter, E volving)

• 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 with 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 1 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.

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 underinterpretation 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 either spare a patient the need for a biopsy.