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Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that this Medicare contractor will provide limited coverage for the Pigmented Lesion Assay / 
PLA (DermTech, Inc., La Jolla, CA), an RNA gene expression test conducted on skin samples obtained non-
invasively 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 one 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 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 patients body 
    The test may not be ordered for the same lesion a second time. 
    Only one 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. You can find these rules in the 
Local Coverage Determination (LCD) MolDX: Pigmented Lesion Assay L38151. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.