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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 the provider, supplier, or beneficiary, as appropriate, must furnish to the intermediary or 
carrier sufficient information to determine whether payment is due and the amount of payment. You can find 
this rule at 42 CFR 424.5. 
 
The rules say for Medicare to consider coverage and payment for any item or service, the information 
submitted by the supplier or provider must corroborate the documentation in the beneficiary's medical 
documentation and confirm that Medicare coverage criteria have been met. You can see this in the Centers for 
Medicare and Medicaid Services, Internet Only Manual, Publication 100-08, Medicare Program Integrity 
Manual, Chapter 3, Section 3.3.2.1. 
 
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.  
 
You can find this information in the Centers for Medicare and Medicaid Services, 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.