Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2 
A 60-year-old male enrollee has requested reimbursement for CPT 81529, which is an oncology 
(cutaneous melanoma, mRNA, gene expression profiling by real-time RT-PCR of 31 genes (28 
content and three housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm 
reported as recurrence risk including likelihood of sentinel lymph node metastasis, on 3/8/22. 
The  Health  Insurer  has  denied  this  request  and  reported  that  the  service  at  issue  was 
investigational for the evaluation of the enrollees melanoma. The physician reviewer found that 
for a thin melanoma, pathologic stage pT1a, the standard treatment involves wide excision of 
the lesion site with appropriate margins. In this case, a dermatopathology report dated 2/25/22 
described the clinicopathologic features of the initial tumor on the posterior upper left arm as 
Clark level II, 0.3 mm depth, without ulceration, lymphovascular invasion, perineural invasion, or 
regression, which is otherwise a low risk tumor. The GEP test resulted in a class 1a score. Under 
the National Comprehensive Cancer Network (NCCN) guidelines, standard treatment in this 
clinical setting would be re-excision with appropriate margins, which was performed on 4/15/22.  The NCCN guidelines for cutaneous melanoma state that it is unclear whether GEP  platforms 
provide  clinically  actionable  prognostic  information  when  compared  with  known 
clinicopathologic  factors  as  described  above.  The  impact  of  these  tests  on  treatment 
recommendations has not been established. It also remains unclear whether GEP tests can 
reliably predict outcome across the risk spectrum of cutaneous melanoma, and prospective 
validation studies are necessary to more accurately define the clinical utility of GEP testing as 
part of the multidisciplinary decision-making process. Grossman and colleagues report that more 
evidence is needed to support using GEP testing to inform recommendations about sentinel 
lymph node biopsy, follow-up, or other adjuvant treatment. The authors further recommend 
against routine use of GEP testing to direct patient management until prospective studies support 
their clinical utility. In a meta-analysis of GEP tests including the DecisionDX-Melanoma test, 
Marchetti and colleagues concluded that the prognostic ability of GEP tests appeared to be poor 
at correctly identifying recurrence in patients with stage I disease, suggesting limited potential 
for clinical utility in these patients. In this clinical setting, a DecisionDx-Melanoma GEP test was 
not likely to have been more beneficial than standard clinical care treatment involving re-excision 
with appropriate margins followed by routine dermatologic surveillance per the NCCN guidelines. 
Therefore, CPT 81529, which is an oncology (cutaneous melanoma, mRNA, gene expression 
profiling by real-time RT-PCR of 31 genes (28 content and three housekeeping), utilizing formalin-
fixed paraffin-embedded tissue, algorithm reported as recurrence risk including likelihood of 
sentinel lymph node metastasis, on 3/8/22, was not likely to have been more beneficial for 
evaluation of the patients condition than any available standard therapy.