Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Non-small-cell lung carcinoma
Treatment: current procedural terminology (CPT) code: 0242U: targeted genomic sequence analysis panel, solid organ neoplasm, cell free circulating deoxyribonucleic acid (DNA) analysis of 55-74 genes, interrogation for sequence variants, gene copy number amplifications, and gene rearrangements

The insurer denied coverage for current procedural terminology (CPT) code: 0242U: targeted genomic sequence analysis panel, solid organ neoplasm, cell free circulating deoxyribonucleic acid (DNA) analysis of 55-74 genes, interrogation for sequence variants, gene copy number amplifications, and gene rearrangements.
The denial is upheld.

The patient is a male with history of Non-small-cell lung carcinoma (NSCLC) treated with concurrent chemotherapy then Keytruda (Pembrolizumab) with recurrence. He has a past medical history of atrial fibrillation, coronary artery disease, intravenous drug use, hepatitis C, prostate cancer, and chronic obstructive pulmonary disease (COPD). The provider has performed Guardant360, and tissue testing could have been obtained. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome when undergoing Guardant360.

CPT code: 0242U: targeted genomic sequence analysis panel, solid organ neoplasm, cell free circulating deoxyribonucleic acid (DNA) analysis of 55-74 genes, interrogation for sequence variants, gene copy number amplifications, and gene rearrangements, has final approval from the appropriate regulatory bodies for this diagnosis. This is FDA [Food and Drug Administration] approved as a companion diagnosis for NSCLC.     

The patient was not a good candidate for CPT code: 0242U. The patient has a performance status (PS) of three and would not be eligible for palliative chemotherapy. There would be questionable value of testing in this situation as he would be unlikely to tolerate the prescribed therapy. In general, individuals with PS of three or four should not be offered systemic therapy.     

CPT code: 0242U is not the best available treatment for this patient at this time. As stated by Ettinger DS, et al., per the National Comprehensive Cancer Network (NCCN), tissue based testing should preferentially be conducted over blood based testing.     
  
Adverse risks are not increased over standard treatment/services. The request under review, Guardant360, is testing so there are no risks.     

Although Frampton, G.M., et al., noted with the use of this assay across the broad spectrum of cancer cell line types resulted in "clinically actionable alterations" in 76% of tumors, at the moment there are no prospective or controlled trials showing that the use of this information to direct therapy improves health outcomes for patients with the diagnosis of renal cell cancer. In fact, a study showed that the use of broad molecular mutation testing to direct therapy resulted in no improvement in progression free survival and the conclusion was that "off label use of molecularly targeted agent should be discouraged."

Le Tourneau, C., et al., "The use of molecularly targeted agents outside their indications does not improve progression-free survival compared with treatment at physician's choice in heavily pretreated patients with cancer. Off-label use of molecularly targeted agents should be discouraged, but enrollment in clinical trials should be encouraged to assess predictive biomarkers of efficacy."

The requested service, Guardant360, is not likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                   

The carrier's denial of current procedural terminology (CPT) code: 0242U: targeted genomic sequence analysis panel, solid organ neoplasm, cell free circulating deoxyribonucleic acid (DNA) analysis of 55-74 genes, interrogation for sequence variants, gene copy number amplifications, and gene rearrangements should be upheld.