Appeal type: Lab
Decision: Partially Favorable

 
We decided that the Plan has to pay for the BRAF (81210) and EGFR (81235). We decided that the Plan does 
not have to pay for KRAS.  
 
You asked the Plan to pay for the gene analysis. You say that you would like reconsideration because this gene 
analysis is listed as medically necessary in Medicare's coverage policy. The Plan says that this service has not 
been reported correctly. 
 
We decided that the Plan has to pay for the BRAF (81210) and EGFR (81235). 
 
The Plan follows Medicare rules. Medicare rules say that BRAF gene analysis is considered medically 
necessary for patients who have malignant melanoma, non-small cell lung cancer, hairy cell leukemia, or 
metastatic colorectal cancer when needed to determine if a Medicare covered therapy is a reasonable option 
given the individual's specific clinical presentation. 
 
EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, 
exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) [when specified as EGFR mutation analysis 
testing] EGFR testing is considered medically necessary as a technique to predict treatment response for 
individuals with non-small cell lung cancer undergoing treatment with EGFR tyrosine kinase inhibitor (TKI) 
therapy. 
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pay for the gene analysis. Our reviewer says that 
BRAF gene analysis is actionable and medically necessary to determine if a Medicare covered therapy is a 
reasonable option given the member's specific clinical presentation. EGFR gene analysis is actionable and 
medically necessary as a technique to predict treatment response for this member. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the gene analysis have been met. Therefore, we decided that the Plan has to pay 
for the BRAF (81210) and EGFR (81235). 
 
We also decided that the Plan does not have to pay for KRAS. 
 
The Plan follows Medicare rules. Medicare rules say that KRAS gene analysis, variants in codons 12 and 13, is 
considered medically necessary in patients with colorectal cancer or non-small cell lung cancer when needed to 
determine if a Medicare covered therapy is a reasonable option given the individual's specific clinical 
presentation. 
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pay for KRAS. Our physician reviewer found KRAS 
gene analysis is not actionable and not medically necessary as it is not needed to determine if a Medicare 
covered therapy is a reasonable option given the member's specific clinical presentation. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of KRAS have not been met. Therefore, we decided that the Plan does not have to 
pay for KRAS. 
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.