Appeal type: Lab
Decision: Favorable

 
We decided that the Plan has to pay for (BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA 
repair associated) (e.g., hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full 
duplication/deletion analysis (i.e., detection of large gene rearrangements)) (81162) provided April 25, 2022. 
 
You asked the Plan to pay for the laboratory services. You say that the medical records provided will show 
proof of medical necessity. The Plan denied your request. The Plan says that charges for or in connection with 
services or supplies that are determined by the Plan considered to be experimental or investigational are 
excluded from coverage. 
 
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item 
or service, then that item or service will be covered when it is medically necessary.  
 
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 laboratory services. Our reviewer says 
that the requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found the enrollee, with a history of metastatic prostate cancer, status post prostatectomy, Lupron, and 
Xgeva therapy. Per the reviewed literature, Despite the development of several treatment options for mCRPC 
patients, metastatic PCa remains a lethal disease with poor prognosis. Molecular characterization of mCRPC 
patients should be routinely integrated into the clinics in order to select patients who are more likely to respond 
to targeted agents and to minimize toxicities from unnecessary therapies. Furthermore, the emerging role of 
BRCA2 underlines the growing importance of genetic counselling and the multidisciplinary approach in the 
management of PCa patients. Recent evidence highlights that gBRCA2 is an independent prognostic factor 
associated with shorter CSS in mCRPC patients, and the type of first-line treatment might affect the outcome of 
gBRCA2 carriers. Moreover, it has been demonstrated that gBRCA2 is a strong predictor of response to PARP 
inhibitors. The role of PARP inhibitors in non-BRCA DDR mCRPC patients remains less clear, and further 
studies should investigate this specific issue. The review has determined that the items/services at issue in this 
case are medically reasonable and necessary. 
 
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 laboratory services have been met. Therefore, we decided that the Plan has 
to pay for (BRCA1 (BRCA1, DNA repair associated), BRCA2 (BRCA2, DNA repair associated) (e.g., 
hereditary breast and ovarian cancer) gene analysis; full sequence analysis and full duplication/deletion 
analysis (i.e., detection of large gene rearrangements)) (81162) provided April 25, 2022.  
 
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.