Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Stereotactic Body Radiation Therapy (SBRT). 
 
You asked the Plan to pre-approve SBRT. You say that the enrollee has locally advanced, unresectable 
pancreatic cancer. The enrollee has had an excellent response to chemotherapy with resolution of any 
radiographic adrenal abnormality with no evidence of tumor progression. The provider recommends curative 
intent MRI-guided SBRT to cover all sites of disease, which has shown to be safe and effectively, particularly 
for those enrollees with unresectable pancreatic cancer. The Plan denied your request. The Plan says SBRT 
does not meet criteria/guidelines based on the type and/or stage of the cancer. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered.  
 
 
 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 pre-approve SBRT. Our reviewer says that the 
requested items/services are not considered medically reasonable and necessary in this case.  Our physician 
reviewer found for this enrollee with a pancreatic head cancer, there has been an excellent response to systemic 
therapy. The LCD for SBRT for this enrollee requires that it must be safe to target the entire systemic disease 
burden. The enrollee had a 2 cm left sided adrenal lesion that was new and then resolved, which is consistent 
with metastatic disease. The case file includes a screen capture of the current imaging that shows a fullness in 
the pancreatic head, in the location in which July 2022 imaging showed a 2.7 cm mass. The insurer had denied 
SBRT as the criteria of being able to safely encompass all disease was not met (and of relevance the NCCN 
criteria of SBRT for non-metastatic pancreatic cancer is not met). The radiation oncologist claimed that the 
adrenal lesion was from direct extension of the tumor. The insurer felt that the imaging reports describing a 
discrete metastasis was not consistent with direct extension. As the pancreatic head is generally slightly right of 
center (and this enrollee shows imaging clearly showing the center of the primary cancer to be in the head of 
the pancreas), and the left adrenal left center, it is unclear how a 2.7 cm cancer could directly invade into the 
left adrenal gland which is certainly more than 2.7 cm away. There is no pre-chemo imaging that shows a 
contiguous mass that would support this dubious claim.  While SBRT has been used in enrollees  
with metastatic disease, and perhaps once could argue to treat the primary site and left adrenal with SBRT, 
based on current NCCN guidelines SBRT is not an accepted standard of care for enrollees with metastatic 
disease, and SBRT to the pancreas would not meet the insurers LCD requiring being able to encompass all 
sites of disease. The decision is unfavorable. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of SBRT have not been met. Therefore, we decided that the Plan does not have to 
pre-approve Stereotactic Body Radiation Therapy (SBRT).