Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve stereotactic body radiation therapy (SBRT). 
 
You asked the Plan to pre-approve the SBRT. You say that the records provided support the need for the 
treatment being requested. The Plan denied your request. The Plan says that the request does not meet medical 
necessity criteria. 
 
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 pre-approve the SBRT. Our reviewer says that the 
requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found the enrollee has a recent diagnosis of intermediate risk T1c prostate cancer. Notably, his 
genomic score is high risk and he has an iliac lymph node that, based upon its size, is clinically determined to 
be reactive in the absence of a biopsy or Axumin PET. Stereotactic body radiotherapy, delivering high 
fractional doses to the prostate in 3-5 fractions is an emerging approach to the treatment of prostate cancer. 
Many clinical studies supporting the efficacy and safety of SBRT in the treatment of prostate cancer have been 
published. At least one study has shown excellent five-year biochemical control rates with very low rates of 
serious toxicity. Additionally, numerous studies have demonstrated the safety of SBRT for prostate cancer after 
a follow-up interval long enough (two to three years) to provide an opportunity to observe the incidence of late 
GU or GI toxicity. While it is necessary to observe patients treated for prostate cancer for extended intervals to 
gauge the rate of long term (beyond 10 years) biochemical control and overall survival, the interim results 
reported appear at least as good as other forms of radiotherapy administered to patients with equivalent risk 
levels followed for the same duration post-treatment. Data supporting the use of SBRT for prostate cancer have 
matured to a point where SBRT could be considered an appropriate alternative for select patients with low to 
intermediate risk disease. Our physician reviewer found that SBRT for prostate cancer should not be 
considered investigational and should be considered an accepted standard. As such, the requested SBRT 
treatment has been found to meet the medically necessary criteria in this case. 
 
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 SBRT have been met. Therefore, we decided that the Plan has to pre-
approve stereotactic body radiation therapy (SBRT).  
 
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.