Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve proton beam radiotherapy (PBRT). 
 
You asked the Plan to pre-approve proton beam radiotherapy (PBRT). You say that the requested PBRT is 
medically necessary. The Plan denied your request. The Plan says that the enrollee does not meet criteria for 
PBRT. 
 
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 proton beam radiotherapy (PBRT). Our 
reviewer says that the requested PBRT is medically necessary. Our physician reviewer found proton cases can 
be challenging. Proton therapy will always present a plan with lower normal tissues exposures. These 
reductions (1) may not reflect reality due to dosimetric uncertainties and (2) may not be clinically meaningful if 
they do not reduce suprathreshold exposures in the non-proton plan to acceptable levels.  
 
For this enrollee, the non-proton plan for this enrollee meets all of the above lung and cardiac constraints (with 
a mean dose less than 10 Gy). Her situation is complicated by having a bundle block that is managed with a life 
vest. So arguably she is at higher risk. It cannot be determined if a better optimized IMRT plan would better 
meet dosimetric constraints. It is not specified if motion management was used. Nevertheless, for this enrollee, 
it is plausible that the heart would receive higher doses with IMRT, that proton therapy could reduce exposures, 
and that specifically for this enrollee, those reductions might be clinically meaningful. 
 
Thus, for this enrollee, I believe that proton therapy can be considered medically necessary and would meet 
American Society for Radiation Oncology (ASTRO) and National Comprehensive Cancer Network (NCCN) 
criteria and would be within accepted standards of care. 
 
In this case, the enrollee meets the LCD criteria. The enrollee meets criteria #1 shown for the heart. The 
enrollee meets criteria #4 in that the intent of treatment is curative. The enrollee meets criteria #6 in that the 
enrollee's record demonstrates why Proton beam radiotherapy is considered the treatment of choice for the 
individual patient. Specifically, the record addresses the lower risk to normal tissue, the lower risk of disease 
recurrence, and the advantages of the treatment over IMRT or 3-dimensional conformal Dosimetric evidence of 
reduced normal tissue toxicity and/or improved tumor control. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of proton beam radiotherapy (PBRT) have been met. Therefore, we decided that 
the Plan has to pre-approve proton beam radiotherapy (PBRT).  
 
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.