Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve proton beam therapy (77470, 77520, 77522, 77523, 77525). 
 
You asked the Plan to pre-approve proton beam therapy. You say that the therapy is medically necessary. The 
Plan denied your request. The Plan says that the request does not meet the Medicare or health plan coverage 
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 Proton Beam Therapy. Our reviewer 
says that the requested items/services are considered medically reasonable and necessary in this case. Our 
physician reviewer found the use of proton therapy is an accepted radiation technology, that has proven 
efficacy and tolerability. Certain conditions such as base of skull chordomas and chondrosarcomas, and 
pediatric CNS malignancies are probably best treated with proton therapy, due to the sharp dose fall off, 
allowing high dose delivery to the tumor, while relatively sparing the neighboring normal tissue. For this 
enrollee, the planning records include a DVH and a table that summarizes dose reductions from proton therapy 
in a manner that is not clinically meaningful, i.e., it describes reduction in exposure without showing an 
unacceptable non-proton-based plan (which would not be plausible as non-proton-based radiation is used 
routinely). The mean heart dose and cardiac V25-40 for treatment of right sided breast cancer is generally quite 
low regardless of APBI technique (and seemingly is with this enrollee). The lung V20 is similar between the 2 
plans, with lung V10 higher in the non-proton-based plan (perhaps excessive in the non-proton plan though 
arguably could be reduced with better lung optimization, and novel techniques to account for breathing). 
Apparently, this enrollee agreed to apparently enrolled on a Phase II study (NCT01245712). In general, it 
makes sense to support prospective studies, and this would fulfill the ASTRO model policy criteria. 
Nevertheless, it is not specified if a clinical trial review was sought or whether this insurer allows for clinical 
trial exceptions. As such, this did not weigh into the decision as it is a separate question on whether or not the 
LCD criteria are met. Nevertheless, the LCD criteria do appear to have been met. 
 
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 Therapy have been met. Therefore, we decided that the Plan has 
to pre-approve proton beam therapy (77470, 77520, 77522, 77523, 77525).  
 
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.