Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve proton beam radiation therapy (PBRT). 
 
You asked the Plan to pre-approve PBRT. You say that proton beam radiation therapy is the most appropriate 
and effective course of treatment for the patient's specific condition. The Plan denied your request. The Plan 
says proton beam radiation therapy is not the standard of care for prostate cancer and is therefore not medically 
necessary. 
 
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 PBRT. Our reviewer says that the 
requested items/services are not considered medically reasonable and necessary in this case. Our physician 
reviewer found the use of proton therapy is an accepted radiation technology, which has proven efficacy and 
tolerability. Most (or all) radiation oncologists believe that proton therapy has a role in the treatment of some cancer patients.  Proton therapy is an accepted, safe and effective treatment modality for prostate cancer. 
Whether proton therapy for prostate cancer affords any advantage over intensity modulated radiation therapy 
(IMRT) is very controversial.  Most reports, including a systemic review conclude that patients treated with 
proton therapy fare comparably and/or better to patients treated with photon radiation (i.e. IMRT). There is no 
clear evidence that proton beam therapy for prostate cancer offers any clinical advantage over other forms of 
definitive radiation therapy. Clinical trials are necessary to establish a possible advantage of this expensive 
therapy. Nothing in the case file suggests that standard dosimetric constraints cannot be met with a non-proton 
based treatment, and it is not plausible that proton therapy would be needed to meet these constraints. Proton 
therapy will almost always reduce dose to surrounding normal tissues. The bottom line is that proton therapy 
for prostate cancer is not experimental, and in fact is an accepted treatment approach.  While proton therapy is 
not an experimental therapy, any potential benefit or detriment of proton therapy over standard IMRT is an 
investigational question being pursued in randomized studies. Thus, whether proton therapy affords a benefit 
over other standard approaches (IMRT/IGRT) for prostate cancer is an area of investigation and remains 
controversial. To date, there are no compelling data to suggest that proton therapy is superior to or more 
beneficial than IMRT/IGRT. The generally accepted standard of care for prostate cancer is to only offer proton 
beam therapy on clinical trials, and to not routinely offer it to patients.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of PBRT have not been met. Therefore, we decided that the Plan does not have to 
pre-approve proton beam radiation therapy (PBRT).