Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve proton treatment delivery; complex (77525). 
 
You asked the Plan to pre-approve proton beam therapy. You say that the therapy being offered give him the 
greatest chance at attacking prostate cancer. The Plan denied your request. The Plan says the request is not 
medically necessary. A review of the literature indicates that PBRT is not the standard of care for prostate 
cancer and Proton Beam therapy for primary treatment of prostate cancer should only be performed within the 
context of a prospective clinical trial. 
 
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 proton beam therapy. 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. 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. 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. The bottom line is that proton therapy for prostate cancer is not experimental, and in fact is an 
accepted treatment approach.  While the reviewer does not think that proton therapy is an experimental therapy, 
any potential benefit or detriment of proton therapy over standard IMRT is an investigational question. Other 
treatment approaches (IMRT +/- IGRT) are also highly effective and well tolerated. 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 is 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. While NCCN 
guideline consider proton therapy a reasonable alternative they do not describe it as being necessary in lieu of 
non-proton-based treatment and are quite explicit in that there is no evidence of its superiority. The decision is 
unfavorable as the LCD criteria is not 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 not been met. Therefore, we decided that the Plan 
does not have to pre-approve proton treatment delivery; complex (77525).