Appeal type: Imaging
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve proton beam radiation therapy (PBRT) to be provided 
out of network (OON). 
 
You asked the Plan to pre-approve the OON PBRT. You say that you believe that proton therapy would be the 
best for your cancer and that you should be allowed to go OON to get this treatment. The Plan denied your 
request. The Plan says there is no evidence that this treatment is clinically superior to other standard 
approaches. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered. Plans are only required to approved non-emergency OON care if medically 
necessary services are not available in-network 
 
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 OON PBRT. Our reviewer says that 
the requested PBRT services are not considered medically reasonable and necessary in this case. Our physician 
reviewer found The difference between proton and photon irradiation is that the protons (or charged particles) 
stop abruptly in the tissue so there is less exit dose through normal tissue. 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. 
 
Whether proton therapy for prostate cancer affords any advantage over IMRT is very controversial.  Most 
reports conclude that patients treated with proton therapy fare comparably and/or better to patients treated with 
photon radiation (i.e. IMRT). It is noteworthy that the depth of proton delivery is more susceptible to changes 
in tissue density (such as changes of air in the rectum). In fact, a study shows that proton 
therapy has resulted in a greater risk of gastrointestinal toxicity versus IMRT. Thus there are compelling data 
showing worse outcomes with proton therapy.  
While PBRT 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- i.e. for intermediate to low risk 
prostate cancer. 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. As such, the requested use of PBRT is 
not supported as reasonable and necessary 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 OON PBRT have not been met. Therefore, we decided that the Plan does 
not have to pre-approve proton beam radiation therapy (PBRT) to be provided out of network (OON).