Appeal type: Outpatient Therapies
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 services. You say that the radiation dose reductions achieved using 
proton beam therapy would translate into a notable reduction in the predicted excess risk of a secondary 
malignancy of the rectum, and result in a reduction of the predicted excess risk of a secondary bladder cancer 
as compared to IMRT. The Plan denied your request. The Plan says the type of treatment requested is not 
known to be more effective than other types of radiation therapy for the enrollee's type of cancer. 
 
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 services. Our reviewer says that 
the requested 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 (Bragg peak) 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 published in JAMA. 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 PBRT services have not been met. Therefore, we decided that the Plan does not 
have to pre-approve proton beam radiation therapy (PBRT).