Appeal type: Outpatient Therapies
Decision: Favorable

 
We decided that the Plan has to pre-approve Proton Beam Therapy (PBT) with Image Guided Radiation 
Therapy (IGRT) (77387, 77525, G6002). 
 
You asked the Plan to pre-approve PBT with IGRT. You say that the therapy is medically necessary for the 
enrollee. The Plan denied your request. The Plan says that the enrollee does not meet criteria for approval of 
the requested therapy. 
 
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 PBT with IGRT. 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 case, the enrollee has 
Stage IV disease with apparent regional lymph node involvement. Radiotherapy is clearly indicated. The 
bottom line is that proton therapy for prostate cancer is not experimental, and in fact is an accepted treatment 
approach.  While he does not think that proton therapy is an experimental therapy, any potential benefit or 
detriment of proton therapy over standard IMRT for routine cases is unknown. For this case, a plan comparison 
was provided showing a more conformal delivery with proton therapy, albeit not explicitly showing which 
organs or tissues show a clinically meaningful benefit, outside of suggesting lower 2nd cancer risks (which is 
debatable). Despite his opinion on the need for proton therapy for prostate cancer, the LCD criteria appear to 
have been met. Per the L35075 LCD coverage is limited to providers who have demonstrated experience in 
data collection and analysis with a history of publication on the peer-reviewed medical literature. This applies 
for this case. Specifically for prostate cancer, the LCD (L30575) also requires physician documentation of the 
enrollee stage and other factors (which would include Gleason score and PSA) and documentation of the 
range of therapy choices which is documented in the consultation note. As the criteria are met, the decision is 
favorable. 
 
 We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of PBT with IGRT have been met. Therefore, we decided that the Plan has to pre-
approve Proton Beam Therapy (PBT) with Image Guided Radiation Therapy (IGRT) (77387, 77525, G6002).  
 
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.