Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve proton beam therapy, 28 fractions (77387, 77522, 77523). 
 
You asked the Plan to pre-approve proton beam therapy. You say that the requested therapy is medically 
necessary. The Plan denied your request. The Plan says that the request does not meet the Medicare or health 
plan coverage criteria. 
 
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 proton beam therapy. Our reviewer says 
that the requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found the NCCN guidelines acknowledge ongoing studies and state The NCCN panel believes that 
there is no clear evidence supporting a benefit or decrement to proton therapy over IMRT for either treatment 
efficacy or long-term toxicity. Conventionally fractionated prostate proton therapy can be considered a 
reasonable alternative to X-ray based regimens. The ASTRO model policy for proton therapy states In the 
treatment of prostate cancer, the use of PBT is evolving as the comparative efficacy evidence is still being 
developed. For an informed consensus on the role of PBT for prostate cancer to be reached, it is essential to 
collect further data, especially to understand how the effectiveness or proton therapy compares to other 
radiation modalities. It emphasizes the need to enroll patients on studies. 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. 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. 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 
patient 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 proton beam therapy have been met. Therefore, we decided that the Plan has to 
pre-approve proton beam therapy, 28 fractions (77387, 77522, 77523).  
 
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.