Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve Proton Beam Radiation Therapy (PBRT) (77523, 77387, 77427, 
99205). 
 
You asked the Plan to pre-approve PBRT. You say that you disagree with the denial. The Plan denied your 
request. The Plan says that it was determined that that proton radiation is not appropriate. 
 
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 PBRT. Our reviewer says that the 
requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found that 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. Nothing in the case file suggests that standard dosimetric constraints 
cannot be met with a non-proton-based treatment, and it is not plausible that proton therapy would be needed to 
meet these constraints. 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 intensity-modulated 
radiation therapy (IMRT) is an investigational question. Other treatment approaches (IMRT +/- image-guided 
radiation therapy (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. Particularly with the use of the Space OAR hydrogel spacer (which was discussed with 
the enrollee but unclear if he is to undergo placement), the risk of gastrointestinal (GI)/rectal toxicity is low 
(since the rectum is pushed away from the prostate) such it is even more unlikely that there would be a 
potential benefit from proton therapy. Despite the reviewers opinion on the need for proton therapy for 
prostate cancer, the LCD criteria appear to have been met. Per the 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 also requires physician documentation of the enrollee stage and 
other factors (which would include Gleason score and prostate specific antigen (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 PBRT have been met. Therefore, we decided that the Plan has to pre-approve 
Proton Beam Radiation Therapy (PBRT) (77523, 77387, 77427, 99205).  
 
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.