Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Proton Beam Treatment (PBT) and 41 fractions (77014, 
77370, 77470, 77520, 77522, 77523, 77525, G6002). 
 
You asked the Plan to pre-approve PBT and 41 fractions. You say that the enrollee has an extensive number of 
symptoms and comorbidities such as skin rash, nasal drainage, insomnia, hemorrhoids, decreased strength of 
the urinary stream, and erectile dysfunction. He has also had a hernia repair, appendectomy, and 
hemorrhoidectomy. Long-term side effects of radiation also include irritation, incontinence, and obstruction. 
PBT reduces the probability of these long-term side effects by minimizing unnecessary exposure to the 
enrollee's bladder, penile bulb, and rectum. The Plan denied your request. The Plan says the request does not 
meet the Medicare or health plan coverage criteria. 
 
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 PBT and 41 fractions. Our reviewer 
says that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found whether proton therapy for prostate cancer affords any advantage over IMRT is very 
controversial.  Most reports, including a systemic review conclude that enrollees treated with proton therapy 
fare comparably and/or better to enrollees treated with photon radiation. Do not routinely recommend proton 
beam therapy for prostate cancer outside of a prospective clinical trial or registry. 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. 
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 essential to collect further data, especially to understand how the 
effectiveness or proton therapy compares to other radiation modalities. and emphasizes the need to enroll 
enrollees on studies. The bottom line is that proton therapy for prostate cancer is not experimental, and in fact 
is an accepted treatment approach.  While our 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. 
Other treatment approaches (IMRT +/- 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 SpaceOAR hydrogel spacer, the risk of 
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. 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. 
The decision is unfavorable as the reviewer does not believe the LCD criteria are met. 
 
 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 and 41 fractions have not been met. Therefore, we decided that the Plan 
does not have to pre-approve Proton Beam Treatment (PBT) and 41 fractions (77014, 77370, 77470, 77520, 
77522, 77523, 77525, G6002).