Appeal type: Outpatient Therapies
Decision: Unfavorable

We decided that the Plan does not have to pre-approve proton beam therapy services.
You asked the Plan to pre-approve the proton beam therapy services. You say that the proton beam therapy is medically appropriate for treatment of the enrollee's prostate cancer. You say that, since proton beam is better able to concentrate the radiation in the target and has no exit dose beyond the target, the prostate can be treated with just two lateral beams as compared to multiple x-ray beam angles. You say that this means there is far less radiation exposure to non-target normal tissues, which reduces the risk of secondary malignancies from radiation exposure. While proton therapy is not 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. 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. The Plan denied your request. The Plan says the standard of care for radiation therapy for prostate cancer is standard radiation therapy, including Intensity modulated radiation therapy (IMRT.)
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 the proton beam therapy services. Our reviewer says that proton beam therapy services are not considered medically reasonable and necessary in this case. Our physician reviewer found 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 the recommended dose constraints cannot be met with the non-proton based treatment, and it is not plausible that proton therapy would be needed to meet these constraints. Proton therapy will almost always reduce dose to surrounding normal tissues. Simply demonstrating that proton therapy will reduce the low dose to normal tissues does not necessarily demonstrate that it is clinically needed relative to IMRT though, as the reductions should be clinically meaningful, and reduce toxicity risks in a clinically meaningful manner. 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. We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of the proton beam therapy services have not been met. Therefore, we decided that the Plan does not have to pre-approve proton beam therapy services.