Appeal type: Practitioner Services
Decision: Unfavorable

We decided that the Plan does not have to pre-approve proton beam radiation therapy (PBRT) for prostate cancer.

You asked the Plan to pre-approve the PBRT. You say that PBRT would be the best option for this enrollee. The Plan denied your request. The Plan says this service is not covered routinely and would only be covered if provided through a clinical trial.

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 PBRT. Our reviewer says that the requested services are not considered medically reasonable and necessary in this case. Our physician reviewer found whether proton therapy (in general) affords any benefit over conventional radiation therapy is a heated issue, with quite disparate opinions among experts in the field. Specifically for prostate cancer, there is controversy regarding the claim that PBRT would always lead to less radiation toxicity to the rectum. In fact, a study published in Journal of the American Medical Association shows that proton therapy has resulted in a greater risk of gastrointestinal toxicity versus intensity-modulated radiation therapy (IMRT). Another study
based on a Medicare database compared prostate IMRT with proton therapy; they concluded that "there was no difference in toxicity in a comprehensive cohort of Medicare beneficiaries with prostate cancer at 12 months post-treatment". 

Some assert that that proton therapy could lower the risk of second, radiation-associated, malignancies. IMRT does result in a greater deposition of low dose to normal tissue, which theoretically increases the risk of second malignancies. While proton therapy reduces the low dose deposition, proton therapy results in a greater dose rate and appreciably more neutron exposure (compared to essentially none with IMRT), and thus the benefit of protons over IMRT in reducing radiation-associated malignancies is controversial. In a study examining dose delivered to a phantom (i.e. model of a patient), in which only 5 prostate cancer cases were analyzed, the authors concluded that the "estimated secondary cancer risk using scattering mode in proton therapy is either significantly lower than the cases in IMRT treatment or, at least, does not exceed the risk induced by conventional IMRT." In another study of 1116 patients (matched pair of 558 patients treated with proton therapy) the risks of 2nd malignancies in prostate cancer survivors was not greater among those treated with proton therapy, and a decreased risk was not seen (for which longer follow-up was needed to ascertain). 

The American Society of Radiation Oncology (ASTRO) released guidelines regarding the use of PBRT for prostate cancer in which it indicates that it should not be routinely recommended outside of clinical trials, and states 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." 

Overall, 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. 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. As such, the requested PBRT would not be considered reasonable and necessary in this case. 

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 PBRT have not been met. Therefore, we decided that the Plan does not have to pre-approve proton beam radiation therapy (PBRT) for prostate cancer.