Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve proton beam radiotherapy (PBRT) for breast cancer. 
 
You asked the Plan to pre-approve the PBRT. You say that this is medically necessary treatment and should be 
covered. The Plan denied your request. The Plan says this has not been shown to be better than IMRT for 
treatment of breast cancer. 
 
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 PBRT is not considered medically reasonable and necessary in this case. Our physician reviewer 
found a proton is the charged nucleus of a hydrogen atom (hydrogen atom minus an electron). Charged 
particles (such as protons and carbon) can be used to deliver therapeutic radiation. ?Standard radiation? is 
delivered with a linear accelerator (LINAC), which delivers photon therapy (akin to high energy light), while 
protons (and other charged particles) are generated from a cyclotron. The difference between proton and photon 
irradiation is that the protons (or charged particles) stop abruptly in the tissue (Bragg peak) so there is less exit 
dose through normal tissue. 
 
While small studies have demonstrated the ability of proton therapy to reduce lung and cardiac (for left sided 
breast cancer) dose exposure, it is not clear if such reductions are clinically meaningful for proton therapy to be 
recommended for general use. Many other technologies allow for reduction in normal tissue dosing, including 
IMRT, Tomotherapy, prone breast radiation (although not feasible in the post-mastectomy setting), motion 
management (breath hold, gating, tracking/monitoring). When treating patients with complex target volumes 
and/or when needing to treat internal mammary, supraclavicular and axillary nodes, proton therapy may often 
yield a better dose distribution. This does not apply to this case. 
 
Proton therapy may be medically necessary for well-selected patients but is not acceptable for routine use. 
Indeed, a recent study of patients ?who were considered suboptimal candidates for conventional RT were 
eligible? led the authors to conclude ?Proton beam RT for breast cancer has low toxicity rates and similar rates 
of disease control compared with historical data of conventional RT. Routine use of proton therapy for breast 
cancer is not an accepted standard of care. IMRT that is photon based is designed to facilitate normal tissue 
sparing and could very readily be considered in this patient. While proton therapy can be used (and is often 
used for select patients with unique anatomic considerations) the case file does not provide a plausible rationale 
for the need of proton therapy over conventional radiation and/or IMRT in this patient. 
 
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 radiotherapy (PBRT) for breast cancer.