Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve proton beam radiation therapy (PBRT) for treatment of 
esophageal cancer. 
 
You asked the Plan to pre-approve the PBRT. You say that the enrollee would be best served by PBRT which 
would reduce radiation exposure to other organs. The Plan denied your request. The Plan says IMRT is the 
standard of care for esophageal 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 services are 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 accelerators (LINAC), which deliver photon therapy (akin to high energy light), while 
protons (and other charged particles) are (usually) 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 significantly less exit dose through normal tissue. 
 
In one study, the outcomes of 132 patients treated with proton therapy for esophageal cancer were compared 
against the outcomes of 211 treated with IMRT. IMRT was associated with worse survival outcomes for Stage 
III esophageal cancer patients (and not for Stage I-II disease, which this patient has). There were no significant 
differences in rates of treatment-related toxicities were observed between groups.  
 
Recent systematic reviews of the heart, lung and esophagus (QUANTEC reviews) provide guidelines that help 
clinicians evaluate the acceptability of a radiation plan. Clinically meaningful reduction in the lung volume 
receiving >20 Gy, and heart volume receiving high doses can warrant consideration of IMRT. Based on the 
dosimetric analyses provided by the treating physician in this case, the non-proton plan meets acceptable heart 
and lung radiation dose constraints.  
 
Case reviews for proton therapy for esophageal cancer are challenging since proton therapy will invariably 
reduce normal tissue exposure- but not always in a clinically meaningful way, and an IMRT plan can often be 
made to look better or worse depending on beam arrangement, planning parameters, etc. What is needed to 
establish necessity is to show that proton therapy will result in a clinically meaningful benefit by reducing 
normal tissue exposure below threshold levels (or improving target coverage unachievable with IMRT). The 
case file does not adequately document need showing an IMRT that would be unacceptable. As such, PBRT for 
this patient would not be considered medically reasonable and necessary. 
 
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 treatment of esophageal cancer.