Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve Proton Beam Radiation Therapy (PBRT.) 
 
You asked the Plan to pre-approve PBRT. You say that the clinical documentation, comparison study and letter 
of medical necessity support coverage of PBRT. You say that they could not safely get adequate coverage for 
radiation planning of the enrollee's clinical sites that need targeting, in particular within the left chest wall 
while adequately sparing the left anterior descending artery of the heart within normal constraints. The Plan 
denied your request. The Plan says that there are not enough studies on PBRT for breast cancer to show it is 
safe and effective. The Plan says that there are some studies that show it has more side effects than other forms 
of radiation. 
 
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item 
or service, then that item or service will be covered when it is medically necessary.  
 
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 PBRT. Our reviewer says that PBRT is 
considered medically reasonable and necessary in this case. Our physician reviewer found the use of proton 
therapy is an accepted radiation technology, that has proven efficacy and tolerability. 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 intensity-
modulated radiation therapy (IMRT), prone breast radiation, and motion management. This patient was unable 
to tolerate deep inspiration breath hold, and prone treatment is not feasible after mastectomy. 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. Proton therapy is not itself 
investigational, but rather whether or not it is superior to non-proton based IMRT, for routine use, is an 
investigational question. Despite the uncertainty of any benefit of proton therapy for use in the general 
population, there is some understanding about acceptable lung and heart exposure relative to risk of toxicity. 
The reduction in mean heart dose with proton therapy in this patient is significant, largely due to the intent to 
treat the regional nodes. The patients volumes are complex, the prescribed dose is high, and the dosimetric 
advantage with proton therapy is substantial for this patient. While proton therapy is not necessary for routine 
use in breast cancer, this case is arguably exceptional due to the large, complex-shaped treatment field. PBRT 
in this case would be in accordance with accepted standards of care. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of PBRT have been met. Therefore, we decided that the Plan has to pre-approve 
Proton Beam Radiation Therapy (PBRT.)  
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.