Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve proton beam radiation therapy (PBRT). 
 
You asked the Plan to pre-approve PBRT. You say that the requested proton beam radiation therapy (PBRT) is 
medically necessary. The Plan denied your request. The Plan says the requested proton beam radiation therapy 
(PBRT) is not medically necessary. 
 
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 PBRT. Our reviewer says that the 
requested proton beam radiation therapy (PBRT) is not medically necessary. Our physician reviewer found 
proton therapy can be considered medically necessary when justified with quantitative dosimetric information 
that shows a clinically meaningful reduction in radiation dose exposure of normal tissues.  In order for toxicity 
risks to be reduced, there should be a clinically significant reduction in dose to critical structures, with an 
evidence basis of benefit with dose reduction. 
  
The letter of appeal mentions reirradiation, yet the consultation note mentions not having prior radiotherapy 
records. The planning objective do not describe composite dose measures, but only the target volume 
prescription and constraints from the proton therapy course. Notably, prior planning records could be readily 
obtained, and often plans can be shipped in DICOM format and brought into the planning system to evaluate 
prior treatment. 
 
If the lesion to be treated is in a different location than the previously treated lesion, SBRT with photon-based 
radiation (IMRT, VMAT or DCA) would be standard of care.  
  
If the lesion to be treated is a recurrence of a previously treated lesion, or in close proximity to the previously 
treated lesion, then any radiation technique (SBRT, proton therapy, hypofractionated VMAT) will have risks 
associated with the cumulative radiation dose. SBRT and SBRT-like techniques for hypofractionated VMAT 
are designed to have a rapid dose fall off (measured by ratio of 50% isodose line to prescription isodose line or 
R50 and by the dose at 2 cm from the target) such that the dose exposure to the lung and previously treated 
liver site would be minimized.  
  
If the enrollee previously underwent radiation to the same site, or a site close to the target volume, and a non-
proton based treatment would result in unacceptable normal tissue exposure, then proton therapy could be 
justified. However, the case records do not adequately document this to support the need for proton therapy 
(which is needed to support medical necessity for non-standard of care proton therapy). 
 
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 not been met. Therefore, we decided that the Plan does not have to 
pre-approve proton beam radiation therapy (PBRT).