Appeal type: Supplemental Benefit
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve proton treatment delivery; intermediate (77523). 
 
You asked the Plan to pre-approve proton treatment delivery. You say that you are requesting reconsideration 
stating the enrollee has a cancer of the head and neck region and presents for consideration of radiotherapy 
with intensity modulated proton therapy (IMPT). It is imperative that the enrollee receive treatment as soon as 
possible. The Plan denied your request. The Plan says the requested therapy does not meet the requirements for 
approval. 
 
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 proton treatment delivery. Our reviewer 
says that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found use of proton therapy is an area of active investigation. Proton therapy may be 
considered when normal tissue constraints cannot be met with photon-based therapy and has typically been 
used to treat enrollees with the most challenging disease, for which other RT options were not felt to be safe or 
of any benefit. Most of the compelling data has been on enrollees with para-nasal sinus cancers. proton therapy 
is not an accepted standard of care for routine practice for typical locally advanced head and neck cancers but 
should be considered for exceptional cases. Such cases would be those for which the anatomic spread of the 
cancer results in optimized, IMRT plan that is unacceptable due to normal tissue constraints not being met, and 
a proton plan that eliminates or reduces the excessive normal tissue exposures. It should also be plausible that 
proton therapy is needed (as opposed to IMRT plan being unacceptable due to a suboptimal plan generated 
simply to make proton therapy look better). Generally, it is necessary 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). For this enrollee, the appeal letter is written in very generic, template 
form. It provides no plausible basis for this enrollee having had exceptional circumstances which would 
necessitate proton therapy. It describes comparative dosimetry from a case control as opposed to using 
patient-specific dosimetry to discuss need. There is no comparative plan other than a sample plan from a 
published study. While preliminary retrospective data, with small numbers of enrollees, are promising, it is 
notable that proton therapy is being investigated in ongoing Phase III studies for oropharyngeal cancers (this 
enrollee has an oropharyngeal tongue base cancer). Based upon the provided records, it is not plausible that 
proton therapy would provide a clinically meaningful benefit over a well-designed IMRT plan. While not 
experimental, its potential benefit over non-proton-based radiation is an investigational question. Thus, proton 
therapy is not necessary as it would not meet ASTRO or NCCN criteria and therefore would not be furnished in 
accordance with accepted standards of medical practice. The decision is unfavorable as the LCD criteria are not 
met. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of proton treatment delivery have not been met. Therefore, we decided that the 
Plan does not have to pre-approve proton treatment delivery; intermediate (77523).