Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve proton beam therapy (PBT) (77387, 77470, 77523, G6002). 
 
You asked the Plan to pre-approve PBT. You say that you disagree with the denial. The Plan denied your 
request. The Plan says that use of PBT would appear to exceed the medical need in this case and thus Medicare 
cannot cover the PBT. It is not generally accepted to use PBT here given its experimental and unproven nature. 
 
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 PBT. Our reviewer says that the 
requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found 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. 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). The case file does not include a plan comparison or composite plan comparison (with the prior 
treatment) though the prior radiation therapy makes the need for proton therapy plausible and would likely 
fulfill the ASTRO model policy criteria. For this enrollee, while contralateral salivary gland sparing would 
easily be done with IMRT or proton therapy, the contralateral salivary glands would have already received 
suprathreshold doses and have been affected by the prior radiation. For this enrollee, there is a need to try to 
spare the ipsilateral salivary glands (which is a challenge with oral cavity cancers that are close to 
submandibular and parotid regions) as well as minimize dose to midline structures that would have been 
exposed from the prior radiation (cord, larynx). In summary, proton therapy is not experimental, but rather is 
simply another means if delivering radiation, and has been in use for the treatment of oncology enrollees for 
decades. There are dosimetric advantages to using proton therapy over IMRT in select situations, in which 
proton therapy offers a clinically meaningful benefit. For this case, the reviewer believes that it is plausible 
proton therapy would be more beneficial to this enrollee than standard therapy. While his prior radiation 
involved the contralateral neck, proton therapy would likely allow better sparing of ipsilateral salivary glands 
and midline anatomy. It is plausible that the dosimetry with proton therapy will allow better normal tissue dose 
exposure, making it plausible that proton therapy would be better. The decision is favorable as the LCD criteria 
is 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 PBT have been met. Therefore, we decided that the Plan has to pre-approve 
proton beam therapy (PBT) (77387, 77470, 77523, G6002).  
 
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.