Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve proton beam radiation therapy. 
 
You asked the Plan to pre-approve proton beam radiation therapy. You say that the cancer that you have in 
your chest is close to your esophagus. Proton beam radiation is more accurate and could avoid damage to the 
heart valve or esophagus. The Plan denied your request. The Plan says that proton beam radiation therapy is not 
medically necessary for the patient's specific condition. There are not enough clinical studies showing that 
proton beam radiation is superior to other types of radiation for sarcoma 
 
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 proton beam radiation therapy. Our 
reviewer says that the requested items/services are 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 generated from a cyclotron.  The difference 
between proton and photon irradiation is that the protons (or charged particles) stop more abruptly in the tissue 
(Bragg peak) so there is less exit dose through normal tissue. 
 
The use of proton therapy is an accepted radiation technology, that has proven efficacy and tolerability. Proton 
therapy is not investigational- it is simply a different means to deliver radiation. You have an unresectable 
thoracic sarcoma and would be treated similarly to a patient with advanced stage non-small cell lung cancer 
(NSCLC), though treated to higher doses. Proton therapy is an accepted, safe and effective treatment modality 
for Stage II-III lung cancer, The National Comprehensive Cancer Network (NCCN) guidelines for non-small 
cell lung cancer (NSCLC) include proton therapy as a means to deliver conformal radiation, although do not 
address specific indications for proton therapy over intensity-modulated radiation therapy (IMRT). The 
guidelines state that technologies such as 4D-CT and/or PET/CT simulation, IMRT/VMAT, IGRT, motion 
management, and proton therapy are appropriate when needed to deliver curative radiation therapy safely. 
These guidelines do not specify that proton therapy should be used in lieu of other modalities, but rather 
acknowledge proton therapy as an alternative to be considered. 
 
The recently released American Society for Radiation Oncology (ASTRO) model policy includes in Group 1  
disease sites which frequently support the need of proton therapy: Primary tumors of the mediastinum, 
including thymic tumors, mediastinal tumors, mediastinal lymphomas and thoracic sarcomas.  Though the 
policy still requires demonstration of a plausible clinically meaningful benefit. Indications for coverage 
include: 
 
1. The target volume is near one or more critical structures and a steep dose gradient outside the target must be 
achieved to avoid exceeding the tolerance dose to the critical structure(s), which would portend a higher risk of 
toxicity. This is suggested in this case. 2. A proton-based technique would decrease the probability of clinically 
meaningful normal tissue toxicity by lowering an integral dose-based metric and/or organ at risk dose volume 
constraint associated with toxicity. This is also suggested in this case. 3. The same or an immediately adjacent 
area has been previously irradiated, and the dose distribution within the patient must be sculpted to avoid exceeding the cumulative tolerance dose of nearby normal tissue. This is not applicable in this case. 
 
ASTRO is the largest radiation oncology organization whose mission is to improve patient care through 
education, clinical practice, advancement of science and advocacy.  This case shows the isodose lines of a 
plan comparison but no actual dose-volume histogram (DVH) data or planning data. Nevertheless, it is 
plausible that proton therapy would reduce cardiac, esophageal and lung exposures in a clinically meaningful 
manner. Proton cases can be challenging. It cannot be determined if a better optimized IMRT plan would better 
meet dosimetric constraints.   Nevertheless, in the case of a patient with a large central, unresectable tumor, 
treated to higher doses than for NSCLC, it is plausible that the heart, lung and esophagus would receive high 
doses and that proton therapy could reduce exposures. 
 
Thus, our physician reviewer found that in this cas,. proton therapy can be considered medically necessary and 
would meet ASTRO criteria and would be within 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 proton beam radiation therapy have been met. Therefore, we decided that the 
Plan has to pre-approve proton beam radiation therapy.  
 
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.