Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve Proton Beam Therapy (PBT) (77387, 77523). 
 
You asked the Plan to pre-approve PBT. You say that the requested therapy is medically necessary. 
 The Plan denied your request. The Plan says that the request does not meet the Medicare or health plan 
coverage criteria. 
 
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 the use of proton therapy is an accepted radiation technology, that has proven efficacy and 
tolerability. Certain conditions such as base of skull chordomas and chondrosarcomas, and pediatric CNS 
malignancies are probably best treated with proton therapy, due to the sharp dose fall off, allowing high dose 
delivery to the tumor, while relatively sparing the neighboring normal tissue. When treating enrollees with 
complex target volumes and/or when needing to treat internal mammary, supraclavicular, and axillary nodes, 
proton therapy may yield a better dose distribution that is clinically meaningful. 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. Either the QUANTEC reports or the cooperative group studies 
such as NRG 1005 can provide guidance for acceptable normal tissue exposure. For this enrollee, the records 
describe a comparison plan with proton therapy vs.VMAT; it is not specified if either plan was generated using 
deep inspiration breath hold. Screen captures show isodose lines (showing the regional nodes are included). 
Dose-volume histograms are not included as is a summary table. The ipsilateral lung V20 is reduced from 35% 
to ~9% and the mean heart dose from 5.6 Gy to 0.1 Gy. The right coronary artery means doses similarly 
reduced. The heart dose exceeds the RTOG 1005 acceptable variation of <5 Gy and the lung exposure is 
reduced from unacceptable (per NRG/RTOG protocol) values to acceptable values. Notably, the regional nodal 
treatment in this enrollee makes the lung and heart exposures high, and for the RTOG/NRG 1005 study, whole 
breast (and not regional nodes) was treated. It would be expected that when treating regional nodes, the heart 
and lung constraints would be difficult to meet. Also notably, RADCOMP constraints are met with both plans. 
While proton therapy is not necessary for routine use and is not cost-effective outside of those cases where a 
non-proton-based plan cannot achieve sufficient sparing of the heart and lung (i.e., meeting accepted 
constraints), the decision is favorable for this enrollee. While any potential benefit of proton therapy over 
standard IMRT is investigational, with the dosimetric differences described, it is plausible that there would be a 
benefit in this enrollee, even if a better optimized IMRT were plan were run to better prioritize lung sparing. 
The treatment would be in accordance with accepted standards of care and the LCD criteria are 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, 77523). 
  
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.