Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast cancer

Treatment: 77523 x 28, proton treatment delivery; intermediate, 77520 x 28, proton treatment delivery; simple without compensation, 77525 x 28, proton treatment delivery; complex.

The insurer denied 77523 x 28, proton treatment delivery; intermediate, 77520 x 28, proton treatment delivery; simple without compensation, 77525 x 28, proton treatment delivery; complex.

The denial is upheld.

This is the case of a patient with right breast cancer with a close margin, status post mastectomy, sentinel lymph node biopsy (SLNB), and tissue expander placement. The request is for approval of postoperative proton radiation.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. Proton radiation is not proven to yield superior outcomes in this setting.

Proton beam therapy (PBT) is considered reasonable in instances where sparing the surrounding normal tissue cannot be adequately achieved with photon-based radiotherapy and is of added clinical benefit to the patient. 

"Radiation therapy plays an important role in the multidisciplinary management of breast cancer. Recent years have seen improvements in breast cancer survival and a greater appreciation of potential long-term morbidity associated with the dose and volume of irradiated organs. Proton therapy reduces the dose to nontarget structures while optimizing target coverage. However, ...studies have yet to demonstrate that protons improve upon the treatment outcomes achieved with photon radiation therapy." (Mutter, R. W. et al. 2021)

"The clinical experiences with PBT for patients with breast cancer are limited, and fewer studies have centered on accessing the clinical outcomes of long-term follow-up... Although the potential for PBT to prevent cardiac deaths is dosimetrically apparent, it needed to further evaluate whether PBT could actually reduce late cardiac toxicity due to the short of long-term follow-up data." (Hu, M. et al. 2018)      

The requested proton treatment delivery does have final approval from the appropriate regulatory bodies for this diagnosis. Proton radiation is Food and Drug Administration (FDA) approved for solid tumors in general.     

This patient is not a good candidate for the requested proton treatment delivery codes.

Proton radiation is not proven to yield superior outcomes in this setting. It is the subject of ongoing trials at this time.     

The requested proton treatment delivery is not proven to be the best available treatment for this patient at this time. Proton radiation is not proven to yield superior outcomes in the patient's setting.     

The adverse risks are not increased over standard treatment.     

Proton radiation is not supported by the American Society for Radiation Oncology (ASTRO) Model policy in the patient's setting. The treating provider did not supply a proton/photon comparison to show that photon radiation cannot provide adequate safety/precision (the provided comparison is for a case control). The patient has not received prior radiation to an abutting area in the past and does not have a genetic nor comorbid condition that increases her risk for normal tissue toxicity.   

In summary, the denial of 77523 x 28, proton treatment delivery; intermediate, 77520 x 28, proton treatment delivery; simple without compensation, 77525 x 28, proton treatment delivery; complex and coverage for the requested treatment should be upheld.  This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.