Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer (brain metastases-secondary malignant
neoplasm of brain)
Treatment: Radiation Therapy with Daily Picture Studies, Pre-service (Proton Beam Therapy)
The insurer denied the Radiation Therapy with Daily Picture Studies, Pre-service (Proton Beam Therapy)
The denial is overturned. 

The patient is a female with a diagnosis of stage IV (four) breast cancer status post (s/p) prior radiation to the left breast and stereotactic radiosurgery (SRS) to the brain two times (X2).  The patient subsequently presented with leptomeningeal disease.  Palliative cranio-spinal radiation therapy was recommended and proton therapy was requested.

Yes, the proposed radiation therapy is medically necessary.
According to attending physician's note, the plan is to deliver 30 gray (Gy) in ten fractions.

Because of the extensive volume of radiation required, and that the target is in close proximity to critical structures such as cochlea, brainstem and temporal lobes, conventional radiation techniques can result in adverse effects on vision, hormone, and neurocognitive functioning in this young patient.  In addition, proton therapy can also help reduce the risk of injury to heart, lung, thyroid, gastrointestinal (GI) tract and reproductive organs.  This is especially true given that this patient had prior radiation to the left breast and regional nodes as well as the brain.  Furthermore, studies have shown that there is a potential reduction of the incidence of radiation induced secondary cancer by using proton beam radiation. 

Other types of radiation therapy such as photon intensity modulated radiation therapy (IMRT) or tomotherapy have also been used to treat this disease, however, they are not the optimal modalities for this patient.  A study by Brown et al. evaluated 40 adult patients with meduloblastoma treated with proton therapy; the authors concluded that "Patients treated with p-CSI (proton craniospinal irradiation) experienced less treatment-related morbidity including fewer acute gastrointestinal and hematologic toxicities".  

Because of the special "Bragg peak" characteristic, proton beam radiation therapy therefore, is the most appropriate treatment for this patient at this time.

In regards to the daily image-guided radiation therapy (IGRT), per Medicare, daily image-guided radiation therapy (IGRT) is indicated when intensity modulated radiation therapy (IMRT) or proton therapy is being utilized. The reason for using image-guided radiation therapy (IGRT) is basically the same for using proton therapy.  Image-guided radiation therapy (IGRT) is indicated when the target needs to be very conformal, when the treatment margins are narrow or when there is history of prior radiation that abuts or overlaps the current radiation field. In this case, the image-guided radiation therapy (IGRT) request would meet all of the above criteria.

Lastly, according to eviCore guideline, brain metastasis should be treated with three-dimensional (3D)-conformal radiation therapy (CRT). However, this is not a typical brain metastasis. This patient had leptomeningeal disease. Three-dimensional (3D) would have been an appropriate technique if the patient is receiving whole brain radiation therapy.  However, this patient requires craniotomy-spinal irradiation and three-dimensional (3D) would result in excessive toxicity, especially given that the patient already had prior radiation to her breast and brain.

A proton/photon comparison plan was performed.  The proton plan was able to significantly reduce dose to the heart, lung, esophagus, bilateral kidneys bilateral lens and stomach.  For example, the Dmax to the lens was about 15 gray (Gy) with photon (which exceeded tolerance) and less than six gray (Gy) with proton therapy (with tolerance).  Given that the surrounding critical structures would exceed tolerance with photon therapy and that the proton therapy can reduce the doses to those structures to within tolerance, the requested proton therapy is considered medically necessary.