Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Adenocarcinoma of the gallbladder

Treatment: 30 treatments of simple with and without compensation, intermediate and complex proton beam radiotherapy

The insurer denied coverage for 30 treatments of simple with and without compensation, intermediate and complex proton beam radiotherapy.

The denial is overturned.

This is a female patient who has a history of adenocarcinoma of the gallbladder as well as pain in mouth, tonsillectomy and adenoidectomy who was seen for complaints of abdominal pain. The patient's computed tomography (CT) scan revealed a gallbladder mass. The patient underwent a resection of the gallbladder mass, which revealed a 7 cm poorly differentiated adenocarcinoma invading the perimuscular connective tissue but not through the visceral peritoneum. A chart note indicated that the patient has had complete radical resection which revealed negative margins. The patient started chemotherapy and was tolerating treatment well. She wanted to discuss chemoradiotherapy. The patient's physical examination did not reveal any significant abnormalities. The patient and physician reviewed the treatment plan and it was recommended to schedule a proton simulation.

Based on the review of the medical record, this patient's cholangiocarcinoma was treated with resection and chemotherapy, and is now to be considered for postoperative radiation and chemotherapy using protons per SWOG 0809 trial. It should be noted that in this trial, the mode of radiation was photon using either three dimensional planning or intensity-modulated radiation therapy (IMRT), not proton. The patient is now anticipated to receive post-operative radiation to the tumor bed, including the use of proton beam radiation therapy (PBRT). The patient's physician will need to consider delivery of 60 Gy RBE to the tumor bed and draining lymphatics. The treatment field will involve intra-abdominal organs, including the liver. 

In this case, the patient will be treated according to the SWOG 0809 trial. The use of photons will result in greater dose to the liver and other surrounding normal tissue which can result in greater long-term complications using photons. In this situation, protons will result in less toxicity to the normal tissue and sufficiently dose the target. Given the comparison of proton to photon radiation, the photon plan will not be as good as protons to meet target and normal tissue constraints, particularly the liver. Regarding medical necessity, while proton therapy may not be a standard of medical practice, it may be safe and effective and may be considered more effective than standard photon therapy for this patient's condition. A proton plan can reduce the dose to the normal tissues at risk, such as the liver, below tolerance, within acceptable limits sufficiently beyond the ability of a photon plan to do so for the required delivered dose. The records do reflect that the proton plan would limit dose to normal tissue, maintaining dose tolerance of the critical tissues in the field. The proton plan will be the best modality that will allow this patient to be safely treated. 

For these reasons noted above, included from the clinical information provided, the NCCN and ASTRO guidelines, given that the patient can be better treated with a proton plan that significantly improves normal tissue dosing over a photon plan, proton beam therapy for this patient with an indication for post-operative radiation and chemotherapy, with extensive disease requiring comprehensive postoperative radiation, a postoperative treatment plan utilizing proton therapy is considered optimal treatment option for this patient.

The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of 30 treatments of simple with and without compensation, intermediate and complex proton beam radiotherapy (CPT codes 77520, 77522, 77523, and 77525) should be overturned.