Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Esophageal Squamous Cell Carcinoma. 
Treatment: 1:25 fractions (treatment sessions) of proton beam therapy (PBT). 

The insurer denied coverage for 1:25 fractions (treatment sessions) of proton beam therapy (PBT). 

The denial is overturned. 

This case involves a patient who has been previously diagnosed with esophageal squamous cell carcinoma.  The documentation detailed the patient initially presented with a 2-month history of dysphagia to liquids and solids.  He did undergo an esophagogastroduodenoscopy (EGD) which found an esophageal stricture.  The biopsy did reveal in situ and invasive squamous cell carcinoma (SCC), moderately differentiated.  Computed tomography (CT) scan of the chest revealed an area of mural thickening of the distal esophageal/gastroesophageal junction with associated gastric hepatic ligament lymphadenopathic measuring approximately 1.6 cm (centimeter).  The documentation indicated he was seen to discuss the role of radiation therapy in the management of care.  He was recommended to undergo trimodality therapy with neoadjuvant chemoradiation with concurrent carboplatin and paclitaxel chemotherapy followed by definitive surgery. 

The patient is a candidate for combined pre-operative chemoradiation. The treatment field will involve mediastinal organs, including the spinal cord, lung, and esophagus. The patient will also be enrolled in a clinical trial. Proton radiation is generally accepted as medically necessary for the following conditions:  intracranial arteriovenous malformations (AVMs);  Ocular tumors, including intraocular/uveal melanoma (includes the iris, ciliary body, and choroid); or Skull-based tumors (e.g., chordomas or chondrosarcomas). National Comprehensive Cancer Network (NCCN) Guidelines version 4.2021 for Esophageal and Esophagogastric Junction Cancers describes appropriate radiation as Intensity Modulated Radiation Therapy (IMRT) photons or other conformal techniques, including proton therapy to spare normal structures as needed. Enrollment in a clinical trial is preferred. The American Society for Radiation Oncology (ASTRO) Report on Emerging Technologies indicates the proton beam therapy for esophageal cancer is a Group 2 classification, which may be considered in appropriate situations. Update indicates that for sites other than those listed above, there is a continued need for clinical evidence development and comparative effective analysis for appropriate use of proton beam therapy for these various disease sites. Regarding medical necessity, while proton therapy may not be a standard of medical practice. it may be safe and effective. A proton plan can reduce the dose to the normal tissues at risk, such as the lung and heart, below tolerance, within acceptable limits sufficiently beyond the ability of a photon plan to do so for the required delivered dose for some situations. The records do reflect that the proton plan would limit dose to normal tissue, maintaining dose tolerance of the critical tissues, heart, and lung, in the field. The photon plan comparison shows that the photon plan is unacceptable. Tolerances for the organs listed, including lung and heart are exceeded. This means that the proton plan is the best modality that will allow this patient to be safely treated. The patient is young and has a significant life expectancy, so minimizing dose to surrounding tissues is critically important. The photon plan is not reasonable nor appropriate. It is not an appropriate level of service that can be safely provided, compared to protons.  For their complexity, protons are shown to add a clinically significant benefit over photons for this patient. 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 will reduce normal tissue dosing, proton beam therapy for this patient with esophageal cancer, a treatment plan utilizing proton therapy is medically necessary. 

The health plan did not act reasonably with sound medical judgment in the best interest of the patient. 

The insurer's denial of coverage for 1:25 fractions (treatment sessions) of proton beam therapy to treat esophageal cancer is overturned. Medical Necessity is substantiated.