Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Lung Cancer

Treatment: Proton Beam Radiation Therapy (PBRT)

The insurer denied the Proton Beam Radiation Therapy (PBRT). The denial was reversed.   

This is a male patient with a diagnosis of non-small cell carcinoma of the right middle lobe of the lung. He was evaluated for concurrent combination chemotherapy and radiation, including the use of proton therapy.  This particular treatment will deliver a course of radiation to the tumor and to the involved lymphatics with proton therapy and multi-agent chemotherapy in order to obtain local control, and potentially improve the patient's overall survival.  

As per the National Comprehensive Cancer Network (NCCN) Guidelines, Version 4.2018, non-small cell lung carcinoma, the goals of modern radiation therapy are to maximize tumor control and minimize treatment toxicity.  More advanced technologies than 3-D are appropriate when needed to deliver curative radiation therapy safely.  These technologies include but are not limited to 4D-CT and/or PET-CT simulation, IM RT/VMAT, IGRT, motion management and proton therapy. Nonrandomized comparisons of using advanced technologies versus older techniques have demonstrated reduced toxicity and improved survival. 

The patient's provider had provided a comparison of the proton and photon intensity-modulated radiation therapy (IMRT).  While the dose for protons may be lower than photons, it should also be clinically significant if it is to be considered for use over that of photon IMRT.  Proton beam radiation therapy is a type-precise radiation which is used to treat cancer among other conditions. Protons compared to photons deliver a low entrance dose.  The proton also has a high dose "Bragg peak" region designed to cover the tumor with minimal to no "exit dose" after passing through the tumor region.  Given the protons' radiobiological properties, protons are useful in minimizing damage to normal tissue, potentially resulting in fewer side effects. Protons are FDA approved, not subject to institutional review board (IRB).  

The ASTRO's 2014 and 2017 Updated Model Policy on Proton Beam Therapy indicates the following sites that have been supported for the use of proton beam therapy: ocular tumors, tumors that approach or are located at the base of the skull, such as chordoma, chondrosarcoma, primary or metastatic tumors of the spine where the spinal cord has been previously irradiated.  They note that all other tumors have a need for continued clinical evidence development and comparative effective analysis for the appropriate use of proton beam therapy.  

Based on the medical records provided, the patient's comorbid pulmonary conditions are concerning for standard treatment with photon therapy. The patient was noted to have idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD). This indicated that the patient's lung tissues were already compromised by his IPF and had low reserve of normal lung tissue apart from the cancer. In addition, this patient's respiratory status was complicated by his coexisting chronic obstructive pulmonary disease (COPD) that further limited his respiratory reserve. superior to other accepted radiation therapy modalities in all clinical cases, it prefers its use in certain conditions, such as this patient's case. This patient was at a high-risk for developing pneumonitis if the standard photon therapy was to be used over the proton therapy. Thus, given this patient's complex pulmonary status, proton therapy is considered medically necessary to safely and effectively treat this patient's medical condition.

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

The carrier denial of coverage for Proton Beam Radiation Therapy (PBRT) is reversed.  The medical necessity is substantiated.