Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Metastatic breast cancer
Treatment: Proton Beam Therapy (PBT), codes 77014, 77370, 77470, 77522, 77523, 77525 and G6002
The insurer denied coverage for PBT, codes 77014, 77370, 77470, 77522, 77523, 77525 and G6002 
The denial is overturned

This case involves a patient diagnosed with metastatic breast cancer who was being recommended PBT. A visit note stated that kyphoplasty from thoracic (T) 4- T7 and computed tomography (CT) guided biopsy noted pathology consistent with metastatic breast carcinoma. Magnetic resonance imaging (MRI) of the brain with and without contrast showed new enhancing leptomeningeal metastatic disease in the posterior fossa, including along the cerebellum, brainstem, and internal auditory canals, and less so with cerebral hemispheres. There was mild bilateral cerebral edema secondary to contiguous parenchymal infiltration with multiple new small enhancing parenchymal metastases, including in the basal ganglia. Another MRI of the total spine showed no suspicious leptomeningeal enhancements in the spinal cord.  The patient was seen for an initial consultation with plans made for referral to radiology oncology for consideration of proton craniospinal irradiation (CSI).  

It was determined that the patient's diagnosis was included in the National Comprehensive Cancer Network (NCCN) Guidelines and ASTRO model policy for PBT use. The patient was status-post chemotherapy and additional kyphoplasty at T8-T10.  The physician wanted to deliver craniospinal irradiation using protons over 10 fractions.  

Current peer-reviewed medical literature has noted that PBT is a form of radiotherapy that uses particles with unique physical properties that enable treatment delivery with minimal dose deposition beyond the treatment target. PBT has emerged as an exciting radiotherapy modality for breast cancer due to the ability to minimize exposure to the heart, lungs, muscle, and bone. Radiation therapy plays an important role in the multidisciplinary management of breast cancer. The NCCN guidelines version 2.2022 regarding central nervous system cancers has stated that proton therapy may be helpful in the setting of primary spinal cord tumors to better spare surrounding normal tissues, uninvolved cord, and nerve roots. NCCN states that proton therapy is recommended to spare critical structures and uninvolved tissue. It was also noted that preliminary data suggests that proton therapy could reduce the radiation dose to developing brain tissue and potentially diminish toxicities without compromising disease control. The NCCN goes on to state that proton beam CSI may be considered when clinically appropriate and when toxicity is a concern.  

As noted by the physician, per ASTRO Guidelines, Proton Therapy is considered a Group 2 recommendation for patients when treated in accordance to Coverage with Evidence Development (CED) on Institutional Review Boards - National Institute of Health (IRB-NIH) approved clinical trial and or national registry. This patient qualifies for registry onto a national registry approved by the Center for Medicare Services (CMS).

There is emerging evidence that shows proton therapy is an effective modality of treatment for the patient's condition. 

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for Proton Beam Therapy (PBT), Current Procedural Terminology (CPT) codes 77014, 77370, 77470, 77522, 77523, 77525 and G6002 is substantiated.