Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast cancer.
Treatment: Proton beam radiation therapy.
The insurer denied the proton beam radiation therapy.
The denial was overturned.

This is a female patient who is status post total mastectomy as well as prophylactic right total mastectomy for left breast invasive ductal carcinoma.  The documentation indicated the patient had multifocal ER positive/PR positive/HER-2 positive with 2/19 involved lymph nodes.  The documentation did indicate the patient did receive 12 weeks of THP and completed AC therapy.  The documentation indicated the patient has been recommended to undergo post-mastectomy proton therapy.  A consultation note indicated the patient was a postmenopausal woman who palpated a mass to the left breast in the upper outer quadrant in mid-2019.  Biopsies were performed showing malignant cells consistent with adenocarcinoma.  The patient then underwent an MRI of the right breast which was normal. The patient did receive THP and completed AC chemotherapy.  Surgical evaluation and post treatment ultrasound was performed in late 2018 showing a decrease in axillary adenopathy.  In early 2019 the patient underwent bilateral mastectomy with left sentinel lymph node biopsy and axillary dissection with immediate reconstruction. The patient was being considered for continuing HP versus TDM.  The patient ultimately decided to proceed with HP.  She was being seen to discuss possible proton therapy.

The AP will need to consider delivery of 50 Gy RBE to the tumor and draining lymphatics, including internal mammary nodes.  Proton radiation is generally accepted as medically necessary for the following conditions: 1. intracranial arteriovenous malformations (AVMs); 2. Ocular tumors, including intraocular/uveal melanoma (includes the iris, ciliary body and choroid); or 3. Skull-based tumors (e.g., chordomas or chondrosarcomas).  All other clinical situations are generally either medically unnecessary or investigational.  

National Comprehensive Cancer Network (NCCN) Guidelines version 3.2017 for Breast Cancer describes appropriate postoperative radiation as IMRT photons or other conformal techniques, including proton therapy.  The ASTRO Report on Emerging Technologies indicates the proton beam therapy for recurrent metastatic tumors while not necessarily a standard of care currently, may be considered in appropriate situations.  The 2017, June 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.  This update also indicates that proton beam would not be considered necessary in situations where proton beam therapy does not offer a clinical advantage over that of well-planned photon-based therapy.  
Regarding medical necessity, a proton plan can reduce the dose to the normal tissues at risk, such as the heart, below tolerance, within acceptable limits sufficiently beyond the ability of a photon plan to do so.  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. The patient will also be treated in the context of a clinical trial, as per recommendations of national guidelines. It is an appropriate level of service that can be safely provided.  In addition, the records reflect that the patient's performance status or KPS is essentially 100.  This would mean that the purpose of treatment has efficacy given that her long-term survival is reasonable. 


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

The carrier's denial of coverage for Proton beam radiation therapy is overturned.  The medical necessity is substantiated.