Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Recurrent Breast Cancer.
Treatment: Pre-service request for proton beam radiation therapy.

The insurer denied coverage for Pre-service request for proton beam radiation therapy.  The denial is overturned.

The patient  is a female that has recurrent breast cancer in the right supraclavicular lymph node and retrocrural lymph node. The treating physician will need to deliver a therapeutic dose to a previously treated region. Records reflect that a comparison has been done that shows a photon plan will exceed normal tissue tolerances for the lung, heart, brachial plexus and surrounding normal tissues.
 
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 3.2021 for Breast Cancer describes appropriate postoperative radiation as Intensity Modulated Radiation Therapy (IMRT) photons or other conformal techniques, including proton therapy. The America Society for Therapeutic Radiology & Oncology (ASTRO) Report on Emerging Technologies indicates the proton beam therapy for breast cancer, while not necessarily a standard of care currently, may be considered in appropriate situations. A Group 1 indication is listed as cases where re-irradiation with photons will have cumulative critical structure dose exceed tolerance dose. The records indicate that the use of photons will result in a greater dose to the heart, lung, brachial plexus, 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, achieving the goal of maintaining normal tissue tolerances 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 lung, brachial plexus, and heart. 

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 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, in particular the heart, brachial plexus, and lung, maintaining dose tolerance of the critical tissues in the field.
 
The photon plan comparison does show that the photon plan is unacceptable. The tolerances for the organs listed, including lung and heart are shown to be exceeded. The proton plan will be the better 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 shown to be unacceptable. 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 recurrent breast 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 the pre-service request for proton beam radiation therapy to treat breast cancer is reversed.  Medical necessity is substantiated.