Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Nasopharyngeal squamous cell carcinoma.

Treatment: Proton beam radiation therapy (PBRT).

The insurer denied coverage for proton beam radiation therapy (PBRT).

The denial is overturned. 

This is a female patient newly diagnosed with Epstein Barr virus (EBV) positive, nasopharyngeal squamous cell carcinoma status post-fine-needle aspiration (FNA). The intent of the treatment was definitive. The technique that would be used to deliver the radiation therapy was external beam radiation therapy (EBRT). The EBRT technique was proton beam therapy. The patient was to receive treatment concurrently with chemotherapy.

The patient has stage II EBV positive nasopharyngeal squamous cell carcinoma. She is to be considered for radiation treatment, including proton beam radiation therapy (PBRT). The attending physician (AP) is considering delivery of a definitive dose to the tumor, which is located near the base of the skull and other critical structures, including parotid glands, mandible, oral cavity, and larynx. Proton radiation per the American Society for Radiation Oncology (ASTRO) Model Policy 2017 is generally accepted as medically necessary for group 1 tumors, including advanced or un-resectable head and neck tumors. National Comprehensive Cancer Network (NCCN) Guidelines version 1.2021 for Head & Neck Malignancies describes appropriate postoperative radiation as Intensity-modulated radiation therapy (IMRT) photons or other conformal techniques, including proton therapy. This update indicates that for proton beam therapy achieving highly conformal dose distributions is especially important for patients whose primary tumors are periocular in location and/or invade the orbit, skull base and/or cavernous sinus; extend intra-cranially or exhibit extensive perineural invasion; and who are being treated with curative intent and or will have long life expectancies following treatment. Proton beam therapy is also to be used to treat patients with the most challenging disease, for which other radiation therapy options are not felt to be safe or of any benefit. The guidelines further indicate that there are a few randomized and single institution reports and systemic comparisons demonstrating safety and efficacy of proton beam therapy in the above-mentioned specific clinical scenarios. This patient falls into the category described above. She has disease, located in a specific anatomical area such as base of skull, spinal cord or previously treated regions that require extremely specific and conformal dosing.
 
The ASTRO Report on Emerging Technologies indicates the proton beam therapy for head and neck tumors, while not necessarily a standard of care currently, may be considered in appropriate situations. 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. The AP has indicated that for a photon plan they are concerned with tolerances of the tissues near the tumor, including parotid glands, brainstem, spinal cord, cochlea, and oral cavity. The proton plan could lower the dose to the pharyngeal constrictor muscles, base of brain, and anterior mediastinal structures within reasonable limits for tolerance. The proton plan meets all the criteria listed from the ASTRO report and per NCCN guidelines that it can be used over photon therapy in this situation.

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

The carrier's denial of coverage for proton beam radiation therapy (PBRT) is overturned. The medical necessity is substantiated.