Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Left parotid mucoepidermoid carcinoma.

Treatment: Radiation therapy for head/neck cancer.

The insurer denied coverage for radiation therapy for head/neck cancer.

The denial is overturned. 

This is a female patient who is status post parotidectomy with facial nerve preservation. This patient has stage 3 mucoepidermoid carcinoma of the left parotid gland for which radiation treatment, including Proton-Beam Radiotherapy (PBRT), is being considered. The patient's physician is considering the delivery of a definitive dose to the tumor, which is located near the base of the skull and other critical structures, including remaining salivary glands and brain stem.  

Based on the literature review, proton radiation is generally accepted as medically necessary for the following conditions: intracranial arteriovenous malformations (AVMs); ocular tumors, including intraocular/uveal melanoma; or skull-based tumors (e.g., chordomas or chondrosarcomas). All other clinical situations are generally either medically unnecessary or investigational. The National Comprehensive Cancer Network (NCCN) Guidelines for Head & Neck Malignancies describes appropriate postoperative radiation as Intensity-Modulated Radiation Therapy (IMRT) photons or other conformal techniques, including proton therapy. 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 intracranial weight or exhibit extensive perineural invasion; 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. In this case, this patient fell into the category described above. The patient has the disease, located in a specific anatomical area such as the base of the skull, spinal cord, or previously treated regions that require extremely specific and conformal dosing. The records indicate that the patient will be entered into a sponsored clinical trial. Guidelines strongly suggest that patients such as this one be enrolled in trials.

Regarding medical necessity, while proton therapy may not be a standard of medical practice, it may be considered more safe and effective than standard photon therapy for this patient's particular condition. While there are concerns of tolerances of the tissues near the tumor, including the base of the brain, brain stem, and spinal cord with photon therapy, the proton plan could minimize/prevent this by administering a lower dose to the oral cavity, pharyngeal constrictor muscles and larynx, and interior mediastinal structures within reasonable limits for tolerance. As per the literature review, it may be possible that protons will reduce short term toxicity and reduce significant long-term side effects. The patient has a relatively long life expectancy where consideration of reduction or potential elimination of long-term treatment effects will be critical in the decision-making. Based on the review of the medical record and literature, the requested procedure is considered an appropriate level of service that can be safely provided, better than a photon plan for protecting critical structures. 

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

The carrier's denial of coverage for radiation therapy for head/neck cancer should be overturned. The medical necessity is substantiated.