Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Adenocarcinoma of the Left Parotid Gland. 
Treatment: Proton Beam Radiation Therapy. 

The insurer is denied coverage for Proton Beam Radiation Therapy. 

The denial is overturned. 

This male with a past medical history of parotid adenocarcinoma with recurrent left pleomorphic adenoma status post 3 excisions presented for an evaluation of adjuvant radiation therapy. The patient was initially found to have a benign left parotid "golf ball sized" lesion status post left parotid excision approximately 25 years prior to presentation. He noted recurrent swelling pre- and post-auricular masses. He also underwent an excision of a left superficial and deep lobe parotidectomy. 70 Gray (Gy) of proton beam therapy was recommended. Multiple normal tissues or organs at risk (OAR) were noted to be in play.  The goal was to preserve swallowing function, speech, salivary production, and neurocognitive preservation with proton beam therapy. 

Proton radiation, per the American Society of Radiation Oncology (ASTRO) Model Policy 2017 is generally accepted as medically necessary for group 1 tumors, including advanced or unresectable 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 intracranial weight or exhibit extensive perineural invasion; and who are being treated with curative intent and or will have long life expectancies following treatment. The patient 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. 

In this case, the records do indicate an improvement of proton therapy over photon therapy. 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 proton plan could lower the dose to the pharyngeal constrictor muscles, base of brain, and anterior mediastinal structures within reasonable limits for tolerance. It may be possible that protons will reduce short-term toxicity and reduce significant long-term side effects. The treating physician has provided a comparison of proton versus photon plans. The comparison showed a significant advantage for the proton plan. It shows that proton beam plan will be better preserving tolerance to the larynx, oral cavity, and mandible, and secondarily, swallowing function.  The dose distribution is superior compared to photons plan such that there is no exit dose resulting in much reduced acute and chronic side effects compared to photon treatment. The potential for dysgeusia, mucositis, nausea, and pharyngitis are significantly reduced for the proton plan. This will result in less longer-term issues and side effects, including improved neurocognitive function.  The photon plan exceeds tolerance levels for the left cochlea, also. As this patient is expected to have a significant five-year survival, this will be important. This patient has a long life expectancy where consideration of reduction or potential elimination of long-term treatment effects will be critical.  The comparison shows the proton plan meets all the criteria listed from the ASTRO report and per the NCCN guidelines that it can be used over photon therapy in this situation.  The photon plan is shown to fail to meet the constraint for the left cochlea and therefore, is not acceptable when there is an alternative proton plan that does meet all constraints. 

The proton plan is considered an appropriate level of service that can be safely provided to this patient; better than a photon plan for protecting critical structures.  For these reasons, included from the clinical information provided, the NCCN and ASTRO guidelines, proton beam therapy for this patient with a tumor in the left parotid bed/head and neck region with an indication for post-operative radiation treatment of his current disease, is considered medically necessary. 

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 proton beam radiation therapy for the treatment of adenocarcinoma of the left parotid gland should be overturned.  The medical necessity is substantiated.