Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Stage I adrenocortical carcinoma of the left submandibular gland

Treatment: Proton beam therapy (PBT).

The insurer denied coverage for proton beam therapy (PBT). The denial upheld.

This patient is male with stage I adrenocortical carcinoma of the left submandibular gland. The letter of medical necessity noted that the patient had undergone surgical resection and selective left neck dissection with closest margin less than 1 mm from the inked margin and there was extensive perineural invasion. The provider's treatment plan was established to treat the skull base to 60 C GE given the extensive nerve involvement. The provider noted in the letter that they would be very close to the skull base and he would need radiation therapy to this area with protons to decrease the dose to the skull base and decrease the integral dose given he was young. The provider requested proton beam therapy (PBT).

The patient is to be considered for radiation treatment, including PBRT. The AP is considering delivery of 60 Gy CGE to the tumor and involved lymphatics. Proton radiation is generally accepted as medically necessary for the following conditions: 1. intracranial arteriovenous malformations; 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 3.2019 for Head & Neck Malignancies describes appropriate radiation modalities as IMRT photons or other conformal techniques, including proton therapy. The guidelines further note that proton therapy can be considered when normal tissue constraints cannot be met by photon-based therapy. The guidelines also list IMRT photons as the preferred radiation modality. 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. 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 the proton beam therapy does not offer a clinical advantage over that of well-planned photon-based therapy.

The photon plan is most likely the best modality that will allow this patient to be safely treated. It is an appropriate level of service that can be safely provided. Based on a comparison of plans, the photon plan is acceptable. For the reasons noted above, including the clinical information provided, the NCCN and ASTRO guidelines, given that the patient may be adequately treated with a reasonable IMRT photon plan, proton beam therapy for this patient with a tumor in the head and neck region would not be considered medically necessary.

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient. The requested Radiation Therapy (Proton Beam Therapy (PBT) is not medically necessary.

Based on the above, the medical necessity for the requested Radiation Therapy (Proton Beam Therapy PBT) is not substantiated. The insurer's denial is upheld.