Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Pituitary Adenoma.
Treatment:  Radiation Therapy for Non-Cancer Radiation Therapy.

The insurer denied the Radiation Therapy for Non-Cancer Radiation Therapy.  The denial was overturned.    

This is a female patient with a history of Cushing's disease and a pituitary mass.  The patient is status post transsphenoidal surgery and adrenalectomy resulting in primary adrenal insufficiency.   Recommendations were made for radiation treatment, including Proton Beam Radiation Therapy (PBRT).  The patient's MRI from the previous year showed a soft tissue prominence that enhanced on postcontrast image extending from the pituitary gland into the suprasellar cistern along with the caudal portion of the pituitary infundibulum.  The appearance was unchanged.  It was noted it may represent pituitary neoplasm or an infiltrative leptomeningeal process, as described in prior reports.

As per the American Society for Radiation Oncology (ASTRO) guidelines, 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.  The National Comprehensive Cancer Network (NCCN) Guidelines for Central Nervous System Cancers states that for proton beam therapy achieving highly conformal dose distributions is especially important for patients who have primary tumors with good long-term prognosis to better spare un-involved brain and preserve cognitive function.  Proton beam therapy is also to be used to treat patients with the most challenging disease, for which other radiation therapy (RT) options are not felt to be safe or of any benefit.  In this case, this patient falls into the category described above.  The patient has good prognostic features with the potential for long-term survival and has specific anatomical areas, such as the hippocampus, eyes, retina, cochlea, and temporal lobes that require specific conformal dosing for them to be spared.  The patient's medical records also reflect a comparison of photons versus protons planning where proton planning can meet the constraints appropriately, while photon therapy will essentially fail to meet these constraints.

The ASTRO Report on Emerging Technologies indicates that the proton beam therapy for central nervous system tumors is a group 1 category.  Medical necessity requirements have been shown to be met, including for malignant primary central nervous system (CNS) tumors.  A recent update indicates that for sites other than those listed above, excluding group 1 category, 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.  Regarding medical necessity, proton therapy for group 1 tumors (such as in this case) may be considered 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 patient's attending physician has indicated that for a photon plan they are concerned with tolerances of multiple structures, including the eyes, cochlea, hippocampus, and temporal lobes, and they provided evidence that the proton plan can reduce the dose to the within acceptable limits, better than the photon plan. 

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

Based on the above, the medical necessity for Radiation Therapy for Non-Cancer Radiation Therapy is substantiated.  The insurer's denial should be overturned.