Diagnosis: Meningioma.
Treatment: Proton beam therapy.

The insurer denied coverage for proton beam therapy.

The denial is overturned.

This is an adult patient with a left medial clinoid meningioma in close proximity to the left optic nerve status post partial resection and decompression of the left optic nerve. A surveillance magnetic resonance imaging (MRI) scan showed an increase in the size of a residual meningioma. Proton beam therapy is being requested to treat this patient's progressing meningioma.

Compared to photon beam Radiation Therapy (RT), Proton beam RT can achieve a significantly sharper dose gradient due to its Bragg peak patterns of energy release and thus can deliver a therapeutic high dose to the target with significantly better dose conformity and sparing of adjacent normal tissues. Proton beam therapy, therefore, can be considered as a form of delivering superior conformal RT. Proton beam therapy in this case can reduce risks of radiation induced blindness and hormonal dysfunction of pituitary gland in this patient with good long-term prognosis.

The American Society for Radiation Oncology (ASTRO) states that Proton beam therapy is an advanced type of external-beam radiation therapy that uses proton rather than photon beams to deliver radiation doses to a tumor. Proton therapy offers a high degree of precision, which allows radiation oncologists to target an escalated dose of radiation directly on a tumor and spare nearby healthy tissue. Proton therapy is particularly beneficial for patients with tumors that are near critical structures, such as lung tumors near the heart. Based on new evidence published since the original policy was issued, the updated model policy outlines two categories of appropriate clinical indications, or diagnoses, for proton beam therapy.

For indications in Group 1, coverage is recommended; for Group 2, coverage is recommended if additional requirements (outlined below) are met. Disease sites were assigned to one of the two categories based on evidence in published clinical data and current Medicare coverage.

Group 1 indications, or the clinical scenarios that frequently support the use of proton therapy based on medical necessity and published clinical data, were updated with five additions and one modification. Group 1 indications, with additions marked by asterisks, include: Malignant and benign primary central nervous system (CNS) tumors, which includes skull base meningioma, as in this case. Therefore, the use of proton beam therapy with its superior dosimetric conformity in order to maximize sparing of optic nerve/chiasm and pituitary gland, is consistent with the ASTRO guideline for proton beam therapy.

It is critical to achieve sharp radiation dose gradient between targeted tumor volume and optic chiasm/pituitary gland/brain in order to avoid radiation complications to these critical normal tissues. For local control of the skull based on recurrent progressing skull base meningioma, the dose of radiation necessary is > 5400 centigray (cGy), which carries high risks of radiation damage/injury to brain, optic nerve/chiasm and dysfunction of the pituitary gland and can result in brain necrosis, permanent visual loss, and hypopituitarism with hormonal deficiency.

The National Comprehensive Cancer Network (NCCN) clinical practice guideline on CNS cancer includes proton beam therapy for treatment of brain tumor in patients with good long-term prognosis to better spare the uninvolved brain and preserve cognitive function. As such, proton beam therapy (PBT) is considered medically necessary for this patient.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for proton beam therapy (PBT) is substantiated.