Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Metastatic Non-Small Lung Cancer with Leptomeningeal Disease.

Treatment: radiation therapy for brain metastases.

The insurer is denied coverage for radiation therapy for brain metastases.

The denial is upheld. 

This case involves a patient who was seen for a consultation due to a history of metastatic non-small cell lung cancer with leptomeningeal disease.  The documentation indicated she initially presented with a right lower lung cavity mass.  The biopsy did confirm adenocarcinoma.  She had metastatic disease in the celiac node and bone metastasis was noted to the left ilium.  She did begin therapy with medication and was enrolled in a protocol to receive craniospinal radiation with proton beam therapy.  The documentation indicated on physical examination there were no significant findings.  She was alert and oriented and resting comfortably.  It was recommended she receive craniospinal radiation with protons.

The patient has metastatic non-small cell lung cancer with leptomeningeal disease. She is being evaluated for craniospinal radiation. 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. National Comprehensive Cancer Network (NCCN) Guidelines for Central Nervous System Cancers 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 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. This patient falls into the category described above. She has reasonable prognostic features with the potential for survival and has specific anatomical areas such as hippocampus, eyes, retina, cochlea, optic nerves, chiasm, and temporal lobes and organs anterior to the spinal cord that requires specific conformal dosing for them to be spared. The records provided, however, do not provide a comparison of photons versus protons planning where proton planning can be shown to meet the constraints appropriately while the photon therapy plan will fail to meet these constraints.

The American Society for Radiation Oncologist (ASTRO) Report on Emerging Technologies indicates the proton beam therapy for central nervous system tumors is a group 1 category. For this category, medical necessity requirements have been shown to be met, including for malignant primary central nervous system (CNS) tumors. The records again, do not indicate specifically an improvement of proton therapy over photon therapy. Regarding medical necessity, proton therapy for group 1 tumors 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 treating physician has indicated that for a photon plan they are concerned with tolerances of multiple structures, including the hippocampus, brainstem, lens, retina, optic nerves, and chiasm. They provide evidence that the proton plan should reduce the dose to the within acceptable limits, better than the photon plan. However, there are not specific constraints provided that show protons are necessary over photons for a dose of 30 Gy [radiation dose]. Records are not provided which show that protons can meet normal tissue tolerances adequately and safely where photon therapy cannot adequately and safely meet these tolerances. The proton plan is not shown to be the best modality that will allow this patient to be safely treated. It may be an appropriate level of service that can be safely provided. Again, a comparison is not provided to show the necessity for protons over photons. For these reasons, included from the clinical information provided, the NCCN and ASTRO guidelines, proton beam therapy for this patient with leptomeningeal disease from non-small cell lung cancer has not been shown to be medically necessary for approval by the health plan. 

Based on the above, the medical necessity for the radiation therapy for brain metastases provided is not substantiated. The insurer's denial is upheld.