Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Lung Cancer.
Treatment: Image Guided Radiation Therapy (Proton Beam Therapy).

The insurer denied the Image Guided Radiation Therapy (Proton Beam Therapy).  The denial is overturned.

This is a female with stage IIIB T3N2M0 [a large (T3) tumor that has spread to the
nearby lymph nodes (N2) but has not spread to other parts of the body (M0)]
squamous cancer of the right lower lobe of the lung status post neoadjuvant
chemo-immunotherapy. She also has multiple medical conditions including
scleroderma and poor pulmonary function with a forced expiratory volume in one
minute (FEV1) of 49% (percent) predicted. Proton beam therapy is planned for definitive
treatment on Institutional Review Board (IRB) approved registry trial.

Yes, the proposed treatment is medically necessary.

Published studies have reported that some patients with scleroderma treated with
radiation experience considerable toxicities. Critical structures in this case includes
lung, esophagus and spinal cord. The potential adverse long-term (clinical
complications) outcome would be high risks of radiation pneumonitis, pulmonary
fibrosis, radiation esophagitis/fibrosis/obstruction/perforation and spinal cord
myelitis

In this patient with scleroderma, a form of collagen-vascular disorder, the risks of
the radiation induced acute and long term complications from photon radiation
therapy (RT) will be significantly higher than general population. Proton beam
therapy can deliver high doses to the targeted tumor with sparing of the adjacent
normal tissues, which can result in higher chances of tumor control with decreased
risks of complications to adjacent normal tissues.

No, the health plan did not act reasonably, with sound medical judgment and in the
best interest of the patient.

The American Society for Radiation Oncology (ASTRO) Proton Beam Therapy
Model Policy 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, include: 1) Patients with genetic syndromes making total volume of radiation minimization crucial, such as but not limited to neurofibromatosis one (NF-1) patients and retinoblastoma patients.

Due to genetic condition of systemic fibrosis/scleroderma and interstitial lung disease with poor forced expiratory volume in one second (FEV1) of 49% predicted, this patient is at high risk of  developing complications from photon radiation therapy (RT). The requested proton beam therapy meets the Group-1 indications in the American Society for Radiation Oncology (ASTRO) policy for proton beam therapy, and it is considered medically necessary for this patient's condition.

In addition, the National Comprehensive Cancer Network (NCCN) clinical practice guideline on non-small cell lung cancer version 7 states that more advanced technologies are appropriate when needed to deliver curative radiation therapy (RT) safely and that these technologies include proton beam therapy.