Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Prostate Cancer 
Treatment: Proton Radiation Therapy 
The insurer denied coverage for proton radiation therapy. 
The denial is overturned. 
 
The patient is an adult male seeking authorization for proton radiation therapy. The patient presented for an evaluation related to prostate cancer. The patient had presented with a prostate-specific antigen (PSA) of 26.7. The prostate-specific antigen had been increasing over several years. The patient underwent biopsy which confirmed adenocarcinoma including Gleason 3+ (plus) 4= (equals) 7 in 75% (percent) of 2 cores in the right base, Gleason 4+3=7 in 50% of 2 cores in the right midgland, Gleason 3+4=7 in 50% of 1 core at the right apex, Gleason 4+3=7 in 80% of 1 core in the right lateral base, Gleason 4+3=7 in 50% of 2 cores in the right lateral midgland, and Gleason 4+4=8 in 5% of 1 core in the right lateral apex. Positron emission tomography - computed tomography (PET-CT) demonstrated increased uptake in the right side of the prostate as well as mild increased activity in the right scapula and a small focus of increased radiotracer activity in the right L (lumbar) 3-4 facet joint. Bony metastatic disease could not be ruled out. Additionally, there was a 0.4 centimeter (cm) pulmonary nodule in the periphery of the right upper lung lobe. The patient had been on Orgovyx and the most recent prostate-specific antigen, 1 week after starting, was 8 per the patient. Lower urinary tract symptoms included urinary frequency and nocturia. The provider recommended definitive proton therapy to the prostate and proximal seminal vesicles to 7020 centigray (cGy) in 26 fractions, and 4680 cGy in 26 fractions to the pelvic lymph nodes (integrated boost), and androgen deprivation therapy (ADT) for 18 months. The patient was also a candidate for their stereotactic body radiation therapy (SBRT) trial, where he would receive 4000 cGy in 5 fractions every other day. Protons were the preferred treatment modality to reduce volumetric dose to the rectum and bladder, thereby reducing the risk of side effects. Potential risks and benefits of treatment were explained to the patient after which he voiced understanding. 

In this case, the patient was being treated for stage T3aN0M0 (Tumor stage three - Node stage zero - Metastasis stage zero) (Gleason 4+4=8) high-risk adenocarcinoma of the prostate and a PSA of 26. The provider felt that proton radiation therapy was best suited to treat the patient. The patient had currently signed and consented to a national registry approved by Centers for Medicare and Medicaid (CMS). Given the patient's age, curable disease, and multiyear life expectancy, proton beam therapy was medically necessary to minimize acute and late toxicities associated with treatment. Per the National Comprehensive Cancer Network Clinical Practice Guidelines, the standard treatment for this patient would be external beam radiation therapy (EBRT) with androgen deprivation therapy. However, it is noted that the patient has submitted to be in a clinical trial for proton radiation therapy. As noted by the American Society for Radiation Oncology, coverage of proton therapy for the treatment of nonmetastatic prostate cancer is recommended if the patient is enrolled in either an institutional review board (IRB)-approved study or a multi-institutional registry that adheres to Medicare requirements for Coverage with Evidence Development (CED). Given the participation in the clinical trial, the patient is an exception as medically necessary to standard treatments. Therefore, the denial of coverage for proton radiation therapy is overturned. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably, with sound medical judgment, or in the best interest of the patient. 

The medical necessity for Proton Radiation Therapy is substantiated.