Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Prostate Cancer

Treatment: Proton beam radiation therapy (PBRT); procedure codes 77387, 77370, 77470, S8030, 77435, 77432, 63620, 61795, 77338, 61800, 77301, 77295, 77520

The insurer denied coverage for PBRT; procedure codes 77387, 77370, 77470, S8030, 77435, 77432, 63620, 61795, 77338, 61800, 77301, 77295, 77520

The denial is overturned

This case involves an adult patient diagnosed with prostate cancer. An appeal was submitted stating that the physician was requesting certification for proton beam therapy (PBT) to treat the patient's prostate cancer, T (tumor) 1, N (lymph node) 1, M (metastasis) 0, and Gleason score 4+3 = 7. The physician stated that it is medically necessary to treat the patient's prostate cancer and pelvic nodes to a high dose of 70.2 Gray (Gy) in 26 fractions of PBT and a simultaneous integrated boost technique, and a definitive setting. Per the American Society for Therapeutic Radiology and Oncology (ASTRO) Guidelines, Proton Therapy is considered a group II recommendation for patients when treated in accordance with Coverage with Evidence Development (CED) on Institutional Review Board-National Institutes of Health approved clinical trial and/or national registry. The patient has signed and consented to a national registry approved by the Centers for Medicare and Medicaid Services (CMS) and meets the CED requirements and ASTRO Group II for CED. 

Magnetic Resonance Imaging identified prostate lesions with enlarged left iliac lymph nodes measuring up to 1.5 centimeters in short axis, suspicious for metastatic disease. A Computed Tomography was also conducted noting hydronephrosis and renal stones along with small hazy opacity along the peripheral aspect of the left upper lung. A prostate biopsy was revealed 2 cores Gleason 7 with 95% (percent) involvement, 9 cores Gleason 7 with 100% involvement, and 1 core Gleason 6 with 35% involvement. Prostate-specific antigen serum was elevated at 9.0. This was up from 3.1. The physician noted that traditional radiation therapy associated with prostate cancer is widely known to cause genitourinary events such as urinary incontinence. The physician stated that it is imperative not to worsen the patient's urinary symptoms. PBT eliminates the urinary side effects that traditional radiation therapy has been known to impose. 

Current medical literature states that the evolution of three-dimensional conformal radiation therapy and intensity-modulated radiation therapy have allowed physicians to spare surrounding normal organs and reduce adverse effects. The introduction of PBT and its physical advantage of depositing its energy in tissue at the end-of-range maximum may potentially spare critical organs. Per the ASTRO Model Policies, PBT is not a new technology. In the treatment of prostate cancer, the use of PBT is evolving as the comparative efficacy evidence is still being developed. PBT for primary treatment of prostate cancer should only be performed within the context of a prospective clinical trial or registry. 

The patient has signed and consented to a national registry approved by CMS and meets the CED requirements and ASTRO Group II for CED. Given the evidence shown within the context of current peer-reviewed medical literature noting the benefits of PBT for patients diagnosed with prostate cancer and the benefits of using this treatment to spare the surrounding soft tissues, the proposed treatment is considered as one of the new standards of care for the patient's condition. 

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 beam radiation therapy (PBRT); procedure codes 77387, 77370, 77470, S8030, 77435, 77432, 63620, 61795, 77338, 61800, 77301, 77295, 77520 is substantiated.