Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Adenocarcinoma of the prostate.
Treatment: Proton beam radiation therapy (procedure codes 77522, 77523, 77525 and 55874).
The insurer denied coverage for proton beam radiation therapy (procedure codes 77522, 77523, 77525 and 55874). The denial is overturned.

This is a male patient who has been diagnosed with adenocarcinoma of the prostate.  The documentation indicated he has a history of adenocarcinoma of the prostate with a Prostate-Specific Antigen (PSA) score of 9.56. A biopsy confirmed a Gleason 8 cancer.  Magnetic resonance imaging (MRI) of the patient's prostate showed localized disease.  The documentation does indicate the patient wants to receive definitive therapy and after a lengthy discussion he ruled out surgical intervention. He does have a significant family history of colon cancer and wanted to reduce the risk of secondary cancer.  Consequently, he began proton beam therapy in hopes of minimizing the risk of secondary cancer. The recommendation was made for proton beam therapy in light of the patient's young age.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome regarding proton beam therapy for patients with prostate cancer. Proton beam radiation therapy has final approval from the appropriate regulatory bodies for this diagnosis. The American Society for Radiation Oncology (ASTRO) states that proton beam therapy for primary treatment of prostate cancer should only be performed within the context of a prospective clinical trial or registry. This is secondary to a lack of literature to support proton beam therapy over other radiation therapy techniques. National Comprehensive Cancer Network (NCCN) states that photon or proton external beam radiation therapy (EBRT) are both effective at achieving highly conformal radiotherapy with acceptable and similar biochemical control and long-term side effect profiles in patients with prostate cancer. The patient's records reflect a history of rectal issues and a large prostate. Given the ability of proton beam radiation to reduce dose to surrounding organs over intensity-modulated radiation therapy (IMRT), the proposed treatment was warranted. 

Regarding medical necessity, proton therapy is safe and effective and may be considered more effective than standard photon therapy for this patient's condition. A proton plan can reduce the dose to the normal tissues at risk, such as the rectum and bladder, below tolerance, within acceptable limits sufficiently beyond the ability of a photon plan to do so for the required delivered dose. The records do reflect that the proton plan would limit dose to normal tissue, maintaining dose tolerance of the critical tissues in the field. The proton plan may be the best modality that will allow this patient to be safely treated. The patient is young and has a significant life expectancy, so minimizing dose to surrounding tissues is critically important. It is an appropriate level of service that can be safely provided. In addition, the records reflect that the patient's Karnofsky Performance Score (KPS) is essentially 100. This would mean that the purpose of treatment has efficacy given that his long-term survival is reasonable. For these reasons noted above, included from the clinical information provided, the NCCN and ASTRO guidelines, given that the patient can be better treated with a proton plan that will reduce normal tissue dosing, proton beam therapy for this patient with an indication for definitive radiation, inside of a clinical trial, a treatment plan utilizing proton therapy is the most appropriate treatment for this patient. Proton beam radiation therapy is likely to be more beneficial than any of the standard treatments/procedures for this patient.

Based on the above, the medical necessity for proton beam radiation therapy (procedure codes 77522, 77523, 77525 and 55874) is substantiated. The insurer's denial is overturned.