Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Prostate cancer
Treatment: Ablation of Malignant Prostate Tissue Transrectal 
with High Intensity Focused Ultrasound (code 55880)
The insurer denied: Ablation of Malignant Prostate Tissue Transrectal with High Intensity Focused Ultrasound (code 55880)
The denial is Upheld

The patient is an elderly male with history of prostate cancer diagnosed last year. Pathology report indicated Gleason 7 (3+4) in 4 locations, right apex, right mid, right base and left base involving < (less than) 50% of each core. PSA (prostate-specific antigen) was 1.1. The patient had a CT (computed tomography) of abdomen and pelvis 8 months ago, with no evidence of pelvic or abdominal metastases. The bone scan was negative for bony metastases. MRI (magnetic resonance imaging) of the prostate 5 months ago revealed 12mm (millimeter) left mid and apical posterior peripheral zone lesion, PiRADS (Prostate Imaging Reporting and Data System) 4, and 8mm (millimeter) left mid and apical anterior fibromusculostromal lesion PiRADS (Prostate 
Imaging Reporting and Data System) 3. The patient has history of erectile dysfunction on sildenafil, irritable bowel syndrome, anxiety and depression. The patient does not want surgery. He was evaluated for radiation therapy, but the patient appeal noted that he was told that it was not an option. The patient elected to proceed with HIFU (High Intensity Focused Ultrasound).

The health plan should not cover the Ablation of Malignant Prostate Tissue Transrectal with High Intensity Focused Ultrasound (code 55880).

Current guidelines, including the NCCN (National Comprehensive Cancer Network) and AUA (American Urological Association) guidelines do not support the use of HIFU (High Intensity Focused Ultrasound) in individuals with favorable intermediate risk prostate cancer, citing that there is lack of sufficient documentation comparing the results of HIFU (High Intensity Focused Ultrasound) to surgery and radiation and active surveillance. As the requested service is not considered a generally accepted standard of care (as per AUA [American Urological Association] and NCCN [National Comprehensive Cancer Network] guidelines) and there is lack of scientific 
evidence on the impact of the requested service on health outcomes and comparison to accepted therapies the requested service should not be covered. The AUA (American Urological Association) guidelines on localized prostate cancer note, "For 
patients with favorable intermediate-risk prostate cancer, clinicians should discuss active surveillance, radiation therapy, and radical prostatectomy. "Clinicians should inform patients with intermediate-risk prostate cancer considering whole gland or 
focal ablation that there are a lack of high-quality data comparing ablation outcomes to radiation therapy, surgery, and active surveillance."
A number of institutional, multi-site, and population-based studies have reported outcomes of various ablative therapies; however, with absence of randomization, non-standardized protocols, and insufficient follow-up, the role of ablative therapy in the management of clinically localized prostate cancer remains to be defined."
The NCCN (National Comprehensive Cancer Network) guidelines on prostate cancer note, "Cryotherapy or other local therapies are not recommended as routine primary therapy for localized prostate cancer due to lack of long-term data comparing these treatments to radiation or radical prostatectomy. At this time, the panel recommends only cryosurgery and high-intensity focused ultrasound (HIFU [High Intensity Focused Ultrasound]; category 2B) as local therapy options for RT [radiotherapy] recurrence in the absence of metastatic disease."