Transurethral Waterjet Ablation of the Prostate

Jurisdiction: J8 MAC Part B. States: Indiana, Michigan. Type: Active LCD

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General Information Benign prostatic hyperplasia (BPH) is a histological diagnosis characterized by an increased number of epithelial and stromal cells in the prostate. It is common in men over the age of 40, and the incidence increases with age. In the United States, 8 million men older than 50 years old suffer from BPH. In many cases BPH is asymptomatic, however, symptoms may occur with prostate enlargement and compression of the urethra leading to bothersome lower urinary tract symptoms (LUTS), including voiding symptoms such as hesitancy, weak stream, straining, prolonged voiding, and storage symptoms (frequency, urgency, and nocturia). LUTS/BPH can have a significant impact on the quality of life and can cause serious complications such as infections, bleeding, calculus formation, urinary retention and decline of renal function when untreated. 1 First line treatment generally consists of treatment with medications such as alpha blockers, PDE5 Inhibitors, or finasteride/dutasteride. If treatment with medications is not successful, surgical options may then be considered. Transurethral resection of the prostate (TURP) and open simple prostatectomy (OSP) are the standard surgical treatments for LUTS/BPH and are highly effective and provide improved outcomes in urinary functions. However, neither TURP nor OSP are without considerable perioperative complication and morbidity. 2 Recently, new minimally invasive surgeries have emerged as alternatives for the resection of the prostate to manage LUTS in men with BPH. One such surgery is transurethral waterjet ablation which is minimally invasive; water based surgical therapy that combines image guidance and robotics to remove prostatic tissue. 3 The system works by pumping high pressure saline (500 to 8000 pounds per square [PSI]) through a probe nozzle to cut and dissect tissue at predetermined system parameters. 3 Covered Indications Treatment for LUTS/BPH will be considered reasonable and necessary ONCE per lifetime in patients with: All of the following indications: Prostate volume of 30-150ml 4,5 Persistent moderate to severe symptoms despite maximal medical management including ALL of the following: International Prostate Symptom Score (IPSS) ≥12 4 Maximum urinary flow rate (Qmax) of ≤15 mL/s 4,5 Failure, contraindication or intolerance to at least 3 months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride) Only treatment using an FDA approved/cleared device will be considered reasonable and necessary. Limitations Transurethral waterjet ablation of the prostate is not considered reasonable and necessary for patients with the following: Body mass index ≥ 42kg/m2 6 Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines 7 ) or a prostate specific antigen (PSA) > 10 ng/mL unless the patient has had a negative prostate biopsy within the last 6 months. Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum 6 Active urinary tract or systemic infection 6 Treatment for chronic prostatitis 6 Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture 6 Damaged external urinary sphincter 6 Known allergy to device materials 8 Inability to safely stop anticoagulants or antiplatelet agents preoperatively. 8 Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.