Transurethral Waterjet Ablation of the Prostate

Jurisdiction: JL MAC Part B. States: Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania. 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 most common in men over the age of 40, and the incidence increases with age. In the United States, 8 million men greater than 50-years-old suffer from BPH. In many cases BPH is asymptomatic, however, symptoms may occur due to 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 Transurethral waterjet ablation is a surgical-based 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 inch [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 when performed using an FDA approved/cleared device ONCE in patients with the following: Indications including ALL of the following: Prostate volume of 30-150 mL. 4,5 Persistent moderate to severe symptoms despite maximal medical management including ALL of the following: International Prostate Symptom Score (IPSS) ≥12. Maximum urinary flow rate (Q max ) 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). Limitations The following are considered not reasonable and necessary: Body mass index 6 ≥42 kg/m². 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. 8 Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum. 6 Active urinary tract infection or systemic infection. 9 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. 9 Inability to safely stop anticoagulants or antiplatelet agents preoperatively. 9 CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provisions in an LCD states services will be considered reasonable and necessary only if performed by appropriately trained providers. Patient safety and quality of care mandate that healthcare professionals who perform transurethral waterjet ablation of the prostate are appropriately trained and credentialed by a formal residency/fellowship program. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings. All aspects of care must be within the provider’s medical licensure and scope of practice. Notice: Services performed for any given diagnosis must meet all the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, all existing CMS national coverage determinations, and all Medicare payment rules.