Proposed LCD - Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH) (DL38378)

CMS National Coverage PolicyN/ACoverage Indications, Limitations, and/or Medical NecessityThis LCD addresses use of the fluid jet system treatment of lower urinary tract symptoms attributable to benign prostatic hyperplasia (LUTS/BPH).Treatment for LUTS/BPH treatment will be considered reasonable and necessary when performedONCEin patients with the following:Indications includingALLof the following :Prostate volume of 30-150 cc by transrectal ultrasound (TRUS)1,2Persistent moderate to severe symptoms despite maximal medical management includingALLof the following:International Prostate Symptom Score (IPSS) 121Maximum urinary flow rate (Qmax) of 15 mL/s (voided volume greater than 125 cc)1Failure, contraindication or intolerance to at least three 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.LimitationsThe following are considered not reasonable and necessary:Body mass index  42kg/m2Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines4) 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 diverticulum3Active urinary tract or systemic infection5Treatment for chronic prostatitis3Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture3Damaged external urinary sphincter3Known allergy to device materials5Inability to safely stop anticoagulants or antiplatelet agents preoperatively.5General InformationAssociated InformationN/ASources of InformationN/ABibliographyGilling P BN, Bidair, M, et al. . 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