Proposed LCD - Fluid Jet System Treatment for LUTS/BPH (DL38367)

CMS National Coverage PolicyLanguage quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1862(a)(1)(D) refers to limitations on items or devices that are investigational or experimental.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.CMS Publications:CMS Publication 100-02,Medicare Benefit Policy Manual, Chapter 14,10 Coverage of Medical DevicesCMS Publication 100-04,Medicare Claims Processing Manual, Chapter 23,30 Services paid under the Medicare Physicians Fee ScheduleCMS Publication 100-08,Medicare Program Integrity Manual, Chapter 13,5.1 Reasonable and necessary provisions in LCDs7.1 Evidence supporting LCDs.Coverage 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).IndicationsTreatment for LUTS/BPH 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) >10ng/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, Barber N, Bidair, M, et al. 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Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. 2019;36(6):1326-1336.Desai M, Bidair M, Zorn KC, et al. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial.BJU International.2019;08:08.Bhojani N, Bidair M, Zorn KC, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results.Urology.2019;129:1-7.Bach T, Giannakis I, Bachmann A, et al. Aquablation of the prostate: single-center results of a non-selected, consecutive patient cohort.World J Urol.2018.Bach T, Gilling P, El Hajj A, Anderson P, Barber N. First Multi-Center All-Comers Study for the Aquablation Procedure.J Clin Med2020;9(603).Giulio R, Sebastiano C, Giorgio B, et al. Aquabeam System for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique.International journal of impotence research.2019:1.Kasivisvanathan V, Hussain M. Aquablation versus transurethral resection of the prostate: 1 year United States - cohort outcomes.Canadian Journal of Urology.2018;25(3):9317-9322.Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc).Advances in Therapy.2018;35(6):832-838.Yafi FA, Tallman CT, Seard ML, Jordan ML. Aquablation outcomes for the U.S. cohort of men with LUTS due to BPH in large prostates (80-150 cc).International Journal of Impotence Research.2018;30(5):209-214.AUA. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019, 2020). 2020;https://www.auanet.org/guidelines/benign-prostatic-hyperplasia-(bph)-guideline. Accessed 8/26/2020.Gravis S, Cornu JN, Gratze, C, et al. EAU Guidelines: Management of Non-neurogenic Male LUTS; Chapter 5: Disease Management. 2019;https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts/#5. Accessed 9/14/2020.NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia.https://www.nice.org.uk/Guidance/IPG629. Accessed accessed 8/1/2019.Labban, M., et al., Aquablation for benign prostatic obstruction: Single center technique evolution and experience.Investigative and ClinicalUrology, 2021. 62(2): p. 210.Bach, T., et al., First multi-center all-comers study for the aquablation procedure.Journal of Clinical Medicine, 2020.9(2): p. 603.