Proposed LCD - Transurethral Waterjet Ablation of the Prostate (DL38705)

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations forTransurethral Waterjet Ablation of the Prostate.Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment forTransurethral Waterjet Ablation of the Prostateand must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM Publication 100-02,Medicare Benefit Policy Manual,Chapter 14, Section 10 Coverage of Medical DevicesCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 23, Section 30 Services paid under the Medicare Physicians Fee ScheduleCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Coverage Indications, Limitations, and/or Medical NecessityCompliance 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 InformationBenign 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.1First 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.2Recently, 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.3The 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.3Covered IndicationsTreatment 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)4,5Persistent moderate to severe symptoms despite maximal medical management includingALLof the following:International Prostate Symptom Score (IPSS) 124Maximum urinary flow rate (Qmax) of 15 mL/s4(voided volume greater than 125 cc)Failure, contraindication or intolerance to at least three months of conventionalmedical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)2. Onlytreatment using an FDA approved/cleared device will be considered reasonable and necessary.LimitationsThe following are considered not reasonable and necessary:Body mass index  42kg/m26Knownor suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines7) 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 diverticulum6Active urinary tract or systemic infection8Treatment for chronic prostatitis6Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture6Damaged external urinary sphincter6Known allergy to device materials8Inability to safely stop anticoagulants or antiplatelet agents preoperatively.8Notice: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.General InformationAssociated InformationPlease refer to the relatedBilling and Coding Article: Article Title (A58227) for documentation and utilization requirements as applicable.Sources of InformationContractor Medical Directors Waterjet Ablation WorkgroupBibliographyZorn KC, Goldenberg SL, Paterson R, So A, Elterman D, Bhojani N. Aquablation among novice users in Canada: A WATER II subpopulation analysis.JCan Urol Assoc2019;13(5):E113-E118.Chung ASJ, Woo HH. Update on minimally invasive surgery and benign prostatic hyperplasia.Asian J Urol. 2018;5(1):22-27.Hwang_EC, Jung_JH, Borofsky_M, Kim_MH, Dahm_P. Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.Cochrane Database of Systematic Reviews2019, Issue 2. Art. No.: CD013143.Gilling P, Barber N, Bidair, M, et al. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial.Can J Urol. February 2020; 27(1):10072-10079.Desai M, Bidair M, Bhojani N et al. Aqablation for benign prostatic hyperplasia in large prostate (80-150 cc): 2-year results.Can J Urol.2020; 27(2): 10147-10153.Nguyen DD, Barber N, Bidair M, Gilling P, Anderson P, Zorn KC, et al. Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates.BJU Int.2020;125(1):112-122.Carroll PR, Kellogg Parsons J, Andriole G, et al. NCCN GuidelinesInsights Prostate Cancer Early Detection, Version 2.2016 Featured Updates to the NCCN Guidelines JNatl Compr Canc Netw2016;14(5):509519.FDA Approval: DeNovoClassification Request for AQUABEAM System. Accessed 7/2/19].Gilling P, Barber N, Bidair M, et al. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes.Urol.2019;125:169-173.Gilling P, Barber N, Bidair M, et al. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained.Adv Ther. March 8, 2019.AUA Guidelines: Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019). 2019.Nickel JC, Aaron L, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms /benign prostatic hyperplasia (MLUTS/BPH): 2018 update.Can Urol Assoc J.2018; 12:303-312.NICE Transurethral water jet ablation for LUTS caused by BPH. 2018Taktak S, Jones P, Haq A, Rai BP, Somani BK. Aquablation: a novel and minimally invasive surgery for benign prostate enlargement.Ther Adv Urol 2018, Vol. 10(6): 183188.Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, et al. WATER II (80150 mL) procedural outcomes.BJU Int2019;123(1):106-112.Sturch P, Woo HH, McNicholas T, Muir G. Ejaculatory dysfunction after treatment for lower urinary tract symptoms: retrograde ejaculation or retrograde thinking?BJU Int.2015;115(2):186-187.Bjojani N, Bidair M, Zorn KC, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150cc): 1-year Results.Urology Gold Journal.May 2019.Misrai V, Rijo E, Zorn KC, Barry-Delongchamps N, Descazeaud A. Waterjet Ablation Therapy for Treating Benign Prostatic Obstruction in Patients with Small- to Medium-size Glands: 12-month Results of the First French Aquablation Clinical Registry.Eur Urol(2019).Kasivisvanathan V, Hussain M. Aquablation versus transurethral resection of the prostate: 1 year United States - cohort outcomes.Can J Urol.2018;25(3):9317-9322.Kasraeian, A., et al., Aquablation for BPH: United States single-center experience. The Canadian Journal of Urology, 2020. 27(5): p. 10379.Labban, M., et al., Aquablation for benign prostatic obstruction: Single center technique evolution and experience. Investigative and Clinical Urology, 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.(AUA) AUA. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019, 2020). 2020. Accessed 8/26/2020.Lerner, L. B., McVary, K. T., Barry, M. J., Bixler, B. R., Dahm, P., Das, A. K., ... & Wilt, T. J. (2021). Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA guideline part IIsurgical evaluation and treatment. The Journal of urology, 206(4), 818-826.Gravis S, Cornu JN, Gratze, C, et al. EAU Guidelines: Management of Non-neurogenic Male LUTS; Chapter 5.3: Surgical Management. 2020: Disease Management. 2019. Accessed 9/14/2020.NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia. Accessed 8/1/2019.