Transurethral Waterjet Ablation of the Prostate

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for transurethral 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 for transurethral waterjet ablation of the prostate and 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 Devices
• CMS IOM Publication 100-04, Medicare Claims Processing Manual,
  • Chapter 23, Section 30 Services paid under the Medicare Physicians Fee Schedule
• CMS IOM Publication 100-08, Medicare Program Integrity Manual,
  • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social 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.

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 inch [PSI]) through a probe nozzle to cut and dissect tissue at predetermined system parameters.³

Covered Indications

Treatment for LUTS/BPH treatment will be considered reasonable and necessary when performed ONCE in patients with the following:

1. Indications including ALL of the following:
   1. Prostate volume of 30-150 cc by transrectal ultrasound (TRUS)^4,5
   2. Persistent moderate to severe symptoms despite maximal medical management including ALL of the following:
   1. International Prostate Symptom Score (IPSS) ≥12
   2. Maximum urinary flow rate (Qmax) of ≤15 mL/s (voided volume greater than 125 cc)⁴
   3. Failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)
2. Only treatment using an FDA approved/cleared device will be considered reasonable and necessary.

Limitations

The following are considered not reasonable and necessary:

1. Body mass index⁶ ≥42 kg/m^².
2. Known or 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.
3. Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum.⁶
4. Active urinary tract or systemic infection.⁸
5. Treatment for chronic prostatitis.⁶
6. Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture.⁶
7. Damaged external urinary sphincter.⁶
8. Known allergy to device materials.⁸
9. Inability to safely stop anticoagulants or antiplatelet agents preoperatively.⁸

Provider Qualifications

The Medicare Program Integrity Manual 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.

The focus of this updated literature review is aimed at the safety and efficacy of transurethral waterjet ablation in men greater than 80 years of age suffering from benign prostatic hyperplasia (BPH), acute urinary retention, and chronic urinary retention.

Evidentiary Outcomes:

Initial clinical experience was reported in 2016, and the technology obtained FDA clearance in 2017 after the publication of the WATER trial, a PHASE III multicenter international, double-blind, randomized, non-inferiority study with 181 subjects comparing Aquablation (116/181) to TURP (65/181).⁹ Men 45-80 years old with prostate size 30-80 cc (by TRUS), moderate-severe LUTS (International Prostate Symptom Score [IPSS] ≥12), and maximum urinary flow rate (Qmax) <15ml/s were included and stringent exclusion criteria applied. Although treatment was by an unblinded research team, after randomization, a separate blinded team performed all follow-up. The primary endpoint was the change in the IPSS at 6 months; scores decreased by 16.9 points for Aquablation and by 16.1 points for TURP, respectively (noninferiority p<0.0001 and superiority p=0.1347). The primary safety endpoint was the proportion of subjects with adverse events, defined as Clavien-Dindo grade 2 or higher or any grade 1 with persistent disability. The 3-month primary safety endpoint rate was lower in the Aquablation group than in the TURP group (26% vs. 42%, p=0.0149). At 2 years, IPSS score improvement was sustained (14.7 in Aquablation and 14.9 in TURP [p=0.834, 95% CI for difference -2.1 to 2.6]), and Qmax improvement was large in both groups (11.2 and 8.6 cc/s for Aquablation and TURP, respectively [p=0.1880, 95% CI for difference -1.3 to 6.4]).¹⁰ Two year reduction in post-void residual (PVR) was 57 and 70 cc for Aquablation and TURP, respectively (p=0.3894). Prostate specific antigen (PSA) decreased significantly in both groups by 1 point (p< 0.01). Re-treatment rates were 4.3% and 1.5% (p=0.42) in the Aquablation and TURP groups, respectively. Among the subset of sexually active men without the condition at baseline, anejaculation was less common after Aquablation (10% vs. 36%, p=0.0003). When post-Aquablation cautery was avoided rates of anejaculation were lower (7% vs.16%, p=0.1774), and this resulted in the reduced grade 1 persistent events found in the Aquablation group. The authors believe that Aquablation avoids damage to tissues involved in ejaculation through precise, image-based targeting, and robotic execution. Limitations of the study include the risk of performance bias as surgeons were not blinded and unknown generalizability to a broader population. Three year results were essentially unchanged.⁴

A 2019 Cochrane Review based on 1-year Aquablation trial results, found evidence of similar results, with TURP to be of moderate-certainty related to the urologic symptom score (IPSS) primary outcome measure. All other metrics were graded low-certainty to very low-certainty (adverse events, retreatments, erectile function, ejaculatory dysfunction).³ Evidence was downgraded mainly due to study limitations (performance, reporting, and attrition bias), and imprecision (confidence intervals that crossed the assumed thresholds of clinically important differences or few events, or both). For example, both sexual outcome (erectile and ejaculatory function) results were downgraded 2 levels for a combination of imprecision and study limitations (high risk of performance and attrition bias). The authors recommend larger, more rigorously conducted, and transparently reported, studies comparing Aquablation to other techniques (laser enucleation, prostatic urethral lift, robotic-assisted simple prostatectomy) for which there is also increasing interest.

In a study by Nguyen et al,⁶ the authors looked to determine if the effectiveness of Aquablation is independent of prostate size by comparing its outcomes in 2 clinical trials. The first trial that was conducted was with men whose prostate was between 30 and 80 mL (WATER I) and the other trial was conducted with men whose prostates were between 80 and 150 mL (WATER II). WATER I trial is a prospective, double-blind, multicenter, international clinical trial comparing the safety and efficacy of Aquablation and TURP as surgical treatments of LUTS due to BPH in men aged 45–80 years with a prostate volume between 30 and 80 mL, as measured by TRUS. Patients were enrolled at 17 centers. One hundred sixteen men participated. The Water II trial was a prospective, multicenter, international clinical trial of Aquablation for the surgical treatment of LUTS/BPH in men aged 45–80 years with a prostate volume between 80 and 150 mL, as measured by TRUS. Patients were enrolled at 13 US and 3 Canadian sites. One hundred one men participated. The studies parameters included patients who completed the IPSS. Patients completed questionnaires such as the Incontinence Severity Index (ISI), the International Index of Erectile Function (IIEF-5), and the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Patients received uroflowmetry, PVR measurements and underwent standard laboratory blood assessment. These questionnaires and measurements were provided at baseline. PVR and lab test were required postoperatively at 1 and 3 months. Adverse events were rated by the clinical events committee as possible, probably or definitely related to the study procedure and were classified using Clavien-Dindo grade for 3 months after treatment. The inclusion and exclusion criteria were the same for both studies. The inclusion criteria included patients with moderate-to severe symptoms indicated by a baseline IPSS of ≥12 and a maximum urinary flow rate (Qmax) of <15 mL/s. Exclusion criteria included patients with a body mass index of ≥42 kg/m^², a history of prostate or bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum, active infection, treatment for chronic prostatitis, diagnosis of urethral stricture, meatal stenosis or bladder neck contracture, a damaged external urinary sphincter, stress urinary incontinence, post-void residual urine volume (PVR) >300 mL or urinary retention. The comparison between the 2 studies revealed the mean operative time for WATER I was 33 minutes and 37 minutes for WATER II. The actual treatment time was 4 minutes (WATER I) and 8 minutes (WATER II). For International Prostate Symptom Score, the mean change at 12 months averaged 15.1 for WATER I and 17.1 for WATER II (p=0.605). Clavien-Dindo grade ≥II events at 3 months mark occurred in 19.8% of WATER I patients and 34.7% of WATER II patients (p=0.468).⁶ The authors concluded outcomes and effectiveness of Aquablation are comparable, and are independent of prostate size, with the expectation that with larger prostates, a higher risk of complication is possible.

In the April 2020 publication of WATER II by Desai et al⁵ 2-year safety and effectiveness data of the Aquablation procedure in men with symptomatic benign prostatic hyperplasia (BPH) and large volume prostates (80-150 cc) were evaluated. Enrolled participants averaged a prostate volume of 107 cc and a large median lobe in 83%, a group typically excluded from undergoing TURP. The evidence supports superior improvements from Aquablation at mid-term (2 year) follow-up and quality long-term results for the treatment of LUTS related to BPH.

American Urological Association (AUA) amended guidelines now include Aquablation, but do not classify it as a minimally invasive surgical treatment (MIST) since general anesthesia is required. Based on the 1-year WATER study results, the AUA found parity between Aquablation and TURP on IPSS, LUTS, and quality of life (QOL) scores (Quality of Evidence: Moderate). Their recommendation is: “Aquablation may be offered to patients with LUTS attributed to BPH provided prostate volume >30/<80g; however, patients should be informed that long-term evidence of efficacy and re-treatment rates remains limited”¹¹ (Conditional Recommendation; Evidence Level: Grade C).

Canadian Urological Association (CUA) 2018 guidelines also give a “conditional recommendation based on moderate-quality evidence” that Aquablation may be offered to men “interested in preserving ejaculatory function, with prostates <80 cc, with or without a middle lobe”.¹²

A 2018 National Institute for Health and Care Excellence (NICE) systematic review based on 6-month WATER results concluded the procedure should only be used with “special arrangements,” a defined designation meaning there are uncertainties about safety and effectiveness.¹³

Summary of Evidence related to Reconsideration Request

The original studies did not define the use of this procedure in men greater than or equal to the age of 80 years, therefore, data supporting use of this treatment was lacking in that population. Additional literature was submitted and reviewed that included men ≥80 years of age.

Gilling et al²⁰ in a 2022 publication, reported the results of a double-blinded randomized control trial conducted at multiple centers with a 5 year follow-up of patients that received TURP versus transurethral waterjet ablation. One hundred and eighty four men age 45 to 80 years with LUTS secondary to BPH were studied comparing the safety and efficacy of Aquablation and TURP for those with moderate-to-severe symptoms as measured by IPSS and maximum urinary flow rate (Qmax). The primary safety endpoint was the proportion of subjects with adverse events rated by the clinical events committee as possibly, probably, or definitely, related to the study procedure. The primary efficacy endpoint was the change in IPSS from baseline to 6 months. Secondary safety endpoints included resection time, total operative time, length of hospital stay, reoperation or reintervention rate, the proportion of sexually active subjects reporting worsening sexual function, and the proportion of subjects with a serious device or procedure-related adverse event. Primary safety endpoints were successfully achieved at 3 months as the Aquablation study group had a lower event rate than the TURP study group. Procedure-related ejaculatory dysfunction was lower for Aquablation. The primary efficacy endpoint was successfully achieved at 6 months, where the mean IPSS decreased from baseline by 16.9 points for Aquablation and 15.1 points for TURP. The mean difference in change score at 6 months was 1.8 points greater for the Aquablation study group. At 5 years, IPSS scores improved by 15.1 points in the Aquablation study group and 13.2 points in the TURP study group (p=0.2764). For men with larger prostates (≥ 50 mL), IPSS reduction was 3.5 points greater across all follow up visits in the Aquablation study group compared to the TURP study group (p=0.0123). Improvement in peak urinary flow rate was 125% and 89% compared to baseline for Aquablation and TURP, respectively. The risk of patients needing a secondary BPH therapy, defined as needing BPH medication or surgical intervention, up to 5 years due to recurrent LUTS was 51% less in the Aquablation study arm compared to the TURP study arm. The authors of the study observed that the Aquablation procedure improved BPH-related urinary symptoms compared to the referenced standard treatment (TURP) over 5 years.²⁰ Study limitations included lower than expected follow-up percentages at 4 and 5 years which the authors attributed to the COVID-19 pandemic. Additional study limitations include non US-based study facilitation, author identified conflict of interests, and lack of measurements of direct cost effectiveness.

An additional retrospective observational study published in 2020,²¹ documented the use of Aquablation at a single center in the United States. This study was comprised of 55 men with a mean prostate volume of 100 cc (range 27-252 cc) and a prominent obstructing middle lobe in 85% of them. Baseline assessment and a follow-up assessment at 3 months were completed. A substantial improvement of 80% (17 points) was seen in BPH symptoms scores. By uroflowmetry, Qmax improved by 182% (14 mL/sec). IPSS QOL improved by 3.3 points.²¹ The age of male subjects included those >80 years (range 50-84 years old), but the actual number of subjects over 80 years old was not reported. Limitations for this study included a small sample size, a high risk of bias (as was an industry sponsor conducted data analysis), the observational study design, and a short follow-up period.

In summary, the promising short-term, single-study Aquablation data has resulted in conditional recommendations in some guidelines (AUA, CUA, NICE). A conditional recommendation with Grade C evidence level (AUA) which translates to “Balance between Benefits & Risks/Burdens unclear Alternative strategies may be equally reasonable Better evidence likely to change confidence”, echoing the Cochrane Review recommendation: “any recommendation for or against the use of Aquablation would be based on only very low-certainty evidence.” However, these guideline recommendations predate publication of mid-term (3-year) results, which demonstrate persistent similar outcome with TURP.⁴ These studies and recommendations demonstrate the safety and effectiveness of Aquablation as an option for men aged equal to or less than 80, with moderate to severe LUTS due to benign prostate hyperplasia as indicated by International Prostate Symptom Score (IPSS) equal to or greater than 12 and a 30-80 cc prostate. Also, the ability to preserve sexual function is a major consideration.

In addition, a 2-year safety and effectiveness study of the Aquablation procedure for treatment in men with symptomatic benign prostatic hyperplasia (BPH) and large volume 80-150 cc prostates has been reported.⁵

Overall, it was determined that there was a low certainty of evidence of the submitted literature to support the removal of prostate volumes from covered indications or the removal of suspected or known prostate cancer individuals from the limitations. In the study by Kasraeian et al²¹, men with larger prostatic volumes were recorded, however, the average volume was 100 cc and does not show sufficient evidence of safety and efficacy in men with larger prostates (>150 cc). Two of the articles submitted with the reconsideration provided moderate²¹ and strong²⁰ certainty of evidence in the demonstrated safety and efficacy of this procedure in those equal to and greater than 80 years of age. Specifically, the 5 year trial data by Gilling et al²⁰ shows positive long-term outcomes and a less invasive approach in this age population that may be beneficial. Therefore, the age limitation has been removed from the policy. Based on the 2 and 3 year results combined with recommendations from the AUA and CUA, water jet treatment of LUTS/BPH is considered to be reasonable and necessary when performed as outlined in this LCD.

Please refer to the related Draft Billing and Coding Article: Transurethral Waterjet Ablation of the Prostate (A58243) for documentation and utilization requirements as applicable.

Contractor Medical Directors Waterjet Ablation Workgroup

This bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.

1. Zorn KC, Goldenberg SL, Paterson R, So A, Elterman D, Bhojani N. Aquablation among novice users in Canada: A WATER II subpopulation analysis. J Can Urol Assoc 2019;13(5):E113-E118.
2. Chung ASJ, Woo HH. Update on minimally invasive surgery and benign prostatic hyperplasia. Asian J Urol. 2018;5(1):22-27.
3. 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 Reviews 2019, Issue 2. Art. No.: CD013143.
4. 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.
5. Desai M, Bidair M, Bhojani N et al. Aquablation for benign prostatic hyperplasia in large prostate (80-150 cc): 2-year results. Can J Urol. 2020;27(2):10147-10153.
6. Nguyen DD, Barber N, Bidair M, 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.
7. Carroll PR, Kellogg Parsons J, Andriole G, et al. NCCN Guidelines® Insights Prostate Cancer Early Detection, Version 2.2016 Featured Updates to the NCCN Guidelines J Natl Compr Canc Netw 2016;14(5):509–519.
8. FDA Approval: De Novo Classification Request for AQUABEAM System. Accessed July 2, 2019.
9. 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.
10. 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.
11. AUA Guidelines: Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019). 2019.
12. 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.
13. NICE Transurethral water jet ablation for LUTS caused by BPH. 2018.
14. Taktak S, Jones P, Haq A, Rai BP, Somani BK. Aquablation: a novel and minimally invasive surgery for benign prostate enlargement. Ther Adv Urol 2018;10(6):183–188.
15. Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, et al. WATER II (80–150 mL) procedural outcomes. BJU Int 2019;123(1):106-112.
16. 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.
17. 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.
18. 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).
19. 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.
20. Gilling PJ, Barber N, Bidair M, et al. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022;29(1):10960-10968.
21. Kasraeian A, Alcantara M, Alcantara KM, Altamirando JA, Kasraeian A. Aquablation for BPH. Can J Urol. 2020;27(5):10378-10381.
22. Burton CS, Dobberfuhl AD, Comiter CV. Outcomes of Aquablation in Men With Acute and Chronic Urinary Retention. Urology. Oct 2023;180:214-218. doi:10.1016/j.urology.2023.06.028
23. D'Agostino D, Colicchia M, Corsi P, et al. The combination of waterjet ablation (Aquabeam((R))) and holmium laser power for treatment of symptomatic benign prostatic hyperplasia: early functional results. Cent European J Urol. 2021;74(2):222-228. doi:10.5173/ceju.2021.0049
24. Labban M, Mansour M, Abdallah N, et al. Aquablation for benign prostatic obstruction: Single center technique evolution and experience. Investig Clin Urol. Mar 2021;62(2):210-216. doi:10.4111/icu.20200249
25. Brierly RD, Mostafid AH, Kontothanassis D, Thomas PJ, Fletcher MS, Harrison NW. Is transurethral resection of the prostate safe and effective in the over 80-year-old?. Ann R Coll Surg Engl. 2001;83(1):50-53.
26. Bach T, Gilling P, El Hajj A, Anderson P, Barber N. First Multi-Center All-Comers Study for the Aquablation Procedure. J Clin Med. 2020;9(2):603. Published 2020 Feb 24. doi:10.3390/jcm9020603
27. US Food and Drug Administration. 501(k) Premarket Notification Database. 21 CFR§ 876.4350; 2023. Updated June 24, 2024. Accessed June 26, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231024

• Request for Coverage by a Practitioner (Part B)