Local Coverage Determination (LCD)

Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH)

L38378

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Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

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Source LCD ID
N/A
LCD ID
L38378
Original ICD-9 LCD ID
Not Applicable
LCD Title
Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH)
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL38378
Original Effective Date
For services performed on or after 04/01/2020
Revision Effective Date
For services performed on or after 10/22/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
09/07/2023
Notice Period End Date
10/21/2023
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Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

N/A

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This 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 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)1,2
    2. Persistent moderate to severe symptoms despite maximal medical management including ALL of the following:
      1. International Prostate Symptom Score (IPSS) ≥121
      2. Maximum urinary flow rate (Qmax) of ≤15 mL/s (voided volume greater than 125 cc)1
      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)
  1. 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 index ≥ 42kg/m2
  2. Known 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.
  3. Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum3
  4. Active urinary tract or systemic infection5
  5. Treatment for chronic prostatitis3
  6. Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture3
  7. Damaged external urinary sphincter3
  8. Known allergy to device materials 5
  9. Inability to safely stop anticoagulants or antiplatelet agents preoperatively.5

 

Summary of Evidence

Background

Benign prostatic hyperplasia (BPH) is a histological diagnosis defined as 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. Many cases are 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). Serious consequences can develop, including acute urinary retention, recurrent urinary tract infections, bladder stones and diverticula, hematuria, and renal insufficiency 7. The condition impacts quality of life (QOL) and is a substantial economic burden with a US estimated annual expenditure over 4 billion dollars8.

Treatment for BPH varies based on symptom severity and ranges from conservative management (monitoring, lifestyle modifications), to medical management (alpha-blockers, 5-alpha-reductase inhibitors, antimuscarinic and beta-3 agonists), and finally surgical treatment in approximately 25% of men over 50 years old. Transurethral resection of the prostate (TURP) is considered the gold standard surgical intervention for BPH secondary to small to medium size prostates (30-80 cc). Interest in alternative surgical options arises from the complications associated with TURP, including dilutional hyponatremia (TUP syndrome), sexual dysfunction (erectile dysfunction (6.5%), anejaculation (>5%) retrograde ejaculation (53-75%)), infection, urethral strictures, bladder neck stenosis or contracture, and hematuria7,9. The most common surgical procedure for large prostates (> 80 cc) is simple prostatectomy, which is effective with a low re-operation rate, but requires an abdominal approach and has a higher risk of bleeding, longer hospital stay (5 days), and catheterization times. Laser enucleation with holium (HoLEP) or thulium (ThuLEP) laser is an option for large prostates and offers shorter hospital stay and less bleeding, but is technically challenging with limited use in the United States10.

In recent years, minimally invasive treatment options have emerged with the main goal to be equally effective to TURP, but with a more favorable safety and convenience profile. Ideally, this includes the rapid and durable relief of LUTS without compromise of sexual function, under local anesthesia in an ambulatory setting, with a short convalescence11. Increasingly, a balance between symptomatic improvement in LUTS and preservation of sexual function is expected12.

The only FDA cleared (De Novo classification for the resection and removal of prostate tissue for the treatment of LUTS resulting from BPH) Fluid Jet System, is the AquaBeam System (PROCEPT BioRobotics)5. This transurethral approach uses a high-velocity saline jet and real-time ultrasound imaging with robotic assistance for targeted removal of prostate parenchyma while ideally sparing collagenous structures (blood vessels, surgical capsule, bladder neck). Pre-treatment, transrectal ultrasound (TRUS) maps out the specific region of the prostate to be resected while limiting resection in key anatomical areas (bladder neck, vermontanum, ejaculatory ducts, external urinary sphincter). Although resection limits are automatically computer generated, the surgeon ultimately defines the area of treatment, and the resection is then executed automatically via a robotic arm. After completion, flushed tissue particles can be sent for histological analysis; hemostasis is achieved using electro-cautery or traction from a 3-way catheter balloon. By minimizing conductive heat damage to erective nerves, Aquablation has a theoretical advantage in preserving sexual function. Operative time is reportedly short (mean 33 minutes)6,8, and trials of novice users report a short learning curve13. Surgeons rate the procedure to be of similar to less work than TURP or other open/robotic-assisted procedures10.

Primary Evidence

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)14,15. 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. After randomization, although treatment was by an unblinded research team, a separate blinded team performed all follow-up. The primary endpoint was the change in the IPSS at six months; scores decreased by 16.9 points and 15.1 points for Aquablation and TURP, respectively (noninferiority p<.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). The rate of persistent grade 1 events was lower after Aquablation (7% vs 25%, p = 0.0004), while the rate of grade 2 and greater events was similar (20% for Aquablation, 23% for TURP (p = 0.3038)). Safety results remained consistent at 6 months.

At two 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)16. Two-year reduction in post-void residual (PVR) was 57 and 70 cc for Aquablation and TURP, respectively (p = 0.3895). Prostate specific antigen (PSA) decreased significantly in both groups by 1 point (p < 0.01). Retreatment 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 hypothesize that Aquablation avoids damage to tissues involved in ejaculation though 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 population16. Three-year results were essentially unchanged providing mid-term data on efficacy and safety.

At five years, IPSS score improvement was sustained (15.1 points in the Aquablation group and 13.2 points in TURP (p=.2764)). In men with large prostates (≥ 50mL) there was a 3.5 greater reduction in Aquablation group compared to TURP (p= .0123). The earlier reported decrease in ejaculatory dysfunction was maintained (7% Aquablation group vs. 25% TURP, p=0.0004). They also reported 51% reduction in future BPH therapy (medication or another procedure) in Aquablation group compared to TURP.17

WATER II was a prospective, uncontrolled, multi-centered international clinical trial to determine if the Aquablation technique was safe in men with large prostates (80-150 cc)2,18,19. The mean prostate size was 107mL (range 80-150cc) with a middle lobe in 83%. Mean operative time was 37 minutes, mean resection time 8 minutes, and average length of hospital stay 1.6 days. Functional outcomes such as IPSS and Qmax, were similar to those seen in the Water study. The primary safety endpoint, defined as CD Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g., ejaculatory disorder, erectile dysfunction, or permanent incontinence), at 3 months occurred in 45.5%, which met the study design goal of less than 65% (P <0.0001). Ejaculatory dysfunction occurred in 19% of sexually active men. While no electrocautery was used at time of surgery, 10 patients required transfusion and five cryptoscopic fulgurations for delayed bleeding. Severe hemorrhage rate for open simple prostatectomy is reported from 7-29%, but lower for alternative laser procedures9. The 2-year data (n=86) reported reoperation rate of 2%2. Complications rates are higher for larger prostates as they are typically more vascular and difficult to treat and the presence of middle lobe also makes this technically more difficult. A comparison of 1-year WATER I and WATER II results were similar except for an expected increase in the risk of complications in larger prostates (by 3 months, Clavien-Dindo grade ≥ II events occurred in 19.8% of WATER I patients and 34.7% of WATER II patients (p = 0.468)). The authors conclude 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 possible3.

A 2019 prospective, single-center, cohort study conducted in Germany evaluated the applicability of Aquablation to a non-selected patient collective20. 118 consecutive patients with symptomatic BPH were enrolled and followed for 3 months post-procedure. Mean prostate volume at time of enrollment was 64.3 ± 32ml (range 20-154 ml); the number >80ml was not reported. Aquablation was successfully performed in all, with 10% experiencing significant bleeding requiring transfusion (2.5%) or second surgical intervention for bleeding (3.4%). IPSS, Qmax, and PVR improved significantly post procedure and out to 3 months. The same author also published in 2020 a multi-center trial of Aquablation procedure performed in commercial setting with prostates ranging from 20-150ml in volume and reported similar safety and effectiveness outcomes. The mean IPSS reduction at one year was 15.3 and comparable to the reduction of 15.1 and 17.0 at one year in WATER and WATERII studies, respectively. The most common complication reported was post-procedure bleeding, however large prostate size predisposes to this risk and modification in technique improved bleeding outcomes in later portion of the study21.

A 2019 Cochrane Review based on 1-year WATER trial results, found evidence of parity with TURP to be of moderate-certainty related to the urologic symptom score (IPSS) primary outcome measure. All other metrics were graded low-certainty (QOL), to very low-certainly (adverse events, retreatments, erectile function, ejaculatory dysfunction) (1). 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 two 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. However, this report was limited to the first 12 months of the WATER1 data7.

A 2019 systematic review reports on functional (IPSS, Qmax, QOL, PVR), sexual (erectile dysfunction, anejaculation), and safety outcomes 22. Nine studies were examined for a total of 445 patients screened. In addition to WATER I (1-year) and WATER II, a WATER I cohort analysis 23, pooled analysis on WATER I and II cohorts24, and WATER II subpopulation analysis were included 13. The review reports improved outcomes in all functional outcome criteria for Aquablation, and statistical non-inferiority to TURP. In terms of safety, in the trials that compared Aquablation to TURP, outcomes (bleeding, urethral strictures, urinary retention, UTI, dysuria, bladder spasm, voiding dysfunction) were similar. Sexual outcomes, available in five papers, appear promising with International Index of Erectile function (IEEF-5) reduced as compared to TURP (33% vs. 56% in sub-analysis of WATER I, p=0.025). In two papers, there were no post-treatment erectile dysfunction13,24, and one paper reported no difference from baseline 25. Ejaculation rates also show better maintenance after Aquablation, with lower rates of anejaculation, compared to TURP. In a population of 92 patients, no significant decrease in Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) at three months was reported24. The review was limited by relatively small sample size and follow-up compared to other standard techniques, extreme heterogeneity in the description, and even reporting, of many outcomes (especially sexual), and lack of standardized validated questionnaires. The authors conclude that other multicenter randomized comparison trials (vs. TURP and laser therapy) with larger cohorts and longer follow-up are needed.

The original studies excluded men over the age of 80 therefore data supporting use in that population was lacking. Additional literature has been submitted that included men ≥ 80 years old. A 2020 real world report of experience with Aquablation in a single center in US reported on 55 men with mean prostate volume of 100cc (range 27-252cc) and 85% had prominent obstructing middle lobe reported successful outcomes and similar length of hospital stay, BPH symptom reduction and Qmax improvement in those with prostate volume >100cc compared to <100cc. Age of subjects included men >80 (range 50-84), but the number of subjects over 80 was not reported. Limitations include the lack of reporting the number of subjects in each group, risk of bias (industry sponsor conducted data analysis) and study design.26 A 2020 prospective observational study reported on 59 men who underwent Aquablation aged 54-86 (the distribution of age was not reported) and reported positive outcomes including several inexperienced surgeons. In the 2020 International prospective OPEN WATER study included all comers with BPH and prostate size 20-150cc. 27 They reported IPSS decrease from 21.6 at baseline to 6.5 at 12-months (p= <0.0001). They included men ages 38-88 with mean age 68 (age distribution was not reported) 28 

Analysis of Evidence (Rationale for Determination)

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 1-year WATER study results, they find parity between Aquablation and TURP on IPSS, LUTS, and QOL scores (Quality of Evidence: Moderate). Their recommendation: “Aquablation may be offered to patients with LUTS attributed to BPH provided prostate volume >30/<80g”.29,30 . (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”9.

European Association of Urology (EAU) guidelines states: “The first clinical experience provides encouraging results, with a low risk of sexual dysfunction, but further modifications of the AquaBeam system may be necessary. Longer term follow up would help assess the clinical value of Aquablation”26. They state Aquablation appears to be as effective as TURP both subjectively and objectively; however, there are still some concerns about the best methods of achieving post-treatment hemostasis (Strength of rating 1b)31.

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 effectiveness32.

In summary, promising short-term, single study, Aquablation results have 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.

Further follow reports 2-year safety and effectiveness of the Aquablation procedure for treatment with men with symptomatic benign prostatic hyperplasia (BPH) and large volume 80-150 cc prostates.

The initial non-coverage policy by CGS predated the publication of mid-term (3-year) results, which demonstrates persistent outcome parity with TURP.

CGS reconsidered the initial non-coverage decision after the publication of the WATER I 3-year data, which was released after the draft policy was posted, and provided sufficient evidence in support of use of the technology for prostates 30-80cc range. The use of the technology in prostates between 80-150cc is supported by the WATERII data. There is less clarity on the benefits in this population, however, given the limited access to laser treatments for large prostate in the U.S. and the potential for lower morbidity as compared to the alternative procedure of open proctectomy, we will allow expansion to 150cc conditional on continued positive outcomes in real world population.

Therefore, CGS considers water jet treatment of LUTS/BPH to be medically reasonable and necessary when performed as outlined in this LCD.

A 2023 reconsideration request to remove the limitation of age >80 was received and submitted literature reviewed. Several real-world studies that included men greater than the age of 80 were submitted. While the quality of evidence is weak it does demonstrate the utilization of the procedure in this age population. Significantly the five-year WATER trail data shows positive long-term outcomes and a less invasive approach in the octogenarian population may be beneficial therefore the limitation has been removed from the policy.

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Bibliography
  1. Gilling P BN, Bidair, M, et al. . Three—year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial. Can J Urol. 2020;27(1).
  2. Desai Mea. Aquablation for benign prostatic hyperplasia in large prostates (80-150cc):2-year results. Can J Urol. 2020;27(2):10147-10153.
  3. Nguyen DD BN, 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.
  4. Carroll PR KPJ, Andriole G, et al. . NCCN Guidelines® Insights Prostate Cancer Early Detection, Version 2. J Natl Compr Canc Netw. 2016;14(5):509-519.
  5. FDA. FDA Approval: De Nova Classification Request for AQUABEAM System. Accessed 7/2/19.
  6. Gilling P, Anderson P, Tan A. Aquablation of the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year Results. Journal of Urology. 2017;197(6):1565-1572.
  7. 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;2:CD013143.
  8. Taktak S, Jones P, Haq A, Rai BP, Somani BK. Aquablation: a novel and minimally invasive surgery for benign prostate enlargement. Therapeutic Advances in Urology. 2018;10(6):183-188.
  9. Nickel JC AL, 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.
  10. Desai M, Bidair M, Bhojani N, et al. WATER II (80–150 mL) procedural outcomes. 2019;123(1):106-112.
  11. Chung ASJ, Woo HH. Update on minimally invasive surgery and benign prostatic hyperplasia. Asian Journal of Urology. 2018;5(1):22-27.
  12. Sturch P WH, McNicholas T, Muir G. Ejaculatory dysfunction after treatment for lower urinary tract symptoms: retrograde ejaculation or retrograde thinking? . BJU Int 2015;115(2):186-197.
  13. Zorn KC, Goldenberg SL, Paterson R, So A, Elterman D, Bhojani N. Aquablation among novice users in Canada: A WATER II subpopulation analysis. Canadian Urological Association Journal. 2019;13(5):E113-E118.
  14. Gilling P, Barber N, Bidair M, et al. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation vs. Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. Journal of Urology. 2018;199(5):1252-1261.
  15. Gilling PJ, Barber N, Bidair M, et al. Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urology. 2019;125:169-173.
  16. Gilling P, Barber N, Bidair M, et al. Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. 2019;36(6):1326-1336.
  17. Gilling, P.J., 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): p. 10960-10968.
  18. 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.
  19. 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.
  20. 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.
  21. Thorsten Bach PG, Albert El Hajj, Paul Anderson, Neil Barber. First Multi-Center All-Comers Study for the Aquablation Procedure. J Clin Med 2020;9(603).
  22. 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.
  23. 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.
  24. 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.
  25. 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.
  26. Kasraeian, A., et al., Aquablation for BPH: United States single-center experience. The Canadian Journal of Urology, 2020. 27(5): p. 10379.
  27. Labban, M., et al., Aquablation for benign prostatic obstruction: Single center technique evolution and experience. Investigative and Clinical Urology, 2021. 62(2): p. 210.
  28. Bach, T., et al., First multi-center all-comers study for the aquablation procedure. Journal of Clinical Medicine, 2020. 9(2): p. 603.
  29. (AUA) AUA. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (2018, amended 2019, 2020). 2020. Accessed 8/26/2020.
  30. 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 II—surgical evaluation and treatment. The Journal of urology, 206(4), 818-826.
  31. 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.
  32. NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia. Accessed 8/1/2019.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/22/2023 R11

R9
Revision Effective 10/22/2023
Revision Explanation: Finalizing policy after open comment period ended July 29, 2023.

  • Provider Education/Guidance
03/23/2023 R10

R8
Revision Effective 03/23/2023
Revision Explanation: Annual review, no changes were made. 

  • Other (Annual Review)
04/07/2022 R9

R7
Revision Effective 04/07/2022
Revision Explanation:  Typo in #2 under limitations in coverage section. The underline should have been under the < sign and not the 10, this has been corrected to < 10.

  • Typographical Error
03/24/2022 R8

R6
Revision Effective 03/24/2022
Revision Explanation: Annual Review, no changes were made.

  • Other (Annual Review)
03/17/2022 R7

R5
Revision Effective 03/17/2022
Revision Explanation: Updates to multiple references within the Bibliography section.

  • Provider Education/Guidance
03/25/2021 R6

R4
Revision Effective 03/25/2021
Revision Explanation: Annual review, no changes were made.

  • Other (Annual Review)
11/09/2020 R5

R3
Revision Effective 11/09/2020
Revision Explanation: Updated Bibliography

  • Provider Education/Guidance
11/09/2020 R4

R3
Revision Effective 11/09/2020
Revision Explanation: Updated notice period for policy until 11/08/2020. This is the final notice period as all comments have been reviewed. The policy will become effective 11/09/2020.

  • Provider Education/Guidance
11/01/2020 R3

R2
Revision Effective 11/01/2020
Revision Explanation: Extended notice period for policy until 10/31/2020 with new start date of notice 08/03/2020. Policy will not be effective until 11/01/2020

  • Provider Education/Guidance
09/01/2020 R2

R2

Revision Effective 09/01/2020

Revision Explanation: Extended notice period for policy until 08/31/2020 with new start date of notice 04/15/2020. Policy will not be effective until 09/01/2020

  • Provider Education/Guidance
06/01/2020 R1

R1

Revision Effective 07/01/2020

Revision Explanation: Extended notice period for policy until 05/31/2020 with new start date of notice 03/26/2020. Policy will not be effective until 06/01/2020

  • Provider Education/Guidance
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08/29/2023 10/22/2023 - N/A Currently in Effect You are here
03/13/2023 03/23/2023 - 10/21/2023 Superseded View
03/28/2022 04/07/2022 - 03/22/2023 Superseded View
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