Response to Comments: Transurethral Waterjet Ablation of the Prostate

Several comments were received requesting that the indication “Maximum urinary flow rate (Q_max) of ≥15 mL/s (voided volume greater than 125 cc)” pertaining to catheter-dependent patients be revised. Commentators noted that acute or chronic urinary retention associated with benign prostatic hyperplasia (BPH) inhibits the passage of meaningful amounts of urine and some patients depend on catheterization to relieve their symptoms. The voided volume for patients with either an indwelling catheter or those who require intermittent catheterization is either below the 125 cc threshold or non-existent. Numerous professional practice encounters were disclosed as examples of the direct negative impact this indication has had on Medicare beneficiaries. Multiple pieces of literature (Burton 2023, Labban 2021, Lerner 2021, Gilling 2022, Bhojani 2023, Bach 2020, Kasraeian 2020, Marhamati 2024, and Zorn 2024) were submitted as supporting evidence for transurethral waterjet ablation to be considered safe for the treatment of acute and chronic urinary retention with BPH and to remove the parenthetical requirement of “voided volume greater than 125 cc” for catheter-dependent patients.

Thank you all for your comments, subject matter expertise, as well as the professional experiences shared within the context of this comment. We acknowledge that a treatment barrier for catheter-dependent patients was an unintended consequence of the parenthetical statement. Following the review of evidence, it was decided that the parenthetical language “voided volume greater than 125 cc” should be removed from the covered indications. The revised summary and analysis of evidence supports the revision of the covered indication “Maximum urinary flow rate (Q_max) of ≤15 mL/s (voided volume greater than 125cc)” and removal of the parenthetical statement. The indication has been revised to “Maximum urinary flow rate (Q_max) of ≤15 mL/s” in the final LCD.

Several comments were received requesting that the 150 cc limit of prostate volume be removed from the covered indications. It was noted that very large prostates (those greater than 150 cc) can be effectively treated with Aquablation and maintain low rates of adverse effects. Men with very large prostates have limited surgical treatment options and these options come with a higher risk of complications in comparison to Aquablation. Submitted literature included Helfand 2021, Omidele 2024, Kasraeian 2020, Marhamati 2024, Gilling 2022, Bhojani 2023, and Zorn 2024, as well as FDA 510(k) letters and National Institute for Health and Care Excellence (NICE) guidelines/support of Aquablation.

Thank you for your comments. The submitted full text literature was reviewed as well as articles found through an expanded scientific literature search. All literature was analyzed for real-world data, relevance to the Medicare population, peer-reviewed publication, and quality of evidence. Much of the literature focused on small (<30 g), average (30-80 g), or large (80-150 g) prostates apart from Kasraeian 2020, Helfand 2021, and Helfand 2022. The 2022 publication by Helfand et al notably stated that there are surgical differences in men with very large prostates including the need for multiple waterjet passes during the procedure and greater risk for complications and bleeding. The article discussed further anatomical considerations, scenarios in which there should be alternative probe and scope placement, and instructional techniques that necessitate additional provider education to perform Aquablation on this population of men. The number of participants with very large prostates in conjunction with the number of studies focusing on transurethral waterjet ablation in very large prostates does not provide sufficient long-term evidence of safety for removal of the 150 mL prostate volume limitation. A full summary of evidence and analysis of evidence is included in the final LCD. Providers may submit updated peer-reviewed full-text articles to support coverage/limitations for transurethral waterjet ablation of the prostate via the reconsideration process outlined on our website once the LCD is finalized.

Comments were received regarding the required measurement of prostate volume by transrectal ultrasound (TRUS). Requests were made to include other imaging modalities as a means of measuring prostate volume including MRI or CT. Clinicians stated that patients will often receive an MRI or CT prior to Aquablation for one reason or another. They stated that a single choice for imaging to gain a prostate size measurement is too restrictive and that a transrectal ultrasound can cause unnecessary detriment to their patients. Articles including an abstract of Lee 2007, full text literature Choe 2023, citation of Paterson 2016, and guidelines for assessing prostate anatomy by the American Urological Association (AUA) were submitted as supporting evidence.

Thank you for your comments. The submitted full text literature was reviewed as well as articles found through an expanded scientific literature search. All literature was analyzed for real-world data, relevance to the Medicare population, peer-reviewed publication, and quality of evidence. Multiple studies reported that MRI may provide a more accurate measurement of prostate volume, but that TRUS is the preferred method of measurement. The peer-reviewed evidence does not support specific measurement techniques of TRUS or MRI as superior or preferred for prostate volume determination; therefore, the final LCD has been revised to allow providers to use their discretion when choosing an imaging option.

Several comments were received requesting that the limitation “Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines) or a prostate specific antigen (PSA) >10 ng/mL unless the patient has had a negative prostate biopsy within the last 6 months” be removed. A recent FDA clearance (K231024) removed this contraindication based on a circulating tumor cell (CTC) study conducted on patients with benign prostatic hyperplasia (BPH) and prostate cancer undergoing Aquablation. The CTC results showed a small transient increase in CTCs post-operatively and reduced to baseline status by day 2. Urologists have a considerable proportion of patients with low-risk prostate cancer on active surveillance who also have lower urinary tract symptoms (LUTS) with BPH but are ineligible for Aquablation given the current LCD limitation. The NCCN guidelines indicate conservative management is a preferred or recommended course of treatment of all prostate cancer risk groups and PSA levels depending on life expectancy and symptomology. Utilization of a conservative management approach has grown substantially with low-risk and intermediate-risk groups. Men in these categories tend to be older and, as such, are at an increased risk from LUTS due to BPH, but unable to access symptom relief through Aquablation. The theoretical concerns for potential exposure to metastatic hazards during Aquablation therapy are not proven in literature to increase oncological risk. Several studies including Hilscher 2022, Eschwège 2009, Jahn 2015, Eggener 2022 as well as FDA documents, the updated NCCN guidelines, and the AUA guidelines were submitted to support these comments. Preliminary unpublished data comparing cohorts who received Aquablation for BPH under active prostate cancer surveillance, diagnosed prostate cancer, and those with BPH alone were additionally written. Consensus was made that restricting access to men with suspicion of prostate cancer disproportionately impacts groups with certain demographic characteristics such as age and ethnicity where there is a prevalence for higher prostate cancer risk.

Thank you for your comments. The submitted full text literature was reviewed as well as articles found through an expanded scientific literature search. All literature was analyzed for real-world data, relevance to the Medicare population, peer-reviewed publication, and quality of evidence. The 2024 NCCN Prostate Cancer guidelines recommend conservative treatment and active surveillance for all prostate cancer risk groups and PSA levels based on life expectancy. The NCCN Prostate Cancer Guideline updates did not impact the PSA score limitation. These guidelines do not establish a role for transurethral waterjet ablation of the prostate in patients with known or suspected prostate cancer. All studies reviewed noted improvements in PSA levels without mention of cutoffs or intervention differences based on PSA level. While Hilscher 2022 showed little to no risk of adverse oncological outcomes for patients with PSA under 10 ng/mL, it did note that more extensive follow-up is needed for those with higher PSA levels. This study also focused on findings associated with transurethral resection of the prostate (TURP), not Aquablation. Currently, there is insufficient evidence to support the removal of the limitation for known or suspected prostate cancer or prostate specific antigen (PSA) >10 ng/mL. The final LCD provides a summary of evidence and analysis of evidence to support our coverage decision. Providers may submit updated peer-reviewed full text articles to support coverage for transurethral waterjet ablation of the prostate via the reconsideration process outlined on our website once the LCD is finalized.

A comment was received that the age limitation (≤80 years old) should be removed from the LCD as well as comments supporting the removal of the age limitation in the proposed LCD, DL38712.

Thank you for your comment. Evidence was reviewed in response to a reconsideration request. Following review of the evidence the Contractor agrees that the age limitation originally noted in the covered indications section should be removed. The final LCD has been revised to remove the age limitation and includes a summary and analysis of the evidence to support this change.

A comment was received from a member of the AUA which states that the AUA has amended Aquablation guidelines to say that Aquablation is no longer considered 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 transurethral resection of the prostate on International Prostate Symptom Score, LUTS, and quality of life (QOL) scores. The AUA recommendation remains unchanged and is as follows: “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”. The AUA has supported the creation of the Current Procedural Technology (CPT) 0421T for waterjet ablation of the prostate and conducted a Relative Value Update Committee (RUC) survey to develop work and practice expense relative value units for the 0421T Category I code which will be effective in 2026. The commenter noted a final code has not yet been assigned, but that these points were made to ensure the LCD reflects this change when finalized. The AUA noted their involvement with the CPT and RUC survey as further proof that they support the use of this technology to treat LUTS and BPH.

Thank you for your comment. We have reviewed the language in the LCD regarding transurethral waterjet ablation of the prostate as a minimally invasive surgical treatment (MIST) as well as what defines MIST within the AUA BPH treatment guidelines. Based on the findings, we agree that transurethral waterjet ablation of the prostate is no longer a MIST. Statements indicating that this procedure is minimally invasive have been removed from the final LCD. The corresponding LCD article, Billing and Coding: Transurethral Waterjet Ablation of the Prostate, includes coverage of CPT 0421T. We appreciate the information regarding a new code being released in 2026. The associated billing and coding article will be updated as applicable with quarterly/annual CPT/HCPCS code updates.

Comments were received suggesting that the LCD should be retired due to its outdated clinical guidelines and most recent peer-reviewed publication findings. Revisions for the reconsideration request associated with this proposed LCD were reiterated by commenters: removal of the age limitation (≤80 years old), clarification of the voided volume requirement for catheter dependent patients, removal of the prostate volume size limitation (30-150 cc), and removal of the limitation for known or suspected prostate cancer or prostate specific antigen (PSA) >10 ng/mL. Comments stated that updated evidence would effectively obliterate these foundational indications and limitations that serve as primary anchors to the LCD. Collective empathies were noted that if these indications were removed and/or significantly revised, the LCD would lose much of its relevance and would warrant retirement altogether. Some commentators believe this LCD restricts beneficiary coverage and impacts patient care as it was originally written and is currently drafted.

Thank you for your comments. Please refer to the prior comments and responses regarding the suggested revisions. Following an expanded literature search and review, the Contractor has decided to revise the LCD rather than retire it. The final LCD provides a summary of evidence and analysis of evidence to support our coverage decisions.

A comment was received that the limitation of bladder calculus is restrictive and not aligned with appropriate clinical patient care or AUA guidelines. The comment referenced the publication by Sandhu et al that bladder stones are frequently treated concomitantly with benign prostatic hyperplasia (BPH) and the underlying cause of bladder stones is often urinary retention/incomplete bladder emptying and urinary stasis secondary to BPH. The AUA guidelines amended in 2023 were cited to say that surgery is recommended for patients who have renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to BPH, and/or with LUTS/BPH refractory to or unwilling to use other therapies. Additionally, these guidelines indicate cystolithalopaxy can be performed concomitantly with the surgical procedure used to remove the obstructing prostate tissue. The comment included a reference from Chapelle 2024 that patients who do not concomitantly undergo BPH surgery with bladder stone removal are more likely to form recurrent stones and undergo additional surgery. The commenter said these patients are condemned to higher rates of additional surgery and morbidity and additional costs associated with a second procedure and anesthetic. The request was made to remove the limitation based on the presence of bladder calculus.

Thank you for your comment. The submitted full text literature was reviewed as well as articles found through an expanded scientific literature search. All literature was analyzed for real-world data, relevance to the Medicare population, peer-reviewed publication, and quality of evidence. The literature does not provide sufficient evidence for removal of bladder calculus from the limitations. A full summary of evidence and analysis of evidence is included in the finalized LCD.

A comment was received to addend the LCD limitation of PSA >10 ng/mL requiring a negative biopsy within the last 6 months and to also allow waterjet ablation for patients with a negative MRI and PSA density below 0.1. Supporting full text evidence included Hugosson 2024, Omri 2020, and Wang 2024 suggesting data shows a low risk of clinically significant prostate cancer in patients with negative MRIs and low PSA densities. An article abstract from Nordstrom 2017 was also submitted.

Thank you for your comment. The submitted full text literature was reviewed as well as articles found through an expanded scientific literature search. All literature was analyzed for real-world data, relevance to the Medicare population, peer-reviewed publication, and quality of evidence. Searched and submitted evidence reviewed was insufficient to warrant revision of this limitation; therefore, the limitation of PSA >10 ng/mL will remain unchanged. A full summary and analysis of the evidence reviewed is included in the finalized LCD. PSA density is not within the scope of this LCD reconsideration, therefore not reviewed. Providers may submit peer-reviewed full text articles to support the use of prostate specific antigen density for patients being considered for transurethral waterjet ablation of the prostate via the reconsideration process outlined on our website once the LCD is finalized.