LCD Reference Article Response To Comments Article

Response to Comments: Transurethral Waterjet Ablation of the Prostate (L38682)

A60346

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Source Article ID
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Article ID
A60346
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Transurethral Waterjet Ablation of the Prostate (L38682)
Article Type
Response to Comments
Original Effective Date
12/15/2025
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Transurethral Waterjet Ablation of the Prostate DL38682. Thank you for the comments.

Response To Comments

Number Comment Response
1

Comments were received that supported the draft LCD overall from several commenters. A few commenters included a request to reconsider the reimbursement.

Payment is a separate issue from coverage and will not be addressed in this Response to Comments document.

2

Several comments were received about the removal of the requirement for measurement of prostate volume by transrectal ultrasound. (TRUS)

In the draft LCD, one of the Contractors inadvertently neglected to remove this requirement. This was corrected in its final LCD, based on a re-review of the document and prior known evidentiary support for such removal.

3

A comment was received that the five-year study results of Water II had not been reviewed in the recent draft LCD, as that supported prostate volumes for the procedure at 30-150mL.

Initially, this LCD was not a collaborative LCD among all Medicare Administrative Contractors (MACs) as it is now. Many had already changed prostate volume from an upper limitation of 80mL to 150mL with the results of Water II two-year outcomes and the study was discussed in those LCDs. The five-year study, Bhojani N, Bidair M, Kramolowsky E, et al. Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results. J Urol. Jul 2023;210(1):143-153. doi:10.1097/JU.0000000000003483 was reviewed, mentioned in the LCD and is listed in the bibliography. The five-year results confirmed the two-year outcomes regarding this point for coverage and limitations for several of the Contractors.

4

A comment was received that there should be no limit to prostate volume because there was simply no evidence to exclude coverage for patients with prostate volumes below 30 or above 150mL. No evidence was submitted with this comment.

The Contractors make coverage decisions based on evidence. There is evidence to support the current coverage volumes in the LCD, based on several studies. Water I and II limited the volumes of prostates ultimately in the ranges noted in the LCD. The LCD reviews a number of studies that suggest there may be more complications for those with a prostate volume above 150mL. “Due to the multiple planning periods, adjustments of the handpiece, and swipes of the beam, Aquablation in very large prostates does have additional procedure-related risks such as a greater chance for bleeding.” Helfand BT, Kasraeian A, Sterious S, et al. How I do it: Aquablation in very large prostates (> 150 mL). Can J Urol. 2022;29(2):11111-11115.)

A more recent study by Ringler et al., 2025 was a retrospective cohort study (retrospective and observational). Enrollment included 170 patients, allocated in a 1:4 ratio with fewer than 20% of patients falling into the >than 150 mL group. Outcomes essentially only involved a sample of 33 patients to represent this patient population but overall were similar to those of Helfand et al for the > 150 mL group. The authors mention the sample size as a study limitation and conclude their discussion with the following: “This study is, therefore, among the first to demonstrate the safety and efficacy of Aquablation in prostate volumes greater than 150mL, albeit with greater need for follow-up and retreatment compared to prostate volumes <150 mL.” Another limitation is the single center retrospective observational design of the study.( Ringler R, Gangwish D, Horning P, Kuperus J, Palmateer G, Zwaans B, Hafron J, Peters K.Does size matter? A single institution’s comparison of Aquablation in prostates greater than or less than 150 mL. The Prostate. 2025; 85:140-147.)

The numbers in these studies are small and there are other issues with design but the suggestion that the trend might exist gives us pause to hold volume at the line where there is reasonable evidence and await further quality studies on other prostate volumes.
No literature was submitted with this comment.

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Associated Documents

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Medicare BPM Ch 15.50.2
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