Local Coverage Article Response to Comments

Response to Comments: Transurethral Waterjet Ablation of the Prostate


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Response to Comments: Transurethral Waterjet Ablation of the Prostate
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Response to Comments
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In addition to the Open Meeting of July 15th, Noridian received eight additional comments from Jurisdictions E and F. The responses below address the three issues emphasized in all of the Comments. In addition, one author added additional observations regarding preserved sexual function in his series of patients. Noridian again wishes to express appreciation to all presenters and Commenters.

Response To Comments


Multiple commenters recommended removing the upper limit of prostate volume (currently 80 ml) or increase upper limits to at least 150 ml. Based on The 2-year results of the WATER II study (prostates 80 mL to 150 mL) demonstrated comparable outcomes in safety and efficacy to those reported in the WATER study (prostates 30 mL to 80mL). The mean prostate size for the study was 107 ml and 83% of the participants had a large median lobe. Compared to the gold standard for large prostates simple prostatectomy, aquablation offers a shorter average length of stay, decrease rates of incontinence, ejaculation dysfunction, and erectile dysfunction. Aquablation clearly provides a needed surgical benefit for larger prostates. This recommendation is aligned with the FDA label where no prostate size limitation is imposed.

Noridian Healthcare Solutions agrees to amend prostate volume to 30-150 cc after careful review of very recently published literature.


Multiple commenters recommended removing post-void residual (PVR) urine volume restrictions, >300 mLs from the limitation section of the LCD. Commenters stated patients with high PVR have obstructive disease that requires surgical treatment. Many of these patients are also catheter dependent pre-procedure and no longer require a catheter post-procedure. Commenters stated that findings suggest that robotically executed removal of prostate tissue may be more effective and consistent especially in more complex and large anatomy therefore improving bladder function. As a result, the PVR exclusion should be removed from the proposed LCD for Aquablation.

Noridian Healthcare Solutions received multiple comments regarding the limitation by post-void residual. After review of the recently published literature, Noridian agrees to remove limitation #8 post void residual urine volume >300 mL.


A comment was submitted supporting the creation of an LCD for aquablation procedure/technology as they believe this will add another valuable tool in the BPH treatment arsenal. However, a few language changes to the proposed LCD were recommended. For limitation # 2:" Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines) or a prostate specific antigen (PSA) > 10 ng/ml," the following amendment was suggested: "Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines unless the patient has had a negative prostate biopsy within the last 6 months". The commenter feels the current limitation will exclude candidates who would otherwise be well suited for this treatment as BPH is a known factor in PSA elevation.

Noridan Healthcare Solutions would expect that each provider evaluates each patient according to NCCN guidelines for prostate cancer detection and performs a workup according to the guidelines. Suggestion to incorporate the verbiage of “unless the patient has had a negative prostate biopsy within the last 6 months” in limitation #2 is accepted.

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