LCD Reference Article Response To Comments Article

Response to Comments: Transurethral Waterjet Ablation of the Prostate

A58377

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A58377
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Article Title
Response to Comments: Transurethral Waterjet Ablation of the Prostate
Article Type
Response to Comments
Original Effective Date
11/12/2020
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The following are the comment summaries and contractor responses for Novitas Solutions Proposed Local Coverage Determination (LCD) DL38712, Transurethral Waterjet Ablation of the Prostate which was posted for comment on 06/25/2020, and presented at the July 2020 Open Meeting. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number Comment Response
1

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. A commenter noted health insurers, Anthem and Humana have national policies that allow coverage of aquablation without restrictions to size of prostate. This recommendation is aligned with the FDA label where no prostate size limitation is imposed.

We appreciate your comments. After careful review of very recently published literature, Novitas/First Coast agrees to amend prostate volume to 30-150 cc.

2

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. A commenter noted health insurers, Anthem and Humana have national policies that allow coverage of aquablation without restrictions to post-void residuals. Commenters feel that PVR should not be exclusion criteria as there are very little data to support this as a predictor of poor outcomes.

Novitas/First Coast agrees to remove limitation #8 post void residual urine volume > 300 ml.

3

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.

We appreciate your comments, Novitas/First Coast would expect that providers evaluate each patient according to NCCN guidelines for prostate cancer detection and perform a workup according to the guidelines. The 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 and has been added to the final LCD.

4

A comment was submitted indicating that the American Urological Association (AUA) includes aquablation in their 2019 BPH surgical guidelines. The commenter noted that a multicenter international water study spanning three years demonstrated that aquablation equaled TURP in efficacy. The study indicated a notable improvement for aquablation over TURP in significantly lowering impact in sexual function and medication restarts at three years (aquablation is 9% compared to 14% for TURP). The commenter hopes that coverage will be provided for Medicare patients.

We appreciate your comments, it is the intention of Novitas to provide limited coverage for transurethral waterjet ablation of the prostate as outlined in this LCD.

5

A comment was submitted indicating that it was appropriate to address the possibility of spreading prostate cancer following aquablation. If the patient presents with elevated prostate-specific antigen (PSA) levels, tests should be performed to assess the presence of cancer such as MRI or biopsy. If cancer is present, then appropriate treatment should be discussed with the patient to address the cancer. However, if cancer is not detected through biopsy but is still present, there is nothing to suggest the risk of spreading the cancer is higher with aquablation than any other BPH surgical techniques.

We appreciate your comments, it would be expected that providers evaluate each patient according to NCCN guidelines for prostate cancer detection and perform a workup according to the guidelines. A suggestion addressed in comment #3 to incorporate the verbiage of “unless the patient has had a negative prostate biopsy within the last 6 months” in limitation #2 is accepted and has been added to the final LCD.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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