LCD Reference Article Response To Comments Article

Response to Comments: Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH)

A58465

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Article ID
A58465
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH)
Article Type
Response to Comments
Original Effective Date
11/01/2020
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The following are the additional comments on the Proposed Local Coverage Determination (LCD) DL38367 (Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH)) which was originally posted for comment on 9/26/2019, and presented at the 10/16/2019 Open Meeting. After the policy was presented additional literature was published that led to re-evaluation of the coverage decision.

Response To Comments

Number Comment Response
1

Procept Bio Robotics submitted new papers and three-year data from WATER trial. The supporting literature submitted included: Gilling et al 2020 (WATER3), Bach et al 2020 and the European Association of Urology BPH Guidelines.

The supporting literature was reviewed. Additional new literature reviewed included the 2020 Desai and the policy was changed from non-coverage to coverage based on the review of the new literature.

NGS reconsidered the initial non-coverage decision after the publication of the WATER 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 30-80 cc range. The use of the technology in prostates between 80-150 cc 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 determined expansion to 150 cc conditional on continued positive outcomes in real world population as outlined in the LCD.

 

 

2

We received several comments from providers requesting coverage for large prostate and reporting success with the procedure in their practice.

Thank you for your comments- see Comment #1

3

The American Urological Association submitted a letter of support for coverage for Aquablation, including expansion for large prostates.

Thank you for your comments- see Comment #1

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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