Local Coverage Article Response to Comments

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


Expand All | Collapse All

Contractor Information

Article Information

General Information

Article ID
Article Title
Response to Comments: Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH)
Article Type
Response to Comments
Original Effective Date
Retirement Date
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Article Guidance

Article Text

The following are the additional comments on the Proposed Local Coverage Determination (LCD) DL38378 (Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH)) which was originally posted for comment on 10/30/2019, and presented at 10/29/2019 Open Meeting. After the policy was presented additional literature was published that lead to re-evaluation of coverage decision. The final notice period begins 09/24/2020 through 11/08/2020. The LCD becomes final on 11/09/2020

Response To Comments


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.

CGS 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 30-80cc range. The use of the technology in prostates between 80-150cc 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 150cc conditional on continued positive outcomes in real world population as outlined in the LCD.


We received several comments from providers in J15 requesting coverage for large prostate and reporting success with the procedure in their practice.

Thank you for your comments- see Comment #1


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

Associated Documents

Related Local Coverage Documents
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
09/15/2020 09/24/2020 - N/A Currently in Effect You are here