LCD Reference Article Response To Comments Article

Response to Comments: Water Vapor Thermal Therapy for LUTS/BPH

A59340

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Document Note

Posted: 4/6/2023
From 02/09/2023 to 03/22/2023 this article displayed on the MCD only for NGS Contract Numbers 13101 (Part A, J – K, Connecticut) and 13102 (Part B, J – K, Connecticut). On 3/23/2023 the display was corrected to include all of the following contract numbers which were inadvertently omitted:
(MAC - Part A - 06101 - J - 06) National Government Services, Inc., (MAC - Part A - 06201 - J - 06) National Government Services, Inc., (MAC - Part A - 06301 - J - 06) National Government Services, Inc., (MAC - Part B - 06102 - J - 06) National Government Services, Inc., (MAC - Part B - 06202 - J - 06) National Government Services, Inc., (MAC - Part B - 06302 - J - 06) National Government Services, Inc., (A and B and HHH MAC - 13201 - J - K) National Government Services, Inc., (A and B and HHH MAC - 13102 - J - K) National Government Services, Inc., (A and B and HHH MAC - 13202 - J - K) National Government Services, Inc., (A and B and HHH MAC - 13282 - J - K) National Government Services, Inc., (A and B and HHH MAC - 13292 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14411 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14211 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14311 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14511 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14111 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14112 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14212 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14312 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14512 - J - K) National Government Services, Inc., (A and B and HHH MAC - 14412 - J - K) National Government Services, Inc.

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General Information

Source Article ID
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Article ID
A59340
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Water Vapor Thermal Therapy for LUTS/BPH
Article Type
Response to Comments
Original Effective Date
04/01/2023
Revision Effective Date
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Revision Ending Date
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Retirement Date
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CMS National Coverage Policy

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Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Water Vapor Thermal Therapy for LUTS/BPH Local Coverage Determination. The official notice period for the final LCD begins on February 9, 2023, and the final determination will become effective on April 1, 2023.

Response To Comments

Number Comment Response
1

The following comments were received from Teleflex Interventional Urology in opposition to changing the prostate volume to larger than 80cc:

  • The major concern with this change is that it falls outside of the indications for use specifically cleared by the Food and Drug Administration (FDA), which has been unchanged since the original clearance obtained in 2016. 
  • The data underlying the Bole article is of inferior quality and often incomplete as acknowledged by the authors themselves, limiting the conclusions that can accurately be drawn from the study.
  • The Garden study highlights the unclear therapeutic benefit to patients with large glands treated with Rezum and should prompt caution in expanding the use of this technology to this patient population. 
  • Troubling safety outcomes emerged from both articles including urgency and hematuria in over 50% of subjects.

MACs have discretion to establish coverage of off label use of drugs and devices. This can be based on current peer reviewed literature, best practices and guidelines. The comments about the two cited studies are noted. The American Urologic Association guidelines do not currently recommend water vapor thermal therapy in prostates larger than 80cc. Further research is needed in this area.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L37808 - Water Vapor Thermal Therapy for LUTS/BPH
Related National Coverage Documents
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SAD Process URL 2
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Public Versions
Updated On Effective Dates Status
02/02/2023 04/01/2023 - N/A Currently in Effect You are here

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