Retired Local Coverage Article Response to Comments

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


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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
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Article Text

CGS Administrators, LLC received comments on proposed policy DL38378-Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH) from 10-30-2019 through 12-14-2019. Comments were received from the provider community. The notice period begins 02-15-2020 through 03-31-2020. The LCD becomes final on 04-01-2020.

Response To Comments


We received a comment from the manufacturer of the Aquablation device (Procept Biorobotics) regarding the recent granting by CMS to Aquablation therapy a new technology add-on payment (NTAP) and transitional pass-through payment (TPP) because it represents a “substantial clinical improvement.”

Both NTAP and TPP are payment methodologies and do not ensure coverage. This device is potentially eligible for transitional pass-through payment. However, according to CMS regulation 42 CFR 419.66 “Transitional pass-through payments: Medical Devices,” one component of eligibility for additional Medicare payment is section (b)(2): “The device is determined to be reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body part (as required by section 1862(a)(1)(A) of the Act).” Coverage requires determination that the technology is reasonable and medically necessary. This determination of reasonable and necessary, and therefore coverage, is based on evidence review by the Medicare Contractor Administrators (MACs). We have conducted a comprehensive evidence review and rationale for decision making, as outlined in the LCD. We maintain concerns about the balance between benefit and risk of this new technology, and seek maturation of the data, especially in regards to safety.


We received a comment from the manufacturer of the Aquablation device (Procept Biorobotics) regarding “several limitations to the draft review,” mostly consisting of noting that the guidelines and societal recommendations cited in the draft did not have the benefit of the most recent data;. Specifically, they reviewed 6-12 month data and did have the benefit of the most recent (2 years) data.

In the evidence review section of the LCD, the most current two-year data was reviewed, and findings are summarized in the LCD. During the development of the LCD, the most current clinical guidelines, consensus documents, and societal recommendations were used to supplement the research. Coverage decisions are based on the composite of these factors. 


We received a comment from the manufacturer of the Aquablation device (Procept Biorobotics) regarding the comparison of Aquablation to other surgical treatment modalities for BPH.

WATER I provides a comparison between the water jet system and TURP. We did not identify any other papers comparing Aquablation with other technologies for the management of BPH. New literature that provides this evidence can be submitted as part of the reconsideration process.


Two private practice urologist states support for the Aquablation procedure as a treatment for benign prostatic hyperplasia stating it would fill an unmet need for the treatment of BPH for men with larger volume prostates. They comment that the efficacy, safety, and durability have been demonstrated by the Water 1 and Water 2 trials.

We appreciate the comments and agree that fluid jet therapy is a promising future alternative, especially for large prostates. See response #1.

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Public Versions
Updated On Effective Dates Status
10/11/2022 04/01/2020 - 10/11/2022 Retired You are here
02/07/2020 04/01/2020 - N/A Superseded View