LCD Reference Article Response To Comments Article

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

A57922

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Source Article ID
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Article ID
A57922
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
04/01/2020
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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 Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia (BPH) LCD. The official notice period for the final LCD begins on February 13, 2020, and the final determination will become effective on April 1, 2020.

 

Response To Comments

Number Comment Response
1

We received a comment from the manufacturer of the Aquablation device (Procept Biorobotics) which focused on the following three areas: 1/ a review of the literature already detailed in the draft; 2/ “several limitations to the draft review” mostly consisting of noting that the guidelines cited in the draft did not have the benefit of the most recent data; and 3/ 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 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 (including the most recent data). 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.

2

Two comments from academic urologists who participated in the WATER studies particularly focused on the advantages “of the fluid jet technique over other large prostate resective standard of care techniques (laser enucleation, open prostatectomy), such as shorter operative time, hospital stay, learning curve, and less sexual side effects.” One also claims that waiting for longer follow-up is not necessary because as a resective, rather than ablative technique, “durability should be comparable to TURP and any transurethral debulking procedure and there should not be an additional risk of late adverse events.” The other noted: “While I believe we have good surgical options available for the treatment of BPH, these techniques have inherent limitations on outcomes based on prostate size of surgeon experience.”

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

3

We received similar comments from two other academic surgeons. One noted: “there is a better reduction in AUA Symptom Index with Aquablation than with Urolift or Rezum, both of which are approved and covered technologies with the same level of evidence, and this is borne out in my clinical practice.” Another that “Aquablation is a surgical intervention that meets a current unmet need. Because of the way the technology was designed, it can be used for all shapes and sizes of prostates. In addition, because the waterjet is so precise, it does not have the same sexual side effects that are associated with other current therapies.”

We appreciate the comments and agree that fluid jet therapy is a promising future alternative, especially for large prostates. However, comparison with such minimally invasive procedures as Urolift and Water Vapor Thermal Therapy can be misleading. Also see response #1.

4

We received testimonials from two private practice urologists claiming equal to superior results compared to those “reported in the published clinical studies,” especially for large prostates, “for which there are limited options such as open simple prostatectomy.” With respect to larger prostates, one noted that Aquablation therapy “has the effectiveness of removing the obstructing adenoma like a simple prostatectomy transurethrally. It takes less time than laser enucleation without the need to use a morcellator to get out the residual tissue. This can be problematic in some cases.”

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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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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