Noridian CAC Meeting for Alternatives to TURP

Tuesday, November 12 Agenda Shown Below

Minutes and transcript will eventually appear on CAC home page here:
https://med.noridianmedicare.com/web/jfb/policies/lcd/cac


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https://med.noridianmedicare.com/web/jfa/policies/lcd/cac/cac-agenda-111219

[November 12, 2019]

CAC Meeting Agenda, Key Questions for Discussion, and Bibliography: Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia

The purpose of the meeting is to obtain advice from Contractor Advisory Committee (CAC) members and subject matter experts (SMEs) regarding the strength of published evidence on the Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia.

View the related CAC information on this page.

• Agenda
• Key Questions for Discussion
• Bibliography

Agenda

2-4 p.m. CT

1. Welcome and Introduction
   • Facilitator: Dr. Laurence Clark, MD, FACP
2. Key Questions and Discussion
   • CAC Members, Invited Subject Matter Experts, Contractor Medical Directors
3. Closing Remarks and Adjournment

Key Questions for Discussion

General Questions

1. Roehrborn, Teplitsky and Das in an August 2019 review state "critically, in head to head comparison with TURP, Aquablation has equivalent objective results with much shorter resection times and significantly fewer sexual side effects." Do you concur with this general statement?
2. In the same review, the authors provide a cautionary statement, acknowledging literature reporting of trial data of essentially one year. Do you have concern over the long term durability of results?
3. There is one study that reports a head to head trial including effectiveness and side effects with TURP, are there any studies providing a head to head comparison with other Minimally Invasive Therapies for BPH? Corollary question: do you classify Aquablation as a MIST [minimally invasive], or does the use of general anesthesia vs. spinal anesthesia make it a "more invasive" procedure?
4. In the general acceptance of this technology by NICE, there is a reference to "special arrangements." Does this imply uncertainties about safety and efficacy?
5. Does the WATER II study define a specific role for this technology in the treatment of symptomatic patients with larger prostates (i.e. 80-150gms)?

Questions with Evidence Analysis- Evidence Rating 1-5, 1- lack of supporting evidence-better evidence is likely to change confidence, 3-moderate evidence-better evidence could change confidence, 5- strong evidence- further research is unlikely to change confidence

1. Rate the evidence on Waterjet technology in terms of reduction of LUTS due to BPH with prostates less than 80 gm.
2. Rate the evidence on Waterjet technology in terms of safety with prostates less than 80 gm.
3. Rate the evidence on Waterjet technology in terms of reduction of sexual side effects.
4. Rate the evidence on retreatment needs with this technology.
5. Rate the evidence on Waterjet technology being non-inferior to TURP
6. Rate the evidence on Waterjet technology in terms of reduction of LUTS due to BPH with prostates greater than 80 gm.
7. Rate the evidence on Waterjet technology in terms of safety for prostates 80-150 gm.
8. Rate the evidence on Waterjet technology compared to non-TURP procedures for prostates less than 80 gm. And 80-150 gm, respectively

Approval process question: This technology combines a computer limited area of resection, robotic execution, and high-velocity saline jet, and is FDA-cleared

Bibliography

Suggested Reading for Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia Panelists (please feel free to suggest additional articles or more recent substitutions)

1. Gilling, P., et al, Aquablation - image-guided robot-assisted waterjet ablation of the prostate: initial clinical experience. BJU International, 2016. 117(6): p. 923-9.
2. Gilling, P., P. Anderson, and A. Tan, Aquablation of the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year Results. Journal of Urology, 2017. 197(6): p. 1565-1572.
3. Gilling, P., P. Anderson, and A. Tan, AQUABLATION OF THE PROSTATE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA: TWO-YEAR RESULTS: PD23-11. Journal of Urology, 2017. 197(4)(Supplement): p. e451.
4. Gilling, P., et al., WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation vs. Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. Journal of Urology, 2018. 199(5): p. 1252-1261.
5. Gilling, P., et al., Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. 2019. 36(6): p. 1326-1336.
6. Gilling, P., et al., MID-TERM RESULTS USING AQUABLATION, AN IMAGE GUIDED ROBOT-ASSISTED WATER JET ABLATION OF THE PROSTATE, FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH).: PD21-06. Journal of Urology, 2016. 195(4)(Supplement): p. e458.
7. Gilling, P.J., et al., Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urology, 2019. 125: p. 169-173.
8. Giulio, R., et al., "Aquabeam® System" for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique. 2019: p. 1.
9. Hwang, E.C., et al., Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. Cochrane Database of Systematic Reviews, 2019. 2: p. CD013143.
10. Harris E. Foster, M.M.J.B., MD; Philipp Dahm, MD; Manhar C. Gandhi, MD; Steven A. Kaplan, MD; Tobias S. Kohler, MD; Lori B. Lerner, MD; Deb J. Lightner, MD; J. Kellogg Parsons, MD; Claus G. Roehrborn, MD; Charles Welliver, MD; Timothy J. Wilt, MD; Kevin T. McVary, MD Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELIN. May 2019; Available from: https://auau.auanet.org/content/v02-01-prostate-aquablation-novel-image-guided-robot-assisted-prostate-ablation-using-water .
11. Bhojani, N., et al., Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results. Urology, 2019. 129: p. 1-7.
12. Desai, M., et al., Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial. BJU International, 2019. 08: p. 08.
13. NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia. accessed 8/1/2019]; Available from: https://www.nice.org.uk/Guidance/IPG629 .

Last Updated Oct 29, 2019

The Odd History and Placement of a Statutory Clause about NCD Transparency

This is a footnote; see master article here.

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The language on NCDs being required to show and present all evidence is a little quirky.  

First, the language is just plugged in before 1862(b) with no clear rationale for placement there.

Where did it come from?   This paragraph appears in draft versions of Medicare Modernization Act / MMA in 2002/2003 that can still be found via Google.  OK so far so good.  But weirdly - It does not seem to appear in the final version of MMA at Congress.gov. in December 2003. 

However, the language appears in the SSA at least as old as 2005, again based on cloud files via Google.   

Here at SSA.gov

Social Security Act §1862

Not here, in Congress.gov  PL 108-391 "as signed by President"

Text - H.R.1 - 108th Congress (2003-2004): Medicare Prescription Drug, Improvement, and Modernization Act of 2003

But yes, visible in contemporary versions of SSA 1862 such as 2005.

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The language is:

^ In making a national coverage determination (as defined in paragraph (1)(B) of section 1869(f)) the Secretary shall ensure consistent with subsection (l) that the public is afforded notice and opportunity to comment prior to implementation by the Secretary of the determination; meetings of advisory committees with respect to the determination are made on the record; in making the determination, the Secretary has considered applicable information (including clinical experience and medical, technical, and scientific evidence) with respect to the subject matter of the determination; and in the determination, provide a clear statement of the basis for the determination (including responses to comments received from the public), the assumptions underlying that basis, and make available to the public the data (other than proprietary data) considered in making the determination.

2019 OPPS Final Rule: DOS Amended (Only re: Blood Bank Exclusion)

Medicare Regulations

42 Code of Federal Regulations

Part 414 – Medicare Part B

• See Word Doc in Cloud here.
• As amended, OPPS final rule, November 2019 for CY2020

https://gov.ecfr.io/cgi-bin/text-idx?SID=b6e65254d25210532674cda6ef7390c2&mc=true&tpl=/ecfrbrowse/Title42/42cfr414_main_02.tpl

42 CFR 414 Part “G” – Clinical Laboratory Diagnostic Tests

https://gov.ecfr.io/cgi-bin/text-idx?SID=b6e65254d25210532674cda6ef7390c2&mc=true&node=sp42.3.414.g&rgn=div6

42 CFR 414.510 DATE OF SERVICE

§414.510   Laboratory date of service for clinical laboratory and pathology specimens. The date of service for either a clinical laboratory test or the technical component of physician pathology service is as follows:
(a) Except as provided under paragraph (b) of this section, the date of service of the test must be the date the specimen was collected.
(b)(1) If a specimen was collected over a period that spans 2 calendar days, then the date of service must be the date the collection ended.
(2) In the case of a test performed on a stored specimen, if a specimen was stored for— (i) Less than or equal to 30 calendar days from the date it was collected, the date of service of the test must be the date the test was performed only if— (A) The test is ordered by the patient's physician at least 14 days following the date of the patient's discharge from the hospital; (B) The specimen was collected while the patient was undergoing a hospital surgical procedure; (C) It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted; (D) The results of the test do not guide treatment provided during the hospital stay; and (E) The test was reasonable and medically necessary for the treatment of an illness.
(ii) More than 30 calendar days before testing, the specimen is considered to have been archived and the date of service of the test must be the date the specimen was obtained from storage.
(3) In the case of a chemotherapy sensitivity test performed on live tissue, the date of service of the test must be the date the test was performed only if— (i) The decision regarding the specific chemotherapeutic agents to test is made at least 14 days after discharge; (ii) The specimen was collected while the patient was undergoing a hospital surgical procedure; (iii) It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted; (iv) The results of the test do not guide treatment provided during the hospital stay; and, (v) The test was reasonable and medically necessary for the treatment of an illness. (4) For purposes of this section, “chemotherapy sensitivity test” means a test identified by the Secretary as a test that requires a fresh tissue sample to test the sensitivity of tumor cells to various chemotherapeutic agents. The Secretary identifies such tests through program instructions.
(5) In the case of a molecular pathology test or a test designated by CMS as an ADLT under paragraph (1) of the definition of an advanced diagnostic laboratory test in §414.502, the date of service of the test must be the date the test was performed only if— (i) The test was performed following a hospital outpatient's discharge from the hospital outpatient department; (ii) The specimen was collected from a hospital outpatient during an encounter (as both are defined in §410.2 of this chapter); (iii) It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter; (iv) The results of the test do not guide treatment provided during the hospital outpatient encounter; and (v) The test was reasonable and medically necessary for the treatment of an illness.	(5)  In the case of a molecular pathology test ^ PERFORMED BY A LABORATORY OTHER THAN A BLOOD BANK OR CENTER, [continues unchanged] or a test designated by CMS as an ADLT under paragraph (1) of the definition of an advanced diagnostic laboratory test in §414.502, the date of service of the test must be the date the test was performed only if— …