LCD Reference Article Response To Comments Article

Response to Comments: Endoscopic Treatment of GERD (DL34659)

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A58568
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Response to Comments: Endoscopic Treatment of GERD (DL34659)
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Response to Comments
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02/14/2021
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Endoscopic Treatment of GERD (DL34659). Thank you for the comments.

Response To Comments

Number Comment Response
1

Dear WPS policy team,

Thank you for taking into consideration our comment for the draft LCD DL34659 ‘Endoscopic Treatment of GERD’. The draft language is in line with our FDA documentation and with your fellow MACs.
We agree with the language as constructed in DL34659.
Thanks for your hard work for the Medicare program.

Craig Gonzales, RN MBA
Sr. Director, Healthcare Economics EndoGastric Solutions

Thank you for your comments.

2

To Whom It May Concern:

I write this letter regarding the proposed LCD DL34659 Endoscopic Treatment of GERD. I applaud WPS in recognizing the benefit of the endoscopic fundoplication or Transoral Incisionless Fundoplication (TIF) performed by the Esophyx device. Clearly, the literature cited including the TEMPO trial shows that it provides an improvement in recalcitrant gastroesophageal reflux disease compared to medication alone. However, the TIF has never been compared to a standard surgical fundoplication (e.g. Nissen, Toupet, etc.). It remains unclear how well the TIF would compare to the more involved procedure. Undoubtedly, the lack of surgical incisions and the recovery associated with TIF is an appealing option for those who are candidates. As the LCD identifies, patients with a hiatal hernia of 2 cm or greater or even a patulous gastroesophageal junction (Hill Grade 3 or greater) are not candidates. Some enterprising surgeons and gastroenterologists have combined a surgical repair of the hiatal hernia with simultaneous TIF procedure dubbed the “hybrid” procedure alluding to the combined surgical and endoscopic components. Ultimately, there is data from the two studies that are provided in the proposed LCD. However, review of these publications will demonstrate that the data is still lacking and that this change in coverage determination is unwarranted.

Both articles cited in the LCD provide relatively short follow up timelines with 6 months median follow up in one and 14.5 months mean follow up in the other. , In the first study, one quarter of the patients continued to take daily acid suppression medications within the short follow up period. Suggesting the limited benefit of the TIF component in reducing acid exposure. In the second study, it remains unclear how long the follow up was for the 46 patients who underwent the combined hiatal hernia repair and TIF. Moreover, since the data for improvement in GERD-HRQL scores are combined in the second manuscript, one cannot discern the benefit of the Nissen vs. TIF when combined with a hiatal hernia repair. Standard surgical fundoplication procedures have recent publications following these patients out to 15 or more years demonstrating much better outcomes than the TIF procedure alone has demonstrated (specifically regarding post procedure esophageal pH and GERD quality of life scores). , , Therefore, I would argue that the “hybrid” procedure that involves a single episode surgical hiatal hernia repair and TIF remains in the exploratory phase and has not generated enough data to support mainstream adoption. There is no published comparison of patients undergoing standard fundoplication and the hybrid procedure. However, a clinical comparison with the submitted manuscripts would suggest the that surgical fundoplication combined with a hiatal hernia repair remains clinically superior to the combination of a hiatal hernia repair and a TIF.

In addition to the questionable clinical outcomes for the hybrid procedure, one must consider the cost implications. A surgical fundoplication can be completed during the exact same portion of the procedure as the laparoscopic hiatal hernia repair with the addition of between 3 and 12 additional sutures without additional cost to payor or the patient. However, the TIF procedure is typically performed by a different provider and requires the use of an additional device with an approved APC code for separate reimbursement. One must consider this cost differential as well.

The combination of limited early outcomes and questionable cost implications raise a concern about the proposed LCD that would change the coverage for the hybrid procedure with simultaneous hiatal hernia repair and TIF procedure. Therefore, I would request that WPS consider withdrawing the proposed changes while continuing to support the isolated TIF procedure as an innovative and less invasive option for recalcitrant gastroesophageal reflux disease in appropriate patients.

Sincerely,

Don J. Selzer, MD, MS
J8 Contractor Advisory Committee
Indiana General Surgery Representative

Trad KS, Fox MA, Simoni G, Shughoury AB, Mavrelis PG, Raza M, Heise JA, Barnes WE. Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm. Surg Endosc. 2017;31:2498-508.
1 Chang CG, Thackeray L. Laparoscopic hiatal hernia repair in 221 patients: outcomes and experience. J Soc Laparoendosc Surg. 2016;20(1):1-7.
1 Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2911;202:740-7.
1 Oor JE, Roks DJ, Broeders JA, Hazebroek EJ, Gooszen HG. Seventeen-year outcome of a randomized clinical trial comparing laparoscopic and conventional Nissen fundoplication: a plea for patient counseling and clarification. Ann Surg. 2017;266:23-8.
1 Hakanson BS, Lundell L, Bylund AM, Thorell A. Comparison of laparoscopic 270o posterior partial fundoplication vs total fundoplication for the treatment of gastroesophageal reflux disease: a randomized clinical trial. JAMA Surg. 2019;154(6):479-85.
1 Csendes A, Orellana O, Cueno N, Martinez G, Figueroa M. Long-term (15-year) objective evaluation of 150 patients after laparoscopic Nissen fundoplication. Surgery. 2019;166:886-94.

I want to take this opportunity to thank you for your comments concerning DL34659. The changes to the document were requested as a reconsideration of the previous version of the policy. Transoral incisionless fundoplication (TIF) was allowed but only in patients with a hiatal hernia of 2 cm or less in that document. Hiatal hernias are common and often associated with gastroesophageal reflux disease (GERD).

In the article by Chang as cited in DL34659, the greatest GERD-HRQL score decreases were seen in the patients with a fundoplication procedure whether it was a TIF or laparoscopic Nissen. The fact that there are no studies with direct comparison of TIF with open or laparoscopic Nissan fundoplication is limiting and would certainly be welcome in evaluating treatment of GERD. Additional literature as cited in the draft suggests that the two procedures can be safely combined. Please note, the MACs are limited from making treatment decisions based on cost alone at this time. WPS will continue to monitor the literature in this arena and adjust medical policy as needed based on that information.

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Medicare BPM Ch 15.50.2 SAD Determinations
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