LCD Reference Article Response To Comments Article

Response to Comments: Stretta Procedure

A58512

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A58512
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Article Title
Response to Comments: Stretta Procedure
Article Type
Response to Comments
Original Effective Date
11/12/2020
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The comment period for the Stretta Procedure DL34553 Local Coverage Determination (LCD) began on 4/23/20 and ended on 7/7/20. The notice period for L34553 begins on 11/12/20 and will become effective on 12/27/20. The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

I would like to voice my strong support for coverage of the Stretta procedure DL34553.

This procedure has been extremely helpful to numerous of my patients, whose gastroesophageal reflux (GERD) would be otherwise remain uncontrolled. GERD, aside from impairing quality of life and work-related productivity, can lead to Barrett's esophagus, a pre-cancerous condition necessitating frequent surveillance testing, and esophageal cancer. I have had numerous patients, who have benefited tremendously after this procedure. This procedure also is critically important to our Bariatric Surgery program and their patients, especially who have undergone laparoscopic sleeve gastrectomy and have no other option to improve their medically refractory GERD.

In summary, I would appreciate your actions to ensure patients with refractory GERD are able to afford and undergo such a beneficial treatment provided by the Stretta procedure.

Thank you for your comments and support of the policy.

2

I would highly recommend that Stretta be covered. There are a multitude of patients that suffer from GERD that have symptoms refractory to medical management yet, are not interested or appropriate candidates for either fundoplication or magnetic sphincter augmentation. Stretta is fast, safe, and reliable in my experience. There have been a number of patients that I have seen or who have sought me out for this procedure who cannot receive it due to insurance considerations; I would consider these patients sub- optimally treated. Given that more “expensive” operations such as fundoplication and paraesophageal hernia repair are considered medically necessary, I fail to see or understand why a well-studied endoscopic outpatient intervention is not when patients’ GERD symptoms are not well-controlled. These symptoms can be a significant impediment to quality of life and physical and mental health. Although Stretta is not 100% effective (no procedures are), I think that the procedure offers an extremely valuable tool in the armamentarium of interventions available to physicians such as myself who treat reflux.

Thank you for your comments and support of the policy.

3

Thank you for the opportunity to provide comments to Palmetto GBA’s proposed LCD DL34553, Stretta Procedure.

It is my recommendation that Stretta be covered by Palmetto GBA under Part A and Part B of Medicare. Stretta is an effective, safe, and extremely valuable procedure for physicians to be able to provide to beneficiaries with GERD who are in specific patient populations.

What is Stretta?

Esophagogastroduodenoscopy (EGD) with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, the Stretta procedure, for the management of patients with gastroesophageal reflux disease (GERD) delivers non- ablative radio frequency energy to the lower esophageal sphincter which stimulates hypertrophy of the smooth muscle fibers of the sphincter. The procedure involves insertion of a flexible balloon-tipped catheter with needle electrodes for energy delivery via the esophagus. Precisely controlled radiofrequency energy is applied through 4 electrodes inserted into the esophageal wall at multiple sites both above and below the squamocolumnar junction to create lesions in the smooth muscle of the gastroesophageal junction. As the muscle regenerates, compliance of the sphincter is decreased, resulting in collagen contraction, tissue shrinkage and tightening of the gastroesophageal junction, limiting the number and severity of transient reflux events.

Stretta is a mature and well-understood anti-reflux procedure that works well in specific patient populations. To date, there are 50 peer reviewed publications regarding this procedure, with over 30,000 Stretta procedures performed worldwide. Stretta may be performed in a surgical suite or an endoscopy room under general or moderate sedation. Physicians who perform upper endoscopy - general surgeons, endoscopic surgeons, bariatric surgeons, and gastroenterologists - are all capable of performing Stretta, and the patient preparation is the same as for an EGD.

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) gave the following recommendation on Stretta:

  • Based on existing evidence, Stretta significantly improves health related quality of life score, heartburn scores, the incidence of esophagitis, and esophageal acid exposure in patients with GERD, but does not increase lower esophageal sphincter basal pressure. In addition, it decreases the use of PPI by approximately 50%. The effectiveness of the procedure diminishes some over time, but persistent effects have been described up to 10 years after the procedure in appropriately selected patients with GERD. Stretta is more effective than PPI, but less so than fundoplication. Stretta is safe in adults and has a short learning curve. (Level of evidence +++, strong recommendation)

Efficacy

The hypothesis that Stretta alters esophageal gastric junction (EGJ) resistance dynamically was established in a double-blind randomized crossover study of Stretta and sham treatment in 22 patients with GERD. Stretta decreased EGJ compliance, while administration of sildenafil normalized EGJ compliance back to pre-Stretta level, arguing against EGJ fibrosis as the underlying mechanism. The authors concluded that decreased EGJ compliance, which reflects altered LES neuromuscular function, may contribute to symptomatic benefit by decreasing refluxate volume. A number of clinical trials have confirmed that Stretta effectively improves GERD symptoms and reduces but does not normalize esophageal acid exposure. Several meta-analysis papers have shown that Stretta is effective for symptom relief, is safe and well tolerated, and allows patients to decrease intake of proton pump inhibitors (PPI) medications.

The durability of Stretta’s effects has been documented in multiple studies. Several studies demonstrate that roughly 75% of patients are completely off PPI after Stretta at four-year follow-up. Dughera, Reymunde, and Noar have shown that 72%, 86%, and 75% of patients remain off PPI, respectively. Stretta has been shown to have long- term efficacy results similar to laparoscopic Nissen fundoplication (LNF), with a ten-year follow-up study showing that 72% of patients had a normal HRQL score at ten years, and 64% of patients having a greater than 50% reduction in PPI use with 41% off of medication entirely. Because there are no gross anatomical changes, Stretta may be used before or after other anti-reflux procedures and is repeatable if patients become symptomatic post-treatment.

The evidence on endoscopic radiofrequency (RF) energy in patients who have GERD includes 4 RCTs, a nonrandomized comparative study, and observational studies with longer term follow-up. Relevant outcomes are symptoms, change in disease status, quality of life, medication use, and treatment-related morbidity. The RCTs report some improvements in symptoms and quality of life following treatment with RF energy compared with sham controls.

Stretta is not an ideal treatment for all patients with GERD. Patients with a normal LES tone, no hiatal hernia, and a closed diaphragmatic hiatus have been identified as “Dynamic Failure” (Hill Grade I). These patients have the phenotype of daytime reflux, no esophagitis or Barrett’s, and on ambulatory pH monitoring will have predominantly upright reflux. The main mechanism for GERD in these patients is inappropriate transient LES relaxation (tLESRs). The major stimulus for tLESRs is distension of the proximal stomach. Interventions that decrease the distensibility of the proximal stomach have been shown to decrease tLESRs. This is one of the predominant mechanisms for endoscopic radiofrequency (RF) treatment for GERD.

Health plans identify the following as Stretta candidates:

  • Daily heartburn or regurgitation for greater than six (6) months; and
  • Unsuccessful or partial response to anti-secretory pharmacologic therapy; and
  • Have adequate esophageal peristalsis; and
  • Have a 24-hour pH study demonstrating pathologic acid reflux (total acid exposure time greater than four (4%) percent, or a DeMeester composite score greater than 14.7); and
  • Have non-erosive reflux disease; or
  • Have grade I and II esophagitis by Savary-Miller criteria or have grades of esophagitis healed by drug therapy.

Patient perspective is an important consideration in the management of GERD, which may lead some to pursue endoscopic therapy with Stretta compared to more permanent, surgical options.

  • Patients who are in the ‘gap’ between medical management (65-70%) and surgical necessity (5%). These patients often struggle to find relief for their GERD symptoms, and this can lead to further complications.
  • Patients who have altered anatomy due to a previous anti-reflux procedure, such as a LNF, or post-bariatric patients. While post bariatric patients may undergo a conversion to a Roux-en-Y, and post Nissen patients may have a revision performed, these procedures are considerably more risky than Stretta.
  • Patients who respond to PPI, but do not wish to be on medication long-term due to side effects or interactions with other medications. Numerous studies document correlation of PPI/H2RA medications and side effects, such as dementia, which are of concern in the 65+ population.
  • Patients who may not be good surgical candidates, or who do not want to risk a surgical procedure. As the Stretta procedure does not create any gross anatomical changes, other surgical procedures remain as available options should Stretta not provide the patient with adequate symptom control.

There are no known absolute contraindications to the use of radiofrequency in humans. The use of the Stretta System is contraindicated when, in the judgment of the physician, radiofrequency surgical procedures would be contrary to the best interests of the patient. The use of the Stretta System may be contraindicated in the following:

  • Subjects under the age of 18
  • Pregnant women
  • Patients without a diagnosis of GERD
  • Hiatal hernia > 2 cm
  • Significant dysphagia
  • Achalasia or incomplete LES relaxation in response to swallow
  • Poor surgical candidate, ASA IV classification

Safety

Stretta is an extremely safe procedure. As of 1 JUL 2020, there are four reported incidents on the FDA’s MAUDE website. (Search “manufacturer” Mederi, dates 1 JUL 2006 to 1 JUL 2020.) In one instance, a patient died of sepsis a day after Stretta, which was determined to be unrelated to the Stretta procedure. In a second incident, a fuse on the generator blew out, resulting in the machine shutting down and not rebooting. No harm was caused to the patient. A third complaint identified a patient that developed gastroparesis and nausea after the procedure. The fourth complaint was a catheter that had a punctured balloon, discovered during the pre-procedure testing. It was replaced with another catheter and the procedure was conducted without incident.

Potential Risks of Stretta

  • Aspiration
  • Bleeding - transient
  • Bloating
  • Chest pain - transient
  • Difficulty belching - transient
  • Dysphagia - transient
  • Epigastric discomfort - transient
  • Esophageal mucosal laceration
  • Fever - transient
  • Injury to esophageal mucosa
  • Perforation
  • Pharyngitis
  • Vomiting - transient with potential for bleeding or Esophageal injury

Most Stretta patients are able to return to normal activity and work the next day. Pain is generally managed with liquid acetaminophen.

Esophagitis, Barrett’s Esophagus, Esophageal Cancer

There is a well-established link between reflux and esophagitis, Barrett’s Esophagus, and esophageal cancer. One of the more interesting aspects of anti-reflux procedures is the reduction or elimination of esophagitis in Stretta patients. Liu, et al identified that 33 of 41 patients saw a significant improvement in the endoscopic grade of esophagitis, with no erosions or only mildly erosive disease at the six-month mark. Reducing and preventing acid exposure would limit the development of esophagitis, which can lead to Barrett’s, which can then lead to cancer.

Conclusion

Stretta presents a safe, well-established, and well-studied option for the management of GERD in gap reflux patients, patients who do not want to be on long term anti-reflux medications, and patients who have altered anatomy due to a previous anti-reflux or bariatric procedure. Stretta has proven to be an extremely safe and effective treatment in those patient populations. Stretta may help to reduce the risk of Barrett’s esophagus and esophageal cancer by reducing or eliminating esophageal acid exposure from transient reflux events.

We appreciate the opportunity to provide these comments for your consideration, regarding services to Medicare beneficiaries covered by Palmetto.

Thank you for your thorough description of the Stretta procedure including its efficacy and safety. Due to LCDs being required to go through a formal comment and notice period, we would not be able to add Part B services at this time, however we can take this into consideration for a future update.

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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
L34553 - Stretta Procedure
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