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Peroral Endoscopic Myotomy for Treatment of Esophageal Achalasia

Commercial Surgery Policy
Origination: 11/2013
Last Review: 05/2024

Description of Procedure or Service

Esophageal achalasia is characterized by reduced numbers of neurons in the esophageal myenteric plexuses, that leads to reduced peristaltic activity. This reduction or absence in primary peristaltic waves takes place in the distal lower two thirds of the esophagus, that can make it difficult for individuals to swallow. Degeneration of the esophageal muscle in addition to the nerves that control these muscles can lead to complications such as regurgitation, coughing, choking, aspiration pneumonia, esophagitis, ulceration, and weight loss. The estimated prevalence in the United States of 10 cases per 100,000 with an incidence of 0.6 cases per 100,000 per year.

The three types of achalasia defined by the Chicago Classification include:

  • Type I – Classic Achalasia – incomplete lower esophageal sphincter (LES) relaxation, aperistalsis and absence of esophageal pressurization with 100% failed peristalsis and a distal contractile integral (DCI) < 100mmHg.
  • Type II – Incomplete LES relaxation, aperistalsis and panesophageal pressurization in at least 20% of swallows.
  • Type III – (Spastic Achalasia) – Incomplete LES relaxation and premature contractions in at least 20% of swallows.

Treatment

Treatment options for achalasia have traditionally included pharmacotherapy such as injections with botulinum toxin, pneumatic dilation, and laparoscopic Heller myotomy. Although the last two are considered the standard treatments because of higher success rates and relative long-term efficacy compared with pharmacotherapy and botulinum toxin injections, they both are associated with a perforation risk of about 1%. Heller myotomy is the most invasive of the procedures, requiring laparoscopy and surgical dissection of the esophagogastric junction. One-year response rates of 86% and rates of major mucosal tears requiring subsequent intervention of 0.6% have been reported.

Peroral endoscopic myotomy (POEM) is an endoscopic procedure developed in Japan. POEM is performed with the patient under general anesthesia. An incision is made in the distal esophagus and a submucosal tunnel is created with the endoscope. The circular smooth muscle is then cut extending to the proximal stomach. POEM differs from laparoscopic surgery, which involves complete division of both circular and longitudinal muscle layers. Cutting the dysfunctional muscle fibers that prevent the lower esophageal sphincter (LES) from opening allows food to enter the stomach more easily.

Gastroparesis is characterized by symptoms of nausea, vomiting, bloating, early satiety, and pain, which is caused by delayed gastric emptying without mechanical obstruction. The estimated U.S. prevalence of difficult to ascertain due to the weak correlation of symptoms with gastric emptying which results in a high rate of underdiagnosis. Using data from 1996 to 2006, the estimated incidence per 100,000 persons, adjusted for age, was 9.6 for men and 37.8 for women.

Treatment options for gastroparesis have included dietary modification (smaller meal sizes, avoidance of carbonated beverages, smoking or high doses of alcohol, and in some cases enteral nutrition via jejunostomy), optimization of hydration and glycemic control, pharmacotherapy (eg, antiemetics or Metoclopramide, or off-label medications for symptom control such as domperidone, erythromycin, tegaserod or centrally acting antidepressants), gastric electrical stimulation, venting gastrostomy, feeding jejunostomy, intra-pyloric botulinum injection, partial gastrectomy, and pyloroplasty. Gastric peroral endoscopic myotomy (G-POEM), which endoscopically performs the equivalent of pyloroplasty, is being investigated for the treatment of gastroparesis. G-POEM myotomizes the pylorus rather than the circular LES but otherwise consists of the same techniques described above.

Regulatory Status

POEM uses available laparoscopic instrumentation and, as a surgical procedure, is not subject to regulation by the U.S. Food and Drug Administration (FDA).

Related Policies

Gastroesophageal Reflux Disease, Transendoscopic Therapies

Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux Disease (GERD)

Please note that the acronym POEM in this policy refers to peroral endoscopic myotomy. POEMS syndrome, which uses a similar acronym, is discussed in the policy Hematopoietic Cell Transplantation.

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician. 

Policy

Peroral endoscopic myotomy is considered medically necessary as a treatment for esophageal achalasia when it is determined to be medically necessary because the criteria and guidelines shown below are met.

Gastric peroral endoscopic myotomy (G-POEM) is considered investigational for all indications. BCBSNC does not cover services that are considered investigational.

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design therefore member benefit language should be reviewed before applying the terms of this medical policy.

When Peroral Endoscopic Myotomy for Treatment of Esophageal Achalasia is covered

Peroral endoscopic myotomy (POEM) may be considered medically necessary in patients 18 years and older when all the following criteria are met:

  • The individual has an established diagnosis based on esophageal manometry of achalasia type I, II, or III; OR hypercontractile esophagus that has not improved after 3 months of treatment with a calcium channel blocker; OR esophagogastric junction outlet obstruction that has not improved after 6 months of observation; AND
  • The procedure is being performed by a physician who has completed procedure-specific training for POEM with privileges to perform the procedure; AND
  • An Eckardt symptom score is >3; AND
  • The individual does not have a contraindication to the POEM procedure such as but not limited to the following:
    • Severe erosive esophagitis
    • Coagulation disorder
    • Liver cirrhosis
    • Esophageal malignancy
    • Prior therapy that weakens the esophageal mucosa or contributes to submucosal fibrosis, e.g. radiation therapy, mucosal resection or radiofrequency ablation.

When Peroral Endoscopic Myotomy for Treatment of Esophageal Achalasia is not covered

Peroral endoscopic myotomy (POEM) is considered investigational when the above criteria are not met.

Gastric peroral endoscopic myotomy (G-POEM) is considered investigational for all indications.

Policy Guidelines

The evidence for peroral endoscopic myotomy in patients who have achalasia includes systematic reviews of observational studies, randomized controlled trials, nonrandomized comparative studies, and case series. Relevant outcomes are symptoms, functional outcomes, health status measures, resource utilization, and treatment-related morbidity. The comparative studies primarily showed similar outcomes with peroral endoscopic myotomy (POEM) versus Heller myotomy in symptom relief, as assessed by the Eckardt score (Werner, et a.l, 2019). One study showed shorter length of stay and shorter operative time with similar outcomes with POEM compared to Heller myotomy (Costantini et al., 2020). Long-term follow up at four years after POEM showed durable symptom relief in 88% of patients (Campagna et al., 2021). The evidence is sufficient to determine the effects of the technology on health outcomes.For patients who have gastroparesis who receive gastric POEM (G-POEM), the evidence includes 2 meta-analyses, 1 RCT, and several nonrandomized studies. Relevant outcomes are symptoms, functional outcomes, health status measures, resource utilization, and treatment-related morbidity. The studies generally reported treatment success for G-POEM based on a decrease in Gastroparesis Cardinal Symptom Index (GCSI) score and ranged from 60.7% at 1 year to 75% at 3 years in the meta-analyses. One RCT comparing G-POEM to sham was identified which found greater rates of treatment success and gastric retention at 6 months follow-up in the G-POEM group. Both the RCT and the largest observational study found the greatest treatment effect in patients who had a diabetic etiology for gastroparesis. The evidence is insufficient to determine the effects of the technology on health outcomes.

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable codes: 43497

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Scientific Background and Reference Sources

BCBSA Medical Policy Reference Manual [Electronic Version]. 2.01.91, 9/12/13

Specialty Matched Consultant Advisory Panel – 4/2014

BCBSA Medical Policy Reference Manual [Electronic Version]. 2.01.91, 9/11/14

Specialty Matched Consultant Advisory Panel – 5/2015

Medical Director review--5/2015

BCBSA Medical Policy Reference Manual [Electronic Version]. 2.01.91, 11/12/15

Specialty Matched Consultant Advisory Panel – 5/2016

Medical Director review--5/2016

BCBSA Medical Policy Reference Manual [Electronic Version]. 2.01.91, 11/2016

Medical Director review - 11/2016

Specialty Matched Consultant Advisory Panel 5/2017

Medical Director review 5/2017

BCBSA Medical Policy Reference Manual [Electronic Version]. 2.01.91, 11/2017

Specialty Matched Consultant Advisory Panel 5/2018

Medical Director review 5/2018

BCBSA Medical Policy Reference Manual [Electronic Version]. 2.01.91, 11/2018

Specialty Matched Consultant Advisory Panel 5/2019

Medical Director review 5/2019

BCBSA Medical Policy Reference Manual [Electronic Version]. 2.01.91, 12/2019

Specialty Matched Consultant Advisory Panel 5/2020

Medical Director review 5/2020

BCBSA Medical Policy Reference Manual [Electronic Version]. 2.01.91, 12/2020

Specialty Matched Consultant Advisory Panel 5/2021

Medical Director review 5/2021

Campagna Raj, Cirera A., Homstrom, AL, et al. Outcomes of 100 Patients More than 4 Years After POEM for Achalasia. Ann Surg 2021; 273:1135.

Constantini A, Familiari P, Constantini M, et al. POEM Versus Laparoscopic Heller Myotomy in the Treatment of Esophageal Achalasia: A Case-Control Study From Two High Volume Centers Using the Propensity Score. J Gastrointest Surger. 2020 Mar; 24(3):505-515.

Werner, YB, Hakanson B, Martinek J, et al. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia N Engl J Med. 2019 DEC 5; 381(23):2219-2229.

Medical Director review 4/2022

Specialty Matched Consultant Advisory Panel 5/2022

Medical Director review 5/2022

Zhang H, Zhang J, Jiang A and Ni H. Gastric peroral endoscopic myotomy for gastroparesis: a systematic review of efficacy and safety. Gastroenterol Hepatol. Aug-Sept 2019;42(7):413-422.

Ichkhanian Y, Vosoughi K, Aghaie Meybodi, M, et al. Comprehensive analysis of adverse events associated with gastric peroral endoscopic myotomy: an international multicenter study. Surg Endosc. Apr 23 2020.

Mohan BP, Chandan S, Jha LK, et al. Clinical efficacy of gastric peroral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group. Surg Endosc. Oct 3 2019.

Specialty Matched Consultant Advisory Panel 5/2023

Medical Director review 5/2023

Cheatham JG, Wong RK. Current approach to the treatment of achalasia. Curr Gastroenterol Rep. Jun 2011; 13(3): 219-25. PMID 21424734

Pandolfino JE, Kahrilas PJ. Presentation, diagnosis, and management of achalasia. Clin Gastroenterol Hepatol. Aug 2013; 11(8): 887-97. PMID 23395699

Yaghoobi M, Mayrand S, Martel M, et al. Laparoscopic Heller’s myotomy versus pneumatic dilation in the treatment of idiopathic achalasia: a meta-analysis of randomized, controlled trials. Gastrointest Endosc. Sep 2013; 78(3): 468-75. PMID 23684149

Inoue H, Minami H, Kobayashi Y, et al. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. Apr 2010; 42(4): 265-71. PMID 20354937

Hungness ES, Teitelbaum EN, Santos BF, et al. Comparison of perioperative outcomes between peroral esophageal myotomy (POEM) and laparoscopic Heller myotomy. J Gastrointest Surg. Feb 2013; 17(2): 228-35. PMID 23054897

Reddivari AKR, Mehta P. Gastroparesis. [Updated 2022 Sep 30]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK551528/

Kamal F, Khan MA, Lee-Smith W, et al. Systematic review with meta-analysis: one-year outcomes of gastric peroral endoscopic myotomy for refractory gastroparesis. Aliment Pharmacol Ther. Jan 2022; 55(2): 168-177. PMID 34854102

Canakis, A., et al., Long-term outcomes (3 years) after gastric peroral endoscopic myotomy for refractory gastroparesis: a systematic review and meta-analysis. iGIE, 2023. 2(3): p. 344-349.e3.

Hernández Mondragón OV, Contreras LFG, Velasco GB, et al. Gastric peroral endoscopic myotomy outcomes after 4 years of follow-up in a large cohort of patients with refractory gastroparesis (with video). Gastrointest Endosc. Sep 2022; 96(3): 487-499. PMID 35378136

Martinek J, Hustak R, Mares J, et al. Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial. Gut. Nov 2022; 71(11): 2170- 2178. PMID 35470243

Specialty Matched Consultant Advisory Panel 5/2024

Medical Director review 5/2024

Policy Implementation/Update Information

11/12/13 New policy developed. Peroral endoscopic myotomy for treatment of esophageal achalasia is considered investigational. Medical Director review 9/2013. (sk)

5/13/14 Specialty Matched Consultant Advisory Panel review 4/29/14. No change to Policy statement. (sk)

11/11/14 Reference added. Description section updated. Policy Guidelines section updated. No change to Policy statement. (td)

7/1/15 References updated. Specialty Matched Consultant Advisory Panel review 5/27/2015. Description section revised. Medical Director review 5/2015. Policy Statements remain unchanged. (td)

1/26/16 Policy Guidelines section revised. References updated. (td)

7/1/16 Specialty Matched Consultant Advisory Panel review 5/25/2016. Medical Director review 5/2016. No change to Policy Statement. (jd)

12/30/16 References updated. Medical Director review. (jd)

6/30/17 Specialty Matched Consultant Advisory Panel – 5/2017. Medical Director review-- 5/2017. (jd)

6/8/18 Specialty Matched Consultant Advisory Panel 5/2018. Medical Director review 5/2018. (jd)

5/28/19 Minor reformatting to Description section. References updated. Specialty Matched Consultant Advisory Panel 5/2019. Medical Director review 5/2019. (jd)

12/31/19 Minor revisions and references updated. Medical Director review 11/2019. (jd)

6/9/20 Specialty Matched Consultant Advisory Panel 5/2020. Medical Director review 5/2020. (jd)

6/1/21 References updated. Specialty Matched Consultant Advisory Panel 5/2021. Medical Director review 5/2021. (jd)

12/30/21 The following code was added to the Billing/Coding section effective 1/1/22: 43497. (jd)

5/17/22 Description section revised; added the 3 types of achalasia based on the Chicago Classification. Policy statement revised as follows: “Peroral endoscopic myotomy is considered medically necessary as a treatment for esophageal achalasia when it is determined to be medically necessary because the criteria and guidelines show below are met.” When Covered section revised with medically necessary criteria for POEM. When Not Covered section revised as follows: “Peroral endoscopic myotomy is considered investigational when the above criteria are not met.” Policy guidelines and references updated. Specialty Matched Consultant Advisory Panel 5/2022. Medical Director review 4/2022. (jd)

6/30/22 Policy title updated. Policy formatting updated to align with the new utilization management tool. No changes to policy statement or intent. (jd)

5/30/23 Not Covered section updated to include statement: “Gastric peroral endoscopic myotomy (G-POEM) is considered investigational for all indications.” Description, Policy, Policy Guidelines and References sections updated. Specialty Matched Consultant Advisory Panel 5/2023. Medical Director review 5/2023. (tm)

5/29/24 Description, Policy Guidelines and References updated. Specialty Matched Consultant Advisory Panel 5/2024. Medical Director review 5/2024. (tm)

Disclosures:

Medical policy is not an authorization, certification, explanation of benefits or a contract. Benefits and eligibility are determined before medical guidelines and payment guidelines are applied. Benefits are determined by the group contract and subscriber certificate that is in effect at the time services are rendered. This document is solely provided for informational purposes only and is based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. Medical practices and knowledge are constantly changing and BCBSNC reserves the right to review and revise its medical policies periodically.