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Peroral Endoscopic Myotomy (POEM) for Treatment of Esophageal Achalasia and Gastroparesis

Policy Number: MP-537

Latest Review Date: November 2024

Category: Surgery                                                                  

POLICY:

Effective for dates of service on and after January 16, 2024:

Peroral endoscopic myotomy (POEM) as a treatment for pediatric and adult esophageal achalasia is considered investigational.

Peroral Endoscopic myotomy as a treatment for gastroparesis is considered investigational.

Endoscopic closure devices (e.g. Overstitch, Over the Scope clip [OTSC]) is considered investigational.

Effective for dates of service prior to January 16, 2024:

Peroral endoscopic myotomy (POEM) as a treatment for pediatric and adult esophageal achalasia is considered investigational.

Peroral Endoscopic pyloromyotomy as a treatment for refractory gastroparesis is considered investigational.

Endoscopic closure devices (e.g. Overstitch, Over the Scope clip [OTSC]) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Peroral endoscopic myotomy (POEM) is a novel endoscopic procedure developed in Japan. POEM is performed with the patient under general anesthesia. For esophageal achalasia, after tunneling an endoscope down the esophagus toward the esophageal gastric junction, a surgeon performs the myotomy by cutting only the inner, circular lower esophageal sphincter (LES) muscles through a submucosal tunnel created in the proximal esophageal mucosa. POEM differs from laparoscopic surgery, which involves complete division of both circular and longitudinal LES muscle layers. Cutting the dysfunctional muscle fibers that prevent the LES from opening allows food to enter the stomach more easily. For refractory gastroparesis, the same technique is utilized, but a tunnel is typically created 5cm proximal to the pylorus, then an antral myotomy is performed in addition to pyloromyotomy through the submucosal tunnel.

Esophageal Achalasia

Esophageal achalasia is characterized by reduced numbers of neurons in the esophageal myenteric plexuses and reduced peristaltic activity, making it difficult for patients to swallow food and possibly leading to complications such as regurgitation, coughing, choking, aspiration pneumonia, esophagitis, ulceration, and weight loss. Peroral endoscopic myotomy (POEM) is a novel endoscopic procedure that uses the oral cavity as a natural orifice entry point to perform myotomy of the lower esophageal sphincter (LES). This procedure has the intent of reducing the total number of incisions needed and, thus, reducing the overall invasiveness of surgery. Gastric peroral endoscopic myotomy (G-POEM) is a similar procedure with the exception that it myotomizes the pylorus rather than LES. Achalasia is estimated to effect 18 out of every 100,000 individuals in the United States and the incidence of 10.5 cases person-years, with increased rates reported with more advanced age.

Treatment options for achalasia have traditionally included pharmacotherapy such as injections with botulinum toxin, pneumatic dilation, and laparoscopic Heller myotomy (LHM). Although the last two are considered the mainstay of treatment because of higher success rates and relative long-term efficacy compared to pharmacotherapy and botulinum toxin injections, they both are associated with a perforation risk of about 1%. Laparoscopic 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 a novel endoscopic procedure developed in Japan. This procedure is performed with the patient under general anesthesia. After tunneling an endoscope down the esophagus toward the esophageal-gastric junction, a surgeon performs the myotomy by cutting only the inner, circular lower esophageal sphincter (LES) muscles through a submucosal tunnel created in the proximal esophageal mucosa. POEM differs from laparoscopic surgery, which involves the complete division of both circular and longitudinal LES muscle layers. Cutting the dysfunctional muscle fibers that prevent the LES from opening allows food to enter the stomach more easily.

Gastroparesis

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. A systematic review of the literature determined that the prevalence of confirmed gastroparesis, characterized by symptoms and delayed gastric emptying, varies widely in the general population, with estimates ranging from 14 to 268 cases per 100,000 adults. Furthermore, the incidence of this condition spans from 1.9 to 6.3 per 100,000 person-years.

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.

Please note that the acronym POEM in this policy refers to peroral endoscopic myotomy. POEMS syndrome, which uses a similar acronym, is discussed in medical policy #415 (Hematopoietic Stem-Cell Transplantation for Plasma Cell Dyscrasias, including Multiple Myeloma and POEMS Syndrome).

KEY POINTS:

The most recent literature review was updated through September 12, 2024.

Summary of Evidence

For adults who have achalasia who receive peroral endoscopic myotomy (POEM), the evidence includes systematic reviews of primarily observational studies, 4 randomized controlled trials (RCTs), and nonrandomized comparative studies. The relevant outcomes are symptoms, functional outcomes, health status measures, resource utilization, and treatment-related morbidity. Compared with pneumatic dilation (PD) or laparoscopic Heller myotomy (LHM), findings from RCTs demonstrated that POEM had a similar or greater treatment success rate based on the Eckardt score and similar or fewer overall adverse event rates. However, POEM had significantly higher rates of endoscopically confirmed reflux esophagitis and more daily proton-pump inhibitor use at 24 months. An important conduct limitation of the RCTs is that blinded assessment of outcomes was not used. Given that the primary outcome was based on subjective patient report of symptoms, this is a potential source of bias. Additionally, a potential relevance limitation is that the RCTs did not include any US sites. The comparative observational studies showed mostly similar outcomes with POEM and for LHM in symptom relief as assessed by the Eckardt score. Some studies showed a shorter length of stay and less postoperative pain with POEM. However, potential imbalance in patient characteristics in these nonrandomized studies may bias the comparisons between treatments. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For pediatric individuals who have achalasia who receive POEM, the evidence includes several nonrandomized studies and a systematic review. The relevant outcomes are symptoms, functional outcomes, health status measures, resource utilization, and treatment-related morbidity. The studies reported treatment success for POEM based on decreases in Eckardt scores and lower esophageal sphincter (LES) pressure. No randomized clinical trials have been reported. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For adults who have gastroparesis who receive gastric POEM (G-POEM), the evidence consists of 2 meta-analyses, 2 RCTs, 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 demonstrated a notably higher success rate and improvement in gastric retention for G-POEM compared to a sham control group, with the most significant benefit observed in patients with diabetic gastroparesis. Another RCT indicated a trend towards superior 3-month clinical outcomes for POEM over botulinum toxin injection, although the 1-year clinical success rate on intention-to-treat analysis was not significantly higher. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Gastroenterology

In 2020, the American College of Gastroenterology issued evidence-based clinical guidelines on the diagnosis and management of achalasia. The quality of the evidence and the strength of recommendations were rated based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. The evidence review includes the 2 randomized controlled trials (RCTs) of peroral endoscopic myotomy (POEM) compared to laparoscopic Heller myotomy (LHM) or pneumatic dilation (PD). Based on their evaluation, the College made the following recommendations:

  • "In patients with achalasia who are candidates for definite therapy, PD, LHM, and POEM are comparable effective therapies for type I or type II achalasia and POEM would be a better treatment option in those with type III achalasia."
  • "We suggest that POEM or PD result in comparable symptomatic improvement in patients with types I or II achalasia." (GRADE quality=Low, Recommendation strength=Conditional)
  • "We recommend that POEM and LHM result in comparable symptomatic improvement in patients with achalasia." (GRADE quality=Moderate; Recommendation strength=Strong)
  • "We recommend tailored POEM or LHM for type III achalasia as a more efficacious alternative disruptive therapy at the lower esophageal sphincter compared to PD." (GRADE quality=Moderate; Recommendation strength=Strong)
  • "We suggest that in patients with achalasia, POEM compared with LHM with fundoplication or PD is associated with a higher incidence of GERD [gastroesophageal reflux disease]." (GRADE quality=Moderate; Recommendation strength=Strong)
  • We suggest that POEM is a safe option in patients with achalasia who have previously undergone PD or LHM. (GRADE quality=Low; Recommendation strength=Strong)

American Gastroenterological Association Institute

The American Gastroenterological Association (AGA) Institute (2017) published a clinical practice update on the use of POEM for the treatment of achalasia. Based on the expert review, the Institute made the following recommendations:

  •   POEM should be performed by experienced physicians in high-volume centers (competence achieved after an estimated 20 to 40 procedures)
  •   If expertise is available, POEM should be considered primary therapy for type III achalasia
  •   If expertise is available, POEM should be considered comparable to Heller myotomy for any achalasia syndromes
  •   Patients receiving POEM should be considered high-risk to develop reflux esophagitis and be advised of management considerations (eg, proton pump inhibitor therapy and/or surveillance endoscopy) prior to undergoing POEM.

In 2023, the AGA Institute issued a clinical practice update commentary regarding gastric peroral endoscopic myotomy for gastroparesis. Based on an expert review the following recommendations were provided:

  • Gastric POEM (G-POEM), also called peroral endoscopic pyloromyotomy, should be considered for patients with medically refractory gastroparesis
    • 1) Have undergo esophagogastroduodenoscopy to confirm no mechanical gastric outlet obstruction
    • 2) had a solid phase gastric emptying scan (GES) confirming delayed gastric emptying, preferably with retention >20% at 4 hours
    • 3) have moderate to severe symptoms including nausea and vomiting as the dominant symptoms on the gastroparesis cardinal symptom index
      • Patients who have failed gastric electrical stimulator therapy, pyloric stenting and botulinum toxin injection should be offered G-POEM but failure of these alternatives therapies should not be a prerequisite.
  • G-POEM should not be offered to the following patients:
    • Patients with opioid dependence should be weaned off opioids whenever possible and have their gastric emptying re-evaluated.
    • Most patients with postinfectious gastroparesis should not be offered G-POEM
  • G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy
  • Patients should remain on a liquid diet for at least 24 hours before G-POEM to minimize residual gastric contents
  • A high-definition gastroscope, with a waterjet, affixed with a clear distal cap, should be used to perform G-POEM. And a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance is necessary for G-POEM.

American Society of Gastrointestinal Endoscopy

In 2020, the American Society of Gastrointestinal Endoscopy (ASGE) issued an evidence-based guideline on the management of achalasia. The methodologic quality of systematic reviews was assessed using the Methodological Quality of Systematic Reviews-2 (AMSTAR-2) tool and the certainty of the body of evidence was rated as very low to high based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. ASGE rated the strength of individual recommendation based on the aggregate evidence quality and an assessment of the anticipated benefits and harms. ASGE used the phrase "we suggest" to indicate weaker recommendations and "we recommend" to indicate stronger recommendations.This guideline did not include either of the 2 available RCTs of POEM. Based on their evaluation, ASGE issued the following recommendations:

  • "We suggest POEM as the preferred treatment for management of patients with type III achalasia." (Very low quality evidence)
  • "In patients with failed initial myotomy (POEM or laparoscopic Heller myotomy), we suggest pneumatic dilation or redo myotomy using either the same or an alternative myotomy technique (POEM or laparoscopic Heller myotomy)." (Very low quality evidence)
  • "We suggest that patients undergoing POEM are counseled regarding the increased risk of postprocedure reflux compared with pneumatic dilation and laparoscopic Heller myotomy. Based on patient preferences and physician expertise, postprocedure management options include objective testing for esophageal acid exposure, long-term acid suppressive therapy, and surveillance upper endoscopy." (Low quality evidence)
  • We suggest that POEM and laparoscopic Heller myotomy are comparable treatment options for management of patients with achalasia types I and II, and the treatment option should be based on shared decision-making between the patient and provider." (Low quality evidence)

These 2020 ASGE guidelines were endorsed by the American Neurogastroenterology and Motility Society and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

Society of American Gastrointestinal and Endoscopic Surgeons

In 2020, SAGES endorsed the guideline on the management of achalasia issued by ASGE (2020) as described above.

In 2021, SAGES issued its own evidence-based guidelines for the use of POEM for the treatment of achalasia. The expert panel agreed on 4 recommendations for adults and children with achalasia. These include:

  • The panel suggests that adult and pediatric patients with type I and II achalasia may be treated with either POEM or LHM based on surgeon and patient's shared decision making (conditional recommendation; very low certainty evidence).
  • The panel suggests POEM over LHM for type III adult or pediatric achalasia. (expert opinion)
  • The panel recommends POEM over PD in patients with achalasia (strong recommendation, moderate certainty evidence)
  • For the subgroup of patients who are particularly concerned about the continued use of proton pump inhibitors post-operatively, the panel suggests that either POEM or PD can be used based on joint patient and surgeon decision-making (conditional recommendation, very low certainty evidence)

International Society for Diseases of the Esophagus

The International Society for Diseases of the Esophagus (2018) published guidelines on the diagnosis and management of achalasia. The Society convened 51 experts from 11 countries, including several from the U. S., to systematically review evidence, assess recommendations using the GRADE system, and vote to integrate the recommendations into the guidelines (>80% approval required for inclusion). Table 1 summarizes POEM recommendations.

Table 1. Recommendations for the Treatment of Achalasia

Recommendation LOR GOR
POEM is an effective therapy for achalasia both in short- and medium-term follow-up with results comparable to Heller myotomy. Conditional Very low
POEM is an effective therapy for achalasia both in short- and medium-term follow-up with results comparable to PD. Conditional Low
Pretreatment information on GERD, nonsurgical options (PD), and surgical options with lower GERD risk (Heller myotomy) should be provided to the patient. Good practice NA
POEM is feasible and effective for symptom relief in patients previously treated with endoscopic therapies Conditional Very low
POEM may be considered an option for treating recurrent symptoms after laparoscopic Heller myotomy. Conditional Low
Appropriate training (in vivo/in vitro animal model) and proctorship should be considered prior to a clinical program of POEM. Good practice NA

GERD: gastroesophageal reflux disease; GOR: grade of recommendation; LOR: level of recommendation; NA: not applicable; PD: pneumatic dilation; POEM: peroral endoscopic myotomy.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Peroral endoscopic myotomy, POEM**, Esophageal achalasia, endoscopic suturing devices, Overstitch, over the scope clip, OTSC, GPOEM, G-POEM, refractory gastroparesis, gastroparesis

**NOTE: FOR POEMS Syndrome, refer to Policy 415 Single or Tandem Courses of Hematopoietic Stem-cell Transplantation for Plasma Cell Dyscrasias, Including Multiple Myeloma and POEMS Syndrome

APPROVED BY GOVERNING BODIES:

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

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes: 

There are no specific CPT codes for some of these procedures. They would likely be reported with an unlisted procedure code.

43497

Lower esophageal myotomy, transoral (ie, peroral endoscopic myotomy [POEM])

For esophageal achalasia:

43499

unlisted procedure, esophagus

For gastroparesis:

43999

unlisted procedure, stomach

There are no specific CPT codes for endoscopic closure devices.  It would likely be reported with the unlisted procedure, stomach code 43999.

REFERENCES:

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  60. Martins RK, Ribeiro IB, DE Moura DTH, et al. Peroral (POEM) Or Surgical Myotomy For The Treatment Of Achalasia: A Systematic Review And Meta-Analysis. Arq Gastroenterol. Jan-Mar 2020; 57(1): 79-86.
  61. Meng F, Li P, Wang Y, et al. Peroral endoscopic myotomy compared with pneumatic dilation for newly diagnosed achalasia. Surg Endosc. Nov 2017; 31(11): 4665-4672.
  62. Miao S, Wu J, Lu J et al. Peroral Endoscopic Myotomy in Children With Achalasia: A Relatively Long-term Single-center Study.. J. Pediatr. Gastroenterol. Nutr., Feb 2018; 66(2): 257-262.
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  65. Nabi Z, Ramchandani M, Chavan R, et al. Outcome of peroral endoscopic myotomy in children with achalasia. Surg Endosc, Nov 2019; 33(11): 3656-3664.
  66. Onimaru M, Inoue H, Ikeda H et al. Peroral endoscopic myotomy is a viable option for failed surgical esophagocardiomyotomy instead of redo surgical Heller myotomy: a single center prospective study. J Am Coll Surg. 2013 Oct; 217(4):598-605.
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  81. Rodriguez JH, Haskins IN, Strong AT, et al. Per oral endoscopic pyloromyotomy for refractory gastroparesis: initial results from a single institution. Surg Endosc. 2017 Dec; 31 (12):5381-5388.
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POLICY HISTORY:

Medical Policy Panel, September 2013

Medical Policy Group, September 2013 (3): New policy; does not meet medical criteria for coverage and therefore considered investigational

Medical Policy Administration Committee, October 2013

Available for comment September 24 through November 7, 2013

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (3): 2014 Updates to Description, Key Points & References; no change in policy statement

Medical Policy Panel, November 2015

Medical Policy Group, December 2015 (4): Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, November 2016

Medical Policy Group, January 2017 (4):  Updates to Key Points and References.  No change to policy statement.

Medical Policy Panel, November 2017

Medical Policy Group, November 2017(4): Updates to Key Points and References. No change to policy statement.

Medical Policy Group, March 2018 (4): Added previously investigational technique (G-POEM) and device (endoscopic closure devices) to policy. Added CPT codes 43999 and 43499 to Current Coding. Other updates to Description, Key Points, Key Words, and References.

Medical Policy Administration Committee, April 2018

Available for comment April 2 through May 16, 2018

Medical Policy Panel, November  2018

Medical Policy Group, December 2018 (4):  Updates to Key Points and References. No change to policy statement.

Medical Policy Panel, November 2019

Medical Policy Group, November 2019 (5): Updates to Description, Key Points, Practice Guidelines, and References. Policy Statement changed to include pediatric achalasia; no change in policy intent. Available for comment November 22, 2019 through January 06, 2020.

Medical Policy Panel, November 2020

Medical Policy Group, November 2020 (5): Updates to Description, Key Points, Practice Guidelines, and References. No change to Policy Statement.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, December 2021: 2022 Annual Coding Update. Added CPT code 43497 to the Current Coding section.

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (5): Updates to Description and Key Points. No change to Policy Statement.  

Medical Policy Panel, November 2023

Medical Policy Group, November 2023 (11): Updates to Title to remove the word “Refractory”, Description, Key Points, Benefit Application, Current Coding updated code description and References. Policy Statement updated to add the word “Gastric” to Peroral Endoscopic myotomy and removed the word “refractory,” no change to policy intent. Available for comment December 1, 2023 through January 15, 2024.

Medical Policy Administration Committee, December 2023

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (11): Updates to Description, Key Points, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.