451 Form

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Medical Policy Peroral Endoscopic Myotomy for Treatment of Esophageal Achalasia and Gastroparesis Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 451 BCBSA Reference Number: 2.01.91 (For Plan internal use only) NCD/LCD: N/A Related Policies
Surgical and Transesophageal Endoscopic Procedures to Treat Gastroesophageal Reflux Disease, #920 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Peroral endoscopic myotomy is considered INVESTIGATIONAL as a treatment for pediatric and adult esophageal achalasia.

Gastric peroral endoscopic myotomy is considered INVESTIGATIONAL as a treatment for gastroparesis. Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

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CPT Codes / HCPCS Codes / ICD Codes
Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following CPT code is considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes: Code Description 43497 Lower esophageal myotomy, transoral

Description Esophageal Achalasia Esophageal achalasia is characterized by reduced numbers of neurons in the esophageal myenteric plexuses and reduced peristaltic activity, making it difficult for individuals to swallow food and possibly leading to complications such as regurgitation, coughing, choking, aspiration pneumonia, esophagitis, ulceration, and weight loss. Achalasia is estimated to affect 18 out of every 100,000 individuals in the U.S., and the incidence of 10.5 per 100,000 person-years, with increased rates reported with more advanced age.1,

Treatment Treatment options for achalasia have included pharmacotherapy (eg, injections with botulinum toxin), pneumatic dilation, and laparoscopic Heller myotomy.2,3, Although the latter 2 are considered the standard treatments because of higher success rates and relatively long-term efficacy compared with pharmacotherapy, 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.3, One-year response rates of 86% and major mucosal tear rates requiring subsequent intervention of 0.6% have been reported.4,

Peroral endoscopic myotomy (POEM) is a novel endoscopic procedure developed in Japan.3,5, This procedure is performed with the patient under general anesthesia.6, 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.3,6,

Note that the acronym POEM in this review refers to peroral endoscopic myotomy. POEMS syndrome, which has a similar acronym, is discussed in policy #075.

Gastroparesis Gastroparesis is characterized by symptoms of nausea, vomiting, bloating, early satiety, and pain, which is caused by delayed gastric emptying without mechanical obstruction.7,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.8,

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Treatment 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.7, 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.

Summary Description Esophageal achalasia is characterized by reduced numbers of neurons in the esophageal myenteric plexuses and reduced peristaltic activity, making it difficult for individuals 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 is intended to reduce the total number of incisions needed and thus 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.

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. 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 have primarily reported similar outcomes for POEM and for LHM in symptom relief, as assessed by the Eckardt score. Some studies have shown a shorter length of stay and less postoperative pain with POEM. However, potential imbalances in patient characteristics in these nonrandomized studies might have biased the treatment comparisons. 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 4 systematic reviews. 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 RCTs 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 includes 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 61% 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

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significantly higher. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Policy History Date Action 2/2026 Annual policy review. Policy updated with literature review through September 23, 2025; references added. Policy statements unchanged. 1/2025 Annual policy review. Policy updated with literature review through September 12, 2024; references added; Policy statements unchanged. 4/2024 Annual policy review. Policy updated with literature review through September 21, 2023; references added. New investigational policy statement added for use in gastroparesis. Previous policy statement unchanged. Effective 4/1/2024. 1/2023 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2022 Clarified coding information. 1/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2018 Annual policy review. New references added. 12/2016 Annual policy review. New references added. 1/2016 Annual policy review. New references added. 3/2014 New medical policy describing investigational indications. Effective 3/1/2014. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

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68. Bi YW, Lei X, Ru N, et al. Per-oral endoscopic myotomy is safe and effective for pediatric patients with achalasia: A long-term follow-up study. World J Gastroenterol. Jun 14 2023; 29(22): 3497-3507. PMID 37389239
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78. Gregor L, Wo J, DeWitt J, et al. Gastric peroral endoscopic myotomy for the treatment of refractory gastroparesis: a prospective single-center experience with mid-term follow-up (with video). Gastrointest Endosc. Jul 2021; 94(1): 35-44. PMID 33373646
79. Conchillo JM, Straathof JWA, Mujagic Z, et al. Gastric peroral endoscopic pyloromyotomy for decompensated gastroparesis: comprehensive motility analysis in relation to treatment outcomes. Endosc Int Open. Feb 2021; 9(2): E137-E144. PMID 33532550
80. Abdelfatah MM, Noll A, Kapil N, et al. Long-term Outcome of Gastric Per-Oral Endoscopic Pyloromyotomy in Treatment of Gastroparesis. Clin Gastroenterol Hepatol. Apr 2021; 19(4): 816-824. PMID 32450364
81. Husťak R, Vacková Z, Krajciova J, et al. Per-oral endoscopic pyloromyotomy (g-poem) for the treatment of gastroparesis - a pilot single-centre study with mid-term follow-up. Rozhl Chir. 2020; 99(3): 116-123. PMID 32349495
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