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MEDICAL POLICY

POLICY
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DESCRIPTION
SCOPE
BENEFIT APPLICATION
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REFERENCES
CODING
APPENDIX
HISTORY

Peroral Endoscopic Myotomy (POEM) for Treatment of
Esophageal Achalasia
Number
Effective Date
Revision Date(s)
Replaces

2.01.91
December 8, 2015
12/08/15; 11/10/14; 11/11/13
N/A

Policy
[TOP]

Peroral endoscopic myotomy (POEM) is considered investigational as a treatment for esophageal achalasia.
NOTE: This policy addresses POEM. A similar acronym, POEMS syndrome, describes a different condition and
is addressed in a separate medical policy. Please see Related Policies.

Related Policies
[TOP]

2.01.38

Transesophogeal Endoscopic Therapies for Gastroesophageal Reflux Disease

7.01.137

Magnetic Esophageal Ring to Treat Gastroesophageal Reflux Disease (GERD)

8.01.17

Hematopoietic Stem-Cell Transplantation for Plasma Cell Dyscrasias, Including Multiple Myeloma
and POEMS Syndrome

Policy Guidelines
[TOP]

There are no specific CPT codes for this procedure. It would likely be reported with the unlisted procedure,
esophagus code 43499.

Description
[TOP]

Esophageal achalasia is characterized by prolonged occlusion of the lower esophageal sphincter (LES) 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 LES. This procedure has the intent of reducing the total number of incisions

circular lower esophageal sphincter (LES) muscles through a submucosal tunnel created in the proximal esophageal mucosa. is not subject to regulation by the U. 2) Although the last two are considered the mainstay of treatment because of higher success rates and relative long-term efficacy compared with pharmacotherapy and botulinum toxin injections. . Coverage for medical services is subject to the limits and conditions of the member benefit plan.5) Please note that the acronym POEM in this policy refers to peroral endoscopic myotomy. POEM differs from laparoscopic surgery.(2.000. (2) One-year response rates of 86% and rates of major mucosal tears requiring subsequent intervention of 0. (5) After tunneling an endoscope down the esophagus toward the esophageal gastric junction. both are associated with a perforation risk of about 1%. which uses a similar acronym. requiring laparoscopy and surgical dissection of the esophagogastric junction.needed and. 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. Background Estimated U. reducing the overall invasiveness of surgery.6 cases per 100. No randomized controlled trials (RCTs) comparing POEM with other treatment options have been found. (1) Treatment options for achalasia have traditionally included pharmacotherapy such as injections with botulinum toxin. drugs or devices. Benefit Application [TOP] N/A Rationale [TOP] This evidence review was created in September 2013 and has been updated with a search of the MEDLINE database through October 15. Scope [TOP] Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures. Following is a summary of the nonrandomized studies and selected larger series (≥50 patients) on this procedure. as a surgical procedure. This medical policy does not apply to Medicare Advantage. Literature included in this review on the efficacy of peroral endoscopic myotomy (POEM) is comprised of 4 nonrandomized comparative studies and several case series studies. (1.000 per year.4) POEM is performed with the patient under general anesthesia. is discussed in a separate medical policy (See Related Policies). Regulatory Status POEM uses available laparoscopic instrumentation and. pneumatic dilation. and laparoscopic Heller myotomy. (3) Peroral endoscopic myotomy (POEM) is a novel endoscopic procedure developed in Japan by Dr.S. (2. 2015. Haruhiro Inoue et al. Food and Drug Administration. thus.6% have been reported. a surgeon performs the myotomy by cutting only the inner.S. and estimated incidence is 0. Laparoscopic Heller myotomy is the most invasive of the procedures. POEMS syndrome. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. prevalence of achalasia is 10 cases per 100.

However. (2015) reported outcomes on 500 consecutive patients at 1 Japanese institution. p<0. Clinical success as defined as an Eckardt score of 3 or less was achieved in 92% on a per-protocol analysis and 83% on intention-to-treat analysis which included additional patients with technical failure and patients lost to follow-up. In a prospective case series. Procedure times were shorter with POEM.0% vs. (12) mean follow-up period was 10 months (range. . Kumbhari et al. complication rates. Mean (SD) hospitalization was 1. (6) In a retrospective study of a prospective database at Oregon Health & Sciences University (Portland.9 compared with 1. Eckardt scores did not differ statistically between groups (p=0.1% of 105) at more than 3 years. postoperative pain. analgesic use.8% and 21. p=0.1). 2. there was no statistically significant difference in the odds of failure between procedures. 7 mm Hg. clinical response was more frequent in the POEM group than the LHM group (98. Eckardt scores were statistically lower postoperatively in the POEM group compared with the LHM group (p<0. Followup evaluation at 6 months and 1 year showed sustained treatment success of 89% and 82%. p<0.3 at 6 months and 1. (2014) compared outcomes in 37 patients who underwent POEM and 64 patients who underwent LHM for achalasia.18 after POEM. At 3 months after POEM. pre-procedure LES pressure. von Renteln et al. and 61 (58. At 6 months. 11. OR). p=. 102 (27. Narcotic use was similar between groups. Lower esophageal sphincter pressure ranged from 13. In a retrospective study of patients with type III achalasia.01). 3-12 months). (2013) compared outcomes of 18 patients undergoing POEM to 21 patients who underwent LHM. pretreatment Eckardt score. respectively. myotomy length. center. p=0. Selected Case Series Studies Inoue et al. regurgitation. and return to activities of daily living. 302 (60. 7 preoperative. The overall rate of adverse events was lower in the POEM group (27% vs. Ramchandani et al. The median Eckardt score at all time points was 1.01).7 vs. estimated blood loss was less in patients treated with POEM (≤10 mL in all POEM cases vs 50 mL for LHM. although the point estimate of the odds was in favor of POEM (odds ratio.0). previous treatment (Botox/dilatation).06). Bhayani et al.S. nor fullthickness dissection during POEM were significant predictors of treatment failure at 1 year. (8) Defining clinical response as a reduction in Eckardt score to 1 or less. and 16 patients (89%) had treatment success (score≤3) at a median of 6months follow-up. The overall complication rate was 3.001).4%) at 2 months.6) days in the POEM group versus 2. In Multivariate analysis. (10) Outcomes were available for variable proportion of patients at various time intervals after the procedure.03). Mean pretreatment Eckardt score was 6.8%. On multivariable analysis. p<0.Nonrandomized Comparative Studies In a nonrandomized trial with historical control.001). neither age.2%. However. Additionally. resting LES pressure was higher in the POEM group compared with the LHM group (16 mm Hg vs. (7) Full-thickness esophageal injury occurred in 4 POEM patients. p=0.3% of subjects reported symptoms of GERD. The Eckardt score grades 4 major symptoms of achalasia (dysphagia. LHM patients had more severe disease by several different measures.7 at 1 year (p<0. 6%. (2013) reported on 70 patients who underwent POEM at five centers in Europe and North America. There was no difference in length of stay.05).001). Several outcomes related to recovery from surgery were in favor of POEM.6% of 370) at 1 to 2 years. (11) Outcomes at 1 year were available for 102 patients. procedure duration. but at 6 months (64% of patients assessed).001 for both comparisons with pretreatment score). The mean Eckardt score was 1.0. LHM 1. p<0. POEM patients’ Eckardt scores decreased (median 1 post-operative vs. weight loss) each on a 0 (none) to 3 (severe) scale for a maximum score of 12. p=0. total scores of 4 and above represent treatment failure.001). and 8 esophageal and 3 gastric perforations occurred in LHM patients. (5) Operative times were shorter for POEM than for LHM (113 and 125 minutes.7. respectively.9) days in the LHM group (Mann-Whitney U test for all comparisons.2 (1. Postoperative decreases in lower esophageal sphincter (LES) pressures were similar between groups. and length of stay were similar between groups. Hungness et al. esophagitis was observed in 42% of cases.5 vs. reported outcomes on 200 consecutive patients at one institution in India. Myotomy lengths. severity of esophagitis was minor (grade A or B).32. (2015) compared outcomes of 49 patients who underwent POEM versus 25 patients who underwent LHM. 80.006). (9) Postoperative Eckardt scores were similar (POEM 0. (2013) reported on perioperative outcomes in patients with achalasia treated with POEM (n=18) or laparoscopic Heller myotomy (LHM) (n=55) at a single U. Between 16.1 (0. sex. but were higher at 2 hours for POEM patients (3. although fewer patients treated with POEM received ketorolac. Pain scores were similar post-anesthesia and post-operatively on the first day. a nonsteroidal anti-inflammatory drug. retrosternal pain.4 to 11. Ujiki et al.

001 for both comparisons). In 87 previously untreated patients. (LES pressure >15 mm Hg predicts recurrent dysphagia. At least two small case series have evaluated the efficacy and feasibility of POEM for patients with failed Heller myotomy/achalasia recurrence. and of mild inflammation or segmental atelectasis of the lungs was 50%.19) Studies also have compared different POEM techniques. postoperative esophagitis developed in 19%. (2014) also evaluated 1-year outcomes after POEM. The 1-year follow-up evaluation showed overall rates of gastroesophageal reflux disease of 37%. five in Asia. (21) Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this review are listed in Table 1. postoperative esophagitis developed in 6%. the incidence of thoracic effusion was 49%. Ninety-two percent of 39 patients available for symptom assessment had treatment success (Eckardt score <4). Summary of Key Trials NCT No. and mean MCS improved from 43 (10) to 67 (11) (Student t test. mean (SD) PCS improved from 30 (13) to 65 (10). All complications were resolved with conservative treatment. Postoperatively. (2014) reported quality-of-life outcomes in 2 (probably overlapping) patient cohorts who underwent POEM for achalasia at a single center in China. Quality of life was assessed at pretreatment and at 1-year followup using the 36-Item Short-Form Health Survey. 3% patients developed a pneumothorax intraoperatively and another 25% postoperatively. IL) and were more than 1 year post-POEM were included. Title Enrollme a nt NCT01601678 Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized. respectively. (14)) Ling et al. (13) Forty-one patients who were treated at Northwestern University (Evanston. mean (SD) PCS improved from 33 (11) to 69 (18) (Student t test. Controlled Trial Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia POEM vs. (17) In their series of 119 cases.and all patients could be managed adequately with proton pump inhibitor (PPI) therapy.003). p<0. four in Europe. Most patients (37 [90%]) had no previous endoscopic treatment (botulinum toxin injection or pneumatic dilation). (18. 23% of patients developed subcutaneous emphysema intraoperatively and an additional 56%. Three of these patients required treatment with subcutaneous needle decompression. success rates have been reported in over 90% of cases up to 10 months after rescue POEM. The study by Ren et al. and mean (SD) MCS improved from 44 (13) to 67 (15) (Student t test. Table 1. (16) Incidence of intraoperative subcutaneous emphysema and pneumothorax was 12% and 1%. Other complication rates of POEM ranged from 1% to 4%. comparable outcomes have been reported between patients undergoing full-thickness versus circular myotomy. Physical Component Summary (PCS) and Mental Component Summary (MCS) raw scores were transformed to a 0 (poor health) to 100 (good health) scale. 22% of patients required occasional and 12% required daily PPI therapy. Additionally. In 21 patients evaluated. Teitelbaum et al. p=0. In a group of 21 patients who had failed previous pneumatic dilation. (20) An international survey of 16 centers (seven in North America. Pneumatic Dilation for Esophageal Achalasia POEM Trial: Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM) Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM) 220 Primary Completion b Date Dec 2019 100 Dec 2012 60 Aug 2013 200 150 Dec 2013 Jan 2023 30 Feb 2017 NCT01742494 NCT01750385 NCT01768091 NCT01793922 NCT02138643 . At 3 months. (2012) highlighted POEM-specific complications. mean (SD) LES pressure was 11 (4) mm Hg.001). respectively. (15) Incidence of intraoperative subcutaneous emphysema and pneumothorax was 14% and 5%. p<0. and PPI use of 29%. postoperatively. some of which were high-volume centers [≥30 POEMs per center]) reported 841 POEM procedures performed as of July 2012.

PMID 23395699 3. health status measures. However. and thoracic effusion. Aug 2013. The comparative studies showed mostly similar outcomes with POEM versus Heller myotomy for the outcome of symptom relief as assessed by the Eckardt score. a substantial proportion of patients undergoing POEM developed esophagitis requiring treatment. and treatment-related morbidity. Minami H. J Gastrointest Surg. Santos BF.NCT: national clinical trial. Yaghoobi M. PMID 23054897 . Gastrointest Endosc.78(3):468-475. Additionally. 42(4):265-271. Apr 2010. Preventive Services Task Force Recommendations Not applicable. Current approach to the treatment of achalasia. PMID 20354937 5.S. 17(2):228-235.” (22) American College of Gastroenterology In 2013. Pandolfino JE. Wong RK. U. resource utilization. functional outcomes. Long-term outcomes of the procedure are not well described in the literature. et al. The guideline further states that randomized prospective comparison trials are needed. In the case series studies. Clin Gastroenterol Hepatol. Martel M. and the procedure should be performed in the context of clinical trials. Relevant outcomes are symptoms. reported across studies. Teitelbaum EN. Cheatham JG. incidence of adverse events was relatively high. In the absence of an NCD. including subcutaneous emphysema. diagnosis. Kahrilas PJ. potential imbalance in patient characteristics in these nonrandomized studies may bias the comparisons between treatments. However. PMID 23684149 4. References [TOP] 1. Peroral endoscopic myotomy (POEM) for esophageal achalasia. consensus guideline on the surgical management of esophageal achalasia. The guideline stated that the POEM technique “is in its infancy and further experience is needed before providing recommendations. the Society of American Gastrointestinal and Endoscopic Surgeons issued an evidence-based. Hungness ES. Laparoscopic Heller's myotomy versus pneumatic dilation in the treatment of idiopathic achalasia: a meta-analysis of randomized. the American College of Gastroenterology issued a clinical guideline on the diagnosis and management of achalasia. Practice Guidelines and Position Statements Society of American Gastrointestinal and Endoscopic Surgeons In 2011. pneumothorax. Endoscopy. and management of achalasia. Inoue H. Comparison of perioperative outcomes between peroral esophageal myotomy (POEM) and laparoscopic Heller myotomy. The case series studies do not allow conclusions of the efficacy of POEM relative to established treatment. Sep 2013. et al. PMID 21424734 2. and stated to have promise as an alternative to the laparoscopic approach. Some studies showed shorter length of stay and less postoperative pain with POEM. 13(3):219-225. Mayrand S. 11(8):887-897. Curr Gastroenterol Rep. Summary of Evidence The evidence for POEM in individuals with achalasia includes nonrandomized comparative studies and case series. coverage decisions are left to the discretion of local Medicare carriers. controlled trials. Presentation. et al. Feb 2013. with POEM-specific complications. Treatment success at short follow-up periods was reported for a high proportion of patients treated with POEM. Medicare National Coverage There is no national coverage determination (NCD). Jun 2011. Kobayashi Y. (23) POEM was discussed as an emerging therapy. The evidence is insufficient to determine the effects of the technology on health outcomes.

Ren Z. Ann Surg. PMID 23891071 19. J Am Coll Surg. Nov 2012. et al. PMID 26171430 9. Surg Endosc.221(2):256-264. et al. Jun 18 2014. Endoscopy. J Gastroenterol Hepatol. Fockens P. Stavropoulos SN. Friedel D. Guo HM. PMID 23891074 21. et al. Zou X. J Am Coll Surg. Peroral Endoscopic Myotomy Is a Viable Option for Failed Surgical Esophagocardiomyotomy Instead of Redo Surgical Heller Myotomy: A Single Center Prospective Study. et al. Eckardt AJ. Ling TS. Effect of peroral endoscopic myotomy in achalasia patients with failure of prior pneumatic dilation: A prospective case-control study. Chen WF. Yao LQ. Von Renteln D. Jun 2011. Mar 2013. quiz 1250. Symptomatic and physiologic outcomes one year after peroral esophageal myotomy (POEM) for treatment of achalasia. Endosc Int Open.259(6):1098-1103. et al.sages. PMID 23389963 20. et al. Fuchs KH. Li QL. Treatment and surveillance strategies in achalasia: an update. May 27 2015. ACG clinical guideline: diagnosis and management of achalasia. Jul 2014.108(8):1238-1249. Inoue H. PMID 24169175 8. 26(11):3267-3272. Jul 25 2013. Kurian AA. PMID 23665071 13. 45(3):161-166.org/publications/guidelines/guidelines-for-thesurgical-treatment-of-esophageal-achalasia/. Guo H. May 2011. Kumbhari V. Peroral endoscopic myotomy: A short-term comparison with the standard laparoscopic approach. Vela MF. Zapf M. Jul 25 2013. Surg Endosc. Surgery. A comparative study on comprehensive. et al. Teitelbaum EN. Oct 2013. Guidelines for the surgical treatment of esophageal achalasia. PMID 24972973 15. Jun 2015. Santos BF. 23.8(6):311-319. Controversies in Management of Achalasia. Zhong Y. Zhou PH. Per-Oral Endoscopic Myotomy: A Series of 500 Patients. Tieu AH. Eckardt VF. Darisetty S. 217(3):442-451. 145(2):309-311 e303. Gastroenterology. Nat Rev Gastroenterol Hepatol. Yetasook AK. J Gastrointest Surg.15(7):352-358. Li QL. Society of American Gastrointestinal and Endoscopic Surgeons. et al. Ikeda H. J Am Coll Surg. Ikeda H. Am J Gastroenterol. Peroral endoscopic myotomy for achalasia cardia: Treatment analysis and follow up of over 200 consecutive patients at a single center. Modayil RJ. 2015. PMID 26206634 11. Apr 3 2013. Jun 2014. Zhou PH. Aug 2013. Patti MG. PMID 26018637 12. PMID 22609984 18. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Reddy DN. Pandolfino JE. Ramchandani M. PMID 24074429 10. Dig Endosc.6. objective outcomes of laparoscopic Heller myotomy with per-oral endoscopic myotomy (POEM) for achalasia. Jun 28 2014. PMID 23549760 22. http://www. Inoue H. Onimaru M. Effectiveness of peroral endoscopic myotomy in the treatment of achalasia: A pilot trial in Chinese Han population with a minimum of one-year follow-up. Sato H. et al.3(3):E195-201. Ling T.154(4):893-897. Soper NJ. Zhou P. PMID 24939164 14. Accessed November. Peroral endoscopic myotomy for the treatment of achalasia: a clinical comparative study of endoscopic full-thickness and circular muscle myotomy. Bhayani NH. esophagus . Peroral endoscopic remyotomy for failed Heller myotomy: a prospective single-center study. et al. et al. Peroral endoscopic myotomy (POEM) vs laparoscopic Heller myotomy (LHM) for the treatment of Type III achalasia in 75 patients: a multicenter comparative study. Perioperative management and treatment for complications during and after peroral endoscopic myotomy (POEM) for esophageal achalasia (EA) (data from 119 cases). et al. PMID 24628480 16. Aug 2014. The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience. Fisichella PM. discussion 897-900. Onimaru M. Surg Endosc. PMID 24739072 17. Ujiki MB. J Dig Dis. PMID 23877351 Coding [TOP] CPT CPT Number 43499 Description Unlisted procedure. Vaezi MF. Yang T. Dunst CM. Aug 2015. Aug 2013.29(8):16091613. et al. PMID 21522116 7.

©2016 Premera All Rights Reserved. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. Policy updated with literature review through October 15. The Company adopts policies after careful review of published peer-reviewed scientific literature. 912. CPT codes. national guidelines and local standards of practice. Policy statement unchanged. Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. considered investigational. Member contracts differ in their benefits. Policy updated with literature review through August 18. and 18 added. no change to policy statement. . 2014. the Company reserves the right to review and update policies as appropriate. Since medical technology is constantly changing. 6-7. ICD-9 and ICD-10 diagnosis codes removed. Annual Review. these do not relate to adjudication of this policy. Annual Review.Appendix [TOP] N/A History [TOP] Date 11/11/13 11/20/14 12/08/15 Reason New Policy. descriptions and materials are copyrighted by the American Medical Association (AMA). Policy created with literature search through August 1. references 8-11 and 23 added. references 3. 2013. 2015.