MEDICAL POLICY POLICY RELATED POLICIES POLICY GUIDELINES CODING DESCRIPTION SCOPE BENEFIT APPLICATION RATIONALE REFERENCES APPENDIX HISTORY Peroral Endoscopic Myotomy (POEM) for Treatment of Esophageal Achalasia Number Effective Date Revision Date(s) Replaces 2.01.91 February 1, 2017 01/10/17; 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] Coding CPT 43499 Unlisted procedure, esophagus 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 needed and, thus, reducing the overall invasiveness of surgery. For individuals who have achalasia who receive POEM, the evidence includes systematic reviews, nonrandomized comparative studies, and case series. Relevant outcomes are symptoms, functional outcomes, health status measures, resource utilization, and treatment-related morbidity. The comparative studies reported primarily similar outcomes with POEM and with Heller myotomy for symptom relief, as assessed by the Eckardt score. Some studies showed shorter length of stay and less postoperative pain with POEM. However, potential imbalances in patient characteristics in these nonrandomized studies may have biased the treatment comparisons. In the case series, treatment success at short follow-up periods was reported for a high proportion of patients treated with POEM. However, incidence of adverse events was relatively high, with POEM-specific complications, including subcutaneous emphysema, pneumothorax, and thoracic effusion, reported across studies. Additionally, a substantial proportion of patients undergoing POEM developed esophagitis requiring treatment. Case series do not permit conclusions about the efficacy of POEM relative to established treatment, and long-term outcomes of the procedure are not well described in the literature. The evidence is insufficient to determine the effects of the technology on health outcomes. Background 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. Estimated U.S. prevalence of achalasia is 10 cases per 100,000, and estimated incidence is 0.6 cases per 100,000 per year.(1) Treatment options for achalasia have traditionally included pharmacotherapy such as injections with botulinum toxin, pneumatic dilation, and laparoscopic Heller myotomy.(1, 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, 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.(2) One-year response rates of 86% and rates of major mucosal tears requiring subsequent intervention of 0.6% have been reported.(3) Peroral endoscopic myotomy (POEM) is a novel endoscopic procedure developed in Japan by Dr. Haruhiro Inoue et al.(2,4) POEM is performed with the patient under general anesthesia.(5) 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.(2,5) Please note that the acronym POEM in this policy refers to peroral endoscopic myotomy. POEMS syndrome, which uses a similar acronym, is discussed in a separate medical policy (see Related Policies). 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. Scope [TOP] Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. 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. This medical policy does not apply to Medicare Advantage. Benefit Application [TOP] N/A Rationale [TOP] Populations Individuals: With achalasia Interventions Interventions of interest are: Peroral endoscopic myotomy Comparators Comparators of interest are: Esophageal dilatation Heller myotomy Botulinum toxin injection Outcomes Relevant outcomes include: Symptoms Functional outcomes Health status measures Resource utilization Treatment-related morbidity This policy was created in September 2013 and has been updated with a search of the MEDLINE database through October 10, 2016. 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. No randomized controlled trials (RCTs) comparing POEM with other treatment options have been found. Following is a summary of the nonrandomized studies and selected larger series (≥50 patients) on this procedure. Systematic Reviews Several systematic reviews have evaluated the outcomes of POEM. Three recent reviews have summarized outcomes of case series studies.(6-8) The systematic review by Akintoye et al (2016) evaluated outcomes for 2373 patients from 36 studies.(6) Clinical success rates were achieved in 98% of patients (95% confidence interval [CI], 97% to 100%) and mean Eckardt scores decreased from baseline at 1, 6, and 12 months. (The Eckardt score grades 4 major symptoms of achalasia [dysphagia, regurgitation, retrosternal pain, weight loss] each on a 0 [none] to 3 [severe] scale, for a maximum score of 12; total scores of ≥4 represent treatment failure.(9)) The systematic review by Crespin et al (2016) evaluated outcomes for 1299 patients from 19 studies.(7) Improvements in Eckardt scores were statistically significant in all studies. The most frequently reported complications were mucosal perforation, pneumothorax, pneumoperitoneum, and subcutaneous emphysema. The systematic review by Patel et al (2016) evaluated outcomes for 1122 patients from 22 studies.(8) Eckardt scores dropped from 6.8 at baseline to 1.2 postoperatively. There were improvements in lower esophageal sphincter (LES) pressure and symptoms. Two systematic reviews only selected studies comparing POEM to an alternative surgical treatment.(10,11) We only report results from the systematic review by Marano et al (2016) because it included the period of time covered in the other review and assessed more patients and studies.(10) It evaluated outcomes for 486 patients (196 receiving POEM, 290 receiving laparoscopic Heller myotomy [LHM]) from 11 studies. None were randomized. Reviewers rated all studies to have a moderate risk of bias. No information on differences in disease severity between treatment groups was provided. There were no significant differences in the reduction of Eckardt scores, postoperative pain scores, or requirements for analgesics between procedures. Hospital length of stay was shorter for POEM. Section Summary Conclusions on comparative efficacy cannot be determined from these systematic reviews, because reviews of case series do not assess comparator treatments. The systematic reviews evaluating comparative studies only included nonrandomized studies and does not appear to have taken into account differences in patient characteristics. Nonrandomized Comparative Studies In a nonrandomized trial with historical control, Hungness et al. (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.S. center.(5) Operative times were shorter for POEM than for LHM (113 and 125 minutes, respectively, p<0.05). Additionally, estimated blood loss was less in patients treated with POEM (≤10 mL in all POEM cases vs 50 mL for LHM, p<0.001). Myotomy lengths, complication rates, and length of stay were similar between groups. Pain scores were similar post-anesthesia and post-operatively on the first day, but were higher at 2 hours for POEM patients (3.5 vs. 2.0, p=0.03). Narcotic use was similar between groups, although fewer patients treated with POEM received ketorolac, a nonsteroidal anti-inflammatory drug. POEM patients’ Eckardt scores decreased (median 1 post-operative vs. 7 preoperative, p<0.001), and 16 patients (89%) had treatment success (score≤3) at a median of 6months follow-up. In a retrospective study of a prospective database at Oregon Health & Sciences University (Portland, OR), Bhayani et al. (2014) compared outcomes in 37 patients who underwent POEM and 64 patients who underwent LHM for achalasia.(12) Full-thickness esophageal injury occurred in 4 POEM patients, and 8 esophageal and 3 gastric perforations occurred in LHM patients. Mean (SD) hospitalization was 1.1 (0.6) days in the POEM group versus 2.2 (1.9) days in the LHM group (Mann-Whitney U test for all comparisons, p<0.001). Eckardt scores were statistically lower postoperatively in the POEM group compared with the LHM group (p<0.001), but at 6 months (64% of patients assessed), Eckardt scores did not differ statistically between groups (p=0.1). Postoperative decreases in lower esophageal sphincter (LES) pressures were similar between groups. At 6 months, resting LES pressure was higher in the POEM group compared with the LHM group (16 mm Hg vs. 7 mm Hg, p=0.006). (LES pressure >15 mm Hg predicts recurrent dysphagia.(13)) In a retrospective study of patients with type III achalasia, Kumbhari et al. (2015) compared outcomes of 49 patients who underwent POEM versus 25 patients who underwent LHM.(14) Defining clinical response as a reduction in Eckardt score to 1 or less, clinical response was more frequent in the POEM group than the LHM group (98.0% vs. 80.8%, p=.01). However, LHM patients had more severe disease by several different measures. On multivariable analysis, there was no statistically significant difference in the odds of failure between procedures, although the point estimate of the odds was in favor of POEM (odds ratio, 11.32; p=0.06). Procedure times were shorter with POEM. There was no difference in length of stay. The overall rate of adverse events was lower in the POEM group (27% vs. 6%, p=0.01). Ujiki et al. (2013) compared outcomes of 18 patients undergoing POEM to 21 patients who underwent LHM.(15) Postoperative Eckardt scores were similar (POEM 0.7 vs. LHM 1.0). Several outcomes related to recovery from surgery were in favor of POEM; postoperative pain, analgesic use, and return to activities of daily living. Sanaka et al (2016) compared outcomes in their own institution for 36 patients undergoing POEM, 142 undergoing LHM, and 36 undergoing pneumatic dilation.(16) At baseline, patients undergoing the 3 procedures had different characteristics. POEM patients were older, had higher body mass index, and had more prior treatments. After treatment, patients undergoing all 3 procedures had significant improvements as measured by high-resolution esophageal manometry and timed barium esophagram. Eckhardt symptom scores were only available for POEM patients. Long-term outcomes were not reported. Wang et al (2016) retrospectively reviewed outcomes for POEM (n=21) and pneumatic dilation (n=10) in patients ages 65 years and older.(17) All were treated successfully, with decreases in Eckhardt scores. At a mean followup of 21.8 months for POEM and 35 months for pneumatic dilation patients, 1 POEM case failed and 2 pneumatic dilation procedures failed. Section Summary The nonrandomized studies comparing POEM to other procedures are retrospective and involved patients who may not be comparable. Although outcomes were generally similar between POEM and the comparator treatments (LHM, pneumatic dilation), potential confounding and selection bias make outcome comparisons uncertain. The comparative studies did not report long-term outcomes. Selected Case Series Studies Inoue et al. (2015) reported outcomes on 500 consecutive patients at 1 Japanese institution.(18) Outcomes were available for variable proportion of patients at various time intervals after the procedure; 302 (60.4%) at 2 months, 102 (27.6% of 370) at 1 to 2 years, and 61 (58.1% of 105) at more than 3 years. The median Eckardt score at all time points was 1. Lower esophageal sphincter pressure ranged from 13.4 to 11.7. Between 16.8% and 21.3% of subjects reported symptoms of GERD. The overall complication rate was 3.2%. Ramchandani et al. reported outcomes on 200 consecutive patients at one institution in India.(19) Outcomes at 1 year were available for 102 patients. 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. The mean Eckardt score was 1.18 after POEM. In a prospective case series, von Renteln et al. (2013) reported on 70 patients who underwent POEM at five centers in Europe and North America.(20) Mean follow-up period was 10 months (range, 3-12 months). Follow-up evaluation at 6 months and 1 year showed sustained treatment success of 89% and 82%, respectively. Mean pretreatment Eckardt score was 6.9 compared with 1.3 at 6 months and 1.7 at 1 year (p<0.001 for both comparisons with pretreatment score). In Multivariate analysis, neither age, previous treatment (Botox/dilatation), myotomy length, pre-procedure LES pressure, pretreatment Eckardt score, sex, procedure duration, nor fullthickness dissection during POEM were significant predictors of treatment failure at 1 year. At 3 months after POEM, esophagitis was observed in 42% of cases. However, severity of esophagitis was minor (grade A or B), and all patients could be managed adequately with proton pump inhibitor (PPI) therapy. At 3 months, 22% of patients required occasional and 12% required daily PPI therapy. The 1-year follow-up evaluation showed overall rates of gastroesophageal reflux disease of 37%, and PPI use of 29%. Other complication rates of POEM ranged from 1% to 4%. Teitelbaum et al. (2014) also evaluated 1-year outcomes after POEM.(21) Forty-one patients who were treated at Northwestern University (Evanston, IL) and were more than 1 year post-POEM were included. Most patients (37 [90%]) had no previous endoscopic treatment (botulinum toxin injection or pneumatic dilation). Ninety-two percent of 39 patients available for symptom assessment had treatment success (Eckardt score <4). In 21 patients evaluated, mean (SD) LES pressure was 11(4) mm Hg. Ling et al. (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; Physical Component Summary (PCS) and Mental Component Summary (MCS) raw scores were transformed to a 0 (poor health) to 100 (good health) scale. In a group of 21 patients who had failed previous pneumatic dilation, mean (SD) PCS improved from 30(13) to 65(10), and mean MCS improved from 43(10) to 67(11) (Student t test, p<0.001 for both comparisons).(22) Incidence of intraoperative subcutaneous emphysema and pneumothorax was 14% and 5%, respectively; postoperative esophagitis developed in 19%. In 87 previously untreated patients, mean (SD) PCS improved from 33(11) to 69(18) (Student t test, p<0.001), and mean (SD) MCS improved from 44(13) to 67(15) (Student t test, p=0.003).(23) Incidence of intraoperative subcutaneous emphysema and pneumothorax was 12% and 1%, respectively; postoperative esophagitis developed in 6%. The study by Ren et al. (2012) highlighted POEM-specific complications.(24) In their series of 119 cases, 23% of patients developed subcutaneous emphysema intraoperatively and an additional 56%, postoperatively. Three of these patients required treatment with subcutaneous needle decompression. Additionally, 3% patients developed a pneumothorax intraoperatively and another 25% postoperatively. Postoperatively, the incidence of thoracic effusion was 49%, and of mild inflammation or segmental atelectasis of the lungs was 50%. All complications were resolved with conservative treatment. At least two small case series have evaluated the efficacy and feasibility of POEM for patients with failed Heller myotomy/achalasia recurrence; success rates have been reported in over 90% of cases up to 10 months after rescue POEM.(25,26) Studies also have compared different POEM techniques; comparable outcomes have been reported between patients undergoing full-thickness versus circular myotomy.(20) An international survey of 16 centers (seven in North America, five in Asia, four in Europe, some of which were high-volume centers [≥30 POEMs per center]) reported 841 POEM procedures performed as of July 2012.(27) Section Summary Case series have shown improvement in symptoms of achalasia after POEM. Such studies do not permit comparison to other established treatments. Summary of Evidence For individuals who have achalasia who receive peroral endoscopic myotomy (POEM), the evidence includes systematic reviews, nonrandomized comparative studies, and case series. Relevant outcomes are symptoms, functional outcomes, health status measures, resource utilization, and treatment-related morbidity. The comparative studies reported primarily similar outcomes with POEM and with Heller myotomy for symptom relief, as assessed by the Eckardt score. Some studies showed shorter length of stay and less postoperative pain with POEM. However, potential imbalances in patient characteristics in these nonrandomized studies may have biased the treatment comparisons. In the case series, treatment success at short follow-up periods was reported for a high proportion of patients treated with POEM. However, incidence of adverse events was relatively high, with POEM-specific complications, including subcutaneous emphysema, pneumothorax, and thoracic effusion, reported across studies. Additionally, a substantial proportion of patients undergoing POEM developed esophagitis requiring treatment. Case series do not permit conclusions about the efficacy of POEM relative to established treatment, and long-term outcomes of the procedure are not well described in the literature. The evidence is insufficient to determine the effects of the technology on health outcomes. Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this review are listed in Table 1. Table 1. Summary of Key Trials NCT No. Ongoing NCT02138643 NCT01601678 NCT01793922 Unpublished NCT01742494 NCT01750385 NCT01768091 Trial Name Planned Enrollment Completion Date Laparoscopy Heller Myotomy With Fundoplication Associated Versus Peroral Endoscopic Myotomy (POEM) Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial A Prospective Randomized Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM) as Treatment of Idiopathic Achalasia 30 Feb 2017 220 Dec 2019 150 Jan 2023 100 Dec 2012 (unknown) Aug 2013 (unknown) Dec 2013 (unknown) Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia Peroral Endoscopic Myotomy Versus Pneumatic Dilation for Esophageal Achalasia: a Prospective Randomized Controlled Trial 60 200 NCT: national clinical trial. Practice Guidelines and Position Statements Society of American Gastrointestinal and Endoscopic Surgeons In 2011, the Society of American Gastrointestinal and Endoscopic Surgeons issued an evidence-based, 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.”(28) American College of Gastroenterology In 2013, the American College of Gastroenterology issued a clinical guideline on the diagnosis and management of achalasia.(29) POEM was discussed as an emerging therapy, and stated to have promise as an alternative to the laparoscopic approach. The guideline further states that randomized prospective comparison trials are needed, and the procedure should be performed in the context of clinical trials. U.S. Preventive Services Task Force Recommendations Not applicable. Medicare National Coverage There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. References [TOP] 1. Cheatham JG, Wong RK. Current approach to the treatment of achalasia. Curr Gastroenterol Rep. Jun 2011;13(3):219-225. PMID 21424734 2. Pandolfino JE, Kahrilas PJ. Presentation, diagnosis, and management of achalasia. Clin Gastroenterol Hepatol. Aug 2013;11(8):887-897. PMID 23395699 3. 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):468-475. PMID 23684149 4. Inoue H, Minami H, Kobayashi Y, et al. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. Apr 2010;42(4):265-271. PMID 20354937 5. 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):228-235. PMID 23054897 6. Akintoye E, Kumar N, Obaitan I, et al. Peroral endoscopic myotomy: a meta-analysis. Endoscopy. Sep 12 2016. PMID 27617421 7. Crespin OM, Liu LW, Parmar A, et al. Safety and efficacy of POEM for treatment of achalasia: a systematic review of the literature. Surg Endosc. Sep 15 2016. PMID 27633440 8. Patel K, Abbassi-Ghadi N, Markar S, et al. Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Dis Esophagus. Oct 2016;29(7):807-819. PMID 26175119 9. Eckardt AJ, Eckardt VF. Treatment and surveillance strategies in achalasia: an update. Nat Rev Gastroenterol Hepatol. Jun 2011;8(6):311-319. PMID 21522116 10. Marano L, Pallabazzer G, Solito B, et al. Surgery or Peroral Esophageal Myotomy for Achalasia: A Systematic Review and Meta-Analysis. Medicine (Baltimore). Mar 2016;95(10):e3001. PMID 26962813 11. Zhang Y, Wang H, Chen X, et al. Per-oral endoscopic myotomy versus laparoscopic Heller myotomy for achalasia: a meta-analysis of nonrandomized comparative studies. Medicine (Baltimore). Feb 2016;95(6):e2736. PMID 26871816 12. Bhayani NH, Kurian AA, Dunst CM, et al. A comparative study on comprehensive, objective outcomes of laparoscopic Heller myotomy with per-oral endoscopic myotomy (POEM) for achalasia. Ann Surg. Jun 2014;259(6):1098-1103. PMID 24169175 13. Patti MG, Fisichella PM. Controversies in management of achalasia. J Gastrointest Surg. Sep 2014;18(9):1705-1709. PMID 24972973 14. Kumbhari V, Tieu AH, Onimaru M, 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. Endosc Int Open. Jun 2015;3(3):E195-201. PMID 26171430 15. Ujiki MB, Yetasook AK, Zapf M, et al. Peroral endoscopic myotomy: A short-term comparison with the standard laparoscopic approach. Surgery. Oct 2013;154(4):893-897; discussion 897-900. PMID 24074429 16. Sanaka MR, Hayat U, Thota PN, et al. Efficacy of peroral endoscopic myotomy vs other achalasia treatments in improving esophageal function. World J Gastroenterol. May 28 2016;22(20):4918-4925. PMID 27239118 17. Wang X, Tan Y, Lv L, et al. Peroral endoscopic myotomy versus pneumatic dilation for achalasia in patients aged >/= 65 years. Rev Esp Enferm Dig. Oct 2016;108(10):637-641. PMID 27649684 18. Inoue H, Sato H, Ikeda H, et al. Per-oral endoscopic myotomy: a series of 500 patients. J Am Coll Surg. Aug 2015;221(2):256-264. PMID 26206634 19. Ramchandani M, Nageshwar Reddy D, Darisetty S, et al. Peroral endoscopic myotomy for achalasia cardia: Treatment analysis and follow up of over 200 consecutive patients at a single center. Dig Endosc. Jan 2016;28(1):19-26. PMID 26018637 20. Von Renteln D, Fuchs KH, Fockens P, et al. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Gastroenterology. Aug 2013;145(2):309-311 e303. PMID 23665071 21. Teitelbaum EN, Soper NJ, Santos BF, et al. Symptomatic and physiologic outcomes one year after peroral esophageal myotomy (POEM) for treatment of achalasia. Surg Endosc. Dec 2014;28(12):33593365. PMID 24939164 22. Ling T, Guo H, Zou X. Effect of peroral endoscopic myotomy in achalasia patients with failure of prior pneumatic dilation: A prospective case-control study. J Gastroenterol Hepatol. Aug 2014;29(8):16091613. PMID 24628480 23. Ling TS, Guo HM, Yang T, et al. 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. J Dig Dis. Jul 2014;15(7):352-358. PMID 24739072 24. Ren Z, Zhong Y, Zhou P, et al. Perioperative management and treatment for complications during and after peroral endoscopic myotomy (POEM) for esophageal achalasia (EA) (data from 119 cases). Surg Endosc. Nov 2012;26(11):3267-3272. PMID 22609984 25. 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. Oct 2013;217(4):598-605. PMID 23891071 26. Zhou PH, Li QL, Yao LQ, et al. Peroral endoscopic remyotomy for failed Heller myotomy: a prospective single-center study. Endoscopy. Mar 2013;45(3):161-166. PMID 23389963 27. Li QL, Chen WF, Zhou PH, et al. Peroral endoscopic myotomy for the treatment of achalasia: a clinical comparative study of endoscopic full-thickness and circular muscle myotomy. J Am Coll Surg. Jul 25 2013;217(3):442-451. PMID 23891074 28. Stefanidis D, Richardson W, Farrell TM, et al. SAGES guidelines for the surgical treatment of esophageal achalasia. Surg Endosc. Feb 2012;26(2):296-311. PMID 22044977. 29. Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. Aug 2013;108(8):1238-1249; quiz 1250. PMID 23877351 30. Blue Cross Blue Shiled Association. Medical Policy Reference Manual. Peroal Endoscopic Myotomy (POEM) for Treatment of Esophageal Achalasia. Policy No. 2.01.91, 2016. Appendix [TOP] N/A History [TOP] Date 11/11/13 11/20/14 12/08/15 01/10/17 Reason New Policy. Policy created with literature search through August 1, 2013; considered investigational. Annual Review. Policy updated with literature review through August 18, 2014; references 3, 6-7, 912, and 18 added; no change to policy statement. ICD-9 and ICD-10 diagnosis codes removed; these do not relate to adjudication of this policy. Annual Review. Policy updated with literature review through October 15, 2015; references 8-11 and 23 added. Policy statement unchanged. Annual Review. Policy updated with literature review through October 10, 2016; references 6-8, 1011, and 15-16 added. Policy statement unchanged. Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2017 Premera All Rights Reserved. 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You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Getting Help in Other Languages This Notice has Important Information. This notice may have important information about your application or coverage through Premera Blue Cross. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call 800-722-1471 (TTY: 800-842-5357). አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ። ( العربيةArabic): قد يحوي ھذا اإلشعار معلومات مھمة بخصوص طلبك أو.يحوي ھذا اإلشعار معلومات ھامة قد تكون ھناك تواريخ مھمة.Premera Blue Cross التغطية التي تريد الحصول عليھا من خالل وقد تحتاج التخاذ إجراء في تواريخ معينة للحفاظ على تغطيتك الصحية أو للمساعدة.في ھذا اإلشعار اتصل. يحق لك الحصول على ھذه المعلومات والمساعدة بلغتك دون تكبد أية تكلفة.في دفع التكاليف 800-722-1471 (TTY: 800-842-5357)بـ 中文 (Chinese): 本通知有重要的訊息。本通知可能有關於您透過 Premera Blue Cross 提交的 申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期 之前採取行動,以保留您的健康保險或者費用補貼。您有權利免費以您的母 語得到本訊息和幫助。請撥電話 800-722-1471 (TTY: 800-842-5357)。 037338 (07-2016) Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. Français (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermédiaire de Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous devrez peut-être prendre des mesures par certains délais pour maintenir votre couverture de santé ou d'aide avec les coûts. Vous avez le droit d'obtenir cette information et de l’aide dans votre langue à aucun coût. Appelez le 800-722-1471 (TTY: 800-842-5357). Kreyòl ayisyen (Creole): Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo. Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357). Deutsche (German): Diese Benachrichtigung enthält wichtige Informationen. Diese Benachrichtigung enthält unter Umständen wichtige Informationen bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357). Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357). Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso può contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357). 日本語 (Japanese): この通知には重要な情報が含まれています。この通知には、Premera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ ります。この通知に記載されている可能性がある重要な日付をご確認くだ さい。健康保険や有料サポートを維持するには、特定の期日までに行動を 取らなければならない場合があります。ご希望の言語による情報とサポー トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話 ください。 Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 (TTY: 800-842-5357). 한국어 (Korean): 본 통지서에는 중요한 정보가 들어 있습니다. 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다. 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다. 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다. 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오. Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357). ລາວ (Lao): ແຈ້ ງການນ້ີ ມີຂ້ໍ ມູ ນສໍາຄັ ນ. ແຈ້ ງການນ້ີ ອາດຈະມີຂ້ໍ ມູ ນສໍາຄັ ນກ່ ຽວກັ ບຄໍາຮ້ ອງສະ ໝັ ກ ຫື ຼ ຄວາມຄຸ້ ມຄອງປະກັ ນໄພຂອງທ່ ານຜ່ ານ Premera Blue Cross. ອາດຈະມີ ວັ ນທີສໍາຄັ ນໃນແຈ້ ງການນີ້. ທ່ ານອາດຈະຈໍາເປັນຕ້ ອງດໍາເນີນການຕາມກໍານົ ດ ເວລາສະເພາະເພື່ອຮັ ກສາຄວາມຄຸ້ ມຄອງປະກັ ນສຸ ຂະພາບ ຫື ຼ ຄວາມຊ່ ວຍເຫື ຼ ອເລື່ອງ ຄ່ າໃຊ້ ຈ່ າຍຂອງທ່ ານໄວ້ . ທ່ ານມີສິດໄດ້ ຮັ ບຂ້ໍ ມູ ນນ້ີ ແລະ ຄວາມຊ່ ວຍເຫື ຼ ອເປັນພາສາ ຂອງທ່ ານໂດຍບໍ່ເສຍຄ່ າ. ໃຫ້ ໂທຫາ 800-722-1471 (TTY: 800-842-5357). ភាសាែខម រ (Khmer): េសចកត ីជូនដំណឹងេនះមានព័ត៌មានយា៉ងសំខាន់។ េសចកត ីជូនដំណឹងេនះរបែហល ជាមានព័ត៌មានយា៉ងសំខាន់អំពីទរមង់ែបបបទ ឬការរា៉ប់រងរបស់អនកតាមរយៈ Premera Blue Cross ។ របែហលជាមាន កាលបរ ិេចឆ ទសំខាន់េនៅកនុងេសចកត ីជូន ដំណឹងេនះ។ អន ករបែហលជារតូវការបេញច ញសមតថ ភាព ដល់កំណត់ៃថង ជាក់ចបាស់ នានា េដើមបីនឹងរកសាទុកការធានារា៉ប់រងសុខភាពរបស់អនក ឬរបាក់ជំនួយេចញៃថល ។ អន កមានសិទធិទទួ លព័ត៌មានេនះ និងជំនួយេនៅកនុងភាសារបស់អនកេដាយមិនអស លុយេឡើយ។ សូ មទូ រស័ពទ 800-722-1471 (TTY: 800-842-5357)។ ਪੰ ਜਾਬੀ (Punjabi): ਇਸ ਨੋਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ ਕਵਰੇਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹੱ ਤਵਪੂਰਨ ਜਾਣਕਾਰੀ ਹੋ ਸਕਦੀ ਹੈ . ਇਸ ਨੋਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹੋ ਸਕਦੀਆਂ ਹਨ. ਜੇਕਰ ਤੁਸੀ ਜਸਹਤ ਕਵਰੇਜ ਿਰੱ ਖਣੀ ਹੋਵੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ ਇਛੁੱ ਕ ਹੋ ਤਾਂ ਤੁਹਾਨੂੰ ਅੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੁੱ ਕਣ ਦੀ ਲੋ ੜ ਹੋ ਸਕਦੀ ਹੈ ,ਤੁਹਾਨੂੰ ਮੁਫ਼ਤ ਿਵੱ ਚ ਤੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ਮਦਦ ਪ੍ਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ 800-722-1471 (TTY: 800-842-5357). ( فارسیFarsi): اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم. اين اعالميه حاوی اطالعات مھم ميباشد به تاريخ ھای مھم در. باشدPremera Blue Cross تقاضا و يا پوشش بيمه ای شما از طريق شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه. اين اعالميه توجه نماييد شما حق. به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد،ھای درمانی تان برای کسب.اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد ( تماس800-842-5357 تماس باشمارهTTY )کاربران800-722-1471 اطالعات با شماره .برقرار نماييد Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-722-1471 (TTY: 800-842-5357). Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do Premera Blue Cross. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter esta informação e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357). Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). Español (Spanish): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted tiene derecho a recibir esta información y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357). Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357). ไทย (Thai): ประกาศนี ้มีข้อมูลสําคัญ ประกาศนี ้อาจมีข้อมูลที่สําคัญเกี่ยวกับการการสมัครหรื อขอบเขตประกัน สุขภาพของคุณผ่าน Premera Blue Cross และอาจมีกําหนดการในประกาศนี ้ คุณอาจจะต้ อง ดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกันสุขภาพของคุณหรื อการช่วยเหลือที่ มีค่าใช้ จ่าย คุณมีสิทธิที่จะได้ รับข้ อมูลและความช่วยเหลือนี ้ในภาษาของคุณโดยไม่มีค่าใช้ จ่าย โทร 800-722-1471 (TTY: 800-842-5357) Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-722-1471 (TTY: 800-842-5357). Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).
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