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Clinical Policy Title: Peroral endoscopic myotomy (POEM

)
Clinical Policy Number: 08.03.04
Effective Date:
Initial Review Date:
Most Recent Review Date:
Next Review Date:

January 1, 2016
September 16, 2015
September 16, 2015
September 2016

Policy contains:
 Achalasia.
 Dysphagia.

Esophageal motility disorder.
 Peroral endoscopic myotomy (POEM).

Related policies:
CP#00.02.02
CP#09.01.03

Botulinum toxin products
Dysphagia testing

ABOUT THIS POLICY: AmeriHealth Caritas District of Columbia has developed clinical policies to assist with making coverage determinations.
AmeriHealth Caritas District of Columbia’ clinical policies are based on guidelines from established industry sources, such as the Centers for
Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional
societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal
laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular
situation are considered by AmeriHealth Caritas District of Columbia when making coverage determinations. In the event of conflict between
this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws
and/or regulatory requirements shall control. AmeriHealth Caritas District of Columbia’ clinical policies are for informational purposes only and
not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment
decisions for their patients. AmeriHealth Caritas District of Columbia’ clinical policies are reflective of evidence-based medicine at the time of
review. As medical science evolves, AmeriHealth Caritas District of Columbia will update its clinical policies as necessary. AmeriHealth Caritas
District of Columbia’ clinical policies are not guarantees of payment.

Coverage policy
AmeriHealth Caritas District of Columbia considers the use of peroral endoscopic myotomy (POEM) for
achalasia to be investigational and, therefore, not medically necessary.
Limitations:
None.
Alternative covered services:

1

calcium channel blockers. No intervention significantly affects esophageal peristalsis. anticholinergics. Treatment goals are to relieve symptoms. as recommended. and despite initial success of these therapeutic interventions the LES hypertonicity returns over time. High-resolution manometry provides greater topographical detail that allows gastroenterologists to classify diseases into clinically relevant subtypes and remove normal variants from pathologic classification (Friedel. their effectiveness decreases over time.    Open or laparoscopic esophagomyotomy with or without fundoplication. but the disorder can be associated with malignancy (especially involving the gastro-esophageal junction) and as a part of the spectrum of Chagas disease. Botulinum toxin injection. to patients for whom PD and esophagomyotomy are not considered appropriate because of inherent patient-related risks. The majority of cases are idiopathic. heartburn and coughing related to aspiration may occur. βadrenergic agonists and theophylline). Advanced cases can result in malnutrition. characterized by megaesophagus or sigmoid esophagus. generally. Franklin. Esophagectomy is reserved for patients with end-stage achalasia. weight loss. high resting LES pressure and absent esophageal peristalsis. chest pain. Vomiting. Background Achalasia is an esophageal motility disorder of the smooth muscle layer of the esophagus and the lower esophageal sphincter (LES). Incomplete LES relaxation.g. Botulinum toxin injection into the LES is restricted. Other tests include barium contrast radiography and endoscopic assessment of the gastroesophageal junction and gastric cardia. 2013). The diagnostic standard is esophageal manometry on which achalasia displays the following characteristics: incomplete relaxation of the LES in response to swallowing. achalasia is transmitted genetically (Friedel. In rare cases. 2013). regurgitation. Oral pharmacologics (e. 2 . The cardinal presenting symptom is progressive dysphagia. 2014). and each is associated with procedural risks. requiring repeat interventions (ACG. Established treatments for achalasia are open or laparoscopic esophagomyotomy (also known as Heller myotomy). usually for both solids and liquids. Oral pharmacologic interventions. improve esophageal emptying and prevent further esophageal dilation. 2013). to rule out pseudoachalasia and mechanical obstruction. Endoscopically guided pneumatic dilation (PD). 2013. such as calcium channel blockers and long-acting nitrates. and significant esophageal dilation and tortuosity. long acting nitrates. Achalasia is an incurable. 2013). 2014). are among the least effective. chronic condition that requires life-long follow up.. with or without an antireflux procedure. However. increased LES pressure and aperistalsis of the distal one-third of the esophageal body characterize the disorder (Friedel. Current treatment options aim to decrease the resting pressure in the LES (ACG. and pneumatic dilation (PD). Achalasia is rare in the pediatric population and even less so in children younger than five years of age (Franklin.

We included:  Systematic reviews. reporting both costs and outcomes — sometimes referred to as efficiency studies — which also rank near the top of evidence hierarchies. The evidence consists of single-arm studies and four individual. effectively treating the review as a scientific endeavor. 2013. as well as variable prior treatment exposure. it involves an esophageal mucosal incision followed by creation of a submucosal tunnel crossing the esophagogastric junction and myotomy before closure of the mucosal incision. Search terms were: "Peroral endoscopic myotomy" and "Esophageal achalasia"[Mesh]. minimally invasive and potentially effective endoscopic treatment for achalasia (Friedel. indirect comparisons of POEM to laparoscopic Heller myotomy (LHM).  Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other evidence-based practice centers. such as cost-effectiveness. 3 . Systematic reviews use predetermined transparent methods to minimize bias. 2012. Wei 2015). Developed in Japan.Peroral endoscopic myotomy: Peroral endoscopic myotomy (POEM) is a hybrid technique derived from natural orifice transluminal endoscopic surgery and advances in endoscopic submucosal dissection to perform a myotomy. 2015) and three evidence-based guidelines for this policy (Stafanidis. and are thus rated highest in evidence-grading hierarchies. POEM presents a novel. 2015.  The Centers for Medicare & Medicaid Services (CMS).  Economic analyses. Some studies included patients with other types of esophageal motility disorders. Searches AmeriHealth Caritas District of Columbia searched PubMed and the databases of:  UK National Health Services Centre for Reviews and Dissemination. reflecting clinical experience with POEM limited to relatively few centers around the world. 2014). Findings AmeriHealth Caritas District of Columbia identified two systematic reviews (Barbieri. 2013).  Guidelines based on systematic reviews. No randomized studies were published at the time of writing this policy. There is considerable overlap of investigators and. patient groups. one evidence report (Hayes. 2015. We conducted searches on August 14. presumably. ASGE. Vaezi. and benefit or utility studies (but not simple cost studies). which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies.

along with patients with other types of esophageal motility disorders. the Society of American Gastrointestinal and Endoscopic Surgeons. 2014).00. 3 – 12 months). 94 – 98) and 93% (95% CI. 95% CI. range.38 – 2. presumably. 2013. Myotomy length (median 10 cm. P = . POEM was associated with comparable complications (odds ratio [OR] = 1. Mean POEM duration (median 156 minutes. Established alternatives such as LHM and PD are supported by substantially more clinical experience and stronger evidence from randomized controlled studies. case series or indirect comparisons with LHM (n = 551 patients) published from 2010 – 2013. Some involved mixed patient groups that included patients with achalasia. range. 11 – 17). 25 – 27). Summary of clinical evidence: Citation Barbieri (2015) Content Key points:       Hayes (2015) Key points:    Wei (2015) Systematic review of 16 non-randomized studies. such as pneumothorax or pneumoperitoneum. Most common adverse event: post-POEM esophagitis pooled rate was 13% (95% CI. individual cohorts and indirect comparisons to alternative treatments. range: 32 – 64 years). and long-term results are needed. 42 – 112 minutes). 0 – 0. patient groups. Four studies compared POEM with LHM. However. Performed in dedicated settings. 10 – 17). Report noted considerable overlap of authors and. Most common major adverse events that required medical or surgical interventions: hypertensive pneumomediastinum and intramediastinal bleeding treatable with decompression occurred in 14% (95% CI. Guidelines from the American College of Gastroenterology. The results suggest POEM is a feasible and safe procedure achieving equivalent short-term outcomes compared to LHM for achalasia. Conclusions: Highly feasible and safe in short term.61. four reported outcomes comparing different POEM techniques. range. Search and summary report (no systematic review) of 26 studies.5). All studies were conducted in the United States and published in 2013. Body mass index available only in four series (median 26.2% (95% CI. gastroesophageal reflux (OR = 1. Technical and clinical success reported in 97% (95% confidence interval [CI]. controlled studies comparing the long-term efficacy POEM to established alternatives for treatment of achalasia before widespread adoption (Stafanidis. range. POEM should only be performed in centers able to treat POEM complications. Vaezi.70). 6 –14 cm). respectively. the role of POEM as a first-line treatment or salvage therapy must still be defined.56.53 – 2. No randomized studies. post-POEM surgery needed in 0. Key points:   Systematic review and meta-analysis of four studies comparing POEM and LHM. ASGE. 95% CI. Surveillance period (median 6 months. P = 4 . Mean ages from all studies (median 44 years.17. 0. 90 – 95). 0. 2012. and the American Society for Gastrointestinal Endoscopy highlight the need for randomized.The evidence is insufficient to support the use of POEM as a treatment for achalasia.

55. that measures the rhythmic muscle contractions that occur in the esophagus when swallowing. the sphincters relax so food can pass to the stomach. operating time and hospital stay.00). When the LES is closed. Type III reveals a simultaneous high-pressure spasm. and symptomatic recurrence by Eckardt score (OR = 0. Dysphagia — Difficulty swallowing. Central America and Mexico. During swallowing. pressure-sensitive tube passed through the nose. infectious disease caused by a parasite found in the feces of the triatomine (reduviid) bug.24. Pneumatic dilation — A nonsurgical endoscopic procedure that uses inflated balloons to enlarge the circumference of the esophagus.Citation Content  1. The goal is to rupture the circular muscle fibers of the lower esophageal sphincter while leaving the mucosa intact. Peroral endoscopic myotomy (POEM) — A procedure that uses a high-definition upper endoscope to cut the smooth muscles of the lower esophageal sphincter. 95% CI. allowing food and liquids to pass to the stomach. Caused by the lower esophageal sphincter (near the cardia) failing to relax. No significant difference between procedures in other outcomes. Chagas disease — An inflammatory. it prevents acid and stomach contents from traveling backwards from the stomach. Chagas disease is common in South America. Lower esophageal sphincter (LES) — A band of involuntary muscles at the junction of the esophagus and stomach. 5 . P = . Glossary Achalasia — A disorder of the swallowing muscles of the lower portion of the esophagus characterized by a progressive inability to swallow solids and liquids. including pain score. Three subtypes shown on high-resolution manometry are:    Type I shows absence of any motility and contraction within the body of the esophagus.04 – 1. 0. Peristalsis — Successive waves of involuntary contraction passing along the walls of the esophagus or intestine and that force the contents onward. Esophagomyotomy (Heller myotomy) — A surgical procedure that cuts the smooth muscles of the lower esophageal sphincter. Type II shows simultaneous contractions. but rare cases have been found in the southern United States. Manometry — A thin. allowing food and liquids to pass to the stomach. down the esophagus and into the stomach. resulting in functional obstruction of the esophagus and difficulty swallowing. allowing food and liquids to pass to the stomach.13).

Clinical trials: 6 . Lansdale. Childhood achalasia: A comprehensive review of disease. Vaezi MF. Grendell JH. Peroral endoscopic myotomy (POEM) vs laparoscopic Heller myotomy (LHM) for the treatment of Type III achalasia in 75 patients: a multicenter comparative study. June. Endoscopy international open. et al.. Stavropoulos SN. ACG clinical guideline: diagnosis and management of achalasia. Petrosyan M. 108(8): 1238 – 1249. SAGES guidelines for the surgical treatment of esophageal achalasia. 2014. Pasha SF. Related policies AmeriHealth Caritas District of Columbia Utilization Management program description.Pseudoachalasia — A condition with signs and symptoms similar to primary achalasia. quiz 1250. 2015. Pa. 2014. Onimaru M. Systematic review and meta-analysis: Efficacy and safety of POEM for achalasia. Peroral endoscopic myotomy (POEM) for treatment of esophageal achalasia. Iqbal S. Surgical endoscopy. Richardson W. Hayes Inc. Modayil R. Franklin AL. 26(2): 296 – 311. United European gastroenterology journal. 2015. 6(4): 105 – 111. Vela MF. 2015 Aug. Hayes Inc. Kane TD. Per-oral endoscopic myotomy for achalasia: An American perspective. It is also called secondary achalasia. 2013. World journal of gastrointestinal endoscopy. Correale L. 3(3): E195 – 201. Acosta RD. et al. Repici A. Pandolfino JE. et al. Peer-reviewed references: Barbieri LA HC. 2012. The American journal of gastroenterology. Farrell TM. 3(4): 325 – 334.. Hayes Medical Technology Report. Romario UF. Friedel D. 79(2): 191 – 201. References Professional society guidelines/other: ASGE Standards of Practice Committee. Gastrointest Endosc. 2013. Rosati R. Kumbhari V. World journal of gastrointestinal endoscopy. but caused by another disease such as a mass in the esophagus or a nerve disease affecting lower esophageal motility. Stefanidis D. Tieu AH. The role of endoscopy in the evaluation and management of dysphagia. diagnosis and therapeutic management. Chandrasekhara V. 5(9): 420 – 427.

gov Web site. Per-Oral Endoscopic Myotomy.gov/show/NCT01832779. 2015. Efficacy & Safety of Submucosal Endoscopic Myotomy With Mucosal Flap (SEMF) in the Treatment of Patients with Achalasia. 2015. ClinicalTrials. 2015.gov/show/NCT02454335.Searched ClinicalTrials.gov/show/NCT01399476. ClinicalTrials. ClinicalTrials. Published July 21 2011. Updated March 26. Accessed August 17. ClinicalTrials. Per-Oral Endoscopic Myotomy for Esophageal Swallowing Disorders.gov/show/NCT01302288. 2015. ClinicalTrials. ClinicalTrials. ClinicalTrials.” myotomy or "peroral endoscopic myotomy" or “POEM”. Updated February 15. Updated April 12. 2011. 2015. ClinicalTrials. ClinicalTrials. 2012. Accessed August 17. 2015. eight relevant. Updated February 25.gov Web site. Published April 2 2013.gov Web site. . Accessed August 17. Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia: A Registry. Accessed August 17. Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia.gov/show/NCT01438398. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Published May 10 2015.gov/show/NCT02162589. Updated June 1. Twenty-five studies found. ClinicalTrials. 2015.gov/show/NCT01402518. Accessed August 17. ClinicalTrials.gov/show/NCT02482337. CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. ClinicalTrials. 2013. Published March 28 2011. 2015. ClinicalTrials. Accessed August 17. ClinicalTrials. Published June 10 2014. 2015. Published February 23 2011. | Open Studies. Published May 7 2015. Updated June 23. Accessed August 17. ClinicalTrials. POEM Anterior Versus Posterior Approach.> 7 . Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia. 2015. Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia. ClinicalTrials. 2015. 2015. 2015. Updated May 21. Updated July 22. Published July 19 2011.gov Web site.gov Web site.gov on August 17. 2015. using terms “achalasia.gov Web site.gov Web site. Accessed August 17.gov Web site.

20 Description Achalasia Esophageal motility disorder Dysphagia Comments ICD-10 Code K22. Providers are expected to consult the appropriate coding manuals and bill accordingly.8 R13.89 787.0 530. This is not an exhaustive list of codes. CPT Code N/A Description No CPT code Comments ICD-9 Code 530.0 K22.10 Description Achalasia Esophageal motility disorder Dysphagia Comments 8 .Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy.