PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ESOPHAGEAL ACHALASIA

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PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ESOPHAGEAL ACHALASIA

HS-310

Clinical Coverage Guideline page 1 Original Effective Date: 10/16/2015 - Revised: N/A

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Peroral Endoscopic Myotomy (POEM) for Esophageal Achalasia

Policy Number: HS-310

Original Effective Date: 10/16/2015 Revised Date(s): N/A

APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

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PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ESOPHAGEAL ACHALASIA

HS-310

DISCLAIMER

The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: Lines of business (LOB) are subject to change without notice; current LOBs can be found at www.wellcare.com – select the Provider tab, then “Tools” and “Clinical Guidelines”.

BACKGROUND

Peroral endoscopic myotomy (POEM) is recently introduced technique for the treatment of Achalasia cardia (AC).

POEM incorporates concepts of natural orifice translumenal endoscopic surgery and achieves endoscopic myotomy by utilizing a submucosal tunnel as an operating space. Although intended for the palliation of symptoms of

achalasia, there is mounting data to suggest it is also efficacious in the management of spastic esophageal

disorders. The technique requires an understanding of the pathophysiology of esophageal motility disorders as well as knowledge of surgical anatomy of the foregut. POEM achieves short term response in 82% to 100% of patients with minimal risk of adverse events. In addition, it appears to be effective and safe even at the extremes of age and regardless of prior therapy undertaken. Although infrequent, the ability of the endoscopist to manage an

intraprocedural adverse event is critical as failure to do so could result in significant morbidity. The major late adverse event is gastroesophageal reflux which appears to occur in 20% to 46% of patients. Research is being conducted to clarify the optimal technique for POEM and a personalized approach by measuring intraprocedural esophagogastric junction distensibility appears promising. In addition to esophageal disorders, POEM is being studied in the management of gastroparesis (gastric pyloromyotomy) with initial reports demonstrating technical feasibility. Although POEM represents a paradigm shift the management of esophageal motility disorders, the results of prospective randomized controlled trials with long-term follow up are eagerly awaited.¹

Practice Guidelines

The American College of Gastroenterology (ACG) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) have published guidelines on the diagnosis, management and treatment of achalasia however, POEM is not specifically noted.^2,3

Clinical Trials

A total of 32 clinical trials are registered in the ClinicalTrials.gov website related to POEM for the treatment of achalasia. A sample of the trial listings may be found below. To review the details of a clinical trial listed here, please insert the study number into the search field of the form found at this ClinicalTrials.gov website. A sample of trials being conducted include:⁴

NCT01601678: Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A

Randomized, Controlled Trial (POEM rcpmt) (This study is currently recruiting participants.) NCT02073578: Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia (This study is ongoing

but not recruiting participants.)

NCT01832779: Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia (This study is currently recruiting participants.)

NCT02162589: Peroral Endoscopic Myotomy (POEM) For The Treatment Of Achalasia: A Registry (POEM Registry) (This study is currently recruiting participants.)

NCT01512719: POEM- Peroral Endoscopic Myotomy (This study is currently recruiting participants.) NCT01584635: The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of

Achalasia (This study is enrolling participants by invitation only.)

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PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ESOPHAGEAL ACHALASIA

HS-310

POSITION STATEMENT

Applicable To:

Medicaid Medicare

Peroral endoscopic myotomy (POEM) is considered experimental / investigational and not medically necessary.

CODING

CPT Codes – No applicable codes.

HCPCS Codes – No applicable codes.

Non-Covered ICD-9-CM Diagnosis Code 530.0 Achalasia and cardiospasm

Non-Covered ICD-10-CM Diagnosis Code K22.0 Achalasia of cardia

*Current Procedural Terminology (CPT®) 2015 American Medical Association: Chicago, IL.

REFERENCES

1. Kumbhari V, Khashab MA. Peroral endoscopic myotomy. World J Gastrointest Endosc. May 2015; 167(5):496-509).

2. Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. 2013 Aug;108(8):1238-49. (Available at http://www.guideline.gov).

3. Stefanidis D, Richardson W, Farrell TM, Kohn GP, Augenstein V, Fanelli RD. SAGES guidelines for the surgical treatment of esophageal achalasia. Los Angeles (CA): Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); 2011 May. 50 p. (Available at http://www.guideline.gov).

4. Peroral endoscopic myotomy (POEM) for treatment of esophageal achalasia. Hayes Directory Web site. www.hayesinc.com. Published June 25, 2015. Accessed September 10, 2015.

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

10/16/2015  Approved by MPC. New.