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:

Open or laparoscopic esophagomyotomy with or without fundoplication.

Endoscopically guided pneumatic dilation (PD).
Botulinum toxin injection.
Oral pharmacologics (e.g., calcium channel blockers, long acting nitrates, anticholinergics, adrenergic agonists and theophylline).

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

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.
Developed in Japan, 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.
POEM presents a novel, minimally invasive and potentially effective endoscopic treatment for achalasia
(Friedel, 2013).

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

The evidence is insufficient to support the use of POEM as a treatment for achalasia. The results
suggest POEM is a feasible and safe procedure achieving equivalent short-term outcomes compared to
LHM for achalasia. However, the role of POEM as a first-line treatment or salvage therapy must still be
defined, and long-term results are needed. Established alternatives such as LHM and PD are supported
by substantially more clinical experience and stronger evidence from randomized controlled studies.
Guidelines from the American College of Gastroenterology, the Society of American Gastrointestinal and
Endoscopic Surgeons, and the American Society for Gastrointestinal Endoscopy highlight the need for
randomized, controlled studies comparing the long-term efficacy POEM to established alternatives for
treatment of achalasia before widespread adoption (Stafanidis, 2012; Vaezi, 2013; ASGE, 2014).

Summary of clinical evidence:

Citation
Barbieri (2015)

Content
Key points:

Hayes (2015)

Key points:

Wei (2015)

Systematic review of 16 non-randomized studies, case series or indirect comparisons

with LHM (n = 551 patients) published from 2010 2013.
Mean ages from all studies (median 44 years; range: 32 64 years). Body mass index
available only in four series (median 26; range, 25 27). Surveillance period (median 6
months; range, 3 12 months). Mean POEM duration (median 156 minutes; range, 42
112 minutes). Myotomy length (median 10 cm; range, 6 14 cm). Performed in
dedicated settings.
Technical and clinical success reported in 97% (95% confidence interval [CI], 94 98)
and 93% (95% CI, 90 95), respectively.
Most common adverse event: post-POEM esophagitis pooled rate was 13% (95% CI,
10 17).
Most common major adverse events that required medical or surgical interventions:
hypertensive pneumomediastinum and intramediastinal bleeding treatable with
decompression occurred in 14% (95% CI, 11 17); post-POEM surgery needed in 0.2%
(95% CI, 0 0.5).
Conclusions: Highly feasible and safe in short term. POEM should only be performed in
centers able to treat POEM complications, such as pneumothorax or
pneumoperitoneum.

Search and summary report (no systematic review) of 26 studies, individual cohorts and
indirect comparisons to alternative treatments. No randomized studies.
Report noted considerable overlap of authors and, presumably, patient groups. Some
involved mixed patient groups that included patients with achalasia, along with patients
with other types of esophageal motility disorders.
Four studies compared POEM with LHM; four reported outcomes comparing different
POEM techniques.

Key points:

Systematic review and meta-analysis of four studies comparing POEM and LHM. All
studies were conducted in the United States and published in 2013.
POEM was associated with comparable complications (odds ratio [OR] = 1.17; 95% CI,
0.53 2.56; P = .70), gastroesophageal reflux (OR = 1.00; 95% CI, 0.38 2.61; P =

Citation

Content

1.00), and symptomatic recurrence by Eckardt score (OR = 0.24; 95% CI, 0.04 1.55; P
= .13).
No significant difference between procedures in other outcomes, including pain score,
operating time and hospital stay.

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. Caused by the lower esophageal sphincter (near
the cardia) failing to relax, resulting in functional obstruction of the esophagus and difficulty swallowing.
Three subtypes shown on high-resolution manometry are:

Type I shows absence of any motility and contraction within the body of the esophagus.
Type II shows simultaneous contractions.
Type III reveals a simultaneous high-pressure spasm.

Chagas disease An inflammatory, infectious disease caused by a parasite found in the feces of the
triatomine (reduviid) bug. Chagas disease is common in South America, Central America and Mexico, but
rare cases have been found in the southern United States.
Dysphagia Difficulty swallowing.
Esophagomyotomy (Heller myotomy) A surgical procedure that cuts the smooth muscles of the
lower esophageal sphincter, allowing food and liquids to pass to the stomach.
Lower esophageal sphincter (LES) A band of involuntary muscles at the junction of the esophagus
and stomach. When the LES is closed, it prevents acid and stomach contents from traveling backwards
from the stomach. During swallowing, the sphincters relax so food can pass to the stomach.
Manometry A thin, pressure-sensitive tube passed through the nose, down the esophagus and into
the stomach, that measures the rhythmic muscle contractions that occur in the esophagus when
swallowing.
Peristalsis Successive waves of involuntary contraction passing along the walls of the esophagus or
intestine and that force the contents onward.
Peroral endoscopic myotomy (POEM) A procedure that uses a high-definition upper endoscope to
cut the smooth muscles of the lower esophageal sphincter, allowing food and liquids to pass to the
stomach.
Pneumatic dilation A nonsurgical endoscopic procedure that uses inflated balloons to enlarge the
circumference of the esophagus. The goal is to rupture the circular muscle fibers of the lower esophageal
sphincter while leaving the mucosa intact, allowing food and liquids to pass to the stomach.

Pseudoachalasia A condition with signs and symptoms similar to primary achalasia, but caused by another
disease such as a mass in the esophagus or a nerve disease affecting lower esophageal motility. It is also
called secondary achalasia.

Related policies
AmeriHealth Caritas District of Columbia Utilization Management program description.
References
Professional society guidelines/other:
ASGE Standards of Practice Committee, Pasha SF, Acosta RD, Chandrasekhara V, et al. The role of
endoscopy in the evaluation and management of dysphagia. Gastrointest Endosc. 2014; 79(2): 191
201.

Stefanidis D, Richardson W, Farrell TM, et al. SAGES guidelines for the surgical treatment of esophageal
achalasia. Surgical endoscopy. 2012; 26(2): 296 311.
Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. The
American journal of gastroenterology. 2013; 108(8): 1238 1249; quiz 1250.

Peer-reviewed references:
Barbieri LA HC, Rosati R, Romario UF, Correale L, Repici A. Systematic review and meta-analysis: Efficacy
and safety of POEM for achalasia. United European gastroenterology journal. 2015 Aug; 3(4): 325 334.
Franklin AL, Petrosyan M, Kane TD. Childhood achalasia: A comprehensive review of disease, diagnosis
and therapeutic management. World journal of gastrointestinal endoscopy. 2014; 6(4): 105 111.
Friedel D, Modayil R, Iqbal S, Grendell JH, Stavropoulos SN. Per-oral endoscopic myotomy for achalasia:
An American perspective. World journal of gastrointestinal endoscopy. 2013; 5(9): 420 427.
Hayes Inc., Hayes Medical Technology Report. Peroral endoscopic myotomy (POEM) for treatment of
esophageal achalasia. Lansdale, Pa. Hayes Inc.; June, 2015.
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.
Endoscopy international open. 2015; 3(3): E195 201.

Clinical trials:
6

Searched ClinicalTrials.gov on August 17, 2015, using terms achalasia, myotomy or "peroral
endoscopic myotomy" or POEM. | Open Studies. . Twenty-five studies found, eight relevant.
Per-Oral Endoscopic Myotomy for Esophageal Swallowing Disorders. ClinicalTrials.gov Web site.
ClinicalTrials.gov/show/NCT02482337. Published May 7 2015. Updated June 23, 2015. Accessed August
17, 2015.
POEM Anterior Versus Posterior Approach. ClinicalTrials.gov Web site.
ClinicalTrials.gov/show/NCT02454335. Published May 10 2015. Updated May 21, 2015. Accessed August
17, 2015.
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia. ClinicalTrials.gov Web site.
ClinicalTrials.gov/show/NCT01399476. Published July 19 2011. Updated April 12, 2012. Accessed August
17, 2015.
Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia. ClinicalTrials.gov Web site.
ClinicalTrials.gov/show/NCT01302288. Published February 23 2011. Updated February 25, 2011.
Accessed August 17, 2015.
Per-Oral Endoscopic Myotomy. ClinicalTrials.gov Web site. ClinicalTrials.gov/show/NCT01402518.
Published July 21 2011. Updated March 26, 2015. Accessed August 17, 2015.
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia. ClinicalTrials.gov Web site.
ClinicalTrials.gov/show/NCT01832779. Published April 2 2013. Updated July 22, 2015. Accessed August
17, 2015.
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia: A Registry. ClinicalTrials.gov Web
site. ClinicalTrials.gov/show/NCT02162589. Published June 10 2014. Updated June 1, 2015. Accessed
August 17, 2015.
Efficacy & Safety of Submucosal Endoscopic Myotomy With Mucosal Flap (SEMF) in the Treatment of
Patients with Achalasia. ClinicalTrials.gov Web site. ClinicalTrials.gov/show/NCT01438398. Published
March 28 2011. Updated February 15, 2013. Accessed August 17, 2015.

CMS National Coverage Determinations (NCDs):

No NCDs identified as of the writing of this policy.
Local Coverage Determinations (LCDs):
No LCDs identified as of the writing of this policy.>

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is
not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and
bill accordingly.
CPT Code
N/A

Description
No CPT code

Comments

ICD-9 Code
530.0
530.89
787.20

Description
Achalasia
Esophageal motility disorder
Dysphagia

Comments

ICD-10 Code
K22.0
K22.8
R13.10

Description
Achalasia
Esophageal motility disorder
Dysphagia

Comments