Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Achalasia.
Treatment: Ambulatory surgery [Peroral Endoscopic Myotomy].
The insurer denied Ambulatory surgery [Peroral Endoscopic Myotomy].
The determination is overturned.

The patient has a request for per oral endoscopic myotomy (POEM) procedure to treat achalasia. Manometry showed an elevated lower esophagus sphincter pressure, high amplitude contractions, consistent with type III achalasia. She has lost 10 pounds in one month, has chest pain, and regurgitation with every meal. The Eckardt score is 9. A progress note describes difficulty swallowing food, pills, liquids. There is a history of cardiomyopathy diagnosed and hypertension. The patient weighs 250 pounds with a body mass index (BMI) of 41.6. She is described as having type III variant achalasia and requesting POEM procedure. A copy of an esophagogastroduodenoscopy (EGD) and manometry report was documented showing elevated lower esophageal sphincter pressure, high resting pressure, high amplitude contractions of the esophagus. A report notes complaining of dysphagia, regurgitation, narrowing of the distal esophagus that did not allow barium tablet to pass, biopsy negative for eosinophilic esophagitis, recommend POEM procedure. At issue is whether the POEM procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The POEM procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
This patient has documentation of type III achalasia, has elevated resting pressure of the distal sphincter, high amplitude contractions of the esophagus, and the scientific literature has shown effectiveness and long-term favorable effect with this procedure. Since this procedure affords a longer Myotomy then a Heller Myotomy (surgical approach), and the literature describes this as the best approach for type III achalasia, the requested procedure is likely to be more beneficial than standard treatments for achalasia.
POEM has been proposed as the procedure of choice for type III achalasia because POEM can deliver a longer myotomy that is generally not possible with pneumatic dilation or the Heller procedure, and a longer myotomy might be more effective at controlling symptoms caused by the esophageal spasm of type III achalasia. In type III achalasia which is characterized by rapidly propagating pressure due to spastic contractions, POEM was superior to laparoscopic Heller myotomy (LHM) due to longer myotomy 16 versus (vs) 8 cm, shorter procedure time and significant better clinical outcome (98.0% vs. 80.8%) (Khumbari etal.).
Onimaru described long term favorable effect with POEM: "The majority of patients in this study obtained symptom improvement 10 years after POEM, suggesting that the clinical efficacy of POEM is favorable. These are the longest-term clinical results with POEM to date. The clinical results of POEM were satisfying enough regardless of various patient and procedural factors. Even in cases for which additional treatment was required, symptoms scores improved to below their pre-POEM baselines, suggesting that the technique plays a significant role in treatment of achalasia."
Ahmed described this as a standard of care approach: "Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. It is manifested by a loss of peristalsis in the lower part of the esophagus and failure of the lower esophageal sphincter (LES) to relax. Peroral endoscopic myotomy (POEM) is a minimally invasive intervention that aims to treat achalasia. It is regarded as the endoscopic equivalent of Heller myotomy. POEM is a form of natural orifice transluminal endoscopic surgery that is completed by creating a submucosal tunnel in the lower part of esophagus to reach the inner circular muscle bundles of the LES to perform myotomy, while preserving the outer longitudinal muscle bundles. The result is decreased resting pressure of the LES, facilitating the passage of ingested material."
Perbtani in a followup study: "The clinical efficacy of POEM has been commonly established by the reduction in the Eckardt score (less than [<] 3) after the procedure. However, achalasia can lead to significant impairment in the patient's quality of life that may go beyond the 4 classical achalasia symptoms as measured by the Eckardt score. The aims of our study were (1) to evaluate the effect of POEM on short and long-term health-related quality of life (HRQOL) and to (2) assess the association between HRQOL and Eckardt scores. POEM improved all dimensions of HRQOL as measured by the 36-Item Short Form Health Survey questionnaire (SF-36) survey at both short- and long-term follow-up. A strong association was seen between Eckardt score and all HRQOL domains."
Cho describing POEM as the main therapy for achalasia: "Peroral endoscopic myotomy (POEM) has been established as an optional treatment for achalasia. POEM is an endoluminal procedure that involves dissection of esophageal muscle fibers followed by submucosal tunneling. Inoue first attempted to use POEM for the treatment of achalasia in humans. Expanded indications of POEM include classic indications such as type I, type II, type III achalasia, failed prior treatments, including Botulinum toxin injection, endoscopic balloon dilation, laparoscopic Heller myotomy, and hypertensive motor disorders such as diffuse esophageal spasm, jackhammer esophagus. As POEM emerged as the main treatment for achalasia, various adaptations to tunnel endoscopic surgery have been attempted."
Bowers in a review supporting POEM: "Although there has been debate regarding the optimal procedure to palliate dysphagia in patients with achalasia, emerging reports of longer term follow-up of patients after peroral endoscopic myotomy (POEM) suggest that the POEM procedure is efficacious in relief of dysphagia, and that there is infrequent need for subsequent procedures for treatment of failure or reflux. The number of centers in the United States of America performing POEM for esophageal achalasia continues to increase. This report assesses the current knowledge of technical issues of POEM, outcomes after POEM and the status of POEM centers in the United States (US), and presents the argument for surgeons to participate in the practice of POEM."
Bechara summarized the current standard of care view on POEM: "Peroral endoscopic myotomy (POEM) was first performed in Japan in 2008 for uncomplicated achalasia. With excellent results, it was adopted by highly skilled endoscopists around the world and the indications for POEM were expanded to include advanced sigmoid achalasia, failed surgical myotomy, patients with previous endoscopic treatments and even other spastic oesophageal motility disorders. With increased uptake and performance of POEM, variations in technique and improved management of adverse events have been developed. Now, 6 years since the first case and with greater than (>)3,000 procedures performed worldwide, long-term data has shown the efficacy of POEM to be long-lasting. A growing body of literature also exists pertaining to the learning curve, application of novel technologies, extended indications and physiologic changes with POEM. Ultimately, this once experimental procedure is evolving towards becoming the preferred treatment for achalasia and other spastic esophageal motility disorders."
Kumbhari in a study with advantages of POEM when studied head on with Heller myotomy: "Type III achalasia is characterized by rapidly propagating pressurization attributable to spastic contractions. Although laparoscopic Heller myotomy (LHM) is the current gold standard management for type III achalasia, peroral endoscopic myotomy (POEM) is conceivably superior because it allows for a longer myotomy. Our aims were to compare the efficacy and safety of POEM with LHM for type III achalasia patients. Clinical response was significantly more frequent in the POEM cohort (98.0% vs 80.8%; probablility (P)=0.01). POEM patients had significantly shorter mean procedure time than LHM patients (102min vs 264 min).