Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Achalasia
Treatment: Per oral endoscopic myotomy
The insurer denied the Per oral endoscopic myotomy.
The denial is overturned. 

The patient is a man. He carries the diagnosis of a primary esophageal motility disorder (achalasia).  He has comorbid health conditions of hypertension, hyperlipidemia, BMI (body mass index) 32 kg/m2 (kilograms per meters squared), and sleep apnea.  His symptoms of dysphagia have been present for three years.  He has realized weight loss as a result of solid and liquid dysphagia.

The patient has been evaluated for this condition with esophageal manometry and contrast UGI (upper gastrointestinal series).  These studies show a dilated esophagus to the level of the gastroesophageal junction and manometry findings of type II/III achalasia.  The medical records include clinical reports from the treating surgeon and appeal material.  The treatment plan is per oral endoscopic myotomy (POEM).

The Plan policy states that it considers the POEM (per oral endoscopic myotomy) procedure to be investigational for the treatment of esophageal achalasia.  The appeal materials from the patient and provider include recent literature regarding the per oral endoscopic myotomy (POEM) procedure.

Yes, the health plan should cover the Per oral endoscopic myotomy.

Based on the current standard of care and evidence-based literature, the POEM (per oral endoscopic myotomy) procedure as proposed in this case is medically appropriate.

This patient has been evaluated with endoscopy, contrast UGI (upper gastrointestinal series), and esophageal manometry.  Findings were consistent with the diagnosis of a motor disorder of the esophagus (Achalasia).

Esophageal achalasia is a primary esophageal motility disorder of unknown etiology, characterized by absence of esophageal peristalsis and increased or normal resting pressure of the lower esophageal sphincter (LES), which fails to relax completely in response to swallowing.  Dysphagia, as in this case, is the most common symptom, experienced by virtually all patients.  Achalasia is the motor disorder for which esophageal myotomy is utilized.  Treatment is directed toward elimination of the outflow resistance at the level of the gastroesophageal junction. The following treatment modalities are available to achieve this goal:

Historically, pneumatic dilatation was the first line of treatment for esophageal achalasia, while surgery was reserved for patients who had persistent dysphagia after multiple dilatations or who had suffered a perforation during dilatation. The success rate of pneumatic dilatation is 55-70% with a single dilation but can be increased to nearly 90% with multiple dilations. However, the risk of perforation with each dilation is at least 3-5% and has been reported as high as 12% in some series. These patients may require open surgery to close the perforation and perform a myotomy. Furthermore, when stratified by age, balloon dilation is less than 50% effective in patients younger than 40 years old and is rarely effective in adolescents.

Intrasphincteric injection of botulinum toxin (BOTOX) injection is less effective than balloon dilation and requires re-treatment to maintain an efficacy rate of 65%. Of greater concern is the fact that BOTOX (botulinum toxin) injection leads to scar formation in the submucosal plane which results in a more difficult myotomy and higher mucosal perforation rate (up to 30%) during dissection. Thus, BOTOX (botulinum toxin) should be reserved for the treatment of patients who are poor candidates for surgery and poor candidates for balloon dilation (dilated sigmoid esophagus) or as a bridge to surgery. An additional utility for BOTOX (botulinum toxin) is in aiding in the diagnosis of patients who have equivocal findings on initial evaluation. A good response to BOTOX (botulinum toxin) is usually an indication that the patient will have long-term relief following surgical myotomy.

Today, minimally invasive surgery has completely changed this treatment algorithm and a laparoscopic Heller myotomy and fundoplication is preferred by most gastroenterologists and surgeons as the primary treatment modality. When properly performed, a Heller myotomy can be expected to result in permanent relief of dysphagia in 85-100% of patients. Because of the lack of esophageal peristalsis, a partial (Dor or Toupet), rather than a total fundoplication is frequently added to prevent reflux.

A recent prospective, randomized study demonstrated that Heller myotomy plus a partial fundoplication is superior to Heller myotomy alone in regard to the incidence of postoperative reflux as measured by 24 hour pH (potential of hydrogen) testing. Patients can usually eat the morning of the first postoperative day, and can be discharged home after one or two days. In the only prospective, randomized trial performed comparing balloon dilation with surgery, myotomy outperformed balloon dilation 95% to 65%.

More recently, an endoscopic technique has been described for myotomy (per oral endoscopic myotomy (POEM), and outcomes have been reported over the past decade.  This approach achieves similar reduction in esophageal outflow pressure with a less invasive endoscopic method of access to the esophagus.

Yes, the per oral endoscopic myotomy is likely to be more beneficial.

An endoscopic technique has been described for myotomy (per oral endoscopic myotomy), and outcomes have been reported over the past decade. Based on the expanding body of peer reviewed literature the American Gastroenterology Association (AGA) published guidelines for use of POEM (per oral endoscopic myotomy). According to the guidelines from the AGA (American Gastroenterology Association): Per-oral endoscopic myotomy should be viewed as primary therapy among patients with type III achalasia when performed by appropriately trained and experienced physicians. POEM (per oral endoscopic myotomy) is a safe, effective, and minimally invasive management option in achalasia per these 2017 guidelines. POEM (per oral endoscopic myotomy) should be considered as treatment option comparable with laparoscopic Heller myotomy for any of the achalasia syndromes.

Based on current literature and the most recent AGA (American Gastroenterology Association) guidelines, the peroral endoscopic myotomy is considered medically appropriate as a treatment for esophageal achalasia in appropriate clinical circumstances as in this case. The peroral endoscopic myotomy (POEM) is medically appropriate for this patient. This endoscopic approach achieves similar reduction in esophageal outflow pressure as the laparoscopic Heller myotomy with a less invasive endoscopic method of access to the esophagus.