Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Achalasia.
Treatment:  POEM (per oral endoscopic myotomy).

The insurer denied the POEM (per oral endoscopic myotomy.  The denial is upheld. 

The patient is a female with hypothyroidism.

Pertinent to this review, the patient reported prior to performance of peroral endoscopic myotomy (POEM) the following: weight loss, GERD (gastroesophageal reflux disease)/regurgitation, hoarseness x 2 years, dysphagia to solids and liquids, and abdominal pain unresponsive to Prilosec OTC (over the counter) or Pepcid AC.

Video esophagram and UGI (upper gastrointestinal) series showed a dilated and aperistaltic esophagus, obstruction to passage of a 12.5mm barium tablet through the distal-most esophagus, but no reflux.  The examination was interpreted as consistent with achalasia, type unspecified.

For the original report, no confirmatory esophageal manometry was provided, nor were the results of pre-operative EGD.  

The POEM procedure, as performed above, is under review.  There is no evidence that conventional treatment options for management of achalasia were discussed, offered to, nor tried with and failed by the patient prior to her undergoing the POEM procedure.

No, the health plan should not cover the 43499 - POEM for achalasia.

Whereas the patient's manometry established the diagnosis of achalasia, there is no documentation that she was offered, nor tried and failed, conventional treatment options prior to the performance of POEM.

No, the 43499 - POEM for achalasia is not likely to be more beneficial.

Achalasia is a rare motility disorder of the esophagus characterized by the absence of peristalsis and a defective relaxation of the lower esophageal sphincter (LES) resulting in an impaired bolus transport and stasis of food in the esophagus [Boeckxstaens, 2005].  Because its exact etiology still is unknown, current treatment options of achalasia are directed only at relieving the functional obstruction at the level of the LES.  Three manometric subtypes are identified based on the residual esophageal wave pattern: type I, in which the esophageal body shows minimal contractility; type II, in which there is no peristalsis but intermittent periods of compartmentalized esophageal pressurization; and type III, in which there are spastic contractions in the distal esophagus (1).

Recommendations for treatment from the American College of Gastroenterology (ACG) for achalasia, include the following:  1) Initial treatment: either graded pneumatic dilation or laparoscopic surgical myotomy with a partial fundoplication; 2) PD and LHM should be performed in high-volume centers of excellence; 3) choice of initial therapy should be guided by patients' age, gender, preference, and local institutional expertise; 4) Botulinum toxin therapy is recommended in patients who are not good candidates for, or are unwilling or cannot undergo, more definitive therapy with PD or surgical myotomy, and 5) esophagectomy should be reserved for patients, who have failed PD and/or myotomy and who are good candidates for surgery.

ACG opines: "the efficacy of both PD and Heller myotomy decreases over time.  Repeat treatment will be required by a good proportion of patients after 5 years." (3)

POEM, as proposed for the patient, is not listed above by ACG as a recommended treatment option for her achalasia.  Although none of the standard-of-care specialty-society recommended treatment options listed above were tried with the patient, comparisons of the POEM procedure she did undergo have been reported in the medical literature.

In the patient's case, esophageal manometry established the diagnosis for the patient of Type II achalasia.  This type of achalasia has historically been shown to best benefit from pneumatic dilation.  However, the patient's available records do not support that prior to performance of POEM, more conventional treatments like dilation, Botox injection, Heller myotomy (HM) had been offered to, nor tried and failed by, the patient.  

POEM is achieving increasing popularity, and it can no longer be considered unproven for the patient's indication of Type II achalasia.  Nevertheless, although POEM is an attractive treatment option for some achalasia patients, the patient's available records do not unequivocally demonstrate in her case that it is medically appropriate with greater likelihood of benefit than available standard approaches.  As stated, provided documents do not support that dilation, Botox, Heller myotomy were tried and failed in the patient's case.  The provider's statement neither supports the medical appropriateness of POEM in this situation, nor its superiority in the patient's specific circumstance of Type II achalasia in lieu of non-invasive conventional treatment options that have proven benefit and are specialty-society recommended.  As such, the denial is upheld.