Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Gastroparesis.
Treatment:  43999 - Gastric peroral endoscopic myotomy.

the insurer denied the 43999 - Gastric peroral endoscopic myotomy.  The denial is upheld. 

The patient is a female with h/o (history of) severe GERD (gastroesophageal reflux disease), s/p (status post) Nissen fundoplication.  Now, she now has been diagnosed with severe gastroparesis.  Her symptoms include persistent nausea, severe bloating, regurgitation of food after eating.  She can only eat a very small amount of food, mostly smoothies, and she is not able to tolerate solid foods.

The patient's gastric emptying study done revealed severe gastroparesis with 75% of the food retained at four hours.  She underwent EGD (esophagogastroduodenoscopy) with prepyloric injection with Botox, and she had no relief of her symptoms.  She also failed prokinetic agents, including Reglan, Erythromycin, and Domperidone. 

The GI (gastroenterology) attending would like to treat the patient's gastroparesis with G-POEM (gastric per oral endoscopic myotomy) for the treatment of gastroparesis.  However, he quotes literature, which states that gastroparesis is a heterogenous disorder, and not all patients with gastroparesis benefit from G-POEM.  Only a subgroup of patients with pyloric dysfunction benefit from this procedure, and, therefore, the patient should undergo impedance planimetry for assessing pyloric distensibility, and it could potentially be useful to identify subgroup of the patients for which endoscopic pyloric-directed therapy can be utilized.  Of note, on review of the records, results of an impedance planimetry were not included.

No, the health plan should not cover the proposed G-POEM for the treatment of severe gastroparesis in this patient.

Gastric peroral endoscopic myotomy (G-POEM) is a novel, minimally invasive, flexible endoscopic procedure that is emerging as a new treatment option for select patients with refractory gastroparesis.  Pyloric-directed therapies, such as surgical pyloroplasty and pyloric stenting, in open-label and retrospective reports were shown to improve symptoms of gastroparesis.  Thus, G-POEM emerged as an extension to these pyloric-directed therapies.  Early experience in the U.S. and Europe showed good clinical response rates.  Overall, the clinical response rate, as determined by symptomatic improvement, following G-POEM reached 73 to 86 percent after up to 12 months of follow-up (1-3).

Gastroparesis is a heterogeneous disorder, and not all patients with gastroparesis will have pyloric dysfunction.  Thus, not all patients will benefit from G-POEM.  Impedance planimetry should be performed to select the subgroup of patients with pyloric dysfunction who would potentially benefit from the endoscopic, pyloric myotomy (G-POEM).  No parameters currently identify target patients for G-POEM, and no factors reliably predict a patient's clinical response to G-POEM.  Currently, the ideal patient population and long-term outcomes are unclear, thus should not be performed in the clinical setting yet.  Furthermore, more robust data are needed on its long-term outcomes and safety, refining the procedural technique and demonstrating benefit from an economic perspective.

No, the requested health service(G-POEM) is not likely to be more beneficial than any standard treatment for the management of this condition.

With only 100 or so cases described in the medical literature and no consensus on outcomes, G-POEM is unarguably an experimental procedure with the potential to permanently alter gastric anatomy with unknown consequences.