Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Gastroparesis.
Treatment:  Surgery (gastro peroral endoscopy myotomy-GPOEM).

The insurer denied the Surgery (gastro peroral endoscopy myotomy-GPOEM).  The denial is upheld. 

The patient is a female with insulin-requiring diabetes, diarrhea-predominant irritable bowel syndrome (IBS), bronchitis/asthma, thyroid nodule, morbid obesity (body mass index [BMI] 39.3, at 215 pounds and 62 inches) with fatty liver and elevated liver function tests (LFTs), pancreatitis (status post [S/P] endoscopic retrograde cholangiopancreatography [ERCP]), post-traumatic stress disorder (PTSD)/anxiety, status post (S/P) breast reduction two times, ganglion cyst removals two times, cesarean (C)-section two times, appendectomy, cholecystectomy, hysterectomy and left salpingo-oophorectomy, laparoscopic adhesiolysis, and former tobacco smoker.

The physician appeal letter as provided notes that the patient "has been suffering with symptoms of gastroparesis.  She has been hospitalized many times and has required feeding tubes in the past to maintain nutrition.  She has exhausted all her medical options.  She has responded to Botox in the past."  Charting reports state "severe diabetic gastroparesis symptomatic with weekly nausea/vomiting.  Gastric emptying study [report not provided] showed severely delayed gastric emptying.  Botox injection performed improved patient symptoms significantly."  

However, inconsistent with the above provider statement of failed medical therapy,
charting by a nurse practitioner (NP) notes "improvement with gabapentin for her
abdominal pain and colestipol for diarrhea; reflux controlled with omeprazole 40mg
daily; she does use dicyclomine as needed with some relief."  The note also
revealed that no biopsies were obtained at the time of the
esophagogastroduodenoscopy (EGD).  Neither notes documented any tenderness
or abnormalities at the time of independent abdominal examinations.

No, the proposed treatment with gastric per-oral endoscopic myotomy (43999) is
not medically necessary.

Gastroparesis is a chronic disorder with an incompletely understood complex
pathophysiology; treatment options are limited.  Only metoclopramide is Food and
Drug Administration (FDA)-indicated for this condition.  Peroral endoscopic myotomy (POEM) has been adapted to performance in the stomach (termed gastric or G-POEM) for the treatment of severe medically refractory gastroparesis, such that endoscopic pyloromyotomy (G-POEM) procedure myotomizes the pylorus.  For gastro peroral edoscopy myotomy-GPOEM (G-POEM), a submucosal tunnel is typically created five centimeters (cm) proximal to the pylorus along the greater curvature or anterior gastric wall.  A two centimeter (cm) antral myotomy is then performed in addition to pyloromyotomy via the submucosal tunnel.

Several case reports show that gastric per-oral endoscopic myotomy (G-POEM) in
some cases offers benefit in management of severe refractory gastroparesis.  Limited data has demonstrated normalization in 47-70% of gastric emptying rates, and reduction in nausea and vomiting (but not bloating) in up to 86% of patients.  In
Malik's recent series, 33% of patients experienced no benefit or worsening of gastric emptying.  Durability of response is uncertain, and longer duration of disease has been associated with lower one-year outcomes.  Recorded complications, from 6.7-14.3%, include: pyloric channel and prepyloric ulceration, pneumoperitoneum.  Mohan's meta-analysis is the largest comparative series of three hundred and thirty-two, and 375 patients underwent gastric per-oral endoscopic myotomy (GPOEM) (11 studies) and surgical pyloroplasty (seven studies), respectively.  The pooled rate of clinical success, based on the Gastroparesis Cardinal Symptom Index (GCSI) score, with G-POEM was 75.8% and with surgical pyloroplasty was 77.3%, with no significance.  The pooled rate of clinical success, based on the four-hour gastric emptying scintigraphy (GES) results, with G-POEM was 85.1% and with surgical pyloroplasty was 84%.  The overall adverse events were comparable.  Based on meta-regression analysis, idiopathic gastroparesis, prior treatment with botulinum toxin and gastric stimulator seemed to predict clinical success with gastric per-oral endoscopic myotomy (G-POEM).

However, all cited authors agree that gastric per-oral endoscopic myotomy (GPOEM)
is still a novel technique that while promising is not standard-of-care.  Further, no objective data was presented with the patient's records that demonstrate significant gastroparesis, improvement in gastric emptying rates pre- versus post-Botox, nor does available documentation support that her symptoms are medically-refractory.  Of further concern unique to the patient's case is that she is high risk for endoscopic sedation.  Gastro peroral edoscopy myotomy (G-POEM) may not at this time represent her best or safest option.