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A.2.01.91
Esophageal achalasia is characterized by reduced numbers of neurons in the esophageal myenteric plexuses and reduced peristaltic activity, making it difficult for patients to swallow food and possibly leading to complications such as regurgitation, coughing, choking, aspiration pneumonia, esophagitis, ulceration, and weight loss. Peroral endoscopic myotomy is a novel endoscopic procedure that uses the oral cavity as a natural orifice entry point to perform myotomy of the lower esophageal sphincter. This procedure is intended to reduce the total number of incisions needed and thus the overall invasiveness of surgery. Gastric peroral endoscopic myotomy (G-POEM) is a similar procedure with the exception that it myotomizes the pylorus rather than the lower esophageal sphincter. Achalasia is estimated to affect 18 out of every 100,000 individuals in the U.S., and the incidence of 10.5 per 100,000 person-years, with increased rates reported with more advanced age.
Treatment
Treatment options for achalasia have included pharmacotherapy (eg, injections with botulinum toxin), pneumatic dilation, and laparoscopic Heller myotomy. Although the latter two are considered the standard treatments because of higher success rates and relatively long-term efficacy compared with pharmacotherapy, both are associated with a perforation risk of about 1%. Heller myotomy is the most invasive of the procedures, requiring laparoscopy and surgical dissection of the esophagogastric junction. One-year response rates of 86% and major mucosal tear rates requiring subsequent intervention of 0.6% have been reported.
Peroral endoscopic myotomy is a novel endoscopic procedure developed in Japan. This procedure is performed with the patient under general anesthesia. After tunneling an endoscope down the esophagus toward the esophageal-gastric junction, a surgeon performs the myotomy by cutting only the inner, circular lower esophageal sphincter muscles through a submucosal tunnel created in the proximal esophageal mucosa. Peroral endoscopic myotomy differs from laparoscopic surgery, which involves the complete division of both circular and longitudinal lower esophageal sphincter muscle layers. Cutting the dysfunctional muscle fibers that prevent the lower esophageal sphincter from opening allows food to enter the stomach more easily.
Gastroparesis
Gastroparesis is characterized by symptoms of nausea, vomiting, bloating, early satiety, and pain, which is caused by delayed gastric emptying without mechanical obstruction. The estimated U.S. prevalence of difficult to ascertain due to the weak correlation of symptoms with gastric emptying which results in a high rate of underdiagnosis. A systematic review of the literature determined that the prevalence of confirmed gastroparesis, characterized by symptoms and delayed gastric emptying, varies widely in the general population, with estimates ranging from 14 to 268 cases per 100,000 adults. Furthermore, the incidence of this condition spans from 1.9 to 6.3 per 100,000 person-years.
Treatment
Treatment options for gastroparesis have included dietary modification (smaller meal sizes, avoidance of carbonated beverages, smoking or high doses of alcohol, and in some cases enteral nutrition via jejunostomy), optimization of hydration and glycemic control, pharmacotherapy (eg, antiemetics or Metoclopramide, or off-label medications for symptom control such as domperidone, erythromycin, tegaserod or centrally acting antidepressants), gastric electrical stimulation, venting gastrostomy, feeding jejunostomy, intra-pyloric botulinum injection, partial gastrectomy, and pyloroplasty. Gastric peroral endoscopic myotomy (G-POEM), which endoscopically performs the equivalent of pyloroplasty, is being investigated for the treatment of gastroparesis. G-POEM myotomizes the pylorus rather than the circular lower esophageal sphincter but otherwise consists of the same techniques described above.
Peroral endoscopic myotomy uses available laparoscopic instrumentation and, as a surgical procedure, is not subject to regulation by the U.S. Food and Drug Administration (FDA).
Peroral endoscopic myotomy is considered investigational as a treatment for pediatric and adult esophageal achalasia.
Gastric peroral endoscopic myotomy is considered investigational as a treatment for gastroparesis.
None
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
04/01/2014: Approved by Medical Policy Advisory Committee.
11/11/2014: Policy reviewed; description updated regarding response rates. Policy statement unchanged.
08/04/2015: Code Reference section updated for ICD-10.
06/01/2016: Policy number A.2.01.91 added. Investigative definition updated in Policy Guidelines section.
12/02/2016: Policy description updated. Policy statement unchanged.
01/05/2018: Policy reviewed; no changes.
01/04/2019: Policy description updated regarding treatment. Policy statement unchanged.
12/10/2019: Policy description updated regarding treatment. Policy statement revised to specify treatment for "pediatric and adult" esophageal achalasia as investigational. It previously stated: Peroral endoscopic myotomy is considered investigational as a treatment for esophageal achalasia.
01/13/2021: Policy reviewed; no changes.
12/13/2021: Code Reference section updated to add new CPT code 43497, effective 01/01/2022.
01/26/2022: Policy reviewed; no changes.
12/15/2022: Policy description updated. Policy statement unchanged.
03/15/2024: Policy title updated to add "Gastroparesis." Policy description updated regarding gastric peroral endoscopic myotomy and gastroparesis. Policy section updated to add that gastric peroral endoscopic myotomy is considered investigational as a treatment for gastroparesis. Code Reference section revised to update the description for CPT code 43499.
01/29/2025: Policy description updated regarding new data for achalasia and gastroparesis. Policy statements unchanged.
Blue Cross and Blue Shield Association Policy # 2.01.91
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description |
CPT-4 | |
43497 | Lower esophageal myotomy, transoral (ie, peroral endoscopic myotomy [POEM]) |
43499 | Unlisted procedure, esophagus (use for G-POEM: no specific code) |
HCPCS | |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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