Thursday, January 17, 2019

CPT 43647,43648, 43881, 43882, E0765 - laparoscopy gastric nerostimulaor

Coding Code Description CPT

43647 Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum
43648 Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum
43881 Implantation or replacement of gastric neurostimulator electrodes, antrum, open
43882 Revision or removal of gastric neurostimulator electrodes, antrum, open

HCPCS

E0765 FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting
L8680 Implantable neurostimulator electrode, each
L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension

Introduction
Gastroparesis is a condition in which the normal movement of food from the stomach to the small intestine is drastically slowed or has stopped. This can lead to nausea and vomiting.

Gastric electrical stimulation (GES) is a treatment that sends weak electrical signals to the nerves and smooth muscles in the lower stomach. This treatment helps decrease nausea and vomiting caused by gastroparesis. A small battery-powered device is surgically placed in the skin in the lower belly area. Wires are then placed in the area to be stimulated. This policy discusses when GES may be considered medically necessary. It has also been proposed as a treatment for obesity. The one published medical study that looked at using GES for obesity did not show it improved weight loss. GES for obesity is considered investigational (unproven) because more medical studies are needed.

 Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. Therest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Service Medical Necessity Gastric electrical stimulation

Gastric electrical stimulation may be considered medically necessary in the treatment of chronic, intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology when ALL of the following criteria are met:

* Significantly delayed gastric emptying as documented by standard scintigraphic imaging of solid food AND
* Patient is refractory or intolerant of prokinetic medications and antiemetic medications AND
* Patient’s nutritional status is sufficiently low that total parenteral nutrition is likely to become medically necessary Gastric electrical stimulation is investigational for the treatment of obesity and all other indications.

Documentation Requirements

The medical records submitted for review should document that medical necessity criteria are met. The record should include clinical documentation of ALL of the following:
* Member has chronic, intractable nausea and vomiting secondary to gastroparesis (inability to empty food) caused by diabetes or for an unknown reason
* Significantly delayed gastric emptying confirmed by standard scintigraphic imaging (gastric emptying scan) of solid food
* Member has not responded or is intolerant to the use of prokinetic (antireflux) and antiemetic (antinausea and vomiting) medications
* The need for parenteral nutrition is likely to become medically necessary because of member’s inadequate nutritional status.




Description

Gastric electrical stimulation (GES) is performed using an implantable device designed to treat chronic drug-refractory nausea and vomiting secondary to gastroparesis of diabetic, postsurgical or idiopathic etiology. The device may be referred to as a gastric pacemaker.

Background

Gastric electrical stimulation (GES, also referred to as gastric pacing) has been investigated primarily as a treatment for gastroparesis. Currently available devices consist of a pulse generator which can be programmed to provide electrical stimulation at different frequencies.

The pulse generator is connected to intramuscular stomach leads, which are implanted during laparoscopy or open laparotomy (see Regulatory Status section). Gastroparesis is a chronic disorder of gastric motility characterized by delayed emptying of a solid meal from the stomach. Symptoms include bloating, distension, nausea, and vomiting.

When severe and chronic, gastroparesis can be associated with dehydration, poor nutritional status, and poor glycemic control in diabetics. While most commonly associated with diabetes, gastroparesis is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson disease, and psychological pathologic conditions. Some cases may not be associated with an identifiable cause, and are referred to as idiopathic gastroparesis. Treatment of gastroparesis includes prokinetic agents such as cisapride and metoclopramide, and antiemetic agents such as metoclopramide, granisetron, or ondansetron. Severe cases may require enteral or total parenteral nutrition. GES has also been investigated as a treatment of obesity. It is used to increase a feeling of satiety with subsequent reduction in food intake and weight loss. The exact mechanisms resulting in changes in eating behavior are uncertain but may be related to neurohormonal modulation and/or stomach muscle stimulation.

Summary of Evidence

For individuals who have gastroparesis who receive gastric electrical stimulation (GES), the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms and treatment-related morbidity. Five crossover RCTs have been published. A 2017 meta-analysis of these 5 RCTs did not find a significant benefit of GES on the severity of symptoms associated with gastroparesis. Patients generally reported improved symptoms at follow-up whether or not the device was turned on, suggesting a placebo effect. The evidence is insufficient to determine the effects of the technology on health outcomes.

A Hayes Medical Technology Directory report analyzed the evidence (n=10 studies) for GES for the treatment of gastroparesis. The report evaluated controlled studies (n=7studies/18-241 patients) and uncontrolled studies (n=3 studies/131-233 patients). The controlled trials included RCTs (n=3 studies), prospective (n=2), and retrospective studies (n=2). Patients were selected who had symptomatic gastroparesis refractory to medical treatment with diagnoses of diabetic gastric neuropathy or idiopathic gastroparesis. Exclusion criteria included the structural cause of symptoms, psychogenic vomiting, chemical dependency, previous gastric surgery, and pregnancy. Outcomes measured were gastroparesis symptom severity and gastric retention assessed by scintigraphy. Additional outcomes included the need for nutritional support, and changes in antiemetic and/or prokinetic medications. Follow-up timeframe varied among studies, the longest follow-up being four years. The report found poor to fair quality evidence indicating that GES may improve gastroparesis symptoms and gastric emptying as well as decrease the need for nutritional support in some patients with refractory gastroparesis. Overall, GES was found to be safe with the device removal rate ranging from 7%-12% in most studies, primarily due to lack of symptom improvement. It was noted that despite the low quality of the supportive evidence, GES may be an option for patients with debilitating gastroparesis that is refractory to medical treatment (Hayes, 2016 update).

Overall, the evidence for gastric electrical stimulation is not very strong. However, this Premera policy requires that the patient has tried and failed other treatments and that their nutritional status is so depleted that total parenteral nutrition (TPN) may soon become medically necessary. TPN is invasive and not without its own risks. Therefore, even though the evidence for gastric electrical stimulation is not strong and the Enterra Therapy System had only been approved by the FDA under a Humanitarian Device Exemption (HDE), GES may be helpful and allow the patient to avoid the risks associated with receiving ongoing TPN.

For individuals who have obesity who receive GES, the evidence includes 1 published RCT. Relevant outcomes are change in disease status and treatment-related morbidity. The SHAPE trial did not show significant improvement in weight loss with GES compared to sham stimulation. The evidence is insufficient to determine the effects of the technology on health outcomes.

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