Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Gastric Pacemakers and Sacral nerve neuromodulation for fecal incontinence require pre-authorization.

2)    Gastric pacemakers are used to treat gastroparesis that has not responded to medical treatment.

3)    Sacral nerve neuromodulation for fecal incontinence

Gastric Pacemakers:

1) “Gastric Pacemaker” means a medical device that:

a)    Uses an external programmer and implanted electrical leads to the stomach; and

b)    Transmits low-frequency, high energy electrical stimulation to the stomach to entrain and pace the gastric slow waves to treat gastroparesis.

1)    Gastric Pacemakers will only be used in medical centers in which an institutional review board has approved use of the device.

2)    If a battery of the neurostimulator runs down, the physician will obtain prior written authorization and approval for a replacement surgery.

3)    Gastric pacing is covered for gastroparesis (K31.84) when:

a)    The nausea and vomiting is debilitating and interfering with activities of daily living and;

b)    An adequate trial (at least 3 months) of medication has failed to control the nausea and vomiting.

Sacral nerve neuromodulation for fecal incontinence:

Sacral nerve neuromodulation requires prior authorization criteria that there be scientific evidence of effectiveness for the treatment of fecal incontinence when all of the following criteria are met:

1)    Chronic fecal incontinence of greater than 2 incontinent episodes on average per week with duration greater than 6 months or for more than 12 months after vaginal childbirth; AND

2)    Documented failure or intolerance to conventional conservative therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment for at least 6 months and/or surgical corrective therapy performed more than 12 months [or 24 months in case of cancer] previously); AND

3)    Patient is not a good candidate for or has failed  sphincteroplasty AND

4)    A successful percutaneous test stimulation, defined as at least 50% improvement in symptoms, was performed; AND

5)    Condition is not related to an anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) or chronic inflammatory bowel disease; AND

6)    Incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.

Codes Used In This BI:

43647             Laparoscopy surgical; implantation of gastric stimulator electrodes

43648             Laparoscopy revision or removal of gastric stim electrodes

43881             Implantation of gastric neurostimulator electrodes, open

43882             Revision or removal of gastric neurostimulator electrodes, open

64561             Percutaneous implantation neuromuscular electrodes; sacral nerve

64581             Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)

64585           Revision or removal of peripheral neurostimulator electrode array

64590             Insertion or replacement of peripheral or gastric stimulator

64595             Revision or removal of peripheral or gastric stimulator

1)    Gastric pacing is not covered for:

a)     Treatment of obesity.

b)    Treatment of diabetes

c)     Initial treatment of gastroparesis.

2)    Revision or removal of gastric pacers will only be covered if the original placement was covered or if the original placement met criteria for coverage.

3)    Nonspecific codes are not covered (43659, 43999) since specific codes are available

Gastroparesis

Gastroparesis is a chronic gastric motility disorder of diabetic (both type 1 and type 2 diabetes) or idiopathic etiology.  It is characterized by delayed gastric emptying of solid meals.  Patients with gastroparesis exhibit bloating, distension, nausea, and/or vomiting.  In severe and chronic cases, patients may suffer dehydration, poor nutritional status, and poor glycemic control (in diabetics).  Although gastroparesis is often associated with diabetes, it is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson disease, and psychological pathology.  Therapeutic options of gastroparesis include prokinetic agents such as metoclopramide, and anti-emetic agents such as metoclopramide, granisetron, or ondansetron.  Patients with severe gastroparesis may require enteral or total parenteral nutrition.

Gastric pacing (gastric pacemaker) entails the use of a set of pacing wires attached to the stomach and an external electrical device that provides a low-frequency, high-energy stimulation to entrain the stomach at a rhythm of 3 cycles per minute.  However, the gastric pacemaker is cumbersome and problematic for chronic use because of external leads. 

Thus, a newer, implantable device (the Enterra Therapy System by Medtronic, Minneapolis, MN) was developed to provide gastric electrical stimulation.  Unlike gastric pacing, the Enterra delivers a high-frequency (12 cycles per minute), low-energy stimulation to the stomach.  This stimulating frequency does not entrain the stomach, and therefore does not normalize gastric dysrhythmias; hence, the term gastric electrical stimulation is employed to differentiate between the Enterra and gastric pacing.

The Enterra System was designed to treat intractable nausea and vomiting secondary to gastroparesis.   Electrodes are implanted in the serosa of the stomach laparoscopically or during a laparotomy, and are connected to the pulse generator that is implanted in a subcutaneous pocket.  The Enterra Therapy System (Medtronic, Minneapolis, MN) is currently the only gastric electrical stimulator that has received approval from the U.S. Food and Drug Administration (FDA).  It was cleared by the FDA as a humanitarian use device.  Thus, the manufacturer was not required to submit the level of evidence that would be required to support a pre-market approval application.  The data presented to the FDA documenting the "probable benefit" of gastric electrical stimulation (Gastric Electrical Stimulation System) were based on a multi-center double-blind cross-over study (FDA, 2000), which included 33 patients with intractable idiopathic or diabetic gastroparesis.  In the initial phase of the study, all patients underwent implantation of the stimulator and were randomly assigned to stimulation-ON or stimulation-OFF for the first month, with cross-over to OFF and ON during the second month.  The baseline vomiting frequency was 47 episodes per month, which significantly declined in both ON and OFF groups to 23 to 29 episodes, respectively.  However, there were no significant differences in the number of vomiting episodes between the two groups, suggesting a placebo effect.  Thus, long-term results of gastric electrical stimulation must be validated in longer term randomized studies.  It is important to note that gastric electrical stimulation did not return gastric emptying to normal in the majority of the treated-patients. 

There exist preliminary data that suggested gastric pacing may be beneficial to patients with refractory gastroparesis.  Forster et al (2001) reported the findings of 25 patients who underwent gastric pacemaker placement.  Both the severity and frequency of nausea and vomiting improved significantly at 3 months and improvements were sustained for 12 months.  Gastric emptying time was also numerically faster over the 12-month period.  Three of the devices were removed and 1 patient died of causes unrelated to the pacemaker 10 months postoperatively.  The authors stated that after placement of the gastric pacemaker, patients rated significantly fewer symptoms and had a modest acceleration of gastric emptying.

Obesity is a major health problem among adults in the United States.  It is also an increasing health concern among American children as well as adolescents.  Various methods are employed in the management of obesity.  One of the new approaches is gastric pacing, which is intended to induce early satiety through electrical stimulation of the gastric wall.  However, the effectiveness of this technique in treating obesity has not been established.  Buchwald and Buchwald (2002) considered gastric pacing as an experimental procedure for the management of morbid obesity.

An assessment of gastric pacing for obesity by the Swedish Council on Technology Assessment in Healthcare (SBU, 2004) found that "[t]here is insufficient scientific evidence on the short-term patient benefit of gastric pacing" for obesity, and that "[t]here is no scientific evidence on the long-term patient benefit of gastric pacing" for this indication.  The assessment concluded:

“Gastric pacing is still an experimental method and should be used only in scientific studies that have been approved by a research ethics committee.  Trials that include adequate control groups are very much needed.”

Fecal Incontinence

Per UpToDate, initial medical interventions should try to improve stool consistency and reduce stool frequency.  This can include the use of bulking agents and antidiarrheals.  If initial management fails, diagnostic testing (such as anorectal manometry and endorectal ultrasound) should be considered to identify functional or structural/anatomic problems.  Depending on the diagnostic workup, biofeedback may be an option. 

If medical therapies have failed, sphincteroplasty may be an option.  When medical therapies and sphincteroplasty have failed (or are contraindicated) sacral nerve stimulation can be considered.

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