Effective Date: 04/01/2007
Title: Gastric Pacemaker
Revision Date: 11/01/2020
CPT Code(s): 43647, 43648, 43881, 43882, 64561, 64581, 64585, 64590, 64595
will apply to all services performed on or after the above Revision date which
will become the new effective date.
services referred to in this policy that were performed before the revision
date, contact customer service for the rules that would apply.
nerve neuromodulation for fecal incontinence require
pacemakers are used to treat gastroparesis that has not responded to medical
neuromodulation for fecal incontinence
“Gastric Pacemaker” means a medical device that:
Uses an external
programmer and implanted electrical leads to the stomach; and
high energy electrical stimulation to the stomach to entrain and pace the
gastric slow waves to treat gastroparesis.
Gastric Pacemakers will
only be used in medical centers in which an institutional review board has
approved use of the device.
If a battery of the
neurostimulator runs down, the physician will obtain prior written authorization
and approval for a replacement surgery.
Gastric pacing is covered
for gastroparesis (K31.84) when:
The nausea and vomiting
is debilitating and interfering with activities of daily living
An adequate trial (at
least 3 months) of medication has failed to control the nausea and vomiting.
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:
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
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
Patient is not a good
candidate for or has failed sphincteroplasty
A successful percutaneous
test stimulation, defined as at least 50% improvement in symptoms, was
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
Incontinence is not
related to another neurologic condition such as peripheral neuropathy or
complete spinal cord injury.
Used In This BI:
Laparoscopy surgical; implantation of gastric stimulator electrodes
Laparoscopy revision or removal of gastric stim electrodes
Implantation of gastric neurostimulator electrodes, open
Revision or removal of gastric neurostimulator electrodes, open
Percutaneous implantation neuromuscular electrodes; sacral nerve
Incision for implantation of neurostimulator electrode array; sacral
nerve (transforaminal placement)
64585 Revision or removal of
peripheral neurostimulator electrode array
Insertion or replacement of peripheral or gastric stimulator
Revision or removal of peripheral or gastric stimulator
pacing is not covered for:
treatment of gastroparesis.
removal of gastric pacers will only be covered if the original placement was
covered or if the original placement met criteria for coverage.
codes are not covered (43659, 43999) since specific codes are available
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 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.
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.”
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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al. Gastric pacing is a new surgical treatment for gastroparesis. Am J
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Rabine JC, Barnett JL. Management of the
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Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.