Effective Date:04/01/2007 |
Title:Gastric Pacemaker
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Revision Date:11/01/2020
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Document:BI189:00
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CPT Code(s):43647, 43648, 43881, 43882, 64561, 64581, 64585, 64590, 64595
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Public Statement
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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
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Medical Statement
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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
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Limits
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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
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Reference
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-
Forster J, Sarosiek I, Delcore R, et
al. Gastric pacing is a new surgical treatment for gastroparesis. Am J
Surg. 2001; 182(6):676-681.
-
Horowitz M, Su YC, Rayner CK, Jones
KL. Gastroparesis: prevalence, clinical significance and treatment. Can J
Gastroenterol. 2001; 15(12):805-813.
-
Rabine JC, Barnett JL. Management of the
patient with gastroparesis. J Clin Gastroenterol. 2001; 32(1):11-18.
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Bortolotti M. The "electrical way" to cure
gastroparesis. Am J Gastroenterol. 2002; 97(8):1874-1883.
-
Abell TL, Van Cutsem E, Abrahamsson H, et
al. Gastric electrical stimulation in intractable symptomatic
gastroparesis. Digestion. 2002; 66(4):204-212.
-
Abell T, McCallum R, Hocking M, et
al. Gastric electrical stimulation for medically refractory
gastroparesis. Gastroenterology. 2003; 125(2):421-428.
-
Smith DS, Ferris CD. Current concepts in
diabetic gastroparesis. Drugs. 2003; 63(13):1339-1358.
-
Jones MP, Maganti K. A systematic review of
surgical therapy for gastroparesis. Am J Gastroenterol. 2003;
98(10):2122-2129.
-
Forster J, Sarosiek I, Lin Z, et al. Further
experience with gastric stimulation to treat drug refractory gastroparesis.
Am J Surg. 2003; 186(6):690-695.
-
Lin Z, Forster J, Sarosiek I, McCallum RW.
Treatment of diabetic gastroparesis by high-frequency gastric electrical
stimulation. Diabetes Care. 2004; 27(5):1071-1076.
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Lin Z, Forster J, Sarosiek I, McCallum RW.
Effect of high-frequency gastric electrical stimulation on gastric
myoelectric activity in gastroparetic patients. Neurogastroenterol Motil.
2004; 16(2):205-212.
-
National Institute for Clinical Excellence
(NICE). Gastroelectrical stimulation for gastroparesis. Interventional
Procedure Guidance 103. London, UK: NICE; December 15, 2004. Available at:
http://www.nice.org.uk/page.aspx?o=82715. Accessed April 22, 2011.
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Parkman HP, Hasler WL, Fisher RS. American
Gastroenterological Association medical position statement: Diagnosis and
treatment of gastroparesis. Gastroenterol. 2004; 127(5):1589-1591.
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Lin Z, Forster J, Sarosiek I, McCallum RW. Et
al. Treatment of diabetic gastroparesis by high-frequency gastric electrical
stimulation. Diabetes Care. 2004; 27(5):1071-1076.
-
McCallum R, Lin Z, Wetzel P, et al. Clinical
response to gastric electrical stimulation in patients with postsurgical
gastroparesis. Clin Gastroenterol Hepatol. 2005; 3(1):49-54.
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Van der Voort IR, Becker JC, Dietl KH, et al.
Gastric electrical stimulation results in improved metabolic control in
diabetic patients suffering from gastroparesis. Exp Clin Endocrinol
Diabetes. 2005; 113(1):38-42.
-
Cutts TF, Luo J, Starkebaum W, Is gastric
electrical stimulation superior to standard pharmacologic therapy in
improving GI symptoms, healthcare resources, and long-term health care
benefits? Neurogastroenterol Motil. 2005; 17(1):35-43.
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Lin Z, McElhinney C, Sarosiek I, et al.
Chronic gastric electrical stimulation for gastroparesis reduces the use of
prokinetic and/or antiemetic medications and the need for hospitalizations.
Dig Dis Sci. 2005; 50(7):1328-1334.
-
Oubre B, Luo J, Al-Juburi A, et al. Pilot
study on gastric electrical stimulation on surgery-associated gastroparesis:
Long-term outcome. South Med J. 2005; 98(7):693-697.
-
Gourcerol G, Leblanc I, Leroi AM, et al.
Gastric electrical stimulation in medically refractory nausea and vomiting.
Eur J Gastroenterol Hepatol. 2007; 19(1):29-35.
-
Filichia LA, Cendan JC. Small case series of
gastric stimulation for the management of transplant-induced gastroparesis.
J Surg Res. 2008; 148(1):90-93.
-
McKenna D, Beverstein G, Reichelderfer M, et
al. Gastric electrical stimulation is an effective and safe treatment for
medically refractory gastroparesis. Surgery. 2008; 144(4):566-572;
discussion 572-574.
-
Soffer E, Abell T, Lin Z, et al. Review
article: Gastric electrical stimulation for gastroparesis -- physiological
foundations, technical aspects and clinical implications. Aliment Pharmacol
Ther. 2009; 30(7):681-694.
24.
O`Grady G, Egbuji JU, Du
P, et al. High-frequency gastric electrical stimulation for the treatment of
gastroparesis: A meta-analysis. World J Surg. 2009; 33(8):1693-1701.
25.
Altomare DF,
Giuratrabocchetta S, Knowles CH, et al. (2015) Long-term outcomes of sacral
nerve stimulation for fecal incontinence. Br J Surg. Mar 2015; 102(4):407-415.
PMID 25644687.
26.
George AT,
Kalmar K, Panarese A et al. (2012) Long-term outcomes of sacral nerve
stimulation for fecal incontinence. Dis Colon Rectum 2012; 55(3):302-6.
27.
Leroi AM,
Parc Y, Lehur PA et al. (2005) Efficacy of sacral nerve stimulation for fecal
incontinence: results of a multicenter double-blind crossover study. Ann Surg
2005; 242(5):662-9.
28.
Markland AD, Burgio KL, Whitehead WE, et al. Loperamide
Versus Psyllium Fiber for Treatment of Fecal Incontinence: The Fecal
Incontinence Prescription (Rx) Management (FIRM) Randomized Clinical Trial. Dis
Colon Rectum 2015; 58:983.
29.
Fecal
Incontinence Management in Adults. UpToDate (accessed 4/18/2018)
https://www.uptodate.com/contents/fecal-incontinence-in-adults-management
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Application to Products
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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.
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Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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