Medical Policy

Effective Date:04/01/2007 Title:Gastric Pacemaker
Revision Date:11/01/2020 Document:BI189:00
CPT Code(s):43647, 43648, 43881, 43882, 64561, 64581, 64585, 64590, 64595
Public Statement

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

Medical Statement

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

Limits

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

Reference
  1. 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.
  2. Horowitz M, Su YC, Rayner CK, Jones KL. Gastroparesis: prevalence, clinical significance and treatment. Can J Gastroenterol. 2001; 15(12):805-813.
  3. Rabine JC, Barnett JL. Management of the patient with gastroparesis. J Clin Gastroenterol. 2001; 32(1):11-18.
  4. Bortolotti M. The "electrical way" to cure gastroparesis. Am J Gastroenterol. 2002; 97(8):1874-1883.
  5. Abell TL, Van Cutsem E, Abrahamsson H, et al. Gastric electrical stimulation in intractable symptomatic gastroparesis. Digestion. 2002; 66(4):204-212.
  6. Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003; 125(2):421-428.
  7. Smith DS, Ferris CD. Current concepts in diabetic gastroparesis. Drugs. 2003; 63(13):1339-1358.
  8. Jones MP, Maganti K. A systematic review of surgical therapy for gastroparesis. Am J Gastroenterol. 2003; 98(10):2122-2129.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. Parkman HP, Hasler WL, Fisher RS. American Gastroenterological Association medical position statement: Diagnosis and treatment of gastroparesis. Gastroenterol. 2004; 127(5):1589-1591.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. 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

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.