MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Gastric Electrical Stimulation

Number 7.01.522

Effective Date October 14, 2013

Revision Date(s) 10/14/13; 08/14/12; 09/13/11; 11/09/10; 09/15/09; 01/08/08; 01/09/07; 01/10/06; 01/11/05; 06/08/04

Replaces 7.01.73

Policy

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.
  • Patient is refractory or intolerant of prokinetic medications and antiemetic medications.
  • Patient’s nutritional status is sufficiently low that total parenteral nutrition is likely to become medically necessary.

Gastric electrical stimulation is investigational for obesity and all other indications.

Related Policies

1.01.507

Electrical Stimulation Devices

8.03.01

Functional Neuromuscular Electrical Stimulation

Policy Guidelines

There are CPT codes that are specific to insertion of the gastric stimulation device:

43647 Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum

43648 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

64590 Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct, or inductive coupling

64595 Revision or removal of peripheral or gastric neurostimulator pulse generator:

There are also specific codes for electronic analysis and programming of gastric neurostimulator pulse generator:

95980 Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements), gastric neurostimulator pulse generator/transmitter; intraoperative, with programming.

95981 Subsequent, without reprogramming.

95982 Subsequent, with reprogramming.

Prior to 2012, when the procedure was performed in the treatment of obesity, there were specific category III CPT codes:

0155T Laparoscopy, surgical; implantation or replacement of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity)

0156T Revision or removal of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity)

0157T Laparotomy, implantation or replacement of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity)

0158T Laparotomy, revision or removal of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity)

The CPT code book instructs that after January 1, 2012, laparoscopic procedures related to gastric stimulation electrodes for morbid obesity should be reported using code 43659 (unlisted laparoscopy procedure, stomach), and laparotomy procedures related to gastric stimulation electrodes for morbid obesity should be reported using 43999 (unlisted procedure, stomach).

The insertion of the gastric neurostimulator pulse generator is coded with 64590 and revision or removal of the pulse generator is coded with 64595, regardless of the indication.

The following HCPCS codes may be used:

L8680 Implantable neurostimulator electrode, each (implant requires 2 leads)

L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

L8686 Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension

L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

L8688 Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

Description

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

Background

Currently, only one gastric electrical stimulator has received approval from the US Food and Drug Administration (FDA) (see note below), the Gastric Electrical Stimulator (GES) system (now called Enterra™ Therapy System), manufactured by Medtronic. The GES system consists of four components: the implanted pulse generator, two unipolar intramuscular stomach leads, the stimulator programmer, and the memory cartridge. With the exception of the intramuscular leads, all other components have been used in other implantable neurological stimulators, such as spinal cord or sacral nerve stimulation. The intramuscular stomach leads are implanted either laparoscopically or during a laparotomy and are connected to the pulse generator that is implanted in a subcutaneous pocket. The programmer sets the stimulation parameters, which are typically set at an ON time of 0.1 sec alternating with an OFF time of 5.0 sec.

Gastroparesis is a chronic disorder of gastric motility characterized by delayed emptying of a solid meal. 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. 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.

Gastric electrical stimulation has also been investigated as a treatment of obesity as a technique to increase a feeling of satiety with subsequent reduced food intake and weight loss. The exact mechanisms resulting in changes in eating behavior are uncertain but may be related to neuro-hormonal modulation and/or stomach muscle stimulation. There are no gastric electrical stimulation devices approved by the FDA for the treatment of obesity. The Transcend® Implantable Gastric Stimulation device, manufactured by Transneuronix, Corporation and acquired by Medtronic in 2005, is currently available in Europe for treatment of obesity. Medtronic announced in December 2005 that the preliminary results of the Screened Health Assessment and Pacer Evaluation, or SHAPE trial, which was initiated by Transneuronix using the Transcend device, “did not meet the efficacy endpoint of a difference in mean excess weight loss at one year.”

Note: It should be noted that the Enterra System received FDA approval through a "humanitarian device exemption. “This - regulatory category was established in 1996 and only applies to devices intended to benefit less than 4,000 patients. The approval process is similar to that of a pre-market approval application (PMA), but is exempt from the effectiveness requirements of a PMA. Thus the application is not required to provide results of scientifically valid clinical investigations, but must contain sufficient information for the FDA to determine that the device does not pose unreasonable or significant risk of illness or injury. A humanitarian use device may only be used in facilities that have an Institutional Review Board (IRB) to supervise clinical testing of the device.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.

Benefit Application

N/A

Rationale

Rationale

This policy was original created in 2004 and has been regularly updated with searches of the MEDLINE database. The most recent literature search was performed through August, 2013.

Gastroparesis (Idiopathic or Diabetic)

The evidence on gastric electrical stimulation (GES) for gastroparesis consists of 2 small randomized crossover trials, and numerous case series. The case series include several that report on medium and/or long-term use (greater than 1 year of follow-up) of the device.

In a 2012 systematic review and meta-analysis, Chu and colleagues (1) evaluated 10 studies on GES for the treatment of gastroparesis. Included in the meta-analysis were 2 randomized controlled trials (RCT) by Abell (2) and McCallum (3), both et al. and 8 observational studies, totaling 601 patients who received GES for more than 1 month. The treatment arms of the RCTs were combined with the single-arm case series to give summary estimates of treatment effect. This review did not attempt to evaluate the RCTs separately from the case series and, therefore, did not attempt to evaluate the RCTs separately from the case series and, therefore, did not attempt to make conclusions on the efficacy of GES compared to a control group.

The meta-analysis found gastric electrical stimulation significantly improved scores for total symptom severity, nausea severity, and vomiting severity. Gastric emptying times at 2 and 4 hours also significantly improved. In the sub-analysis of 197 patients with diabetic gastroparesis, total symptom severity scores and gastric emptying at 2 and 4 hours significantly improved. In the sub-analysis of 65 patients with idiopathic gastroparesis, total symptom severity scores and gastric emptying at 4 hours significantly improved but not at 2 hours. In the sub-analysis of 40 patients with post-surgical gastroparesis, total symptom severity scores and gastric emptying at 2 hours significantly improved but not at 4 hours. A sub-analysis of nausea and vomiting severity scores was not presented. Infection (3.87%) was the most common complication followed by device migration (2.69%) and pain at the site of implant (0.67%). Other infrequent complications (1.18%) included peptic ulcer disease, electrode penetration of the stomach lumen, erosion of the skin after abdominal wall trauma, and implant wire-related small bowel obstruction. While this meta-analysis found GES provided significant benefit in gastroparesis treatment, interpretation of results must be made with caution, since the majority of studies analyzed were low-quality observational studies. Only 2 studies had control groups, and the control groups of these RCTs were not included in the combined analysis.

Randomized, Controlled Trials

The data presented to the U.S. Food and Drug Administration (FDA) documenting the “probable benefit” of the GES system was based on a multicenter, double-blinded crossover study, the Worldwide Anti-Vomiting Electrical Stimulation Study (WAVESS). (4) The study included 33 patients with intractable idiopathic or diabetic gastroparesis. The primary endpoint of the study was a reduction in vomiting frequency, as measured by patient diaries. In the initial phase of the study, all patients underwent implantation of the stimulator and were randomly and blindly assigned to stimulation on or stimulation off for the first month, with crossover 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, no significant differences were found in the number of vomiting episodes between the 2 groups, suggesting a placebo effect.

The final results of the WAVESS study were reported in 2003, which allows further review of the data. (2) When looking individually at those with idiopathic gastroparesis, there was a similar drop in vomiting frequency compared to baseline regardless of whether the device was turned on or off, suggesting a placebo effect. In contrast, in those with diabetic gastroparesis, compared to baseline, there was a small drop in vomiting frequency with the device turned off, compared to a larger drop in vomiting frequency with the device turned on. In the second open-label phase of the trial, all patients had their stimulators turned on for the remainder of the 6 to 12 months’ follow-up. During this period, the vomiting frequency declined in both the idiopathic and diabetic subgroups. The cause of this continuing decline is uncertain, related to either a placebo effect or some sort of long-term effect of gastric stimulation.

McCallum and colleagues performed a multicenter prospective study to evaluate GES (Enterra therapy) in patients with chronic intractable nausea and vomiting from diabetic gastroparesis (DGP). (3) In this study, 55 patients with refractory DGP (5.9 years of DGP) were given implants of the Enterra system. After surgery, all patients had the stimulator turned on for 6 weeks and then were randomly assigned to groups that had consecutive 3-month cross-over periods with the device on or off. After this period, the device was turned on in all patients, and they were followed up unblinded for 4.5 months. During the initial 6-week phase with the stimulator turned on, the median reduction in weekly vomiting frequency (WVF) compared with baseline was 57%. There was no difference in WVF between patients who had the device turned on or off during the 3-month cross-over period. At 1 year, the WVF of all patients was significantly lower than baseline values (median reduction, 68%; p less than 0.001). One of the patients had the device removed due to infection; 2 patients required surgical intervention due to lead-related problems.

Case Series

Anand and colleagues reported on 214 consecutive drug-refractory patients with the symptoms of gastroparesis (146 idiopathic, 45 diabetic, 23 after surgery) who consented to participate in a variety of clinical research and clinical protocols at 3 centers from January 1992 through January 2005, resulting in 156 patients implanted with a GES device and 58 patients as controls. (5) At last follow-up (median 4 years), most patients who received implants (135 of 156) were alive with intact devices, significantly reduced gastrointestinal symptoms, and improved health-related quality of life, with evidence of improved gastric emptying. Also, 90% of the patients had a response in at least 1 of 3 main symptoms. Most patients who were explanted, usually for pocket infections, were later re-implanted successfully.

In a case series of 12 patients receiving a gastric stimulation device, Abell and colleagues reported rapid improvement in nutritional parameters (e.g., body mass index, serum albumin). (6) Forster and colleagues reported on their experience at a single institution among 55 patients with gastroparesis, as documented by gastric retention. (7) While the total symptom score improved, gastric emptying did not change. The authors reported significant improvements in upper gastrointestinal symptoms, health-related quality of life, nutritional status, glucose control, and hospitalizations at 6 and 12 months in a retrospective review of 48 adult patients with diabetes who received a gastric electrical stimulation implant. (6) The review also noted that gastric emptying was not significantly faster. Similarly, van der Voort and colleagues reported that 17 patients with diabetic gastroparesis experienced a decrease in nausea and vomiting and an improvement in glucose control in a prospective case series examining the 12-month outcomes. (8)

Several trials were identified that evaluated the use of a temporary gastric stimulator. Temporary stimulators are intended to be used to determine whether or not an individual patient will respond to GES prior to undertaking a permanent implant. In 2013, Lahr and colleagues reported significant improvement during temporary GES (placement for at least 4 days) in 95 drug-refractory patients with symptoms of gastroparesis (abdominal pain, bloating, early satiety, nausea, vomiting). (9) For the entire group of patients, abdominal pain decreased from a baseline of 2.95 on a 0-4 modified Likert scale to 1.12 after temporary GES (p<0.001). In a sub-set of patients reporting severe pain at baseline (n=68), as defined by a score of 3-4 on the pain scale, mean pain scores decreased from 3.62 to 1.29 (p<0.001). There were also reductions of similar magnitude on symptom scores for early satiety, abdominal distension, nausea, and vomiting. (9)

Abell et al. (10) performed a trial of temporary GES in 58 patients with 1 of 3 etiologies (idiopathic, diabetic, postsurgical). A temporary device was placed in all patients with the device turned on or off for 4 consecutive days, followed by cross-over to the other group for an additional 4-day period. The frequency of vomiting decreased in both groups. At day 3, the decrease in vomiting was significantly greater for the GES group; however, by day 8, the differences between groups were no longer significant.

Andersson et al. (11) tested a temporary GES in 27 patients with drug-refractory nausea/vomiting. Fourteen patients were treated with temporary GES in open-label fashion, and 13 had a randomized, cross-over trial in which the device was turned on for 12-14 days and off for 12-14 days. These authors reported that the majority of patients (22/27) improved following GES placement. Of the 13 patients in the randomized cross-over phase, 6 had improvement in symptoms during the on period and 7 did not. Of the 7 patients who did not improve during the on period, there was improvement with an increased intensity of stimulation.

Elfvin et al. (12) treated 3 children with intractable vomiting who were younger than 3 years-old with a temporary GES. There were no adverse events of GES placement. All 3 children responded to the temporary GES and were implanted with a permanent device. Following permanent placement, all 3 children reported at least a 50% reduction in vomiting episodes. Significant improvement after GES placement in symptoms of nausea and vomiting were also reported in another series of 16 children with functional dyspepsia and gastroparesis who failed medical therapy. (13)

The durability of GES treatment was evaluated in several publications. Lin and colleagues reported on outcomes beyond 3 years in patients receiving GES for gastroparesis. (14) Of 55 patients, 10 died of non-pacemaker-related complications, 6 had the devices removed, and 2 could not be reached. In the remaining 37 patients, symptoms, hospital days, and the use of medications had sustained reductions (from baseline) beyond 3 years. Mason and colleagues reported on the 20-month follow-up of 27 of 29 patients referred for gastrectomy who instead received GES for refractory gastroparesis. (15) Three patients required additional procedures due to poor outcomes. Nutritional support was discontinued in the 19 patients who were dependent on supplemental feeding prior to the procedure. Gastric emptying rates improved. While these results are encouraging, given the findings of the WAVESS study, randomized trials are needed to determine the efficacy of GES in gastroparesis.

McCallum et al. reported on long-term follow-up for 188 patients who received a GES and had at least 1 year of follow-up visits. (16) This sample was drawn from a total of 221 patients treated with a GES system between 1 and 11 years prior to the study. The authors report that symptoms, hospitalizations, and medication use all improved over the time period of the study. The percent of patients with at least 50% improvement in symptoms was 58% for diabetic patients, 53% for postsurgical gastroparesis, and 48% for idiopathic disease. A total of 13 patients (7%) had their device removed due to infection.

GES placement using minimally invasive surgical approaches has also been evaluated in several publications. Laparoscopy has been reported in at least two studies as a feasible approach in placement of GES for patients with medically refractory diabetic or idiopathic gastroparesis. (17, 18)

McCallum et al (19) treated thirty-two idiopathic subjects in a prospective, multicenter, double-blinded, randomized, crossover study to evaluate the safety and efficacy of Enterra GES for the treatment of chronic vomiting. The stimulator was turned on for 1 ½ months followed by double-blind randomization to consecutive 3 month crossover periods with the device either on or off. Twenty-five subjects completed the crossover phase and 21 finished 1 year of follow-up. During the unblinded on period, there was a reduction in weekly vomiting frequency from baseline. At 1 year, weekly vomiting frequency remain decreased, accompanied by improvements in gastroparesis symptoms. Gastric emptying and days of hospitalization.

Conclusions

Numerous case series and uncontrolled studies on GES have been published. These studies generally report improvements in symptoms following treatment.

Obesity

There has only been 1 RCT published on GES for the treatment of obesity: the SHAPE trial. In 2009, Shikora and colleagues reported on a randomized, controlled, double-blind study to evaluate GES for the treatment of obesity. (20) All 190 patients participating in the study received an implantable gastric stimulator and were randomized to have the stimulator turned on or off. All patients were evaluated monthly, participated in support groups and reduced their diet by 200-kcal/day. At 12 months follow-up there was no difference in excess weight loss between the treatment group (weight loss of 11.8% */- 17%) and the control group (weight loss of 11.7% +/- 16.9%) using intention-to-treat analysis (p=0.717).

Practice Guidelines and Position StatementsThe American College of Gastroenterology published a clinical practice guideline on management of gastroparesis in 2013. (21) The recommendations for this guideline were based on review of the evidence base through 2011. The evidence on GES consisted of the two randomized crossover trials and the case series, as described above. The recommendation for GES was that “GES may be considered for compassionate treatment in patients with refractory symptoms, particularly nausea and vomiting. Symptom severity and gastric emptying have been shown to improve in patients with DG [diabetic gastroparesis], but not in patients with IG {idiopathic gastroparesis} or PSG [postsurgical gastroparesis], [Conditional recommendation (there is uncertainty about trade-offs), moderate level of evidence (further research would be likely to have an impact on the confidence in the estimate of effect).]”(21)

The National Institute for Health and Care Clinical Excellence (NICE) issued guidance on gastroelectrical stimulation for gastroparesis in 2004. (22) This guidance indicates there is insufficient evidence to support gastroelectrical stimulation for gastroparesis outside of audit or research purposes. This guidance was considered for reassessment in October 2009, and it was concluded that NICE would not be updating the guidance at that stage.

Medicare National Coverage

There is no national coverage determination.

References

  1. Chu H, Lin Z, Zhong L et al. Treatment of high-frequency gastric electrical stimulation for gastroparesis. J Gastroenterol Hepatol 2012; 27(6):1017-26.
  2. Abell T, McCallum R, Hocking M et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology 2003; 125(2):421-8.
  3. McCallum RW, Snape W, Brody F et al. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol 2010; 8(11):947-54; quiz e116.
  4. FDA Summary of Safety and Probable Benefit. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf/H990014b.pdf. Last accessed October 1, 2013.
  5. Anand C, Al-Juburi A, Familoni B et al. Gastric electrical stimulation is safe and effective: a long-term study in patients with drug-refractory gastroparesis in three regional centers. Digestion 2007; 75(2-3):83-9.
  6. Abell T, Lou J, Tabbaa M et al. Gastric electrical stimulation for gastroparesis improves nutritional parameters at short, intermediate, and long-term follow-up. JPEN J Parenter Enteral Nutr 2003; 27(4):277-81.
  7. Forster J, Sarosiek I, Lin Z et al. Further experience with gastric stimulation to treat drug refractory gastroparesis. Am J Surg 2003; 186(6):690-5.
  8. 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.
  9. Lahr CJ, Griffith J, Subramony C et al. Gastric electrical stimulation for abdominal pain in patients with symptoms of gastroparesis. Am Surg 2013; 79(5):457-64.
  10. Abell TL, Johnson WD, Kedar A et al. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc 2011; 74(3):496-503 e3.
  11. Andersson S, Ringstrom G, Elfvin A et al. Temporary percutaneous gastric electrical stimulation: a novel technique tested in patients with non-established indications for gastric electrical stimulation. Digestion 2011; 83(1-2):3-12.
  12. Elfvin A, Gothberg G, Lonroth H et al. Temporary percutaneous and permanent gastric electrical stimulation in children younger than 3 years with chronic vomiting. J Pediatr Surg 2011; 46(4):655-61.
  13. Teich S, Mousa HM, Punati J et al. Efficacy of permanent gastric electrical stimulation for the treatment of gastroparesis and functional dyspepsia in children and adolescents. J Pediatr Surg 2013; 48(1):178-83.
  14. Lin Z, Sarosiek I, Forster J et al. Symptom responses, long-term outcomes and adverse events beyond 3 years of high-frequency gastric electrical stimulation for gastroparesis. Neurogastroenterol Motil 2006; 18(1):18-27.
  15. Mason RJ, Lipham J, Eckerling G et al. Gastric electrical stimulation: an alternative surgical therapy for patients with gastroparesis. Arch Surg 2005; 140(9):841-6; discussion 47-8.
  16. McCallum RW, Lin Z, Forster J et al. Gastric electrical stimulation improves outcomes of patients with gastroparesis for up to 10 years. Clin Gastroenterol Hepatol 2011; 9(4):314-19 e1.
  17. Timratana P, El-Hayek K, Shimizu H et al. Laparoscopic gastric electrical stimulation for medically refractory diabetic and idiopathic gastroparesis. J Gastrointest Surg 2013; 17(3):461-70.
  18. Zehetner J, Ravari F, Ayazi S et al. Minimally invasive surgical approach for the treatment of gastroparesis. Surg Endosc 2013; 27(1):61-6.
  19. McCallum RW, Sarosiek I, Parkman HP, et al. Gastric electrical stimulation with Enterra therapy improves symptoms of idopathic gastroparesis. Neurogastroenterol Motil. 2013,
  20. Shikora SA, Bergenstal R, Bessler M et al. Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial. Surg Obes Relat Dis 2009; 5(1):31-7.
  21. Shikora SA. Implantable gastric stimulation for the treatment of severe obesity. Obes Surg 2004; 14(4):545-8.
  22. Camilleri M, Parkman HP, Shafi MA et al. Clinical guideline: management of gastroparesis. Am J Gastroenterol 2013; 108(1):18-37; quiz 38.
  23. National Institute for Clinical Excellence. Gastroelectrical stimulation for gastroparesis. December 2004. Available online at: http://publications.nice.org.uk/gastroelectrical-stimulation-for-gastroparesis-ipg103/guidance. Last accessed October 1, 2013
  24. Blue Cross and Blue Shield Association. Medical Policy Reference Manual. Gastric Electrical Stimulation. Policy 7.01.73, 2013.
  25. Hayes, Inc. Hayes Medical Technology Directory. Gastric Electrical Stimulation for Gastroparesis. Lansdale, PA: Hayes, Inc.; April 2008.

Coding

Codes

Number

Description

CPT

43645

Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption

 

43647

Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum

 

43648

Revision or removal of gastric neurostimulator electrodes, antrum

 

43659

Unlisted laparoscopy procedure, stomach

 

43881

Implantation or replacement of gastric neurostimulator electrodes, antrum, open

 

43882

Revision or removal of gastric neurostimulator electrodes, antrum, open

 

43999

Unlisted procedure, stomach

 

64590

Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct, or inductive coupling

 

64595

Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver

 

64999

Unlisted procedure, nervous system (used for implantation, revision, or removal of neurostimulator leads)

 

95970

Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e., cranial nerve, peripheral nerve, autonomic nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming

 

95971

Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (i.e., peripheral nerve, autonomic nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

 

95972

complex spinal cord or peripheral neurostimulator (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, first hour

 

95973

complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour (List separately in addition to code for primary procedure)

 

95980

Electronic analysis of implanted neurostimulator pulse generator system (eg. rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; intraoperative, with programming

 

95981

subsequent, without reprogramming

 

95982

subsequent, with reprogramming

ICD-9 Procedure

05.9

Other operations on nervous system

 

44.99

Other operation on stomach (one or the other of the above are used for implantation or replacement of peripheral neurostimulator lead, open or laparoscopic approach) 

 

86.95

Insertion or replacement of dual array neurostimulator pulse generator 

ICD-9 Diagnosis

250.6

Diabetes with neurological manifiestations

 

278.00

Obesity, unspecified

 

278.01

Morbid obesity

 

536.3

Gastroparesis

HCPCS

E0765

FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting

 

L8680

Implantable neurostimulator electrode, each (implant requires 2 leads)

 

L8685

Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

 

L8686

Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension

 

L8687

Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

 

L8688

Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

ICD-10-CM
(effective 10/01/14)

E08.43

Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy

 

E09.43

Drug or chemical induced diabetes mellitus with neurological complications with diabetic autonomic (poly)neuropathy

 

E10.43

Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy

 

E11.43

Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy

 

E13.43

Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy

 

K31.89

Other diseases of stomach and duodenum

ICD-10-PCS
(effective 10/01/14)

0DH60MZ, 0DH63MZ,
0DH64MZ

Surgical, gastrointestinal system, insertion, stomach, stimulation lead, code by approach open, percutaneous or percutaneous endoscopic

     

Type of Service

Surgery

 

Place of Service

Inpatient / Outpatient

 

Appendix

N/A

History

Date

Reason

01/18/01

Add to Surgery Section - New Policy

03/11/03

Replace Policy - 2002 updates added; policy statement unchanged.

05/11/04

Replace Policy - Policy revised; no change in policy statement; new HCPC code added.

06/08/04

Replace Policy - Policy replaces BC.7.01.73 due to policy statement being changed from investigational to medically necessary.

09/01/04

Replace Policy - Policy renumbered from PR.7.01.122. No changes to dates.

01/11/05

Replace Policy - BCBSA update, scheduled review date changed. Policy statement adds obesity as investigational.

06/16/05

Device name change added - Reference to Enterra added to Gastric Electrical Stimulation System for clarification purposes only. MPC approval not needed.

01/10/06

Replace Policy - Policy reviewed with literature search; codes updated; policy statement unchanged.

02/06/06

Codes updated - No other changes.

06/06/09

Disclaimer and Scope update - No other changes.

09/18/06

Codes Updated - No other changes.

01/09/06

Replace Policy - Policy updated with literature review. No change in policy statement. Codes updated.

02/26/07

Codes Updated - No other changes.

04/02/07

Codes Updated - No other changes.

01/08/08

Replace Policy - Policy updated with literature review; no change to the policy statement.

01/13/09

Code Updates - Code S2213 deleted

09/15/09

Replace Policy - Policy updated with literature review; no change to the policy statement. References added.

02/09/10

Code Update - New 2010 codes added.

11/09/10

Replace Policy - Policy updated with literature review; no change to the policy statement. Reference added.

09/15/11

Replace Policy – Policy updated with literature review; no change in policy statement.

08/20/12

Replace Policy. Policy updated with literature review, references 21 and 22 added; no change in policy statement.

10/09/12

Update Related Policies – Add 8.03.01.

02/04/13

Code update. HCPCS code E0765 added to the policy.

02/12/13

Update Related Policies, add 1.01.507.

10/14/13

Replace policy. Policy updated with extensive literature revision. No change in policy statement. CPT codes 0155T, 0156T, 0157T and 0158T removed from policy; they were deleted effective 1/2012.

12/03/13

Coding Update. Add ICD-10 codes.


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