Clinical UM Guideline


Subject:  Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury
Guideline #:  CG-SURG-08Current Effective Date:  10/08/2013
Status:ReviewedLast Review Date:  08/08/2013

Description

The Vocare® Bladder System (also known as the FineTech-Brindley Bladder Control System) (FineTech Medical Ltd., England) is an implantable device used for the treatment of neurogenic bladder secondary to spinal cord injury. The device consists of extradural electrodes that are attached to the sacral anterior nerve roots, a subcutaneously implanted receiver-stimulator, and an external battery-powered controller and transmitter. Unlike the sacral nerve neuromodulation (that is the Interstim® device) the Vocare device is self-activated and is designed to elicit functional contraction of the innervated muscles. Implantation of the Vocare device is frequently performed in conjunction with a posterior rhizotomy. The rhizotomy results in an areflexic bladder limiting incontinence and autonomic hyperreflexia.

Note: Please see the following related document for additional information:

Clinical Indications

Medically Necessary:

Self-activated electrical stimulation of intact anterior sacral nerve roots using an implantable device (e.g., Vocare Bladder System/FineTech Brindley Bladder Control System) to provide urination on demand and reduce post-void residual volume is considered medically necessary for individuals who meet all of the following criteria:

Not Medically Necessary: 

Self-activated electrical stimulation of the anterior sacral roots is considered not medically necessary for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT 
63185Laminectomy with rhizotomy, 1 or 2 segments
63190Laminectomy with rhizotomy; more than 2 segments
63655Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural [when specified as sacral root neurostimulator] l
  
HCPCS 
L8680Implantable neurostimulator electrode, each
L8682Implantable neurostimulator radiofrequency receiver
L8684Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement
  
ICD-9 Procedure 
03.1Division of intraspinal nerve root (rhizotomy)
03.93Implantation or replacement of spinal neurostimulator lead(s) [when specified as sacral root neurostimulator]
  
ICD-10 ProcedureICD-10-CM draft codes; effective 10/01/2014
018R0ZZDivision of sacral nerve, open approach
018R3ZZDivision of sacral nerve, percutaneous approach
018R4ZZDivision of sacral nerve, percutaneous endoscopic approach
00HU0MZInsertion of neurostimulator lead into spinal canal, open approach
00HU3MZInsertion of neurostimulator lead into spinal canal, percutaneous approach
00HU4MZInsertion of neurostimulator lead into spinal canal, percutaneous endoscopic approach
00HV0MZInsertion of neurostimulator lead into spinal cord, open approach
00HV3MZInsertion of neurostimulator lead into spinal cord, percutaneous approach
00HV4MZInsertion of neurostimulator lead into spinal cord, percutaneous endoscopic approach
  
ICD-9 Diagnosis 
 All diagnoses
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014
 All diagnoses
   
Discussion/General Information

Spinal cord injury (SCI) can result in varying degrees of neurological impairment depending on the location and severity of the injury. The American Spinal Injury Association (ASIA) Impairment Scale is a system used to classify or describe the extent of spinal cord injuries:

  1. Complete: No motor or sensory function is preserved in the sacral segments S4-S5.
  2. Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5.
  3. Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3.
  4. Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more.
  5. Normal: Motor and sensory function are normal.

Supra-sacral spinal cord injury may result in neurogenic bladder, characterized in part by frequent urinary tract infections from inadequate bladder emptying. The high bladder pressures related to large post-void residuals can lead to autonomic dysreflexia, vesicoureteral reflux, upper urinary tract dilations, hydronephrosis, and eventual renal failure. 

Sacral anterior root stimulation is intended to provide bladder evacuation by delivering electrical stimulation to intact spinal nerve roots in order to elicit functional contraction of the innervated muscles. Implantation of a sacral anterior root stimulator is typically performed in conjunction with a simultaneous posterior rhizotomy. The rhizotomy results in an areflexive bladder with low intravesicular pressure and high compliance. When the user activates the implanted stimulator, the urethral sphincter and bladder contract and relax, allowing the bladder to empty on demand with low residual urine volumes.

Sacral anterior root stimulation has been successfully used in Europe for many years, with large reported case series. In this country, only one implantable device, the Vocare Bladder System, has received approval by the FDA for stimulation of the sacral anterior nerve root. The FDA-labeled indication, approved in 1999, includes the following:

The Neurocontrol Vocare Bladder System is indicated for the treatment of patients who have clinically complete spinal cord lesions with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.

The use of the Vocare Bladder System consists of the following implantable external and surgical components.

The Vocare Bladder System received FDA approval through a Humanitarian Device Exemption and as such, randomized clinical trials were not required for approval. The FDA approval was based on a trial of 23 subjects who underwent implantation of the device in association with posterior rhizotomy and were followed for a minimum of three months. During this study (Creasey, 2001), comparisons were made with the device turned on and off; thus subjects served as their own controls. There was a significant improvement in bladder emptying, as measured by voided volumes and post void residual.

A Cochrane Review (2009) briefly described anterior sacral root stimulation and stated: "These devices have demonstrated efficacy so that it is unlikely that randomized trials will be undertaken (Brindley, 1994; Creasey, 1993; Van Kerrebroeck, 1993)."

References

Peer Reviewed Publications:

  1. Brindley GS. The first 500 patients with sacral anterior root stimulator implants: general description. Paraplegia. 1994; 32(12):795-805.
  2. Creasey GH. Electrical stimulation of sacral roots for micturition after spinal cord injury. Urol Clin North Am. 1993; 20(3):505-515.
  3. Creasey GH, Grill JH, Korsten M, et al. Implanted Neuroprosthesis Research Group. An implantable neuroprosthesis for restoring bladder and bowel control to patients with spinal cord injuries: a multicenter trial. Arch Phys Med Rehabil. 2001; 82(11):1512-1519.
  4. Jezernik S, Craggs M, Grill WM, Creasey G, Rijkhoff NJ. Electrical stimulation for the treatment of bladder dysfunction: current status and future possibilities. Neurol Res. 2002; 24(5):413-430.
  5. Van Kerrebroeck PE, Koldewijn EL, Debruyne FM. Worldwide experience with the Finetech-Brindley sacral anterior root stimulator. Neurourol Urodyn. 1993; 12(5):497-503.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Spinal Injury Association. ASIA Impairment Scale. Available at: http://www.acc.co.nz/for-providers/clinical-best-practice/spinal-injury-guidelines/PRD_CTRB091020. Accessed on June 18, 2013.
  2. Herbison GP, Arnold EP. Sacral neuromodulation with implanted devices for urinary storage and voiding dysfunction in adults. Cochrane Database Syst Rev. 2009; (2):CD004202.
  3. U.S. Food and Drug Administration (FDA) Database. Vocare Bladder System Approval Order, Summary of Safety and Probable Benefit and Labeling. No. H980008. Rockville, MD: FDA. March 24, 1999. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=H980008. Accessed on June 18, 2013.
Index

FineTech-Brindley Bladder Control System
Neurogenic Bladder
Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury
Spinal Cord Injury, Sacral Nerve Stimulation for
Vocare Bladder System

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 

History
StatusDateAction
Reviewed08/08/2013Medical Policy & Technology Assessment Committee (MPTAC) review. Reference section updated.
Reviewed08/09/2012MPTAC review. Description and Reference sections updated.
Reviewed08/18/2011MPTAC review. Coding, Discussion and Reference sections updated.
Reviewed08/19/2010MPTAC review. Discussion, Coding and References links updated.
Reviewed08/27/2009MPTAC review. Note below Description, Discussion and References updated.
Reviewed08/28/2008MPTAC review. Medically Necessary statement and Not Medically Necessary statement clarified. No change to stance. Description, Discussion and References updated.
Revised08/23/2007MPTAC review. Medically Necessary statement clarified. Added Not Medically Necessary statement. References and Coding updated.
Reviewed09/14/2006MPTAC review. Updated References and Coding.
 11/22/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised09/22/2005MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. 
Pre-Merger Organizations

Last Review Date

Guideline Number

Title

Anthem, Inc.

 

 No document
Anthem BCBS

07/08/2002

Anthem SE Memo1118Stimulation of the Sacral Anterior Root Combined with Posterior Sacral Rhizotomy in Patients with Spinal Cord Injury
WellPoint Health Networks, Inc.

06/24/2004

2.08.10Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury