Clinical UM Guideline
|Subject:||Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury|
|Guideline #:||CG-SURG-08||Current Effective Date:||10/08/2013|
|Status:||Reviewed||Last Review Date:||08/08/2013|
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:
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.
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.
|63185||Laminectomy with rhizotomy, 1 or 2 segments|
|63190||Laminectomy with rhizotomy; more than 2 segments|
|63655||Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural [when specified as sacral root neurostimulator] l|
|L8680||Implantable neurostimulator electrode, each|
|L8682||Implantable neurostimulator radiofrequency receiver|
|L8684||Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement|
|03.1||Division of intraspinal nerve root (rhizotomy)|
|03.93||Implantation or replacement of spinal neurostimulator lead(s) [when specified as sacral root neurostimulator]|
|ICD-10 Procedure||ICD-10-CM draft codes; effective 10/01/2014|
|018R0ZZ||Division of sacral nerve, open approach|
|018R3ZZ||Division of sacral nerve, percutaneous approach|
|018R4ZZ||Division of sacral nerve, percutaneous endoscopic approach|
|00HU0MZ||Insertion of neurostimulator lead into spinal canal, open approach|
|00HU3MZ||Insertion of neurostimulator lead into spinal canal, percutaneous approach|
|00HU4MZ||Insertion of neurostimulator lead into spinal canal, percutaneous endoscopic approach|
|00HV0MZ||Insertion of neurostimulator lead into spinal cord, open approach|
|00HV3MZ||Insertion of neurostimulator lead into spinal cord, percutaneous approach|
|00HV4MZ||Insertion of neurostimulator lead into spinal cord, percutaneous endoscopic approach|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014|
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:
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)."
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
FineTech-Brindley Bladder Control System
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.
|Reviewed||08/08/2013||Medical Policy & Technology Assessment Committee (MPTAC) review. Reference section updated.|
|Reviewed||08/09/2012||MPTAC review. Description and Reference sections updated.|
|Reviewed||08/18/2011||MPTAC review. Coding, Discussion and Reference sections updated.|
|Reviewed||08/19/2010||MPTAC review. Discussion, Coding and References links updated.|
|Reviewed||08/27/2009||MPTAC review. Note below Description, Discussion and References updated.|
|Reviewed||08/28/2008||MPTAC review. Medically Necessary statement and Not Medically Necessary statement clarified. No change to stance. Description, Discussion and References updated.|
|Revised||08/23/2007||MPTAC review. Medically Necessary statement clarified. Added Not Medically Necessary statement. References and Coding updated.|
|Reviewed||09/14/2006||MPTAC review. Updated References and Coding.|
|11/22/2005||Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
|Revised||09/22/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
Last Review Date
|Anthem SE Memo1118||Stimulation of the Sacral Anterior Root Combined with Posterior Sacral Rhizotomy in Patients with Spinal Cord Injury|
|WellPoint Health Networks, Inc.|
|2.08.10||Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury|