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Sacral Nerve Stimulation/Neuromodulation

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 08.01.21 
Original Effective Date: September 2013 
Reviewed: August 2014 
Revised: February 2015 


Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description: 

Sacral nerve neuromodulation (SNM), also known as sacral nerve stimulation, is defined as the implantation of a permanent device that modulates the neural pathways controlling bladder or rectal function. This policy addresses use of SNM in the treatment of urinary or fecal incontinence, urinary or fecal nonobstructive retention, and chronic pelvic pain in patients with intact neural innervation of the bladder and/or rectum

 

Treatment using sacral nerve neuromodulation (SNM), also known as indirect sacral nerve stimulation (SNS), is one of several alternative modalities for patients with fecal or urinary incontinence (urge incontinence, significant symptoms of urgency-frequency, or nonobstructive urinary retention) who have failed behavioral (e.g., prompted voiding) and/or pharmacologic therapies. Urge incontinence is defined as leakage of urine when there is a strong urge to void. Urgency-frequency is an uncontrollable urge to urinate, resulting in very frequent, small volumes and is a prominent symptom of interstitial cystitis (also called bladder pain syndrome). Urinary retention is the inability to completely empty the bladder of urine. Fecal incontinence can arise from a variety of mechanisms, including rectal wall compliance, efferent and afferent neural pathways, central and peripheral nervous systems, and voluntary and involuntary muscles. Fecal incontinence is more common in women, due mainly to muscular and neural damage that may occur during vaginal delivery.

 

The SNM device consists of an implantable pulse generator that delivers controlled electrical impulses. This pulse generator is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root. Two external components of the system help control the electrical stimulation. A control magnet is kept by the patient and can be used to turn the device on or off. A console programmer is kept by the physician and used to adjust the settings of the pulse generator.

 


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Prior Approval: 

 

Not applicable.


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Policy: 

Urinary Incontinence

 

 

A.  A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in patients who meet all of the following criteria:

  1. There is a diagnosis of at least one of the following:
    1. Urge incontinence
    2. Urgency-frequency syndrome
    3. Non-obstructive urinary retention
    4. Overactive Bladder (OAB)
  2. There is documented failure or intolerance to at least two conventional conservative therapies (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy, a minimum of 6 months.)
  3. Incontinence is not related to a neurologic condition.

 The trial criteria for those diagnoses with overactive bladder includes:

  • their OAB has not responded to conservative management including drugs, AND
  • they are unable to perform clean intermittent catheterization. 

B.  Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in patients who meet all of the following criteria:

  1. All of the criteria in A (1-3) above are met. 
  2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 1 week. Urinary retention: At least a 50% reduction in catheter volume/catheterization; Urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes or the number of pads/diapers used per day; Urinary urge/frequency: At least 50% reduction in one of the following: number of voids daily, volume per void and frequency per void.

Other urinary/voiding applications of sacral nerve neuromodulation are considered investigational, including but not limited to treatment of interstitial cystitis, stress incontinence or urge incontinence due to a neurologic condition, e.g., detrusor hyperreflexia, multiple sclerosis, spinal cord injury, or other types of chronic voiding dysfunction.

 

Fecal Incontinence

 

A.  A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in patients who meet all of the following criteria:

  1. There is a diagnosis of 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.
  2. There is documented failure or intolerance to conventional conservative therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, rectal surgery performed more than 12 months [or 24 months in case of cancer] previously).
  3. A trial of temporary sacral nerve stimulation should be considered for people with faecal incontinence in whom sphincter surgery is deemed inappropriate. These may be patients with intact anal sphincters, or those with sphincter disruption. In those with a defect, contraindications to direct repair may include atrophy, denervation, a small defect, absence of voluntary contraction, fragmentation of the sphincter or a poor-quality muscle.
  4. The 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.
  5. Incontinence is not related to a neurologic condition, including but not limited to peripheral neuropathy or spinal cord injury.

B.  Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in patients who meet all of the following criteria:

  • All of the criteria in A (1-5) above are met.
  • A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 1 week.

Sacral nerve neuromodulation is investigational in the treatment of chronic constipation or chronic pelvic pain.





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Procedure Codes and Billing Guidelines: 

  • To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
  • 64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)
  • 64581 Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)

  • 64590 Incision and subcutaneous placement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling
  • 95970 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse 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 (ie, cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming

  • 95971 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

  • 95972 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, first hour

  • 95973 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (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)

  • L8679 Implantable neurostimulator, pulse generator, any type

  • L8680 Implantable neurostimulator electrode, each

  • L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver

  • L8684 Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement

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

  • L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension

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

  • L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension

  • L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only

  • C1767 Generator, neurostimulator (implantable), nonrechargeable

  • C1778 Lead, neurostimulator (implantable)

  • C1787 Patient programmer, neurostimulator

  • C1816 Receiver and/or transmitter, neurostimulator (implantable)

  • C1820 Generator, neurostimulator (implantable), with rechargeable battery and charging system

  • C1897 Lead, neurostimulator test kit (implantable)


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Selected References: 

  1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Sacral nerve stimulation for the treatment of urge incontinence. TEC Assessments 1998; Volume 13, Tab 18.
  2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Sacral nerve stimulation for the treatment of refractory urinary urgency/frequency in adults. TEC Assessments 2000; Volume 15, Tab 7.
  3. Food and Drug Administration (FDA). Summary of Safety and Effectiveness: Medtronic Interstim System for Urinary Control. Last accessed Sept, 2013.
  4. National Institute for Clinical Evidence (NICE). Faecal incontinence: the management of faecal incontinence in adults. NICE clinical guideline 49. 2007.
  5. Rao SS, American College of Gastroenterology Practice Parameters C. Diagnosis and management of fecal incontinence. American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol 2004; 99(8):1585-604.
  6. American College of Obstetricians and Gynecologists (ACOG). Chronic pelvic pain: ACOG practice bulletin no. 51 2004 (reaffirmed 2008). Last accessed Sept, 2013
  7. Medicare National Coverage Decision. Sacral Nerve Stimulation for Urinary Incontinence. January 1, 2002. Last accessed Sept, 2013
  8. National Institute for Clinical Evidence (NICE) Urinary incontinence: The management of urinary incontinence in women. NICE guideline CG171. 2013. Available online at: http://www.nice.org.uk/CG171

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Policy History: 

 

Date                                        Reason                                Action

September 2013                      Literature review                New policy

August 2014                           Annual review                    Policy revised

February 2015                                                                Policy revised                     


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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

 
Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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