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Date Printed: October 20, 2017: 11:56 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. 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.

02-61000-23

Original Effective Date: 01/01/01

Reviewed: 03/23/17

Revised: 04/15/17

Subject: Sacral Nerve Neuromodulation/Stimulation

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Treatment using sacral nerve neuromodulation (SNM) 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. Urgency-frequency is a prominent symptom of interstitial cystitis. 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.

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.

Prior to implantation of the permanent device, patients undergo an initial testing phase to estimate potential response to treatment. The first type of testing developed was percutaneous nerve evaluation (PNE). This procedure is done under local anesthesia, using a test needle to identify the appropriate sacral nerve(s). Once identified, a temporary wire lead is inserted through the test needle and left in place for several days. This lead is connected to an external stimulator, which is carried by patients in their pocket or on their belt. Patients then keep track of voiding symptoms while the temporary device is functioning. The results of this test phase are used to determine whether patients are appropriate candidates for the permanent device. If patients show a 50% or greater reduction in incontinence frequency, they are deemed eligible for the permanent device. The second type of testing is a 2-stage surgical procedure. In the first stage, a quadripolar-tined lead is implanted (stage 1). The testing phase can last as long as several weeks, and if patients show a 50% or greater reduction in symptom frequency, they can proceed to stage 2 of the surgery, which is permanent implantation of the neuromodulation device. The 2-stage surgical procedure has been used in various ways. These include its use instead of PNE, for patients who failed PNE, for patients with an inconclusive PNE, or for patients who had a successful PNE to further refine patient selection.

POSITION STATEMENT:

 

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request to expedite the medical review process.

1. Click the link Sacral Nerve Neuromodulatoin/Stimulation - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

Urinary Incontinence/Non-Obstructive Urinary Retention

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead meets the definition of medical necessity in members who meet ALL of the following criteria:

1. There is a diagnosis of one of the following:

a. Urge incontinence

b. Urgency-frequency syndrome

c. Non-obstructive urinary retention

d. Overactive bladder.

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).

3. Incontinence is not related to a neurologic condition AND

4. The member is an appropriate surgical candidate.

Permanent implantation of a sacral nerve neuromodulation device meets the definition of medical necessity in members who meet ALL of the following criteria:

1. ALL of the criteria listed above (1-4) are met AND

2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Other urinary/voiding applications of sacral nerve neuromodulation are considered experimental or investigational, including but not limited to treatment of 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). The evidence is insufficient to determine the effects of the technology on health outcomes.

Fecal Incontinence

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead meets the definition of medical necessity in members 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, performed more than 12 months [or 24 months in case of cancer] previously.)

3. 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.

4. The member has not had rectal surgery in the previous 12 months, or in the case of cancer, the member has not had rectal surgery in the past 24 months.

5. Incontinence is not related to a neurologic condition AND

6. The member is an appropriate surgical candidate.

Permanent implantation of a sacral nerve neuromodulation device meets the definition of medical necessity in members who meet ALL of the following criteria:

1. All of the criteria listed above (1-6) above are met AND

2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Sacral nerve neuromodulation is considered experimental or investigational in the treatment of chronic constipation or chronic pelvic pain. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding

64561

Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed

64581

Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)

64585

Revision or removal of peripheral neurostimulator electrodes

64590

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

64595

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

95970

Electronic analysis of implanted neurostimulator pulse generator system (e.g., 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 (i.e. cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming

95971

Electronic analysis of implanted neurostimulator pulse generator system (e.g., 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 (i.e. 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

HCPCS Coding

A4290

Sacral nerve stimulator test lead, each

E0745

Neuromuscular stimulator, electronic shock unit

L8679

Implantable neurostimulator pulse generator, any type

L8680

Implantable neurostimulator electrode, each

L8681

Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only

L8682

Implantable neurostimulator radiofrequency receiver

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, 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

LOINC Codes

The following information may be required documentation to support medical necessity: Physician history and physical, treatment plan, treatment notes including documentation of symptoms, behavior or pharmacologic interventions, and prior test stimulation (if applicable).

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician visit note/treatment notes including documentation of symptoms

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment plan

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Current, Discharge, or Administered Medications (i.e., pharmacologic interventions)

34483-8

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Neuromuscular electrophysiology studies (i.e. electronic analysis of implanted neurostimulator pulse generator system)

27897-8

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Sacral Nerve Stimulation for Urinary Incontinence (230.18) located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Sacral Neuromodulation (L36296) located at fcso.com.

DEFINITIONS:

Detrusor: general term for any body part that pushes down.

Hyperreflexia: exaggerated reflexes.

Neuromodulation: electrical stimulation of a peripheral nerve, transcutaneously or by implanted stimulator.

Stress incontinence: involuntary loss of urine when straining or coughing.

Urge incontinence: sudden strong urge to urinate followed by an involuntary loss of urine.

Urgency frequency: uncontrollable urge to urinate followed by frequency, small volume voids.

Urinary retention: the inability to completely empty the bladder of urine.

RELATED GUIDELINES:

Pelvic Floor Stimulation as a Treatment of Urinary Incontinence, 01-97000-06

OTHER:

Indexing Terms:

Note: 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.

Incontinence, Urge, Sacral Nerve Stimulation
Interstim® Device
Sacral Nerve Stimulation

REFERENCES:

  1. Abrams P, Blaivas JG, Fowler CJ, The Role of Neuromodulation in the Management of Urinary Urge Incontinence, BJU International, Vol 91, Issue 4, Pages 355-359, July 2009.
  2. Altomare DF, Ratto C, Ganio E, et al, Long-Term Outcomes of Sacral Nerve Stimulation for Fecal Incontinence, Dis Colon Rectum, 2009 January; 52(1): 11-7.
  3. American Urological Association (AUA) Guideline. Diagnosis and Treatment of Interstitial Cystitis/Bladder Pain Syndrome, 2011, accessed at auanet.org 04/23/14.
  4. American Urological Association (AUA). Guideline on Diagnosis and Treatment of Overactive Bladder, 2014; accessed at auanet.org 08/26/15.
  5. American Urological Association (AUA). Position Statement Regarding Sacral Nerve Stimulation for Urinary Incontinence. October 18, 2000, accessed at auanet.org 04/23/14.
  6. Blue Cross Blue Shield Association Medical Policy Reference Manual, 7.01.69 Sacral Nerve Neuromodulation/Stimulation, 01/17.
  7. Blue Cross Blue Shield Association Technology Evaluation Center (TEC) Sacral Nerve Stimulation Urge Incontinence. TEC Assessments 1998, Tab 18.
  8. Blue Cross Blue Shield Association. Technology Evaluation Center (TEC). Sacral Nerve Stimulation Urinary Urgency/Frequency. TEC Assessments 2000, Tab 7.
  9. Centers for Medicare & Medicaid Services (CMS), NCD for Sacral Nerve Stimulation for Urinary Incontinence (230.18), accessed at cms.gov.
  10. Centers for Medicare and Medicaid Services (CMS) Manual System, Pub. 100-3, Medicare National Coverage, Chapter 1, Part 4, Section 230.18, Sacral Nerve Stimulation for Urinary Incontinence, 01/01/02, accessed at cms.gov 08/24/15.
  11. El-Gazzaz G, Zutshi M, et al, Sacral Neuromodulation for the Treatment of Fecal Incontinence and Urinary Incontinence in Female Patients: Long-Term Follow-up, International Journal of Colorectal Disease, Vol 24, Number 12, December 2009.
  12. First Coast Service Options, Inc, LCD for Sacral Neuromodulation (L36296), accessed at fcso.com.
  13. Groenendijk PM, et al, Urodynamic Evaluation of Sacral Neuromodulation for Urge Urinary Incontinence, BJU Int. 2008 February; 101(3): 325-9.
  14. Hayes, Inc. Hayes Medical Technology Directory, Implantable Sacral Nerve Stimulation for Urinary Voiding Dysfunction Lansdale, PA: Hayes, Inc.; April 2003. Update performed 03/14/08.
  15. Herbison GP, Arnold EP, Sacral Neuromodulation with Implanted Devices for Urinary Storage and Voiding Dysfunction in Adults, National Institutes of Health, April 15, 2009.
  16. Kenefick NJ. Sacral nerve neuromodulation for the treatment of lower bowel motility disorders. Ann R Coll Surg Engl. 2006 Nov; 88(7): 617-23.
  17. Leroi AM, Parc Y, Lehur PA, Mion F, Barth X, Rullier E, Bresler L, Portier G, Michot F; Study Group. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg. 2005 Nov; 242(5): 662-9.
  18. Mowatt G, Glazener C, Jarrett M. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD004464. DOI: 10.1002/14651858.CD004464.pub2.
  19. National Collaborating Centre for Women’s and Children’s Health, Urinary Incontinence: The Management of Urinary Incontinence in Women, London (UK), Royal College of Obstetricians and Gynaecologists (RCOG), October 2006, accessed at guideline.gov. 04/16/10.
  20. National Guideline Clearinghouse (NGC). Guideline summary NGC-5720 Chronic Pelvic Pain; Agency for Healthcare Research and Quality (AHRQ); accessed at guideline.gov 04/22/13.
  21. National Institute for Clinical Excellence (NICE), Faecal Incontinence (QS54) Quality Standards, Issued February 2014. Accessed at nice.org 08/26/15.
  22. National Institute for Clinical Excellence (NICE). Faecal Incontinence: The Management of Faecal Incontinence in Adults; NICE Clinical Guideline 49. 2007; accessed at nice.org.uk 04/22/13.
  23. Oerlemans, D, Van Kerrebroeck P, Sacral Nerve Stimulation for Neuromodulation of the Lower Urinary Tract, Neurourology and Urodynamics, Vol 27 Issue 1, pages 28-33, 2008.
  24. Ontario Ministry of Health and Long-Term Care. Sacral nerve stimulation for urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence. Toronto: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care (MAS). 2005:62. Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care (MAS).
  25. Rao SS, American College of Gastroenterology Practice Guidelines-Diagnosis and Management of Fecal Incontinence, 2004; accessed at s3.gi.org/physicians/guidelines/FecalIncontinence.pdf 08/26/15.
  26. Roth TJ, Vandersteen DR, Hollatz P, Sacral Neuromodulation for the Dysfunctional Elimination Syndrome: A Single Center Experience with 20 Children, The Journal of Urology, Vol 180, Issue 1, pages 306-311, July 2008.
  27. Satish SC, Practice Guidelines- Diagnosis and Management of Fecal Incontinence, American Journal of Gastroenterology, 2004, 1585-1604.
  28. Tjandra JJ, et al, Practice Parameters for the Treatment of Fecal Incontinence, Dis colon Rectum 2007; 50: 1497-1507, accessed at fascrs.org 04/23/14.
  29. White, WM, Dobmeyer-Dittrich C, Klein FA, Wallace LS, Sacral Nerve Stimulation for Treatment of Refractory Urinary Retention: Long-Term Efficacy and Durability, Urology, Vol 71, Issue 1, Pages 71-74, January 2008.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 03/23/17.

GUIDELINE UPDATE INFORMATION:

01/01/01

New Medical Coverage Guideline.

01/01/02

Annual HCPCS coding update.

07/25/02

Reviewed.

08/15/03

Reviewed; no changes in coverage statement MCG changed to Active but no longer scheduled for routine review.

01/01/05

Annual HCPCS coding update: consisting of the revision of 64590, 95970, 95971, 95972 and 95973.

01/01/06

Annual HCPCS coding update: consisting of the deletion of E0752, E0754, E0756 and E0759 and the addition of L8680, L8681, L8682, L8683 and L8684.

01/01/07

Annual HCPCS coding update: consisting of the revision of 64590 and 64595.

09/15/07

Review and revision of guideline consisting of updated references and reformatted guideline.

09/15/08

Review and revision of guideline consisting of updated references.

01/01/09

Annual HCPCS coding update: revised descriptor for code L8681.

07/15/09

Annual review: position statements maintained, coding and references updated.

06/15/10

Annual review: position statements maintained and references updated.

10/15/10

Revision: formatting changes and related ICD-10 codes added.

08/15/11

Revision; formatting changes.

10/01/11

Revision; formatting changes.

01/01/12

Annual HCPCS update. Revised descriptor for codes 64561, 64581, & 95970-95973.

05/15/12

Annual review; title, position statements, coding/billing section, and references updated; formatting changes.

10/15/12

Permanent implantation criteria updated; formatting changes.

01/01/13

Annual HCPCS update. Revised descriptor for code 64561.

06/15/13

Annual review; position statement section and references updated; formatting changes.

01/01/14

Annual HCPCS update. Added code L8679.

06/15/14

Annual review; Update position statements, coding, and references; formatting changes.

01/01/15

Annual HCPCS/CPT update. Revised code 95972.

10/15/15

Annual review; position statements, coding, & references updated; formatting changes.

01/01/16

Annual HCPCS/CPT update; code 95972 revised, code 95973 deleted.

01/01/17

Annual CPT/HCPCS update. Revised 95972; formatting changes.

04/15/17

Revision; position statements maintained, description section and references updated.

Date Printed: October 20, 2017: 11:56 AM