LCD/NCD Portal

L29273

 

SACRAL NEUROMODULATION

 

 

01/01/2013

 

Indications and Limitations of Coverage and/or Medical Necessity

 

 

Indications

• Effective January 1, 2002, sacral nerve stimulation is covered for the treatment of urinary urge incontinence, urgency-frequency syndrome and urinary retention.

o Sacral nerve stimulation involves both a temporary test stimulation to determine if an implantable stimulator would be effective and a permanent implantation in appropriate candidates.

o Both the test and the permanent implantation are covered.

• Effective for dates of service on or after March 14, 2011, MAC J9 will consider the use of sacral nerve stimulation medically reasonable for the treatment of fecal incontinence in those patients who have failed or are not candidates for conservative treatments (i.e., biofeedback, dietary management, pharmacotherapy, strengthening therapy).

• The patient must also have a weak but structurally intact sphincter.

Limitations

• The following limitations for coverage apply for urinary indications:

o Patient must be refractory to conventional therapy (documented behavioral, pharmacologic and/or surgical corrective therapy) and be an appropriate surgical candidate such that implantation with anesthesia can occur.

o Patients with stress incontinence, urinary obstruction, and specific neurologic diseases (e.g., diabetes with peripheral nerve involvement) that are associated with secondary manifestations of the above three indications are excluded.

o Patient must have had successful test stimulation in order to support subsequent implantation. Before a patient is eligible for permanent implantation, he/she must demonstrate a 50% or greater improvement through test stimulation. Improvement is measured through voiding diaries.

o Patient must be able to demonstrate adequate ability to record voiding diary data such that clinical results of the implant procedure can be properly evaluated.

• The following limitations for coverage apply for fecal indications:

o The use of sacral nerve stimulation for the treatment of fecal incontinence requires the patient to have a 2-3 week test stimulation trial.

 The patient must have had successful test stimulation in order to support subsequent implantation.

 Before a patient is eligible for permanent implantation, he/she must demonstrate a 50% or greater improvement through test stimulation.

 Improvement is measured through diaries of episodes of fecal incontinence per week.

o The patient must be able to demonstrate adequate ability to record fecal incontinence diary data such that clinical results of the implant procedure can be properly evaluated.

 SNS for patients that do not have an adequate response to the test stimulation will be considered not medically reasonable and necessary.

o Diathermy is a contraindication for sacral nerve stimulation

o Patients who are unable to operate the neurostimulator are not candidates for SNS for fecal incontinence

 

 

CPT/HCPCS Codes

 

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)

 

 

ICD-9 Codes that Support Medical Necessity

 

595.1 CHRONIC INTERSTITIAL CYSTITIS

787.60 FULL INCONTINENCE OF FECES

788.20 RETENTION OF URINE UNSPECIFIED

788.21 INCOMPLETE BLADDER EMPTYING

788.29 OTHER SPECIFIED RETENTION OF URINE

788.31 URGE INCONTINENCE

788.41 URINARY FREQUENCY

788.63 URGENCY OF URINATION

788.64 URINARY HESITANCY

788.65 STRAINING ON URINATION

 

 

Documentation Requirements

• Documentation maintained by the treating physician must indicate the medical necessity of this procedure.

o The selected behavioral and pharmacological treatments tried and the patient’s response to them must be included.

o A report of the trial stimulation with the patient’s response must be included.

o The medical record must document how fecal incontinence or significant symptoms of urinary incontinence, urgency/frequency, or retention have affected the patient’s ability to work or perform activities outside the home.

• In addition, for the treatment of fecal incontinence the medical record must reflect that one or more of the following conservative measures have been implemented before the test stimulation and subsequent permanent implantation of the SNS lead occurs:

o biofeedback therapy,

o dietary management,

o pharmacotherapy,

o Strengthening therapy.

 If the patient is not a candidate for or intolerable to conservative therapy, the medical record must clearly reflect this rationale.

 The medical record must also reflect that the patient does not receive diathermy.

 The medical record must also reflect that the patient is capable of operating the neurostimulator.

 A complete history and physical must be maintained in the medical record and should reflect that the patient has a weakened but structurally intact anal sphincter.

 

 

Treatment Logic

• Sacral nerve stimulation for the treatment of urinary urge incontinence, urgency-frequency syndrome and urinary retention.

• Sacral nerve stimulation for the treatment of fecal incontinence in those patients who have failed or are not candidates for conservative treatments.

•  Sacral nerve stimulation involves both a temporary test stimulation to determine if an implantable

Sources of Information and Basis for Decision

 

Abrams P et al. Fourth International Consultation on Incontinence recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40

 

American Medical Association, (1999). CPT Changes, An Insider’s View 2002.

 

Buback, D. (2001). The use of neuromodulation for treatment of urinary incontinence. AORN Journal, 176-190.

 

Chan M, Tjandra JJ. Sacral Nerve Stimulation for Fecal Incontinence: External Anal Sphincter Defect vs. Intact Anal Sphincter. Dis Colon Rectum. 2008;51:1015-1025.

 

Dudding TC, Meng Lee E, Paiz O, Pares D, Vaizey CJ, McGuire A, et al. Economic evaluation of sacral nerve stimulation for faecal incontinence. British Journal of Surgery. 2008;95:1155-1163.

 

Hetzer F, Bieler A, Hahnloser D, Lohlein F, Clavien P, Demartines N. Outcome and cost analysis of sacral nerve stimulation for faecal incontinence. British Journal of Surgery. 2006;93:1411-1417.

 

Hetzer F, Hahnloser D, Clavien P, Demartines N. Quality of Life and Morbidity After Permanent Sacral Nerve Stimulation for Fecal Incontinence. Archives of Surgery. 2007;142:8-13.

 

Jezernik, S. (2002). Electrical stimulation for the treatment of bladder dysfunction: Current status and future possibilities. Neurological Research; 24: 413-430.

 

Matzel KE. Sacral nerve stimulation for fecal disorders: evolution, current status, and future directions. Acta Neurochir Suppl. 2007;97(1):351-357

 

Michelsen H, Thompson-Fawcett M, Lundy L, Krogh K, Laurberg S, Buntzen S. Six year Experience with Sacral Nerve Stimulation for Fecal Incontinence. Dis Colon Rectum. 2010;53(4):414-421.

 

Michelsen H, Christensen P, Krogh K, Rosenkilde M, Buntzen S, Theil J, et al. Sacral nerve stimulation for faecal incontinence alters colorectal transport. British Journal of Surgery. 2008;95:779-784.

 

Mowatt G, Glazener CMA, Jarrett M. Sacral nerve stimulation for faecal incontinence and constipation in adults (Review). The Cochrane Library. 2009, Issue 1.

 

Munoz-Duyos A, Navarro-Luna A, Brosa M, Pando J, Sitges-Serra A, Marco-Molina C. Clinical and cost effectiveness of sacral nerve stimulation for faecal incontinence. British Journal of Surgery. 2008;95:1037-1043.

 

National Institute for Health and Clinical Excellence. Faecal incontinence: the management of faecal incontinence in adults. NICE Clinical Guideline 49, June 2007.

 

Pares D, Norton C, Chelvanayagam S. Fecal Incontinence: The Quality of Reported Randomized, Controlled Trials in the Last Ten Years. Dis Colon Rectum. 2008;51:88-95.

 

Tan J, Chan M, Tjandra J. Evolving Therapy for Fecal Incontinence. Dis Colon Rectum. 2007;50:1950-1967.

 

Tjandra JJ, Chan M, Yeh CH, Murray-Green C. Sacral Nerve Stimulation is More Effective than Optimal Medical Therapy for Severe Fecal Incontinence: A Randomized, Controlled Study. Dis Colon Rectum. 2007;51:494-502.

 

Wald A. Fecal Incontinence in Adults. New England Journal of Medicine. 2007;356:1648-1655.

 

Walsh, N. (2002). Implant may tame seniors’ urge incontinence – Sacral neuromodulator. OB/GYN News.

 

Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, et al. Sacral Nerve Stimulation for Fecal Incontinence: Results of a 120-patient Prospective Multicenter Study. Annals of Surgery. 2010;251:441-449.

 

Whitehead WE et al. Fecal incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009;137(2):512-517.

 

 

01/01/2013

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD SACRAL NEUROMODULATION