L29273-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Sacral Neuromodulation (L29273)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29273

LCD Title Sacral Neuromodulation

Contractor's Determination Number 64561

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2012

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administratice law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4,

Sections 230.16 and 230.18

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 32, Section 40

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. 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. 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:

• 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.

• 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.

• Patient must have had a 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.

• 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:

• 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 a 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.

• 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.

• Diathermy is a contraindication for sacral nerve stimulation

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

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

64561 PERCUTANEOUS IMPLANTATION OF NEUROSTIMULATOR ELECTRODE ARRAY; SACRAL NERVE (TRANSFORAMINAL PLACEMENT)

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 - 788.29 RETENTION OF URINE UNSPECIFIED - 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

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Documentation maintained by the treating physician must indicate the medical necessity of this procedure. The selected behavioral and pharmacological treatments tried and the patient’s response to them must be included. A report of the trial stimulation with the patient’s response must be included. 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: biofeedback therapy, dietary management, pharmacotherapy, 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.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters they

may be subject to review for medical necessity.

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.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number 2

Revision History Explanation Revision Number:2 Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2012 Revised Effective Date:01/01/2012

LCR B2012-008

December 2011 Connection

Explanation of Revision: Annual 2012 HCPCS Update. Descriptors revised for CPT codes 64561 and 64581. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:08/01/2011 Revised Effective Date: 03/14/2011

LCR B2011-087

July 2011 Connection

Explanation of Revision: This LCD has been revised based on an outside request to add the new indication for fecal incontinence. The “Indications and Limitations”, “Documentation Requirements”, “ICD-9 CM diagnosis codes that support medical necessity”, “Utilization Guidelines” and “Sources of Information” sections have all been revised accordingly. These revisions will be effective for claims processed on or after 07/22/2011 for dates of service on or after 03/14/2011.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29273) replaces LCD L6421 as the policy in notice. This document (L29273) is effective on 02/02/2009.

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

64561 descriptor was changed in Group 1

64581 descriptor was changed in Group 1

Reason for Change