Radiofrequency Treatment for Urinary Incontinence (L31615)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402
Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L31615

LCD Title
Radiofrequency Treatment for Urinary Incontinence

Contractor's Determination Number
GU-021

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.

Primary Geographic Jurisdiction


Oversight Region



Original Determination Effective Date
For services performed on or after 06/15/2011

Original Determination Ending Date


Revision Effective Date
For services performed on or after 04/01/2012

Revision Ending Date


CMS National Coverage Policy
Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Indications and Limitations of Coverage and/or Medical Necessity
Radiofrequency energy has been investigated as a technique to shrink and stabilize the endopelvic fascia of the urethra, thus improving the support for the urethra and bladder neck in the treatment of urinary incontinence. Proponents of this service believe that unlike radiofrequency ablation which necroses tissue, radiofrequency micro-remodeling utilizes lower temperatures to denature collagen in microscopic sites, resulting in a change in luminal function (dynamic compliance), but not gross anatomic narrowing or thickening.

At present, the literature and scientific evidence supporting the use of radiofrequency micro-remodeling by a transurethral, transvaginal, or paraurethral approach, (Renessa„¢ and similar devices) especially for the Medicare population, is insufficient to warrant coverage. These procedures are considered investigational, and are not eligible for coverage for the treatment of urinary 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.


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.



CPT/HCPCS Codes

53860TRANSURETHRAL RADIOFREQUENCY MICRO-REMODELING OF THE FEMALE BLADDER NECK AND PROXIMAL URETHRA FOR STRESS URINARY INCONTINENCE

ICD-9 Codes that Support Medical Necessity

Note: ICD-9 codes must be coded to the highest level of specificity.
XX000Not Applicable

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
  1. All documentation must be maintained in the patient's medical record and available to the contractor upon request.

  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
  3. The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.

Appendices

Utilization Guidelines

Sources of Information and Basis for Decision
Appell RA and Davila GW. Treatment options for patients with suboptimal response to surgery for stress urinary incontinence. Current Medical Research and Opinion 2007; 23 (2): 258-292.

Appell RA, Juma S, Wells WG, et al. Transurethral Radiofrequency Energy Collagen Micro-Remodeling for the Treatment of Female Stress Urinary Incontinence. Neurourology and Urodynamics 2006; 25: 331-336.

Appell RA, Singh G, Klimberg IW, et al. Nonsurgical, radiofrequency collagen denaturation for stress urinary incontinence: retrospective three-year evaluation. Expert Rev. Med. Devices 2007; 4 (4); 1-7 (part of Future Drugs, Ltd.; www.future-drugs.com).

DuBeau CE. Treatment of Urinary Incontinence. Accessed on 09/04/2009 through website - http://www.uptodate.com.

Edelstein PS. A preclinical study of nonsurgical radiofrequency collagen remodeling for treatment of stress urinary incontinence. Expert Rev. Med. Devices 2006; 3 (6); 743-748 (part of Future Drugs, Ltd.; www.future-drugs.com).

Elser DM. Stress urinary incontinence in women: What options lie between traditional therapies and surgery? Women's Health 2007;3(6) 725-733 (part of Future Medicine, Ltd.; www.futuremedicine.com).

Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness for SURx RF System (date stamped May 30, 2002). Accessed on 09/04/2009 through website http://www.fda.gov.

Gil KM, Somerville AM, Cichowski S et al. Distress and quality of life characteristics associated with seeking surgical treatment for stress urinary incontinence. Health and Quality of Life Outcomes 2009; 7:8. Accessed through Medline search 09/14/2009; accessible as per article from http://www.hqlo.com/content/7/1/8.

Information from manufacturer's website, Novasys Medical®, accessed on 09/04/2009 through website - http://www.novasysmedical.com.

Juma S, Appell RA. Nonsurgical transurethral radiofrequency treatment of stress urinary incontinence in women. Women's Health 2007; 3(3) 291-299 (part of Future Medicine, Ltd.; www.futuremedicine.com).

Karliner L. Radiofrequency Micro-remodeling for the Treatment of Female Stress Urinary Incontinence. California Technology Assessment Forum 2008; submitted hard copy during comment period.

Lenihan JP. Comparison of the Quality of Life After Nonsurgical Radiofrequency Energy Tissue Micro-Remodeling in Premenopausal and Postmenopausal Women with Moderate-to-Severe Stress Urinary Incontinence. American Journal of Obstetrics and Gynecology 2005; 192 (6); 1995-2001.

Lenihan JP, Palacios P, Sotomayor M. Oral and Local Anesthesia in the Nonsurgical Radiofrequency-Energy Treatment of Stress Urinary Incontinence. The Journal of Minimally Invasive Gynecology 2005; 12 (5); 415-419.

Shamliyan TA, Kane RL, Wyman J, et al. Systematic Review: Randomized, Controlled Trials of Nonsurgical Treatments for Urinary Incontinence in Women. Ann Intern Med 2008; 148: 459-473.

Sotomayor M and Bernal GF. Transurethral delivery of radiofrequency energy for tissue micro-remodeling for in the treatment of stress urinary incontinence. Int Urogynecol J 2003; 14; 373-379.

Sotomator M and Bernal GF. Twelve-month results of nonsurgical radiofrequency energy micro-remodeling for stress urinary incontinence. Int Urogynecol J Int Urogynecol J 2005; 16: 192-196.

Wells WG and Lenihan JP. Use of in-office anesthesia during non-surgical radiofrequency collagen denaturation for stress urinary incontinence. Curr Med Res Opin 2007; 23(6): 1279-1284.

Other Contractor(s)' Policies

April 28, 2010, the FDA issued a "RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I" for the Renessa RF System, model PR0918 [Recall # Z-1404-2010 (all lots)]. "Because of complaints received by the firm, the instructions for use were revised to emphasize potential side effects."

Advisory Committee Meeting Notes
Wisconsin 01/28/2011
Illinois 01/26/2011
Michigan 02/02/2011
Minnesota 01/20/2011
Iowa, Kansas, Missouri, Nebraska 02/10/2011
Open Meeting Date: 01/06/2011

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.

Start Date of Comment Period
02/10/2011
End Date of Comment Period
03/27/2011
Start Date of Notice Period
05/01/2011

Revision History Number
X
Revision History Explanation
04/01/2012 annual review no change in coverage.

Reason for Change
Maintenance (annual review with new changes, formatting, etc.)

Related Documents
This LCD has no Related Documents.

LCD Attachments
There are no attachments for this LCD.


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Page Last Updated: Tuesday, 03-Apr-2012 13:53:37 CDT