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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.

01-97000-06

Original Effective Date: 12/15/02

Reviewed: 09/26/13

Revised: 01/01/17

Subject: Pelvic Floor Stimulation as a Treatment of Incontinence

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:

Pelvic floor stimulation (PFS) is proposed as a nonsurgical treatment option for women and men with urinary incontinence. This approach involves either electrical stimulation of pelvic floor musculature or extracorporeal pulsed magnetic stimulation.

Urinary incontinence is a common condition defined as an involuntary leakage of urine. Women are twice as likely to be affected as men, and prevalence increases with age. The severity of incontinence affects quality of life and treatment decisions. The types of urinary incontinence include stress, urge, overflow, functional, transient, mixed, and post-prostatectomy incontinence. Nonsurgical treatment options may include pharmacologic treatment, pelvic muscle exercises (PME), bladder training exercises, electrical stimulation, and neuromodulation.

Pelvic floor stimulation (PFS) involves the electrical stimulation of pelvic floor muscles using either a probe wired to a device for controlling the electrical stimulation or, more recently, extracorporeal electromagnetic (also called magnetic) pulses. The intent of the intervention is to stimulate the pudendal nerve in order to activate the pelvic floor musculature; it is thought that activation of these muscles will lead to improved urethral closure. In addition, PFS is thought to improve partially denervated urethral and pelvic floor musculature by enhancing the process of reinnervation. The methods of electrical PFS have varied in location (e.g., vaginal, rectal), stimulus frequency, stimulus intensity or amplitude, pulse duration, pulse to rest ratio, treatments per day, number of treatment days per week, length of time for each treatment session, and overall time period for device use between clinical and home settings. Variation in the amplitude and frequency of the electrical pulse is used to mimic and stimulate the different physiologic mechanisms of the voiding response, depending on the type of etiology of incontinence, i.e., either detrusor instability, stress incontinence, or a mixed pattern.

Magnetic pelvic floor stimulation does not require an internal electrode; patients may sit, fully clothed, on a specialized chair.

Patients receiving electrical PFS may undergo treatment in a physician’s office or physical therapy facility, or patients may undergo initial training in a physician’s office followed by home treatment with a rented or purchased pelvic floor stimulator. Magnetic PFS may be delivered in the physician’s office.

POSITION STATEMENT:

Electrical or magnetic stimulation of the pelvic floor muscles as a treatment for urinary incontinence is considered experimental or investigational because available data are insufficient to determine whether this treatment is as effective as the available alternatives. Additionally, the treatments lack standardization of delivery and there are minimal data for magnetic stimulation.

Electrical or magnetic stimulation of the pelvic floor muscles as a treatment for fecal incontinence or chronic constipation is considered experimental or investigational because available data are insufficient to determine whether this treatment is as effective as the available alternatives. The treatments lack standardization of delivery and there are minimal data for magnetic stimulation.

BILLING/CODING INFORMATION:

The following codes may be used:

CPT Coding:

97014

Application of a modality to one OR more areas; electrical stimulation (unattended)

97032

Application of a modality to 1 OR more areas; electrical stimulation (manual), each 15 minutes (one-on-one contact)

HCPCS Coding:

E0740

Non-implanted pelvic floor electrical stimulator, complete system (Investigational)

G0283

Electrical stimulation (unattended), to one OR more areas for indication(s) other than wound care, as part of a therapy plan of care

REIMBURSEMENT INFORMATION:

Refer to section 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: Non-Implantable Pelvic Floor Electrical Stimulator (230.8) located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Therapy and Rehabilitation Services (L29289) located at fcso.com.

DEFINITIONS:

Functional incontinence: a type of incontinence when getting to and using the toilet when the need arises is the cause. There may be musculoskeletal problems that prevent the sufferer from moving quickly enough to get to the bathroom, remove clothing to use the toilet, or transfer from a wheelchair to a toilet. Musculoskeletal problems include back pain or arthritis. There may also be neurological problems such as Parkinson's disease or multiple sclerosis (MS). In other cases, functional incontinence may result from problems with thinking or communicating.

Mixed incontinence: results from both stress and urge symptoms and causes.

Overflow incontinence: this results from overdistension of the bladder. There may be urine dribbling and urge or stress incontinence symptoms. This may results from drugs, a neurologic condition such as diabetic neuropathy, bladder outlet or urethral obstruction, BPH or uterine/bladder prolapses.

Stress incontinence: an involuntary loss of urine when coughing, laughing, sneezing, etc., commonly caused by displacement of the urethra and bladder neck or urethral sphincter deficiency. Childbirth in women may contribute to this development and in males, may occur after a prostatectomy.

Transient incontinence: a type of incontinence that often disappears in time or after treatment. Causes may include alcohol and drug use, heart failure, venous insufficiency, inflammation of the urethra or the vagina, sexually transmitted diseases or urinary tract infections.

Urge incontinence: an abrupt, strong desire to void, resulting in the involuntary loss of urine. It may be associated with involuntary detrusor contractions (detrusor overactivity or instability) and/or several other factors (disease, drugs).

RELATED GUIDELINES:

Sacral Nerve Modulation/Stimulation, 02-61000-23

Posterior Tibial Nerve Stimulation for Voiding Dysfunction, 02-64000-01

OTHER:

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.

Other names used to report electrical pelvic floor stimulation:
Pathway™ CTS2000
MyoTrac Infiniti™
InCare PRS

Other names used to report magnetic pelvic floor stimulation:
Extracorporeal Electromagnetic Stimulation
NeoControl® Pelvic Floor Therapy System

REFERENCES:

  1. 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. Neurourology and Urodynamics 29:213–240 (2010).
  2. AHRQ National Guideline Clearinghouse. NGC-4011. Management of urinary incontinence in primary care. A national clinical guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN); 2004 Dec.
  3. AHRQ Guideline Clearinghouse. NGC-6743. Urinary Incontinence in Women. Finnish Medical Society Duodecim. Urinary incontinence in women. In: EBM Guidelines. Evidence-Based Medicine [Internet]. Helsinki, Finland: Wiley Interscience. John Wiley & Sons; 2008 Aug 8.
  4. AHRQ National Guideline Clearinghouse. NGC- 6801. Conservative Management of Urinary Incontinence. Society of Obstetricians and Gynaecologists of Canada, Robert M, Ross S, Farrel SA, Easton WA, Epp A, Girouard L, Gupta C, Lajoie F, Lovatsis D, MacMillan B, Schachter J, Schulz J, Wilkie DH. Conservative management of urinary incontinence. J Obstet Gynaecol Can 2006 Dec;28(12):1113-8.
  5. AHRQ National Guideline Clearinghouse. NGC-7325. Incontinence in men. In: Guidelines on urinary incontinence. Arnhem, The Netherlands: European Association of Urology (EAU); 2009 Mar.
  6. AHRQ National Guideline Clearinghouse. NGC-7884. (1) Incontinence in women. In: Guidelines on urinary incontinence. (2) 2010 addendum to 2009 urinary incontinence guidelines. Arnhem, The Netherlands: European Association of Urology (EAU); 2009 Mar. p. 28-43. 2010 Addendum to 2009 Guideline Summary. (Accessed 08/28/13).
  7. AHRQ National Guideline Clearinghouse. NGC-7873. Recommendations for the management of urge urinary incontinence in women. Austin (TX): University of Texas at Austin, School of Nursing; 2010 May. (Accessed 08/28/13)
  8. AHRQ National Guideline Clearinghouse. NGC-8401. Urinary incontinence. Columbia (MD): American Medical Directors Association (AMDA); 2010.
  9. AHRQ National Guideline Clearinghouse. NGC-9099. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. Gormley EA, Lightner DJ, Burgio KL, Chai TC, Clemens JQ, Culkin DJ, Das AK, Foster HE Jr, Scarpero HM, Tessier CD, Vasavada SP. Linthicum (MD): American Urological Association (AUA); 2012 May. (Accessed 08/28/13)
  10. AHRQ Agency for Healthcare Research and Quality (AHRQ). Guideline Syntheses: Assessment and Management of Urinary Incontinence in Women. Revised March 2010.
  11. American College of Obstreticians and Gynecologists. FAQ081: Gynecologic Problems; Urinary Incontinence. May 2011.
  12. American Urological Association. Guideline for the Surgical Management of Female Stress Urinary Incontinence: 2009 Update. ©2009 American Urological Association, Inc.
  13. Blue Cross and Blue Shield Association Medical Policy Reference Manual – 1.01.17 Pelvic Floor Stimulation as a Treatment of Urinary Incontinence. April 2013. (Accessed 08/28/13).
  14. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). – “Magnetic Stimulation in the Treatment of Urinary Incontinence in Adults” TEC Assessments 2000, Tab 8.
  15. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). “Pelvic Floor Electrical Stimulation in the Treatment of Urinary Incontinence in Adults” TEC Assessments 2000, Tab 2.
  16. Blue Cross Blue Shield of Florida Technology Assessment “Electric Stimulation for the Treatment of Urinary Incontinence” January 1996.
  17. California Technology Assessment Forum (CTAF). Electrical Stimulation for the Treatment of Urinary Incontinence in Women. Technology Assessment. San Francisco, CA: October 20, 2004. (Accessed 09/26/11).
  18. California Technology Assessment Forum (CTAF). Magnetic Stimulation for the Treatment of Urinary Incontinence in Women. Technology Assessment. San Francisco, CA: October 20, 2004.
  19. Castro, Rodrigo A., Arruda, Raquel M., Zanetti, Miriam R. D. et al. Single-blind, randomized, controlled trial of pelvic floor muscle training, electrical stimulation, vaginal cones, and no active treatment in the management of stress urinary incontinence. Clinics, 2008, vol.63, no.4, p.465-472. ISSN 1807-5932. (Accessed 08/28/13).
  20. Centers for Medicare & Medicaid Services (CMS) Manual System, Pub. 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 230.8, Non-Implantable Pelvic Floor Electrical Stimulator. 06/19/06. (Accessed 08/28/13).
  21. ClinicalTrials.gov. Conservative Treatment of Postprostatectomy Incontinence. NCT00212264. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Last updated April 25, 2012.
  22. ClinicalTrials.gov. Vaginal Electrical Stimulation versus Neuromodulation. NCT01525485. University of Oklahoma. Last updated August 7, 2012.
  23. ECRI Health Technology Assessment Information Services – Custom Hotline Response “Pelvic Floor Stimulation for Treatment of Urinary Incontinence” 05/10/05.
  24. ECRI Health Technology Assessment Information Services – Windows on Medical Technology “Magnetic Muscle Stimulation for the Treatment of Urinary Incontinence” 04/02.
  25. Florida Medicare Part B Local Coverage Determination. L6196 THERSVCS Therapy and Rehabilitation Services 07/01/08. Retired 02/01/09.
  26. Florida Medicare Part B Local Coverage Determination. Therapy and Rehabilitative Services (L29289). Last revised 01/01/13. (Accessed 08/28/13).
  27. Gilling PJ, et al. A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence. BJU International 103, 1386-1390 (2009).
  28. Goode PS, Burgio KL, Locher JL, Roth DL, Umlauf MG, Richter HE, Varner RE, Lloyd LK. Effect of behavioral training with or without pelvic floor electrical stimulation on stress incontinence in women: a randomized controlled trial. JAMA. 2003 Jul 16; 290(3): 345-52.
  29. Hayes, Inc. Hayes Medical Technology Directory. Pelvic Floor Electrical Stimulation for the Treatment of Urinary Incontinence. Lansdale, PA: Hayes, Inc.; March 2006. Update performed 03/26/08.
  30. Hayes, Inc. Hayes Medical Technology Directory. Extracorporeal Magnetic Stimulation for Urinary Incontinence. Lansdale, PA: Hayes, Inc.; July 2003. Update performed 04/13/08.
  31. Holroyd-Leduc JM, Straus SE. Management of urinary incontinence in women: scientific review. JAMA. 2004 Feb 25; 291(8): 986-95.
  32. Imamura M, Abrams P, et al. Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence. Health Technol Assess. 2010 Aug;14(40):1-188, iii-iv. (Accessed 08/28/13)
  33. Knorst, Mara R. et al . Physical therapy intervention in women with urinary incontinence associated with pelvic organ prolapse. Rev. bras. fisioter., São Carlos, v. 16, n. 2, Apr. 2012 . Available at: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1413-35552012000200004&lng=en&nrm=iso
  34. Landefeld CS, Bowers BJ, Feld AD, Hartmann KE, Hoffman E, Ingber MJ, King JT, McDougal WS, Nelson H, Orav EJ, Pignone M, Richardson LH; Rohrbaugh RM, Siebens HC, Trock BJ. National Institutes of Health State-of-the-Science Conference Statement: Prevention of Fecal and Urinary Incontinence in Adults. Ann Intern Med. 2008 Mar;148(6):449-58.
  35. MacDonald R, Fink HA, Huckabay C, Monga M, Wilt TJ. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU INT. 2007 Jul; 100(1): 76-81. Epub 2007 Apr 13.
  36. Magali R, Ross S. The Society of Obstetricians and Gynaecologists of Canada. Clinical Practice Guideline: Conservative Management of Urinary Incontinence. No. 186, December 2006.
  37. Massimo R, Sighinolfi MC, Micali S, De Stefani S, Bianchi G. Sexual Function and Quality of Life in Women with Urinary Incontinence Treated by a Complete Pelvic Floor Rehabilitation Program (Biofeedback, Functional Electrical Stimulation, Pelvic Floor Muscles Exercises and Vaginal Cones). The Journal of Sexual Medicine, Vol. 7, #3, p. 1039-1316. March 2010.
  38. National Institute for Health and Clinical Excellence (NICE). Clinical Guideline 40. Urinary incontinence: the management of urinary incontinence in women, October 2006. Available at: www.nice.org.uk. (Accessed 08/28/13)
  39. National Institutes of Health Consensus and State-of-the Science Statements. Prevention of Fecal and Urinary Incontinence in Adults. Volume 24, Number 1 (2007).
  40. Neumann PB, Grimmer KA, Deenadayalan Y. Pelvic floor muscle training and adjunctive therapies for the treatment of stress urinary incontinence in women: a systematic review. BMC Women’s Health. 2006 Jun 28; 6:11.
  41. Rivalta M, Sighinolfi MC, Micali S. Urinary Incontinence and Sport: First and Preliminary Experience with a Combined Pelvic Floor Rehabilitation Program in Three Female Athletes. Health Care for Women International, 31:435–443, 2010.
  42. Shamliyan T, Wyman J, Bliss DZ, Kane RL, Wilt TJ. Prevention of Fecal and Urinary Incontinence in Adults. Evidence Report/Technology Assessment No. 161 (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-02-0009.) AHRQ Publication No. 08-E003. Rockville, MD. Agency for Healthcare Research and Quality. December 2007. Structured Abstract.
  43. Shamliyan TA, Kane RL, Wyman J, Wilt TJ. Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med. 2008 Mar 18; 148(6): 459-73. Epub 2008 Feb 11.
  44. Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Apr. (Comparative Effectiveness Reviews, No. 36.) Available at: http://www.ncbi.nlm.nih.gov/books/NBK92960/.
  45. U.S. Food and Drug Administration (FDA). 510(K). Summary of safety and effectiveness K090750, RT300. 2009. Accessed 09/21/10.
  46. Wallis MC et al. Pelvic Static Magnetic Stimulation to Control Urinary Incontinence in Older Women: A Randomized Controlled Trial. Clinical Medicine & Research Volume 10, Number 1: 7-14. (2012). (Accessed 08/28/13)

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/26/13.

GUIDELINE UPDATE INFORMATION:

12/15/02

Reformat, review & revision of original Medical Coverage Guideline (10/95).

04/15/03

HCPCS coding update; added G0283.

12/15/03

Review of guideline; no change in coverage statement.

12/15/04

Review and revision of guideline; consisting of updated references.

01/01/06

Review and revision of guideline; consisting of updated references.

11/15/06

Review and revision of guide line consisting of updated references.

07/15/07

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

11/15/08

Scheduled review; no change in position statement. Update references.

01/01/09

Annual HCPCS coding update: deleted 0029T.

11/15/09

Scheduled review; no change in position statement. Update references.

01/01/10

Annual HCPCS coding update: revised descriptor for code 97032.

11/15/10

Scheduled review. No change in position statement; references updated.

11/15/11

Scheduled review. Update description section, maintain position statement and update references.

10/15/12

Scheduled review. Added coverage statement (E/I) for electrical or magnetic stimulation of the pelvic floor muscles for treatment of fecal incontinence and chronic constipation. Revised description and definitions. Updated references.

10/15/13

Scheduled review. Position statement maintained. Revised program exceptions section. Updated references.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/17

Annual CPT/HCPCS update. Revised E0740 descriptor.

Date Printed: August 22, 2017: 07:04 AM