Clinical Policy: Urinary Incontinence Devices and Treatments Form

CENTENE®  
Corporation  

Clinical Policy: Urinary Incontinence Devices and Treatments  
Reference Number: CP.MP.142  
Date of Last Revision: 11/23  
Coding Implications  
Revision Log  

See Important Reminder at the end of this policy for important regulatory and legal information.  

Description  
Sacral neuromodulation (SNM) or sacral nerve stimulation (SNS) refers to stimulation of nerves that innervate the bladder and pelvic floor to treat lower urinary tract dysfunction. SNS involves both a temporary test stimulation to determine if an implantable stimulator would be effective, and a permanent implantation in appropriate candidates.  

Urethral bulking agents (UBAs) are injectable substances used to increase tissue bulk, which can be injected periurethrally to treat urinary incontinence. The U.S. Food and Drug Administration (FDA) has approved several bulking agent products for treating urinary incontinence.¹²  

Note:  
- For biofeedback treatment for urinary incontinence, please refer to CP.MP.168 Biofeedback.  
- For posterior tibial nerve stimulation treatment for urinary incontinence, please refer to CP.MP.133 Posterior Tibial Nerve Stimulation for Voiding Dysfunction.  

Policy/Criteria  
  

  


CLINICAL POLICY  
Urinary Incontinence Devices and Treatments  

  

IV. It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence in the published peer-reviewed literature to support the use of UBA injection of autologous fat, non-FDA approved procedures, and any other circumstances than those specified above.  

Background  
The three major categories of treatment for urinary incontinence are behavioral, pharmacologic and surgical. The first choice should be the least invasive treatment with the fewest potential adverse complications for the patient. Before treatment begins, a complete evaluation and appropriate urodynamic testing should be completed.  

Sacral neuromodulation (SNM)  
SNM, a minimally invasive form of electrical stimulation, is delivered via the InterStim system. This implantable system involves chronic modulation of the S3 and, less frequently, the S4 nerve via a transforaminal route. A wire lead in the foramen is connected to a stimulation device. Modulation implies that the therapy is thought to act indirectly, via a central afferent mechanism, targeting reflex centers in the spinal cord and pons, influencing reflexes between the bladder, urethral sphincter, and pelvic floor. Stimulation implies a more direct effect on efferent nerves, as in functional electrical stimulation.  

A distinct advantage of SNM is that it is tested for potential success prior to surgical implantation of a permanent device. The evaluation gives patients and physicians an opportunity to find out in as few as three to seven days whether adequate symptom reduction is achieved. The most common adverse events experienced during clinical studies of patients with SNM included pain at implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations. Any of these may require additional surgery or cause return of symptoms.  

In the United States, SNM is approved for the treatment of nonobstructive urinary retention. Success rates in general are not as promising as for urgency urinary incontinence and overactive bladder, but it is reasonable to try prior to more invasive and permanent solutions.¹  

American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU)  
AUA/SUFU recommendations state that clinicians may offer SNM as third-line treatment for carefully selected patients who have severe refractory OAB symptoms or who are not candidates for second-line therapy and are willing to undergo a surgical procedure. Recommendation (Grade C; benefits outweigh risk/burdens).³  

National Institute for Health and Care Excellence (NICE)  
According to NICE, sacral nerve stimulation (SNS) can be recommended for those with urge incontinence and urgency-frequency when the patient understands what is involved and agrees to the treatment. SNS should only be tried when other treatments for incontinence have been unsuccessful, changes in daily lives have been made, or learning techniques to help control the bladder, have been put in place.⁸  

Periurethral Bulking Agents  
Urethral bulking agent (UBA) therapy, also known as periurethral injection therapy, is rarely used as a primary treatment for stress urinary incontinence (SUI) but remains an option for women with persistent/recurrent SUI who wish to avoid surgery or who are unable to tolerate surgical procedure.⁹ Although UBA is an option for this type of incontinence, it can be more invasive and usually requires repeat injections. The most common complications associated with UBA are urinary retention and urinary tract infection, but these are easily managed.³,10,11,12  

Candidates for periurethral bulking agents also include women and men who are incontinent after prostate surgery. UBA used to treat intrinsic sphincteric deficiency is being performed less frequently in current practice. Surgical interventions are generally more efficacious in both, whereas injectable therapy can be considered in cases in which surgery is contraindicated or as an adjunct to surgery if symptoms persist. In women with severe intrinsic sphincter deficiency or urethral hypermobility, the best long-term results are obtained with a pubovaginal sling or retropubic bladder neck suspension procedure.³,10,11,12  

United States Food and Drug Administration (FDA) approved products for periurethral injection therapy include:  
- Carbon-coated zirconium oxide beads suspended in a water-based gel (Durasphere EXP, FDA approved in 1999)  
- Crosslinked polydimethylsiloxane (Macroplastique, FDA approved October 30, 2006)  


Evidence in major reviews shows low efficacy rates compared with surgical incontinence therapies, a need for repeat treatments because of symptom recurrence, and problems with the injection of some synthetic agents.  

Currently, there has been increased interest in autologous skeletal muscle derived stem cell injections for the treatment of SUI specifically due to intrinsic urinary incontinence. This therapy involves obtaining a biopsy of the patient’s skeletal muscle, which is then processed ex vivo to ensure a large quantity of myogenic cells in the product. The product is then injected into the urethral sphincter, transurethrally or periurethrally. Additional peer-reviewed studies are necessary to confirm the efficacy of this treatment.¹⁰  

Coding Implications  
This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2022, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. The inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.  

| CPT® Codes | Description |
|------------|-------------|
| 51715 | Endoscopic injection of implant material into the submucosal tissue of the urethra and/or bladder neck |
| 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 electrode array |
| 64590 | Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling |
| 64595 | Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver |

| HCPCS Codes | Description |
|-------------|-------------|
| A4290 | Sacral nerve stimulation test lead, each |
| L8603 | Injectable bulking agent, collagen implant, urinary tract, 2.5 ml syringe, includes shipping and necessary supplies |


| HCPCS Codes | Description |
|-------------|-------------|
| L8606 | Injectable bulking agent, synthetic implant, urinary tract, 1 ml syringe, includes shipping and necessary supplies |
| 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, nonrechargeable, includes extension |
| L8687 | Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension |
| L8688 | Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension |
| L8689 | External recharging system for battery (internal) for use with implantable neurostimulator, replacement only |

| Reviews, Revisions, and Approvals | Date | Approval Date |
|----------------------------------|------|---------------|
| Policy adopted from Health Net NMP#215, Urinary Incontinence Devices and Treatments. Formerly, up to 5 UBA treatments were noted as covered, and beyond that would be considered a treatment failure. However, since this specific information could not be found in references, it was removed. | 04/17 | 04/17 |
| SNM: Changed order of criteria regarding symptoms and diagnosis. Added frequency/urgency as an acceptable symptom in I.B; added overactive bladder as an indication in I.A; added pharmacotherapy and self-catheterization, if tolerated, as required conservative measures for urinary retention in I.D; added to I.E. that urgency/frequency, or retention symptoms should be reduced by a trial of SNM by 50% if present. | 03/19 | 03/19 |
| UBAs: Added an indication for post-bladder support surgery; in II.C. added not having to have surgery as a reason to have UABs injected. Specialist reviewed. References reviewed and updated. |  |  |
| Separated out criteria for trial and placement of SNM, with trial criteria being the same as permanent placement, excluding the permanent placement requirement for a positive response to the trial. | 10/19 | 10/19 |
| References reviewed and updated. Added ICD-10: R35.0. | 02/20 | 03/20 |


| Reviews, Revisions, and Approvals | Date | Approval Date |
|----------------------------------|------|---------------|
| Annual reviewed completed; references reviewed and updated, codes reviewed. Specialist reviewed. Replaced “member” with “members/enrollees” in all instances. | 03/21 | 03/21 |
| Annual review. Replaced investigational language in IV, to “insufficient evidence in the published peer-reviewed literature to support the use of UBA injection of autologous fat, non- FDA approved procedures, and any other circumstances than those specified above.” Added HCPCS code A4290. Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date.” References reviewed, updated and reformatted. Reviewed by specialist. | 11/21 | 11/21 |
| Annual review. Updated criteria section to clarify abbreviations. Criteria I.D. # 1 updated to include continence-support pessaries as a conservative measure. Updated background with no impact on criteria. Removed ICD-10 codes. References reviewed and updated. | 11/22 | 11/22 |
| Removed continence support pessaries from criteria I.D.1. Revised order in which conservative therapies are listed in I.D.2. | 06/23 | 06/23 |
| Annual review. Added note under Description to refer to CP.MP.133 Posterior Tibial Nerve Stimulation for Voiding Dysfunction. Updated criteria I.B. from, urinary retention have been present for at least 12 months, to urinary retention have been present for at least 6 months. Minor rewording in Criteria with no clinical significance. Background updated with no impact on criteria. References reviewed and updated. Reviewed by external specialist. | 11/23 | 11/23 |

  

Important Reminder  


This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.  

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.  

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.  

This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Members/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.  

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.  

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein is strictly prohibited. Providers, members/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.  

Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.  

Note: For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.  

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