Sacral Nerve Neuromodulation/Stimulation

POLICY NUMBER

A.7.01.69

DESCRIPTION

Sacral nerve neuromodulation, also known as sacral nerve stimulation, involves the implantation of a permanent device that modulates the neural pathways controlling bladder or rectal function. This policy addresses the use of sacral nerve neuromodulation to treat urinary or fecal incontinence, fecal nonobstructive retention, and chronic pelvic pain in individuals with intact neural innervation of the bladder and/or rectum.

Treatment

Treatment using sacral nerve neuromodulation, also known as indirect sacral nerve stimulation, is one of several alternative modalities for individuals with urinary or fecal incontinence (urge incontinence, significant symptoms of urgency-frequency, or nonobstructive urinary retention) who have failed behavioral (e.g., prompted voiding) and/or pharmacologic therapies.

The sacral nerve neuromodulation device consists of an implantable pulse generator that delivers controlled electrical impulses. This pulse generator is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root. Two external components of the system help control the electrical stimulation. A control magnet, kept by the individual, is used to turn the device on or off. A console programmer is kept by the physician and used to adjust the settings of the pulse generator.

Before implantation of the permanent device, individuals undergo an initial testing phase to estimate potential response to treatment. The first type of testing developed was percutaneous nerve evaluation. This procedure is done with the patient under local anesthesia, using a test needle to identify the appropriate sacral nerve(s). Once identified, a temporary wire lead is inserted through the test needle and left in place for 4 to 7 days. This lead is connected to an external stimulator, which is carried by patients in their pocket or on their belt. The results of this test phase are used to determine whether individuals are appropriate candidates for the permanent device. If individuals show a 50% or greater reduction in symptom frequency, they are deemed eligible for the permanent device.

The second type of testing is a 2-stage surgical procedure. In the first stage, a quadripolar-tined lead is implanted (stage 1). The testing phase can last as long as several weeks, and if individuals show a 50% or greater reduction in symptom frequency, they can proceed to stage 2 of the surgery, which is permanent implantation of the neuromodulation device. The 2-stage surgical procedure has been used in various ways. They include its use instead of percutaneous nerve evaluation, for individuals who failed percutaneous nerve evaluation, for individuals with an inconclusive percutaneous nerve evaluation, or for individuals who had a successful percutaneous nerve evaluation to refine individual selection further.

The permanent device is implanted with the individual under general anesthesia. The electrical leads are placed in contact with the sacral nerve root(s) via an incision in the lower back, and the wire leads are extended through a second incision underneath the skin, across the flank to the lower abdomen. Finally, a third incision is made in the lower abdomen where the pulse generator is inserted and connected to the wire leads. Following implantation, the physician programs the pulse generator to the optimal settings for that individual. The individual can switch the pulse generator on and off by placing the control magnet over the area of the pulse generator for 1 to 2 seconds.

This policy does not address pelvic floor stimulation, which refers to electrical stimulation of the pudendal nerve. Pelvic floor stimulation is addressed separately (see the Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence medical policy). Also, this policy does not address devices that provide direct sacral nerve stimulation in individuals with spinal cord injuries.

In 1997, the InterStim® Sacral Nerve Stimulation system (Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for the indication of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments. In 1999, the device received the FDA approval for the additional indications of urgency-frequency and urinary retention in patients without mechanical obstruction. In 2006, the InterStim II System (Medtronic) was approved by the FDA through the premarket approval process for treatment of intractable cases of overactive bladder and urinary retention. The new device is smaller and lighter than the original and is reported to be suited for those with lower energy requirements or small stature. The device also includes updated software and programming options.

In 2011, the InterStim System was approved by the FDA through the premarket approval process for the indication of chronic fecal incontinence in patients who have failed or could not tolerate more conservative treatments.

In 2020, the InterStim X™ device was approved by the FDA. This latest generation of the InterStim device does not require recharging and has a battery life of at least 10 years and up to 15 years if used at a low-energy setting.

The InterStim device has not been specifically approved by the FDA for the treatment of chronic pelvic pain.

In 2019, the Axonics® Sacral Neuromodulation System (Axonics) received premarket approval from the FDA for both fecal incontinence and treatment of urinary retention and symptoms of overactive bladder. This system has a rechargeable battery that has a device life of 15 years after implantation.

In 2023, the Virtis™ Sacral Neuromodulation System (Nuvectra) was approved by the FDA for treatment of urinary retention and symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency in patients who have failed more conservative treatments.

Note: This policy does not address pelvic floor stimulation, which refers to electrical stimulation of the pudendal nerve. Pelvic floor stimulation is addressed separately in the  Pelvic Floor Stimulation as a Treatment of Urinary and Fecal Incontinence  policy. In addition, this policy does not address devices that provide direct sacral nerve stimulation in patients with spinal cord injuries.  

POLICY

Urinary Incontinence and Non-obstructive Retention

Criteria A

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in individuals who meet all of the following criteria:

1. There is a diagnosis of at least one of the following:

   1. Urge incontinence

   2. Urgency-frequency syndrome 

   3. Non-obstructive urinary retention 

   4. Overactive bladder.

2. There is documented failure or intolerance to at least two conventional conservative therapies (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy).

   1. The individual is an appropriate surgical candidate.

   2. Incontinence is not related to a neurologic condition.

Criteria B

Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in individuals who meet all of the following criteria:

1. All of criteria A.1 and 2 above are met.

2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Other urinary/voiding applications of sacral nerve neuromodulation are considered investigational, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition (eg, detrusor hyperreflexia, multiple sclerosis, spinal cord injury, or other types of chronic voiding dysfunction).

Fecal Incontinence

Criteria A

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in individuals who meet all of the following criteria:

1. There is a diagnosis of chronic fecal incontinence of greater than 2 incontinent episodes on average per week for more than 6 months or for more than 12 months after vaginal childbirth.

2. There is documented failure or intolerance to conventional conservative therapy (eg, dietary modification, the addition of bulking and pharmacologic treatment) for at least a sufficient duration to fully assess its efficacy.

3. The individual is an appropriate surgical candidate.

4. The condition is not related to an anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) or chronic inflammatory bowel disease.

5. Incontinence is not related to a neurologic condition.

6. The individual has not had rectal surgery in the previous 12 months, or in the case of cancer, the individual has not had rectal surgery in the past 24 months.

Criteria B

Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in individuals who meet all of the following criteria:

1. All of criteria A.1 through 6 above are met.

2. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

Sacral nerve neuromodulation is considered investigational in the treatment of chronic constipation or chronic pelvic pain. 

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

The International Continence Society has defined overactive bladder syndrome as "urinary urgency, usually accompanied by increased daytime frequency and/or nocturia, with urinary incontinence (OAB-wet) or without (OAB-dry), in the absence of urinary tract infection or other detectable disease" (available at https://www.ics.org/glossary/symptom/overactivebladderoaburgencysyndrome) .

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/1998: Approved by the Medical Policy Advisory Committee (MPAC), HCPCS E0751, E0753 added.

5/21/2001: Code Reference section revised; E0751 deleted, typo 64586 should be 64585, ICD-9 diagnosis codes added, CPT code 95972, 95973 added.

2/15/2002: Investigational definition added.

2/21/2002: CPT codes updated in the policy section, HCPCS E0751 added.

5/2/2002: Type of Service and Place of Service deleted.

5/30/2002: ICD-9 procedure code 04.93 added.

6/21/2004: Sources updated, Code Reference section updated, HCPCS E0751, E0753 deleted, HCPCS E0752, E0754, E0759 added, CPT codes 95970, 95971 description revised, CPT 95972, 95973 deleted, ICD diagnosis code range 788.20-788.29 listed separately.

2/21/2005: CPT code 64561, 64555, 64581, 64590 description revised, ICD-9 procedure code 04.92, 04.93 description revised, HCPCS E0745 description revised.

10/18/2005: Policy Guidelines updated.

11/15/2005: ICD9 procedure codes 86.97, 86.98 added.

3/21/2006: Coding updated. HCPCS 2006 revisions added to policy.

3/23/2006: Policy reviewed, no changes.

9/22/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.

1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions.

1/3/2007: Policy section re-written for clarification.

9/18/2007: Policy reviewed, no changes. Title of policy changed to "Sacral Nerve Neuromodulation/Stimulation for Pelvic Floor Dysfunction", formerly titled "Sacral Nerve Stimulation (SNS) for Urinary Incontinence."

12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions.

7/23/2009: Policy Statement Section updated to include criteria for medically necessary treatments of urge incontinence, urgency-frequency, and non-obstructive urinary retention, Code Reference Section updated with ICD-9 Procedure codes 04.92 and 86.94 added to Covered Codes Table for second step, CPT codes 95972 and 95973 added to Covered Codes Table for third step, Deleted HCPCS codes E0754, E0756, E0757, and E0758 removed from Covered Codes table second step.

06/24/2010: Policy description updated to include information regarding sacral nerve neuromodulation for fecal incontinence. Policy statement regarding fecal incontinence changed from investigational to medically necessary under specified conditions. FEP verbiage added to the Policy Exceptions section. Added ICD-9 code 787.6 to the Covered Codes table. 

10/19/2010: Annual ICD-9 code update: 787.6 deleted/expanded to the fifth digit. Added 787.60 and 787.63 to the Covered Codes table. 

07/29/2011: Policy description updated regarding available devices. Policy statement unchanged.

07/12/2012: Policy statement regarding Urinary Incontinence and Non-obstructive Retention divided into two parts for trial and permanent implantation. Deleted outdated references from the Sources section.

11/15/2013: Deleted "for Pelvic Floor Dysfunction" from the policy title. Policy statement updated as follows: Length of successful percutaneous test stimulation in medically necessary statements changed from at least 2 weeks to at least 1 week. Fecal incontinence policy statement separated into 2 statements; 1 on trial stimulation and 1 on permanent implantation. Edits made to statements so that criteria for fecal and urinary incontinence are similar, when applicable.

07/16/2014: Policy reviewed; description updated regarding a second type of testing to estimate potential response to treatment. Medically necessary policy statement regarding a trial period of sacral nerve neuromodulation updated to add "syndrome" and "Overactive bladder" to the patient criteria. Policy guidelines updated to define overactive bladder syndrome as stated by the International Continence Society.

08/26/2014: Policy reviewed; description updated. First medically necessary policy statement regarding fecal incontinence revised for clarity: 1) Removed "performed more than 12 months [or 24 months in case of cancer] previously" from second criteria statement. It previously stated: There is documented failure or intolerance to conventional conservative therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, performed more than 12 months [or 24 months in case of cancer] previously). 2) Added the following statement: The patient has not had rectal surgery in the previous 12 months, or in the case of cancer, the patient has not had surgery in the past 24 months.

12/31/2014: Code Reference section updated to revise the description of the following CPT code: 95972.

08/31/2015: Medical policy revised to add ICD-10 codes. Code Reference section updated to add ICD-9 procedure code 04.93 to the Covered Codes table for steps 2 and 4. Added ICD-9 procedure codes 04.92, 86.94, and 86.97 to the Covered Codes table for step 4.

11/16/2015: Policy description updated. Policy section updated to make the following changes to the Urinary Incontinence part B section: "I. A (1-4)" was corrected and changed to "A. 1-4" and the period of trial stimulation changed from "1 week" to "48 hours." Fecal Incontinence criteria for A.2 was updated to close parentheses after "pharmacologic treatment." It previously stated: There is documented failure or intolerance to conventional conservative therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment for at least a sufficient duration to fully assess its efficacy)." Fecal Incontinence part B section was updated to make the following changes: "I. A (1-5)" was corrected and changed to "A. (1-6)" and the period of trial stimulation changed from "1 week" to "48 hours." Policy guidelines section updated to add medically necessary and investigative definitions.

12/31/2015: Code Reference section updated to revise the code description for CPT code 95972.

05/31/2016: Policy number A.7.01.69 added.

09/30/2016: Code Reference section updated to add the following new ICD-10 procedure codes: 05H00MZ, 05H03MZ, 05H04MZ, 05H30MZ, 05H33MZ, 05H34MZ, 05H40MZ, 05H43MZ, 05H44MZ, 05P002Z, 05P00MZ, 05P03MZ, 05P04MZ, 05P0XMZ, 05P30MZ, 05P33MZ, 05P34MZ, 05P3XMZ, 05P40MZ, 05P43MZ, 05P44MZ, 05P4XMZ.

01/30/2017: Policy description updated. Policy statements unchanged.

05/04/2018: Policy description updated. Policy statements unchanged. Policy Guidelines updated to define overactive bladder syndrome.

12/21/2018: Code Reference section updated to revise code descriptions for CPT codes 95970, 95971, and 95972, effective 01/01/2019.

05/13/2019: Policy reviewed; no changes.

05/22/2020: Policy description updated to remove information regarding urinary and fecal incontinence. Policy section updated to add headings for the listed criteria. Policy Guidelines updated regarding the definition of overactive bladder and to remove information regarding sacral nerve stimulation steps.

07/20/2021: Policy reviewed. Medically necessary statement under Criteria A for urinary incontinence and non-obstructive retention updated to change "conventional therapies" to "conventional conservative therapies." Medically necessary statement under Criteria A for fecal incontinence updated with a minor edit to the policy statement; intent unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

12/13/2021: Code Reference section updated to revise code description for CPT codes 64575 and 64581, effective 01/01/2022.

06/01/2022: Policy reviewed; no changes.

06/06/2023: Policy description updated regarding devices. Policy statements updated to change "patients" to "individuals."

12/21/2023: Code Reference section updated to add new 2024 CPT codes 64596, 64597, and 64598. Revised the code description for CPT codes 64590 and 64595, effective 01/01/2024.

05/21/2024: Policy description updated to change "patient" to "individual." Policy statements unchanged.

05/14/2025: Policy description updated regarding pelvic floor stimulation. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy #7.01.69

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

1. In the first step, the patient undergoes a peripheral nerve stimulation test to determine candidacy for permanent implantation. A temporary test needle is placed percutaneously onto the sacral nerve. The following codes may be used to describe the stimulation test:

2. Those patients with a positive result of the peripheral nerve stimulation test will undergo permanent implantation of the electrode and pulse generator. The following codes may be used:

3. Some patients will require analysis and reprogramming of the device once implanted. The following codes may be used:

4. Some patients may require revision or removal of the implanted electrodes or pulse stimulator. The following codes may be used:

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