Friday, January 18, 2019

CPT 64561, 64581, A4290, E0745, L8679 - Sacral Nerve neuromodulation

Introduction

The brain communicates with the body by sending electrical signals along nerves. When it comes time to go to the bathroom, the brain sends signals to specific nerves that travel throughthe lower back to the muscles that control the opening and closing of the bladder and bowel.

Weak electrical signals may be used to address certain kinds of bowel and bladder problems that have not responded to other treatments. This procedure is known as sacral nerve neuromodulation. Another name for it is sacral nerve stimulation. This procedure involves implanting a small device under the skin in the lower back area. Small wires are also implanted so that the electric current activates the nerve important to either bladder or bowel function. This treatment usually is done in two steps. The first is a temporary placement to find out if sacral nerve stimulation works. The second is surgery to place the permanent implant. This policy describes when sacral nerve stimulation may be considered medically necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Service Medical Necessity Urinary Incontinence and Non-obstructive Retention Sacral nerve neuromodulation

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in patients who meet ALL of the following criteria:
* There is a diagnosis of at least one of the following:
o Urge incontinence
o Urgency-frequency syndrome
o Nonobstructive urinary retention
o Overactive bladder AND

* There is documented failure or intolerance to at least 2 conventional conservative therapies (eg, 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) AND

* The patient is an appropriate surgical candidate (see Definition of Terms) AND

* Incontinence is not related to a spinal cord injury or progressive, systemic neurologic condition (such as multiple sclerosis or diabetic neuropathy) Permanent implantation, sacral nerve neuromodulation device Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in patients who meet ALL of the following criteria:

* All of the criteria above are met AND

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

Fecal Incontinence

Sacral nerve neuromodulation


A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted


Service Medical Necessity lead may be considered medically necessary in patients who meet all of the following criteria:

* There is a diagnosis of chronic fecal incontinence of more than 2 incontinent episodes on average per week for more than 6 months, or for more than 12 months after vaginal childbirth AND
* 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 AND
* The patient is an appropriate surgical candidate (see Definition of Terms) AND
* The condition is not related to an anorectal malformation (eg, 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 AND
* Incontinence is not related to a spinal cord injury or progressive, systemic neurologic condition (such as multiple sclerosis or diabetic neuropathy) AND
* The patient has not had rectal surgery in the previous 12 months, or in the case of rectal cancer, the patient has not had rectal surgery in the past 24 months Permanent implantation, sacral nerve neuromodulation device Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in patients who meet all of the following criteria:
* All of the criteria above are met AND
* A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.


Service Investigational

Other applications, urinary incontinence and nonobstructive retention 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). Other applications, chronic constipation or chronic pelvic pain Sacral nerve neuromodulation is investigational in the treatment of chronic constipation or chronic pelvic pain. Coding Sacral nerve neuromodulation involves several steps that are identified by the following codes.

Code Description CPT


64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)

64581 Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)

A4290 Sacral nerve stimulation test lead, each
E0745 Stimulator electronic shock unit
L8679 Implantable neurostimulator, pulse generator, any type
L8680 Implantable neurostimulator electrode each (Note: Reported with 1-unit for each contact point on the implanted lead)
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


Related Information Definition of Terms

Inappropriate surgical candidates: Includes patients with bleeding disorders, anatomical limitations, skin disease at risk for infection, psychiatric disease, or patients who are pregnant.30 Overactive bladder (OAB): The International Continence Society has defined that overactive bladder syndrome as “urinary urgency, with or without urgency urinary incontinence, usually with increased daytime frequency and nocturia…” (available online at http://wiki.ics.org/Overactive+Bladder, Accessed May 2018).

Evidence Review Description


Sacral nerve neuromodulation (SNM), 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 use of SNM in the treatment of urinary or fecal incontinence, urinary or fecal nonobstructive retention, an


Background

Urinary and Fecal Incontinence


Urge incontinence is defined as leakage of urine when there is a strong urge to void. Urgencyfrequency is an uncontrollable urge to urinate, resulting in very frequent, small volumes and is a prominent symptom of interstitial cystitis (also called bladder pain syndrome). Urinary retention is the inability to empty the bladder of urine completely. Fecal incontinence can arise from a variety of mechanisms, including rectal wall compliance, efferent and afferent neural pathways,  central and peripheral nervous systems, and voluntary and involuntary muscles. Fecal incontinence is more common in women, due mainly to muscular and neural damage that may occur during vaginal delivery.

Treatment

Treatment using sacral nerve neuromodulation, also known as indirect sacral nerve stimulation, is one of several alternative modalities for patients with urinary or fecal incontinence (urge incontinence, significant symptoms of urgency-frequency, nonobstructive urinary retention) who have failed behavioral (eg, 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 patient, 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, patients undergo an initial testing phase to estimate potential response to treatment. The first type of testing developed was percutaneous nerve evaluation (PNE). 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 patients are appropriate candidates for the permanent device. If patients 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 patient  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 PNE, for patients who failed PNE, for patients with an inconclusive PNE, or for patients who had a successful PNE to refine patient selection further.

The permanent device is implanted with the patient 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 patient. The patient can switch the pulse generator between on and off by placing the control magnet over the area of the pulse generator for 1 to 2 seconds.

Summary of Evidence

For individuals with urinary incontinence who have failed conservative treatment who receive SNM, the evidence includes randomized controlled trials (RCTs), systematic reviews, and case series. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity.

Results from the RCTs and case series with long-term follow-up have suggested that SNM reduces symptoms of urge incontinence, urgency-frequency syndrome, nonobstructive urinary retention, and overactive bladder in selected patients. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. For individuals with fecal incontinence who have failed conservative treatment who receive SNM, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. Although relatively small, the available trials had a low risk of bias and demonstrated improvements in incontinence relative to alternatives. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with constipation who have failed conservative treatment who receive SNM, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. The available trials have not consistently reported improvements in outcomes with SNM. Additional studies are needed to demonstrate the health benefits of this technology. The evidence is insufficient to determine the effects of the technology on health outcomes.


For individuals with chronic pelvic pain who receive SNM, the evidence is limited to case series. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. The

Clinical Input Received from Physician Specialty Societies and Academic Medical Centers


While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received from 4 physician specialty societies and 2 academic medical centers while this policy was under review in 2012. Reviewers from 2 specialty societies and 2 academic medical centers provided opinions on the possible medical necessity of implantable leads for test stimulation, as part of a 2-stage process for device implantation. All 4 respondents supported the use of implantable leads for test stimulation as an alternative to percutaneous test stimulation for patients who had failed percutaneous test stimulation and/or for patients with inconclusive percutaneous test stimulation. Reasons for support included a longer period of interrupted treatment with stage-1 stimulation due to less lead migration and a higher rate of positive tests compared with percutaneous test stimulation.

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