Response to Comments: Sacral Nerve Stimulation for the Treatment of Urinary and Fecal Incontinence

I perform basic testing for chronic fecal incontinence with Medtronic Interstim. The patients I treat come to me as a last resort in hopes to have a normal life again. Most patients are confined to their home given the amount of fecal incontinence they experience and cannot go out in public. The primary goal of basic testing and trial phase is for 50% clinical improvement. Since I do basic testing, the FDA only allows the leads to be in place for 7 days. If these leads are left any longer the patient is at an increased risk of infection. I have placed many basic leads over the past year and most patients notice the benefit of stimulation before the 7 days is over. I have had only 1 patient that needed to undergo phase 1 testing which is longer than 7 days before deciding if this was beneficial for her. Seven days is plenty of time to know if the Medtronic Interstim is giving clinical improvement of 50%. I recommend Palmetto GBA removes more than 1 week from the Fecal Incontinence (FI) section.

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

Chronic Fecal incontinence is an extremely debilitating condition for patients, and we appreciate Palmetto GBA’s support and coverage for this life-changing therapy.

At Issue: The Fecal Incontinence (FI) criteria section states: “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 1 week) improvement in symptoms;”

• FDA labeling for trial leads is only approved for 7 days: Many providers test FI patients using a disposable basic evaluation lead. The FDA-approved manual states: “The lead is a temporary device intended to be implanted for no more than 7 days.” Trialing beyond 7 days would put the patient at risk for infection.
• FDA labeling for Sacral Nerve Stimulation therapy during the trial phase for FI patients does not require a duration of more than 1 week. The primary objective of the trial is to achieve a 50% improvement.
• Commercial payer coverage: Almost all commercial carriers only require a 50% improvement in FI symptoms during the trial. Virtually no policies require a more than 1 week trial. There are a couple payers that require the trial be at least 48 hours. This is consistent with FDA recommended use for the trial lead.
• Many providers often document a 50% improvement in FI patients within 3-5 days. Additionally, there have been no reported adverse events or patients receiving less than optimal treatment if their trial phase was less than a week.

Summary

• A more than 1 week trial contradicts the FDA-approved use of the trial lead and places patients at risk of infection is implanted beyond 7 days. These leads are widely used nationally by providers trialing fecal incontinent patients often achieving a 50% improvement within 3-5 days.

Request: We are asking Palmetto GBA to remove the phrase “more than 1 week” found in proposed LCD DL39543. This would make the testing phase consistent with FDA labeling of the trial lead and help to minimize patient infection.

Thank you for your consideration and for covering this vital, life-changing therapy for your Medicare patients.

References and sample coverage policies were provided for review.

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

It has come to my attention that Palmetto will be requiring Fecal Incontinence (FI) trials to last "more than 1 week". This is concerning, because the FDA has only approved Peripheral Nerve Evaluation (PNE) for sacral nerve stimulators for less than 1 week. How is it possible for a clinician to simultaneously abide by the FDA recommendation while adhering to your new policy of "more than 1 week"?

Patients with fecal incontinence suffer from severe life-changing / embarrassing situations. It affects their quality of life and ability to work. FI reduces work productivity and increases likelihood of urinary tract infections and serious long term side effects. This can have devastating outcomes in my patient's overall health.

By including the language "more than 1 week" for FI trials, this would effectively make it impossible to safely evaluate patients with a device that is only approved for less than 1 week. Please consider changing this language.

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

I regularly take care of patients with both fecal incontinence and urinary incontinence. I have been involved in sacral nerve stimulation for the treatment of both urinary and fecal incontinence now for nearly 10 years. Fecal incontinence is an incredibly distressing condition for affected patients, and it is important to give patients access to the most effective therapy options available to enable them to live their most complete lives free from the social stigma of FI.

I have thoroughly read the verbiage under the Fecal Incontinence (FI) documentation requirements contained in LCD DL39543. I am writing to explain why the verbiage “(more than 1 week)” under the FI definition of a successful percutaneous test stimulation would be grossly in error as a deviation from standard practice, and indeed from FDA guidelines, and would have the effect of limiting patient access to best practice care.

Percutaneous test stimulation can either be done in the office with basic evaluation or in the operating room under general anesthesia with advanced evaluation. The advanced evaluation protocol in the operating room requires 2 separate operating room visits, separated by up to 2 weeks, with 2 separate anesthesia events for the patient.

The protocol for basic evaluation in the office is especially appealing to patients as it reduces barriers to access of care by removing the necessity of 2 separate operating room visits and 2 separate anesthesia events. Patients can have basic evaluation leads placed in the office under simple local anesthetic. These leads are approved for implantation for up to 7 days per FDA labeling. Standard of care, and indeed this FDA labeling, requires that these leads are removed by 7 days post implantation, with efficacy suggested by at least 50% improvement in FI episodes during this up to 7-day trial period.

Alternatively, advanced evaluation protocol leads use a different implantation system that is more invasive and requires a 2-step, 2 surgical day approach with 2 separate visits to the operating room. This trial period is FDA approved for up to 2 weeks. This advanced evaluation protocol indeed would be appropriate to use for patients who have infrequent FI episodes requiring longer than the 7-day evaluation possible through the simpler basic evaluation.

If this proposed LCD goes forward as written, the phrase “(more than 1 week)” will negate the possibility of appropriate basic evaluation for FI patients, and will require all of them to go through the more invasive advanced evaluation protocol process described above. Many of my patients are older, and the prospect of having to go through 2 separate anesthesia events with 2 separate full operating room procedures within 2 weeks would pose unacceptable barriers to care. The basic evaluation leads are by label FDA approved for up to 7 days, which is inherently incompatible with your proposed LCD verbiage.

One other unintended consequence of this proposed LCD verbiage is that indeed fewer patients will be offered the highly effective sacral nerve stimulation therapy for FI. Many local gastroenterologists engage in the treatment algorithm for FI by offering basic evaluation in their own practices (again FDA approved by label for up to 7 days total trial). They then refer patients with successful trials to specialists such as myself for implantation of the sacral nerve stimulation systems. Their engagement in this evaluation process ensures that more patients indeed are considered for and offered this important effective therapy. These proposed changes in the LCD verbiage would have the unintended effect of negating their ability to provide such basic evaluations, and would result in less patients being offered or considered for this therapy.

I am hereby strongly requesting that the verbiage “(more than 1 week)” be removed from this LCD, as there simply is not the need for this verbiage, which would otherwise have the unintended effect of negating the potential for basic evaluation protocols in the office setting, and create unintended barriers to care that do not need to exist. There is already standard of care practice to address patients who have infrequent FI episodes and who require longer evaluation - these patients indeed should have the advanced evaluation for up to 2 weeks. It should not however be the purpose of this proposed LCD to mandate against the role of basic evaluation in the appropriate patient, and to remove the ability for clinical judgment from the clinician. The patient and the provider should retain the clinical freedom to decide what is in the best interest of that individual patient, either to utilize basic evaluation protocols or advanced evaluation protocols. The verbiage of this proposed LCD would steal that decision away from the patient and the clinician.

I urge you please to remove the verbiage “(more than 1 week)” from this LCD. To leave this verbiage in place will do harm to patient care.

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

I have heard of a negative to the Palmetto GBA DL39543 policy regarding InterStim trials and needing the trial to be more than 1 week.

This is a bad idea and will negatively impact patients. The primary goal of the trial phase is to achieve a 50% improvement in their symptoms. Patients almost always can see improvement within the first day and usually require no more than 5 days to notice if they are responding to sacral neuromodulation. The pudendal nerve evaluation trials are approved for up to 7 days per FDA patients are at risk of infection past 7 days or more than a week of trailing. We recommend removing the leads after 4 to 5 days so it's not to cause dangerous complications.

Mandating a trial last more than 7 days will likely cause harm to patients without providing any clinical benefit.

Please do not pass this change.

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

Fecal Incontinence (FI) affects our patient's quality of life in that they cannot leave their home for extended periods of time. The patient's that we have used sacral nerve stimulation therapy on have been very pleased with the results. Upon placement of the trial leads the patient experiences results in 3 to 5 days. We remove the temporary leads by the 7th day per FDA guidelines, as the leads are approved for trialing only up to 7 days per FDA-labeling. There being a risk of infection after this time frame.

It is my recommendation that Palmetto GBA remove the "more than 1 week" language from the FI section. If the language of the proposed policy change takes effect, patients will be required to have a more invasive Advanced Evaluation that entails general anesthesia, a permanent scar and higher risk of infection. The 7-day Basic Evaluation is the least invasive way to see if sacral neuromodulation will benefit the patient. When the patient has a Basic Evaluation and the leads are removed, they are exactly the same as they were before the Basic Evaluation.

Why would you want to make a simple diagnostic test more invasive?

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

I am writing this letter in regard to the verbiage under the Fecal Incontinence (FI) documentation requirements contained in DL39543 LCD. This verbiage “(more than 1 week)” under the FI definition of a successful percutaneous test stimulation is erroneous and directly contradictory to both current standard of care and FDA labeling. My role in the evaluation of sacral nerve stimulators is to place the temporary, external stimulator prior to consideration of permanent surgically implanted devices. The standard of care is to have the temporary stimulator for 5 days, during which symptom relief is quantified. To extend the trial beyond the standard of care 5-day trial could lead to dangerous complications such as stimulator lead site infection and central nervous system infection.

I would strongly advise that this verbiage be adjusted or dropped from DL39543 LCD.

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

I use sacral neuromodulation for both fecal and urinary incontinence. Pertaining to the possible change in guidelines for fecal incontinence for a trial period greater than 7 days, there is a great concern with increased infection risk and not being aligned with FDA approval. I routinely leave my trial period leads for 7 days in both urinary and fecal incontinence patients and feel that this is all the time that is necessary. In addition to this, with the trial period patients cannot bathe, it is pretty hard for them not to bathe for the 7 days. It would be more difficult for them to not bathe for an even longer period of time. This treatment makes such a large impact for quality of life. It should not be made more difficult to achieve for this patient subset.

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

I have concerns about this proposal. In office assessments are indicated for up to 7 days not at least 7 days. The data is usually clear within 3 days. These are often elderly patients who do not need a test prolonged with the accompanying inconvenience and risk of wire infection for no clinic benefit.

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

The comment below was received multiple stakeholders:

We strongly urge the Center for Medicare and Medicaid Services (CMS) to revise the Local Coverage Determination for Sacral Nerve Stimulation (SNS) for the Treatment of Urinary and Fecal Incontinence (LCD: DL39543) to address the critical unmet needs of people with neurogenic bladder and bowel dysfunction, particularly those living with spinal cord injury (SCI).

Currently, the covered indications for SNS include limitations on coverage for people with neurogenic bowel and bladder. Limitations related to coverage for urinary incontinence include the following language:

“Patients with stress incontinence, urinary obstruction, and specific neurologic disease (e.g., diabetes with peripheral nerve involvement, multiple sclerosis, spinal cord injury) which are associated with secondary manifestations of the above 3 indications are excluded.”

Limitations related to coverage for fecal incontinence include the following language:

“Incontinence is not related to another neurologic condition such as peripheral neuropathy or complete spinal cord injury.”

As outlined in our rationale, below, we assert that people living with spinal cord injury can benefit from Sacral Nerve Stimulation, and that these technologies are reasonable and necessary for this population.

There is a critical unmet need of people living with spinal cord injury for bladder and bowel management solutions. Over 250,000 people in the U.S. have a spinal cord injury and there are 10,000 new cases each year (1). Urinary incontinence is 1 of the leading causes of morbidity in persons with spinal cord injury (SCI) and is associated with decreased quality of life (2, 3) and high financial costs (4,5). The vast majority of individuals with SCI, both male and female, have neurogenic detrusor overactivity (NDO) (6), consisting of bladder overactivity, in which the bladder contracts spontaneously at small fluid volumes (7). NDO can cause high pressure voiding with little urination, large post-void residual volumes, and low bladder compliance, resulting in frequent urinary tract infections, ureteric reflux and obstruction, and episodes of autonomic dysreflexia with dangerous rises in blood pressure (8). Therefore, restoring bladder control is of major importance for individuals with SCI and NDO.

Current treatments insufficiently address NDO. Bladder overactivity can lead to low bladder capacity, incontinence, and other complications, and can be managed using a number of different methods (6). Timed voiding strategies, intermittent or indwelling catheterization, pharmaceuticals, or surgery can help manage bladder dysfunction, but do not restore function. Catheterization and pharmaceutical methods both have significant side effects and are not well tolerated. Dorsal rhizotomy, which constitutes surgical cutting of the sensory afferent nerves, ablates reflexive contractions of the bladder wall but it is a permanent surgical intervention and is also not well accepted (9, 10). Individuals living with SCI report that current solutions insufficiently address their bladder and bowel needs, and they continue to live with significant challenges associated with their bladder and bowel management (11).

Sacral neuromodulation can restore bladder and bowel control for individuals with SCI. Urinary and fecal continence can be improved in some able-bodied participants with urgency, frequency, and urge incontinence by electrical stimulation of sacral mixed nerves – i.e. sacral neuromodulation. Sacral neuromodulation requires an initial 1-month trial phase wherein a temporary lead is placed and connected to an external stimulator device in order to assess potential effectiveness for that patient. Patients who demonstrate a clinical benefit during this trial phase advance to receiving a permanent implantation of a pulse generator. Sacral neuromodulation is reimbursed by Medicare, except in the case of patients with neurogenic bladder or bowel dysfunction, including patients with SCI. We believe that this exception is not necessary and may lead to an overall inefficient use of Medicare dollars.

The mechanism of action of sacral stimulation (SNS) appears to involve modulation of spinal cord reflexes that control bladder and bowel function (12). These spinal reflex pathways are spared for individuals with a spinal lesion of the cervical or thoracic cord. That is, most individuals with SCI or other neurological disorders maintain intact spinal cord reflex pathways that are modulated by SNS. The mechanism by which SNS works for otherwise healthy patients would also be the same mechanism by which SNS would work for patients with neurological diseases or disorders. These individuals could benefit from SNS. Several studies have report successes testing SNS with individuals with SCI. One study found that the success rate of the trial phase of SNS for SCI patients was low, but in the permanent phase the success rate of SNM was optimistic (13). This demonstrates the value of the trial period in identifying responders to this technology, and should give reassurance that the permanent implant would be effective. A recent review concluded that SNS appears to be safe and effective in special neurological populations of patients with multiple sclerosis, Parkinson’s disease, and SCI (14). Therefore, by offering the initial trial phase to patients with neurogenic bladder or bowel dysfunction, their doctor can determine if that patient qualifies for the implant in the same way as for patients with idiopathic bladder and bowel dysfunctions.

In summary, any patient who has intact spinal reflex pathways that control bladder and bowel and have difficulty maintaining urinary or fecal continence, whether or not it is neurogenic in origin, could benefit from sacral nerve stimulation. The initial trial phase can be used, at low risk and low cost, to determine if the patient is receiving a clinical benefit from sacral nerve stimulation before incurring the risks and costs associated with implantation of the SNS system. Therefore, we believe that Palmetto GBA should remove the exclusion of coverage of SNS for individuals with neurogenic bladder and bowel. This coverage would be humane, help to address a critically unmet need, and reduce costs in the long term for what is a lifelong disability.

References

1. National Spinal Cord Injury Statistical Center. Spinal cord injury. Facts and figures at a glance. J Spinal Cord Med. 2005;28(4):379–80.
2. Kachourbos MJ, Creasey GH. Health promotion in motion: improving quality of life for persons with neurogenic bladder and bowel using assistive technology. SCI Nurs Publ Am Assoc Spinal Cord Inj Nurses. 2000;17(3):125–9.
3. Wielink G, Essink-Bot ML, van Kerrebroeck PE, Rutten FF. Sacral rhizotomies and electrical bladder stimulation in spinal cord injury. 2. Cost-effectiveness and quality of life analysis. Dutch Study Group on Sacral Anterior Root Stimulation. Eur Urol. 1997;31(4):441–6.
4. Creasey GH, Kilgore KL, Brown-Triolo DL, Dahlberg JE, Peckham PH, Keith MW. Reduction of costs of disability using neuroprostheses. Assist Technol Off J RESNA. 2000;12(1):67–75.
5. Creasey GH, Dahlberg JE. Economic consequences of an implanted neuroprosthesis for bladder and bowel management. Arch Phys Med Rehabil. 2001 Nov;82(11):1520–5.
6. Consortium for Spinal Cord Medicine. Bladder management for adults with spinal cord injury: a clinical practice guideline for health-care providers. J Spinal Cord Med. 2006;29(5):527–73.
7. Watanabe T, Rivas DA, Smith R, Staas WE, Chancellor MB. The effect of urinary tract reconstruction on neurologically impaired women previously treated with an indwelling urethral catheter. J Urol. 1996 Dec;156(6):1926–8.
8. Shingleton WB, Bodner DR. The development of urologic complications in relationship to bladder pressure in spinal cord injured patients. J Am Paraplegia Soc. 1993 Jan;16(1):14–7.
9. Martens FMJ, Heesakkers JPFA. Clinical results of a brindley procedure: sacral anterior root stimulation in combination with a rhizotomy of the dorsal roots. Adv Urol. 2011;2011:709708.
10. Sanders PMH, Ijzerman MJ, Roach MJ, Gustafson KJ. Patient preferences for next generation neural prostheses to restore bladder function. Spinal Cord. 2011 Jan;49(1):113–9.
11. Bourbeau D, Bolon A, Creasey G, et al. Needs, priorities, and attitudes of individuals with spinal cord injury toward nerve stimulation devices for bladder and bowel function: a survey. Spinal Cord. 2020;58(11):1216-1226.
12. Stefan De Wachter, Donald Vaganee, Thomas M Kessler. Sacral Neuromodulation: Mechanism of Action. Eur Urol Focus. 2020 Sep 15;6(5):823-825. doi: 10.1016/j.euf.2019.11.018.
13. Maolin Hu, Shicong Lai, Yaoguang Zhang, Ming Liu, Jianye Wang. Sacral Neuromodulation for Lower Urinary Tract Dysfunction in Spinal Cord Injury: A Systematic Review and Meta-Analysis. Urol Int. 2019;103(3):337-343. doi: 10.1159/000501529.
14. Connie N Wang, Doreen E Chung. Neuromodulation for lower urinary tract symptoms in special populations. Neurourol Urodyn. 2022 Nov;41(8):1948-1957. doi: 10.1002/nau.24954.

Palmetto GBA thanks you for your comments and the literature citations. National Coverage Determination 230.18 states specific neurologic diseases (e.g., diabetes with peripheral nerve involvement) which are associated with secondary manifestations of the above three indications are excluded. This would also include those with spinal cord injuries. Guidance for NCD revision request can be found on www.cms.gov – How to Request an NCD | CMS.   

I have been treating patients suffering with fecal incontinence (FI) for over 10 years and have seen irrefutable and durable patient benefit with sacral neuromodulation. This minimally invasive procedure is indicated in patients suffering with chronic FI refractory to multiple conservative measures. Patients often have significant degradation of their quality of life and social and economic productivity before they finally seek assistance with their disease process. The societal costs of FI are measured by loss of productivity and high likelihood of earlier admission into skilled nursing care as a consequence of caregiver burden and burnout. Thankfully, sacral neuromodulation (SNS) has dramatically improved the outcomes in regard to FI. In order to give the patients confidence in their proposed treatment and to be fiscally and environmentally responsible considering the cost of the implanted generators, trial periods with external stimulators have become the standard of care. During a trial period the patient must demonstrate a greater than 50% improvement in the number of baseline incontinent episodes. The 2 available trial leads include a percutaneous lead placed in the office under local anesthetic (PNE) or a tunneled tined lead placed under fluoroscopy (x ray) in the outpatient operating room setting. The latter affords a longer trial period (up to 14 days) but incurs an overall increase in cost with 2 separate operative procedures and 2 episodes of anesthetic (cost/risk) for the patient. The in-office trial with a percutaneous lead (PNE) allows for a safe and cost-effective office procedure but requires that the leads be removed no later than 7 days.

I am concerned regarding the recommendations to require the trial phase to last "more than 1 week." This recommendation in LCD DL39543 will put patients at risk! The current SNS systems including Medtronic and Axonics only have FDA indication for percutaneous trial for UP TO 7 DAYS. This is because of the risk of infection and lead migration with longer trial periods. Patients typically considered for PNE are all having multiple episodes of incontinence in a given week and most are experiencing multiple episodes of incontinence each day. I typically use a 5-7 day trial for PNE but never longer for sake of the above-mentioned risk and FDA labeling for use. This is ample time to prove 50% or greater benefit.

I am imploring that Palmetto GBA remove the "more than 1 week" requirement for the trial phase in LCD DL39543. Not removing the "more than 1 week" requirement for trial phases will insist that licensed providers perform in office PNE "off label" from FDA indications and expose patients to increased risk of infection and lead migration. More patients will inevitably be pushed to undergo formal advanced evaluation with tunneled leads requiring 2 outpatient surgical procedures and 2 anesthetics as opposed to 1. This will increase patient risk and cost.

By removing the "more than 1 week" requirement we can continue to provide patients with the adequate 5-7 day trial reducing cost and patient risk.

Thank you for your comment. The LCD language regarding length of time for basic testing will be changed to be consistent with FDA language and other payor policies. It will read “A successful percutaneous test stimulation, defined as at least 50% sustained (more than 48 hours) improvement in symptoms.”

Why is spinal cord injury excluded? There is a long history of sacral nerve stimulation for SCI and a robust safety profile. Please reconsider this restriction.

Palmetto GBA thanks you for your comment. National Coverage Determination 230.18 states specific neurologic diseases (e.g., diabetes with peripheral nerve involvement) which are associated with secondary manifestations of the above three indications are excluded. This would also include those with spinal cord injuries. Guidance for NCD revision request can be found on www.cms.gov – How to Request an NCD | CMS.