1. Introduction
The primary nerve stimulator currently being adopted for the treatment of fecal or urinary incontinence is sacral nerve stimulation (SNS). This technique involves the insertion of an electrode adjacent to the sacral nerves, which is linked to an implanted pulse generator. The electrode is connected to the generator via an extension, which runs under the skin from an exit site near the pelvic area to the location of the generator. The pulsing stimulator is designed to modulate the activity of the selected sacral nerve, which is known to affect bladder, bowel, and urinary function. A more recent therapy receiving increased attention is tibial nerve stimulation (TNS). This technique is analogous to SNS, but involves the insertion of a needle near the tibial nerve and subsequent electrical stimulation. While both SNS and TNS have shown positive results, they are limited in their invasiveness, patient comfort, and inability to externally control the stimulator intensity. These issues are addressed by PTNM, which utilizes a similar technique to TNS, but involves the use of the NUROTM system which is an external stimulator and tined lead that insulates the electrode, preventing movement or loss of stimulation efficacy. This lead is inserted through a needle placed near the tibial nerve, and is connected to an external pulse generator. (Tilborghs & De Wachter, 2022)
1.1 Overview of Axonics Therapy
The Axonics system is designed to function for at least 15 years, and therefore milestone payment assignment was explored. Milestone method payment comes with a nine-month time frame and is designed to cover the cost of the device and the cost of the procedure. With the Axonics System, the cost of the procedure would fall under the inpatient payment using the IPPS method. Medicare payment rates would need to be assessed to accurately determine the expected revenue of the treatment of the patient. The quality of life improvement and cost of possible adverse events of the patient can be difficult to measure, and therefore it is suggested that further IT filters should be assigned.
Axonics Modulation Technologies, Inc. has developed a sacral neuromodulation system, which is expected to effectively treat urinary and bowel dysfunction. The Axonics System is a rechargeable implantable pulse generator with smart MRI condition designed to function for at least 15 years. The system also features a tined lead specifically designed to prevent lead migration. In the SACRAL trial, the Axonics System met all primary and secondary endpoints with an 89% response rate in urinary voiding symptoms and an 80% response rate in urinary incontinence episodes. This data was presented to the Medicare Administrative Contractor where it was discussed with FDA clearance, the Axonics System would likely be indicated for patients who are not candidates for the current sacral neuromodulation devices and are good candidates for chronic disease.
Urinary and bowel dysfunction can be frustrating for patients and a difficult ailment to treat for physicians. While most patients benefit from more conservative therapies such as dietary modifications, physical therapy, and oral medications, a portion of patients do not achieve satisfactory results or they cannot tolerate the side effects of those therapies. These patients often suffer from urinary and bowel dysfunction due to a miscommunication between the brain and the sacral nerves, which are responsible for urinary and bowel function. This miscommunication can result from a variety of clinical conditions or events that interfere with the normal function of the nerve, such as overactive bladder, urinary retention, constipation, fecal incontinence, and irritable bowel syndrome. In the United States, urinary and bowel dysfunction affects tens of millions of men and women, and it is estimated that only a small fraction of these patients are being treated by and seen by a physician specifically for their urinary and bowel issues.
1.2 Importance of Medicare Coverage
Despite several years of treatment, many individuals suffering from OAB symptoms have failed to attain sufficient benefits from current modalities and thus are considered refractory to those treatments. In the heart of refractory OAB lies the unmet medical need, the lack of acceptable solutions. For those patients who have failed or are intolerant to medication, UUI sufferers, and even fecal incontinence patients, the burdens of their condition are substantial. For these patients, significant symptom reduction or continence improvement would lead to a dramatic increase in quality of life. Unfortunately, the current available solutions are not designed to treat all OAB symptoms, have limited effectiveness, or do not provide a long-term solution. Currently, OAB refractory patients and UUI patients have an option to receive InterStim therapy to manage their symptoms. InterStim therapy is an effective reversible neuromodulation therapy that has helped hundreds of thousands of patients gain more symptom control. While seeking an additional long-term solution for these patients, Axonics is developing a durable therapy that enhances neuromodulation through its rechargeable sacral neuromodulation SNM system.
2. Medicare Coverage Criteria for Axonics Therapy
The Medicare national coverage determination (NCD) for sacral nerve stimulation (NCD #230.16) lists the indications for urinary and fecal incontinence. Although the NCD specifies that coverage does not expand to “new” technologies, it does not define what constitutes this term and it has not been updated since its expansion to include non-FDA approved indications for Interstim therapy in 2005. Medicare coverage for Interstim therapy is determined by local coverage determinations (LCDs). Only 9 LCDs (Hawaii, Colorado, South Carolina, Pennsylvania, New York, Massachusetts, New Hampshire, Maine, and Wisconsin) currently provide coverage for Interstim incontinence indications. Therefore, it is possible for a Medicare patient to receive Interstim therapy in a state other than those listed and have it not covered by these broad NCD indications. Local decision-makers need clearer instructions on what constitutes a new technology, NCDs for those technologies, and a more comprehensive and uniform expansion of coverage to truly impact a large percentage of Medicare patients with urinary and fecal incontinence. (PA)
2.1 Eligibility Requirements for Medicare Coverage
The existence of Axonics therapy fulfills the initial step requirements in coverage determination if there are clinical trials to support the therapy and there is a Medicare benefit category. Clinical trials/studies have proven that PTNS is effective in treating urinary incontinence and symptoms of overactive bladder in the short term and long term duration. PTNS will fall under the indirect category as there were trials to support sacral nerve stimulation, which therapy is designed to bridge the gap from. PTNS has been FDA approved in the United States and there is a National Coverage Determination by Medicare for the treatment of urinary incontinence and symptoms of overactive bladder. Both Axonics therapy and tined lead stimulation have direct and immediate results from the testing phase to cure the bladder and bowel control problems. Effectiveness and safety of the tined lead stimulation have been proven. High success rates will lead to a product with low risk and potential patients will not have to worry about payout of pocket costs being denied in the final step requirements in coverage determination. However, since PTNS is not a Medicare benefit category, patients will still be at risk for unexpected costs in case of coverage denial. The existence of Axonics therapy fulfills the initial step requirements in coverage determination if there are clinical trials to support the therapy and there is a Medicare benefit category. Clinical trials/studies have proven that PTNS is effective in treating urinary incontinence and symptoms of overactive bladder in the short term and long term duration. PTNS will fall under the indirect category as there were trials to support sacral nerve stimulation, which therapy is designed to bridge the gap from. PTNS has been FDA approved in the United States and there is a National Coverage Determination by Medicare for the treatment of urinary incontinence and symptoms of overactive bladder. Both Axonics therapy and tined lead stimulation have direct and immediate results from the testing phase to cure the bladder and bowel control problems. Effectiveness and safety of the tined lead stimulation have been proven. High success rates will lead to a product with low risk and potential patients will not have to worry about payout of pocket costs being denied in the final step requirements in coverage determination. However, since PTNS is not a Medicare benefit category, patients will still be at risk for unexpected costs in case of coverage denial.
National Coverage Determination 230.6 will apply for sacral nerve stimulation therapy. This therapy has been used with a variety of bladder and bowel control problems. However, coverage has been approved with a variety of limitations and restrictions. Axonics therapy is essentially a miniaturized version of sacral nerve stimulation that was proven to be safe and effective in several clinical trials and has been FDA approved in the United States.
The basic eligibility is defined as all conditions listed should be met. It is covered as reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Axonics therapy bridges the gap between PTNS and pacemaker for bladder and bowel control. This therapy offers the same two-staged approach for diagnosis and treatment. Temporary tined lead stimulation is recommended for the diagnosis phase and chronic tined lead simulation if there is more than 50% improvement in urinary incontinence symptoms or frequency.
2.2 Documentation and Medical Necessity
– Physician office notes documenting a minimum of two urinary tract infections in the prior 12 months. This should include the number of occurrences in the last year, the type of organism isolated, and the antibiotic sensitivities. – Voiding diary or equivalent document over a 3-day period. – Documentation of failure of at least 2 medications tried for treatment of urge incontinence or urinary urgency frequency. Step therapy requirement must be utilized to determine failure. Information regarding the dosage, frequency, and duration of drug therapy and indication of adverse side effects from the medications. – A urodynamic study that exists prior to the pre-sacral neuromodulation trial assessment. The study must show detrusor overactivity as the cause of urinary symptoms (incontinent episodes or frequency/urgency). It must be accompanied by a written request from the office of the treating physician or a verbal communication from the treating physician directly to the office that specifies the purpose for ordering the test. – An sEMG performed within 6 months prior to the proposed day of SNM implantation.
Documentation required for sacral neuromodulation for lower urinary tract dysfunction:
2.3 Limitations and Restrictions
Exposure to PTNS has increased over the past 10 years and many primary care physicians, urologists, and other advanced practice providers may not understand the coverage and payment policies of PTNS therapy. Common restrictions and limitations are the denial of payment due to medical necessity and non-coverage of PTNS under local coverage determinations. PTNS coverage is denied when the medical physician does not have sufficient evidence to prove that the patient has a documented urinary voiding dysfunction diagnosis related to overactivity where PTNS is the secondary line of therapy. PTNS does not meet the coverage criteria under the local coverage determinations because it does not specifically name PTNS where the policy is non-ambiguous, and there is no appellate process to contest a non-coverage decision. (La‐Anyane et al.2024)
For Medicare to provide coverage for PTNS (e.g., Axonics Therapy), the treatment must be reasonable and necessary for the diagnosis or treatment of illness or injury in accordance with section 1862(a)(1)(A) of the Social Security Act. Medicare will consider coverage of PTNS after a review of the published clinical evidence. Medicare has determined that the treatment must be evaluated based on whether the results are generally followed in medical practice, the treatment is considered safe and effective, and the treatment results in a medical improvement of the beneficiaries’ condition and functional status. PTNS meets the definition of reasonable and necessary treatment as results of clinical trials have demonstrated the safety and efficacy of PTNS, and that patients had a significant improvement in lower urinary tract symptoms.
3. Process for Obtaining Medicare Coverage for Axonics Therapy
The first step to obtaining Medicare coverage for InterStim Therapy is the Initial Consult and Evaluation performed by the patient’s Urologist or Urogynecologist. During this visit, the physician will perform a comprehensive evaluation of the patient’s symptoms, medical history, and prior treatments for OAB and/or Urinary Retention. This often includes having the patient fill out a voiding diary to assess their voiding pattern and severity of incontinence or frequency/urgency. Due to the fact that this is a Medicare patient, the physician will be sure to document within the patient’s medical records that their symptoms have been chronic and have not improved with behavioral or medical therapy.
With Medicare being a popular insurance carrier for patients suffering from Overactive Bladder and/or Urinary Retention, below is the step by step process the patient and physician should follow in order to obtain Medicare coverage for InterStim Therapy.
After a patient has been recommended InterStim therapy by his or her physician, the patient will likely ask, “how can I get this benefitted therapy covered by my insurance?” Most insurance carriers have some form of coverage for InterStim Therapy, however each carrier may have their own unique policy, limitations, and pre-authorization requirements. It is important for the patient to understand their insurance benefits and requirements for coverage, and stay involved and informed during this process.
3.1 Initial Consultation and Evaluation
Define recommended content for the work. 3.1 Initial Consultation and Evaluation This section is a crucial part of the process. According to the decision memo, the patient must have symptoms of urinary urge incontinence, urgency-frequency, and urinary retention, and demonstrable failure of an anticholinergic medication to render these symptoms adequately managed. Overactive bladder is defined as urinary urgency, usually accompanied by frequency and/or nocturia, with or without urge incontinence. Failure to render symptoms adequately managed is defined as the patient discontinuing anticholinergic medication due to intolerable side effects or the medication failing to adequately control symptoms. The symptoms and a confirmed diagnosis of OAB must occur for at least 6 months in duration. Local Coverage Determination (LCD) policies may exist and can provide additional guidance for coverage. An assessment by the surgeon or the physician who will be managing the interim care is required to ensure that all other alternative treatments have been considered and/or tried. This assessment will also ensure that the patient has the mental capacity to operate the system and is not immunocompromised. A brief trial of the therapy should be given to the patient using an external stimulator to help predict the probability of success with the implanted system. Success is defined as a 50% improvement in symptoms of urgency incontinence. These symptoms would be quantified at baseline using a voiding diary. Following successful testing, the physician will submit for pre-authorization of the InterStim system to the insurance provider with documentation to include the clinical and symptom improvement of the patient since the onset of OAB, the severity of the condition, the impact on the quality of life of the patient, the discussion of alternative treatments, and a cost estimate. A Medicare beneficiary will need to obtain a pre-authorization of the InterStim system before proceeding to implant. This process generally takes 30 days.
3.2 Pre-authorization and Documentation Submission
Lastly, following completion and verification of the above documentation, the healthcare provider should verify that the patient meets the coverage criteria on the date of implant.
Step four: In the case where the pre-authorization has been passed or the letter of medical necessity was successful, the next forms of documentation will need to be used to provide confirmation that the patient meets the coverage criteria. This is aimed to help phase in the transition of Medicare beneficiaries in complying with Medicare coverage policies.
Step two and three: the healthcare provider will need to provide documentation and a letter of medical necessity. Documentation may require pertinent medical records and results to determine if the patient meets the coverage criteria and should be attached with the pre-authorization to avoid additional requests for more information. A letter of medical necessity should state that the patient meets the coverage criteria and the therapy is medically necessary. In some cases, there may be a request for additional information, a healthcare provider or patient may need to consider using this request to submit another pre-authorization if deemed necessary to confirm medical necessity. If the patient has received a letter to request additional information in an attempt to bypass the supplemental pre-authorization, an informative response may be used to save the patient from oral or written testimony. Content from the initial pre-authorization to the submission of the letter may require months of waiting and may need persistence in providing documentation and confirmation that the therapy is medically necessary. (Klein & Busis, 2020)
Step one: The Check List should be reviewed to verify that necessary information is submitted to the Medicare Contractor. Prior to submitting a pre-authorization, the healthcare provider should verify with the Medicare contractor to determine where the pre-authorization should be submitted. The Medicare Administrative Contractor (MAC) local coverage determination and policy article should be reviewed when preparing the pre-authorization form. Pre-authorization for the sacral nerve stimulation is not a requirement, though it is a formalities review to provide documentation confirming that the SNM is medically necessary and that the patient meets the medical coverage policy. If the patient has additional secondary insurance, especially Medicaid, the provider should verify if pre-authorization is required for that insurance carrier. Upon successful completion of the axonics pre-authorization, the patient can proceed to the next step.
When a patient and/or healthcare provider has determined that Axonics Therapy is right for the patient Medicare, coverage policies suggest ensuring that the patient meets the coverage criteria for the therapy. At this time, the Healthwell Foundation or other charitable financial assistance may also be considered to reduce the potential financial burden to the patient.
To request Medicare coverage for Axonics Therapy, the healthcare provider may need to submit documentation to illustrate eligibility consistent with Medicare coverage policies. This may include completion of a pre-authorization process, providing documentation of medical necessity, or responding to a request for additional information.
3.3 Appeals and Reconsideration Process
If the pre-authorization has been denied, or if coverage is partial or terminated, there is a right to an internal appeal. An appeal is a formal request to reconsider a decision. The appeal process varies by different Medicare contractors, but all provide the following levels of appeal: 1. Reconsideration by the Part A or Part B (A/B) Medicare Administrative Contractor (MAC) 2. Review by an Administrative Law Judge (ALJ) 3. Review by the Medicare Appeals Council 4. Judicial Review in Federal District Court. The contractor has 60 days from receipt of the request to complete the reconsideration. An extension of the 60-day period is available if the contractor can demonstrate that more time is required. If your appeal concerns an admission, services provided or a decision that an ongoing course of treatment is no longer reasonable and necessary, and in these instances for pre-service requests, the MAC must issue a decision within 14 calendar days of receipt of the request for reconsideration.
4. Resources and Support for Patients Seeking Medicare Coverage
If you have questions about Medicare coverage or want to apply for Medicare, call 1-800-MEDICARE or visit [Link] This message contains important information about this coverage decision and the options available to you. An organization composed of healthcare providers that exist only for the purpose of reviewing Medicare coverage of a specific medical item or service may request national coverage for the item or service on behalf of all providers. If between policies, the request is to cover an item or service nationwide, the NCD process begins with an internal analysis by the Centers for Medicare & Medicaid Services. Any interested person (as defined at 42 CFR §405.102) may request a reconsideration regarding an NCD. During reconsideration, the contractor prepares a record concerning the NCD. The person requesting reconsideration may submit comments to the contractor on the NCD (42 CFR § 426.130). In order to be both informed and influential in the decision, interested parties should discover evidence related to the health care effectiveness of a given treatment. An organization that has an interest in a non-covered item or service can also request the development of an NCD. This is a request for CMS to make a national coverage determination that would apply to all Medicare beneficiaries. The CMS will only open an NCD upon receipt of a request to make a coverage determination. However, the decision to initiate an NCD can also be made at CMS’ own discretion, or upon the recommendation of a Medicare coverage advisory group. Redetermination of an adverse local coverage determination. An AAG is a form of reconsideration in which there is a hearing before an administrative law judge on the record pursuant to 5 USC § 553 or any statute implementing the Administrative Procedure Act. This may result in a decision, dismissal, or reversal of a coverage determination. Any party to the hearing may request a decision by the administrator, Departmental Appeals Board review, or judicial review of the decision.
4.1 Medicare Helpline and Online Resources
The Medicare Helpline (1-800-MEDICARE) is the official telephone service available to Medicare beneficiaries. Available 24 hours a day, 7 days a week in both English and Spanish, representatives are able to provide information on coverage and benefits, and also assist with processing claims. In addition to general inquiries, this service is essential in resolving issues regarding denied coverage or claims, and is able to start the appeals process during a call. Guidance provided in this manner can be invaluable for individuals seeking initial or continued coverage of OAB therapy with SNM. The official Medicare website (www.medicare.gov) continues to be a growing resource in providing information and self-service tools for Medicare beneficiaries. The coverage of treatments for Overactive Bladder and Incontinence is addressed in detail under the section for Incontinence and Bladder Control Problems. Information on coverage criteria for prescription drug coverage (Part D) is also helpful, as certain medications may be a prerequisite before trying SNM for OAB. Search tools for locating and comparing Medicare plans and providers are important to consider when choosing alternative or supplemental insurance to Original Medicare with the hopes of favorable coverage for SNM. Provided resources on this site continually address needs of beneficiaries seeking health information, and a comprehensive view of coverage and treatment options.
4.2 Patient Advocacy Organizations
Patient advocacy organizations have played a major role in educating both patients and doctors in understanding the nature of sacral nerve stimulation. One major benefit of having this therapy now approved for coverage is that the organizations can turn their efforts towards helping patients gain access, as opposed to attempting to gain coverage approval. One such organization is the National Association for Continence. As a founding member of the Sacral Nerve Stimulation Consortium, the NAFC has been instrumental in providing information to patients and caregivers. Their efforts included the development of a disease and treatment registry – a resource used to connect patients interested in SNS with physicians familiar with the therapy. Another important advocacy group specifically for sufferers of urinary and bowel disorders is the Simon Foundation. The Simon Foundation has provided educational and emotional support to patients with incontinence through online resources and publications. Now that the therapy for urinary and bowel incontinence has been approved for coverage, efforts by the Simon Foundation can be directed toward helping patients gain access to this treatment option. This includes outreach to doctors to ensure they are informed about the therapy, efforts to ensure Medicare and private insurers cover the treatment, and resources to help patients find physicians with experience in sacral nerve stimulation. The American Urological Association and The Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction have been instrumental in helping physicians gain knowledge and training in sacral nerve stimulation. Now that it is a covered treatment option, these groups can focus on education and dissemination of treatment guidelines to ensure patients receive the highest quality care. This includes an effort to create a SNS registry much like that of the European Association of Urology. This would be a resource for patients and physicians to discuss treatment options and locate others with similar conditions who have received successful outcomes with SNS. (Gibson et al.2021)
4.3 Financial Assistance Programs
Additionally, several private health foundations and charities in the United States may serve as an additional resource for financial assistance for which Axonics Therapy patients may qualify to help cover the cost of care. Please contact your local representative or contact Axonics Modulation Technologies, Inc. for more information on resources.
Offering support and assistance for patients in understanding and navigating through the insurance and benefits verification process for SNM therapy, Axonics also created resources like the Pre-Verification Worksheet.
All manufacturers funding and resources for financial assistance are subject to change. Please contact the manufacturer directly for the most up-to-date information on any patient financial support programs. Axonics Modulation Technologies, Inc. offers patient assistance programs for Tined Lead patients who have limited financial means. For eligible patients, Axonics patient assistance programs can help contribute to the Tined Lead System cost. Eligibility requirements for patient assistance programs include low-income and uninsured patients. Actual eligibility is determined on an individual basis by Axonics.
References:
Tilborghs, S. & De Wachter, S., 2022. Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects. Expert review of medical devices. researchgate.net
PA, W. I., . Fecal Incontinence Evaluation and Treatments. Therapy. icarehealthplan.org
La‐Anyane, O., Alba, B.E., Harmon, K.A., To, J., Siotos, C., Adepoju, J., Madrigrano, A., Alvarado, R., O’Donoghue, C., Perez, C.B. and Kurlander, D.E., 2024. United States insurance coverage of immediate lymphatic reconstruction. Journal of Surgical Oncology, 129(3), pp.584-591. [HTML]
Klein, B. C. & Busis, N. A., 2020. COVID-19 is catalyzing the adoption of teleneurology. Neurology. [HTML]
Gibson, W., Johnson, T., Kirschner‐Hermanns, R., Kuchel, G., Markland, A., Orme, S., Ostaszkiewicz, J., Szonyi, G., Wyman, J. and Wagg, A., 2021. Incontinence in frail elderly persons: report of the 6th International Consultation on Incontinence. Neurourology and urodynamics, 40(1), pp.38-54. [HTML]
