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Is Aquablation Covered by Medicare

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Is Aquablation Covered by Medicare?

1. Introduction

In making a decision for Medicare coverage, an important degree of influence is public support. Patient and public involvement was crucial in the recent decision to award Rezum an individual code. The Rezum system is a convective water vapor therapy system uses steam to ablate obstructive prostate tissue. This code separates Rezum from other BPH therapies and offers faster cost recovery. The American Urological Association has been monitoring the MIST III trial and in April 2019 issued a statement to CMS recommending a national coverage determination for Aquablation therapy. The LUGPA are also seeking a sustainable APC payment code for Aquablation with good evidence of high-value care procedure. (Nguyen et al.2021)

Although many patients have private insurance that could cover the high cost of Aquablation, urologic care is the third largest Medicare expenditure, meaning lower socioeconomic men who fail medical treatment for BPH and desire an operative management represent a large demographic. Currently, all Medicare reimbursable BPH therapies carry the same prospective care APC payment for 90-day global period regardless of the service provided. This raises future concerns that under the physician fee schedule/care episode grouper, Aquablation will be lumped with other BPH therapies and not receive adequate reimbursement. This is an important issue because if costs to urologists are high and Medicare reimbursement is low, there will be disincentive and access barriers for patients to receive Aquablation therapy. This has occurred previously in patients receiving prostate brachytherapy for prostate cancer.

Unfortunately, to date there is a dearth of data on the real cost of Aquablation compared to other BPH treatments. The MIST II trial randomized patients to either TURP or Aquablation and tracked economic outcomes. These results demonstrated that compared to TURP, Aquablation resulted in higher operative costs due large to the price of disposable equipment. However, Aquablation achieved faster recovery, which in the long term alleviated costs to patients and gave better health results. The main limitation with this analysis is that it only took into account costs saved by the healthcare system and did not lend insight to the total cost burden of BPH treatment on the patient.

In recent times, a new waterjet ablation therapy (Aquablation) has been developed for the treatment of BPH. This procedure uses a heat-free, water-based ablation with advanced imaging for targeted and effective treatment of BPH. It utilizes an intuitive robot to help the urologist perform a personalized treatment, so that the patient can receive better outcomes. The result of this advanced technology has been very positive, with multiple studies indicating that Aquablation is associated with low morbidity, shorter catheterization time, and good initial functional outcomes. All of which are desirable attributes for an operation.

1.1 What is Aquablation?

A few men are not good candidates for Aquablation. For example, men that are younger, more sexually active, those concerned with maintaining ejaculation, or have mild urinary symptoms may be better served by medical therapy. Men that have a modestly enlarged gland, 30-80g, and men with an enlarged median lobe are optimal candidates for Aquablation. Men with significantly larger prostates may still be treated with Aquablation, though retreatment rates may be higher and improvements in symptom scores and urine flow rates may not be as substantial. Men with smaller glands less than 30g are not candidates. Finally, urinary symptoms caused by other processes such as prostate cancer, urethral stricture, or overactive bladder would not be optimally treated by Aquablation. (Parsons et al., 2020)

Aquablation is a form of surgical therapy that involves the use of a high-pressured stream of water to remove tissue from the prostate. This procedure is completed using the FDA approved Robotic surgical system. The surgeon will use a cystoscope to control the movement, depth, and duration of the aquablation in a virtual environment. The surgeon applies hydro-ablation to the prostate using the robot to plan and execute an exacting and replicable tissue removal. The robot maintains continuous pressure and precise movement to translate the treatment plan into a well-defined resection that is meticulously controlled and uniform across the entire prostate. This approach enables an unprecedented level of safety and control as well as enables the treatment of prostates of any size or shape.

1.2 Importance of Medicare Coverage for Aquablation

In recent years, we have seen an explosion in the number of intra- and extracapsular surgical options for patients suffering with lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS due to BPH). These treatments range from traditional transurethral resection of the prostate (TURP), to minimally invasive options such as Urolift and Rezum therapy. These treatments are usually first line in patients with BPH, but may not be ideal for those with larger prostates or more severe symptoms. These patients traditionally are offered open simple prostatectomy, which is highly morbid, associated with significant risk and side effects, and often requires lengthy hospital stays. High speed robotic Aquablation therapy offers an alternative to open surgery for patients with larger prostates. This therapy fuses real-time ultrasound imaging with robotics to provide a heat-free water jet ablation, ensuring targeted, consistent, and reproducible prostate resection. This therapy is a novel and promising treatment for many of our patients suffering from LUTS due to BPH. (Nedbal et al.2024)The bulk of our patients suffering from BPH are of older age and have multiple medical comorbidities. Due to its minimally invasive nature, Aquablation therapy is an attractive option for these patients compared to traditional open surgery. As Aquablation is still a new technology, availability is limited and is currently only being offered at a few centers in the United States. Therapy with conventional TURP is widely available and covered by Medicare, which of course is very attractive for patients with Medicare insurance. Given the fact that Aquablation is aimed at an older population of patients, it is crucial that this treatment become more widely available and that insurance coverage becomes a possibility.

2. Medicare Coverage Criteria for Aquablation

For Medicare to cover medical or surgical therapy, there must be documentation that the therapy is medically necessary for the patient’s condition. According to the National Coverage Determination, there is currently no national Medicare policy for the coverage of transurethral waterjet ablation of the prostate (TUMT). In the absence of a national policy, a Local Coverage Determination (LCD) should specify whether the therapy is covered in a particular jurisdiction. An LCD includes: the indication and limitations of coverage, a review of the evidence, and when applicable, a policy article. The LCD can be found through the Medicare Coverage Database at the Centers for Medicare & Medicaid Services website [Link] According to the Medicare Benefit Policy Manual, the LCD is to be based on a review of the available evidence and is to be made by medical experts who were consulted on an ad hoc advisory committee in order to augment the fiscal Intermediary’s or Carrier’s decisions. In many cases, the evidence review may be based on a technology assessment which can be found through the Agency for Healthcare Research and Quality at [Link] Decisions to cover a service at the local level will usually begin with a request by a physician or other Medicare provider, patient or a Medicare carrier. If the carrier determines an adverse benefit category, essentially, the therapy is either not reasonable and necessary, is experimental/investigational, or is a cosmetic procedure, there is no requirement for a formal policy or a technology assessment. An NCD would be necessary to provide coverage for the therapy. An NCD is a determination of whether the therapy is reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body member and is based on the available evidence. An NCD is limited to a specific therapy performed on a defined population. This could potentially define a coverage determination for an aquablation therapy in the future. A request for an NCD can be made by any party, however, usually be initiated by medical providers or patients. (Kava et al.2021)

2.1 Eligibility Requirements for Medicare Coverage

Medicare coverage for a surgical procedure requires that specific clinical criteria be met. While all patients using Medicare are eligible, the clinical criteria listing must also be matched. Coverage is not dependent upon the enrollment of a patient in a specific type of Medicare plan. This Medicare coverage policy specifies patient eligibility criteria. Patient selection is critical to optimal outcomes with minimally invasive or invasive procedures. It is expected that patients with greater illness severity will be at a higher risk for adverse events from a surgical intervention, and therefore more likely to experience a favorable balance of risk and benefit. In general, the more ill a patient, the more aggressive/invasive the treatment they will be able to tolerate in return for a higher chance of symptom improvement. Medicare patients presenting with LUTS due to BPH often have a combination of bladder outlet obstruction and urinary retention. These patients are symptomatic and experience significant reductions in quality of life. These patients are not eligible for Aquablation or any other invasive surgical BPH treatment, as these procedures are excluded for patients with urinary retention or a history of urinary retention. A history of acute or chronic urinary retention in the medical record is an absolute contraindication in both FDA approved and CE marked countries and is defined as either the inability to void or the incomplete emptying of the bladder accompanied by an elevated post void residual volume. High retention patients are at a greater risk for adverse events from any invasive BPH procedure, and the required need for an indwelling or intermittent catheter leads to an unfavorable risk/benefit ratio. These patients often experience resolution of their LUTS if the inciting cause of retention is an acute illness or medication, and they are also at higher risk for a decompensation of their voiding ability with a resultant further increase in the post void residual volume. In these Medicaid patients, a trial without catheter is often successful, and these patients may be candidates for a bladder outlet procedure without the need for a resection. A determination is then made by the treating physician as to whether a patient has failed all conservative and medical therapy options, and is therefore more likely to benefit from a surgical intervention for symptom relief. Failure of said therapies is an eligibility criterion for any surgical BPH treatment. Since the expected duration of symptom relief from a surgical BPH procedure is 2 years, patients with a life expectancy of less than 2 years are less likely to experience a favorable benefit. A calculated prognosis is a requirement for Aquablation and is also needed to rule out patients with severe co-morbidities. Children and young adults with BPH are not eligible candidates for Medicare coverage of an MCC designated procedure. In some states, Medicaid programs do not cover MCB5 procedures, and therefore younger BPH patients with Medicaid coverage may inquire about a coverage determination. (Das et al., 2020)

2.2 Documentation and Medical Necessity

In 2005, the Medicare program established National Coverage Determinations (NCDs) regarding the evaluation and management of BPH that set requirements for coverage based on the specific treatment. Since Aquablation is a relatively new procedure, it has yet to be assigned a specific NCD. In the absence of a specific NCD for a particular treatment, Medicare contractors have the authority to create their own Local Coverage Determinations (LCDs) to provide guidance on whether a treatment is reasonable and necessary and therefore covered by Medicare. To date, there has been variation in LCD guidance for different BPH treatments. In a study of specific BPH procedure coverage, Sood et al found that only 66.1% of Medicare beneficiaries were eligible for treatment based on LCD criteria. Therefore, for many patients and providers, it is unclear what treatments are covered by Medicare, causing potential financial risk. In the case of BPH treatments, this may influence the treatment choice of older adult patients with limited income. When a patient receives any type of medical procedure, claims are submitted to Medicare on their behalf that are then reviewed by Medicare contractors who act as the gatekeepers for determining whether a service will be covered. The existence of an NCD is a requirement for Medicare coverage of a particular service but provides only a minimum requirement, therefore LCD criteria often supersede NCDs. Coverage of a service is ultimately determined by an assessment of medical necessity based on the individual patient’s specific condition and overall health. Claims for BPH procedures that do not meet LCD criteria are often denied, with patients and providers rarely understanding the detailed reasons for CMS contractor denial of a service that might have been deemed medically necessary for an individual patient. This lack of transparency and understanding of medical necessity criteria can be frustrating for patients and providers. Failure of a procedure affects patients as well, who must understand that a denial of coverage means they will be liable for payment and the denial could affect their future insurability. Given that BPH is a condition predominantly affecting the elderly, this creates potential financial risk for a population already with limited income and resources. (Guralnik et al.2022)

2.3 Prior Authorization Process

The prior authorization is the process by which medical necessity is documented and confirmed. It is a mandatory process for all Medicare patients. Medicare requires that certain clinical documentation be submitted depending on the patient’s history. It may take several weeks for the prior authorization request to be reviewed. During this time period, Aquablation provider’s office will be contacted by Centralized Prior Authorization (CPA) contractor for additional documentation if necessary. If the medical records submitted satisfy Medicare’s criteria, Aquablation procedure will be authorized and the procedure can be scheduled. If the request is denied, the patient and provider’s office will receive a written letter of denial with the reason of why it was not approved. See Medicare Learning Network.pub 100-08, Medicare Program Integrity Manual, CMS Pub# 100-108, 100-18.

3. Potential Benefits of Aquablation Coverage

For the past several years, BPH management with TURP has been an inpatient only procedure. There are other BPH procedures not considered first line treatments as alternative procedures: TUNA, interstitial laser coagulation, and open simple prostatectomy. These procedures may be performed on an outpatient basis. Policymakers and healthcare providers have voiced the need for covered effective BPH treatments as an alternative to drug therapy or invasive surgery that preserves the quality of life for Medicare beneficiaries. With the possibility of a treatment benefit that carries a payment modifier, there is the ability to track outcomes through the continuum of care to determine the service’s effectiveness. The availability of an MPS code for aquablation treatment will allow for tracking resource utilization throughout the episode of care.

3.1 Improved Access to Treatment

Recent information published from the MTOPS trial showed that a higher AUA symptom score, a larger prostate volume and a larger transition zone volume led to a higher risk of clinical progression of BPH. This trial has been seminal in predicting the outcomes of BPH progression and will be used as a determinant for patient enrollment in many BPH therapy modalities in the future. At present, no other BPH therapy has been shown to be as feasible as AIP for larger prostates. AIP remains an effective and safe BPH therapy for “very large” prostates and our recent data has shown that it has potential to be scaled to primary care. Despite the known advantages of AIP, we are observing that it is infrequently performed in the VA healthcare system and nationwide. Patients with large prostate volumes and higher AUA symptom scores who are at risk of BPH progression are therefore not receiving the most appropriate treatment. BPH treatment selection in current practice may not include AIP due to the lack of data and tools to assist in therapy selection. As strategic payment reform phases out volume-based reimbursement and begins to establish reimbursement based on the value of care, comparative effectiveness analysis will be critical for BPH therapy selection. High risk patients with low surgical risk tolerance and those with a desire for improved voiding function and symptom score improvement will benefit most from AIP relative to watchful waiting, medical therapy and other surgical approaches. Our observations on barriers to BPH therapy selection and the clinical outcomes from various BPH therapy modalities in current practice were driving factors for BAAP development.

Focus for treatment of BPH has shifted from improved clinical outcomes to include more emphasis on improving patient experiences and outcomes. The ideal treatment for BPH should restore normal voiding functions while minimizing effects on sexual and erectile function and maintaining durable symptomatic improvement with a low risk for de novo urinary incontinence. Safety and tolerability are of utmost importance to both the EAU and AUA for the treatment of LUTS/BPH.

3.2 Reduced Financial Burden for Patients

Medicare is the primary insurer of American seniors and covers an estimated 67% of BPH cases. In 1987, Medicare spending for BPH was approximately $915 million, and this number would be significantly higher today. A 1999 AUA survey also found that compared to men paying out-of-pocket or using standard private insurance, Medicare patients have the highest IPSS, indicating that Medicare patients have more severe BPH on average. This is important because higher IPSS is directly correlated with higher spending on BPH treatment. Therefore, improvements in Medicare BPH treatment such as coverage and operational CMS decisions are of great importance to reducing the financial impact of BPH on seniors.

The financial burden of benign prostatic hyperplasia (BPH) treatment is well-documented. Despite the fact that BPH is not a life-threatening condition, a great deal of money is spent each year on BPH treatment. This is due to the high prevalence rate of BPH in older men and the relatively high cost of BPH treatment. Studies in Maryland and Michigan estimated that the direct costs of treating BPH between 1988 and 1994 were $2505 and $2913 million, respectively. Indirect costs calculated in these studies were over twice as much, and when extrapolated to include all 50 states, estimated the national costs of BPH treatment at $6 billion. More recent estimates would likely place these figures even higher. Due to the fact that BPH is a condition that affects primarily the elderly, much of this financial burden is placed on our nation’s seniors.

3.3 Enhanced Quality of Life for Medicare Beneficiaries

Following treatment, patients with BPH typically experience drastic improvement in urinary symptoms and quality of life. Relief is sustained for at least 4 years, which is particularly important to Medicare patients who generally have more co-morbidities, increased need for services, and are at higher risk for complications. Seniors are more likely to have untreated BPH and suffer from the most severe symptoms, as they are less likely to report bothersome LUTS to a physician. Success rates of medical therapies and TURP decrease as symptom severity increases and retreatment is often required. With a simple, effective minimally invasive surgical option available, Medicare patients may be more likely to seek treatment and gain relief from their bothersome LUTS before it progresses to severe disease states. Easier recovery and reduced risk for complications and need for additional treatment will also have a significant impact on elderly patients, particularly those who are frail or have multiple co-morbidities.

4. Advocating for Aquablation Coverage

Post-reimbursement payment, there will undoubtedly be a significant push from urologists and prostate patients alike to make BPH aquablation therapy a covered service under Medicare. Many urologists likely hired aquablation-trained medical scribes and scribes experienced with surgeries in order to recover the documentation productivity lost due to the reduced reimbursement. Prior to Medicare’s 2019 decision to cut BPH procedures, they were paying around $3,000. This included the facility and the professional fees for each surgery. Fast forward to 2019, and there was a mandated 15% reduction on all BPH surgeries. Under the unified payment system, this means the most Medicare will pay for a BPH procedure is around $600. With reimbursement rates this low, both urologists and patients now question the sustainability of continuing TURP and other BPH procedures. Ideally, there could be discussions between CMS and the manufacturer to arrive at a higher, yet reasonable reimbursement strictly for the aquablation therapy. Patients are not always fully aware of the costs potentially incurred with their medical procedures. This includes the costs that are covered by insurance, but also the costs that they must pay out of pocket. The decision to have a BPH procedure is typically not something that patient feels they need to rush into. Many MCG (middle class and geriatric) men can live years with BPH symptoms and have disease progression that can be monitored. Given this, they may decide to “put off” the procedure until a later date. In an era of the $6,000-a-month high-deductible plan, patients need to be cost-conscious and have an understanding of what they will be paying out of pocket for their medical care. Lower Medicare reimbursement rates for BPH procedures mean that urologists will frequently opt for lower cost office-based BPH procedures like prostate artery embolization (PAE) and transurethral microwave therapy (TUMT). Failure to receive a fair reimbursement rate for aquablation therapy will likely result in patients not having the option to receive the procedure and certainly higher costs for those patients who are Medicare beneficiaries.

4.1 Engaging with Medicare Representatives

This is an extremely important move as Medicare is close to or the only insurer for many patients in the United States. Without Medicare approval, Aquablation with AquaBeam could not be an option for many men with bothersome lower urinary tract symptoms due to benign prostatic hyperplasia. Men who meet or are in the future newly diagnosed with BPH would still have to rely on medical therapy, possibly for years or even decades, to avoid going through other invasive BPH treatments that overly damage tissue like TURP or surgical options requiring anesthesia. By relieving symptoms of BPH earlier in its course of progression, men could possibly have better long-term control and improvement in their quality of life. We believe that with proper education about the chronic nature of BPH and its available treatments, some medications can be avoided and several men could even find that Aquablation is a preferred choice over other office-based procedures or surgical treatments making them eligible candidates in deciding between enrollment in Medicare Advantage Plans or a return to original Medicare with a third-party supplement. It is not clear how to best facilitate discussions with Medicare representatives at this time but we plan to start with a letter of introduction to Aquablation with AquaBeam and seek guidance or information on the local coverage determination process. Based on feedback from the AUA advocacy office, this is frequently in the form of treating an LCD much like a private payer’s policy coverage determination. We will also seek out if there is a CPT code specific to BPH or if Ablative therapy for the prostate is bundled under a CPT code specific to Cancer in order to facilitate the option of requesting a new CPT code or change of status for an existing code. We would then relate this information back to our industry contacts in order to further develop nationwide strategies.

4.2 Utilizing Patient Advocacy Organizations

These organizations also have the ability to lead public opinion campaigns and generate media attention for specific issues. This can be a double-edged sword because media attention to Medicare non-coverage can have negative effects on physician adoption of a new technology and/or patient acceptance. However, when leveraged properly, public opinion and media campaigns can result in high-level meetings with CMS officials and even Congressional leaders, and in some cases have led to successes in reversing non-coverage decisions.

Patient advocacy organizations such as the American Urological Association (AUA) and the Large Urology Group Practice Association (LUGPA) have a long history of involvement in a variety of public policy issues that affect the practice of medicine, and Medicare coverage and reimbursement are high on that list. These organizations have established relationships with key decision makers at the Centers for Medicare and Medicaid Services (CMS), and have been successful in influencing coverage decisions through formal and informal communications with CMS staff and leaders.

4.3 Collaborating with Healthcare Providers

Healthcare providers have a unique role in the healthcare system as advocates for their patients and healthcare professionals who deliver the treatments that patients need. Their perspective is highly influential on health policy making and healthcare system design, and their advocacy is important to create an efficient system that delivers the best care for patients. Urologists have been engaged in advocacy with local and national private health insurers to help facilitate TURP coverage for their patients for many years. By sharing their opinions and scientific evidence, many urologists have been able to change the policy and coverage for their patients to help facilitate access to care. A similar level of urologist engagement in advocacy with Medicare and other payers can help facilitate change in surgical treatment covered for BPH. One of the most effective ways to accomplish this is through organization of large groups of providers to create momentum in a directed effort to change or create a new policy. This has been done by other medical specialties to facilitate change in Medicare policy and has been effective in the past.

References:

Nguyen, D.D., Barber, N., Bidair, M., Gilling, P., Anderson, P., Zorn, K.C., Badlani, G., Humphreys, M., Kaplan, S., Kaufman, R. and So, A., 2021. WATER versus WATER II 2-year update: comparing aquablation therapy for benign prostatic hyperplasia in 30–80-cm3 and 80–150-cm3 prostates. European Urology Open Science, 25, pp.21-28. sciencedirect.com

Parsons, J.K., Barry, M.J., Dahm, P., Gandhi, M.C., Kaplan, S.A., Kohler, T.S., Lerner, L.B., Roehrborn, C.G., Stoffel, J.T., Welliver, C. and Wilt, T.J., 2020. AUA GUIDELINE. auanet.org

Nedbal, C., Castellani, D., De Stefano, V., Giulioni, C., Nicoletti, R., Pirola, G., Teoh, J.Y.C., Elterman, D., Somani, B.K. and Gauhar, V., 2024. Will Aquablation Be the New Benchmark for Robotic Minimally Invasive Surgical Treatment for Benign Prostatic Hyperplasia?. European Urology Focus. sciencedirect.com

Kava, B.R., Smith, W.R., Mettu, J.R., Bhatia, S., Mohan, P.P. and Badlani, G.H., 2021. Treatments for Benign Conditions of the Prostate Gland. In Interventional Urology (pp. 285-316). Cham: Springer International Publishing. [HTML]

Das, A. K., Han, T. M., Uhr, A., & Roehrborn, C. G., 2020. Benign prostatic hyperplasia: an update on minimally invasive therapy including Aquablation. Can J Urol. canjurol.com

Guralnik, J.M., Sternberg, A.L., Mitchell, C.M., Blackford, A.L., Schrack, J., Wanigatunga, A.A., Michos, E., Juraschek, S.P., Szanton, S., Kalyani, R. and Cai, Y., 2022. Effects of vitamin D on physical function: results from the STURDY trial. The Journals of Gerontology: Series A, 77(8), pp.1585-1592. nih.gov

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