1. Introduction
Urolift was FDA approved in 2013 with the aim of providing an effective, yet safe method of treating BPH. It involves the insertion of a delivery device to transport tiny permanent implants into the prostate. These implants serve to hold the prostate lobes apart, so as to increase the opening of the urethra and relieve compression. This is done in an outpatient setting and typically does not require prolonged use of a catheter. The procedure is relatively quick and has been effective in most patients. This procedure is deemed a desirable alternative to drug therapy or more invasive surgical methods, but the main issue that patients are faced with is the initial cost and insurance coverage. If Urolift was a covered Medicare benefit, most patients with BPH would easily choose this method over other treatments. However, without the coverage, it is only accessible to patients who are willing to pay a substantial fee out of pocket for the procedure. (Bortnick et al.2020)
Urolift is a minimally invasive surgical procedure designed to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). This condition, characterized by the enlargement of the prostate, can often lead to complications in elderly patients. The prostate wraps around the urethra and, as such, when it enlarges, it can cause compression of the urethra and a subsequent narrowing of the urinary passage. This leads to difficulty in urination and causes adverse effects on the patient’s quality of life. While certain prescription medications can be used to treat this condition, they may have side effects and are not usually desirable in the elderly population. Additionally, traditional surgical procedures are generally more invasive and carry a risk of side effects such as incontinence or erectile dysfunction.
1.1 What is Urolift?
Also very common in older men is the development of health conditions that can complicate the management of BPH. BPH often occurs with other health conditions, such as hypertension, diabetes, and heart disease, that carry a risk for long-term bleeding complications from BPH treatments. Treatment of these health conditions can also include the use of blood thinning medications, which can put men at an increased risk for bleeding associated with BPH treatments. Finally, the greater the age, the more likely a man is to develop conditions such as acute urinary retention or BPH-related urinary incontinence, which usually require more invasive treatment of BPH. Given the frequency of these conditions in older men, it is important to provide a BPH treatment that has low risk and is not made more complicated by these other health problems. UroLift is useful in these situations, as it is less risky and less likely to cause long-term complications than other surgical BPH treatments, and it has been shown to be safe and effective in men taking blood thinners. UroLift is a day procedure done with only local anesthesia in men with urinary retention and is often suitable for men who would be considered too high risk for more invasive surgery. (Bortnick et al.2020)
Enlargement of the prostate occurs as a man ages; in fact, about 90% of men over the age of 85 will develop an enlarged prostate. Symptoms of BPH, which can have a significant negative impact on the quality of life, include difficulty initiating urination, a weak urinary stream, urinary urgency and frequency, and incontinence.
UroLift® is a new minimally invasive treatment for benign prostatic hyperplasia (BPH), also known as an enlarged prostate. The prostate is a male reproductive gland that surrounds the urethra and is responsible for making semen, which transports sperm. BPH is a common condition in older men, occurring when the prostate enlarges and squeezes the urethra, impeding urine flow and causing discomfort.
1.2 Importance of Medicare Coverage
The RUC process is time-consuming and resource-intensive as the panel reviews approximately 300 CPT codes annually. RUC meetings are typically held 3 times per year. New codes are prioritized by recent additions to the fee schedule, nature of the service, if the code is a harbinger for other codes and potential for Medicare expenditure change, and if the CPT code appears to be misvalued. When considering RVUs for a CPT code, the RUC will compare the code to other similar codes of service. The goal is to establish RVUs reflecting the true value in physician work and allocate Medicare funds accordingly without under or overvaluing a code. UroLift being a new and unique treatment, there are no similar services to compare and thus establishing RVUs is problematic. However, the potential for CPT category 0340T to be misvalued remains as inadequacy in UroLift RVUs will have negative implications on patient access and physician use of the treatment. Failure to obtain RVUs or undervaluation of UroLift RVUs would render the treatment a nonviable option for many physicians and the patients seeking this treatment.
The AUA lobbied the American Medical Association’s (AMA) CPT Editorial Panel to obtain a new CPT code category 0340T for UroLift implantation. This is the first and thus far only BPH treatment CPT code. Obtaining the CPT code was a significant achievement in establishing UroLift as a standard of care BPH treatment. However, the next important step is to obtain CPT code relative value units (RVUs). Medicare and most third-party payers use the Resource Based Relative Value Scale (RBRVS) to determine how much a physician will be reimbursed for a given service. RVUs are a measure of how much time and work it takes a physician to provide a given service, and each CPT code has recommended RVUs for three different components of physician work, practice expense, and malpractice expense. The combined RVU value is multiplied by a dollar figure known as the conversion factor to determine physician reimbursement for a given service. CPT codes are assigned new or revised RVUs through review by the RUC. The RUC is an independent group of physicians convened by the AMA for evaluating relative values and establishing new RVUs for new and revised CPT codes. In today’s healthcare climate, a new or revised CPT code without further RUC review does not guarantee RVUs. With only current CPT code category 0340T and no assigned RVUs to date, Medicare coverage and patient access to UroLift are uncertain.
(Gaffney et al.2021)Step one in obtaining Medicare coverage for a new treatment or procedure is to apply for a Category I Current Procedural Terminology (CPT) code. New CPT codes are reviewed annually by the CPT Editorial Panel. If the code is approved, it will usually be published in January of the following year. CPT codes are used by both public and private healthcare payers to identify what services were provided to a patient and are integral for patient access to a new treatment.
Patients suffering from bladder outlet obstruction (BOO) due to benign prostatic hyperplasia (BPH) have a number of treatment options. Evaluation of new procedures and surgical techniques is important to assure patient safety and efficacy of treatment. Patients consider many factors when choosing treatment, including potential side effects, long-term benefits, and impact on quality of life. Some prostate treatments may make a patient impotent or cause retrograde ejaculation and are therefore not ideal for a sexually active patient. Treatments that carry potential sexual side effects are often rejected by patients despite their high efficacy. Coverage of new BPH treatments by third-party payers is often a determining factor in patient and physician decision for treatment. High patient out-of-pocket expense or denial of coverage for a new treatment leads to decreased patient access and has the potential to render a treatment obsolete.
2. Medicare Coverage for Urolift
If you are a retired person, 65 years or more of age, then you would probably be enrolled in Medicare. As Urolift is being used in the treatment of Benign Prostatic Hyperplasia, one would be interested in knowing if it is covered by Medicare. Medicare has criteria and a set of conditions that are required to be fulfilled before the services being provided are covered by Medicare. As such, according to the National Coverage Determination, services such as Urolift are not covered by Medicare. The National Coverage Determination is a policy made by Medicare that lists the conditions required to be fulfilled and requirements to be met by a service or treatment in order for it to be covered by Medicare. According to the NCD made by Medicare, surgery for the treatment of Benign Prostatic Hyperplasia is covered only if it meets the following criteria. (Wu et al., 2023)
2.1 Criteria for Medicare Coverage
Urolift has a Medicare procedure code now, but there are some conditions. Medicare’s limited coverage policy on “prostate stents” includes Urolift and other similar procedures. This policy enables your Medicare carrier to make decisions on coverage of Urolift on an individual basis. To simplify, if you have Medicare insurance, then it is possible that you will be approved for the procedure. However, you will have to go through certain pre-approval steps. This may cause a delay in the procedure and in some rare cases could mean that you will not be approved for Urolift. It can be difficult to determine if your Urolift procedure will be approved by Medicare. In general, the coverage and approval process varies by state and by carriers within the state. By contacting your carrier directly or by having your Urolift doctor’s office do this for you, you should be able to get a better idea about your coverage. Currently, there are also many efforts by patients and urologists to advocate for improved Urolift coverage with Medicare, with the hopes that the process will become simpler and more uniform across US states. (Gaffney et al.2021)
2.2 Limitations and Restrictions
If an item or service is found to be reasonable and necessary, Medicare provides coverage. A determination is based on an advancement in both the disease state or patient quality of life and not on the basis of cost or improved efficacy. Coverage is based on a National Coverage Determination that generally occurs only after FDA clearance. According to the Local Coverage Determination from Noridian, Urolift may only be covered when performed in a Hospital Outpatient Department or Ambulatory Surgical Center. This automatically rules out coverage for any surgeries performed in an inpatient setting, which can occur when a patient has a complicated overstay in the hospital or a transient stay in a skilled nursing facility. Medicare may not reimburse for procedures performed in these settings, or a patient is subject to a Part B deductible and co-insurance. Unfortunately, because a patient’s site of service cannot always be predicted or controlled, this may result in unforeseen out of pocket costs. Another restriction is that Urolift should not be considered a purely elective procedure. Instead, it is recommended for patients with moderate to severe symptoms that do not want to be reliant on medications, and are not good candidates for more invasive surgery. Urolift is designed for patients with a diagnosis of Benign Prostatic Hyperplasia and a BPH related diagnosis code is required for coverage. Although the determination of medical necessity is often based on chart notes and lab results, this requirement may make Urologists very hesitant about recommending the procedure to Medicare patients. A patient with a BPH diagnosis who believes Urolift is the best option for him may be disappointed to find that Medicare will not cover the procedure in his current state.
3. Alternative Options for Coverage
Urolift is not covered by Medicare, but patients have options for coverage through private insurance companies. It is recommended that patients call their insurance company to discuss coverage for Urolift. Payment assistance information is also available from NeoTract, Inc. at 925-241-8444 or on the web at [Link] Urology San Antonio will assist patients with the required information to submit a claim to the insurance company for Urolift. Patients may also be able to submit the claim to their insurance themselves. A claim denial letter from the insurance company is required for Medicare patients to pursue the option of obtaining a private insurance plan for Urolift. If patients are enrolled in a Medicare Advantage plan, and have a signed ABN, there is a possibility of obtaining partial or full coverage because Urolift is assigned a generic CPT code that is an open benefit. (Del et al.2022)If patients are not eligible for obtaining insurance coverage for Urolift, or have a claim denied even with assistance, there is a possibility of obtaining coverage through the Texas Medicaid program. This is an open benefit, however claims submission and approval can be quite complex. Urology San Antonio has successfully navigated this process and provided Urolift to numerous patients with Medicaid coverage. Patients are encouraged to discuss this with their physician or contact the local Health and Human Services office to obtain more information.
3.1 Private Insurance Coverage
The UroLift System is a unique medical device that has been designated with its own CPT code, 52441. This is a major breakthrough because it means that physicians can now use UroLift as a treatment option for your patients dealing with BPH. As UroLift is an innovative procedure, it may take time before it becomes established as a standard of care in our healthcare system. Until that time, UroLift may be used as a non-covered benefit and may not be covered in some markets. Pricing and reimbursement rates vary by region, so an out-of-pocket expense may or may not be significant to the patient. Pricing and reimbursement rates are also determined by many factors such as physician specialty, patient demographics, and how the practice is set up to accept insurance payments. During the early stages of UroLift, there are a few tactics to utilize in providing UroLift to your patients, such as using “investigational” ICD-10 codes or using UroLift as an out-of-network service. UroLift is a safe and effective treatment reimbursed at a level willing to establish UroLift as a standard of care in the U.S. healthcare system. In 2016 or 2017, we expect Medicare to cover UroLift as a benefit as UroLift becomes established in the practice of Urology meeting coverage policy guidelines. UroLift will also be issuing other reimbursement resources to help navigate coverage and payment regulations in delivering UroLift to your patients. (Gaffney et al.2021)
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3.2 Medicaid Coverage
Medicaid coverage for UroLift tends to be more difficult in comparison to Medicare due to less established ground in state policies. State policies and approved benefits can be found with relative ease on the Medicaid website. Urologists and BPH patients should be mindful of updated policies and communicate with state Medicaid representatives if considering UroLift with Medicaid. Coverage limitations may restrict UroLift to patients with more severe medical conditions, to certain UroLift providers, or provide less rewardable compensation to the patient’s satisfaction. It is important for covered patients to be proactive with current policy information and to capitalize on a potentially covered procedure with prompt timing. (Anezaki et al.2024)
Medicaid is state-funded insurance that often covers non-Medicare patients, and the rules and benefits are managed by individual states. UroLift is a minimally invasive treatment option for patients with enlarged prostate, or BPH, that may be covered by Medicaid at times. As with any medical procedure, though, the process of acquiring UroLift with Medicaid coverage can be time-consuming and challenging. A recent study published in The Journal of Urology found that about 50% of the states provided some form of coverage for BPH therapies, including UroLift, though only about 27% of them would cover UroLift specifically. Coverage and acceptance policies vary with individual states, and some may have more limitations than others given their regional budget and priorities.
3.3 Patient Assistance Programs
If you do not meet the requirements for private insurance coverage or Medicaid, you may still be able to obtain financial assistance for your UroLift procedure through various pharmaceutical sponsored patient assistance programs. Each program has its own set of eligibility requirements that a patient must meet in order to qualify. Eligibility requirements are based on factors such as insurance coverage, income, and federal poverty level. If you are eligible, each program provides assistance for a different amount of time. Some programs provide assistance for a single surgery, while others cover a period of 3-6 months. Each company has trained representatives available to assist you with the application process, or to answer any questions about the program. Arizona Pharmaceuticals has a program called The Patient Access Network (PAN) that may provide assistance for men with Medicare Part D. PAN provides assistance for a single surgery. It is essential you talk with your physician’s office before applying for assistance through these programs. Oftentimes, the staff will have to submit a pre-authorization claim to your insurance company to verify the procedure is covered, and to confirm that you are eligible to receive assistance. Your physician’s office staff can assist you or apply on your behalf by initiating a conference call with a company representative. (Collier et al.2022)
4. Conclusion
There are other procedures for BPH that are available but patients do not often want to pay out of pocket for them. The universal concern about those with BPH is providing good healthcare coverage and without the support of insurance, patients are unlikely to pursue treatment. (open) In concern for Urolift and Medicare, there is potential for categorizing Urolift as a “covered under medical exceptions” or further scientific evaluation for establishing it as a “medical necessity” for treatment of BPH. According to the references, there appears to still be a lack of sufficient data in comparison to the other treatments of BPH provided by Medicare. Urologists who are looking to treat Medicare patients with Urolift are suggested further communication with the patient and the insurance company to determine the best course of action; which sometimes may lead to a last cost to the Urologist themselves. (6) It is crucial to consider that BPH treatment is more than likely to be a long term event for the patient and while Medicare insurance coverage is not optimal today, there is potential for changes in flexibility regarding coverage of this new and appealing procedure for BPH.
References:
Bortnick, E., Brown, C., Simma-Chiang, V. and Kaplan, S.A., 2020. Modern best practice in the management of benign prostatic hyperplasia in the elderly. Therapeutic Advances in Urology, 12, p.1756287220929486. sagepub.com
Gaffney, C.D., Basourakos, S.P., Al Hussein Al Awamlh, B., Wu, X., Cai, P.Y., Hijaz, A., Jaeger, I., Lee, R.K. and Shoag, J.E., 2021. Adoption, safety, and retreatment rates of prostatic urethral lift for benign prostatic enlargement. The Journal of Urology, 206(2), pp.409-415. [HTML]
Wu, X., Zhou, A., Heller, M., Chi, T., & Kohlbrenner, R., 2023. Comparison of Minimally Invasive Procedures for Benign Prostatic Hyperplasia: A Cost-effectiveness Analysis. Radiology. [HTML]
Del Giudice, F., Oh, J.K., Basran, S., Nicaise, E., Song, P.H., Kim, W., Kim, S.Y., Min, G.E., Yoo, K.H., Cho, H.J. and Lee, S., 2022. Recent trends in the diagnostic and surgical management of benign prostatic hyperplasia in the US from 2004 to 2017: annual changes in the selection of treatment options and medical costs. Applied Sciences, 12(17), p.8697. mdpi.com
Anezaki, H., Endo, F., Swan, G., Takashima, K. and Rojanasarot, S., 2024. Cost-effectiveness analysis of minimally invasive surgical treatments for benign prostatic hyperplasia: implications for Japan’s public healthcare system. Journal of Medical Economics, (just-accepted), pp.1-18. tandfonline.com
Collier, E.K., Price, K.N., Hsiao, J.L. and Shi, V.Y., 2022. Demystifying pharmaceutical patient assistance programs. Journal of Dermatological Treatment, 33(1), pp.336-341. [HTML]
