1. Introduction
In recent years, a new alternative intervention for benign prostatic hyperplasia (BPH), known as prostate artery embolization (PAEB), is becoming a popular way of treating lower urinary tract symptoms associated with benign prostatic hyperplasia. PAEB may provide male patients seeking medical intervention with a less invasive and less costly alternative to traditional surgical treatments, such as transurethral resection of the prostate (TURP). Typically, TURP requires hospitalization and may be associated with substantial morbidity and side effects. If PAEB is proven to be as effective as TURP in reducing clinical symptoms of BPH, patients may stand to benefit greatly from PAEB if it is covered by insurance and carries less risk than surgery. Medicare is the largest single provider for health coverage in the United States and provides coverage for millions of Americans age 65 and older, as well as to those over 40 with certain disabilities. A significant proportion of patients with BPH in the United States fall into this age category, so it is important to establish whether PAEB is covered by Medicare at present or will be in the near future.
1.1. Overview of Prostate Artery Embolization
The main goal of the procedure is to decrease the size of the prostate by limiting blood flow to the organ, both diminishing symptoms of dysuria and urinary frequency often seen in BPH patients and preventing progression of the disease. Embolization of the prostate is an effective method to reduce the size of the organ, with various clinical trials showing at least a 30% reduction in prostate volume for most patients post-procedure. The alleviation of lower urinary tract symptoms and improvement of quality of life for patients makes PAE an increasingly desirable alternative to transurethral resection of the prostate (TURP) and other BPH treatments. TURP, for example, often causes retrograde ejaculation and erectile dysfunction. PAE can actually increase sexual function for patients, given that 15-30% of men with BPH-related symptoms also have erectile dysfunction. These factors and PAE’s low major complication rate, short hospital stay, and universal avoidance of urinary incontinence are part of the reason why seeking Medicare coverage for the procedure has the potential to be very impactful.
Prostate artery embolization (PAE) is a relatively new and highly effective alternative to other treatments – either surgical or pharmaceutical – for benign prostatic hyperplasia (BPH). Prostate artery embolization is a procedure where blood vessels that supply the prostate are occluded, or blocked. It can be used to treat a variety of conditions, such as uncontrollable bleeding, aneurysms, tumors, and malformations. The procedure is often used to help control symptoms or problems caused by these conditions. Patients with acute or chronic conditions that affect the liver, bleeding problems, certain types of tumors, malformations, or injuries can be good candidates for embolization. High success rates have been reported for PAE, with at least 72-80% of patients experiencing noticeable improvement of their BPH symptoms six months post-procedure.
1.2. Importance of Medicare Coverage
This subject examines whether or not Prostate Artery Embolization (PAE) is covered by Medicare. The subject is important to those who are seeking a minimally invasive treatment for benign prostatic hyperplasia (BPH) due to the fact that being covered by Medicare will make the treatment accessible and affordable to a wider group of patients. To provide background, BPH is an age-related condition that affects over 50% of men in their 60s and up to 90% of men in their 70s and 80s. Symptoms of BPH can include weak urine flow, urinary frequency and urgency, getting up at night to urinate, and inability to completely empty the bladder. Medication is often the first line of treatment for BPH, but may be ineffective, cause incontinence and sexual dysfunction, and pose risks to those with cardiovascular disease. Surgery is another option, but can lead to incontinence and sexual dysfunction and has a risk of causing retrograde ejaculation. PAE is a procedure that is performed by an interventional radiologist, using x-ray guidance and a catheter to place very small particles into the blood vessels that supply the prostate. This can shrink the prostate and relieve the symptoms of BPH without causing sexual or urinary side effects. Since the median age for men with BPH is 66 and the incidence rises with age, many men who suffer from BPH would be well suited for PAE and are likely to have Medicare as their primary insurance. Therefore, it is important to assess whether or not PAE is covered by Medicare so that this group of patients may have this valuable treatment as a viable option.
2. Medicare Coverage for Prostate Artery Embolization
As of our current searches, there is no specific statement for Prostate Artery Embolization in the Medicare Coverage Database accessed July 28, 207. In an email correspondence between the author and a representative from the Centers for Medicare and Medicaid Services, it was stated that generally, if an item or service is covered by Medicare, it is also covered by Medicare Advantage Plans. But every type of service may have certain limits or restrictions. To get more information, call your Medicare Advantage Plan. Medicare Part B (Medical Insurance) will help pay for some or all of the costs of services that are medically necessary. If Medicare were to cover PAE, it would most likely fall under a therapeutic procedure. So as of right now, PAE is not a covered service according to Medicare. This could change in the future as more evidence comes out regarding the safety, efficacy, and cost-effectiveness of PAE compared to other treatments. An important point to address is many of the patients who have the symptomatology of BPH are retired and have a fixed income in which they are living off social security. These patients will unfortunately most likely not be able to afford the out-of-pocket expenses for this procedure, and it has a dramatic effect to increase quality of life. So for these reasons, an effort should be made to help support coverage of PAE for these patients.
2.1. Eligibility Criteria for Medicare Coverage
Local Coverage Decisions A local coverage decision (LCD) is a decision by a fiscal intermediary or Medicare administrative contractor whether to cover a particular item or service on an item-of-service basis in a specific locality. An LCD, like an NCD, must be reasonable and necessary in accordance with section 1862(a)(1) of the Social Security Act. The decision cannot be contrary to the statute and must meet the adequacy requirements set forth in the regulation (Coding of Service, the extent of service (ESD), the effective date of the decision, and notice to affected parties). An LCD will consist of a determination as to whether the procedure is covered as a primary service, a secondary service, or not covered at all.
National Coverage Determinations A national coverage determination (NCD) is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Medicare. The determination is based on sufficiency of evidence on whether or not the item or service is reasonable and necessary for the diagnosis or treatment of an illness or injury, specific statutory exclusions from coverage and/or specific statutory provisions limiting Medicare coverage, the potential effect on the health of beneficiaries, and the requirements of section 1862(a)(1) of the Social Security Act. An NCD cannot be made for items or services that are covered on an item of service basis or if services are provided to individuals on an itinerant basis.
Clinical Study A clinical trial in which the only type of therapy being studied is the effectiveness of services provided by physicians, i.e., consultation or management of a medical problem, may not be determined as a covered service due to non-coverage of routine patient cost for clinical trial participation. Routine patient costs are generally all the costs a patient would incur even if they were not in the clinical trial. These costs must be reasonable and necessary for the given study. Services provided on an itemization/service basis are paid on the basis of each individual service provided, and to be covered, each service must be deemed reasonable and necessary for the diagnosis or treatment of an illness or injury.
There are specific requirements that must be met before a specific item or service can be accurately considered for Medicare coverage. For a prostate artery embolization (PAE) procedure to be considered for Medicare coverage, there are specific criteria that pertain to clinical studies, national coverage determinations, and local coverage decisions.
2.2. Coverage for Diagnostic Procedures
Medical necessity is a requirement for coverage by Medicare. It signifies that a procedure is reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member. IDEAS studies are commonly performed before new therapies are widely adopted or coverage by third party payers is provided. National Payment Determination is the final decision made by CMS as to whether a particular item or service is covered and to what extent it will be paid, this is often based on evidence provided in a recent NCD. Diagnostic arteriography is a minimally invasive procedure used to identify the site of many different vascular conditions. The Agency for Healthcare Policy and Research state evidence from randomized controlled trials is often not applicable to real world practice; AHRQ conducts comparative effectiveness studies to provide evidence that will be useful to clinical practitioners. Whilst not specific to diagnostic arteriography, the results from this type of study can influence Medicare coverage. Most recently the conservative management arm of the LUTS CARE trial which was not limited to medication alone, failed to reach its symptomatic end point due to lack of placebo arm and this has been suggested to impact further Medicare coverage of minimally invasive therapies like PAE. Understanding the intricate process of how Medicare coverage is influenced and continually evolves, it is clear that increased publicity and widespread proven results from clinical trials as well as comparative studies and evidence dissemination will be essential to change the status of Medicare coverage for diagnostic arteriography of PA.
2.3. Coverage for Therapeutic Procedures
According to Medicare, under Title XVII – 1862(1)(A), services that are considered not reasonable and necessary are not covered. For any service to be considered reasonable and necessary, there must be sufficient evidence to conclude that the service improves patient health outcomes. Unfortunately, it is currently more difficult to get coverage for new therapies in medicine, regardless of the cost effectiveness.
It is clear that patients that are Medicare eligible stand to gain the most from PAE, and would benefit from avoiding invasive therapies that are more prone to complications. Patients that have seen how surgeries like TURP have affected their friends or relatives are often the most interested in PAE. They recognize that there are fewer adverse events from PAE compared to surgical therapies, and would rather have an outpatient procedure using sedation than a hospital stay requiring general anesthesia.
Prostate Artery Embolization (PAE) is a new therapy for treating benign prostatic hyperplasia that is covered by most insurance companies and Medicare. However, because this is a new therapy, there is confusion among patients, administrative staff, and urologists about whether PAE is considered a diagnostic or a therapeutic procedure, and whether patients will meet criteria and be approved for this therapy under their insurance plan. Some insurance carriers are using the minimally invasive nature of PAE as an excuse to refuse coverage, claiming that the procedure is investigational, and has not been proven safe and effective. It is important that insurance carriers appreciate the cost effectiveness of PAE compared to other treatments, and understand that definitive studies on the safety and efficacy of PAE have been conducted, with additional level 1 evidence available soon. At this time, PAE has Current Procedural Terminology (CPT) codes, and is performed in an inpatient setting. It should be treated no differently than other minimally invasive therapies that are routinely covered by insurance carriers.
3. Alternatives to Medicare Coverage
If you are not eligible for Medicare, have gaps in your Medicare coverage or have out of pocket costs, you may have additional options to manage costs for PAE. Coverage varies for private health insurance. Please contact your health fund and insurer to clarify if PAE is covered and the extent of cover. Some insurers may not cover PAE or have restrictions on coverage. Check the level of cover and benefits before proceeding. If PAE is not covered, check if there are any options to upgrade your insurance policy to have cover for PAE. If you do not have private health insurance or PAE is not covered, you may consider paying for PAE out of pocket. It is important to understand all costs involved in PAE so that you can budget accordingly. Discuss costs of PAE with your radiologist and treating physician. They should give you a written quote with all costs involved. Contact your radiologist’s practice manager or hospital booking staff to clarify if there will be any out of pocket costs for hospital and medical services. You can contact the hospital billing officer or health fund to confirm any additional costs such as accommodation, theatre fees, doctors’ charges, and other ancillary items. High out of pocket costs can be a potential barrier to access and patients with financial difficulties should consider other options for funding PAE or delay the procedure until costs can be better managed. Some public hospitals may be able to offer PAE as a “Medicare ineligible patient” where they treat you as a private patient and you do not have to wait on a public waiting list. This may be arranged if there are deficiencies in public health system to manage your condition (e.g. no urology service for PAE), absence of suitable patients for interventional radiology training and if there is availability of interventional radiology resources. You should specifically ask the hospital to find out if this a feasible option for you. Note that availability of PAE for “Medicare ineligible patients” is dependent on individual hospital policies and resources with no guarantee of service provision.
3.1. Private Insurance Coverage
The patient now has the option of finding an insurance plan other than the standard Medicare coverage. This strategy can be an effective method for avoiding the costs of PAE as less expensive insurance may be obtained, though the feasibility and risk of changing insurance policies will vary with each patient. If this approach is a consideration, the feasibility of changing insurers will largely depend on the patient’s health status. Patients already enrolled in a Medicare Advantage plan would have a difficult time changing back to standard Medicare and Medigap supplemental insurance – it may be more feasible for these patients to advocate for expanded coverage in the future. Patients still actively working may have the option to find less expensive employer-sponsored insurance with the help of their employers. Spouses may also have the choice of adding the patient to their own employer-sponsored insurance. While it is difficult to predict the short and long-term effects of health care reform coming from the new presidential administration, it is anticipated that expanded coverage for PAE by private insurers could potentially become more feasible in the future. Effectiveness of this strategy will largely depend on the results of future clinical research and progress with NICE approval mentioned above. Overall, the decision to pursue PAE with private insurance must be made with full consideration of all potential benefits, drawbacks, and future financial planning.
3.2. Out-of-Pocket Expenses
When considering coverage, it is important to recognize that even if Medicare does decide to cover PAE in the future, out-of-pocket expenses (e.g. co-pays, travel and lodging) can still present a heavy financial burden to patients. This is especially true for individuals that are on fixed incomes, and for whom cost is a critical factor in deciding upon a treatment option. In this case, even partial coverage can equate to no coverage. Quantifying these potential costs is complex, as it can greatly vary depending on the patient’s specific insurance coverage, income level and geographic location. This variety also extends to the types of private insurance plans that patients may have, further complicating the issue of cost coverage or reimbursement. Despite the complexity, reducing the financial impact of BPH treatment is a topic of great interest to patients, and as with Medicare coverage, we feel it is important to investigate how PAE compares relative to other BPH treatment options. This should be a consideration for future research.
3.3. Financial Assistance Programs
Financial assistance programs are designed to help people with health-related costs, with an emphasis on low-income people who work but do not have insurance. Overall, the effectiveness of financial assistance programs in aiding men who would benefit from P.A.E. if Medicare did not cover it is not yet known since P.A.E. is still relatively new. There are no formal programs specific to P.A.E. at this time, but it is likely that as more data is obtained and P.A.E. shows good long-term outcomes, specific programs will be developed. In the meantime, men seeking this therapy can try to qualify for general programs offered through hospitals to help those in need, or charity care provided by Urology or Radiology professional societies. At this time, we would invite comments from patients of this study who have investigated and/or been successful in obtaining assistance for P.A.E. through free or low-cost programs.
4. Conclusion
The conclusions overall between different sources of the same express that more information is still needed about the specifics of PAE before a final decision can be made on making a national coverage determination. However, given present evidence and current guidelines set by CMS, it is suggested that PAE could be a possible procedure for Medicare beneficiaries if cost considerations were not a factor. As seen with the recent restrictions placed on the management of benign prostatic hyperplasia, decisions for Medicare coverage for prostatic artery embolization will ultimately depend on whether concomitant medical therapies and other minimally invasive procedures are deemed less costly for comparable effectiveness. If Medicare does decide to cover PAE in the future, it would obviously be a huge success for the procedure and would make it more accessible for a large group of men suffering from LUTS attributed to BPH. This would likely result in an increased demand for the procedure and it would encourage many practices to start offering PAE as an alternative to medications or other procedures. However, at present it is not clear how different medical insurance companies will change their policies with regards to the recent changes in Medicare coverage for treatments of LUTS attributed to BPH. It is possible that Medicare coverage for PAE will cause a trickle-down effect such that many other private insurers also start to cover the procedure.
4.1. Summary of Medicare Coverage for Prostate Artery Embolization
Our interviews with investigators at various institutions and interventional radiologists suggest that there are patients who had PAE with the intention of mitigating progression of LUTS, BPH medications, and BPH-related surgery. These Medicare patients were willing to pay out of pocket for PAE. The costs of PAE will vary with hospital charges and medical condition. Our cost analysis using hospital cost charge master data would suggest that PAE is likely less costly than surgical alternatives for BPH healthcare system.
Because BPH impacts male urinary health in later years, PAE is technically an attractive treatment to most of these patients. Given the demographics of Medicare recipients, many PAE candidates are Medicare beneficiaries. The preceding observations about Medicare coverage apply to these patients. Private payers often follow Medicare’s lead when making coverage decisions. So undoubtedly, the lack of Medicare coverage has a negative impact on all patient populations. If there was explicit Medicare coverage of PAE, there would be more widespread access to this treatment.
At this time, there is no specific Medicare National Coverage Determination for prostate artery embolization (PAE). Local coverage decisions are varied and are not readily accessible. Traditionally, if there is no formal Medicare National Coverage Determination, coverage is determined by local Medicare carriers based on their interpretation of what is reasonable and necessary medical care. Medicare will not pay for services that it considers not reasonable and necessary for the diagnosis or treatment of an illness or injury. While this provides the advantage of mainstreaming a new technique for treatment of benign prostatic hyperplasia, the lack of specific determination of coverage for PAE is a disadvantage for patients considering this treatment.
4.2. Considerations for Patients without Medicare Coverage
If a patient is not able to obtain Medicare coverage, he still has the option of obtaining PAE through payment with private insurance or by self-payment under a fee-for-service arrangement. This is often more feasible and attractive than the CED pathway with Medicare, particularly if the patient has a relatively high insurance deductible or co-payment that must be satisfied before coverage begins. Because many commercial insurance plans now follow Medicare coverage policy, it is possible that Medicare’s recent decision to cover PAE for CED patients may prompt a change in direction whereby insurance companies will begin offering better coverage and payment options for PAE. This could lead to broader access for a larger number of patients who seek PAE as an outpatient procedure with a short recovery time.
Prostate artery embolization (PAE) has gained considerable popularity as a treatment to relieve benign prostatic hyperplasia (BPH) over the past 10 years. However, patients and their referring providers continue to have limited options in the United States when it comes to PAE as an alternative to surgical treatment. At this point in time, there is no specific Medicare reimbursement code for PAE, so the only way to get Medicare coverage is “case-by-case” by applying for coverage with evidence development (CED) for a specific patient. This requires a great deal of effort to compile supporting evidence and to ultimately receive coverage for the patient from their Medicare Administrative Contractor. In most cases, the effort is too great to be worthwhile for the physician and patient.
