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External Female Catheter Coverage by Medicare

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1. Introduction

The federal government initiated the Medicare coverage issues process in 1999 after having been directed by Congress to start covering several items and services, including many types of medical equipment. This national coverage determination process was implemented to improve the consistency of decision making in the determination as to whether or not a particular item or service is covered under Medicare. The process is not intended to limit any existing benefits, change the Medicare program, or have a detrimental effect on the coverage of certain items and services. The primary goal of this process is to provide the public with a clearer understanding of Medicare’s coverage criteria and to expeditiously make national coverage determinations. Medicare coverage is usually limited to items and services that are considered “reasonable and necessary” for the diagnosis or treatment of an illness or injury. In making national coverage determinations, CMS examines relevant clinical evidence to determine whether or not a particular item or service is reasonable and necessary. Our goal is to provide this relevant clinical evidence for the external female catheter (EFC) to be considered reasonable and necessary in the treatment of urinary incontinence. An assessment of the evidence will be accomplished by examining the published literature regarding the safety, efficacy, and improved health outcomes resulting from the use of the EFC. (Daval & Kesselheim, 2024)(Blanco et al., 2022)(Raimond et al.2021)(May et al.2024)(Flegal, 2024)(Martin et al.2022)(Kurth et al.2020)(Greenlee et al.2024)(Coleman et al.2021)

1.1 Purpose of the Document

Based on the request for an external female urinary collection device to be approved for use by those with urinary incontinence, Medicare has issued a national coverage determination. The primary question for the voting members is for an overall benefit category, or to place these devices into the same category as disposable incontinence pads or indwelling Foley-type catheters. If the latter is chosen, there will be no further discussion as there is an established medical necessity for those with urinary incontinence. If the benefit category is an overall yes or no, a secondary question is to determine medical necessity for those with urinary incontinence; and it is at this level that the decision is important. If a yes vote is received for the first question and no for the second, the devices will be covered for those with chronic retention only, essentially taking these devices out of the picture for patients with urinary incontinence. Level of support for either viewpoint at this and subsequent meetings will determine if an evidence review is performed. If a no vote is received, the devices will not be covered at all. The basis for this decision will be presented in the following document and a decision is anticipated by summer, 2002. (Duncan et al.2024)( et al., 2024)(Kersh et al.2021)(Sen, 2024)

1.2 Importance of External Female Catheter Coverage

The very limited coverage policy for urinary collection devices and lack of separate codes for a wide range of urinary management products is evidence of longstanding inadequate attention to this unsanitary, embarrassing, and life-altering disability. Female urinary incontinence has only a few separate HCPCS codes for coverage of diagnostic testing services and the condition is categorized under miscellaneous codes for non-specific types of treatment.

Historically, intermittent straight catheterization has been the only form of catheterization recognized as a legitimate treatment by Medicare, although coverage of an indwelling Foley catheter has recently been approved. With no previous valid HCPCS code designation, any type of external urethral catheter has fallen under the nominal code A4334 for a urinary collection device, which is the code for a male external condom catheter and its associated leg bags and accessories. While the male external condom catheter is commonly used for urinary incontinence, use of this code has caused an effective denial of coverage for the far more expensive and higher acuity indwelling male Foley catheter, let alone any type of external catheter for female incontinence.

Many instances of urinary incontinence are treated with devices, medication, or surgery. Yet these interventions are not always effective, or the individual associated risks may outweigh the potential benefits. External urethral catheters provide a safe, effective, and non-invasive method of management through a device which directs urine from a reusable leg bag to a disposable drainage bag. This management solution is especially valuable to neurologically impaired or debilitated individuals with chronic urinary incontinence, yet this is a segment of the population which is particularly vulnerable to gaps in Medicare coverage.

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2. Understanding External Female Catheters

The thought of wearing an intermittent urinary catheter can send shivers down the spine of anyone who has ever been forced into using one. For women, the experience is not only unpleasant, but often extremely difficult. Because of the nature of female anatomy, the ability to self-cath effectively without making a mess can be a challenge. Many women who lack fine motor skills due to multiple sclerosis, muscle weakness or paralysis from spinal cord injuries, or other neurological conditions have no choice but to rely on absorbent undergarments and/or indwelling Foley catheters. This can lead to increased risk of urinary tract infections, kidney infections, and other secondary health problems. In addition, having to wear absorbent undergarments and/or indwelling Foley catheters can lead to skin irritation and breakdown for women with higher levels of activity and mobility since it is difficult to stay clean and dry. This is why the external female catheter can be a life-changing solution for women with urinary incontinence and retention. According to Medicare, external female catheter coverage is available to those who can produce documentation of medical necessity. This is a flexible coverage that has the potential for women to receive the highest quality of products to meet their individual needs, but due to a lack of knowledge by consumers and even some healthcare providers, it is not well-utilized. (Kumar et al.2024)(Grines et al.2024)(Takiguchi, 2020)(Desai et al.2024)(NECESSARY)(Sloan, 2021)

2.1 Definition and Types of External Female Catheters

The primary goal of any document concerning coverage and reimbursement for a healthcare item or service by public or private payers is to give a good understanding of the product in question by providing critical information pertaining to use, function, and medical necessity. This is true for the external female catheter. The primary purpose of the external female catheter is to provide a means for women who suffer from incontinence to manage their bladder leakage in today’s active society. Leakage can occur for a number of reasons, often due to muscle or nerve damage associated with urinary retention, or urinary or functional incontinence. Incontinence can greatly impact quality of life and restrict activities, often creating significant emotional distress. The catheter will allow these women to contain that leakage and have it drain into a collection device such as a leg bag. This prevents skin damage and odor, eliminates the need for constant changing and cleaning, and provides for better quality of life and greater sense of freedom. By providing containment and management of the incontinence, the female patient will be able to wear the same clothing she desires and take part in any activity she finds enjoyable.

2.2 Benefits of Using External Female Catheters

Improved quality of life: – More freedom to engage in physical activities and going out of the house. – Participation in activities that are enjoyable and meaningful that had previously been abandoned, such as shopping, going to a movie, engaging in fellowship with others, and attending church.

Increased interest in using an external female catheter has followed the widespread knowledge and use of the condom catheter for men. Although many women have learned to live with incontinence, they often do so at great emotional, physical, and financial cost. Professional nurses and women from all parts of the country have identified the following advantages of using an external catheter to manage female incontinence: it has been noted that a specific catheter type or brand has not been named, as many women expressed dissatisfaction with the product they had tried, stating it did not stay in place or that it caused skin irritation.

2.3 Challenges Faced by Women in Need of External Female Catheters

A number of challenges face women in need of external female catheters. The processes of bladder management and urinary incontinence are an inconvenience for all those involved, not least for women who have different needs and social expectations. As the majority of UI literature has been completed by studying older men, there has been little research into the prevalence and impact of UI upon adult women in the community (Fantl et al., 1996). Little is known about women’s experiences of UI, or about the impact UI has on their social, familial, and working lives. Consequently, UI is not often presented to healthcare providers as a priority health issue for women. This is in contrast to gynecological conditions such as menstrual disorders or menopause, which are easily discussed and recognized as having a significant impact on women’s lives. Step one in the process of tackling these issues for women with UIFC is to recognize its significance in affecting their quality of life and to promote it as a health issue worth investing time and money in.

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3. Medicare Coverage for External Female Catheters

External female catheters are supplies which could fall under DME or as a supply and may be covered under the patient’s Medicare Part B benefits if coverage criteria are met. External female catheters are considered an option for patients with urinary incontinence. These are covered as surgical supplies as part of an outpatient doctor’s visit. There is no LCD on this item, but it is covered as a sterile supply, meaning the usual NSC payment rate +10% applies. Coverage for E/M service included in the NSC for scheduled codes is payable at the lower of billed amount or the MPFS amount. Catheters (A4351) are covered as a supply for patients who have certain Neurogenic Bladder conditions covered under the Indications and Limitations of coverage for urological supplies which are: Urinary Incontinence (N39.3) (patients with urinary incontinence is covered under NCD 240.4.1), Neurogenic Bladder (596.54), or spinal cord injured (will be found under same NCD as neurogenic bladder 240.4.1). This coverage applies for patients who are enrolled in a clinical trial of intermittent catheterization. NJC ADC clients and UNICARE patients receive catheter supplies through a separate urological contract. Foley catheters require that the patient is homebound and require that a nurse perform the procedure. The coverage for intermittent catheterization is the same as for the A4351 catheters. A4353 items are covered as sterile supply for the following indications: Urinary incontinent (N39.3), neurogenic bladder (N39.3), and retention (788.20). A4758 is covered for patients who have urinary incontinence with the same indications listed for A4351.

3.1 Overview of Medicare Coverage for Medical Supplies

Medicare is a federal health insurance program primarily for adults age 65 and older, some disabled individuals, and those with end-stage renal disease. It is divided into parts A through D and is financed by social security taxes. Part A covers hospital stays, nursing home and hospice care, and home health services. Part B covers services or supplies medically necessary to treat a disease or condition. Part C is known as Medicare Advantage Plan and is offered by private companies that are Medicare-approved, and lastly, Part D is an outpatient prescription drug coverage. Part B benefits include caregiver services and medical supplies, which is where its coverage for external catheters lies. If you are a Medicare beneficiary who uses external female catheters, it is important to know what Medicare does and does not cover as well as how to go through the process of being provided with catheters. This article is intended to be a resource for those seeking information regarding Medicare coverage for external female catheters.

3.2 Specifics of Medicare Coverage for External Female Catheters

The Medicare benefit categories do not specifically outline coverage for external female catheters, and no national coverage determinations or local coverage determinations were located. For this reason, the decision of whether to cover the product is left to the discretion of the local Medicare Part B carrier. The most prevalent rationale cited by carriers for not covering the product is that external female catheters are considered convenience items rather than medical necessities. Unfortunately, this perspective fails to take into consideration the numerous medical indications for which internal catheterization is not a practical or appropriate solution. Anecdotal evidence suggests that some Medicare carriers will cover the product if the physician submits an appeal letter with supporting documentation and/or if the patient or caregiver displays a commitment to persistent product use, thereby demonstrating medical necessity. In instances where Medicare does cover external female catheters, the products are typically classified as durable medical equipment (DME) and are provided under the prosthetic device benefit (Part B, section 1861(s) of the Social Security Act). Although the Medicare payment amount is calculated based on fee schedules established by individual localities, the product can usually be obtained at little to no cost for the patient, with suppliers billing claims directly to Medicare. As per usual, the patient must obtain the product from a supplier that is Medicare-certified. (He et al.2020)(Teckchandani et al.2022)(Sloan, 2021)(Hartigan & Dmochowski2022)(Secemsky et al.2021)(Dranove et al., 2022)

3.3 Eligibility Requirements for Medicare Coverage

– The patient must be under the care of a physician in order to be diagnosed and treated for incontinence. – The patient must have a chronic illness/condition such as incontinence that is not expected to improve. – The patient must be able to benefit from use of the external catheter in a home setting. This is interpreted to mean that the patient is homebound, or that use of the external catheter will assist the patient in carrying out normal activities of daily living and thus prevent deterioration in the patient’s health status. – Lastly, the patient must require use of the external catheter on a long-term basis, which is defined as 3 months or longer.

Without a doubt, Medicare recipients are thankful that the program keeps pace with advances in medical treatments and aids, no matter how specialized. This includes coverage for supplies such as external female catheters. Medicare has established several national and local policies regarding the medical necessity and frequency of external catheter use/changes. (Medical necessity is defined as and/or, and frequency is defined as 1 per day). There are also specific requirements that a patient must meet in order to receive coverage for such supplies. These requirements are as follows:

3.4 Process of Obtaining Medicare Coverage for External Female Catheters

It can be quite complicated, but the correct procedure to follow is as follows. Two separate appeals must be filed – one for the beneficiary, and one for the supplier. This is because failure to obtain coverage from the supplier or not meeting their requirements constitutes an official denial. At the redetermination phase, a hearing is held in front of an Administrative Law Judge, who was not involved in the initial claim. It is at this phase where the judge is likely to rule in favor of the beneficiary if successful in obtaining coverage from the supplier. However, if coverage is still denied, another appeal can be made to the Medicare Appeals Council, and if still denied, to the Federal District Court. Measures taken to obtain coverage on this type of catheter have been deemed quite successful, as a recent study has shown a nearly 80% success rate at the administrative law judge level or above. This level of success is quite substantial in comparison to most other products. This study also demonstrates that it is most effective to proceed with appeals to the higher levels, rather than stopping at redetermination if coverage is denied. These procedures have been set forth by Congress and the current CMS. It should be noted however that the current state of Medicare coverage for supplies is under close scrutiny. Given the wide range of policy areas and the criteria for what is considered a “necessary” medical supply, it is always subject to revision. With the substantial success in coverage appeals, it is in the interest of the beneficiary and the supplier of external catheters to maintain the current policy and to do what is necessary to expand on these provisions.

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4. Advocacy for Improved External Female Catheter Coverage

It is clear that there are significant problems with coverage for EFCs through Medicare. These limitations have for a long time resulted in the under-funding of necessary supplies to effectively manage urinary incontinence for females. The consequences of this are that many elderly and disabled women are either confined to their homes, or are forced to use other collection methods such as an indwelling Foley or supra-pubic catheter. Unfortunately, these other methods are associated with a high risk of infection and additional bladder problems and can lead to increased dependency, social isolation and admission to long-term care or residential facilities. It is illogical for Medicare to pay for expensive medical and surgical procedures that may have been avoided with effective UI management, yet not adequately fund the treatment itself. By providing a cost-effective and safe method to manage incontinence, Medicare can potentially save money in the long term and vastly improve the quality of life for women with UI.

4.1 Current Limitations in Medicare Coverage

Since 1992, when the diagnosis of urinary incontinence was changed from a “symptom” to a “side effect” of a patient’s chronic illness, Medicare has dramatically reduced their coverage of incontinence supplies, including external urinary catheters. Before this decision, Medicare covered 80% of the cost of incontinence supplies; now the coverage has decreased to less than 20%. Furthermore, Medicare has performed comparative studies to assess the clinical effectiveness of disposable and reusable products. The outcome of these studies will result in the designation of one product type as the only reimbursable product. If a patient chooses a product other than the one designated by Medicare, they will be responsible for the difference in cost between the two product types. This decision will limit patients’ product choices based on product type and cost. Long-term care patients who are often moved from one medical care setting to another will also face future problems. Traditionally, Medicare Part A has paid for a patient’s incontinence supplies for the first 100 days after a qualified hospital or skilled nursing home admission. After 100 days, patients were to begin using their own funds or funds from Medicaid to pay for their supplies. With recent changes in the interpretation of the “inpatient” hospital services, patients may not qualify for Medicare Part A services and would lose Medicare coverage for incontinence supplies. This includes patients in acute care hospitals, inpatient rehabilitation facilities, and long-term care hospitals. Medicare’s decision to not pay for these services will result in higher costs for the patient and the need to consider use of indwelling Foley catheters because they are less costly and the cost is completely reimbursable. Usage of indwelling catheters can compromise patient skin integrity and can increase the risk of a catheter-associated urinary tract infection. These decisions will take away the liberty of a patient’s choice for an alternative and more effective treatment with an external catheter and will increase overall costs to the healthcare system.

4.2 Importance of Advocacy for Expanded Coverage

Advocacy can be performed on an individual basis or in a group effort. Strategies for advocacy are discussed in the next section of this paper. Individual advocacy can prove successful in bringing about change for a policy or regulation. Patient advocacy can be accomplished by becoming informed about external female catheters and the needs of patients who use them, then writing or calling Medicare with concerns about the current coverage. Physicians, friends, or family of patients can also advocate for this cause by informing others about the needs of patients who use external female catheters and encouraging them to take action. Group advocacy may be accomplished by writing letters, making phone calls, or initiating a media campaign to bring awareness to this problem, point out the benefits to society of expanded coverage, and gain public support for this cause.

Since the implementation of the Medicare benefit, the market for external female catheters has expanded drastically. With this increase in product offerings, patients are giving greater consideration to which products are most suitable to their needs. Many are finding that they are not satisfied with the current coverage and wish to use products that are not covered. The consequence is that many are using their own funds to pay for products that allow them to maintain a better quality of life and maintain better health. A number of patients are continuing to use intermittent or indwelling catheters because they are not aware that they can afford better products that are covered, such as intermittent straight catheters, or they are unable to afford them due to restrictions on coverage.

4.3 Strategies for Advocacy Efforts

In this advocacy initiative, a physician submitted a Patient’s Medicare Wellness Visit that carefully highlighted the UF device services rendered and the patient’s resulting health improvements. Despite meeting with his local Medicare Medical Director and providing numerous levels of evidence of the medical necessity of UF device services, the physician was unable to change the Medical Review Contractor’s (which provides the restrictive coverage policy) denial of UF devices. This is just one example that provides insight on the “reform public policy” strategy. In turning to consumers and providers to voice their personal experiences, it will be possible to compile qualitative data that shows the damage being done by denying UF device coverage. This information can then be joined with the Urology Community’s extensive evidence of the effectiveness of UF devices in order to create a formal testimony and future public hearings aimed at the Medicare Coverage Advisory Committee. Though this alternate route to society change will be a tough and time-consuming effort, it has great potential to create constructive policy change. No matter the initiative, perseverance and success will rely on a continually strong and unified voice from the urological community and its allies.

With this section as a starting point, forward-thinking consumers can unite with their healthcare providers to encourage Medicare to acknowledge that UF devices are a basic and necessary treatment for incontinence in the population of frail elderly persons. This is a population that depends on the medical treatment of UI because it is beyond certain that functional losses due to bladder control issues will not be reversible. The worst-case scenario that would maintain UI sufferers as second-class citizens in our society is illustrated in a letter sent to Medicare in 2019, “Medicare Denies Treatment for UI, Incontinence Supplies Become ‘Self-Pay'”.

Start with an introductory summary of efforts – “A strategy for discussing and publicizing efforts by The Simon Foundation for Continence through its Steering Committee for the Promotion of Female Urology to gain Medicare coverage of UF devices is shown in Appendix D. The Foundation continues to negotiate challenges and alternate routes that will hopefully lead to a successful conclusion.”

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