Female External Catheters Covered by Medicare

1. Introduction

As of the present date, the Health Care Common Procedure Coding System (HCPCS) has approved multiple female external urinary management devices for coverage by Medicare. The approved codes are listed in Table 1. Only a couple of these devices are regularly utilized and prescribed by physicians, in part due to lack of knowledge and patient awareness of device availability and Medicare coverage. Pricing and availability of these products can vary locally and should receive further investigation from patients and healthcare providers.

There are two main purposes for utilization of these devices. First, the maintenance of skin integrity in patients who have difficulty with continence. This can include but is not limited to patients with spinal cord injuries, neurological conditions, or limited mobility. Female external devices are a much easier and comfortable way to keep the patient dry and avoid skin breakdown than using absorbent products. The second main use for these devices is for a temporary incontinence solution pre or postoperatively. Device utilization is often based on duration of leakage, cost, ease of use, and what is best for the patient’s lifestyle.

In 1992, the first female urinary management device received approval from the FDA. Since then, the technology and designs for these products have expanded, offering patients biomechanically sound devices that are contoured for a woman’s anatomy, comfortable, and easy to use. Female external urinary management devices are composed of an externally worn sheath that is connected via tubing to a bedside drainage. The sheath requires a sticker and adhesive to hold in place and is often changed on a daily basis.

Female external catheters are covered by Medicare. They are a convenient alternative to absorbent products and indwelling catheters, and an effective and less invasive way to manage UI. Medicare coverage of female external catheters has changed in recent years. This article will explore the types of female external urinary management devices covered by Medicare and explain Medicare’s variable policies regarding coverage for these devices. This information can be important when choosing the right device for a patient in order to maximize insurance benefits.

2. Eligibility Criteria for Medicare Coverage

2.2. Medical Necessity The use of external catheters can help to avoid UI episodes caused by urinary incontinence and UI episodes with a strong and sudden urge to void. The Supreme Court’s 1989 decision in Bowen v. American Hospital Association, “medical necessity” is defined as health-care services or supplies needed to prevent, diagnose, or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medical practice. This decision provides encouragement to contest claim denials on the basis that incontinence supplies are medically necessary to avoid UI episodes and prevent infections for individuals otherwise eligible for Medicare. The definition of “medical necessity” is a relative term, as it depends on the individual specifics of a case and what is regarded as accepted standards of medical practice. To avoid claim denials, it is important to document all case-specific information for up to one year to demonstrate a consistent medical condition and necessity for incontinence supplies at the time of claim submission. This encompasses a physician’s order, medical history, and treatment information.

2.1. Age Requirement The age requirement for Medicare coverage is dependent upon the situation. If a person over 65 receives incontinence supplies through intermittent catheterization, Medicare Part B may cover the supplies if the beneficiary is eligible for or enrolled in Part B Medicare and has a medical condition requiring sterile intermittent catheterization. If the beneficiary is not eligible for or enrolled in Part B Medicare, receiving incontinence supplies through intermittent catheterization, and has a medical condition requiring sterile intermittent catheterization, Part A may cover the supplies if he or she is receiving home health care or is a hospital inpatient.

Medicare covers supplies related to incontinence for eligible beneficiaries. To be eligible, a person must be aged 65 or older, under 65 and disabled, or any age with End-Stage Renal Disease (ESRD) that requires dialysis or a kidney transplant. A person under the age of 65 is eligible for Medicare after receiving Social Security Disability Insurance (SSDI) or Railroad Retirement Board disability benefits for 24 months.

2.1. Age Requirement

Patients age 65 or older are readily eligible for any and all Medicare benefits. The patient with Medicare due to their age will not have to worry about the requirement of needing to provide medical documentation to prove medical necessity for the ECC. One of the frequent pitfalls with receiving Medicare coverage for specific items involves the fact that one will often have to prove that in fact there is a necessity for the item in question. Most likely the enrollment into getting an ECC is for incontinence (both bowel and urinary) and or overflow incontinence which is secondary to some other medical problems. However, the point where there is a fine waste of time documenting every single physician visit for a frustrating issue for you and your physician to show that in fact it is medically necessary for you to have the item in question. This however is somewhat of an easier paper trail to follow as compared to someone who is under the age of 65 and has Medicare due to a disability. [1][2][3][4][5][6]

Age 65 or older

To qualify for Medicare coverage, the female patient must be age 65 or older, under age 65 with certain disabilities, or any age with End-Stage Renal Disease (ESRD) who requires regular dialysis or has had a kidney transplant.

2.2. Medical Necessity

The therapy required need not involve an oral medication, it must only correct or improve a medical problem in order to maintain health or prevent deterioration. In a patient suffering from urinary incontinence or retention, the improvement of the medical problem will be to discontinue the incontinence or retention. Estrogen replacement therapy has been covered by Medicare, and a female patient no longer suffering from urinary incontinence or retention may discontinue the therapy. Since the medications may have side effects, a catheter may be the preferred treatment option. [7][8][9][10][11][12]

For female patients aged 65 and older, the root of the urinary incontinence may be the result of an estrogen deficiency. Hormone replacement therapy has been known to increase incontinence in these patients. Since these patients are more likely to be treated with hormone replacement therapy, they are possible candidates for the external catheter.

The female external catheter is an alternative in the management and treatment of urinary incontinence or retention. Indwelling urethral catheterization is much more invasive than the female external catheter and is more likely to result in morbidity, particularly in a frail patient who is not ambulatory. The external catheter is designed to help patients with urinary incontinence or retention who are confined to a wheelchair or bed and can be used in conjunction with a bowel program.

The Medicare benefit is a medical insurance program for individuals who are at least 65 and older and for people with disabilities. It has been designed to help potential beneficiaries who have a serious medical problem, have a known diagnosis, and need treatment with a urethral catheter, which is typically inserted by a physician. This procedure may result in considerable discomfort for the patient.

2.3. Prescription Requirement

Remember that the primary goal of the prescribing physician should be improvement in the health status of the patient. An appropriate prescription for a covered item submits the claim for reimbursement to Medicare, which constitutes the assignment of the patient’s right to receive Medicare payment to the supplier. Further information on documentation for the establishment of medical necessity is provided in section 110.3 of the Medicare Policy Manual.

The requirement of medical necessity aids in preventing inappropriate utilization of Medicare funds. In order to establish medical necessity, the stated items on the prescription should logically correspond to the diagnosis and include a description of the type and frequency of catheterization the patient will be performing. For example, a patient diagnosed with urinary incontinence who requires a female external urinary catheter due to unavailability of facilities for clean intermittent catheterization or who cannot perform catheterization on her own may have medical necessity.

There is no specified form or official set of requirements for a prescription. As stated in the Social Security Act, the physician’s prescription must simply be in written form and contain the following information: – Diagnosis or nature of illness or injury – Explanation of why the stated items on the prescription are needed for treatment (to establish medical necessity)

3. Types of Female External Catheters

Adhesive catheters are often selected for female patients with urinary incontinence conditions. They need to be used with the appropriate sized leg bag or bedside drainage collector. This type of catheter generally carries a lower risk of urine leakage, however, skin complications can occur with extended use. Clamp on catheters are selected based on patient preference. This type of catheter generally provides the feeling of better security, but with the tradeoff of increased urine odor and greater risk of urinary tract infection. [13][14][15][16][17][18]

The type of catheter is selected based on the patient’s level of activity, surrounding skin condition, and preference. In general, condom catheters are preferred because they allow female patients increased independence and mobility. Also, this type of catheter generally carries a lower risk of skin complications compared to indwelling urinary catheters. A minimal amount of urine may still collect on the user’s skin. Thus, it is important to monitor skin condition and ask for further medical evaluation if skin irritation occurs.

3.1. Condom Catheters

Overall, the use of a male condom catheter is proven to be cost-effective, efficient, and less invasive than other incontinence devices.

A woman has the option of attaching the drainage tube to an overnight or leg bag. This method can be useful in preventing frequent trips to the bathroom and will save time for those with busy schedules. In the long run, it can diminish the effects of incontinence on a woman’s mental health and physical status. Choosing the correct size of the condom catheter is essential in preventing leakage. Manufacturers have recommended the use of a size small or medium for women as it will fit the female anatomy better than a larger size. Women should measure their thigh or hip circumference to get the best fit.

Condom catheter use for women in the past has been deemed only applicable for the female population. However, a recent medical journal article has been published discussing the use of a condom catheter to aid in the incontinence of both men and women. The article states that women can actually benefit from using the male version of a condom catheter. Men’s condom catheters involve a sheath which contains a combination of silicone and other polymers, including hydrocolloids and acrylics. The catheter is secured to the penis shaft with an adhesive and is attached to a collecting system via a drainage tube. Silicone materials are known to be unbreathable and can cause moisture buildup. Hydrocolloids and acrylics can cause irritation and skin stripping to the surrounding areas. This type of condom catheter may cause more harm than good to the female population.

3.2. Adhesive Catheters

Adhesive catheters are not as commonly used as condom catheters, but they have a few significant advantages. Adhesive catheters resemble a condom catheter, but instead of using a double-sided adhesive strap, the entire catheter is self-sealing. The most widely known adhesive catheter is the Purewick. Cost and availability for this type of catheter can be a disadvantage, and it is not uncommon for insurance companies to only cover Purewick catheters after other catheterization methods have proven to be unsuccessful. Because of this self-sealing design, adhesive catheters can be used effectively for female patients who may be immobile or bedridden, as it still allows for effective urine drainage. The attached drainage bag protects bedding in patients who suffer from incontinence, making for a very useful tool. It is important to remember that adhesive catheters must be changed every 24 hours, and there is an increased risk of developing a urinary tract infection from using any type of indwelling catheter. The National Association for Continence has an informative comparison chart that provides a nice side-by-side feature comparison of various adhesive catheter products along with other female catheter types. This can be a helpful tool for finding the right product depending on each patient’s individual needs.

3.3. Clamp-On Catheters

With modern materials and design, this catheter type is becoming less intrusive, with materials now being silicone-based, allowing greater comfort and less skin irritation. Silicone bands, similar to the type used in adhesive catheter types, are also becoming available, which can be used to secure the tubing to the leg. Silicone bands have the advantage of being easily adjustable and reusable.

The advantage of this type of catheter is that it’s ideal for spinally injured patients or those that have poor hand function. This is because the drainage system can be left in place and won’t become dislodged unless the connector is pulled apart. In this case, using a connector with a lesser degree of interlocking force can be utilized to ease disconnection of the drainage system while in bed, to prevent possible trauma to the user if the tubing gets caught around the user’s neck area. More or less, an airlock type of connection should be used, allowing the connector to disengage relatively easily with little force, but still holding enough to prevent accidental disconnect during normal activity. These types of connectors are available through medical suppliers and also scuba diving shops.

The clamp-on catheter is similar to a condom catheter, with the exception of how the device connects to the body. Housing the condom end is similar, but at the tubing end, a connector is provided to attach to a regular or self-intermittent catheter and a Foley catheter.

Clamp-On Catheter

4. Medicare Coverage for Female External Catheters

C. Despite the possibility that external catheter coverage may be reviewed in the future, it is still an uncertain issue and there are no guarantees that this coverage of male or female external catheters will be provided. In the meantime, those who have purchased or are considering purchasing external catheters and are ineligible for Medicare coverage can take advantage of a particular tax benefit in the US that enables individuals with incontinence to claim incontinence-related products as a medical tax deduction. This tax deduction enables individuals to get some relief from the costs of continence products even if they are not covered by insurance.

B. Despite the current lack of coverage, there is a possibility that coverage of female external catheters may be provided in the future. A bill known as HR 1102 – Finding Solace through Dignity and Compassion Act 2009, which was designed to assist the millions of people suffering with urinary incontinence and/or retention by greatly expanding Medicare coverage of incontinence-related products and treatments, has already been passed by the House of Representatives. Although it was introduced with a focus on providing coverage of medications and physician treatments for urinary incontinence, this bill shows that urinary incontinence is starting to generate attention as an issue that requires further Medicare coverage. With the expansion of Medicare coverage of incontinence-related products and treatments, it is likely that the eligibility of external catheters for coverage under Medicare will be reviewed. This would be excellent news for those individuals who rely on Medicare to assist with the costs of medical products and treatments.

A. In order to ascertain whether catheter coverage is possible for any given product, it is necessary to first take an in-depth look at what specific forms of catheter that Medicare covers. In general, catheters are only covered by Medicare if their use is deemed medically necessary and they are considered to be a DME (durable medical equipment) product. Medicare considers a product to be DME if it is primarily and customarily used to serve a medical purpose, generally not useful to a person who isn’t sick or injured, and appropriate for use in the home. Now, because female external catheters are relatively new products designed to improve the management of incontinence in females, at the time of writing Medicare coverage is limited only to indwelling (Foley) catheters which are connected to a bladder drainage bag. Indwelling catheters are covered by Medicare because they are a medical necessity for those individuals who are unable to control their bladder. Unfortunately, the stigma attached to urinary incontinence in elderly females and the lack of awareness about female external catheters has resulted in there being no Medicare coverage of external catheters for either sex.

4.1. Coverage Limitations

Because female external catheters are intended for urinary incontinence, use of the catheters can potentially change due to a change in the user’s condition, such as an increase or exacerbation in incontinence as a result of a new medical condition. Because of this, and the fact that female external catheters are designed to be worn for several hours or an entire day, medical documentation specifying the frequency of the use of the catheter or the change in the user’s condition must be obtained. Failure to demonstrate medical necessity for catheter use will result in claim denial, or the user may be held financially responsible. If the user has a secondary insurance, it is to be determined if they will cover the excess costs of additional units of catheters, or changes to the frequency or quantity of catheters provided.

Medicare will only provide reimbursement for up to 35 units of female external catheters per month, plus a small additional amount for nonspecific supply costs. Quantity limits in excess of this will require medical documentation to justify the medical necessity. Female external catheters are also subject to the Medicare Competitive Bidding program in certain areas of the country. Suppliers will not deliver more catheters in a three-month period than the frequency of the use of the catheter as supported by documentation, unless an increase in demand for additional catheters is documented. A written order or medical documentation that indicates the number of units per day must also be provided for dispensing more than 35 units per month. A new written order prior to dispensing (WOPD) is required for changes to the frequency or quantity of catheters provided, and a continued, demonstrated medical necessity is required for the changes to be supported.

4.2. Reimbursement Process

Funds may be restricted since, as of present, some individuals with fecal incontinence are using FECs and marketing them to consumers with the idea of them being an ostomy product, thus gaining reimbursement at a higher rate. This leads to a dilemma since the companies that are marketing them as ostomy products need to gain the higher rate of reimbursement to continue promotion of the product, yet creating new codes would potentially allow some individuals to gain a greater rate of reimbursement if FECs were to be classified as a self-catheterization product.

The development for new codes specific to FECs has begun, and due to the introduction of new HCPCS codes for male external urinary collection devices, industry professionals are actively encouraging CMS to establish new codes specific to female external urinary management systems. This would mean that in the future, it would be easier to attain reimbursement, and at a higher rate.

The reimbursement process for FECs is provided through Medicare Part A, Part B, and Medicaid. Reimbursement rates and administrative procedures vary for each program. Nevertheless, it is important to state that for each program, the key to gaining reimbursement for catheters is providing comprehensive documentation. This includes the following: a physician prescription, a letter of medical necessity, and a detailed statement and/or SOAP notes. Keep in mind that the documentation needed mirrors CMS documentation requirements for ostomy products.

References:

[1] R. Bhatia, E. Gilliam, G. Aliberti, A. Pinheiro, et al., “Older adults’ perspectives on primary care telemedicine during the COVID‐19 pandemic,” Journal of the American Geriatrics Society, vol. 2022. Wiley Online Library. nih.gov

[2] T. M. Gill, B. Vander Wyk, L. Leo-Summers et al., “Population-based estimates of 1-year mortality after major surgery among community-living older US adults,” JAMA Surg., 2022, jamanetwork.com. jamanetwork.com

[3] S. A. Graham, N. Stein, F. Shemaj, O. L. H. Branch, et al., “Older adults engage with personalized digital coaching programs at rates that exceed those of younger adults,” Frontiers in digital health, 2021. frontiersin.org

[4] W. Yang, J. L. Hamilton, C. Kopil, J. C. Beck, et al., “Current and projected future economic burden of Parkinson’s disease in the US,” npj Parkinson’s Disease, vol. 6, no. 21, 2020, [Online]. Available: nature.com. nature.com

[5] T. G. Buchman, S. Q. Simpson, K. L. Sciarretta, et al., “Sepsis among medicare beneficiaries: 1. The burdens of sepsis, 2012–2018,” Critical Care Medicine, vol. 48, no. 3, pp. 276-288, 2020. lww.com

[6] L. T. Penberthy, D. R. Rivera, J. L. Lund, et al., “An overview of real‐world data sources for oncology and considerations for research,” CA: A Cancer Journal for Clinicians, vol. 2022. Wiley Online Library. wiley.com

[7] MM Donneyong, TJ Chang, JA Roth, MK Guilds, “The Women’s Health Initiative Estrogen-alone Trial had differential disease and medical expenditure consequences across age groups,” Menopause, vol. 27, no. 9, pp. 1001-1009, 2020. nih.gov

[8] C. J. Bradley, L. M. Sabik, R. Liang, R. C. Lindrooth et al., “Treatment disparities in radiation and hormone therapy among women covered by Medicaid vs private insurance in cancer registry and claims data,” JAMA Health Forum, vol. 2024. [Online]. Available: jamanetwork.com. jamanetwork.com

[9] S. H. Baik, F. Baye, and C. J. McDonald, “Effects of Hormone Therapy on survival, cancer, cardiovascular and dementia risks in 7 million menopausal women over age 65: a retrospective observational study,” medRxiv, 2022. medrxiv.org

[10] R. Zucker, T. Reisman, and J. D. Safer, “Minimizing venous thromboembolism in feminizing hormone therapy: applying lessons from cisgender women and previous data,” Endocrine Practice, 2021. endocrinepractice.org

[11] X. Qin, P. Huckfeldt, J. Abraham, D. Yee, “Hormonal therapy drug switching, out-of-pocket costs, and adherence among older women with breast cancer,” JNCI: Journal of the National Cancer Institute, 2022, academic.oup.com. nih.gov

[12] G. L. Branigan, M. Soto, L. Neumayer, K. Rodgers, et al., “Association between hormone-modulating breast cancer therapies and incidence of neurodegenerative outcomes for women with breast cancer,” JAMA Network Open, vol. 2020. [Online]. Available: jamanetwork.com. jamanetwork.com

[13] M. Fader, C.L. Murphy, D.Z. Bliss, et al., “Technology for managing incontinence: What are the research priorities?,” Journal of the Institution of …, vol. XX, no. XX, pp. XX-XX, 2024. sagepub.com

[14] L. L. Coventry, V. Patton, A. Whyte, X. Liu, H. Kaur, A. Job, “Adherence to evidence-based guidelines for indwelling urinary catheter management: A cross-sectional study,” Collegian, vol. 28, no. 5, pp. 535-541, 2021, Elsevier. collegianjournal.com

[15] S. Saaqib, A. Iqbal, M. Naheed, T. Saeed et al., “A randomized controlled trial of cystoinflation to prevent bladder injury in the adhesive disease of multiple caesarean sections,” Scientific Reports, 2020. nature.com

[16] S. K. Doty and D. Engels, “Containment methods for incontinence,” Nursing made Incredibly Easy, 2021. ceconnection.com

[17] D. A. E. Spoolder and J. P. Geelhoed, “Management of bladder spasms in patients with indwelling urinary catheters: A systematic review,” Continence, 2024. sciencedirect.com

[18] F. C. Oswald, E. Young, F. C. Denison, et al., “Staff and patient perceptions of a community urinary catheter service,” in Community Journal of …, vol. …, no. …, pp. …, 2020, Wiley Online Library. wiley.com