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Female External Catheters Covered by Medicare

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1. Introduction

Female external catheters are devices that are worn on the skin and are used to collect urine. They are an alternative to indwelling or Foley catheters and are self-applied. They are rolled onto the skin like a sleeve and are connected to a drainage bag to collect urine. They are made of a female catheter and a urine collection bag. These catheters are mostly used for incontinence as a standalone treatment or with surgery and are also used for urinary retention because it is a non-invasive alternative to catheterizing or using an indwelling catheter. Female external catheters are also used as a method of incontinence management for people who have multiple sclerosis, spinal cord injury, and other neurological conditions. Female catheters are often the last medical treatment attempted by the patient as they are relatively non-invasive and are more comfortable to use than an indwelling catheter. They are also convenient for the caregiver to use, who has to assist with the patient’s elimination needs. The advantage of an external catheter is that no insertion is required, making it a preferable option for many women. In the past, Medicare has covered many of the types of catheters available on the market today. Policies have since changed, favoring only a few of the major manufacturers. Medicare payees now have fewer options than in the past. This can mean that a patient who has been using a particular catheter for a long time and is comfortable with it may no longer get coverage for that catheter. If that happens, the patient and/or caregiver will have to pay out of pocket for the catheter or choose another type that may not be suitable. This may cause undue stress to the patient or the caregiver. With doctors, nurses, and patients working so hard to improve the quality of life, it is disheartening to see patients with a product that is right for them be unsuccessful in obtaining it due to a lack of coverage. (Hartigan & Dmochowski2022)(Stoddard et al.2021)(Aparasu et al.2020)(Schladen et al., 2021)(Padula et al.2022)

1.1 Importance of Female External Catheters

An external catheter for females is an effective way to manage bladder incontinence. It can be used effectively to manage incontinence but is also an alternative treatment for females with a catheter-dependent neurogenic bladder. It is a comfortable and dignified method of managing female urinary incontinence. Patients who have used the catheters have expressed no smell or skin irritation and have also stated that the catheter sometimes makes them feel as though they do not have incontinence. Measures of patient satisfaction are high, and women describe it as “life-changing.” This type of catheter has cost-effectiveness advantages over other methods of managing urinary incontinence and may have the potential to save money for healthcare providers and/or the patients. This type of catheter can be used for athletes who have incontinence problems during their sport and is allowed by sporting authorities. (Abdel-Fattah et al.2021)

The female external catheter is now becoming a treatment of choice for female bladder incontinence. This is due to the fact that more healthcare providers are looking for less invasive methods to treat incontinence, and it is also preferred by the patients. This is a better option than the indwelling catheter, with fewer risks and less potential for causing damage to the urethral tissue.

Female external catheter is important for females to prevent many diseases. Many healthcare professionals use the term “female catheter,” which generally refers to a urinary catheter specifically designed for women. Catheter usage is an uncomfortable yet essential practice for those who cannot control their bladders. This can occur for a number of reasons, be it through old age, injury, or disease. Since women cover half the population, it’s increasingly important to know about female catheters and the advantages of using them.

1.2 Medicare Coverage for Medical Supplies

You may be wondering if your elderly mom will be able to get her female external catheters covered by Medicare. This is a valid concern because as many of us know, Medicare does not cover everything that your doctor may deem medically necessary. The good news is that Medicare does cover the cost of female external catheters related to incontinence issues. The bad news is that Medicare will only cover the cost of the actual female external catheters, it will not cover any of the supplies needed to use the catheters. This includes adhesive, skin barrier wipes or remover, and leg bags. So when considering Medicare coverage of female external catheters it is important to assess the anticipated overall costs. Everyone wants the most cost-effective solution for their healthcare needs, but how much one is willing to spend varies from individual to individual. Remember that the cost per catheter is likely the cost you will incur with Medicare coverage as opposed to using other methods or supplies.

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2. Types of Female External Catheters

Silicone catheters: Silicone catheters are soft, pliable, nonabsorbent, and hypoallergenic. They are an excellent choice for patients who are allergic to adhesives or latex. Silicone catheters are known for comfortable wear, nonrestrictive to blood flow, and hypoallergenic attributes. They also eliminate the possibility of latex-induced skin irritations or allergies. However, due to the lack of adhesive, silicone catheters must be utilized with a stabilizing device to ensure that a proper seal and drainage occurs. Silicone catheters are known for their flexibility and easy removal without skin irritation. They are an excellent choice for active individuals who require a reliable incontinence solution. Due to the lack of adhesive, removal and replacement is suggested after 24-48 hours of wear. Latex catheters: Latex catheters have been shown for many years to be an effective urinary incontinence tool. They are a secure, reliable, non-slipping fit; however, latex catheters are not recommended for patients with latex allergies. Latex catheters are recommended to change every 2-3 days of wear to eliminate the possibility of urinary tract infections and accretion of salts on the surface. Silicone oil is suggested for ease of removal.

2.1 Silicone Catheters

Silicone catheters have gained popularity in recent years due to their breathability, wicking ability, and hypoallergenic properties. Silicone is a polymer that is made out of a chain of alternating silicon and oxygen atoms. This unique structure allows for the creation of a rubber that is extremely resistant to chemical reactions from other substances. It does not support microbiological growth, thus reducing the risk of urinary tract infection. Because silicone is a non-absorbent material, this catheter has a built-in all-day dryness. Urine will not be absorbed into the catheter, which means less skin irritation, no moisture to promote fungal growth, and overall healthier skin. Most silicone catheters utilize a breathable tape border that permits skin moisture to evaporate. This border also acts as a waterproof barrier so that urine will not seep onto the outer surface of the catheter. The combination of an internal and external urine collection system is ideal for individuals with incontinence. Silicone catheters can be applied with an adhesive or a latex-free non-adhesive material for those with sensitive skin. Although these are very attractive qualities, there are some trade-offs with silicone catheters in comparison to latex. Silicone catheters are more costly, generally ranging between seventy-five cents and one dollar per catheter. Unfortunately, silicone catheters are not covered by Medicare. The lack of coverage from national insurance companies can be a significant barrier, especially for individuals with fixed or limited incomes. (Lindquester et al.2021)(Robles-Torres et al.2021)(Hartigan & Dmochowski2022)

2.2 Latex Catheters

In summary, there are a few options when choosing a female catheter and it is important to make the right choice for your situation. Silicone catheters can be a more comfortable and non-invasive way of managing urinary incontinence. However, the cost of these can be substantial if they are to be used for a long period of time. Hydrocolloid or latex catheters can be an effective way of managing urinary incontinence, short or long term. However, the skin surrounding the area of use must be considered and monitored to avoid damage.

The second type of female catheter is the Latex Catheter. These catheters have an adhesive used in them which is covered by a strip of paper. The catheter is rolled onto itself and inserted into the vagina as in intermittent self-catheterization. Once the catheter is in the correct position, the tube is unrolled and positioned downwards. This type of catheter is often used for the urethral diversion of urine into a container. Latex catheters are available in different styles and designs and can be used for long or short-term catheterization. They are also available as a two-piece system and this allows for different sizes of catheter to be inserted onto the leg bag or valve. Unfortunately, some people are allergic to latex and are unable to use these catheters.

2.3 Hydrocolloid Catheters

Catheters fashioned from hydrocolloid materials are a relatively recent addition to the single use, intermittent catheter market. Hydrocolloids are chemical compounds that form a watertight gel around a catheter to absorb moisture and maintain adhesion to the skin. Suitable for patients with urinary retention, hydrocolloid catheters are increasingly used and are effective for the management of urinary incontinence. However, the medical literature contains few reports on the use of hydrocolloid catheters for incontinent women. A single-blind controlled trial assessed the effectiveness of hydrocolloid catheters for 28 women with urinary stress incontinence who were awaiting surgery. Randomized to hydrocolloid or a paste substitute, women used catheters for up to 7 days. In the hydrocolloid group, 11 of 14 women achieved satisfactory catheterization compared with three of 13 using the paste. Leakage of urine was reduced in 85% of hydrocolloid users compared with 36% using the paste. Undesirable skin effects were fewer in the hydrocolloid group than the paste group. Similar results have been found using hydrocolloid catheters for women requiring clean intermittent catheterization for neurogenic bladder dysfunction. In acne-prone and young patients, a hydrocolloid external catheter is a very good alternative. The expected wear time is far less. High acidity and enzymes found in incontinent stool and urine have no effect on a hydrocolloid adhesive. Hydrocolloid adhesive comes off the body of its own accord after a period of time to produce a dry intact skin. An external catheter and drainage system can be worn for up to 24 hours after which it is removed and the skin cleaned. This is in favorable contrast to adhesive tape and zinc oxide adhesive, which are difficult to remove and often leave the skin sodden with urine. Hydrocolloid adhesives range from tor-shaped urinary patches to large adhesive sheets that can be cut to any shape and size. Brand and product names for hydrocolloid adhesive materials are too numerous to mention. Temperature and humidity can affect the wear time of a hydrocolloid product, and so patients should experiment with different products to find the one most suitable for them. Hydrocolloid adhesive is more expensive than other adhesives, but the cost may be offset by reduced skin care, wound, and catheter changes. Ask a coordinating healthcare professional for more information on hydrocolloid products.

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3. Medicare Coverage for Female External Catheters

Female external catheters must meet the same eligibility requirements as other prosthetic devices to be covered by Medicare. First, the device must be considered reasonable and necessary to treat the patient’s medical condition. This means that the device must be of significant importance to affect the diagnosis or treatment of the patient’s condition and the patient’s condition must be one which either threatens life, causes illness or injury, or results in a significant loss of function. This can be satisfied for female external catheters if the patient’s incontinence causes skin irritation, sores, urinary tract infections, or other adverse medical conditions. These conditions may result in significant loss of function if the incontinence prevents the patient from participating in social activities. Finally, the patient’s condition cannot be well controlled without the use of the device. If a patient uses or has used absorbent pads, adult diapers, or indwelling catheters, these methods may have failed to sufficiently control the incontinence.

Medicare Part B plays an important role in covering female external catheters for patients with urine incontinence problems. Female external catheters are mostly covered under the category of prosthetic devices. Prosthetic devices are covered if they are considered medically necessary. Medicare Manuals contain a National Coverage Determination (NCD) definition of prosthetic devices in section 280.1 which states, “a prosthetic device is any device which replaces all or part of an internal body organ or replaces all or part of the function of a permanently inoperative or malfunctioning internal body organ.” Moreover, this NCD states that when a device meets this definition it must be considered reasonable and necessary to be covered under Medicare. This language applies to external catheters because the use of catheters is to drain unwanted urine from the bladder (a body organ) through a tube or to a collection device.

3.1 Eligibility Criteria for Coverage

Medicare utilizes specific coding indicators to determine coverage of prosthetic devices and supplies, and has determined that the proper coding for FEC is HCPCS A4356. Very often, FEC are billed using the code for a urinary catheter, and there has been frequent denial of coverage for FEC for this reason. However, it is possible to obtain coverage for catheters billed using code A4356, but this may require some communication with the durable medical equipment (DME) supplier and submission of additional documentation on the part of the patient and/or physician. Keep in mind that coverage will not be attained if the prescribing physician is a medical doctor (MD), as Medicare coverage guidelines for prosthetic devices are restricted to services provided by a doctor of osteopathy, podiatry, or allopathic medicine.

Female external catheters (FEC) are covered by Medicare under its category of prosthetic devices, including certain types of medical supplies that are necessary in the administration of a prosthetic device. The eligibility criteria for coverage of FEC is the same as for any prosthetic device. Medicare covers the cost of FEC if the item is medically necessary. The medical necessity of a FEC is closely associated with the patient’s underlying neurological condition that is causing urinary incontinence. If the patient is in need of FEC due to urinary incontinence in association with a stage III or IV sacral ulcer, FEC would not be considered medically necessary in this case. The patient’s capability to self-administer the device, or lack of a caregiver, is also important when determining medical necessity.

3.2 Reimbursement Process

To give an even further example above that is rather unorthodox, the relative reimbursement cost of a specific Foley catheter is determined by the amount of AWP for said Foley catheter. It was told by a reliable source of a paraplegic woman from the state of California who requested to have a specifically designed intermittent catheter for women sent to her. This catheter is designed to be capable of being hidden beneath the user’s hair and is inserted from a sitting rather than standing position. The cost of Cosma Foley catheter was about $160 or two times the greater than the relative reimbursement cost of an intermittent catheter. Subsequently, the reimbursement for female hydrophilic catheters is only around $27, cost for the same type of intermittent catheter mentioned previously.

The amount of reimbursement is determined locally since Medicare is now shelling out (no pun intended) reimbursement for intermittent catheters in the form of a fee schedule. The purpose is to pay different amounts depending on where the patient is located when the product is delivered. To give an example, the average AWP (80cc) for a box of 30 straight tip intermittent catheters in the state of California is usually around $55. Because the fee schedule sets the amount of reimbursement at an average of $34.50 (competent to around 62% of AWP) this would indicate that the patient is receiving payment close to the $34.50 mark when the product is delivered. Assuming AWP for an in/out catheter is equivalent to the above mentioned that of the straight intermittent catheter, the relative cost of providing both types of various catheters is still much more than the reimbursement for intermittent catheters.

The reimbursement process for catheter supplies at the present time still appears to confuse many people. Because an intermittent catheter is often used to facilitate the removal of urine from the bladder in a much similar way a normal functioning individual does, one might think that the reimbursement for this type of catheter would replicate that of the indwelling Foley catheter. However, earlier this decade the HCPCS code for intermittent catheters changed from the old A4351 to the new A4353. Because it is the specific HCPCS code that determines the type of product being dispensed rather than the product itself, this caused a major transformation in the reimbursement cost of intermittent catheters.

3.3 Limitations and Restrictions

3.3.2 The coverage criteria for an external catheter are the following: A. Patient has permanent urinary incontinence due to a non-reversible condition. B. The patient is homebound as defined in the Medicare Benefit Policy Manual (Publication 100-02), Chapter 15, §160. As with other catheters, the mere diagnosis of urinary incontinence will not be sufficient to warrant coverage for an external catheter. The patient must have permanent urinary incontinence caused by a specific non-reversible condition. The term “homebound” means that the patient has a condition due to an illness or injury that restricts the patient to the home and the patient is under the care of a physician. The patient may be temporarily away from home for short periods of time that do not indicate a change in status. (Ameen & Merchant, 2024)(Zuppone et al.2020)(Mykhailovska et al., 2024)

3.3.1 Intermittent straight catheters, indwelling catheters, and an external catheter are covered if medical necessity can be demonstrated. Urinary incontinence alone is not sufficient to meet the coverage criteria for any type of catheter. For patients who are unable to perform intermittent catheterization and are not able to have a caregiver perform the catheterization, an indwelling catheter is covered. Medical necessity can be demonstrated by incontinence and infection resulting from inappropriate and uncontrolled loss of urine. Intermittent straight catheters are covered for patients with urinary retention or who are unable to completely empty their bladder as a result of neurologic pathology. Coverage may be considered in patients who are unable to void urine into a toilet or a urinal.

Medicare provides coverage for a wide variety of catheters. However, assignment criteria and payment methodologies for the various types of catheters differ.

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4. How to Obtain Female External Catheters through Medicare

Don’t get discouraged by initial difficulties. It may be a little bit difficult to find a supplier or a retail pharmacy that will provide you with a female external catheter. Keep in mind that your medical supply coverage cannot be met by a local retail store (though keep those receipts in case of a policy change). You will have to contact multiple medical supply providers in order to find the right type and style of female external catheter to fit your needs. Everyone is different and it may be necessary for you to experiment with different types before finding the catheter that is right for you. Most medical supply retailers are well equipped with catalogues and customer service to assist you. Failing that you may need to contact the manufacturer directly. Don’t give up hope! If it is medically necessary remember that you have a right to access such supplies and insist on the best possible solution for you. Ask your doctor if they can show you a few samples. Often times doctors get sample stock kits from manufacturers that they can distribute to patients.

4.1 Finding Medicare-Approved Suppliers

One can purchase female external catheters from a durable medical equipment supplier. The difficult part is determining which suppliers will accept the assignments (approve and take assignment) from Medicare. In this case, it may require contacting many suppliers in order to find one that does accept the assignment. Another option is to contact the Medicare Medical Supply Help Line (1-800-MEDICARE) to find out which suppliers in a local area that accept the assignment. They can provide a list of several suppliers so that the individual can begin calling these suppliers to find the best price. Finally, if the individual has a Medigap (Medicare supplemental insurance) policy, the insurance company may have a preferred supplier that can be used to get the catheter. It is important to check first with the insurance company to find out if they do have a preferred supplier because using a non-preferred supplier may result in higher out-of-pocket expenses for the individual. Using a Medicare-approved supplier is also important to prevent any unexpected denials or rejections to the claim. If the supplier is not a Medicare-approved supplier, they may not be recognizable to the DME Regional Carrier and the claim may be rejected. If this happens, it can be very difficult and time-consuming to get the supplier and the DME to file the claim again and there is no guarantee that the DME will accept filing a new claim. If the DME does not file the claim again, the beneficiary will be stuck with the bill.

4.2 Submitting Claims and Documentation

The Centers for Medicare/Medicaid Services (CMS) recognizes that the correct billing of Medicare claims is an integral part in reducing billing errors and instances of fraud. This, in turn, will result in cost savings for the Medicare program and prevent over-payment for services. It is a standard expectation that claims be submitted with documentation that provides evidence of medical necessity for the product and supports the information on the claim. This includes patients’ medical records and the supplier’s proof of delivery. Failure to provide documentation that proves the medical necessity of the product as prescribed will result in denial of the claim. Claims must be prepared and filed within one calendar year of the date of service. If a claim is not filed within this time frame, you have no legal basis for Medicare to pay the claim with certain exceptions. Any automatic denials or system rejections of claims from the DME MACs can be corrected with resubmission. And finally, it has been recommended to use the new Health Insurance Claim Number (HICN), instead of the SSN plus a suffix.

To receive female external catheters in a timely and consistent manner, it is important to submit your claims with correct and appropriate documentation the first time. As a pioneer in the Durable Medical Equipment industry, Hollister Incorporated has been awarded a Medicare Demonstration Project focusing on Female External Catheters. The goal of this project is to help Medicare establish appropriate and consistent coding guidelines for female external catheters and correct the disparities of coding direction provided to suppliers.

4.3 Medicare Billing Codes for Female External Catheters

Medicare billing for female external catheters has undergone further improvements. In 1998, Medicare issued an HCPCS code specifically for female external catheters: A4349 (non-urostomy) and A4353 (urostomy). These codes were created as part of the HCPCS Quarterly Update. A4349 is a general code for male external catheters as well, so the more specific code A4353 should be used when billing for a urostomy patient. HCPCS codes are generic and used by many insurance companies, not just Medicare. However, the A4353 code also triggers a higher payment rate for external catheters designated for use by urostomy patients, as per a fee schedule for “Incontinence Supplies” released by HP3 and reposted by the Simon Foundation for Continence. The Simon Foundation is a resource for incontinence patients and has a summary of the Federal Medicare Law regarding insurance coverage for incontinence supplies, but please note that Medicare advantage plans may have different coverage and payment rates for incontinence supplies than does traditional Medicare. Also note that some catheters sold as “female” catheters use the same product number as male catheters, and claims with this product number will be denied if the appropriate gender-specific code is not used. This is an ongoing issue for some patients and suppliers.

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References:

Hartigan, S.M. and Dmochowski, R.R., 2022. The inFlow intraurethral valve-pump for women with detrusor underactivity: A summary of peer-reviewed literature. The Journal of Spinal Cord Medicine, 45(4), pp.489-497. nih.gov

Stoddard, M.D., Russell, D., McDonald, M.V., Dignam, R., Bowles, K.H., Prigerson, H.G. and Chughtai, B., 2021. Nurse perspectives on urinary incontinence in the home hospice setting. Journal of Pain and Symptom Management, 62(2), pp.383-390. jpsmjournal.com

Aparasu, R.R., Sura, S., Earla, J.R., Shiozawa, A., Ng, D.B. and Schermer, C.R., 2020. Antimuscarinic Discontinuation in Patients with Overactive Bladder in Nursing Homes: A Retrospective Study of Medicare Beneficiaries. Advances in Therapy, 37, pp.3584-3605. springer.com

Schladen, M. M., Rounds, A. K., & McManus…, T., 2021. Intermittent Catheter Reimbursement in the United States: The Experience of Nine Stakeholders Through the Lens of Actor-Network Theory.. The Qualitative …. academia.edu

Padula, W.V., Armstrong, D.G. and Goldman, D.P., 2022, February. Complexity bias in the prevention of iatrogenic injury: why specific harms may inhibit performance. In Mayo Clinic Proceedings (Vol. 97, No. 2, pp. 221-224). Elsevier. mayoclinicproceedings.org

Abdel-Fattah, M., Chapple, C., Guerrero, K., Dixon, S., Cotterill, N., Ward, K., Hashim, H., Monga, A., Brown, K., Drake, M.J. and Gammie, A., 2021. Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms. Trials, 22, pp.1-18. springer.com

Lindquester, W.S., Dhangana, R., Warhadpande, S. and Amesur, N.B., 2021. Effects of the MAGIC guidelines on PICC placement volume: Advanced practice provider and physician trends among Medicare beneficiaries from 2010 to 2018. American Journal of Roentgenology, 216(5), pp.1387-1391. ajronline.org

Robles-Torres, J.I., Madero-Morales, P.A. and Gutiérrez-González, A., 2021. Overview of clean intermittent catheterization for neurogenic bladder in a developing country: Is the sterile single-use catheter really necessary?. Revista mexicana de urología, 81(3). scielo.org.mx

Ameen, S. & Merchant, H. A., 2024. Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs. Expert Review of Medical Devices. tandfonline.com

Zuppone, S., Bresolin, A., Spinelli, A.E., Fallara, G., Lucianò, R., Scarfò, F., Benigni, F., Di Muzio, N., Fiorino, C., Briganti, A. and Salonia, A., 2020. Pre-clinical research on bladder toxicity after radiotherapy for pelvic cancers: state-of-the art and challenges. Frontiers in Oncology, 10, p.527121. frontiersin.org

Mykhailovska, N.S., Grytsay, A.V., Shershnyova, O.V. and Mykhailovskyi, Y.M., 2024. The risk factors and screening of main chronic noncommunicable diseases: study guide for the practical classes and individual work for 6th-years students of international faculty. zsmu.edu.ua

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