Female External Catheters Covered by Medicare

1. Introduction

Medicare is a federal insurance program that provides coverage to elderly persons and other specific groups of persons specified in the 1972 Social Security amendments. Title XVIII of these amendments established Medicare to provide medical insurance for persons aged 65 or older and for certain younger persons with disabilities and to persons with end-stage renal disease. Medicare is composed of four different parts, A, B, C, and D, and coverage for specific items and services may vary between these parts. Durable medical equipment is covered under Part B and is defined as medical equipment that can withstand repeated use, is primarily and customarily used to serve a medical purpose, generally is not useful to a person in the absence of an illness or injury, and is appropriate for use in the home. Female external catheters are considered to fall under the category of DME. Written coverage guidelines from CMS, as found by searching the Local Coverage Determinations (LCDs) database, are used by the DME MACs in establishing their own coverage policies. The guidelines list the indications for coverage of a particular item or service and describe the circumstances under which the item will be considered to be reasonable and necessary and therefore covered. Female external catheters are a relatively new concept incontinence care and as of November 2008, there are only coverage guidelines for the product category as a whole, and not for specific products within the category. This paper will analyze and explain the current coverage and coding policies for female external catheters, document history, indications for coverage, and future action steps. [1][2][3][4][5][6]

It is the goal of this detailed paper to explore and explain the policies and practices symbolic of the Centers for Medicare and Medicaid Services (CMS) and the specific Durable Medical Equipment Medicare Administrative Contractors (DME MAC) that contemplate the provision of female external catheters, and take benefit of introducing these devices to the durable medical equipment (DME) benefit. Many people in the US are receiving Medicare benefits and will benefit from understanding how Medicare covers the supplies they need. Incontinence is a common problem that affects millions of elderly persons, and making these supplies available to Medicare beneficiaries can help these individuals remain active and involved in their communities, and avoid more invasive forms of treatment. This paper is expected to be a useful resource for manufacturers seeking information on coding and coverage for these products, and for clinicians and consumers seeking knowledge on how to obtain these products through the Medicare benefit.

2. Benefits of Medicare Coverage for Female External Catheters

The Center for Medicare Advocacy has waived the usual requirement for Medicare coverage, that the items be inexpensive, and has also eliminated the requirement for the items to last three months. This means that catheters can be obtained for free from the manufacturer each month. If the patient is in a Medicare HMO, they may need to change to original Medicare in order to receive this benefit. Patients are likely to lose their battle at the first two levels of appeal, as the government does not want to set a precedent of covering incontinence supplies. In order to eventually win coverage, it will likely be necessary to constitute a lengthy battle at the administrative law judge level. An unpublished decision out of the Fifth Circuit has set a favorable precedent for a Medicare beneficiary in Texas. Other beneficiaries may wish to use this case as a basis for demanding coverage of their supplies. The fact that medical documentation is required for coverage, and that physicians should no longer supply patients with samples, means that many patients with incontinence are going untreated. This is unacceptable given the very high success rate of treating incontinence with the use of female external catheters. [7][8][9][10][11]

3. Eligibility and Requirements for Medicare Coverage

Self-catheterization is a treatment for urinary incontinence or retention, and as such meets the Medicare coverage criteria. Patients doing self-catheterization should use a new sterile catheter each time they catheterize. See below for information affecting coverage of sterile catheters for patient-directed use. Patients using an indwelling Foley catheter are considered to have a long-term need to manage urinary incontinence or retention in a patient at home or in a nursing facility, and as such the use of a Foley catheter meets necessity criteria.

To qualify for Medicare coverage of intermittent catheters and catheter drainage bags, the patient must be seen and treated by a doctor for urinary incontinence or retention. The patient’s physician must document the patient’s urinary tract disease and specify that the planned treatment is for the purpose of urinary incontinence or retention. The required documentation for Medicare is a prescription or a letter of medical necessity signed by the treating physician, indicating the type of catheter, the frequency of change, and the duration of need. This documentation should be kept on file by the supplier and be available to the DMEMAC on request. A detailed written order is not required to be signed by the physician, but must be written by the supplier and kept on file.

4. How to Obtain Medicare Coverage for Female External Catheters

Sometimes, in order to obtain Medicare coverage for medical supplies, a patient may need to receive a prescription for the items they need and submit the prescription to Medicare along with a request for coverage of the items in question. This is the case for female external catheters. A recent change in Medicare policy has made it so that it will cover female external catheters. In order to have the catheters paid for by Medicare, the patient needs to obtain the catheters from a medical supply company. The physician must issue a prescription stating that the patient has incontinence and the catheter is for the treatment of the incontinence. A letter of medical necessity will also need to be drafted by a healthcare provider to show that the supplies are medically necessary for the patient. Once these steps have been taken, the request for Medicare coverage of female external catheters can be submitted. This request should include the prescription and letter of medical necessity, along with a form called the DMEPOS 101A. This form can be found on the Medicare website.

References:

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[7] E. Axman, P. Nordin, M. Modin, and H. de la Croix, “Assessing the validity and cover rate of the national Swedish hernia register,” Clinical Epidemiology, 2021. tandfonline.com

[8] G. T. Werneburg, “Catheter-associated urinary tract infections: current challenges and future prospects,” Research and reports in urology, 2022. tandfonline.com

[9] N. Jasperse, O. Hernandez-Dominguez et al., “A single institution pre-/post-comparison after introduction of an external urinary collection device for female medical patients,” Journal of Infection …, vol. 2022. [Online]. Available: journals.sagepub.com. nih.gov

[10] A. Hafid, S. Difallah, C. Alves, S. Abdullah, M. Folke, “State of the art of non-invasive technologies for bladder monitoring: a scoping review,” Sensors, 2024. [Online]. Available: mdpi.com. mdpi.com

[11] A. Guanche-Sicilia, M.B. Sanchez-Gomez, et al., “Prevention and treatment of phlebitis secondary to the insertion of a peripheral venous catheter: a scoping review from a nursing perspective,” Healthcare, 2021. [Online]. Available: mdpi.com. mdpi.com