*** This policy was implemented in the absence of National Coverage Determinations (NCD) or Local Coverage Determinations (LCD) coverage criteria. This policy applies to all Blue Medicare HMO, Blue Medicare PPO, Healthy Blue + MedicareSM (HMO-POS D-SNP), Blue Medicare Rx members, and members of any third-party Medicare plans supported by Blue Cross NC through administrative or operational services. ***

Description of Procedure or Service

Urinary catheters and external urinary collection devices are designed to drain or collect urine for a member who has permanent urinary incontinence or permanent urinary retention. Permanent urinary retention is defined as retention that is not expected to be medically or surgically corrected in that Member within 3 months.

Policy Statement

Coverage will be provided for a PureWick Urine Collection System or an external urine collection suction pump when it is determined to be medically necessary when the medical criteria and guidelines shown below are met.

Benefit Application

Please refer to the member’s individual Evidence of Coverage (EOC) for benefit determination.  Coverage will be approved according to the EOC limitations if the criteria are met.

Coverage decisions will be made in accordance with:

• The Centers for Medicare & Medicaid Services (CMS) national coverage decisions;
• General coverage guidelines included in original Medicare manuals unless superseded by operational policy letters or regulations; and
• Written coverage decisions of local Medicare carriers and intermediaries with jurisdiction for claims in the geographic area in which services are covered.

Benefit payments are subject to contractual obligations of the Plan.  If there is a conflict between the general policy guidelines contained in the Medical Coverage Policy Manual and the terms of the members’ particular Evidence of Coverage (E.O.C.), the E.O.C. always governs the determination of benefits.

Indications for Coverage

The PureWick External Urine collection system is considered experimental, investigational, and unproven for all indications, including but not limited to use by individuals with permanent incontinence or permanent urinary retention.

There is insufficient literature and/or medical based evidence in peer reviewed publications to assess the safety, efficacy, long term outcomes, or patient management associated with the user of the PureWick external urine collection system for permanent incontinence or urinary retention.

When Coverage Will Not be Approved

The PureWick external urine collection system will not be covered for temporary, reversible or permanent urinary incontinence or retention; convivence (care giver preference or hygiene) or in concurrent use with an indwelling  urinary catheter. The urinary collection pump cannot be approved for investigation or experimental uses.

Billing/ Coding/physician Documentation Information

This policy may apply to the following codes.  Inclusion of a code in the section does not guarantee reimbursement.  

Applicable codes: E2001, A6590. A7001, A7002

The Plan may request medical records for determination of medical necessity.  When medical records are requested, letters of support and/or explanation are often useful but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Special Notes

External Urine collection pump cannot be billed in conjunction with an indwelling catheter system. E2001 is not covered as a stand-alone device without associated external urine collection supplies. External urine management systems are covered as alternatives, not adjuncts, to indwelling catheters. External urine collection pumps and supplies are not separately covered for use in acute inpatient hospitals and/or observation stays.

Clinical Evidence

Female external urinary management systems are intended to reduce the risk of indwelling catheter-associated urinary tract infections (CAUTIs), and skin irritation associated with incontinence pads and diapers. The systems consist of a wicking fabric that is placed against the female urinary tract external genitalia and is connected to continuous low suction to divert urine into a collection vessel (Lopez, 2024). Despite its unique design, studies are conflicting regarding the efficacy of these devices to lower CAUTI’s, further research is needed to demonstrate the superior nature of these devices.

References:

1. National Coverage Determination (NCD) Incontinence Control Devices (230.10) effective date 10/7/1996 accessed via NCD - Incontinence Control Devices (230.10)
   https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=241
2. Local Coverage Determination (LCD) Urological Supplies (L33803) effective date 10/1/2015 accessed via LCD - Urological Supplies (L33803)
   https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=33803&ver=57
3. Urological Supplies – Policy Article A52521 effective date 10/1/2015 accessed via Article - Urological Supplies - Policy Article (A52521)
   https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52521
4. PureWick Urine Collection System – Coding and Billing Instructions – Revised; March 28, 2024 access via PureWick Urine Collection System – Coding and Billing Instructions – Revised
   https://www.cgsmedicare.com/jb/pubs/news/2021/10/cope23571c.html
5. AmeriHealth Medicare Advantage – Urological Supplies effective date 08/12/2024
6. Health alliance Plan of Michigan Urological Supplies for Home Use effective date 10/8/2013 
7. United Health Medicare Advantage Urinary and Fecal Incontinence: Diagnosis and Treatment effective date 3/1/2026

Policy Implementation/Update Information:

Revision Dates: 

03/17/2026: Newly created policy (AR)

04/05/2026: Changed to a non-covered policy per UM Medical Policy Committee. (AR)

Approval Dates: 

Medical Coverage Policy Committee: March 19 2026

Physician Advisory Group Committee: May 19,  2026