LCD Reference Article Response To Comments Article

Response to Comments: Urological Supplies - DL33803

A60353

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Source Article ID
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Article ID
A60353
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Urological Supplies - DL33803
Article Type
Response to Comments
Original Effective Date
11/13/2025
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During the 45-day comment period, which was open from August 28, 2025 through October 11, 2025, the DME MACs received comments from 34 commenters.

NOTE: DME MACs review all submitted comments and may choose to consolidate similar thematic comments or redact or withhold certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language or duplicate/near duplicate submissions. As a result, there may be a discrepancy between the number of comments in the article and the actual number of comments received.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period for the proposed Urological Supplies Local Coverage Determination (LCD) (DL33803).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, to support optimal health outcomes in Medicare beneficiaries.

Response To Comments

Number Comment Response
1

Most commenters expressed their support of the proposed expansion of coverage for intermittent catheterization using a sterile intermittent catheter kit (A4353, A4297) to a subset of beneficiaries with a spinal cord injury at any level. Supportive comments noted the positive impact for Medicare beneficiaries including ease of use, safety, increased independence, facilitation of measurement of urine volumes, limiting spills, equitable access, and improving overall quality of life. Many commenters shared their professional or personal experiences, and anecdotal evidence supporting the use of sterile intermittent catheters by beneficiaries with spinal cord injuries at any level. Many commenters noted that beneficiaries would be less likely to experience infections or require hospitalization with the use of sterile intermittent catheters, which may result in overall cost savings to the Medicare program.

The DME MAC Medical Directors would like to thank the clinicians, associations, suppliers, Medicare beneficiaries, and their families for offering their support for the proposed Urological Supplies LCD (DL33803).

2

Eight commenters requested additional clarification of documentation requirements. One commenter expressed a concern that the proposed LCD language requires a beneficiary to establish immunosuppression to qualify for a sterile intermittent catheter kit, which will increase administrative complexity and reduce timely access. Several commenters recommended the LCD or the policy article include a statement that “A diagnosis of spinal cord injury (SCI) in the medical record is sufficient to establish coverage eligibility.

The DME MAC Medical Directors would like to thank the clinicians, associations, and suppliers for offering their support for the proposed Urological Supplies LCD (DL33803). In consideration of this comment, the final LCD has been revised to explicitly state “…has a diagnosis of spinal cord injury at any level”, and the policy article has been edited to state “For intermittent catheterization using a sterile intermittent catheter kit (A4297, A4353), documentation in the medical records of a diagnosis of spinal cord injury (SCI) is sufficient to establish the beneficiary is immunocompromised.”

3

One commenter especially appreciated, “…the DME MACs proposing and finalizing this change to the LCD prior to January 1, 2026, when the new [HCPCS] codes will go into effect. We appreciate your continued support to ensure Medicare beneficiaries have timely access to the most appropriate supplies to manage their conditions.”

The DME MACs appreciate the comment.

4

One commenter referenced a presentation conducted by a supplier, without any mention of the proposed Urological Supplies LCD.

The DME MACs thank the commenter.

5

Eight commenters conveyed their interest in the DME MACs adopting a broader and more inclusive approach to coverage, either in the final LCD or in future coverage policies. They opined the need for sterile catheter supplies is not limited to individuals with spinal cord injuries. Commenters stated that patients with neurogenic bladder resulting from other congenital and non-congenital conditions may carry the same risks of recurrent urinary tract infections, renal deterioration, and life-threatening complications.

This comment is outside of the scope of this reconsideration, which was limited to Medicare coverage of sterile intermittent urinary catheter kits for individuals with spinal cord injuries at any level. A new reconsideration request for coverage of supplies that were not within the scope of this LCD reconsideration can be submitted to the DME MACs.

6

Two commenters reported what they believed was an error of omission. On page eight of the proposed LCD under the Intermittent Catheterization section and just prior to the list of five criteria it reads: “Intermittent catheterization using a sterile intermittent catheter kit (A4353) is covered when the beneficiary requires catheterization and the beneficiary meets one of the following criteria (1–5)”. The commenters indicated they believe that it is the DME MACs’ intention to also include HCPCS code A4297 when describing the sterile intermittent catheter kit and respectfully ask that this be updated and reflected as such to avoid any potential confusion and/or billing issues.

The DME MACs thank the commenters for identifying this oversight. The HCPCS code A4297 was added to the coverage statement for sterile intermittent catheter kits in the final LCD.

7

Two commenters recommended that spinal cord injury should be removed from the immunosuppression category and be listed as a standalone clinical indication for coverage of HCPCS code A4353.

This comment is outside of the scope of this reconsideration, which was limited to Medicare coverage of sterile intermittent urinary catheter kits for individuals with spinal cord injuries at any level as an example of a condition associated with immunosuppression. A new reconsideration request for revisions that were not within the scope of this LCD reconsideration can be submitted to the DME MACs.

8

Two commenters suggested that the description of urinary catheters with a hydrophilic coating should be aligned with CMS and PDAC, “hydrophilic catheter is a type of (not same as) pre-lubricated catheter having a polymer coating that binds water to the catheter to make it slippery. The hydrophilic coating on a catheter is intrinsic to the catheter product (i.e., you cannot wipe the coating off).”

The DME MACs thank the commenters for identifying this opportunity to maintain consistent terminology. The statement was updated in the final LCD.

9

Two commenters expressed an interest in speeding innovation models to full coverage through the application of an existing model in the CMS Innovation Center.

This comment is outside of the scope of this reconsideration.

10

One commenter offered a general recommendation that coverage decisions should not vary by jurisdiction.

The DME MACs thank the commenter for submitting feedback. The final LCD does apply to all four DME jurisdictions.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L33803 - Urological Supplies
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