November 13, 2025
LCD and Policy Article Revisions Summary for November 13, 2025
Joint DME MAC Publication
Outlined below are the principal changes to the DME MAC Local Coverage Determination (LCD) and Policy Article (PA) that have been revised and posted. The policy included is Urological Supplies. Please review the entire LCD and PA for complete information.
Urological Supplies
LCD
Revision Effective Date: 01/01/2026
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
- Removed: "For example, use of a Coude (curved) tip indwelling catheter (A4340) in a female beneficiary is rarely reasonable and necessary" from indwelling catheters coverage information
- Added: A4297 to catheter insertion tray coverage information
- Added: "One catheter (A4295, A4296); or" to intermittent catheterization coverage information
- Added: A4297 to criterion C in intermittent catheterization coverage information
- Added: "has a diagnosis of spinal cord injury at any level (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD-related Policy Article)" to the examples listed in criterion 2 of the intermittent catheterization coverage information
- Removed: "The beneficiary is a spinal cord injured female with neurogenic bladder who is pregnant (for duration of pregnancy only)," from intermittent catheterization coverage information
- Revised: Intermittent catheterization coverage criterion pertaining to distinct, recurrent urinary tract infections while on a program of sterile intermittent catheterization, to include "with either A4295/A4296 with no sterile lubricant (A4332), or A4351/A4352 with sterile lubricant (A4332)"
- Added: A4295, A4296 and A4297 with 200 per month and a row for "Any combination of A4297 and A4353" with 200 per month to the Usual Maximum Quantity of Supplies table in the intermittent catheterization coverage information
- Added: A4297 to intermittent catheterization coverage information
- Added: "The maximum quantity of sterile catheterization kits (A4297, A4353) is 200 units per month. Billing more than 200 units per month total for A4297 and A4353 will be denied as not reasonable and necessary." below the Usual Maximum Quantity of Supplies table
- Removed: "Use of a Coude (curved) tip catheter (A4352) in female beneficiaries is rarely reasonable and necessary." from intermittent catheterization coverage information
- Revised: "When a Coude tip catheter is used (either male or female beneficiaries), there must be documentation in the beneficiary's medical record of the medical necessity for that catheter." to "When a Coude tip catheter (A4296, A4352) is used, there must be documentation in the beneficiary's medical record of the medical necessity for that catheter."
SUMMARY OF EVIDENCE:
- Added: Information related to spinal cord injury
ANALYSIS OF EVIDENCE:
- Added: Information related to spinal cord injury and HCPCS codes A4295, A4296, A4297
HCPCS CODES:
- Added: A4295, A4296 and A4297 to Group 1 codes (information located in Group 1 Paragraph text)
- Revised: Long descriptor for HCPCS code A4351 and A4352 in Group 1 codes (information located in Group 1 Paragraph text)
BIBLIOGRAPHY:
- Added: Information related to spinal cord injury and HCPCS codes A4295, A4296, A4297
RELATED LOCAL COVERAGE DOCUMENTS:
- Added: Response to Comments article (A60353)
PA
Revision Effective Date: 01/01/2026
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
- Added: "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."
MISCELLANEOUS:
- Added: HCPCS code A4297 to paragraph regarding catheter insertion trays
CODING GUIDELINES:
- Added: "An intermittent catheter with hydrophilic coating (A4295, A4296) is a single use catheter with a hydrophilic coating that, with the addition of water or 0.9% sterile saline, allows for smooth insertion and removal of the catheter without the use of a separate lubricating gel."
- Revised: HCPCS codes referenced as insertion kits and sterile insertion kits, to include "A4297"
11/13/2025: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.
Note: The information contained in this article is only a summary of revisions to the LCDs and/or PAs. For complete information on any topic, you must review the LCDs and/or PAs.

