Urological Supplies - Policy Article

Revised Effective Date: 04/01/2026
CODING GUIDELINES:
Added: “The Tibbe Female External Urinary Device (EUD) (A4318) is a device which is attached to the periurethral area with adhesive and which funnels urine into a closed collection system and can be used with either suction or gravity for drainage.”


04/09/2026: 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.

Revised 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.

Revision Effective Date: 04/01/2023
GENERAL:
Removed: "Catheters and related supplies will be denied as non-covered in situations in which it is expected that the condition will be temporary."


04/10/2025: 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.

Revised Effective Date: 04/01/2023
GENERAL:
Removed: “Permanent urinary retention is defined as retention that is not expected to be medically or surgically corrected in that beneficiary within 3 months” and “(ordinarily at least 3 months)” as clarification


03/20/2025: 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.

Revised Effective Date: 04/01/2023
CODING GUIDELINES:
Revised:
Billing direction for inFlow under
 HCPCS code A4335 for DOS April 1, 2021 through March 31, 2023
Added: Billing direction for inFlow under HCPCS A4341 and A4342 for DOS on or after 04/01/2023
Revised: Billing direction for Initial sizing and insertion to be billed to the Part B MAC
Added: Billing direction for replacement: “If a replacement of the indwelling intraurethral drainage device with valve is performed by the treating practitioner, claims for this service must be billed to the Part B MAC.”
Revised: Billing direction for
activator and charging base
to be billed only as replacement using HCPCS code A4342


04/27/2023: 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.

Revised Effective Date: 04/01/2021
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 FED. REG VOL 217):
Removed: “The link will be located here once it is available.”
Added: “The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.” with a hyperlink to the list


04/14/2022: 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.

Revised Effective Date: 04/01/2021
GENERAL:
Removed: Trademark symbol from first use of inFlow
CODING GUIDELINES:
Revised: inFlow HCPCS billing directions for K1010, K1011 and/or K1012 for DOS 10/01/2020 through 03/31/2021
Added: Billing direction for inFlow under HCPCS A4335 for DOS on or after 04/01/2021
Revised: inFlow replacement language, to include product information instead of K1010, K1011, and K1012


04/29/2021: At this time 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.

Revised Effective Date: 10/01/2020
MODIFIERS:
Removed: inFlow A4335 code from directions
CODING GUIDELINES:
Revised: inFlow HCPCS billing direction, HCPCS A4335 for DOS 07/26/2020 through 9/30/2020 and HCPCS K1010, K1011 and/or K1012 for DOS on or after 10/01/2020
Added: Billing direction for K1010, K1011 and K1012


10/15/2020: At this time 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

Revision Effective Date: 07/26/2020
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217):
Added: Section and related information based on Final Rule 1713
GENERAL:
Revised: Billing direction for inFlow and urological supplies when inserted or used in a practitioner’s office
Revised: “physician” updated to “treating practitioner”
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Directional statement regarding practitioner as supplier
Added: Continued medical need language
MODIFIER:
Added: inFlow device to KX modifier directions
MISCELLANEOUS:
Revised: Format of HCPCS code references, from code ‘spans’ to individually-listed
CODING GUIDELINES:
Revised: Format of HCPCS code references, from code ‘spans’ to individually-listed
Revised: inFlow device statement to replace battery and/or wand with “activator”
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Covered” updated to “ICD-10 Codes that Support Medical Necessity”
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Not Covered” updated to “ICD-10 Codes that DO NOT Support Medical Necessity”


06/11/2020: At this time 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

Revision History Effective Date: 01/01/2019
 ICD-10 CODES THAT ARE COVERED:
 Added: All diagnosis codes formerly listed in the LCD
 ICD-10 CODES THAT ARE NOT COVERED:
 Added: Notation excluding all unlisted diagnosis codes from coverage


02/21/2019: At this time 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.

Revision Effective Date: 01/01/2017
RELATED  LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article

Revision Effective Date: 01/01/2017
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Modifiers section
Added: A4553 to non-covered list

Effective July 1, 2016 oversight for DME MAC Articles is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the Articles.

Revision Effective Date: 01/01/2016
CODING GUIDELINES:
Added: Coding guidelines for the inFlow™ Intraurethral Valve-Pump (A4335)

Revision Effective Date: 08/01/2015
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: KX modifier reference from this section
Revised: Language for HCPCS codes A4217, A4450, A4452 when submitted without correct modifier