Urological Supplies

Revision Effective Date: 04/01/2026
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: Information pertaining to the reasonable and necessary quantity of female external urinary collection devices, to include the Tibbe Female External Urinary Device (A4318) quantity
SUMMARY OF EVIDENCE:
Removed: Summary of evidence information, due to not being applicable to the non-discretionary updates
ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION):
Removed: Analysis of evidence information, due to not being applicable to the non-discretionary updates
HCPCS CODES:
Added: A4318 to Group 1 Codes
BIBLIOGRAPHY:
Removed: Bibliography information, due to not being applicable to the non-discretionary updates


04/09/2026: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 01/01/2026
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: “Intermittent catheterization using a sterile intermittent catheter kit (A4297, A4353) is covered when the beneficiary requires catheterization and the beneficiary meets one of the following criteria (1-5):” to “Intermittent catheterization using a sterile intermittent catheter kit (A4297, A4353) is covered when the beneficiary requires catheterization and the beneficiary meets one of the following criteria (1-4):,” to match the number of criteria listed
HCPCS CODES
:
Revised: Location of A4295, A4296, A4297, A4351 and A4352 information, moving the information from Group 1 Paragraph text to Group 1 Codes HCPCS list


01/08/2026: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations
and a non-substantive update to resolve a typographical error
.

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: I
nformation 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)

Revision Effective Date: 01/01/2024
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”


12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

Revision Effective Date: 10/01/2023
HCPCS CODES:
Revised:

Description of HCPCS code A4344 to “INDWELLING CATHETER, FOLEY TYPE, TWO-WAY, ALL SILICONE OR POLYURETHANE, EACH”


10/12/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 04/01/2023
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Reference to inFlow device to include HCPCS code A4341
SUMMARY OF EVIDENCE:
Removed: Summary of evidence information, due to not being applicable to the non-discretionary changes
ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION):
Removed: Analysis of evidence information, due to not being applicable to the non-discretionary changes
HCPCS CODES:
Added:

HCPCS codes A4341 and A4342
BIBLIOGRAPHY:
Removed: Bibliography information, due to not being applicable to the non-discretionary changes


04/27/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 04/01/2021
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Trademark symbol from first use of inFlow
HCPCS CODES:
Removed: K1010, K1011 and K1012 (effective for DOS on or after 04/01/2021)


04/29/2021: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 10/01/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: HCPCS A4335 from inFlow device reference due to new HCPCS codes as of 10/01/2020
HCPCS CODES:
Added: K1010, K1011 and K1012 (effective DOS on or after 10/01/2020)


10/15/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to add CMS HCPCS coding determinations.

Revision Effective Date: 07/26/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Format of HCPCS code references, from code ‘spans’ to individually-listed
Added: Billing and coverage information for the inFlow device (HCPCS Code A4335)
Removed: Denial statement for inFlow device (A4335)
GENERAL:
Added: References to Standard Written Order (SWO)
REFILL REQUIREMENTS:
Revised: “ordering physicians” to “treating practitioners”
SUMMARY OF EVIDENCE:
Added: Information related to inFlow device
ANALYSIS OF EVIDENCE:
Added: Information related to inFlow device
CODING INFORMATION:
Removed: Field titled “Bill Type” Removed: Field titled “Revenue Codes” Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
DOCUMENTATION REQUIREMENTS:
Revised: “physician’s” to “practitioner’s”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: “Prescriptions (orders)” to “SWO”
BIBLIOGRAPHY:
Added: Section related to inFlow device
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A58231)

Revision History Effective Date: 01/01/2019

COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
 Removed: Statement to refer to diagnosis code section below
 Added:
Refer to Covered ICD-10 Codes in the LCD-related Policy Article
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statement about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction

Revision History Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and directions to Standard Documentation Requirements
Added: General Requirements
Revised: Refill Requirements
HCPCS Code:
Added: A4553
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Direction to Standard Documentation Requirements
Removed: Information under Miscellaneous and Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article

Effective July 1, 2016 oversight for DME MAC LCDs 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 LCDs.

Revision Effective Date: 01/01/2016
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Non-reimbursement language for the inFlow
TM
 Intraurethral Valve-Pump system (A4335)
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to remove start date verbiage from Prescription Requirements (Effective 11/05/2015)

Revision Effective Date: 08/01/2015
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
(Note: Standard Documentation Language updates noted above are effective for DOS on or after 10/31/2014)
Added:  Language for HCPCS codes A4217, A4450, A4452 when submitted without correct modifier