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: 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