Bowel Management Devices - Policy Article

Revision Effective Date: 04/01/2026
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Reference location for Medicare National Coverage Determinations (NCD) Manual, as clarification
CODING GUIDELINES:
Added: Coding guideline information for A4479
Added: Information when billing claims with dates of service on or after April 1, 2026 for A4479 and A4453


04/16/2026: 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.

Revision Effective Date: 04/01/2025
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: “Rectal inserts and electrical incontinence aids are covered under the Prosthetic Devices benefit (Social Security Act §1861(s)(9)).” to “Rectal inserts, electrical incontinence aids, and transanal irrigation (TAI) systems (which are comprised of a TAI device and rectal catheter that has a sealing function [balloon or cone-based]) are covered under the Prosthetic Devices benefit (Social Security Act §1861(s)(9)).”
Revised: “Manual pump enema systems (e.g., Peristeen - Coloplast, Minneapolis, MN) or gravity-administered enema systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability.” to “Gravity-administered enema systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability.”
Revised: “Rectal catheters/tubes and related collection systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability.” to “Fecal collection systems and rectal catheters/tubes used with such systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability.” as clarification
CODING GUIDELINES:
Revised: “HCPCS codes A4458 (ENEMA BAG WITH TUBING, REUSABLE) and code A4459 (MANUAL PUMP ENEMA SYSTEM, INCLUDES BALLOON, CATHETER AND ALL ACCESSORIES, REUSABLE, ANY TYPE) describe devices used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management.” to “HCPCS code A4458 (ENEMA BAG WITH TUBING, REUSABLE) describes a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management.”
Revised: “Fluid is instilled either via gravity or a manual pump.” to “Fluid is instilled via gravity.”
Revised: “The Peristeen transanal irrigation system is a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management. The system consists of an enema bag, a rectal catheter with an inflatable balloon and a pump.” to “The Peristeen transanal irrigation system is a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence in patients with neurogenic bowel dysfunction. The system consists of a water reservoir, a screw top, a disposable rectal catheter with an inflatable balloon, a control unit, tubing, and a pump.”
Revised: Billing information for the Peristeen transanal irrigation system, by changing “dates of service on or after January 1, 2015” to “dates of service on or after January 1, 2015 through March 31, 2025” and by updating the format of the information to a bulleted list
Added: Billing information for the Peristeen transanal irrigation system for claims with dates of service on or after April 1, 2025


04/03/2025: 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: 10/01/2021
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 FED. REG VOL 217):
Revised: “provides” to “provide”
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.

Revision Effective Date: 10/01/2021
CODING GUIDELINES:
Revised: A4459 coding guideline information, to clarify all-inclusive at initial issue
Added: A4453 billing direction, for use when billing disposable catheter refills


12/30/2021: 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: 01/01/2020
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: Trademark symbols, per AMA guidelines
CODING GUIDELINES:
Removed: Trademark symbols, per AMA guidelines


04/01/2021: 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: 01/01/2020
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
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”


02/06/2020: 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: 01/01/2019
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: HCPCS code A4563 for vaginal inserts


01/31/2019: 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
CODING GUIDELINES:
Added: Peristeen
®
coding guidelines


04/05/2018: At this time 21st Century Cures Act applies to new and revised LCDs
that restrict coverage, which require comment and notice. This revision is to an
article that is not a local coverage determination.

Revision Effective Date: 01/01/2017
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: HCPCS Codes A4553 to Statutorily excluded from coverage list
Added: Policy Specific Documentation Requirements
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements Language Article

Revision Effective Date: 07/01/2016
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added:  Jurisdictional statement for vaginal inserts (Effective date 02/12/2015)
CODING GUIDELINES:
Deleted:  Coding guideline definition of vaginal insert (Effective date 02/12/2015)

Revision Effective Date: 07/01/2016
CODING GUIDELINES:
Added:  Coding guideline definition of vaginal insert (Effective date 02/12/2015)

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:
Replaced: Miscellaneous HCPCS Code A4335 with new code A4337

10/01/2015 - Draft Policy Article promoted to final