Local Coverage Determination (LCD)

Bowel Management Devices

L36267

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Contractor Information

LCD Information

Document Information

LCD ID
L36267
LCD Title
Bowel Management Devices
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36267
Original Effective Date
For services performed on or after 12/01/2015
Revision Effective Date
For services performed on or after 01/01/2020
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
10/01/2015
Notice Period End Date
11/30/2015
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2020 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2020 American Dental Association. All rights reserved.

Copyright © 2013 - 2021, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at ub04@aha.org.

CMS National Coverage Policy

National Coverage Determination Manual (Internet-Only Manual 100-03), Chapter 1, Part 4, §230.15, and §280.1.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

Benefit Category and other statutory requirements are discussed in the related Policy Article NONMEDICAL NECESSITY AND COVERAGE RULES section. Refer to the Policy article for information on these criteria.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

  • The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  • The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  • Refer to the Supplier Manual for additional information on documentation requirements.

  • Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the "reasonable and necessary" criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Bed Pans (E0275, E0276) are covered for beneficiaries who are bed-confined (see NCD 280.1).

Rectal inserts and related accessories (A4337) will be denied as not reasonable and necessary because they do not meet the medical evidence requirements outlined in the Centers for Medicare & Medicaid Services (CMS) Program Integrity Manual (Internet-only Manual 100-08), Chapter 13, §13.7.1.

Electrical continence aids are in the experimental stage of development and there is no valid scientific documentation of their effectiveness and safety; therefore, they are denied as not reasonable and necessary (see NCD 230.15).

Rectal catheters/tubes and related collection systems will be denied as statutorily non-covered (no benefit – see related Policy Article).

Enema systems (gravity and manual pump), codes A4458 and A4459 respectively, will be denied as statutorily non-covered (no benefit – see related Policy Article).

Pulsed irrigation and evacuation systems (E0350, E0352) will be denied as statutorily non-covered (no benefit – see related Policy Article).

Incontinence garments (e.g., briefs, diapers) coded A4520 will be denied as statutorily non-covered (no benefit – see related Policy Article).

Disposable underpads (A4554) and non-disposable (A4553) underpads will be denied as statutorily non-covered (no benefit – see related Policy Article).

Toilet seats, raised toilet seats, toilet seat lift mechanisms, bidets and bidet toilet seats are discussed in the Commodes Local Coverage Determination and related Policy Article.


GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Coding Information

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service

HCPCS CODES:

Group 1 Codes
CodeDescription
A4335 INCONTINENCE SUPPLY; MISCELLANEOUS
A4337 INCONTINENCE SUPPLY, RECTAL INSERT, ANY TYPE, EACH
A4458 ENEMA BAG WITH TUBING, REUSABLE
A4459 MANUAL PUMP-OPERATED ENEMA SYSTEM, INCLUDES BALLOON, CATHETER AND ALL ACCESSORIES, REUSABLE, ANY TYPE
A4520 INCONTINENCE GARMENT, ANY TYPE, (E.G., BRIEF, DIAPER), EACH
A4553 NON-DISPOSABLE UNDERPADS, ALL SIZES
A4554 DISPOSABLE UNDERPADS, ALL SIZES
A9270 NON-COVERED ITEM OR SERVICE
E0275 BED PAN, STANDARD, METAL OR PLASTIC
E0276 BED PAN, FRACTURE, METAL OR PLASTIC
E0350 CONTROL UNIT FOR ELECTRONIC BOWEL IRRIGATION/EVACUATION SYSTEM
E0352 DISPOSABLE PACK (WATER RESERVOIR BAG, SPECULUM, VALVING MECHANISM AND COLLECTION BAG/BOX) FOR USE WITH THE ELECTRONIC BOWEL IRRIGATION/EVACUATION SYSTEM

General Information

Associated Information

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider.” It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

  • SWO
  • Medical Record Information (including continued need/use if applicable)
  • Correct Coding
  • Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.


POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.


Miscellaneous


Appendices


Utilization Guidelines
Refer to Coverage Indications, Limitations and/or Medical Necessity

Sources of Information
N/A
Bibliography

N/A

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
01/01/2020 R9

Revision Effective Date: 01/01/2020
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”

As required by CR 10901, the ICD-10 information has been moved to all Policy Articles. There is no change in coverage.

  • Other
01/01/2020 R8

Revision Effective Date: 01/01/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Order information as a result of Final Rule 1713
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: Prescriptions (orders) to SWO

02/06/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713.

  • Provider Education/Guidance
01/01/2017 R7

No changes have been made to this LCD.

04/05/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other
01/01/2017 R6 Revision 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
Added: Denial language for A4553
HCPCS CODES:
Added: HCPCS Code 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
Deleted: Sources of Information
Removed: Information under Miscellaneous and Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
07/01/2016 R5 Revision Effective Date 07/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Coverage statement for vaginal inserts and related accessories; they are not DME MAC Jurisdiction (Effective date 02/12/2015)
SOURCES OF INFORMATION AND BASIS FOR DECISION:
Removed: Links
  • Provider Education/Guidance
  • Other (Vaginal Inserts and related accessories are not DME MAC Jurisdiction)
07/01/2016 R4 Revision Effective Date 07/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Vaginal inserts and accessories information (Effective date 02/12/2015)
HCPCS MODIFIERS:
Deleted: GA, GZ, GY modifiers DOCUMENTATION REQUIREMENTS:
Revised: Standard documentation language to Orders, revise Proof of delivery instructions, and add Correct coding instructions (Effective date 04/28/2016)
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS
Deleted: GA, GZ, GY modifiers section
  • Provider Education/Guidance
07/01/2016 R3 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.
  • Change in Assigned States or Affiliated Contract Numbers
01/01/2016 R2 Revision Effective Date: 01/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Replaced: Miscellaneous HCPCS Code A4335 with new code A4337
HCPCS CODES:
Added: HCPCS Code A4337
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation language to remove start date verbiage from Prescription Requirements (Effective 11/05/2015)
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
12/01/2015 R1 12/01/2015 - Draft LCD promoted to final
  • Other (Draft LCD promoted to final)

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
02/13/2020 01/01/2020 - N/A Currently in Effect You are here
01/31/2020 01/01/2020 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A

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