Local Coverage Article

Bowel Management Devices - Policy Article

A54516

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General Information

Article ID
A54516
Article Title
Bowel Management Devices - Policy Article
Article Type
Article
Original Effective Date
10/01/2015
Revision Effective Date
01/01/2020
Revision Ending Date
N/A
Retirement Date
N/A
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Article Guidance

Article Text

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:

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. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).

In order for any item to be eligible for coverage under Medicare, the item must be eligible for inclusion into one of the existing coverage Benefit Categories. Rectal inserts and electrical incontinence aids are covered under the Prosthetic Devices benefit (Social Security Act §1861(s)(9)). Bed pans are covered under the Durable Medical Equipment benefit (Social Security Act §1861(s)(6)). In order for a beneficiary’s equipment to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

Many bowel management devices (see bulleted list below, not all inclusive) fail one or more of the relevant requirements in §1861(n) of the Act and are thus statutorily excluded from coverage (see the CMS Nation Coverage Determinations Manual (Internet-only Manual 100-03) Chapter 1, Part 4, §280.1):

  • Disposable Sheets and Bags (A4335) – Deny – Non-reusable disposable supplies

  • Incontinence Pads (A4553 and A4554) – Deny – Non-reusable supply; Hygienic item

  • Diapers (A4520) - Deny – Non-reusable supply; Hygienic item

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. In addition, these devices do not meet the Prosthetic Benefit because they do not replace a non-functioning internal body organ.

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. In addition, these devices do not meet the Prosthetic Benefit because they do not replace a non-functioning internal body organ.

Pulsed irrigation and evacuation devices (PIE – P.I.E. Medical Inc., Buford, GA) do not meet the DME benefit because they are considered institutional equipment.

Vaginal inserts and related accessories (Eclipse Vaginal Insert system - Pelvalon, Inc) for the treatment of fecal incontinence are not DME MAC jurisdiction. Claims for vaginal inserts and related accessories (A4563 - RECTAL CONTROL SYSTEM FOR VAGINAL INSERTION, FOR LONG TERM USE, INCLUDES PUMP AND ALL SUPPLIES AND ACCESSORIES, ANY TYPE EACH) submitted to the DME MACs will be rejected as wrong jurisdiction.

REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provides a list of the specified codes, which is periodically updated. The link will be located here once it is available.

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD- related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.

CODING GUIDELINES

Rectal inserts are prosthetic devices constructed of rubber, latex, silicone or other similar material and act as a barrier to the passage of fecal matter through the rectum. Use code A4337 (INCONTINENCE SUPPLY, RECTAL INSERT, ANY TYPE, EACH) for this item. Code A4337 includes the insert and any associated supplies or accessories for insertion and maintenance of the device.

Rectal catheters/tubes and related collection systems are products designed to be inserted into the rectum to collect fecal material. They also serve to assist in protection of perianal skin integrity in the patient with fluid and semi-fluid waste.

An electrical continence aid is a prosthetic device consisting of a plastic plug, molded into the shape of the patient's anal canal, which contains two implanted electrodes that are connected by a wire to a small portable generator. An electrical current is produced which stimulates the anal musculature to cause a contraction sufficient to hold the plug in while allowing the patient to ambulate without incontinence.

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. An enema system consists of an irrigation fluid holding chamber and a rectal catheter (with or without an inflatable balloon). Fluid is instilled either via gravity or a manual pump.

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. Effective for claims with dates of service on or after January 1, 2015, the correct code to bill is A4459 (MANUAL PUMP ENEMA SYSTEM, INCLUDES BALLOON, CATHETER AND ALL ACCESSORIES, REUSABLE, ANY TYPE).

Code A4459 is an all-inclusive code. Separate billing of any of the individual components is not allowed. For billing refills of disposable supplies such as rectal catheters, HCPCS code A9900 (MISCELLANEOUS DME SUPPLY, ACCESSORY, AND/OR SERVICE COMPONENT OF ANOTHER HCPCS CODE) must be used.

Code E0350 describes a colorectal irrigation system that consists of an irrigation fluid holding chamber, a rectal catheter with an inflatable balloon and an electric pump. Irrigation fluid is administered in a pulsatile manner to hydrate stool to a semi-liquid form and allow the liquefied stool to evacuate. Code E0352 describes all disposable supplies and accessories used with code E0350 including, but not limited to, a water reservoir, speculum, valve mechanism and collection bag or box.

Codes E0275 (BED PAN, STANDARD, METAL OR PLASTIC) and E0276 (BED PAN, FRACTURE, METAL OR PLASTIC) describe a shallow vessel placed under a bedridden patient to collect feces and urine. To meet Medicare coverage and DME benefit requirements, they must be durable. Disposable bed pans must be billed using code A9270 (NONCOVERED ITEM OR SERVICE).

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Coding Information

CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
01/01/2020 R10

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.

01/01/2020 R9

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.

01/01/2019 R8

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.

01/01/2017 R7

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.

01/01/2017 R6 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
07/01/2016 R5 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)
07/01/2016 R4 Revision Effective Date: 07/01/2016
CODING GUIDELINES:
Added: Coding guideline definition of vaginal insert (Effective date 02/12/2015)
07/01/2016 R3 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.
01/01/2016 R2 Revision Effective Date: 01/01/2016
CODING GUIDELINES:
Replaced: Miscellaneous HCPCS Code A4335 with new code A4337
12/01/2015 R1 10/01/2015 - Draft Policy Article promoted to final

Associated Documents

Related National Coverage Documents
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
03/24/2021 01/01/2020 - N/A Currently in Effect You are here
01/31/2020 01/01/2020 - N/A Superseded View
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Keywords

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