Bowel Management Devices - Policy Article

**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 provide a list of the specified codes, which is periodically updated.
The required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).  

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.

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. 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).

HCPCS code A4459 is an all-inclusive code at initial issue. Separate billing
of any of the individual components is not allowed at initial issue. For
billing refills of the disposable rectal catheter, HCPCS code A4453 (RECTAL
CATHETER FOR USE WITH THE MANUAL PUMP-OPERATED ENEMA SYSTEM, REPLACEMENT ONLY)
must be used.  

HCPCS 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.

HCPCS 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.