Ostomy Supplies - 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 Section
1862(a)(1)(A) provisions (i.e. "reasonable and necessary").

Ostomy supplies are covered under the Prosthetic Device benefit (Social
Security Act Section 1861(s)(8)). 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.

Ostomy supplies are covered for use on a beneficiary with a surgically created
opening (stoma) to divert urine, or fecal contents outside the body. Ostomy
supplies are appropriately used for colostomies, ileostomies or urinary
ostomies (see covered diagnosis codes below.) Use for other conditions will be
denied as noncovered.

A pouch cover should be coded A9270 and will be denied as a noncovered item.

Ostomy supplies are not separately payable when a beneficiary is in a covered
home health episode. Ostomy supplies must be provided by the home health
agency and payment is included in the home health Medicare payment rate. It is
not appropriate to bill these to the DME MAC.

**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, 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.

For quantities of supplies that exceed the usual maximum amount, there must be
information in the medical record that explains the need for the increased
amount. This information must be available upon request.

Claims for tape and adhesive (A4450, A4452, A5120) that are billed without an
AU modifier or another modifier indicating coverage under a different policy
will be rejected as missing information.

**CONTINUED MEDICAL NEED**

For all DMEPOS items, the initial justification for medical need is
established at the time the item(s) is first ordered, therefore, beneficiary
medical records demonstrating that the item is reasonable and necessary are
created just prior to, or at the time of, the creation of the initial
prescription. Once initial medical need is established, ongoing need for
ostomy supplies is assumed to be met. There is no requirement for further
documentation of continued medical need as long as the beneficiary continues
to meet the Prosthetic Devices benefit.

**CODING GUIDELINES**

BARRIERS:

A solid barrier (wafer) is an interface between the beneficiary's skin and the
pouching system, has measurable thickness and has an adhesive property.
Barriers may be integrated into a "1 piece" pouch, they may be manufactured
with a flange and be part of a "2 piece" pouch system (skin barrier with
flange, e.g., A4414), or they may be used independently (e.g., A4362), usually
with a pouch that does not have its own integral skin barrier. An extended
wear barrier (e.g., A4409) is a pectin-based barrier with special additives
which achieve a stronger adhesive seal, resist breakdown by urine or bowel
effluent, permit longer wear times between changes, and normal wear times for
those who cannot achieve them with standard barriers. There are distinct codes
for extended wear compared to standard wear barriers.

A barrier with built-in convexity (e.g., A4407 or A4411) is one in which an
outward curve is usually achieved with plastic embedded in the barrier,
allowing better protrusion of the stoma and adherence to the skin. There are
distinct codes for barriers with built-in convexity compared to flat barriers.

Ostomy skin barriers greater than 4x4 inches (e.g., A4408) refer to the size
of the skin barriers themselves, and not to the area of any surrounding tape.

FACEPLATES:

A faceplate is a solid interface between the beneficiary's skin and the pouch.
It is usually made of plastic, rubber or encased metal. It does not have an
adhesive property and there is no pectin-based or karaya material that is an
integral part of a faceplate. It can be taken off the skin and reattached
repeatedly. It is secured by means of a separate adhesive and/or an elastic
belt. The clips for attaching the belt are usually a part of the faceplate.
There is no coding distinction between flat and convex faceplates.

The following table lists codes for faceplate systems. When supplying a pouch
with faceplate attached (Column I) a claim may not be made for a component
product from Column II provided at the same time.  
  

Column I

|

Column II  
  
---|---  
  
A4375

|

A4361, A4377  
  
A4376

|

A4361, A4378  
  
A4379

|

A4361, A4381, A4382  
  
A4380

|

A4361, A4383  
  
A4416

|

A4366  
  
A4417

|

A4366  
  
A4418

|

A4366  
  
A4419

|

A4366  
  
A4423

|

A4366  
  
A4424

|

A4366  
  
A4425

|

A4366  
  
A4427

|

A4366  
  
  
POUCHES:

A pouch is a device for collecting stomal output. A pouch for collecting bowel
effluent may be either "drainable" with an opening at the bottom through which
the fecal contents are emptied, or 'closed' with a sealed bottom and no
outlet. A "urinary" pouch normally incorporates anti-reflux devices and a tap
or spigot to empty the urine contents.

A pouch "with barrier attached" is one type of "1 piece" system in which a
solid barrier is part of the pouch. There are distinct codes for 1-piece
pouches with convex barriers and extended wear barriers (see "Barriers").

A pouch "without barrier attached" is a pouch with or without a thin adhesive
coating that is applied either directly to the skin or to a separate barrier.
It is also described as a "1 piece" system.

A pouch, which is part of a "2 piece" system, has a flange, which enables it
to be coupled to a skin barrier with flange.

A pouch "with faceplate attached" or "for use on a faceplate" is generally
rubber or heavy plastic. It is drainable, cleanable, and reusable for periods
of weeks to months, depending on the product.

A "high output" pouch (A4412, A4413, A4435) has a capacity of greater than or
equal to 0.75 liters, is drainable with a large bore solid spout with cap or
plug, and is either part of a 2 piece system (A4412, A4413) or a single-piece
system (A4435).

Codes for pouches with filters (e.g., A4416) describe pouches that have an
opening which allows venting of trapped gas. They typically include materials
such as charcoal to deodorize the vented gas. Code A4368 describes replacement
filter material.

Code A4366 describes a separate ostomy vent that can be added by the
beneficiary to a pouch to allow the release of gas. This code must not be used
for pouches in which a vent with a filter is incorporated in the pouch by the
manufacturer. Those products are described by the codes for ostomy pouches
with a filter (A4416, A4417, A4418, A4419, A4423, A4424, A4425, A4427).

Absorbent material (A4422) that is added to the ostomy pouch may come as
sheets, pads or crystals.

An ostomy pouch with faucet-type tap with valve (e.g., A4429) has a valve for
draining urine.

A locking flange (e.g., A4420) is a lever type flange locking mechanism. It
differs from simple push-on pouch securing mechanisms. The mechanism may be
incorporated either in the pouch flange or skin barrier flange (2 piece
system).

PASTES:

A paste is used as a protective layer and sealant beneath ostomy appliances,
and is applied directly on the skin. It may be primarily pectin based (A4406),
or non-pectin based, e.g., karaya (A4405).

MISCELLANEOUS:

Code A4436 (IRRIGATION SUPPLY; SLEEVE, REUSABLE, PER MONTH) describes an
ostomy accessory that is secured around the stoma using a belt or by locking
onto a faceplate that is attached to the peristomal skin. They are typically
used for a week or more, cleaned and dried between irrigations, before finally
being discarded.

Code A4437 (IRRIGATION SUPPLY; SLEEVE, DISPOSABLE, PER MONTH) describes an
ostomy accessory that is applied directly onto the peristomal skin, and is
discarded after each irrigation due to inability to re-adhere to the skin
surface.

Codes A4436 (IRRIGATION SUPPLY; SLEEVE, REUSABLE, PER MONTH) and A4437
(IRRIGATION SUPPLY; SLEEVE, DISPOSABLE, PER MONTH) describe a monthly supply
allowance for irrigation sleeves. No more than 1 unit of service is billable
per thirty (30) days.

Code A4400 (Ostomy irrigation set) is not valid for claim submission. If an
irrigation kit is supplied, the individual components should be billed using
individual codes, A4398 and A4399.

Ostomy clamps (A4363) are used with drainable pouches and are not used with
urinary pouches. Ostomy clamps are only payable when ordered as a replacement.
Claims for ostomy clamps billed with ostomy pouches will be denied as not
separately payable with ostomy pouches.

When codes A4450, A4452, and A5120 are used with ostomy supplies, they must be
billed with the AU modifier. For this policy, codes A4450, A4452, and A5120
are the only codes for which the AU modifier may be used.

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