This policy is based upon Medicare DME MAC policy. Medicare considers ostomies as prosthetics.

A solid barrier (wafer) is an interface between the member'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), or they may be used independently. usually with a pouch that does not have its own integral skin barrier. An extended wear barrier 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.

A barrier with built-in convexity 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.

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

A faceplate is a solid interface between the member’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.

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.

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 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 or a single-piece system.

Pouches with filters describe pouches that have an opening which allows venting of trapped gas. They typically include materials such as charcoal to deodorize the vented gas..An "ostomy filter, any type, each" describes a replacement filter.

An "ostomy vent, any type, each" describes a separate ostomy vent that can be added by the member to a pouch to allow the release of gas. An ostomy vent is included in pouches in which a vent with a filter is incorporated in the pouch by the manufacturer. Those products are described as ostomy pouches with a filter.

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

An ostomy pouch with faucet-type tap with valve has a valve for draining urine.

A locking flange 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).

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, or non-pectin based, e.g., karaya.

Ostomy clamps are used with drainable pouches and are not used with urinary pouches. Ostomy clams are included with osteomy pouches. Ostomy clamps are only separately payable when ordered as a replacement. .

Appendix

The following table lists faceplate systems. The faceplate components in Column II are included in Column I. When supplying a pouch with faceplate attached (Column I), there is no separate payment for a component product from Column II provided at the same time.

Table 3: Faceplate systems Faceplate Systems(Column I) Faceplate Systems(Column II) Ostomy pouch, drainable, with faceplate attached, plastic, each

Ostomy faceplate, each

Ostomy pouch, drainable, for use on faceplate, plastic, each

Ostomy pouch, drainable, with faceplate attached, rubber, each

Ostomy faceplate, each

Ostomy pouch, drainable, for use on faceplate, rubber, each

Ostomy pouch, urinary, with faceplate attached, plastic, each

Ostomy faceplate, each

Ostomy pouch, urinary, for use on faceplate, plastic, each

Ostomy pouch, urinary, for use on faceplate, heavy plastic, each

Ostomy pouch, urinary, with faceplate attached, rubber, each

Ostomy faceplate, each

Ostomy pouch, urinary, for use on faceplate, rubber, each

Ostomy pouch, closed, with barrier attached, with filter (1 piece), each

Ostomy vent, any type, each

Ostomy pouch, closed, with barrier attached, with built-in convexity, with filter (1 piece), each

Ostomy vent, any type, each

Ostomy pouch, closed, without barrier attached, with filter (1 piece), each

Ostomy vent, any type, each

Ostomy pouch, closed, for use on barrier with non-locking flange, with filter (2 piece), each

Ostomy vent, any type, each

Ostomy pouch, closed, for use on barrier with locking flange, with filter (2 piece), each

Ostomy vent, any type, each

Ostomy pouch, drainable, with barrier attached, with filter (1 piece), each

Ostomy vent, any type, each

Ostomy pouch, drainable, for use on barrier with non-locking flange, with filter (2 piece system), each

Ostomy vent, any type, each

Ostomy pouch, drainable, for use on barrier with locking flange, with filter (2 piece system), each

Ostomy vent, any type, each

Scope of Policy

This Clinical Policy Bulletin addresses ostomy supplies.

Medical Necessity

Ostomy supplies are considered medically necessary for use on a member with a surgically created opening (stoma) to divert urine, or fecal contents outside the body.

Ostomy supplies are considered medically necessary for colostomies, ileostomies or urinary ostomies.

When a liquid barrier is considered medically necessary, either liquid or spray or individual wipes or swabs are considered medically necessary. The use of both is not considered medically necessary.

The following means to prevent/manage drainage are considered medically necessary for persons with continent stomas: stoma caps, stoma plugs, stoma absorptive covers or gauze pads. No more than one of these types of supply are considered medically necessary on a given day.

Either a bag or bottle are considered medically necessary for drainage at night for members with urinary ostomies. Use of both on a given day is considered not medically necessary.

The medically necessary quantity of ostomy supplies for a member is determined primarily by the type of ostomy, its location, its construction, and the condition of the skin surface surrounding the stoma. There will be variation according to individual member's need and their needs may vary over time. The table below lists the maximum number of items/units of service that are usually considered medically necessary. The actual quantity that is considered medically necessary for a particular member may be more or less than the amount listed depending on the factors that affect the frequency of barrier and pouch change.

The explanation for use of a greater quantity of supplies than the amounts listed must be clearly documented in the member’s medical record. If adequate documentation is not provided when requested, the excess quantities will be considered not medically necessary.

Table 1: Number per month Item Number per month Bedside drainage bag, day or night, with or without anti-reflux device, with or without tube, each 2 Skin barrier, solid; 4 X 4 or equivalent; each 20 Adhesive, liquid or equal, any type, per oz. 4 Ostomy belt, each 1 Ostomy skin barrier, liquid (spray, brush, etc.), per oz. 2 Ostomy pouch, drainable,, for use on faceplate, plastic, each 10 Ostomy pouch, urinary, for use on faceplate, plastic, each 10 Irrigation supply, sleeve, each 4 Lubricant, per ounce 4 Ostomy ring, each 10 Ostomy skin barrier, non-pectin based, paste, per ounce 4 Ostomy skin barrier, pectin-based, paste, per ounce 4 Ostomy skin barrier, with flange (solid, flexible or accordion), without built-in convexity, 4 X 4 inches or smaller, each 20 Ostomy skin barrier, with flange (solid, flexible or accordion), without built-in convexity, larger than 4 X 4 inches, each 20 Ostomy pouch, closed, with barrier attached, with filter (1 piece), each 60 Ostomy pouch, closed, with barrier attached, with built-in convexity, with filter (1 piece), each 60 Ostomy pouch, closed; without barrier attached, with filter (1 piece), each 60 Ostomy pouch, closed, for use on barrier with non-lockeing flange, with filter (2 piece), each 60 Ostomy pouch, closed; ror use on barrier with locking flange (2 piece), each 60 Ostomy pouch, closed; for use on barrier with locking flange, with filter (2 piece), each 60 Ostomy pouch, drainable, with barrier attached, with filer (1 piece), each 20 Ostomy pouch, drainable; for use on barrier with non-locking flange, with filer (2 piece system), each 20 Ostomy pouch, drainable; for use on barrier with locking flange (2 piece system), each 20 Ostomy pouch, drainable; for use on barrier with locking flange, with filter (2 piece system), each 20 Ostomy pouch, urinary, with barrier attached, with build-in convecity, with faucet-type tap with valve (1 piece), each 20 Ostomy pouch, urinary, with barrier attached, with faucet-type tap with valve (1 piece), each 20 Ostomy pouch, urinary, for use on barrier with non-locking flange, with faucet-type tap with valve (2 piece), each 20 Ostomy pouch, urinary, for use on barrier with locking flange (2 piece), each 20 Ostomy pouch, urinary; for use on barrier with locking flange, with faucet-type tap with valve (2 piece), each 20 Tape, non-waterproof, per 18 square inches 40 Tape, waterproof, per 18 square inches 40 Ostomy pouch, closed; with barrier attached (1 piece), each 60 Ostomy pouch, closed; without barrier attached (1 piece), each 60 Ostomy pouch, closed; for use on faceplate, each 60 Ostomy pouch, closed; for use on barrier with flange (2 piece), each 60 Stoma cap 31 Ostomy pouch, drainable, with extended wear barrier attached, with filter (1 piece), each 40 Ostomy pouch, drainable, with extended wear barrier attached, with built in convexity, with filter (1 piece), each 40 Ostomy pouch, drainable, with barrier attached (1 piece), each 20 Ostomy pouch, drainable; without barrier attached (1 piece), each 20 Ostomy pouch, drainable; for use on barrier with flange (2 piece system), each 20 Ostomy pouch, urinary; with barrier attached (1 piece), each 20 Ostomy pouch, urinary; without barrier attached (1 piece), each 20 Ostomy pouch, uarinary; for use on barrier with flange (2 piece), each 20 Stoma plug or seal, any type 31 Continent device; catheter for continent stoma 1 Continent device, stoma absorptive cover for continent stoma 150 Ostomy accessory; convex insert 10 Skin barrier; solid, 6 X 6 or equivalent, each 20 Skin barrier; sooid, 8 X 8 or equivalent, each 20 Adhesive or non-adhesive; disk or foam pad 20 Appliance cleaner, incontinence and ostomy appliances, per 16 oz. 1 Gauze, non-impregnated, non-sterile, pad size 16 sq. in. or less, without adhesive border, each dressing 60 Table 2: Number per 6 months Item Number per 6 months Ostomy faceplate, each 3 Ostomy skin barrier, powder, per oz. 10 Ostomy irrigation supply; bag, each 2 Ostomy irrigation supply; cone/catheter, with or without brush 2 Adhesive remover or solvent (for tape, cement or other adhesive), per ounce 16 Bedside drainage bottle with or without tubing, rigid or exandable, each 2 Skin barrier, wipes or swabs, each 150