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

For any item to be covered, 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 statutory and regulatory requirements.  For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted.  If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

The quantity of ostomy supplies needed by a patient 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 patient need and their needs may vary over time. The table below lists the maximum number of items/units of service that are usually medically necessary.  The actual quantity needed for a particular patient may be more or less than the amount listed depending on the factors that affect the frequency of barrier and pouch change.  The medical necessity for use of a greater quantity of supplies than the amounts listed must be clearly documented in the patient’s medical record and available upon request.  If adequate documentation is not provided when requested,  the excess quantities will be denied as not medically necessary. 

Code#/Per Month
A4357 (2)
A4362 (20)
A4364 (4)
A4367 (1)
A4369 (2)
A4377 (10)
A4381 (10)
A4397 (4)
A4402 (4)
A4404 (10)
A4405 (4)
A4406 (4)
A4414 (20)
A4415 (20)
A4416 (60)
A4417 (60)
A4418 (60)
A4419 (60)
A4420 (60)
A4423 (60)
A4424 (20)
A4425 (20)
A4426 (20)
A4427 (20)
A4429 (20)
A4431 (20)
A4432 (20)
A4433 (20)
A4434 (20)
A4450 (40)
A4452 (40)
A5051 (60)
A5052 (60)
A5053 (60)
A5054 (60)
A5055 (31)
A5061 (20)
A5062 (20)
A5063 (20)
A5071 (20)
A5072 (20)
A5073 (20)
A5081 (31)
A5082 (1)
A5083 (150)
A5093 (10)
A5121 (20)
A5122 (20)
A5126 (20)
A5131 (1)
A6216 (60)

Code #/6 Months
A4361 (3)
A4371 (10)
A4398 (2)
A4399 (2)
A4455 (16)
A5102 (2)
A5120 (150)

Provision of ostomy supplies should be limited to a one-month supply for a patient in a nursing facility and a three-month supply for a patient at home.

A supplier must not dispense more than a 3-month quantity of supplies and accessories at a time.  The member or caregiver must specifically request new items before they are dispensed.  The supplier must not automatically dispense a quantity of items on a predetermined regular basis, even if the member has "authorized" this in advance.  Contact with the member or designee regarding refills should take place no sooner than approximately 7 days prior to the delivery/shipping date.  For subsequent deliveries of refills, the supplier should deliver the product no sooner than approximately 5 days prior to the end of usage for the current product.

When a liquid barrier is necessary, either liquid or spray (A4369) or individual wipes or swabs (A5120) are appropriate.  The use of both is not medically necessary.

Patients with continent stomas may use the following means to prevent/manage drainage:  stoma cap (A5055), stoma plug (A5081), stoma absorptive cover (A5083), or gauze pads (A6216).  No more than one type of supply would be medically necessary on a given day.

Patients with urinary ostomies may use either a bag (A4357) or bottle (A5102) for drainage at night.  It is not medically necessary to have both.

Reasons for Noncoverage

Ostomy supplies are covered for use on patients 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.  Use for other conditions will be denied as not medically necessary.

A pouch cover should be coded A9270 and will be denied as a non-covered item. A provider cannot bill the member for the non-covered item.

Claims for tape and adhesive (A4450, A4452, A5120) that are billed without an AU or AV modifier or another modifier indicating coverage under a different policy will be denied as not covered.  A provider can bill the member for the non-covered item.

Services that do not meet the medical necessity criteria in this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost.  The member must agree in writing to assume financial responsibility, in advance of receiving the service.  The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

It is expected that the patient's medical records will reflect the need for the care provided.  The patient's medical records include the physician'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.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier and be available upon request.  Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

The order must include the type(s) of supplies ordered and the approximate quantity to be used per unit of time.  A new order is required if there is an increase in the quantity of the supply used per month and/or the type of supply used.

The supplier must enter the diagnosis code for the ostomy on each claim submitted for ostomy supplies.  If there is more than one ostomy, enter the appropriate codes.

When supplies used are greater than the usual maximum quantity listed in the policy, there must be adequate, clear documentation in the patient’s medical records corroborating the medical necessity of this amount.  Copies of the patient’s medical records that corroborate the order and any additional documentation that pertains to the medical necessity of the items and quantities billed, must be available upon request.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

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, A4397, A4398 and A4399.

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.

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, Coding (PDAC) Contractor for guidance on the correct coding of these items.

Provider News

08/2011, Medicare Advantage changes ostomy supplies denials from non-covered to not medically necessary

Covered Diagnosis Codes

For all procedure codes except for A4450, A4452, and A5120