An external breast prosthesis is an artificial breast form that can be worn after the breast has been surgically removed. There are several different types of prostheses. They may be made from silicone gel, foam, fiberfill or other materials that feel similar to natural tissue. Most are weighted so that they feel the same as the remaining breast (if only one breast has been removed). Some adhere directly to the chest area while others are made to fit into pockets of post-mastectomy bras. Different types of prostheses may also have different features, such as a mock nipple or special shape. In many cases, a woman will be fitted for a prosthesis so that it can be custom-made for her 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 Medicare 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.

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.

A breast prosthesis is covered for a patient who has had a mastectomy.

An external breast prosthesis garment, with mastectomy form (L8015) is covered for use in the postoperative period prior to permanent breast prosthesis or as an alternative to a mastectomy bra and breast prosthesis.

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 external breast prosthesis of the same type can be replaced at any time if it is lost or is irreparably damaged (this does not include ordinary wear and tear).  An external breast prosthesis of a different type can be covered at any time if there is a change in the patient’s medical condition necessitating a different type of item.  Only one breast prosthesis per side for the useful lifetime of the prosthesis will be covered.  Two prostheses, one per side, are allowed for those persons who have had bilateral mastectomies.

A mastectomy bra (L8000) is covered for a patient who has a covered mastectomy form (L8020) or silicone (or equal) breast prosthesis (L8030, L8031, L8035) when the pocket of the bra is used to hold the form/prosthesis.

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 DMEPOS product no sooner than approximately 5 days prior to the end of the usage for the current product.

Reasons for Noncoverage

Breast prostheses, silicone or equal, with integral adhesive (L8031) have not been demonstrated to have a clinical advantage over those without the integral adhesive.  Payment for L8031 will be based on the allowance for the least costly medically appropriate alternative breast prosthesis without integral adhesive, L8030.

The additional features of a custom fabricated prosthesis (L8035), compared to a prefabricated silicone breast prosthesis, are not medically necessary.  Therefore, if an L8035 breast prosthesis is provided to a patient who has had a mastectomy, payment will be based on the allowance for the least costly medically appropriate alternative, L8030.

More than one external breast prosthesis per side will be denied as not medically necessary. 

Services not meeting the criteria on this policy will be denied as 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.

A mastectomy sleeve (L8010) is denied as non-covered, since it does not meet the definition of a prosthesis. The provider can bill the member for the denied service.

The useful lifetime expectancy for silicone breast prostheses is two years.  The useful lifetime expectancy for a nipple prostheses is three months. For fabric, foam or fiber filled breast prostheses, the useful lifetime expectancy is six months.  Replacement sooner than the useful lifetime because of ordinary wear and tear will be denied as non-covered. The provider can bill the member for the denied service.

Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made 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 diagnosis code must be included on each claim for the prosthesis or related item.

If the patient’s medical condition changes, this should be documented by the patient’s physician submitting a new order which explains the need for a different type of breast prosthesis.  The order must be kept in the supplier’s files but need not be submitted with the claim.

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.

Codes A4280 should be used when billing for an adhesive skin support that attaches an external breast prosthesis directly to the chest wall.

The right (RT) and left (LT) modifiers must be used with these codes.  When the same code for bilateral items (left and right) is billed on the same date of service, bill for both items on the same claim line using the RTLT modifiers and 2 units of service.  Claims billed without modifiers RT and/or LT will be rejected as incorrect coding.

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