4) has some form of shoe closure. This includes a shoe with or without an internally seamless toe.

A5509 A diabetic shoe insert is a total contact, multiple density, removable inlay that is directly molded to the patient's foot or a model of the patient's foot and that is made of a suitable material with regard to the patient's condition. For code A5509, molding of the insert must be accomplished by an external heat source (e.g., oven or heat gun).
A5503 Rigid rocker bottoms are exterior elevations with apex position for 51 percent to 75 percent distance measured from the back end of the heel. The apex is a narrowed or pointed end of an anatomical structure. The apex must be positioned behind the metatarsal heads and tapering off sharply to the front tip of the sole. Apex height helps to eliminate pressure at the metatarsal heads. The steel in the shoe ensures rigidity. The heel of the shoe tapers off in the back in order to cause the heel to strike in the middle of the heel. Roller bottoms (sole or bar) are the same as rocker bottoms, but the heel is tapered from the apex to the front tip of the sole.
A5504 Wedges (posting) (A5504) are either of hind foot, fore foot, or both and may be in the middle or to the side. The function is to shift or transfer weight bearing upon standing or during ambulation to the opposite side for added support, stabilization, equalized weight distribution, or balance.
A5505 Metatarsal bars (A5505) are exterior bars which are placed behind the metatarsal heads in order to remove pressure from the metatarsal heads. The bars are of various shapes, heights, and construction depending on the exact purpose.
A5506 Offset heel (A5506) is a heel flanged at its base either in the middle, to the side, or a combination, that is then extended upward to the shoe in order to stabilize extreme positions of the hind foot.
A5508 A deluxe feature (A5508) does not contribute to the therapeutic function of the shoe. It may include, but is not limited to style, color, or type of leather.

The Certifying Physician provides the medical care for the beneficiary's diabetic condition. The certifying physician must be an M.D. or D.O., and may not be a podiatrist.
The Prescribing Physician actually writes the order for the therapeutic shoe, modifications and inserts. The prescribing physician may be a podiatrist, M.D., or D.O
The Supplier is the person or entity that actually furnishes the shoe, modification, and/or insert to the beneficiary and that bills Medicare. The supplier may be a podiatrist, pedorthist, orthotist, prosthetics, or other qualified individual.
The Prescribing physician may be the supplier. The Certifying physician may only be the supplier if the certifying physician is practicing in a defined rural area or a defined health professional shortage area.
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. For the items addressed in this medical policy, "reasonable and necessary" are defined by the following coverage and payment rules.
4) Diabetic shoes, inserts and/or modifications to the shoes are covered if the following criteria are met:
1) The patient has diabetes mellitus (ICD-9 diagnosis codes 250.00-250.93); and
2) The patient has one or more of the following conditions:
3) Previous amputation of the other foot, or part of either foot, or
4) History of previous foot ulceration of either foot, or
5) History of pre-ulcerative calluses of either foot, or
6) Peripheral neuropathy with evidence of callus formation of either foot, or
7) Foot deformity of either foot, or
8) Poor circulation in either foot; and
The certifying physician who is managing the patient's systemic diabetes condition has certified that indications (1) and (2) are met and that he/she is treating the patient under a comprehensive plan of care for his/her diabetes and that the patient needs diabetic shoes.
For patients meeting these criteria, coverage is limited to one of the following within one calendar year:
One pair of custom molded shoes (A5501) (which includes inserts provided with these shoes) and 2 additional pairs of inserts (A5509 or A5511); or One pair of depth shoes (A5500) and 3 pairs of inserts (A5509 or A5511) (not including the non-customized removable inserts provided with such shoes).

Separate inserts may be covered and dispensed independently of diabetic shoes if the supplier of the shoes verifies in writing that the patient has appropriate footwear into which the insert can be placed. This footwear must meet the definitions found in this policy for depth shoes or custom-molded shoes.

Items represented by code A5510 reflect compression molding to the patient's foot over time through the heat and pressure generated by wearing a shoe with the insert present. Since these inserts are not considered total contact at the time of dispensing, they do not meet the requirements of the benefit category and will be denied as non-covered.

Inserts used in non-covered shoes are non-covered.

A custom molded shoe (A5501) is covered when the patient has a foot deformity that cannot be accommodated by a depth shoe. The nature and severity of the deformity must be well documented in the supplier's records and may be requested by the DMERC. If there is insufficient justification for a custom molded shoe but the general coverage criteria are met, payment will be based on the allowance for the least costly medically appropriate alternative, A5500.

A modification of a custom molded or depth shoe will be covered as a substitute for an insert. Although not intended as a comprehensive list, the following are the most common shoe modifications: rigid rocker bottoms (A5503), roller bottoms (A5503), wedges (A5504), metatarsal bars (A5505), or offset heels (A5506). Other modifications to diabetic shoes (A5507) include, but are not limited to flared heels.

Deluxe features of diabetic shoes (A5508) will be denied as non-covered.

Shoes, inserts, and/or modifications that are provided to patients who do not meet the coverage criteria will be denied as non-covered. When codes are billed without a KX modifier (see Documentation section), they will be denied as non-covered.

The particular type of footwear (shoes, inserts, modifications) which is necessary must be prescribed by a podiatrist or other qualified physician, knowledgeable in the fitting of diabetic shoes and inserts. The footwear must be fitted and furnished by a podiatrist or other qualified individual such as a pedorthist, orthotist or prosthetist. The certifying physician (i.e., the physician who manages the systemic diabetic condition) may not furnish the footwear unless he/she practices in a defined rural area or a defined health professional shortage area. The prescribing physician (podiatrist or other qualified physician) can be the supplier (i.e., the one who furnishes the footwear).

There is no separate payment for the fitting of the shoes, inserts or modifications or for the certification of need or prescription of the footwear. The local carrier processes unrelated evaluation and management services provided by the physician.

CODING GUIDELINES:
Code A5507 is only to be used for not otherwise specified therapeutic modifications to the shoe or for repairs to a diabetic shoe(s)

Deluxe features must be coded using code A5508.

Codes for inserts or modifications (A5503 - A5511) may only be used for items related to diabetic shoes (A5500, A5501). They should not be used for items related to footwear coded with codes L3215 - L3253. Inserts and modifications used with L coded footwear must be coded using L codes (L3000 - L3649).

When a single shoe, insert or modification is provided, the appropriate modifier, right (RT) or left (LT), must be used. If a pair is provided, report as two (2) units of service on the claim - the RT or LT modifiers should not be used.

Inserts for missing toes or partial foot amputation should be coded L5000 or L5999, whichever is applicable.

Suppliers should contact the Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) for guidance on the correct coding of these items.
DOCUMENTATION:
Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider" (42 U.S.C. §13951(e)). 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 to the DMERC upon request.

The supplier must keep an order for the shoes, inserts or modifications that has been signed and dated by the prescribing physician on file. If the prescribing physician is the supplier, a separate order is not required, but the item provided must be clearly noted in the patient's record. A new order is not required for the replacement of an insert or modification within one year of the order on file. However, the supplier's records should document the reason for the replacement. A new order is required for the replacement of any shoe. A new order is also required for the replacement of an insert or modification more than one year from the most recent order on file.

The supplier must obtain a signed statement from the certifying physician specifying that the patient has diabetes mellitus, has one of conditions 2a-2f listed in the policy, is being treated under a comprehensive plan of care for his/her diabetes, and needs diabetic shoes. The certifying physician must be either a M.D. or D.O. and may not be a podiatrist. The Statement of Certifying Physician for Therapeutic Shoes developed by the DMERC is recommended (whatever form is used must contain all of the elements contained on the attached recommended form). This statement may be completed by the prescribing physician or supplier but must be reviewed for accuracy of the information and signed by the certifying physician to indicate agreement. A new Certification Statement is required for a shoe, insert or modification provided more than one year from the most recent Certification Statement on file. If the supplier has a current signed statement on file that indicates that the coverage criteria described above have been met, then a KX modifier must be added to the code. A diagnosis code for diabetes (ICD-9 250.00-250.93) should be entered on the claim.

If code A5507 is submitted, the claim must contain a narrative description of the modification or feature provided

The prescribing physician's name and PIN number must be listed in Blocks 17 and 17a of the HCFA-1500 form or the electronic equivalent.

Claims with dates of service on or after July 1, 2002
This is a revision of a previously published policy
INITIALLY PUBLISHED: January 1995
REVISION HISTORY: April 1995 - March 1998 - December 2000 - April 2002