Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if the following criteria are met:
- The patient has diabetes mellitus; and
The certifying physician has documented in the patient's medical record one or more of the following conditions:
a. Previous amputation of the other foot, or part of either foot, or
b. History of previous foot ulceration of either foot, or
c. History of pre-ulcerative calluses of either foot, or
d. Peripheral neuropathy with evidence of callus formation of either foot, or
e. Foot deformity of either foot, or
f. Poor circulation in either foot; and
The certifying physician has certified that (1) and (2) are met and that he/she is treating the patient under a comprehensive plan of care for their diabetes and that the patient needs diabetic shoes.
In order to meet criterion 2, the certifying physician must either:
- Personally document one or more of criteria a-f in the medical record prior to signing the certification statement; or
- Obtain, initial, date (prior to signing the certification statement), and indicate agreement with information from the medical records of a podiatrist, other M.D. or D.O., physician assistant, nurse practitioner, or clinical nurse specialist that documents one or more of criteria a-f.
- NOTE:
- The certification statement is not sufficient to meet the requirement for documentation in the medical record.
Indications and Limitations of Coverage
For an item addressed in this policy to be covered, a written, signed and dated order must be received by the supplier prior to claim submission. If the supplier bills for an item without first receiving the completed order, the item will be denied as non-covered.
For patients meeting the coverage criteria, coverage is limited to one of the following within one year;
One pair of custom molded shoes (A5501) (which includes inserts provided with these shoes) and two additional pairs of inserts (A5512 or A5513); or
One pair of depth shoes (A5500) and three pairs of inserts (A5512 or A5513) (not including the non-customized removable inserts provided with such shoes).
The certifying physician is defined as a Doctor of Medicine (M.D.) or a Doctor of Osteopathy (D.O.) who is responsible for diagnosing and treating the patient's systemic condition through a comprehensive plan of care. The certifying physician may not be a podiatrist, physician assistant, nurse practitioner or clinical nurse specialist.
The prescribing physician actually writes the order for the therapeutic shoe, modifications and inserts. This physician must be knowledgeable in the fitting of diabetic shoes and inserts. The prescribing physician may be a podiatrist, M.D., D.O., physician assistant, nurse practitioner, or clinical nurse specialist. The prescribing physician can be the supplier (i.e., the one who furnished the footwear).
Shoes are also covered if they are an integral part of a covered leg brace. However, different codes are used for footwear provided under this benefit.
The supplier is the person or entity that actually furnishes the shoe, modification and/or insert to the member. The supplier may be a podiatrist, pedorthist, orthotist, prosthetist 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.
Separate inserts may be covered and dispensed independently of the 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.
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 which may be requested for review. If there is insufficient justification for a custom molded shoe but the general coverage criteria are met, payment will be made 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:
Other modifications to diabetic shoes (A5507) include, but are not limited to flared heels.
Reasons for Noncoverage
If criteria 1, 2 or 3 are not met, the therapeutic shoes, inserts and/or modifications to therapeutic shoes will be denied as non-covered. When codes are billed without a KX modifier, they will be denied as non-covered. The provider can bill the member for the denied services.
Quantities of shoes, inserts, and/or modifications greater than those listed above will be denied as non-covered. The provider can bill the member for the denied service.
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. The provider can bill the member for the denied service.
Inserts used in non-covered shoes are noncovered. The provider can bill the member for the denied service.
Deluxe features of diabetic shoes (A5508) will be denied as non-covered. The provider can bill the member for the denied service.
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.
Documentation Requirements
An order for each item billed must be signed and dated by the prescribing 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 code.
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 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 physician who is managing the patient's systemic diabetes condition (i.e., the certifying physician) specifying that the patient has diabetes mellitus, has one of the conditions listed on the policy, is being treated under a comprehensive plan of care for/her diabetes, and needs diabetic shoes. The certifying physician must be an M.D. or D.O. and may not be a podiatrist, physician assistant, nurse practitioner, or clinical nurse specialist. 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.
The ICD-9 code that justifies the need for these items must be included on the claim.
Suppliers must add a KX modifier to codes for shoes, inserts and modifications only if the criteria 1, 2 and 3 on this policy have been met. This information must be substantiated in the patient’s medical record and available upon request. The statement of certifying physician form is not sufficient to meet this requirement.
If criteria 1, 2 and 3 have not been met, the GY modifier must be added to each code. The provider can bill the member for the non-covered services.
If a KX or GY modifier is not included on the claim, it will be rejected as missing information.
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-A5508, A5510, A5512, A5513) may only be used for items related to diabetic shoes (A5500, A5501). They must 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).
The right (RT) and/or left (LT) modifiers must be used when billing shoes, inserts, or modifications. If bilateral items are provided 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.
Inserts for missing toes or partial foot amputation should be coded L5000 or L5999, whichever is applicable.