Complying with the new Medicare policy for fitting and delivery of Therapeutic Shoes

In an effort to ensure that patients with Medicare and diabetes are properly fit with therapeutic footwear and inserts, Medicare on May 20th, 2010 updated its therapeutic shoe policy. The clarification will prevent the practice of some mail order supply companies from simply mailing shoes with custom molded inserts to patients based on a single shoe selecting appointment. The revised clarification of the shoe fitting policy reads as follows:

Appendix C of the DMEPOS Quality Standards published in October 2008 addresses specific requirements for orthoses, prostheses, prosthetic devices, and therapeutic shoes. Those standards include requirements for "an in- person diagnosis-specific functional clinical examination" by the supplier to determine the need for a particular item as well as "face-to-face fitting/delivery" by the supplier. Therefore, in order for therapeutic shoes, inserts, and shoe modifications to be covered, both of the following criteria must be met:
1. Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation of the patient; and,
2. At the time of delivery of the items selected, the supplier must conduct and document an in-person visit with the patient to ensure that the shoes/inserts/modifications are properly fit and meet the beneficiary's needs.

In order to meet these criteria, effective for claims with dates of service on or after July 1, 2010, the following documentation requirements must be met:
- The in-person evaluation prior to selecting the items must include at least an examination of the patient's feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications. For all shoes, it must include taking measurements of the patient's feet. For custom molded shoes (A5501) and inserts (A5513), this visit must also include taking impressions, making casts, or obtaining CAD-CAM images of the patient's feet that will be used in creating positive models of the feet.
- The in-person visit at the time of delivery must include an assessment of the fit of the shoes and inserts with the patient wearing them.


Also, in an effort to ensure that the physician managing the patient's diabetes is aware of the foot conditions being accommodated, a number of pre-payment audits have been recently performed. According to the therapeutic footwear LCD:

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, 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.

Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if the following criteria are met:

1. The patient has diabetes mellitus (ICD-9 diagnosis codes 249.00-250.93); and

2. 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

3. The certifying physician 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.

If criteria 1, 2 or 3 are not met, the therapeutic shoes, inserts and/or modifications to therapeutic shoes will be denied as noncovered. When codes are billed without a KX modifier (see Documentation Requirements section in the accompanying Local Coverage Determination), they will be denied as noncovered.

In order to meet criterion 2, the certifying physician must either:
i. Personally document one or more of criteria a - f in the medical record prior to signing the certification statement; or
ii. 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 of more of criteria a - f.
Note: The certification statement is not sufficient to meet the requirement for documentation in the medical record.

The best way for podiatrists to both comply with the supplier requirement that the certifying physician has documented the qualifying conditions is to send a copy of the Comprehensive Diabetic Foot Evaluation foot and request that a signed copy be sent back. Podiatrists should not dispense shoes and inserts unless they have both a signed copy of the required "Document of Therapeutic Necessity" as well as a signed copy of the certifying physician's chart notes indicating documentation of the qualifying risk factors.

SafeStep has available at additional information about the Medicare therapeutic shoe program, required documentation as well as how to perform the Comprehensive Diabetic Foot Exam.



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