Clinicians! Are You Ordering Diabetic Shoes for Your Patients - JA DME

This article has been revised as of March 2021.

The following section outlines roles of various practitioners that are involved in the decision-making and provision process for Diabetic Shoes:

• Certifying Physician: The practitioner actively treating and managing the patient's systemic diabetic condition. This practitioner must be an M.D. (Doctor of Medicine) or D.O. (Doctor of Osteopathy) as outlined in the Social Security Act §1861(s) (12).
• Prescribing Practitioner: The Certifying Physician, a different MD or DO, physician's assistant (PA), nurse practitioner (NP), clinical nurse specialist (CNS), or podiatrist (DPM). One of these practitioners may conduct the foot exam and write the standard written orders required for Medicare's coverage of Therapeutic Shoes for Persons with Diabetes if the Certifying Physician does not complete the foot exam.
• Supplier: The person or entity that provides the shoes and/or inserts to the Medicare beneficiary and bills the Medicare program. A supplier may be a podiatrist, pedorthist, orthotist, prosthetist or other qualified individual. The Prescribing Practitioner may be the supplier.

Recent Centers for Medicare and Medicaid Services (CMS) Guidance and a new Center for Medicare and Medicaid Innovation recently expanded who may perform the role of the Certifying Physician as described below:

• Primary Care First Model (PCF): Allows nurse practitioners (NPs) that are registered in certain geographic areas to certify that an order for diabetic shoes is required according to Section 1861(s)(12). Additional information, including the PCF Participant list and the Participating Regions and Payer Partners, are located at the bottom of the PCF Model page.
• Nurse Practitioners and Physician Assistants as Certifying Physicians for Therapeutic Shoes and Inserts: CMS has provided guidance to the DME MACs about the delegation of certifying physician (MD or DO) comprehensive management of diabetes responsibilities to nurse practitioners (NP) and physician assistants (PA) prescribing therapeutic shoes and inserts for persons with diabetes. This clarification is specific to NPs and PAs who are practicing under the supervision of an MD or DO (i.e., “incident to”) and does not extend to NPs who practice independently (i.e., bill under their own NPI).

NPs or PAs providing ancillary services as auxiliary personnel could meet the “incident to” requirements if all the following criteria are met:

1. The supervising physician has documented in the medical record that the patient is diabetic and has been, and continues to provide, the patient follow-up under a comprehensive management program of that condition; and
2. The NP or PA certifies that the provision of the therapeutic shoes is part of the comprehensive treatment plan being provided to the patient; and,
3. The Supervising physician must review and verify (sign and date) all the NP or PA notes in the medical record pertaining to the provision of the therapeutic shoes and inserts, acknowledging their agreement with the actions of the NP or PA.

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

1. The beneficiary has diabetes mellitus (Reference diagnosis code section in Policy Article (A52501)).
2. The certifying practitioner has documented in the beneficiary's medical record one or more of the following conditions:
   • Previous amputation of the other foot, or part of either foot, or
   • History of previous foot ulceration of either foot, or
   • History of pre-ulcerative calluses of either foot, or
   • Peripheral neuropathy with evidence of callus formation of either foot, or
   • Foot deformity of either foot, or
   • Poor circulation in either foot.
3. The certifying practitioner has certified that indications (1) and (2) are met and that he/she is treating the beneficiary under a comprehensive plan of care for his/her diabetes and that the beneficiary needs diabetic shoes. The Certifying Practitioner must:
   • Have an in-person visit with the beneficiary during which diabetes management is addressed within six months prior to delivery of the shoes/inserts; and
   • Sign the certification statement on or after the date of the in-person visit and within three months prior to delivery of the shoes/inserts.
4. Prior to selecting the specific items that will be provided; the supplier must conduct and document an in-person evaluation of the beneficiary.
5. At the time of in-person delivery to the beneficiary of the items selected, the supplier must conduct an objective assessment of the fit of the shoe and inserts and document the results.

In order to meet criterion 2, the certifying physician must either:

1. Personally document one or more of the qualifying foot conditions above in the medical record of an in-person visit within six months prior to delivery of the shoes/inserts; or
2. Obtain, initial, date (prior to signing the certification statement), and indicate agreement with information from the medical records of an in-person visit with a podiatrist, other M.D. or D.O., physician assistant, nurse practitioner, or clinical nurse specialist that is within six months prior to delivery of the shoes/inserts. In this scenario, a different practitioner conducts the foot examination.

The certification statement must be completed on or after the date of the in-person visit and within three months prior to delivery of the diabetic shoes by the supplier. The documentation in the medical record must support the information on the certification statement. The certification statement by itself is not sufficient to meet the required documentation in the medical record and must be corroborated by the medical record.

Just a few reminders:

• The Certifying Practitioner must be an MD or DO, NP or PA practicing “incident to”, or NP enrolled in the Primary First Care model that is managing the beneficiary's systemic diabetic condition.
• Another practitioner may conduct the foot exam that includes evidence of at least one of the qualifying foot issues. If this happens, the Certifying Practitioner must obtain a copy of that medical record, indicate agreement, sign and date it.
• The certification statement must be completed within three months of delivery of the diabetic shoes.
• The Diabetic Shoe benefit is an annual benefit. Medicare will consider payment for one pair of diabetic shoes and up to three pairs of insoles per calendar year.
• The supplier must have valid standard written orders in their possession prior to submitting the claim to the DME MAC.

All orders and medical records must meet CMS Signature Requirements.

Following this guidance will help your patients and the Medicare program by verifying there is medical documentation to support the provisions for Therapeutic Shoes for Persons with Diabetes, allow your patients to receive the items needed to treat their diabetic condition, and allow Medicare to pay claims appropriately.

Local Coverage Determinations for Therapeutic Shoes for Persons with Diabetes (L33369):

Jurisdiction A
Jurisdiction B
Jurisdiction C
Jurisdiction D