Minimum Necessary Policy Checklist for Diabetic Shoe Providers

Define Role-Based PHI Access

Build protected health information access controls around each person’s job duties. Specify which roles may view or handle records, what information they need, and under what conditions—for example, eligibility documentation, shoe orders, fitting notes, or claim records. Review permissions when responsibilities change, and use safeguards such as individual accounts and access logging to help prevent inappropriate access.

The HIPAA minimum necessary standard generally applies to uses of PHI and to many disclosures and requests, including those for payment. It does not apply to disclosures to or requests by a health care provider for treatment purposes. Your policy should distinguish that exception from internal workforce access, which should still follow role-based policies.

Document Diabetic Shoe Eligibility

Keep medical-record support showing that the beneficiary has diabetes and at least one qualifying diabetic foot condition. Medicare’s listed conditions are a previous amputation of the other foot or part of either foot, a history of foot ulceration, pre-ulcerative calluses, peripheral neuropathy with callus formation, foot deformity, or poor circulation.

Records should describe the qualifying condition in detail and document management of the beneficiary’s diabetes under a comprehensive diabetes care plan. A therapeutic shoe certification form alone does not replace the supporting medical-record documentation.

Verify Certifying Practitioner Records

Confirm that the signed certification comes from the practitioner Medicare recognizes as the certifying physician: an M.D. or D.O. who personally manages the beneficiary’s systemic diabetes. A podiatrist or clinical nurse specialist cannot serve in this role. An NP or PA may participate when practicing incident to a supervising physician’s authority, with the supervising M.D. or D.O. reviewing and verifying the statement as required.

The certification must state that the beneficiary has diabetes, has a qualifying foot condition, is being treated under a comprehensive plan of care for diabetes, and needs diabetic shoes. If the certifying physician relies on another practitioner’s record to document the foot condition, make sure the physician obtains, initials, dates, and indicates agreement with that record before signing the certification.

Track Visit and Certification Dates

Track the dates separately so the file shows that each timing requirement is met. The in-person visit addressing diabetes management must occur within six months before delivery. The certifying physician must sign the certification on or after that visit and within three months before delivery.

The record documenting the qualifying foot condition must also come from an in-person visit within six months before delivery, and the certifying physician must document the condition before or on the date of signing the certification. Keep the visit note, signed certification, order, and delivery date together for a clear timeline.

Record Supplier Evaluation and Shoe Fitting

Before selecting the specific items, document an in-person supplier evaluation. Include a foot examination and descriptions of abnormalities the shoes, inserts, or modifications need to accommodate, along with measurements of both feet. For custom molded shoes and specified custom inserts, document the impressions, casts, or CAD-CAM images used to create the foot models.

At in-person delivery, document an objective assessment of the fit while the beneficiary is wearing the shoes and inserts. Record whether the items and any modifications fit properly; the beneficiary’s statement that they feel comfortable is not enough by itself.

Maintain Claim Support and Proof of Delivery

Keep the signed and dated order for each item billed, relevant medical records, correct coding support, supplier evaluation and fitting notes, and proof of delivery records. Ensure the documentation identifies the items furnished and supports the diagnosis and claim. Check whether a code-specific written order prior to delivery requirement applies before furnishing the item.

For direct delivery, proof of delivery generally needs the beneficiary’s name, delivery address, item description, quantity, delivery date, and beneficiary’s or authorized designee’s signature. For shipment, retain records that link the supplier’s item and invoice information to tracking and delivery evidence. Medicare requires suppliers to retain proof-of-delivery and claims documentation for seven years from the date of service and provide it to the contractor upon request.

Apply Medicare Coverage Limits

For eligible beneficiaries, Medicare’s annual limit is generally either one pair of custom molded shoes, including the inserts provided with them, plus two additional pairs of covered inserts, or one pair of depth shoes plus three pairs of covered inserts. The ordinary removable inserts supplied with depth shoes do not count toward those three additional pairs. Quantities beyond the applicable limit are not covered under this policy.

A reliable checklist connects each coverage decision to dated practitioner records, a complete supplier evaluation, documented fit, an appropriate order, and retained claim and delivery support.

FAQs

Does the minimum necessary standard apply to provider-to-provider disclosures for treatment?

No. HIPAA’s minimum necessary standard does not apply to disclosures to or requests by a health care provider for treatment purposes. However, internal uses of PHI by workforce members should follow the organization’s role-based access policies.

What medical-record documentation is required to certify diabetic shoes?

The record should document diabetes management and detailed information about at least one qualifying foot condition, such as a prior amputation, ulcer, pre-ulcerative callus, neuropathy with callus formation, foot deformity, or poor circulation. The certifying physician’s statement must also confirm the beneficiary is being treated under a comprehensive diabetes care plan and needs diabetic shoes. The certification statement alone is not sufficient medical-record support.

How soon must the diabetes management visit and certification occur before delivery?

The in-person visit addressing diabetes management must be within six months before delivery. The certification must be signed on or after that visit and within three months before delivery. The foot-condition documentation must also meet the applicable six-month timing requirement.

What documentation must a supplier retain for a Medicare claim?

Retain the signed and dated order, supporting medical records, claim and coding support, supplier evaluation and fitting documentation, and proof of delivery. Proof of delivery should identify the beneficiary, the item and quantity, and the delivery details required for the delivery method used. Keep proof-of-delivery and claims documentation for seven years from the date of service and make it available to the Medicare contractor upon request.