Therapeutic Footwear

Affected Providers

Physicians who are doctors of medicine or doctors of osteopathy and are responsible for diagnosing and treating a patient’s diabetic systemic condition through a comprehensive plan of care, as well as podiatrists and other qualified physicians knowledgeable in fitting diabetic shoes.

HCPCS & CPT Codes

Local Coverage Determination (LCD): Therapeutic Shoes for Persons with Diabetes (L33369) has the current HCPCS and CPT codes.

Background

According to the 2024 Medicare Fee-for-Service Supplemental Improper Payment Data, the improper payment rate for diabetic shoes is 47.1%, with a projected improper payment amount of $35.7 million.

DME Medicare Administrative Contractors (MACs) process claims for diabetic therapeutic shoes. Therapeutic shoes for patients with diabetes aren’t DME and aren’t considered DME or orthotics, but a separate coverage category under Medicare Part B.

We outline other policy requirements in LCD L33369 and Article: Therapeutic Shoes for Persons with Diabetes (A52501).

Denial Reasons

Insufficient documentation accounted for 85.5% of improper payments for diabetic shoes during the 2024 reporting period, while other errors (14.5%) also caused improper payments. “Other” errors include duplicate payment, non-covered or unallowable service, or ineligible Medicare patient errors.

Preventing Denials

The diabetic shoe benefit provides a pair of diabetic shoes, even if only 1 foot suffers from diabetic foot disease. Each shoe is equally equipped to protect the affected limb or the remaining limb.

Definitions

The diabetic shoe benefit may cover these items:

• Custom-Molded Shoes:
  • Constructed over a positive model of the patient’s foot
  • Made from leather or other suitable material of equal quality
  • Have removable inserts, with the choice to alter or replace them as the patient’s condition warrants
  • Have some form of shoe closure
• Depth Shoes
  • Have a full length, heel-to-toe filler that, when removed, gives at least 3/16 of an inch of added depth to accommodate custom-molded or customized inserts
  • Made from leather or other suitable material of equal quality
  • Have some form of shoe closure
  • Available in full and half sizes with at least 3 widths so the sole is graded to size and width of upper parts of shoes according to the American standard last sizing schedule (the numerical shoe sizing system used for shoes sold in the U.S.) or its equivalent
• Inserts
  • Must retain their shape during use for the life of the inserts
  • Are total contact, multiple density, removable inlays directly molded to the patient’s foot or a model of the patient’s foot or directly carved from a patient-specific, rectified electronic model and made of material suitable for the patient’s condition

Coverage Limitations

For each patient, we limit coverage of footwear and inserts to 1 of these within 1 calendar year:

• No more than 1 pair of custom-molded shoes (including inserts provided with them) and 2 more pairs of inserts
• No more than 1 pair of depth shoes and 3 pairs of inserts (not including the non-customized removable inserts provided with them)

Requirements for Therapeutic Shoes for Patients with Diabetes

We cover therapeutic shoes, inserts, or modifications to therapeutic shoes if the patient meets all these criteria:

1. The patient has diabetes mellitus (find the ICD-10 Diagnosis Codes that Support Medical Necessity section in Article A52501).
2. The certifying physician has documented in the patient’s medical record 1 or more of these conditions:
   1. Previous amputation of the other foot or part of either foot
   2. History of previous foot ulceration of either foot
   3. History of pre-ulcerative calluses of either foot
   4. Peripheral neuropathy with evidence of callus formation of either foot
   5. Deformity of either foot
   6. Poor circulation in either foot
3. The certifying physician has certified that the patient met criteria 1 and 2, that they’re treating the patient’s diabetes under a comprehensive plan of care, and that the patient needs diabetic shoes. The certifying physician must:
   1. Have an in-person visit with the patient to discuss diabetes management within 6 months before delivering the shoes or inserts
   2. Sign the certification statement on or after the date of the in-person visit and within 3 months before delivering the shoes or inserts (see the Policy Specific Documentation Requirements in Article A52501)
4. Before selecting the specific items, the supplier must conduct and document an in-person evaluation of the patient (see the Policy Specific Documentation Requirements in Article A52501).
5. The supplier must conduct an objective assessment of the fit of the shoe and inserts and document the results when they deliver the items to the patient. A patient’s subjective statement about fit doesn’t meet this criterion if it’s the only documentation of the in-person delivery.

To meet criterion 2, the certifying physician must either:

1. Personally document 1 or more of the criteria a–f in the medical record of an in-person visit within 6 months before delivering the shoes or inserts and before or on the same day as signing the certification statement
2. Obtain, initial, date (before signing the certification statement), and show agreement with information from the medical records of an in-person visit with a podiatrist, other physician, physician assistant, nurse practitioner, or clinical nurse specialist that was within 6 months before delivering the shoes or inserts. The medical records must document 1 or more of criteria a – f.

Documentation Requirements

To justify payment, you must meet specific requirements when ordering DMEPOS.

Example of Improper Payments Due to Insufficient Documentation for Diabetic Shoes

A supplier bills the claim for HCPCS code A5504 (For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded shoe with wedge(s), per shoe) and submits the following documentation per the review contractor’s request:

• Standard written order with correct HCPCS coding
• Treating practitioner’s medical record that doesn’t have complete certification
• Proof of delivery

What Documentation Was Missing?

The patient’s medical record didn’t have a complete certification by the treating practitioner.

What Happens Next?

The review contractor completes the claim as an insufficient documentation error, and the MAC recoups payment.

Recommendation

To justify payment, the certifying physician must:

• Document in the patient’s medical record that the patient has diabetes
• Certify they’re treating the patient under a comprehensive plan of care for diabetes and the patient needs diabetic shoes
• Document in the patient’s record they have 1 or more of these conditions:
  • Peripheral neuropathy with evidence of callus formation
  • History of pre-ulcerative calluses
  • History of earlier ulceration
  • Foot deformity
  • Earlier amputation of foot or part of foot
  • Poor circulation