The Pedorthic Association of Canada (PAC) has recognized the importance of differentiating the types of orthopaedic footwear that are being used in treatment plans across Canada. In particular, we recognize the important balance between medical necessity and consumer demand. Regarding orthopaedic footwear, PAC shares many of the guidelines and definitions that can be referenced through the International Organization for Standardization-21064 (ISO). This section is designed to be a useful tool to encourage clarity when defining orthopaedic footwear.
PAC has identified the three most crucial points to consider when classifying footwear as orthopaedic:
- Medical need
- Practitioner qualification
Medical need is determined by:
- Congenital deformity (e.g., clubfoot)
- Disease (e.g., diabetic ulcer)
- Trauma/post-surgical (e.g., triple arthrodesis)
- Developmental foot deformity (e.g., hallux valgus)
Practitioner qualification includes the following Canadian designations:
- Pedorthists (C. Ped (C), C. Ped MC & COFS)
- Orthotists (CO (c))
- Chiropodists (D. Ch)
- Podiatrists (DPM)
Note: Canadian Certified Pedorthists are among the few formally trained professionals who can:
- Assess, cast, design, fit, and modify custom-made orthopaedic footwear
- Select, fit, and modify pre-fabricated/mass-produced (in-stock) orthopaedic footwear
Justification refers to the clinician being responsible for providing an informed opinion as to why orthopaedic footwear is appropriate for use in a patient’s treatment plan. PAC has created a checklist to help streamline orthopaedic footwear claims adjudication (see Appendix A: Orthopaedic Footwear Submission Checklist).
PAC defines “orthopaedic footwear” as footwear containing features that are specifically selected by a qualified footcare professional and that are used to “correct” or manage a medical condition. Orthopaedic footwear is used in treatment plans that require unique footwear management strategies that cannot be addressed by traditional footwear retailers.
There are two classifications of orthopaedic footwear:
- Pre-fabricated or mass-produced (in-stock)
Note: Adding a custom-made orthosis does not re-classify the footwear as “orthopaedic”. Custom-made orthoses are a separate matter and should be clearly itemized when billing.
Pre-fabricated/mass-produced (in-stock) orthopaedic footwear is not made for an individual patient, however it incorporates features that are applicable to specific medical needs. Pre-fabricated orthopaedic footwear is available in a range of lengths, widths, styles, and materials, but is not typically purchased at mainstream footwear stores or online. When pre-fabricated/mass-produced (in-stock) orthopaedic footwear is used, a qualified provider should be specific about how the selection of style and brand addresses their patient’s individual medical need.
Considerations when defining pre-fabricated footwear as orthopaedic (not all features are required):
1. Full instep adjustable closure. (e.g., buckles, laces, Velcro)
2. Torsional stability (e.g., stiff shank)
3. Heel counter, which provides stability or decreased pressure on the heel
4. Upper, size, shape, and materials to accommodate and protect the feet. May include features such as:
a. Soft, smooth, and protective interior lining
b. Stretch and/or heat mouldable upper materials to accommodate deformity
c. Extended openings
5. Outsole requirements:
a. Size and shape match or exceed the width of the upper
b. Material may provide greater stability, traction, or reduced friction
c. Conducive to permanent modification(s)
6. Last shape matches the shape of the foot and supports treatment plan
7. Rearfoot and forefoot rocker soles and/or toe spring to promote a natural gait cycle
8. Footwear must be provided by a qualified professional
9. Footwear selection must be justified as forming an integral part of treatment with supporting documentation
Note: Permanent footwear modifications may be added to pre-fabricated footwear as part of the treatment plan and still fulfill the orthopaedic definition. For details, see our full document about modifications.
Recommendation: When considering pre-fabricated orthopaedic footwear claims, we suggest that insurers require: copies of biomechanical assessments; footwear make, model, and size; and description of how footwear features address a patient’s need (see Appendix A: Orthopaedic Footwear Submission Checklist).
Custom-made orthopaedic footwear is typically used for the most serious and complex cases where the client’s foot shape or condition cannot be accommodated by existing pre-fabricated/mass-produced (in-stock) orthopaedic footwear. Providing such footwear is a highly technical endeavour that requires a 3D cast of the patient’s foot. From this cast, a precise and unique “last” is then produced which serves as the foundation in which patterns are cut and assembled from raw materials as designed by the practitioner to address the patient’s individual need. Custom-made orthopaedic footwear may cost, on average, approximately $1,200 – $2,700 per pair of shoes, while custom-made boots may range from $3,000 to $3,500
per pair. Custom-made sandals would be in the range of $600 – $1,000 and could possibly exceed this amount in more complex cases. Custom-made orthopaedic footwear is used to:
- Accommodate foot deformity(ies)
- Accommodate extreme foot shape and size
- Compensate for severe limb discrepancy
- Compensate for foot biomechanical deficiencies
- Accommodate vulnerable (at risk) feet
Recommendation: When considering custom-made orthopaedic footwear claims, we suggest that insurers require: copies of biomechanical assessments; photos of the patient’s feet; design specifications; and information about the manufacturing process.
PAC has identified that the most crucial three points to consider when determining if footwear can be defined as “orthopaedic” are:
- Medical need
- Practitioner qualification
The intention of this section is to provide the basis for consideration of footwear as orthopaedic, while also expanding the term’s definition beyond features alone. Medical conditions can be highly variable and so, too, are their solutions. Due to this fact, defining orthopaedic footwear by one specific list of features is inadequate. Furthermore, as the footwear industry changes to address consumer needs and demands, we can expect that these changes will continue to create confusion when trying to identify footwear as “orthopaedic” by features alone. Styles, brands, makes, and models, will always come and go, but what will never change are medical conditions requiring solutions for treatment.
As demonstrated in the past, PAC will continue to lead the foot orthosis and footwear industry by constantly evolving to meet industry standards and ensuring our guidelines continue to be relevant to maximize patient protection.