On October 27, 2020, CMS announced the single payment amounts for Off-The-Shelf (OTS) Knee Braces product categories included in Round 2021 of the DMEPOS CBP. With this announcement, comes a great need for clarification in the definition of OTS vs. custom-fitted orthotics. The Arctic Bracing SolarTech line clearly fulfills Medicare's custom-fitted orthotic requirements with its innovative silicone-based sculpted patient fit. Take a look below for a quick breakdown of a few key CMS terms and how they apply.
Reasons SolarTech is Custom-Fitted
- SolarTech orthotics require More Than Minimal Self Adjustment at the time of delivery by requiring molding and ultraviolet curing for a proper and individualized fit.
- SolarTech orthotics require a Certified Orthotist or "Individual with Expertise" for appropriate patient fitting at the time of delivery. SolarTech provides the service provider with a definitive measure to mold each orthosis to its patient.
- Once fit properly, our SolarTech orthotics will not fit another patient correctly.
What is a custom-fitted orthotic?
- Devices that are prefabricated
- Devices that may or may not be supplied as a kit that requires some assembly, Note:
- Assembly of the item doesn't change classification from OTS to custom,
- Installation of add-on components doesn't change classification from OTS to custom,
- Use of basic materials in preparing the item doesn't change classification from OTS to custom.
- Devices that require MORE THAN MINIMAL SELF ADJUSTMENT at time of delivery to provide individualized fit, ie:
- The item must be trimmed, bent, molded (with or without heat),
- Or otherwise modified resulting in alterations beyond minimal self-adjustment.
- Devices that require patient fitting at delivery by a CERTIFIED ORTHOTIST (or an individual who has specialized training) in the provision of the orthosis.
**Use of CAD/CAM or similar technology to create an orthosis without a positive model of the patient may be considered as custom-fitted if the final fitting upon delivery to the patient requires more than minimal self-adjustment requiring expertise as described in this section.
Certifications that fulfill Medicare's requirement for Individual with Expertise.
These certifications will fulfill Medicare's requirements.
1. CERTIFIED ORTHOTIST - Orthotists must have certification with one of two entities:
- American Board for Certification in Orthotics and Prosthetics, Inc.
- Board for Orthotics/Prosthetist Certification
2. INDIVIDUALS WITH SPECIALIZED TRAINING
- Treating Practitioner:
- Physician Assistant
- Nurse Practitioner
- Clinical Nurse Specialist
- Occupational Therapist
- Physical Therapist
**Certifications must comply with all applicable Federal & State licensure and regulatory requirements
These certifications will not fulfill Medicare's requirements.
1. CFO - Certified Fitter of Orthotics and Prosthetics
- The only recognized certification from the ABCOP/BOP is that of an Orthotist. A CFO would not be considered to have the "expertise of a certified Orthotist or an individual who has specialized training in the provision of orthotics"
2. ROT/OTC - Registered Orthopedic Technologist/Orthopedic Technician Certified
3. CMA - Certified Medical Assistant
4. DME Program Manager
5. PTA - Physical Therapist Assistant