Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs)
Aetna clinical policy bulletin governing medical necessity, coverage, and coding for ankle orthoses, AFOs, and KAFOs for insured members, including criteria for ambulatory and non-ambulatory use, experimental items, and related administrative rules.
Policy Summary
PayerAetna
PolicyAnkle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs)
Policy CodePolicy 0565
Change TypeNo material changes
Effective Date09/28/2001
Next Review Date06/13/2024
Key ActionPrescribe orthosis/prosthesis by a qualified practitioner and document pre-treatment passive ROM, therapy program, and provision within six months.
No material clinical or coverage changes in this revision.
0565policy identifier
09/28/2001Effective date
07/28/2023Last review
06/13/2024Next review
>=10°ROM threshold
1/6mo
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.
Replacement allowance
Coverage Criteria
Placeholder for later chunks
Placeholder for additional coverage criteria or device-specific information to be inserted here. The content below consolidates related notes and operational guidance referenced elsewhere in this section and preserves existing policy rules.
This placeholder reserves space for future additions such as new device-specific selection criteria, HCPCS/ICD-10 crosswalk updates, or technology assessments (e.g., emerging microprocessor-controlled KAFOs or novel AFO designs).
Until such additions are incorporated, the following operational points apply:
- Any additions to AFOs or KAFOs are not considered medically necessary if the base orthosis is not medically necessary or the specific addition itself is not medically necessary.
- Replacement interfaces for static or dynamic positioning AFOs are covered (up to 1 replacement interface per 6 months) only as long as the member continues to meet medical necessity criteria for the splint.
- Components intended to address knee or hip positioning as part of a static or dynamic positioning ankle-foot orthosis are considered experimental and investigational because their effectiveness is not established.
- Electronic KAFOs (for example, Sensor Walk Electronic KAFO, C‑Brace Orthotronic Mobility System) are considered experimental and investigational due to insufficient evidence of improved ambulation compared to standard KAFOs.
- Aetna HMO plans do not consider static or dynamic positioning AFOs, foot drop splints/recumbent positioning devices, or related replacement interfaces medically necessary when used solely for prevention or treatment of heel pressure ulcers, consistent with Medicare.
- AFOs and KAFOs used solely during sports participation (prophylactic/safety use) are not considered medically necessary.
- Customized high-end items (e.g., custom carbon propulsion devices, specialized dynamic struts) are considered non-covered deluxe items unless specifically supported by the CPB criteria.
Operational note: When this placeholder is updated, any new device-specific HCPCS codes, covered ICD-10 indications, or explicit exclusions should be added to the CPT/HCPCS/ICD-10 code tables and to the relevant criteria groups to maintain consistency across the policy.
Medical Necessity Details
Static/dynamic positioning AFOs — Positioning AFOs for minimally ambulatory or non-ambulatory persons
Positioning AFOs for minimally ambulatory or non-ambulatory persons
Positioning AFO criteria (minimally/non-ambulatory): 1) Used as a component of a therapy program that includes active stretching; 2) Contracture interferes with or is expected to interfere significantly with functional abilities; 3) Reasonable expectation exists to correct the contracture; 4) Plantar flexion contracture with dorsiflexion on passive ROM testing of at least 10 degrees (non-fixed).>=10 degrees
Pre-treatment passive ROM must be measured with a goniometer and documented; documentation of stretching program by professional staff or caregiver required. Static/dynamic positioning AFO not medically necessary for fixed contractures; not indicated for members with foot drop without ankle flexion contracture; HMO restrictions apply for use solely to prevent/treat heel pressure ulcers.
Custom/molded device criteria — Molded-to-patient model AFOs/KAFOs in ambulatory members
Molded-to-patient model AFOs/KAFOs in ambulatory members
Coding
CPT / HCPCS Codes referencedmixed
29405-29425
Application of short leg cast (below knee to toes) [rigid for ankle fractures only] [semi-rigid for ankle sprains only]
29515
Application of short leg splint (calf to foot) [for plantar flexion contractures, without foot drop, with reasonable expectation of correction, that interfere with functional abilities, and are a component of a therapy program]
29580
Strapping: Unna boot [for ankle sprains and soft tissue injuries-not ankle fractures, chronically unstable ankles, or to prevent re-injury]
E1815
Dynamic adjustable ankle extension/flexion device, includes soft interface material
KAFO, fracture orthosis, femoral fracture cast orthosis, soft, prefabricated, includes fitting and adjustment.
L2134
KAFO, fracture orthosis, femoral fracture cast orthosis, semi-rigid, prefabricated, includes fitting and adjustment [for ankle sprains only].
L2136
KAFO, fracture orthosis, femoral fracture cast orthosis, rigid, prefabricated, includes fitting and adjustment [for ankle fractures only].
L2180
Addition to lower extremity fracture orthosis, plastic shoe insert with ankle joints.
1–10 of 104
1/11
ICD-10 example code ranges (covered / not covered notes)ICD-10
M24.571-M24.576
Contracture, ankle and foot.
M24.871-M24.876
Other joint derangement, ankle and foot.
M25.271-M25.279
Other joint derangement, ankle and foot (additional ranges listed).
M25.371-M25.376
Other joint derangement, ankle and foot.
M62.471-M62.479
Contracture of muscle, ankle and foot.
M67.00-M67.02
Contracture of muscle, ankle and foot (additional).
M72.2
Plantar fascial fibromatosis.
M84.461+-M84.473+
Pathological fracture, tibia and fibula, ankle, foot.
S82.301+-S82.309+
Fracture of ankle (ranges listed).
S82.391+-S82.399+
Fracture of ankle (ranges listed).
1–10 of 25
1/3
inv-17: Passive dorsiflexion on ROM testing — at least 10 degrees
Required passive dorsiflexionPassive dorsiflexion on goniometer testing of at least 10 degrees (non-fixed plantar flexion contracture)
DocumentationPre-treatment passive ROM must be measured with a goniometer and recorded in the medical record
Therapy programOrthosis must be used as part of a therapy program that includes active stretching of involved muscles/tendons
inv-18: Provision timeframe — device provided within six months of prescription
Provision timeframeOrthosis/prosthesis must be provided within six months of the date of prescription
Prescriber requirement
Provider Actions & Billing Impact
Prior Authorization
Prior Authorization Likely Required for Advanced KAFOs
Prior authorization likely required for advanced KAFO (L2006): Knee-ankle-foot devices with microprocessor control (HCPCS L2006) are listed as HCPCS codes not covered for indications in this CPB. Providers should obtain prior authorization when proposing an advanced/electronic KAFO (e.g., C-Brace) and document indication and justification because these devices are considered experimental/investigational for listed indications.
Affected code: L2006 (Knee-ankle-foot device with microprocessor control)
Reason: Listed as HCPCS not covered for indications in this CPB; considered experimental/investigational
Custom orthosis prior authorization considerations: Custom-fabricated and molded-to-patient-model orthoses require clear documentation of custom fabrication (materials and substantial fabrication steps) and an exact patient impression when a molded-to-patient model is used. Prior authorization is often required for custom orthoses to verify medical necessity and fabrication method.
Post-operative rehabilitative ankle braces (applied in relation to recent surgery)
purchase (post-operative rehabilitative braces applied within the postoperative period are considered part of surgical care and are treated as purchase)
Repairs to medically necessary orthoses due to wear and tear are considered medically necessary; replacement of complete device or component due to significant change in condition or irreparable wear is medically necessary when device remains indicated. Repair/replacement codes (L4002–L4210, etc.) are provided. No explicit rental vs purchase rule stated in these sections.
Off-the-shelf devices are reusable, do not require custom fitting, and are described as prefabricated; no explicit rental vs purchase rule stated, implied purchase of a reusable prefabricated item is appropriate.
Custom cast‑braces (hinged polypropylene cast-braces requiring impressions and orthotist fitting)
Require custom fitting by an orthotist (impression/fabrication); described as custom fabrication — no explicit rental vs purchase rule provided; custom fabrication implies direct provision (purchase) rather than rental in these notes.
Item
Rental vs Purchase / Replacement consideration
Pediatric stance-control KAFO (SCKAFO) — adjustable-length designs for young children
Children frequently require replacement due to growth; no explicit rental vs purchase rule provided in this excerpt — frequent replacement for growth is noted as a design consideration.
Item
Rental vs Purchase
Other items in excerpt
No rental/purchase rules present in this excerpt for these items — providers should refer to plan-specific billing guidance or full CPB for purchaser vs rental determinations.
Replacement & Repair
inv-65: Positioning AFO replacement interface; complete orthosis/components — replacement interface: 1 per 6 months; complete replacement when clinically indicated
Replacement interface allowanceUp to 1 replacement interface per 6 months for positioning AFOs when member continues to meet medical necessity criteria
Complete replacementReplacement of a complete orthosis or component is medically necessary when there is a significant change in condition or irreparable wear and the device remains medically necessary
Repair coverageRepairs due to wear and tear are considered medically necessary when needed to make the orthosis functional
inv-66: Various orthosis components
Component replacement codesReplacement and repair codes (e.g., L4002–L4210 series) are listed for straps, brims, laces, uprights and other components
Custom-only replacements
Documentation Requirements
Note
Note
Note
Note
Note
Note
Note
Not Covered / Experimental
Electronic KAFOs (for example, Sensor Walk and the C‑Brace Orthotronic Mobility System) are considered experimental and investigational due to insufficient evidence of improved ambulation compared with standard KAFOs. Prophylactic orthotics, sports‑only orthotics, and stabilizing shoes for ankle injuries are also listed among items not covered for the indications in this policy. In addition, take‑home tape and wrapping are not covered as DME.
Take‑home tape and wrapping are not covered as Durable Medical Equipment because they fail to meet durability and reusability requirements. In‑office taping or wrapping performed by a trained healthcare provider may be covered, but patients should not be billed for take‑home tape or wrapping as DME.
Use of HCPCS code L2999 to report the C‑Brace Orthotronic Mobility System is not covered under this policy. Providers should use the appropriate, covered HCPCS codes where applicable and be aware that claims billed with L2999 for the C‑Brace may be denied.
Background & Evidence
This Clinical Policy Bulletin defines medical necessity for ankle orthoses, AFOs, and KAFOs and distinguishes device use across clinical contexts — acute injury, rehabilitation, chronic instability, ambulatory versus non‑ambulatory patients, and custom versus prefabricated devices. It lists devices and uses considered experimental/investigational or not medically necessary (for example, electronic KAFOs, prophylactic/sports‑only orthotics, stabilizing shoes, semi‑rigid casting for prophylaxis, orthoplast stirrups for long‑term prophylaxis, and take‑home taping/wrapping). The policy also specifies documentation expectations (e.g., goniometer measurement of passive dorsiflexion, therapy/stretch program) and administrative details such as timing requirements for provision of prescribed orthoses and coding notes for specific HCPCS/ICD‑10 entries.
Definitions
inv-45: Medical necessity for orthosis/prosthesis — Orthosis (orthopedic brace) and/or prosthesis considered medically necessary when prescribed by qualified provider, will significantly im...
Prescription and qualificationsOrthosis or prosthesis must be prescribed by a physician, nurse practitioner, podiatrist, or other qualified prescriber per state law
Functional benefit requirementDevice must significantly improve or restore physical functions required for mobility-related activities of daily living
Timing and provider performanceDevice must be provided within six months of prescription and services by a duly licensed/certified orthotic/prosthetic provider
inv-46: Molded-to-patient model
DefinitionMolded-to-patient-model: custom-fabricated orthosis made from an impression (plaster or CAD-CAM) used to make a positive model and mold the orthosis
Indications for ambulatory members
Repair, Replacement & Codes
Item / Category
Notes on repair, replacement, rental/purchase
Orthoses and components (replacement straps, brims, laces, cuffs, uprights, bands, pretibial shells, repair labor, minor parts)
Repair of medically necessary orthotic devices for wear and tear is medically necessary; replacement when clinically indicated is medically necessary; replacement and repair HCPCS codes (L4002–L4210, L4205, L4210, etc.) are specified. The excerpt does not provide explicit rental vs purchase rules for these items.
Revision History
2023-07-28last_review
Clinical policy last reviewed.
2001-09-28effective_date
Policy originally became effective.
2024-06-13next_scheduled_reviewLatest
Next scheduled policy review date.
Policy Summary
PayerAetna
PolicyAnkle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs)
Policy CodePolicy 0565
Change TypeNo material changes
Effective Date09/28/2001
Next Review Date06/13/2024
Key ActionPrescribe orthosis/prosthesis by a qualified practitioner and document pre-treatment passive ROM, therapy program, and provision within six months.
Custom-molded AFOs/KAFOs are medically necessary when basic ambulatory medical necessity criteria are met AND one of: 1) condition is expected to be permanent or longstanding (>6 months); 2) need to control the knee, ankle or foot in more than one plane; 3) inability to be fitted with a prefabricated (off-the-shelf) AFO; 4) documented neurological, circulatory, or orthopedic status requiring custom fabrication over a model to prevent tissue injury; 5) healing fracture lacking normal anatomic integrity or anthropometric proportions.
Custom fabrication requires documentation of molding over a patient model and demonstration that prefabricated devices are not suitable.
Clinical indication contexts
Clinical uses informing medical necessity:
Potential indications: Primary clinical contexts include: prophylaxis (use primarily in patients with prior ankle injury), rehabilitation (first few weeks following injury), treatment of acute injury (beginning within about 3 days after injury), and treatment of chronic instability. Choice of device depends on stage and severity of injury and functional goals.
Duration and type of support depend on injury type, severity, and phase (acute swelling typically increases for ~3 days and may persist ~2 weeks).
Evidence-based considerations for advanced orthoses:
Advanced orthoses evidence summary: Microprocessor-controlled KAFOs (MPO), stance-control KAFOs (SCO), and energy-storing AFOs have shown benefits in selected patients: SCOs and MPOs may increase walking velocity and improve gait metrics versus locked KAFOs; MPOs improved gait speed, balance, endurance, quality-of-life measures, and reduced falls in a small crossover study (n=18); evidence quality varies and further research is needed.
Clinical benefit varies by patient characteristics; selection should be individualized and documented.
Evidence summaries relevant to medical necessity decisions
Clinical studies report benefits in specific populations; summarized findings may inform medical necessity determinations:
Microprocessor-controlled KAFO (MPO) outcomes: Randomized crossover and cohort studies report MPO use associated with improved self-selected gait speed, Berg Balance Scale, functional gait assessment, stair assessment index, increased 6MWT distance, improved OPUS and WHOQOL-BREF physical health scores, and fewer falls compared to SCO or locked KAFO in small studies (e.g., n=18).
Sample sizes are small; interpret in context of individual patient need and documentation.
threshold":"","note":"These findings support short-term functional benefits of AFOs after stroke but are not a substitute for individualized medical necessity documentation."}
Clinical guidance notes (informational) — device selection should be individualized and may consider gait classification based on quasi-joint stiffness (QJS).
AFO selection considerations: Select AFO type based on patient-specific gait pattern and ankle joint stiffness (QJS), level of lower-extremity motor control, presence of spasticity, and coexisting knee pathology. Reassess over time as the most appropriate device may change.
Guidance drawn from clinical practice guidelines and gait classification research; not payer-mandated criteria.
Care must be prescribed by a physician, nurse practitioner, podiatrist or other qualified prescriber per state law
Provider performanceOrthotic/prosthetic services must be performed by a duly licensed and/or certified orthotic/prosthetic provider
inv-19: Acute injury timing — Treatment of acute injury beginning within about 3 days following injury
Acute injury timingTreatment of acute ankle injury is defined as beginning within about 3 days following injury
Early swelling courseAnkle swelling increases for about 3 days post-injury with significant swelling persisting ~2 weeks
Taping roleTaping may be used for treatment of acute injury to provide support and help reduce edema during early phase
Include description of substantial work (cutting, bending, molding, sewing) and why prefabricated options are insufficient
Note
When Prior Authorization Is Not Specified
Prior authorization not specified in excerpt: Some parts of this CPB do not state explicit payer-level prior authorization requirements. When prior authorization is not specified, providers must follow plan-specific administrative rules and check benefit plan details.
If no prior authorization instruction is present in the CPB, verify with member plan or prior authorization portal before ordering
Keep documentation in the record showing verification of plan requirements
Prior Authorization
Prior Authorization — General Reminder
Prior authorization: Providers should assume prior authorization may be required for devices or services that are experimental/investigational, custom fabricated, or listed as not covered in HCPCS tables. Obtain authorization and retain approval documentation in the medical record to avoid claim denials.
Obtain prior authorization for experimental/innovative devices and custom-fabricated orthoses when indicated
Retain written prior authorization/approval documentation with the patient chart
Note
Prior Authorization and Administrative Resources
Prior authorization and administrative links: Providers should use the CPB’s administrative links (Clinical Policy Bulletin Notes, Review History, Definitions) and the payer’s prior authorization portals to confirm current prior authorization rules, codes, and submission requirements.
Check Clinical Policy Bulletin Notes and Review History links for updates
Use payer prior authorization portal or contact provider services for plan-specific rules
Denial Risk
Not-Covered Code Alerts
Not-covered specific code note: Certain HCPCS codes are explicitly listed as not covered for indications in this CPB. Submit requests with clear medical necessity rationale and confirm coverage before ordering.
Example not-covered code: L2006 (microprocessor-controlled KAFO) — listed as HCPCS not covered for CPB indications
Also verify use of miscellaneous codes (e.g., L2999) which may be denied if used for excluded systems
Documentation Required
Custom Fitting Requirement
Custom fitting requirement: Cast-braces, custom-fitted systems (e.g., Boston Ankle System), and molded-to-patient-model orthoses require proper impressions and orthotist involvement for fabrication and fine adjustment. Document orthotist credentials and fitting details.
Document exact impression method (plaster cast or CAD-CAM) and date
Document orthotist/prosthetist credentials (ABC, BOC, or state license) and that fine adjustments/fitting were performed
Note
Absent Provider Action Items
None specified in this excerpt: In places where the CPB provides no provider action items, there may still be plan-level administrative requirements. When in doubt, contact the payer.
Absence of a specified action in the CPB does not remove need to follow payer prior authorization or billing rules
Note
No Explicit Prior Authorization in CPB
No explicit authorization or prior authorization: The CPB does not always include explicit authorization instructions. Providers must verify authorization requirements through the payer’s administrative resources prior to providing devices.
Verify prior authorization requirements when CPB is silent
Document verification steps in the chart
Documentation Required
Fabrication Documentation
Fabrication documentation: Clearly document whether the orthosis is prefabricated, pre-fabricated but custom-fitted, or custom-fabricated. For custom devices, include materials, fabrication steps, and reason prefabricated options are inadequate.
State whether device is: prefabricated, prefabricated/custom-fitted, or custom-fabricated
Include fabrication details (materials, molding, trimming, assembly) and justification for custom fabrication
Documentation Required
Custom Device Fitting Documentation
Custom device fitting documentation: For custom-fitted systems (e.g., Boston Ankle System) document the exact impression, orthotist involvement, date of fitting, and any fine adjustments. Ensure fitting is not performed during acute swollen phase when applicable.
Record date and method of impression (plaster cast, CAD-CAM) and who performed it
Document orthotist adjustments and final fitting notes; avoid fitting during acute swelling when noted
Note
Background Evidence Recommendations
Background evidence reporting: When submitting requests for custom or experimental orthoses, include supporting evidence from the literature when available (e.g., systematic reviews, RCTs) especially for indications with limited or evolving evidence.
Include relevant study citations or summaries for support (e.g., rheumatoid arthritis orthosis evidence, AFO post-stroke reviews)
Note limitations of evidence and rationale for anticipated benefit in the individual patient
Documentation Required
Clinical Documentation Recommendations
Clinical documentation recommendations: Provide detailed physical examination findings (e.g., passive ROM with goniometer for plantar flexion contracture), functional limitations, therapy program details, and prior conservative treatments to support medical necessity.
Measure and document pre-treatment passive range of motion with a goniometer for contractures
Describe how the orthosis will improve MRADLs and document therapist/caregiver stretching program when applicable
Include functional assessments such as gait speed, ambulation status, and specific activity limitations
Note
Provider Responsibility Reminder
Providers are responsible for medical advice and treatment: Treating providers are solely responsible for member medical care decisions and must ensure documentation supports medical necessity. The CPB does not replace clinical judgment or plan-specific benefit rules.
Maintain complete medical record supporting the orthosis prescription and fitting
Use CPB guidance alongside clinical judgment and plan benefit terms
Billing Rule
Taping/Wrapping Coverage Limitation
Taping/wrapping coverage limitation: Aetna covers taping or wrapping when applied in-office by a healthcare provider but does not cover take-home tape or wrapping because it does not meet DME durability requirements.
Covered: Tape/wrapping applied by clinician in office
Not covered: Take-home tape or wrapping supplies
Documentation Required
Preference for Off-the-Shelf Devices When Appropriate
Use of off-the-shelf devices before custom: Prefabricated or less complex off-the-shelf options (lace-up braces, air-stirrups, prefabricated AFOs) should be considered first when clinically appropriate; document why they are insufficient if a custom device is requested.
Document trial and failure or inadequacy of prefabricated options before approving custom fabrication
Examples of prefabricated options: lace-up braces, air-stirrups, prefabricated static/dynamic AFOs
Step Therapy
Step Therapy and Prior Conservative Care
No step therapy mandates described: This CPB does not impose explicit step therapy mandates; however, documentation of prior conservative measures (e.g., bracing, physical therapy) strengthens the medical necessity case.
CPB does not list step therapy requirements as utilization controls
Document prior conservative treatments and response
Note
Device Selection Guidance
Device selection guidance: Device choice (AFO vs FES, prefabricated vs custom, KAFO vs AFO) should be individualized based on clinical response and documented functional benefits; when multiple options are reasonable, justify the selected device.
Document rationale for selecting a specific device and expected functional improvements
Reassess device effectiveness over time and document outcomes
Denial Risk
Claim Denial Risk — Billing Impact
Claim denial risk: Claims may be denied if documentation is insufficient, the device is experimental/not covered, or billing uses inappropriate codes. Verify coverage, use correct HCPCS codes, and ensure medical records support billing.
Avoid using miscellaneous codes without documentation of coverage rationale
Retain prior authorization and clinical documentation to reduce denial risk
Some replacement codes are specified 'for custom fabricated orthosis only' (e.g., molded thigh lacer, calf lacer)
Documentation for replacementReason for replacement (wear, growth, damage) and relation to original device should be documented
inv-67: Pediatric KAFO/SCKAFO
Pediatric growth considerationChildren frequently require replacement of pediatric SCKAFO/KAFO devices due to growth
Design adaption noteAdjustable-length/stanced-control designs aim to accommodate children aged 2–6 years to reduce replacement frequency
Replacement documentationDocument growth-related need for replacement when submitting claims
inv-68: Replacement placeholder
Replacement placeholderReplacement requests should reference appropriate repair/replacement HCPCS codes and clinical justification (wear, damage, growth, or condition change)
When clinically indicatedComplete device replacement is allowed when the device remains medically necessary and condition has significantly changed or device is irreparably worn
Supplier/provider notesProvide documentation linking replacement components to original device and prior fittings
Considered for ambulatory members when basic ambulatory criteria are met and at least one specific criterion (e.g., permanent condition >6 months, need to control >1 plane) applies
Fabrication requirementInvolves making an impression of the specific body part to produce a patient model for molding the orthosis
inv-47: Pre-fabricated (off-the-shelf) orthosis
DefinitionPre-fabricated (off-the-shelf) orthosis: manufactured in quantity without a specific patient in mind; may be trimmed, bent, or custom-fitted
Modifications allowedMay be trimmed, bent, molded (with or without heat), or assembled from pre-fabricated components; such modifications do not make it custom-fabricated
Preferred when appropriateAFOs are not considered medically necessary for ambulatory members who could be fitted with prefabricated AFOs instead of custom devices
inv-48: Custom-fabricated (custom-made) orthosis
DefinitionCustom-fabricated (custom-made) orthosis: individually made for a specific patient from basic materials and involving substantial work (cutting, bending, molding, sewing)
Includes molded-to-patientIncludes molded-to-patient-model orthoses made from impressions or CAD-CAM models
Fabrication thresholdMore than trimming or minor modification of a pre-fabricated item is required to qualify as custom-fabricated
inv-49: Ankle-foot orthosis (AFO)
DefinitionAnkle-foot orthosis (AFO): an orthosis that extends above the ankle (usually near top of calf) and is fastened around the lower leg above the ankle
DistinctionDistinct from foot orthotics (shoe inserts) which do not extend above the ankle
Non-ambulatory formsNon-ambulatory AFOs include ankle contracture splints and foot drop splints
inv-50: Knee-ankle-foot orthosis (KAFO)
DefinitionKnee-ankle-foot orthosis (KAFO): device whose below-knee components are same as an AFO but extends to the knee joint and thigh
Use caseKAFOs are indicated when additional knee stability is required beyond what an AFO provides
Custom moldingMolded-to-patient KAFOs follow custom-fabrication criteria for ambulatory members when indicated
inv-51: Static-dynamic AFO
DefinitionStatic-dynamic AFO: a pre-fabricated AFO that applies dorsiflexion force, accommodates plantar fasciitis or plantar flexion contracture up to 45°, has a soft interface, and is used by minimally ambulatory or non-ambulatory patients
Intended usersDesigned for patients who are minimally ambulatory or non-ambulatory
Clinical roleConsidered medically necessary when used as component of therapy program for contractures meeting criteria
inv-52: Foot drop splint
DefinitionFoot drop splint: a pre-fabricated recumbent positioning device designed to maintain the foot at 0° (perpendicular to lower leg) with a soft interface, not designed for ankles with plantar flexion contracture, used by non-ambulatory patients
Not for plantar flexion contractureNot designed to accommodate an ankle with a plantar flexion contracture
Intended settingUsed by non-ambulatory patients as a positioning device
inv-53: FES — Functional Electrical Stimulation as alternative intervention
FES as alternativeFunctional Electrical Stimulation (FES) is an alternative intervention to AFO for improving gait speed, mobility, and balance after stroke; choice may depend on individual response
Evidence baseClinical practice guideline and meta-analyses show both AFO and FES can increase gait speed and mobility; direct comparisons do not indicate overall superiority
Reassessment recommendedDevice appropriateness may change over time; reassessments should ensure the device continues to meet the individual's needs