Clinical UM Guideline

This document addresses orthopedic footwear including shoes, inserts, and modifications to shoes for individuals without diabetes.

Note: Please see the following related document for additional information:

• CG-DME-19 Therapeutic Shoes, Inserts, or Modifications for Individuals with Diabetes

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Medically Necessary:

Shoes, inserts, and modifications are considered medically necessary only in the limited circumstances described below:

1. Shoes are considered medically necessary if they are an integral part of a leg brace that is medically necessary.
2. Heel replacements, sole replacements and shoe transfers involving shoes on a medically necessary leg brace are also considered medically necessary.
3. Inserts and other shoe modifications (such as lifts, wedges, arch supports and other additions) are considered medically necessary if they are on a shoe that is an integral part of a medically necessary leg brace, if they are medically necessary for the proper functioning of the brace.
4. Prosthetic shoes are considered medically necessary if they are an integral part of a prosthesis for individuals with a partial foot amputation.

Not Medically Necessary:

Orthopedic footwear that does not meet the criteria above is considered not medically necessary.

A matching shoe that is not attached to a brace and items related to that shoe are considered not medically necessary.

Shoes are considered not medically necessary when they are put on over partial foot prosthesis or other lower extremity prosthesis that is attached to the residual limb by mechanisms other than being an integral part of the prosthesis.

This document describes clinical studies and expert recommendations and explains whether use of orthopedic footwear is clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Orthopedic footwear refers to special shoes, inserts, or changes made to shoes to help support the foot and leg and improve walking.

What the Studies Show

Some studies show that the right shoe can help a leg brace work better. For example, in people who had a stroke or children with cerebral palsy, certain shoe changes (like rocker-bottom soles) used with ankle-foot braces helped some people walk faster, use less energy, or have better balance.

Studies also show that the shoe a person wears can change how well a brace fits and works. Some braces make it hard to wear regular shoes, so shoe fit and style can affect whether people use the brace.

With prosthetic feet, shoes can change how the prosthetic works. Some shoes can make a prosthetic act more flexibly, which may change how it is used and how safe it is for someone who needs more support.

Overall, the evidence supports orthopedic footwear only when it is needed to help a leg brace or partial foot prosthesis works correctly. There is not enough proof that standard orthopedic shoes or inserts help people’s health when used alone.

When is Orthopedic Footwear Clinically Appropriate?

Orthopedic footwear (including shoes, inserts, or modifications) may be appropriate in these situations:

• The shoe is an integral part of a medically necessary leg brace
• Heel replacements, sole replacements, or shoe transfers are done for a shoe that is part of a medically necessary leg brace
• Inserts or shoe changes (such as lifts, wedges, or arch supports) are needed on a shoe that is part of a medically necessary leg brace and are needed for the brace to work correctly
• The shoe is an integral part of a prosthesis for someone with a partial foot amputation

When is this not Clinically Appropriate?

Orthopedic footwear is not appropriate in other situations. For example, a matching shoe that is not attached to a brace (and items related to that shoe) is not medically necessary. Shoes worn over a partial foot prosthesis or other lower-extremity prosthesis are also not medically necessary when they are not an integral part of the prosthesis.

(Return to Description)

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

Summary

Orthopedic footwear, when prescribed as part of an integrated leg brace or partial foot prosthesis, can influence gait, stability, and load distribution, but the available peer‑reviewed evidence for individuals without diabetes remains limited and heterogeneous. Studies consistently emphasize that shoes, inserts, and shoe modifications function as extensions of ankle-foot orthoses or prosthetic feet rather than stand‑alone treatments, supporting a narrow view of medical necessity when these elements are required for device performance. Evidence directly addressing heel or sole replacement or shoe transfers is sparse, yet related biomechanical and clinical data indicate that relatively small changes in rocker profile, heel height, or in‑shoe interfaces can materially alter brace or prosthetic function. Overall, the current literature aligns more closely with coverage boundaries that restrict orthopedic footwear, inserts, and modifications to scenarios in which they are integral to the safe and effective function of a medically necessary leg brace or partial foot prosthesis than with broad coverage of generic orthopedic footwear in populations without diabetes.

Discussion

A Medicare local coverage determination by CGS Administrators, LLC (CGS) for orthopedic footwear defines orthopedic footwear as items “utilized for the alignment, support, prevention, or correction of deformities or to improve the function of movable parts of the body” and limits medical necessity to situations where the footwear “is reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member” (CGS, 2020).

Rocker-Sole Shoe Modifications Improve Ankle-Foot Orthosis Function but Do Not Restore Push-Off

Rocker-sole modifications to shoes worn with an ankle-foot orthosis (AFO) consistently improve functional mobility and reduce energy expenditure in individuals with poststroke hemiplegia, though the biomechanical benefit is specific to facilitating forefoot rollover rather than restoring active push-off. Two randomized controlled trials independently confirmed this pattern using the same rocker geometry (a forefoot rocker starting at 65% of shoe length at a 15-degree angle) paired with different AFO designs.

A 2016 study randomized 30 individuals with chronic stroke (mean age 59.3 years; mean 29.1 months poststroke; Modified Ashworth Scale score of 3) to receive either standard flat-soled shoes (n=15) or forefoot rocker shoes (n=15) for use with a prefabricated solid polypropylene AFO (Farmani, 2016). Standard shoes produced no statistically significant improvement in any outcome compared to AFO use alone. The addition of rocker shoes, by contrast, significantly improved preferred walking speed (0.71 vs. 0.60 m/s; p=0.005), Timed Up and Go (TUG) performance (18.25 vs. 24.41 seconds; p=0.032), and oxygen cost (0.42 vs. 0.51 mL/kg/m; p=0.031). Between-group comparisons showed that rocker shoes were significantly superior to standard shoes for walking speed (p=0.021), TUG (p=0.043), and energy expenditure (p=0.039). The finding that a standard flat shoe added nothing to AFO function while a rocker-modified shoe produced significant gains establishes that the shoe modification, not the shoe itself, is the functional intervention.

Daryabor and colleagues (2021) extended this finding by evaluating whether the rocker shoe effect varied by AFO joint design. For 20 individuals with chronic stroke randomized to an AFO with plantar flexion stop (AFO-PlfS; n=10) or plantar flexion resistance (AFO-PlfR; n=10), three-dimensional gait analysis showed a significant orthotic effect in both groups for spatiotemporal parameters and maximum ankle dorsiflexion in the single-support phase. Adding a toe-only rocker shoe to either AFO type significantly reduced peak ankle plantar flexor moment during pre-swing (interaction p=0.003) and peak ankle power generation during pre-swing. However, this reduction reflects facilitated rollover for weight progression rather than enhanced push-off, as walking speed, proximal joint kinetics, and center-of-mass displacement did not significantly change with the rocker shoe. The authors concluded that rocker shoes should be prescribed cautiously in stroke survivors, as they facilitate the forefoot rocker of gait without producing a strong push-off function.

Collectively, these trials demonstrate that the type of shoe worn with an AFO materially affects whether the orthotic system achieves its therapeutic objectives. A rigid AFO paired with a flat shoe fails to improve function beyond the brace alone; the same AFO paired with a rocker-modified shoe produces statistically significant and clinically meaningful gains in gait speed, functional mobility, and metabolic efficiency.

Individualized Footwear Design Is Integral to Ankle-Foot Orthosis Function Across Populations

Evidence across populations, including children with cerebral palsy, adults poststroke, and healthy individuals, demonstrates that footwear must be individually designed and, in many cases, iteratively modified as part of the AFO system to achieve optimal biomechanical alignment and clinical outcomes. The strongest randomized evidence and the foundational biomechanical proof-of-concept evidence each contribute a distinct facet of this principle.

In a randomized trial of 19 children with bilateral spastic cerebral palsy (mean age 6 years 11 months; Gross Motor Function Classification System levels II [n=15] and III [n=4]), Bjornson (2024) compared ankle-foot orthosis-footwear combinations with individualized alignment and footwear designs (AFO-FC/IAFD; n=9) against the same rigid AFO with non-individualized alignment and footwear designs (AFO-FC/NAFD; n=10). The individualized intervention included shoe modifications such as internally or externally adjusted sole profiles to optimize shank-to-vertical angle in static standing and timing of heel-off at terminal stance, as well as leg-length-discrepancy corrections through shoe lifts. After 3 months of wear, the individualized group demonstrated significantly greater improvement on the Pediatric Balance Scale total score (mean change +15.6 [standard deviation (SD) 6.5] vs. +4.3 [SD 5.5]; p=0.004), the dynamic subscale (+8.8 [SD 3.8] vs. +3.5 [SD 4.2]; p=0.009), and the static subscale (+5.1 [SD 6.9] vs. +0.6 [SD 3.2]; p=0.04). Parent-reported gait priorities on the Gait Outcomes Assessment List also improved significantly more in the individualized group (total score change +7.9 [SD 9.2] vs. -0.4 [SD 5.5]; p=0.03). The individualized group’s balance improvement exceeded twice the published minimal clinically important difference of 5.8 points; the non-individualized group’s change did not reach the threshold. Because both groups received the same rigid AFO design and the same brand of shoe, the between-group difference is attributable to the shoe modifications and alignment individualization.

The biomechanical necessity of integral footwear was demonstrated by researchers who designed an experimental carbon composite AFO-footwear combination (exAFO-FC) to constrain ankle motion to less than 5 degrees of combined plantar flexion and dorsiflexion (Hovorka, 2021). A conventional thermoplastic solid AFO failed under quasi-static loading at physiological force levels (140 Nm dorsiflexor moment) in cadaveric limbs (n=2), whereas the carbon composite AFO achieved the motion threshold. In a subsequent gait study with 14 healthy individuals, the exAFO-FC in the maximum-restriction condition limited ankle range of motion to 3.7 degrees (SD 2.1) compared to 27.7 degrees (SD 4.2) without the orthosis (p<0.001). The footwear component, consisting of custom shoes with a 4-zone rocker sole profile designed to preserve rollover dynamics, was essential to maintaining forward progression despite near-total ankle constraint. No significant differences in contralateral ankle motion or moments were observed across conditions, indicating that the integrated footwear prevented compensatory gait adaptations that would otherwise result from ankle immobilization. The authors concluded that ankle motion control is most effective when considered as a relationship between the brace, the ankle-foot complex, and the external forces affecting both, and recommended footwear that laces tight over the dorsum of the foot to enhance brace leverage.

Ankle-Foot Orthosis Design Constrains Footwear Options

The practical relationship between AFO design and footwear accommodation was examined in a randomized crossover trial (Highsmith, 2024), which compared conventional thermoplastic AFOs with advanced carbon-fiber energy-storing AFOs in 58 community ambulators with lower-extremity conditions (mean age 52.3 years; etiologies: 64% neurologic injury, 17% foot drop, 11% trauma). Although the study focused on AFO design rather than footwear, it noted that approximately 41% of individuals using conventional AFOs were unable to wear their preferred shoes, whereas a greater proportion could do so with the advanced AFO, suggesting improved real-world usability. On objective mobility measures, the two AFO types did not differ significantly on the TUG or 2-minute walk test. However, individuals reported significantly lower perceived exertion with the advanced AFO (Borg Rating of Perceived Exertion 10.8 vs. 11.7; p=0.015) and fewer self-reported mobility problems on the EuroQol 5-Dimension (EQ-5D) mobility subscale (p=0.037), and 80% preferred the advanced AFO for long-term use (Fisher’s exact test p<0.0001). The footwear compatibility finding, though not the primary study outcome, underscores that AFO design directly constrains footwear options and that the brace-shoe interface is a clinically relevant variable affecting both device utilization and individual preference.

Footwear Alters Prosthetic Foot Mechanical Properties and May Change Functional Classification

Shoes worn with a prosthetic foot do not merely enclose the device; they materially alter its mechanical behavior in ways that can change the prosthesis’s functional classification and, by extension, its clinical appropriateness and reimbursement category. Major and colleagues (2018) quantified this effect in a bench study testing 5 prosthetic feet (the Cadence [high-activity dynamic], Lightfoot [moderate-activity dynamic], Multiflex [low-activity articulated], solid ankle cushioned heel [SACH; low-activity nonarticulated], and Single-axis [low-activity articulated], all sized for an 80-kg individual with a 27-cm foot length) across 5 footwear conditions (barefoot, trainer, hiking boot, leather dress shoe, and flat shoe). The addition of footwear reduced energy return by an average of 6.1% at the heel and 8.0% at midstance across all prosthetic feet. Average stiffness decreased by 13.7 N/mm across all conditions, with the trainer and hiking boot producing the largest changes. Displacement increased by an average of 4.1 mm at the heel.

The clinical significance of these mechanical changes extends beyond biomechanics to device classification. A total of 3 low-mobility prosthetic feet (Multiflex, SACH, and Single-axis) maintained rigid keel classifications according to American Orthotic and Prosthetic Association (AOPA) guidelines when tested barefoot but exceeded the 25-mm displacement threshold to qualify as flexible when combined with a trainer or hiking boot. The Single-axis heel classification changed from cushioned (barefoot and flat shoe) to dynamic when combined with a hiking boot, leather dress shoe, and trainer. These reclassifications have direct implications for healthcare reimbursement policy, as prosthetic feet are prescribed based on functional classifications that assume testing without footwear. The authors emphasized that shoes may also compromise safety-relevant design features: articulated feet intended for low-mobility individuals lost their characteristic rapid transition to foot-flat when shoes were added, a function specifically engineered to provide perceived stability in a population with elevated fall risk.

Clinical Practice Guidelines

No clinical practice guidelines were identified that specifically address orthopedic footwear for populations without diabetes within the four coverage scenarios under review.

Peer Reviewed Publications:

1. Bjornson KF, Fatone S, Orendurff M, et al. Individualized orthotic alignment and footwear for balance and mobility in children with bilateral spastic cerebral palsy: a randomized trial. Dev Med Child Neurol. 2024; 66(1):52-60.
2. Daryabor A, Aminian G, Arazpour M, et al. The effects of ankle-foot orthoses with plantar flexion stop and plantar flexion resistance using rocker-sole shoes on stroke gait: a randomized-controlled trial. Turk J Phys Med Rehabil. 2021; 67(4):449-461.
3. Farmani F, Mohseni Bandpei MA, Bahramizadeh M, et al. The effect of different shoes on functional mobility and energy expenditure in post-stroke hemiplegic patients using ankle-foot orthosis. Prosthet Orthot Int. 2016; 40(5):591-597.
4. Highsmith MJ, Miro RM, Kartel M, et al. Functional and perceptive differences between conventional and advanced ankle foot orthoses in community ambulators post-limb trauma: the injuries managed with advanced bracing of the lower extremity (IM ABLE) study. Front Rehabil Sci. 2024; 5:1277509.
5. Hovorka CF, Kogler GF, Chang Y-H, et al. Material properties and application of biomechanical principles provide significant motion control performance in experimental ankle foot orthosis-footwear combination. Clin Biomech (Bristol). 2021; 82:105285.
6. Major MJ, Scham J, Orendurff M. The effects of common footwear on stance-phase mechanical properties of the prosthetic foot-shoe system. Prosthet Orthot Int. 2018; 42(2):198-207.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD): Durable medical equipment reference list. NCD #280.1. Effective June 9, 2025. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=190. Accessed on March 6, 2026.
2. CGS Administrators, LLC. Jurisdictions B and C. Local Coverage Determination for Orthopedic Footwear (L33641). Revised 01/01/2020. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33641. Accessed on March 6, 2026.

Orthopedic Footwear

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