Latest Review Date: September 2024

Category: Durable Medical Equipment (DME)                                                                    

POLICY:

Custom foot orthotics may be considered medically necessary for the following indications:

1. Adults (skeletally mature feet):

• Acute plantar fasciitis

• Calcaneal spurs (heel spurs)

• Calcaneal bursitis (acute or chronic)

• Neurologically impaired feet (e.g., neuroma; tarsal tunnel syndrome; ganglionic cyst; and neuropathies involving the feet, including those associated with peripheral vascular disease, diabetes, carcinoma, drugs, toxins, and chronic renal disease)

• Inflammatory conditions of the foot (e.g., sesamoiditis, submetatarsal bursitis, synovitis, tenosynovitis, synovial cyst, osteomyelitis, and plantar fascial fibromatosis)

• Acute sports-related injuries (e.g., diagnoses related to inflammatory problems, e.g., bursitis or tendonitis) of the foot

• Musculoskeletal/arthropathic deformities (e.g., deformities of the joint or skeleton that impair walking in a normal shoe, e.g., bunions, hallux valgus, talipes deformities, pes cavus, anomalies of toes) of the foot

• Vascular conditions (e.g., ulceration, poor circulation, peripheral vascular disease, Buerger’s disease or thromboangiitis obliterans, chronic thrombophlebitis) of the foot

2. Pediatrics/Children (skeletally immature feet):

• Torsional conditions (e.g., metatarsus adductus, tibial torsion, femoral torsion)

• Structural deformities (e.g., tarsal coalitions)

• Hallux valgus deformities

• In-toe or out-toe gait

• Musculoskeletal weakness (e.g., pronation, congenital pes planus, if the feet are skeletally immature)

3. The individual must have symptoms associated with the particular foot condition.

Foot orthotics are considered investigational for the following indications:

• Foot orthotic devices such as inserts that are available over the counter.
• Foot orthotic devices such as arch supports.
• Foot orthotics that are not ordered by the treating physician.
• Foot orthotics for pes planus (flat feet), corns, calluses, and hammertoes.
• Foot orthotics prescribed for foot conditions that do not cause symptoms.
• Foot orthotics prescribed for the treatment of symptoms in areas distant from the foot (e.g., back pain).

Orthopedic Shoes may be considered medically necessary for the following indications:

• Orthopedic shoes when an integral part of a covered leg brace, when medically necessary for the proper functioning of the leg brace; or

• Orthopedic shoes with supinator or pronator support for infants, children and juniors.

Orthopedic shoes are not a covered benefit for all other indications. 

Diabetic shoes/inserts (codes A5510, A5512, A5513) may be considered medically necessary in individuals with diabetes. The primary diagnosis should be diabetes and the secondary diagnosis should reflect the foot deformity that is present.

Spinal pelvic stabilizers, specialized custom molded inserts designed to prevent foot injuries and improve foot alignment are considered investigational due to their value in treatment of foot disease has not been proven.

Limitations of Coverage

Foot orthotics are limited to 2 pairs in a 24-month period.

Coverage of diabetic footwear and inserts is limited to one of the following within 365 days: 

• One pair of custom-molded shoes (including inserts provided with such shoes) and two additional pairs of inserts; OR

• One pair of depth shoes and three pairs of inserts (not including the non-customized removable inserts provided with such shoes).

* NOTE: There are varying benefit plans for these services. Please verify benefits prior to applying policy criteria, as benefits will supersede this policy.

DESCRIPTION OF PROCEDURE OR SERVICE:

Foot orthotics are mechanical devices which are placed inside the shoe or attached to the shoe to assist in restoring or maintaining normal alignment of the foot, relieve stress from strained or injured soft tissues, bony prominences, deformed bones and joints, and inflamed or chronic bursae.  The devices can be made of several different types of materials and are usually designed to the measurement, plaster models, and patterns of the foot and leg.  They may be available commercially or may be custom-made. All are concerned with improving foot function, controlling foot motion, reducing shock absorption and minimizing stress forces that could ultimately cause foot deformity and pain.

Foot orthotics may be accommodative or functional.  Accommodative foot orthoses are custom or non-custom inlays fabricated for the purpose of providing relief from callosities and pressure points, and maintaining the integrity of the longitudinal arch and/or the metatarsal heads.  Functional foot orthoses are foot plates fabricated from plaster molds of the feet or electronic (computer) imaging in a semi-weight bearing or non-weight bearing, neutral position, with corrections built in to prevent abnormal compensation during the gait cycle.

Depth shoes are defined, per CMS, as shoes that have a full length, heel-to-toe filler that, when removed, provides a minimum of 3/16 inch of additional depth used to accommodate custom-molded or customized inserts.  They are generally made from leather or other suitable material of equal quality, have some sort of shoe closure, and are available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width of the upper portions of the shoes according to the American standard last sizing schedule or its equivalent.  Inserts are total contact, multiple density, removable inlays that are directly molded to the patient’s foot and that are made of a suitable material with regard to the patient’s condition.

Orthopedic shoes are over the counter footwear (non-custom made and sometimes referred to as therapeutic shoes) designed to provide support and relieve pain and discomfort associated with common foot problems such as blisters, bunions, calluses and corns, hammer toes, plantar fasciitis or heel spurs.

Soft or Flexible Foot Orthotics

Soft or flexible foot orthotics are made from soft compressible materials, such as leather, cork, rubber, soft plastics or plastic foam (Spenco, PPT, Pelite). Many of these are commercially available and used for simple problems. Soft orthotics help to absorb shock, increase balance, and take pressure off uncomfortable or sore spots. They are worn against the sole of the foot and are usually fabricated in full length from heel to toe with increased thickness where weight bearing is indicated and relief where no or little pressure should occur. Plastic foam orthotics are available in different densities and thicknesses and are commonly used for ischemic, insensitive, ulcerated, and arthritic feet.

The advantage of any soft orthotic is that it may be easily adjusted to changing weight-bearing forces. The disadvantage is that it must be replaced more often than rigid orthotics. A soft orthotic is particularly effective for diabetes, the arthritides, and for grossly deformed feet where there is loss of protective fatty tissue on the side of the foot. Soft orthotics are also widely used in the care of healing ulcers in the insensitive foot.

Semi-rigid and Rigid Orthoses

Semi-rigid and rigid orthoses come in a variety of materials such as leather, cork and metals, but most commonly they are made of solid plastics (polymers or polymer composites), which allow minimal flexibility. These orthoses generally extend from the posterior end of the heel to the metatarsal heads (i.e., three-quarter length), and may have medial or lateral flanges. They are molded to provide support under the longitudinal arch and metatarsal area and to provide relief for painful or irritated areas.

Semi-rigid orthotics provide for dynamic balance of the foot while walking. The functional dynamic orthotic helps guide the foot through proper functions, allowing the muscles and tendons to perform more efficiently. The classic, semi-rigid orthotics constructed using laminations of leather and cork, reinforced by a material called Silastic. It may also be made of polymer composites.

Rigid Orthotics

Rigid orthotics are designed to control motion in 2 major foot joints, which lie directly below the ankle joint. They are made of a firm material such as plastic, leather, fiberglass or acrylic polymer. These devices are long-lasting, do not change shape, and are usually unbreakable. The most rigid orthoses (e.g., Whitman, Mayer, and Shaffer plates; Boston arch supports) are made of metal, usually steel or duralumin, and are covered with leather. The finished device normally extends along the sole of the heel to the ball or toes of the foot. It is worn mostly in closed shoes with a heel height under two inches. Strains, aches, and pains in the legs, thighs, and lower back may be due to abnormal function of the foot or a slight difference in the length of the legs.  In such cases, orthoses may improve or eliminate these symptoms which at first may seem only remotely connected to foot function.

KEY POINTS:

This evidence has been updated with a literature review using the PubMed database.  The most recent literature review was performed through September 1, 2024.

Summary of Evidence:

Foot orthotics, orthopedic shoes and diabetic shoes are standard of care for multiple health conditions. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

Journal of Neurological Physical Therapy (2021)

• Strong evidence exists that AFO and FES can each increase gait speed, mobility, and dynamic balance.
• Moderate evidence exists that AFO and FES increase quality of life, walking endurance, and muscle activation, and weak evidence exists for improving gait kinematics.
• AFO or FES should not be used to decrease plantar flexor spasticity. Studies that directly compare AFO and FES do not indicate overall superiority of one over the other. But evidence suggests that AFO may lead to more compensatory effects while FES may lead to more therapeutic effects.
• Due to the potential for gains at any phase post-stroke, the most appropriate device for an individual may change, and reassessments should be completed to ensure the device is meeting the individual's needs.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Foot orthotics, soft orthotics, semi-rigid orthotics, rigid orthotics, depth shoes, inserts, orthopedic shoes, therapeutic shoes, diabetic shoes

APPROVED BY GOVERNING BODIES:

Not applicable.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING:

HCPCS:     

REFERENCES:

1. American Diabetes Association. Preventive foot care in people with diabetes. Diabetes Care. 2000;23 Suppl 1:S55-S56.
2. Ashford RL, Kippen C, Rome K. Interventions for pes planus. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD005120. https://doi.org/10.1002/14651858.CD005120.
3. Daryabor A, Arazpour M, Aminian G. Effect of different designs of ankle-foot orthoses on gait in patients with stroke: A systematic review. Gait Posture. 2018;62:268-279.
4. Duerinck S, Swinnen E, Beyl P, et al. The added value of an actuated ankle-foot orthosis to restore normal gait function in patients with spinal cord injury: A systematic review. J Rehabil Med. 2012;44(4):299-309.
5. Gabriner ML, Braun BA, Houston MN, Hoch MC. The effectiveness of foot orthotics in improving postural control in individuals with chronic ankle instability: A critically appraised topic. J Sport Rehabil. 2015;24(1):68-71.
6. Gélis A, Coudeyre E, Hudry C, Pelissier J, Revel M, Rannou F. Is there an evidence-based efficacy for the use of foot orthotics in knee and hip osteoarthritis? Elaboration of French clinical practice guidelines. Joint Bone Spine. 2008;75(6):714-720. doi:10.1016/j.jbspin.2008.02.013
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Johnston TE, Keller S, Denzer-Weiler C, Brown L. A Clinical Practice Guideline for the Use of Ankle-Foot Orthoses and Functional Electrical Stimulation Post-Stroke. J Neurol Phys Ther. 2021;45(2):112-196. doi:10.1097/NPT.0000000000000347
9. Morris C, Bowers R, Ross K, et al. Orthotic management of cerebral palsy: Recommendations from a consensus conference. NeuroRehabilitation. 2011;28(1):37-46.
10. McDermott P, Wolfe E, Lowry C, et al. Evaluating the immediate effects of wearing foot orthotics in children with joint hypermobility syndrome (JHS) by analysis of temperospatial parameters of gait and dynamic balance: A preliminary study. Gait Posture. 2018;60:61-64.
11. National Institute for Health and Care Excellence (NICE). Diabetic foot problems: Prevention and management. London, UK: National Institute for Health and Care Excellence (NICE); August 26, 2015.
12. Riskowski J, Dufour AB, Hannan MT. Arthritis, foot pain and shoe wear: current musculoskeletal research on feet. Curr Opin Rheumatol. 2011;23(2):148-155. doi:10.1097/BOR.0b013e3283422cf5
13. Walther M, Kratschmer B, Verschl J, et al. Effect of different orthotic concepts as first line treatment of plantar fasciitis. Foot Ankle Surg. 2013;19(2):103-107.
14. Whittaker GA, Munteanu SE, Menz HB, et al. Foot orthoses for plantar heel pain: A systematic review and meta-analysis. Br J Sports Med. 2018;52(5):322-328.
15. Zhang B, Yu X, Liang L, et al. Is the wedged insole an effective treatment option when compared with a flat (placebo) insole: A systematic review and meta-analysis. Evid Based Complement Alternat Med. 2018;654107.

POLICY HISTORY:

Medical Policy Group, August 2006 (3)

Medical Policy Administration Committee, September 2006

Available for comment September 21-November 4, 2006

Medical Policy Group, November 2006 (3)

Medical Policy Administration Committee, January 2007

Available for comment December 20, 2006-February 2, 2007

Medical Policy Group, January 2008 (3)

Medical Policy Administration Committee, February 2008

Medical Policy Group, November 2008

Medical Policy Administration Committee, April 2009

Available for comment March 31-May 14, 2009

Medical Policy Group, November 2010 (1) No policy changes made at this time.

Medical Policy Group, June 2011; Updated Benefit Application

Medical Policy Administration Committee, June 2011

Medical Policy Group, May 2015 (6):  Updates to Title, Description, Policy Statement, Coding and References.  Added non-coverage statement for orthopedic shoes.

Medical Policy Administration Committee May 2015

Available for comment May 9 through June 22, 2015

Medical Policy Group, June 2015 (6):  Added Key Word and Codes A5500, A5501-A5508 to Coding Section only, no change to policy statement.

Medical Policy Group, December 2015 (6):  Clarification to policy statement regarding pes deformities; no change to policy intent.

Medical Policy Group, June 2018 (6): Updated coding section to include K0903; Removed old policy statement.

Medical Policy Group, October 2018 (6): Updates to Description and Key Points. Effective October 03, 2018:  Active Policy but no longer scheduled for regular literature reviews and updates

Medical Policy Group, December 2018: 2019 Annual Coding Update. Added  HCPCS code A5514 to the Current coding section. Moved HCPC code from Current coding section to Previous coding.  Created Previous coding section to include code K0903.

Medical Policy Group, August 2020 (6): Annual review, no change to policy intent. Updates to Key Points and References.

Medical Policy Group, August 2021 (6): Updates to Key Points and Coding.

Medical Policy Group, August 2022 (6): Updates to Description, Key Points, Current Coding, Practice Guidelines, USPSTF and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, September 2023 (6): Updates to Description, Key Points, Current Coding (+A9283, L3140/L3150/L3160/L3170), Practice Guidelines, Benefit Application and References.

Medical Policy Group, September 2024 (6): Updates to Key Points, Practice Guidelines and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.