The Carelon Clinical Appropriateness Guidelines (hereinafter “the Carelon Clinical Appropriateness Guidelines” or the “Guidelines”) are designed to assist providers in making the most appropriate treatment decision for a specific clinical condition for an individual. The Guidelines establish objective and evidence-based criteria for medical necessity determinations, where possible, that can be used in support of the following:

To establish criteria for when services are medically necessary
To assist the practitioner as an educational tool
To encourage standardization of medical practice patterns
To curtail the performance of inappropriate and/or duplicate services
To address patient safety concerns
To enhance the quality of health care
To promote the most efficient and cost-effective use of services

The Carelon guideline development process complies with applicable accreditation and legal standards, including the requirement that the Guidelines be developed with involvement from appropriate providers with current clinical expertise relevant to the Guidelines under review and be based on the most up-to-date clinical principles and best practices. Resources reviewed include widely used treatment guidelines, randomized controlled trials or prospective cohort studies, and large systematic reviews or meta-analyses. Carelon reviews all of its Guidelines at least annually.

Carelon makes its Guidelines publicly available on its website. Copies of the Guidelines are also available upon oral or written request. Additional details, such as summaries of evidence, a list of the sources of evidence, and an explanation of the rationale that supports the adoption of the Guidelines, are included in each guideline document.

Although the Guidelines are publicly available, Carelon considers the Guidelines to be important, proprietary information of Carelon, which cannot be sold, assigned, leased, licensed, reproduced or distributed without the written consent of Carelon. Use of the Guidelines by any external AI entity without the express written permission of Carelon is prohibited.

Carelon applies objective and evidence-based criteria, and takes individual circumstances and the local delivery system into account when determining the medical appropriateness of health care services. The Carelon Guidelines are just guidelines for the provision of specialty health services. These criteria are designed to guide both providers and reviewers to the most appropriate services based on a patient’s unique circumstances. In all cases, clinical judgment consistent with the standards of good medical practice should be used when applying the Guidelines. Guideline determinations are made based on the information provided at the time of the request. It is expected that medical necessity decisions may change as new information is provided or based on unique aspects of the patient’s condition. The treating clinician has final authority and responsibility for treatment decisions regarding the care of the patient and for justifying and demonstrating the existence of medical necessity for the requested service. The Guidelines are not a substitute for the experience and judgment of a physician or other health care professionals. Any clinician seeking to apply or consult the Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment.

The Guidelines do not address coverage, benefit or other plan specific issues. Applicable federal and state coverage mandates take precedence over these clinical guidelines, and in the case of reviews for Medicare Advantage Plans, the Guidelines are only applied where there are not fully established CMS criteria. If requested by a health plan, Carelon will review requests based on health plan medical policy/guidelines in lieu of the Carelon Guidelines. Pharmaceuticals, radiotracers, or medical devices used in any of the diagnostic or therapeutic interventions listed in the Guidelines must be FDA approved or conditionally approved for the intended use. However, use of an FDA-approved or conditionally approved product does not constitute medical necessity or guarantee reimbursement by the respective health plan.

The Guidelines may also be used by the health plan or by Carelon for purposes of provider education, or to review the medical necessity of services by any provider who has been notified of the need for medical necessity review, due to billing practices or claims that are not consistent with other providers in terms of frequency or some other manner.

General Clinical Guideline

Clinical Appropriateness Framework

Critical to any finding of clinical appropriateness under the guidelines for a specific diagnostic or therapeutic intervention are the following elements:

Prior to any intervention, it is essential that the clinician confirm the diagnosis or establish its pretest likelihood based on a complete evaluation of the patient. This includes a history and physical examination and, where applicable, a review of relevant laboratory studies, diagnostic testing, and response to prior therapeutic intervention.
The anticipated benefit of the recommended intervention is likely to outweigh any potential harms, including delay or decreased access to services that may result (net benefit). Unless specifically stated, elective surgery with an infection or open wound at or near a surgical site would be potential harm to a patient.
Widely used treatment guidelines, current clinical literature, and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.
There exists a reasonable likelihood that the intervention will lead to an improved health status for the patient.
The requested intervention should match the intended treatment plan in the medical record.

Providers may be required to submit clinical documentation supporting a request for services. Such documentation must a) accurately reflect the clinical situation at the time of the requested service, and b) sufficiently document the ordering provider’s clinical intent.

If these elements are not established with respect to a given request, the determination of appropriateness will most likely require a peer-to-peer conversation to understand the individual and unique facts that would justify a finding of clinical appropriateness. During the peer-to-peer conversation, factors such as patient acuity and setting of service may also be considered to the extent permitted by law.

If a surgeon performs an authorized surgery and intraoperatively finds it necessary to perform a procedure that was not previously authorized, the surgeon may submit a request for authorization post-service. The necessity for the procedure should be well documented in the operative report and submitted in a timely manner for appropriate review and coverage.

Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions

Requests for multiple diagnostic or therapeutic interventions at the same time will often require a peer-to-peer conversation to understand the individual circumstances that support the medical necessity of performing all interventions simultaneously. This is based on the fact that appropriateness of additional intervention is often dependent on the outcome of the initial intervention.

Additionally, either of the following may apply:

Current literature and/or standards of medical practice support that one of the requested diagnostic or therapeutic interventions is more appropriate in the clinical situation presented; or
One of the diagnostic or therapeutic interventions requested is more likely to improve patient outcomes based on current literature and/or standards of medical practice.

Repeat Diagnostic Intervention

In general, repeated testing of the same anatomic location for the same indication should be limited to evaluation following an intervention, or when there is a change in clinical status such that additional testing is required to determine next steps in management. At times, it may be necessary to repeat a test using different techniques or protocols to clarify a finding or result of the original study.

Repeated testing for the same indication using the same or similar technology may be subject to additional review or require peer-to-peer conversation in the following scenarios:

Repeated diagnostic testing at the same facility due to technical issues
Repeated diagnostic testing requested at a different facility due to provider preference or quality concerns
Repeated diagnostic testing of the same anatomic area based on persistent symptoms with no clinical change, treatment, or intervention since the previous study
Repeated diagnostic testing of the same anatomic area by different providers for the same member over a short period of time

Repeat Therapeutic Intervention

In general, repeated therapeutic intervention in the same anatomic area is considered appropriate when the prior intervention proved effective or beneficial, and the expected duration of relief has lapsed. A repeated request for a therapeutic intervention during the active authorization period for a prior request is not appropriate unless it can be confirmed that the prior intervention was never administered. Requests for ongoing services may depend on completion of previously authorized services in situations where a patient’s response to authorized services is relevant to a determination of clinical appropriateness.

Small Joint Surgery of the Foot and Ankle

General Requirements and Documentation

The following general requirements apply to all indications except where they differ from the specific requirements. The specific requirements take precedence over any stated general requirement.

These guidelines address foot and ankle procedures when performed on an elective, non-emergent basis and not as part of the care of an acute fracture.

The terms in the section provide operational definitions when they are referenced as requirements in the guideline.

Documentation supporting medical necessity and a clearly stated plan of care should be submitted at the time of the request and must include the following components:

Clinical notes describing symptom duration and severity, specific functional limitations related to symptoms, and type and duration of all therapeutic measures provided. If conservative management is not appropriate, the reason must be clearly documented.

Conservative management offered by the provider or other health professionals for this condition(s) should include footwear modification and/or padding/accommodative devices (e.g., foot orthosis) AND at least one of the following complementary strategies to reduce inflammation, alleviate pain, and improve function. The duration of conservative management and/or symptoms should generally be for at least 12 weeks for chronic conditions. Shorter duration of conservative management may be appropriate for severe impacts on activities of daily living (ADLs).

Activity modification
Anti-inflammatory medications and analgesics
Corticosteroid injection(s)
Debridement of associated hyperkeratotic lesions, such as corns or calluses

Documentation of compliance with a plan of therapy that includes elements from these areas is required where conservative management is appropriate.

If conservative management is not appropriate, the medical record must clearly document why such an approach is not reasonable.

Reporting symptom severity – Severity of pain and its impact on function are key factors in determining the need for intervention. For this guideline’s purposes, significant pain and functional impairment refer to pain rated at least 3 on the VAS scale and associated with difficulty performing daily activities, such as walking and wearing reasonable shoes.

Imaging report – The provider shall submit a detailed imaging report for studies obtained within the past 12 months. In the absence of a detailed report, the provider may submit a report from an independent radiologist. The results of all imaging studies should correlate with the clinical findings in support of the requested procedure. Where applicable, radiographic imaging must include weight-bearing anterior-posterior and lateral views of the affected foot.

Imaging reports should describe the presence or absence of subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, or avascular necrosis. The degree of joint space narrowing should also be noted. Where applicable, the requesting provider should measure and record the key angular deformity indices in the medical record.

General Recommendations

Tobacco cessation – Adherence to a tobacco cessation program resulting in abstinence from tobacco and nicotine products for at least 6 weeks prior to surgery is strongly recommended.

Diabetes – It is strongly recommended that a patient with a history of diabetes maintain a hemoglobin A1C of 8% or less prior to surgery.

Body Mass Index (BMI) – It is strongly recommended that a patient with a BMI equal to or greater than 40 attempt weight reduction prior to surgery.

Where there are patient-specific modifiable comorbidities that may adversely impact patient reported outcomes or the health status of the patient, a shared decision-making process to discuss these modifiable comorbidities with the patient is strongly recommended and should be documented.

Hallux Rigidus Surgery

Description and Scope

This guideline addresses surgery for hallux rigidus when performed as an elective, non-emergent procedure.

Hallux rigidus is a painful arthritis of the first metatarsophalangeal (MTP) joint, which can cause stiffness and progressive loss of motion. It is the most common arthritic condition of the foot. The first MTP joint develops progressive degenerative changes resulting in pain, inflammation, and limited motion. The condition is more prevalent in females than males and has an average age of onset of about 50 years. Over 95% of patients have it bilaterally and two thirds have a positive family history.

A variety of scales have been used to grade the severity of hallux rigidus, although the scales proposed by Hattrup and Johnson and Coughlin and Shurnas are most common. For the purposes of interpretation of this guideline, either scale can be used (see Table 1) to determine whether hallux rigidus is mild, moderate or severe. Radiographic confirmation of hallux rigidus must include weight-bearing anterior-posterior (ap) and lateral view of the affected foot.

Table 1. Grading Scales for Hallux Rigidus

Radiographic	Clinical	Qualitative	Hattrup and Johnson¹	Coughlin and Shurnas²
No radiographic evidence for osteoarthritis	No pain +/- mild stiffness		–	0
Mild-to-moderate osteophyte formation with no joint space involvement	Mild pain maximal with flexion, mild stiffness	Mild	I	1
Moderate osteophyte formation and joint space narrowing; subchondral sclerosis	Moderate-to-severe pain constant at the extremes of motion, moderate-to-severe stiffness	Moderate	II	2
Marked osteophyte formation and loss of the joint space, cystic changes with or without subchondral sclerosis	Nearly constant pain (3), pain throughout the range of motion (including midrange) (4)	Severe	III	3 or 4

1. Hattrup SJ, Johnson KA. Subjective results of hallux rigidus following treatment with cheilectomy. Clin Orthop Relat Res. 1988(226):182-91.

2. Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am. 2003;85(11):2072-88.

After non-surgical intervention, a variety of surgical interventions are available to treat hallux rigidus. Cheilectomy involves removal of excess osteophytes and is done to alleviate osseous impaction of the proximal phalanx and metatarsal head through debridement of the articulating joints. Arthrodesis is the most common treatment for patients with advanced hallux rigidus but carries additional risks including the potential for loss of foot function and joint motion, diminished gait efficiency, failure of fixation, nonunion, and transfer metatarsalgia. Alternatives include resection arthroplasty. More recently, implant arthroplasty of the first MTP joint has been proposed as an alternative to arthrodesis for more advanced hallux rigidus as a way of restoring joint motion.

Clinical Indications

Hallux Rigidus Surgery

Surgery for hallux rigidus (including cheilectomy or osteotomy) is considered medically necessary in skeletally mature patients when ALL the following criteria are met:

Mild/moderate hallux rigidus confirmed by radiography with EITHER of the following:
- Limited and/or painful range of motion of the first metatarsophalangeal (MTP) joint
- Activity limiting pain referrable to the first MTP joint
Persistent significant pain and functional impairment of the first MTP joint despite 12 weeks of conservative management OR nonhealing ulcer on the dorsum of the great toe
Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)

First Metatarsophalangeal Joint Arthrodesis

First metatarsophalangeal (MTP) joint arthrodesis is considered medically necessary in skeletally mature patients when ALL the following criteria are met:

Limited and/or painful range of motion first MTP joint
Significant pain and functional impairment of the first MTP joint
Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)
Presence of ONE of the following:
- Severe hallux rigidus confirmed by radiography
- Failed prior hallux valgus/rigidus surgery

First Metatarsophalangeal Joint Arthroplasty

First metatarsophalangeal (MTP) joint arthroplasty is considered medically necessary in skeletally mature patients when ALL the following criteria are met:

ONE of the following implant types* will be used:
- Total prosthetic replacement arthroplasty with double stemmed silastic implants only
- Metallic hemiarthroplasty (metatarsal or phalangeal based)
Limited and/or painful range of motion of the first MTP joint
Significant pain and functional impairment of the first MTP joint
Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)
Presence of ONE of the following:
- Severe hallux rigidus** confirmed by radiography
- Failed prior hallux rigidus surgery

*See Exclusions for a list of excluded implants.

**Resection arthroplasty is an alternative to arthrodesis.

Contraindications

All Hallux Rigidus Procedures

Active infection of the joint
Active systemic bacteremia
Active skin infection at or near the surgical site
Inadequate bone stock for osteotomy or arthrodesis
Inadequate vascular perfusion to the foot

Exclusions

Indications other than those addressed in this guideline are considered not medically necessary including, but not limited to, the following:

Asymptomatic hallux rigidus
Surgical intervention solely for the purposes of improved cosmesis
Implant arthroplasty with ANY of the following:
- Ceramic prosthesis including, but not limited to, Moje implant
- Modular implants including, but not limited to:
  - Metis^® prosthesis
  - OsteoMed ReFlexion 1st MTP Implant System
  - ToeMotion with/without HemiCAP^® Implant
  - Toefit-Plus™ prosthesis
- Molded cylindrical implants including, but not limited to, Cartiva^® Implant
- Bioabsorbable implants including, but not limited to, bioabsorbable poly-L-D-lactic acid RegJoint^® inter-positional implant
Metatarsophalangeal joint arthroplasty for any other indications not included here
Charcot neuroarthropathy

References

Baumhauer JF, Singh D, Glazebrook M, et al. Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus. Foot & ankle international. 2016;37(5):457-69.
Brewster M. Does total joint replacement or arthrodesis of the first metatarsophalangeal joint yield better functional results? A systematic review of the literature. J Foot Ankle Surg. 2010;49(6):546-52.
Coughlin MJ, Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. J Bone Joint Surg Am. 2003;85(11):2072-88.
de Bot RV, H. D.;Eurlings, R.;Stevens, J.;Hermus, J. P. S.;Witlox, A. M. Metallic hemiarthroplasty or arthrodesis of the first metatarsophalangeal joint as treatment for hallux rigidus: A systematic review and meta-analysis. J Foot Ankle Surg. 2021;11:11.
Gibson JN, Thomson CE. Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial. Foot Ankle Int. 2005;26(9):680-90.
Glazebrook M, Blundell CM, O’Dowd D, et al. Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus. Foot Ankle Int. 2019;40(4):374-83.
Glazebrook M, Younger ASE, Daniels TR, et al. Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: A comparison of operative and recovery time. J Foot Ankle Surg. 2018;24(5):440-7.
Goldberg A, Singh D, Glazebrook M, et al. Association Between Patient Factors and Outcome of Synthetic Cartilage Implant Hemiarthroplasty vs First Metatarsophalangeal Joint Arthrodesis in Advanced Hallux Rigidus. Foot Ankle Int. 2017;38(11):1199-206.
Hattrup SJ, Johnson KA. Subjective results of hallux rigidus following treatment with cheilectomy. Clin Orthop Relat Res. 1988(226):182-91.
Kilmartin TE. Phalangeal osteotomy versus first metatarsal decompression osteotomy for the surgical treatment of hallux rigidus: a prospective study of age-matched and condition-matched patients. J Foot Ankle Surg. 2005;44(1):2-12.
Maffulli N, Papalia R, Palumbo A, et al. Quantitative review of operative management of hallux rigidus. Br Med Bull. 2011;98:75-98.
Mao DW, Zheng C, Amatullah NN, et al. Salvage arthrodesis for failed first metatarsophalangeal joint arthroplasty: A network meta-analysis. J Foot Ankle Surg. 2020;26(6):614-23.
Park YH, Jung JH, Kang SH, et al. Implant Arthroplasty versus Arthrodesis for the Treatment of Advanced Hallux Rigidus: A Meta-analysis of Comparative Studies. J Foot Ankle Surg. 2019;58(1):137-43.
Patel HA, Kalra R, Johnson JL, et al. Is interposition arthroplasty a viable option for treatment of moderate to severe hallux rigidus? – A systematic review and meta-analysis. J Foot Ankle Surg. 2019;25(5):571-9.
Roukis TS. Clinical outcomes after isolated periarticular osteotomies of the first metatarsal for hallux rigidus: a systematic review. J Foot Ankle Surg. 2010;49(6):553-60.
Roukis TS. Outcomes after cheilectomy with phalangeal dorsiflexory osteotomy for hallux rigidus: a systematic review. J Foot Ankle Surg. 2010;49(5):479-87.
Smyth NA, Murawski CD, Hannon CP, et al. The Use of a Synthetic Cartilage Implant for Hallux Rigidus: A Systematic Review. Foot ankle spec. 2020:1938640020937160.
So E, Wilson MD, Chu AK, et al. Incidence of Nonunion of the Hallux Interphalangeal Joint Arthrodesis: A Systematic Review. J Foot Ankle Surg. 2018;57(4):776-80.
Stevens J, de Bot R, Hermus JPS, et al. Clinical Outcome Following Total Joint Replacement and Arthrodesis for Hallux Rigidus: A Systematic Review. JBJS rev. 2017;5(11):e2.
Stone OD, Ray R, Thomson CE, et al. Long-Term Follow-up of Arthrodesis vs Total Joint Arthroplasty for Hallux Rigidus. Foot Ankle Int. 2017;38(4):375-80.

Hallux Valgus and Bunionette Surgery

Description and Scope

This guideline addresses surgery for hallux valgus when performed as an elective, non-emergent procedure.

Hallux valgus is a common deformity of the first ray (great toe) characterized by a lateral deviation of the proximal phalanx at the level of the metatarsal joint. It is frequently associated with a concomitant medial (varus) deviation of the first metatarsal. The result is a bony prominence or “bump” on the medial side of the first metatarsophalangeal joint. This is often referred to as a “bunion” and may be associated with soft tissue swelling and pain. In addition, the articular surface of the first metatarsal may have a valgus (lateral) inclination also contributing to the deformity. As the deformity progresses, the sesamoid complex will shift laterally aided by the deforming force of the adductor tendon and the lateral capsule tightens while the medial side attenuates. When conservative management fails, the surgical correction of bony and/or soft tissue hallux valgus is often performed, and over 100 different surgical techniques have been described in the literature. Surgical procedures for hallux valgus include simple bunionectomy, various soft tissue procedures, metatarsal and phalangeal osteotomies, resection arthroplasty, and metatarsophalangeal arthrodesis.

Bunionette deformity, also known as Tailor’s bunion, involves the fifth metatarsal head with a painful lateral bony prominence. It is often associated with constrictive footwear causing pain, inflammation, keratosis, and ulceration. When conservative management fails, surgical methods include condylar excision, proximal or distal osteotomies.

For arthrodesis indications, please see the criteria for hallux rigidus.

Clinical Indications

Hallux Valgus Surgery

Hallux valgus surgery is considered medically necessary when ALL the following criteria are met:

Skeletally mature patient
Significant pain and functional impairment of the first metatarsophalangeal (MTP) joint and/or presence of a pre-ulcer (e.g., Wagner grade 0-1) that persist despite 12 weeks of conservative management OR nonhealing ulcer attributable to the bunion
Radiographic confirmation of an elevated hallux valgus angle (HVA) (metatarsophalangeal angle greater than 15 degrees) or intermetatarsal angle (IMA) greater than 9 degrees
Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)

First Metatarsophalangeal Joint Arthrodesis for Hallux Valgus

First metatarsophalangeal (MTP) joint arthrodesis for treatment of hallux valgus is considered medically necessary when ALL the following criteria are met:

Skeletally mature patient
Significant pain and functional impairment of the first MTP joint and/or presence of a pre-ulcer (e.g., Wagner grade 0-1) that persist despite 12 weeks of conservative management OR nonhealing ulcer attributable to the bunion
Radiographic confirmation of an elevated hallux valgus angle (HVA) (metatarsophalangeal angle greater than 15 degrees) or intermetatarsal angle (IMA) greater than 9 degrees
Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)
History of prior hallux valgus correction with recurrence of moderate to severe deformity
Grade I arthritic change of the first MTP joint (see Table 1 for hallux rigidus grading scales)

Bunionette Surgery

Bunionette surgery is considered medically necessary when ALL the following criteria are met:

Skeletally mature patient
Significant pain and functional impairment of the fifth metatarsophalangeal (MTP) joint and/or presence of a pre-ulcer (e.g., Wagner grade 0-1) that persist despite 12 weeks of conservative management OR nonhealing ulcer attributable to the bunionette
Radiographic confirmation of an elevated intermetatarsal angle (IMA) greater than 9 degrees or presence of lateral bony prominence when only simple exostectomy or resection of the lateral eminence is planned
Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)

Sesamoid Surgery

Sesamoid surgery is considered medically necessary when ALL the following criteria are met:

Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)
Significant pain and functional impairment due to the sesamoid bone
Physical examination or imaging confirmation of a sesamoid condition requiring surgery (e.g., inflammation, fracture, prominence)

Contraindications

All Hallux Valgus/Bunionette Procedures

Active infection of the joint
Active systemic bacteremia
Active skin infection at or near the surgical site
Inadequate bone stock for osteotomy or arthrodesis
Inadequate vascular perfusion to the foot

Exclusions

Indications other than those addressed in this guideline are considered not medically necessary including, but not limited to the following:

Asymptomatic hallux valgus or bunionette deformity
Surgical intervention solely for the purposes of improved cosmesis

References

American College of Occupational and Environmental Medicine (ACOEM). Ankle and Foot Disorders. 2015.
Barg A, Harmer JR, Presson AP, et al. Unfavorable Outcomes Following Surgical Treatment of Hallux Valgus Deformity: A Systematic Literature Review. J Bone Joint Surg Am. 2018;100(18):1563-73.
Bia A, Guerra-Pinto F, Pereira BS, et al. Percutaneous Osteotomies in Hallux Valgus: A Systematic Review. J Foot Ankle Surg. 2018;57(1):123-30.
Biz C, Fosser M, Dalmau-Pastor M, et al. Functional and radiographic outcomes of hallux valgus correction by mini-invasive surgery with Reverdin-Isham and Akin percutaneous osteotomies: a longitudinal prospective study with a 48-month follow-up. J Orthop Surg Res. 2016;11(1):157.
Buciuto R. Prospective randomized study of chevron osteotomy versus Mitchell’s osteotomy in hallux valgus. Foot Ankle Int. 2014;35(12):1268-76.
Caravelli S, Mosca M, Massimi S, et al. Percutaneous treatment of hallux valgus: What’s the evidence? A systematic review. Musculoskelet Surg. 2018;102(2):111-7.
Deenik A, van Mameren H, de Visser E, et al. Equivalent correction in scarf and chevron osteotomy in moderate and severe hallux valgus: a randomized controlled trial. Foot Ankle Int. 2008;29(12):1209-15.
Deenik AR, Pilot P, Brandt SE, et al. Scarf versus chevron osteotomy in hallux valgus: a randomized controlled trial in 96 patients. Foot Ankle Int. 2007;28(5):537-41.
Di Giorgio L, Sodano L, Touloupakis G, et al. Reverdin-Isham osteotomy versus Endolog system for correction of moderate hallux valgus deformity: a Randomized Controlled Trial. Clin Ter. 2016;167(6):e150-e4.
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Glazebrook M, Copithorne P, Boyd G, et al. Proximal opening wedge osteotomy with wedge-plate fixation compared with proximal chevron osteotomy for the treatment of hallux valgus: a prospective, randomized study. J Bone Joint Surg Am. 2014;96(19):1585-92.
Harb Z, Kokkinakis M, Ismail H, et al. Adolescent hallux valgus: a systematic review of outcomes following surgery. J Child Orthop. 2015;9(2):105-12.
Jeuken RM, Schotanus MG, Kort NP, et al. Long-term Follow-up of a Randomized Controlled Trial Comparing Scarf to Chevron Osteotomy in Hallux Valgus Correction. Foot Ankle Int. 2016;37(7):687-95.
Kaufmann G, Dammerer D, Heyenbrock F, et al. Minimally invasive versus open chevron osteotomy for hallux valgus correction: a randomized controlled trial. Int Orthop. 2019;43(2):343-50.
Klugarova J, Hood V, Bath-Hextall F, et al. Effectiveness of surgery for adults with hallux valgus deformity: a systematic review. JBI Database System Rev Implement Rep. 2017;15(6):1671-710.
Lee KB, Cho NY, Park HW, et al. A comparison of proximal and distal Chevron osteotomy, both with lateral soft-tissue release, for moderate to severe hallux valgus in patients undergoing simultaneous bilateral correction: a prospective randomised controlled trial. Bone Joint J. 2015;97-B(2):202-7.
Lee M, Walsh J, Smith MM, et al. Hallux Valgus Correction Comparing Percutaneous Chevron/Akin (PECA) and Open Scarf/Akin Osteotomies. Foot Ankle Int. 2017;38(8):838-46.
Ma Q, Liang X, Lu J. Chevron osteotomy versus scarf osteotomy for hallux valgus correction: A meta-analysis. J Foot Ankle Surg. 2019;25(6):755-60.
Maffulli N, Longo UG, Marinozzi A, et al. Hallux valgus: effectiveness and safety of minimally invasive surgery. A systematic review. Br Med Bull. 2011;97:149-67.
Mahadevan D, Lines S, Hepple S, et al. Extended plantar limb (modified) chevron osteotomy versus scarf osteotomy for hallux valgus correction: A randomised controlled trial. J Foot Ankle Surg. 2016;22(2):109-13.
Malagelada F, Sahirad C, Dalmau-Pastor M, et al. Minimally invasive surgery for hallux valgus: a systematic review of current surgical techniques. Int Orthop. 2019;43(3):625-37.
Martijn HA, Sierevelt IN, Wassink S, et al. Fifth Metatarsal Osteotomies for Treatment of Bunionette Deformity: A Meta-Analysis of Angle Correction and Clinical Condition. J Foot Ankle Surg. 2018;57(1):140-8.
Park HW, Lee KB, Chung JY, et al. Comparison of outcomes between proximal and distal chevron osteotomy, both with supplementary lateral soft-tissue release, for severe hallux valgus deformity: A prospective randomised controlled trial. Bone Joint J. 2013;95-b(4):510-6.
Pentikainen IT, Ojala R, Ohtonen P, et al. Radiographic analysis of the impact of internal fixation and dressing choice of distal chevron osteotomy: randomized control trial. Foot Ankle Int. 2012;33(5):420-3.
Radwan YA, Mansour AM. Percutaneous distal metatarsal osteotomy versus distal chevron osteotomy for correction of mild-to-moderate hallux valgus deformity. Arch Orthop Trauma Surg. 2012;132(11):1539-46.
Resch S, Stenstrom A, Reynisson K, et al. Chevron osteotomy for hallux valgus not improved by additional adductor tenotomy. A prospective, randomized study of 84 patients. Acta Orthop Scand. 1994;65(5):541-4.
Roukis TS. Percutaneous and minimum incision metatarsal osteotomies: a systematic review. J Foot Ankle Surg. 2009;48(3):380-7.
Sahin N, Cansabuncu G, Cevik N, et al. A randomized comparison of the proximal crescentic osteotomy and rotational scarf osteotomy in the treatment of hallux valgus. Acta Orthop Traumatol Turc. 2018;52(4):261-6.
Saro C, Andren B, Wildemyr Z, et al. Outcome after distal metatarsal osteotomy for hallux valgus: a prospective randomized controlled trial of two methods. Foot Ankle Int. 2007;28(7):778-87.
Shimozono Y, Hurley ET, Brown AJ, et al. Sesamoidectomy for Hallux Sesamoid Disorders: A Systematic Review. J Foot Ankle Surg. 2018;57(6):1186-90.
Torkki M, Malmivaara A, Seitsalo S, et al. Surgery vs orthosis vs watchful waiting for hallux valgus: a randomized controlled trial. Jama. 2001;285(19):2474-80.
Waizy H, Panahi B, Dohle J, et al. The Current S2e Guideline for Hallux valgus – Evidence-based Guideline Development Using Meta-analysis. Z Orthop Unfall. 2019;157(1):75-82.
Yammine K, Assi C. A meta-analysis of comparative clinical studies of isolated osteotomy versus osteotomy with lateral soft tissue release in treating hallux valgus. J Foot Ankle Surg. 2019;25(5):684-90.

Metatarsal Osteotomy

Clinical Indications

Metatarsal osteotomy is considered medically necessary in skeletally mature patients when ALL the following criteria are met:

Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)
Significant pain and functional impairment due to the metatarsal deformity and/or presence of a pre-ulcer (e.g., Wagner grade 0-1) that persist despite 12 weeks of conservative management OR non-healing ulcer attributable to the metatarsal deformity
Physical examination or imaging confirmation of an anatomical condition requiring osteotomy

Contraindications

All Osteotomy Procedures

Active infection of the joint
Active systemic bacteremia
Active skin infection at or near the surgical site
Inadequate bone stock for osteotomy or arthrodesis
Inadequate vascular supply to the foot

Exclusions

Indications other than those addressed in this guideline are considered not medically necessary including, but not limited to the following:

Asymptomatic lesser toe or metatarsal deformities
Surgical intervention solely for the purpose of improved cosmesis

Lesser Toe Deformities

Description and Scope

This guideline addresses surgery for lesser toe deformities when performed as an elective, non-emergent procedure and not as part of the care of an acute fracture.

Deformities of the lesser (two through five) toes are generally known as hammer toe, claw toe, and mallet toe. A related deformity of the great toe is known as a hallux malleus.

Hammer toe is characterized by flexion deformity of the proximal interphalangeal joint of one or more of the lesser four toes. In severe or chronic conditions, it may be associated with either flexion or extension of the distal interphalangeal or hyperextension of the metatarsophalangeal joint. The most commonly affected toe is the second, although multiple toes can be involved. Hammer toes are considered flexible if passively correctable or rigid if not correctable to the neutral position.

Mallet toe is characterized by flexion deformity at the distal interphalangeal joint only.

Claw toe deformity is characterized by flexion deformities of the proximal interphalangeal and distal interphalangeal joints as well as hyperextension at the metatarsophalangeal joint.

The main bony procedures used in the treatment of second hammertoe are excisional arthroplasty and arthrodesis of the proximal interphalangeal joint. Arthrodesis of the proximal interphalangeal joint represents the standard treatment for rigid and structured deformities not suited for manual correction. This procedure is performed by removing the articular surfaces of the proximal and intermediate phalanges. Although many systems such as cannulated screws or absorbable pins have been designed for the fixation of arthrodesis, the K-wire is the most utilized traditional method. Surgical management of lesser toe deformity may also include soft-tissue release, tendon transfer, joint resection, joint fusion, metatarsal shortening, or a combination of procedures.

Plastic skin closures in association with deformity correction are characterized by skin incisions placed for advancement of skin flaps for closure of surgical wound gaps created by the deformity correction.

Clinical Indications

Lesser Toe Deformity Surgery

Lesser toe deformity surgery is considered medically necessary in skeletally mature patients when ALL the following criteria are met:

Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)
Significant pain and functional impairment due to the lesser toe deformity and/or presence of a pre-ulcer (e.g., Wagner grade 0-1) that persist despite 12 weeks of conservative management OR non-healing ulcer attributable to the lesser toe deformity
Physical examination or imaging confirmation of a lesser toe deformity requiring surgery

Contraindications

All Lesser Toe Deformity Procedures

Active infection of the joint
Active systemic bacteremia
Active skin infection at or near the surgical site
Inadequate bone stock for osteotomy or arthrodesis
Inadequate vascular supply to the foot

Exclusions

Indications other than those addressed in this guideline are considered not medically necessary including, but not limited to the following:

Asymptomatic lesser toe deformities
Surgical intervention solely for the purposes of improved cosmesis

References

Albright RH, Hassan M, Randich J, et al. Risk Factors for Failure in Hammertoe Surgery. Foot Ankle Int. 2020;41(5):562-571.
Angirasa AK, Barrett MJ, Silvester D. SmartToe R implant compared with Kirschner wire fixation for hammer digit corrective surgery: a review of 28 patients. J Foot Ankle Surg. 2012;51(6):711-3.
Atinga M, Dodd L, Foote J, et al. Prospective review of medium term outcomes following interpositional arthroplasty for hammer toe deformity correction. J Foot Ankle Surg. 2011;17(4):256-8.
Averous C, Leider F, Rocher H, et al. Interphalangeal Arthrodesis of the Toe With a New Radiolucent Intramedullary Implant (Toegrip). Foot Ankle Spec. 2015;8(6):520-4.
Basile A, Albo F, Via AG. Intramedullary Fixation System for the Treatment of Hammertoe Deformity. J Foot Ankle Surg. 2015;54(5):910-6.
Boffeli TJ, Thompson JC, Tabatt JA. Two-Pin Fixation of Proximal Interphalangeal Joint Fusion for Hammertoe Correction. J Foot Ankle Surg. 2016;55(3):480-7.
Catena F, Doty JF, Jastifer J, et al. Prospective study of hammertoe correction with an intramedullary implant. Foot Ankle Int. 2014;35(4):319-25.
Ceccarini P, Rinonapoli G, Sebastiani E, et al. Clinical Comparison Between Shortening Osteotomy of the Proximal Phalanx Neck and Arthrodesis in Hammer Toe Surgery at Mid-Term Follow-Up. J Foot Ankle Surg. 2019;58(2):221-5.
Coillard JY, Petri GJ, van Damme G, et al. Stabilization of proximal interphalangeal joint in lesser toe deformities with an angulated intramedullary implant. Foot Ankle Int. 2014;35(4):401-7.
Coughlin MJ, Dorris J, Polk E. Operative repair of the fixed hammertoe deformity. Foot Ankle Int. 2000;21(2):94-104.
Ellington JK, Anderson RB, Davis WH, et al. Radiographic analysis of proximal interphalangeal joint arthrodesis with an intramedullary fusion device for lesser toe deformities. Foot Ankle Int. 2010;31(5):372-6.
Fazal MA, James L, Williams RL. StayFuse for proximal interphalangeal joint fusion. Foot Ankle Int. 2013;34(9):1274-8.
Ferrier M, Mattei JC, Desmarchelier R, et al. Radiographic and Clinical Comparison of Proximal Interphalangeal Joint Arthrodesis Between a Static and Dynamic Implant. J Foot Ankle Surg. 2019;58(4):657-62.
Frey S, Helix-Giordanino M, Piclet-Legre B. Percutaneous correction of second toe proximal deformity: Proximal interphalangeal release, flexor digitorum brevis tenotomy and proximal phalanx osteotomy. Orthop Traumatol Surg Res. 2015;101(6):753-8.
Guelfi M, Pantalone A, Cambiaso Daniel J, et al. Arthrodesis of proximal inter-phalangeal joint for hammertoe: intramedullary device options. J Orthop Traumatol. 2015;16(4):269-73.
Harmer JL, Wilkinson A, Maher AJ. A Midterm Review of Lesser Toe Arthrodesis With an Intramedullary Implant. Foot Ankle Spec. 2017;10(5):458-64.
Jay RM, Malay DS, Landsman AS, et al. Dual-Component Intramedullary Implant Versus Kirschner Wire for Proximal Interphalangeal Joint Fusion: A Randomized Controlled Clinical Trial. J Foot Ankle Surg. 2016;55(4):697-708.
Joseph R, Schroeder K, Greenberg M. A retrospective analysis of lesser metatarsophalangeal joint fusion as a treatment option for hammertoe pathology associated with metatarsophalangeal joint instability. J Foot Ankle Surg. 2012;51(1):57-62.
Khan F, Kimura S, Ahmad T, et al. Use of Smart Toe© implant for small toe arthrodesis: A smart concept? Foot and Ankle Surgery. 2015;21(2):108-12.
Kramer WC, Parman M, Marks RM. Hammertoe correction with k-wire fixation. Foot Ankle Int. 2015;36(5):494-502.
Matthews AH, Jagodzinski NA, Westwood M, et al. Effectiveness of the Cobb-Stainsby excision arthroplasty. J Foot Ankle Surg. 2018;24(1):49-53.
McKenzie JC, Rogero RG, Khawam S, et al. Incidence and Risk Factors for Pin Site Infection of Exposed Kirschner Wires Following Elective Forefoot Surgery. Foot Ankle Int. 2019;40(10):1154-9.
Mueller CM, Boden SA, Boden AL, et al. Complication Rates and Short-Term Outcomes After Operative Hammertoe Correction in Older Patients. Foot Ankle Int. 2018;39(6):681-8.
Obrador C, Losa-Iglesias M, Becerro-de-Bengoa-Vallejo R, et al. Comparative Study of Intramedullary Hammertoe Fixation. Foot Ankle Int. 2018;39(4):415-25.
O’Kane C, Kilmartin T. Review of proximal interphalangeal joint excisional arthroplasty for the correction of second hammer toe deformity in 100 cases. Foot Ankle Int. 2005;26(4):320-5.
Payo-Ollero J, Casajus-Ortega A, Llombart-Blanco R, et al. The efficacy of an intramedullary nitinol implant in the correction of claw toe or hammertoe deformities. Arch Orthop Trauma Surg. 2019;139(12):1681-90.
Richman SH, Siqueira MB, McCullough KA, et al. Correction of Hammertoe Deformity With Novel Intramedullary PIP Fusion Device Versus K-Wire Fixation. Foot Ankle Int. 2017;38(2):174-80.
Roukis TS. A 1-piece shape-metal nitinol intramedullary internal fixation device for arthrodesis of the proximal interphalangeal joint in neuropathic patients with diabetes. Foot Ankle Spec. 2009;2(3):130-4.
Sandhu JS, DeCarbo WT, Hofbauer MH. Digital arthrodesis with a one-piece memory nitinol intramedullary fixation device: a retrospective review. Foot Ankle Spec. 2013;6(5):364-6.
Scholl A, McCarty J, Scholl D, et al. Smart toe R implant versus buried Kirschner wire for proximal interphalangeal joint arthrodesis: a comparative study. J Foot Ankle Surg. 2013;52(5):580-3.
Schrier JC, Keijsers NL, Matricali GA, et al. Lesser Toe PIP Joint Resection Versus PIP Joint Fusion: A Randomized Clinical Trial. Foot Ankle Int. 2016;37(6):569-75.
Sperati G. Metatarsophalangeal joint arthroplasty with implantation of Osteomed Interflex IPG system: our experience. Acta Biomed Ateneo Parmense. 2014;85 Suppl 2:118-20.
Sung W, Weil L, Jr., Weil LS, Sr. Retrospective comparative study of operative repair of hammertoe deformity. Foot Ankle Spec. 2014;7(3):185-92.
Wei RX, Ling SK, Lui TH, et al. Ideal implant choice for proximal interphalangeal joint arthrodesis in hammer toe/claw toe deformity correction: A systematic review. J Orthop Surg (Hong Kong). 2020;28(1):2309499020911168.

Ankle Arthritis

Description and Scope

This guideline addresses surgery for ankle osteoarthritis when performed as an elective, non-emergent procedure and not as part of the care of an acute fracture.

Ankle osteoarthritis affects approximately 1% of the world’s adult population. The primary cause of ankle osteoarthritis is trauma associated with pain, dysfunction, and impaired mobility. Other causes include rheumatic diseases, gout, hemochromatosis, avascular necrosis, hemophilia, and postinfectious conditions. In the early stages, conservative management may decrease pain and preserve function. Ankle arthrodesis or total ankle arthroplasty may be indicated for advanced cases. Ankle arthrodesis was considered the gold standard treatment in patients with end-stage ankle osteoarthritis until the 1970s, when the first total ankle arthroplasty procedures were described. Although gait efficiency is decreased with ankle arthrodesis, most surgeons still consider it as the procedure of choice to alleviate pain in patients with end-stage ankle osteoarthritis.

Ankle arthrodesis is regarded as a reliable treatment for end-stage ankle arthritis because it yields good results with a low complication rate. A commonly reported risk of ankle arthrodesis is adjacent joint degeneration that occurs more frequently in those with arthritis of the ipsilateral hindfoot and midfoot.

Total ankle arthroplasty was first performed in 1970 as an alternative treatment option to ankle arthrodesis—the gold standard at the time for end-stage ankle degenerative joint disease. Initially, total ankle arthroplasty had high rates of subsidence, loosening, and revision. However, with the advances in implant design such as uncemented implants as well as fixed and mobile-bearing surfaces, total ankle arthroplasty has resulted in improved outcomes.

Clinical Indications

Ankle Arthrodesis

Ankle arthrodesis is considered medically necessary in skeletally mature patients when ALL the following criteria are met:

Imaging evidence of significant joint destruction and cartilage loss, defined as Kellgren-Lawrence grade 3 – 4 or diffuse modified Outerbridge III – IV arthritis of the tibiotalar joint OR avascular necrosis of the talus
Significant pain and functional impairment due to arthritis of the ankle that persist despite 12 weeks of conservative management (unless imaging shows Kellgren-Lawence grade 4 or diffuse modified Outerbridge IV changes)
Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)

Ankle arthrodesis may also be indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Total Ankle Arthroplasty

Total ankle arthroplasty is considered medically necessary in skeletally mature patients when ALL the following criteria are met:

Imaging evidence of significant joint destruction and cartilage loss, defined as Kellgren-Lawrence grade 3 – 4 or diffuse modified Outerbridge III – IV arthritis of the tibiotalar joint OR avascular necrosis of the talus without collapse
Significant pain and functional impairment due to arthritis of the ankle that persist despite 12 weeks of conservative management (unless imaging shows Kellgren-Lawence grade 4 or diffuse modified Outerbridge IV changes)
Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)
Device is FDA approved

Total ankle arthroplasty may also be indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Revision or Conversion of a Prior Ankle Arthroplasty

Revision or conversion of a prior ankle arthroplasty is considered medically necessary when ALL the following criteria are met:

Pain and functional limitation attributable to the arthroplasty
Documented recent evaluation for prosthetic joint infection:
- Recent preoperative investigation using serologic testing (ESR, CRP, and/or IL-6) and
- IF there are abnormal laboratory findings on serologic testing, at least ONE of the following:
  - Synovial fluid testing, such as leukocyte count and neutrophil percentage, aerobic and anaerobic bacterial cultures, leukocyte esterase, alpha defensin testing (Synovasure^®), synovial fluid CRP, synovial fluid PCR for bacteria
  - Intraoperative plan for histopathology and/or aerobic and anaerobic tissue cultures using implant sonication for cultures or PCR
Documentation of adequate lower extremity vascular perfusion (e.g., strong, palpable pedal pulses)
Device is FDA approved
ANY of the following conditions are present:
- Reconstruction after periprosthetic joint infection with lab and clinical confirmation of infection resolution
- Implant loosening confirmed by imaging
- Substantial osteolysis of the distal tibia or talus
- Progressive soft tissue or bone reaction including bearing surface wear or symptomatic synovitis
- Component instability (e.g., clinical instability, component malalignment, displacement of the tibial or talar component)
- Component failure or recall
- Periprosthetic fracture or irreducible dislocation
- Persistent symptoms despite 12 weeks of conservative management in the absence of any of the conditions listed above

Contraindications

Ankle Arthrodesis

Active infection of the joint
Active systemic bacteremia
Active skin infection at or near the surgical site

Ankle Arthroplasty Procedures

Intra-articular injection or ankle arthroscopy within 12 weeks of the planned arthroplasty procedure
Active infection of the joint being replaced
Active systemic bacteremia
Active skin infection at or near the surgical site
Charcot neuroarthropathy
Inadequate bone stock
Severe anatomic deformity in adjacent ankle structures, including hindfoot, forefoot and knee joint
Prior surgery or injury that has adversely affected ankle bone quality
Extensive avascular necrosis of the talar dome
Malalignment (e.g., varus or valgus deformity greater than 15 degrees) not correctable by surgery
Inadequate vascular supply to the foot/ankle
Absence of the medial or lateral malleolus or both
Severe osteoporosis, osteopenia, or other conditions resulting in poor bone quality, as this may result in inadequate bony fixation
High demand sports activities (e.g., contact sports, jumping)
Concurrent immunosuppressive therapy
Insufficient ligament support that cannot be repaired with soft tissue stabilization
Insufficient musculature such that proper component positioning or alignment is not possible
Neurologic impairment with dynamic muscular imbalance across the ankle joint
Prior fusion of the ankle
Psychiatric problems that hinder adequate cooperation during perioperative period

Exclusions for all ankle procedures

Indications other than those addressed in this guideline are considered not medically necessary including, but not limited to, the following:

Asymptomatic ankle osteoarthritis
Surgical intervention solely for the purposes of improved cosmesis
Non-FDA-approved total ankle replacement devices

References

Bai LB, Lee KB, Song EK, et al. Total ankle arthroplasty outcome comparison for post-traumatic and primary osteoarthritis. Foot Ankle Int. 2010;31(12):1048-56.
Barg A, Morris SC, Schneider SW, et al. Surgical procedures in patients with haemophilic arthropathy of the ankle. Haemophilia. 2016;22(3):e156-76.
Bonnin M, Gaudot F, Laurent JR, et al. The Salto total ankle arthroplasty: survivorship and analysis of failures at 7 to 11 years. Clin Orthop Relat Res. 2011;469(1):225-36.
Braito M, Dammerer D, Kaufmann G, et al. Are our expectations bigger than the results we achieve? a comparative study analysing potential advantages of ankle arthroplasty over arthrodesis. Int Orthop. 2014;38(8):1647-53.
Brunner S, Barg A, Knupp M, et al. The Scandinavian total ankle replacement: long-term, eleven to fifteen-year, survivorship analysis of the prosthesis in seventy-two consecutive patients. J Bone Joint Surg Am. 2013;95(8):711-8.
Choi WJ, Lee JS, Lee M, et al. The impact of diabetes on the short- to mid-term outcome of total ankle replacement. Bone Joint J. 2014;96-b(12):1674-80.
Clough TM, Alvi F, Majeed H. Total ankle arthroplasty: what are the risks?: a guide to surgical consent and a review of the literature. Bone Joint J. 2018;100-B(10):1352-8.
Coetzee JC, McGaver RS, Seiffert KJ, et al. Management of Ankle Arthritis After Severe Ankle Trauma. J Orthop Trauma. 2020;34 Suppl 1:S26-S31.
Colorado Division of Workers’ Compensation, Lower Extremity Injury Medical Treatment Guidelines, (2016), Colorado Division of Workers’ Compensation, 216.
Cottom JM, Douthett SM, McConnell KK, Plemmons BS. The effect of tobacco use on incision healing in total ankle arthroplasty: A review of 114 patients. Foot Ankle Spec. 2020;13(1):27-31.
Daniels TR, Mayich DJ, Penner MJ. Intermediate to Long-Term Outcomes of Total Ankle Replacement with the Scandinavian Total Ankle Replacement (STAR). J Bone Joint Surg Am. 2015;97(11):895-903.
de Keijzer DR, Joling BSH, Sierevelt IN, Hoornenborg D, Kerkhoffs GMMJ, Haverkamp D. Influence of Preoperative Tibiotalar Alignment in the Coronal Plane on the Survival of Total Ankle Replacement: A Systematic Review. Foot Ankle Int. 2020 Feb;41(2):160-169.
Di Iorio A, Viste A, Fessy MH, et al. The AES total ankle arthroplasty analysis of failures and survivorship at ten years. Int Orthop. 2017;41(12):2525-33.
Esparragoza L, Vidal C, Vaquero J. Comparative study of the quality of life between arthrodesis and total arthroplasty substitution of the ankle. J Foot Ankle Surg. 2011;50(4):383-7.
Giannini S, Romagnoli M, Barbadoro P, et al. Results at a minimum follow-up of 5 years of a ligaments-compatible total ankle replacement design. Foot Ankle Surg. 2017;23(2):116-21.
Gross C, Erickson BJ, Adams SB, Parekh SG. Ankle arthrodesis after failed total ankle replacement: a systematic review of the literature. Foot Ankle Spec. 2015;8(2):143-51.
Gross CE, Lampley A, Green CL, et al. The Effect of Obesity on Functional Outcomes and Complications in Total Ankle Arthroplasty. Foot Ankle Int. 2016;37(2):137-41.
Hahn ME, Wright ES, Segal AD, et al. Comparative gait analysis of ankle arthrodesis and arthroplasty: initial findings of a prospective study. Foot Ankle Int. 2012;33(4):282-9.
Honnenahalli Chandrappa M, Hajibandeh S, Hajibandeh S. Ankle arthrodesis-Open versus arthroscopic: A systematic review and meta-analysis. J Clin Orthop Trauma. 2017;8(Suppl 2):S71-S7.
Jastifer J, Coughlin MJ, Hirose C. Performance of total ankle arthroplasty and ankle arthrodesis on uneven surfaces, stairs, and inclines: a prospective study. Foot Ankle Int. 2015;36(1):11-7.
Jennison T, Spolton-Dean C, Rottenburg H, et al. The outcomes of revision surgery for a failed ankle arthroplasty: a systematic review and meta-analysis. Bone Jt Open. 2022;3(7):596-606.
Joo SD, Lee KB. Comparison of the outcome of total ankle arthroplasty for osteoarthritis with moderate and severe varus malalignment and that with neutral alignment. Bone Joint J. 2017;99-B(10):1335-42.
Kerkhoff YR, Kosse NM, Metsaars WP, et al. Long-term Functional and Radiographic Outcome of a Mobile Bearing Ankle Prosthesis. Foot Ankle Int. 2016;37(12):1292-302.
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Kim HJ, Suh DH, Yang JH, et al. Total ankle arthroplasty versus ankle arthrodesis for the treatment of end-stage ankle arthritis: a meta-analysis of comparative studies. Int Orthop. 2017;41(1):101-9.
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Lee GW, Wang SH, Lee KB. Comparison of Intermediate to Long-Term Outcomes of Total Ankle Arthroplasty in Ankles with Preoperative Varus, Valgus, and Neutral Alignment. J Bone Joint Surg Am. 2018;100(10):835-42.
Ling JS, Smyth NA, Fraser EJ, et al. Investigating the Relationship Between Ankle Arthrodesis and Adjacent-Joint Arthritis in the Hindfoot. A Systematic Review. J Bone Joint Surg Am. 2015;97(9):e43.
Maffulli N, Longo UG, Locher J, et al. Outcome of ankle arthrodesis and ankle prosthesis: a review of the current status. Br Med Bull. 2017;124(1):91-112.
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Norvell DC, Shofer JB, Hansen ST, et al. Frequency and Impact of Adverse Events in Patients Undergoing Surgery for End-Stage Ankle Arthritis. Foot Ankle Int. 2018;39(9):1028-38.
Onggo JR, Nambiar M, Phan K, et al. Outcome after total ankle arthroplasty with a minimum of five years follow-up: A systematic review and meta-analysis. J Foot Ankle Surg. 2019;25:25.
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Queen RM, Adams SB, Jr., Viens NA, et al. Differences in outcomes following total ankle replacement in patients with neutral alignment compared with tibiotalar joint malalignment. J Bone Joint Surg Am. 2013;95(21):1927-34.
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Schuh R, Hofstaetter J, Krismer M, et al. Total ankle arthroplasty versus ankle arthrodesis. Comparison of sports, recreational activities and functional outcome. Int Orthop. 2012;36(6):1207-14.
Schweitzer KM, Adams SB, Viens NA, et al. Early prospective clinical results of a modern fixed-bearing total ankle arthroplasty. J Bone Joint Surg Am. 2013;95(11):1002-11.
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Slobogean GP, Younger A, Apostle KL, et al. Preference-based quality of life of end-stage ankle arthritis treated with arthroplasty or arthrodesis. Foot Ankle Int. 2010;31(7):563-6.
Smyth NA, Kennedy JG, Parvizi J, et al. Risk factors for periprosthetic joint infection following total ankle replacement. J Foot Ankle Surg. 2019;07:07.
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Trajkovski T, Pinsker E, Cadden A, et al. Outcomes of ankle arthroplasty with preoperative coronal-plane varus deformity of 10 degrees or greater. J Bone Joint Surg Am. 2013;95(15):1382-8.
Trincat S, Kouyoumdjian P, Asencio G. Total ankle arthroplasty and coronal plane deformities. Orthop Traumatol Surg Res. 2012;98(1):75-84.
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Bone Growth Stimulation of the Appendicular Skeleton: Noninvasive, Invasive, Semi-Invasive

Scope

This guideline addresses the use of electrical and ultrasound bone growth stimulation devices for the treatment of orthopedic conditions of the appendicular skeleton. This guideline does not address electrical bone growth stimulation of the spine.

Clinical Indications

Noninvasive Electrical Bone Growth Stimulation

Example devices include PhysioStim™, EBI^® Bone Healing System, CMF OrthoLogic 1000 (OL1000™) Bone Growth Stimulator, OrthoPak® Noninvasive Bone Growth Stimulator System, and OsteoGen^® D40 Implantable Bone Growth Stimulator.

Noninvasive electrical bone growth stimulation is considered medically necessary when ALL the following criteria are met:

Treatment is for ANY of the following conditions:
- Nonunion of a fracture secondary to trauma or surgery of any long bone (clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal or metatarsal bone) or carpal/tarsal bone of the appendicular skeleton
- Congenital pseudarthroses of any bone of the appendicular skeleton
- Failed arthrodesis of the ankle or knee

AND ALL the following apply:

At least 3 months have passed since the date of the fracture or initial/index surgery
No progressive signs of healing have occurred on at least two (2) serial radiographs in the preceding three (3)-month period
The fracture gap is less than 1 centimeter
The device is FDA approved for use on the involved bone

Exclusions

Noninvasive electrical bone growth stimulation of any bone of the appendicular skeleton is considered not medically necessary when the above criteria are not met including, but not limited to, treatment of ANY of the following:

As an adjunct to (that is, at the time of or immediately after) distraction osteogenesis procedures for any indication (for example, limb lengthening, nonunion, or tibial defects)
Delayed/incomplete union fractures
Fresh fractures
Pathological fractures due to bone pathology or tumor/malignancy
Stress fractures
Immediate postsurgical treatment after appendicular skeletal surgery
Nonunion with associated draining osteomyelitis or presence of synovial pseudarthroses
Concurrent use of noninvasive electrical and ultrasound bone growth stimulation devices

Invasive and Semi-Invasive Bone Growth Stimulators

Example device: EBI^® OsteoGen™ Implantable Bone Growth Stimulator.

Implantable and semi-invasive electrical bone growth stimulators are considered not medically necessary for all indications in the appendicular skeleton.

Ultrasound Bone Growth Stimulation (Low-Intensity Pulsed Ultrasound)

Examples of low-intensity pulsed ultrasound system (LIPUS) devices include AccelStim™, Manafuse™, and Exogen 2000^®.

Noninvasive, low-intensity pulsed ultrasound treatment is considered medically necessary for the treatment of the following indications:

Nonunion of a fracture secondary to trauma or surgery of any long bone (clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal or metatarsal bone) or carpal /tarsal bone of the appendicular skeleton when ALL the following criteria are met:
- No progressive signs of healing have occurred on at least two (2) serial radiographs in the preceding three (3)-month period
- The fracture gap is less than 1 centimeter
- The device is FDA approved for use on the involved bone
Fresh, closed, posteriorly displaced distal radius fractures
Fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature adult individuals when these fractures are orthopedically managed by closed reduction and cast immobilization
Closed fracture sites at high risk for nonunion due to location ANDANY of the following:
- Poor vascular supply, for example:
  - Fractures of the carpal navicular bone (scaphoid fracture)
  - 5th metatarsal bone fractures (Jones fracture)
- Fractures associated with at least ONE of the following:
  - Extensive soft tissue
  - Vascular damage
Closed fractures at high risk for nonunion due to a comorbidity which makes healing likely to be compromised including ANY of the following:
- Diabetes
- Renal disease
- Other metabolic diseases
- History of tobacco use
- History of alcoholism
- Nutritional deficiency
- Obese individuals with:
  - Body Mass Index (BMI) greater than 30
  - When greater than 50% over ideal body weight (IBW)
- Severe anemia
- Steroid therapy

Exclusions

Concurrent use of noninvasive ultrasound and electrical bone growth stimulation devices is considered not medically necessary.

Exclusions

Bone growth stimulation devices other than those addressed in this guideline are considered not medically necessary including, but not limited to, the following:

Implantable and semi-invasive electrical bone growth stimulators are considered not medically necessary for all indications in the appendicular skeleton
- Example device: EBI^® OsteoGen™ Implantable Bone Growth Stimulator

References

Aleem IS, Aleem I, Evaniew N, et al. Efficacy of Electrical Stimulators for Bone Healing: A Meta-Analysis of Randomized Sham-Controlled Trials. Sci Rep. 2016;6:31724.
Bawale R, Segmeister M, Sinha S, et al. Experience of an isolated use of low-intensity pulsed ultrasound therapy on fracture healing in established non-unions: a prospective case series. J Ultrasound. 2021;24(3):249–52.
Biglari B, Yildirim TM, Swing T, et al. Failed treatment of long bone nonunions with low intensity pulsed ultrasound. Arch Orthop Trauma Surg. 2016;136(8):1121–34.
Eltayeb NM, Abdelhamid MM, Yousuf HZ, et al. Pulsed electromagnetic field stimulation therapy for Charcot foot ulcer: a randomized controlled trial. Wounds. 2025;37(8):323–8.
Griffin XL, Costa ML, Parsons N, et al. Electromagnetic field stimulation for treating delayed union or non-union of long bone fractures in adults. Cochrane Database Syst Rev. 2011(4):CD008471.
Jauregui JJ, Ventimiglia AV, Grieco PW, et al. Regenerate bone stimulation following limb lengthening: a meta-analysis. BMC Musculoskelet Disord. 2016;17(1):407.
Leighton R, Watson JT, Giannoudis P, et al. Healing of fracture nonunions treated with low-intensity pulsed ultrasound (LIPUS): A systematic review and meta-analysis. Injury. 2017;48(7):1339–47.
Li L, Yang L, Yang Y, et al. Evaluation of the efficacy of physical agent modalities in patients with fractures: a systematic review and network meta-analysis. Front Med (Lausanne). 2025;12:1646903.
Lou S, Lv H, Li Z, et al. Effect of low-intensity pulsed ultrasound on distraction osteogenesis: a systematic review and meta-analysis of randomized controlled trials. J Orthop Surg (Hong Kong). 2018;13(1):205.
Lou S, Lv H, Li Z, et al. The effects of low-intensity pulsed ultrasound on fresh fracture: A meta-analysis. Medicine (Baltimore). 2017;96(39):e8181.
McDaniel M, Eltman NR, Pan J, et al. Evaluation of Low-Intensity Pulsed Ultrasound on Stress Fractures to Reduce the Time to Return to Sport or Activity in the Physically Active Population: A Systematic Review. Cureus. 2023;15(11):e49129.
National Institute for Health and Care Excellence. EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing: a NICE medical technology guidance 2019. Available from: https://www.nice.org.uk/guidance/htg296.
Patterson ED, Elliott C, Dhaliwal G, et al. Risk Factors for the Development of Persistent Scaphoid Non-Union After Surgery for an Established Non-Union. Hand. 2025;20(3):371–9.
Poolman RW, Agoritsas T, Siemieniuk RA, et al. Low intensity pulsed ultrasound (LIPUS) for bone healing: a clinical practice guideline. BMJ (Clinical research ed). 2017;356:j576.
Puts R, Vico R, Beilfus N, et al. Pulsed ultrasound for bone regeneration – outcomes and hurdles in the clinical application: a systematic review. Eur Cell Mater. 2021;42:281–311.
Schandelmaier S, Kaushal A, Lytvyn L, et al. Low intensity pulsed ultrasound for bone healing: systematic review of randomized controlled trials. BMJ (Clinical research ed). 2017;356:j656.
Schluter R, McLeod H, Ebrahimi A, et al. The effect of electrical bone stimulation on bone union in foot and ankle injuries: A scoping review. Acta Orthop Traumatol Turc. 2025;59(6):349–60.
Searle HKC, Lewis SR, Coyle C, et al. Ultrasound and shockwave therapy for acute fractures in adults. Cochrane Database Syst Rev. 2023;3:CD008579.
Seger EW, Jauregui JJ, Horton SA, et al. Low-Intensity Pulsed Ultrasound for Nonoperative Treatment of Scaphoid Nonunions: A Meta-Analysis. Hand. 2018;13(3):275–80.
Simpson AH, Keenan G, Nayagam S, et al. Low-intensity pulsed ultrasound does not influence bone healing by distraction osteogenesis: a multicentre double-blind randomised control trial. Bone Joint J. 2017;99-B(4):494–502.
Struckmann VF, Stolle A, Bocker A, et al. Multicenter consensus statements on the use of low-intensity pulsed ultrasound (LIPUS) in Hand Surgery. Arch Orthop Trauma Surg. 2023;143(11):6965–72.
White NJ, Patterson ED, Dhaliwal GS, et al. Low-Intensity Pulsed Ultrasound Versus Sham in the Treatment of Operatively Managed Scaphoid Nonunions: The SNAPU Randomized Controlled Trial. J Bone Joint Surg Am. 2024;106(17):1573–82.

Codes

The following code list is not meant to be all-inclusive. Authorization requirements will vary by health plan. Please consult the applicable health plan for guidance on specific procedure codes.

Medical necessity reviews are initiated by submitting the correct AMA CPT codes. Specific CPT codes for services should be used when available. The submitted codes must accurately identify the service or procedure to be performed. If no such code exists, contact the health plan directly and report the service or procedure using the appropriate unlisted procedure or Not Otherwise Classified (NOC) code (which often ends in 99). Do not submit a code that is “close to” the procedure performed in lieu of an unlisted code. Correct coding demands that the code reported is appropriate for the service provided (i.e., a code that most accurately represents the service provided), and not a code that is similar but represents another service. (CPT^® Assistant, December 2010) Nonspecific or NOC codes may be subject to additional documentation requirements and review.

CPT/HCPCS

CPT^® (Current Procedural Terminology) is a registered trademark of the American Medical Association (AMA). CPT^® five-digit codes, nomenclature and other data are copyright by the American Medical Association. All Rights Reserved. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein.

20974	Electrical stimulation to aid bone healing; noninvasive (nonoperative)
20979	Low intensity ultrasound stimulation to aid bone healing, noninvasive (nonoperative)
E0747	Osteogenesis stimulator; electrical, noninvasive, other than spinal applications
E0748	Osteogenesis stimulator, electrical, noninvasive, spinal applications
E0749	Osteogenesis stimulator, electrical, surgically implanted
E0760	Osteogenesis stimulator, low intensity ultrasound, non-invasive
27702	Arthroplasty, ankle; with implant (total ankle)
27703	Arthroplasty, ankle; revision, total ankle
27704	Removal of ankle implant
27870	Arthrodesis, ankle, open
28110	Ostectomy, partial excision, fifth metatarsal head (bunionette) (separate procedure)
28285	Correction, hammertoe (eg, interphalangeal fusion, partial or total phalangectomy)
28286	Correction, cock-up fifth toe, with plastic skin closure (eg, Ruiz-Mora type procedure)
28289	Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; without implant
28291	Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; with implant
28292	Correction, hallux valgus with bunionectomy, with sesamoidectomy when performed; with resection of proximal phalanx base, when performed, any method
28295	Correction, hallux valgus with bunionectomy, with sesamoidectomy when performed; with proximal metatarsal osteotomy, any method
28296	Correction, hallux valgus with bunionectomy, with sesamoidectomy when performed; with distal metatarsal osteotomy, any method
28297	Correction, hallux valgus with bunionectomy, with sesamoidectomy when performed; with first metatarsal and medial cuneiform joint arthrodesis, any method
28298	Correction, hallux valgus with bunionectomy, with sesamoidectomy when performed; with proximal phalanx osteotomy, any method
28299	Correction, hallux valgus with bunionectomy, with sesamoidectomy when performed; with double osteotomy, any method
28306	Osteotomy, with or without lengthening, shortening or angular correction, metatarsal; first metatarsal
28307	Osteotomy, with or without lengthening, shortening or angular correction, metatarsal; first metatarsal with autograft (other than first toe)
28308	Osteotomy, with or without lengthening, shortening or angular correction, metatarsal; other than first metatarsal, each
28310	Osteotomy, shortening, angular or rotational correction; proximal phalanx, first toe (separate procedure)
28312	Osteotomy, shortening, angular or rotational correction; other phalanges, any toe
28315	Sesamoidectomy, first toe (separate procedure)
28750	Arthrodesis, great toe; metatarsophalangeal joint

ICD-10 Diagnosis

Refer to the ICD-10 CM manual

Appendix

Wagner classification of diabetic foot ulcers

Grade	Description
0	Skin intact but bony deformities lead to “foot at risk”
1	Superficial ulcer
2	Deeper, full thickness extension
3	Deep abscess formation or osteomyelitis
4	Partial gangrene of forefoot
5	Extensive gangrene

History

Status	Review Date	Effective Date	Action
Revised	04/15/2026	11/15/2026	Independent Multispecialty Physician Panel (IMPP) review. Standardized required duration of conservative management to 12 weeks across all procedures, with an allowance for shorter duration for severe ADL impacts. New criteria for sesamoid surgery. New criteria to address the use of electrical and ultrasound bone growth stimulation devices for treatment of orthopedic conditions of the appendicular skeleton. Added references. Added CPT codes 20974, 20979; HCPCS codes E0747, E0748, E0749, E0760.
Revised	04/21/2025	11/15/2025	IMPP review. Revised Clinical Appropriateness Framework to address unlisted procedures and post-service authorization. General criteria – lowered VAS pain rating threshold from 4 to 3. Hallux Rigidus Surgery – added criterion for nonhealing ulcer on dorsum of great toe. Revision Total Ankle Arthroplasty – added criteria related to periprosthetic joint infection. Total Ankle Arthroplasty – added contraindication for “intra-articular corticosteroid injection within the past 6 weeks in the joint being replaced.” Minor clarifications in multiple sections.
Revised	04/15/2024	11/17/2024	IMPP review. First MTP joint arthrodesis and first MTP joint arthroplasty: removed 3-month requirement for conservative management. For first MTP joint arthroplasty, added allowance for failed prior hallux rigidus surgery. Ankle arthrodesis and total ankle arthroplasty – removed requirement for conservative management when there is severe osteoarthritis. Revision total ankle arthroplasty – added requirement for reconstruction after the management of periprosthetic infection. Added required language to General Clinical Guideline per new Medicare regulations. Updated references.
Updated	n/a	01/01/2024	Annual CPT code update. Description changes for 28292, 28295, 28296, 28297, 28298, 28299.
Revised	04/12/2023	11/05/2023	IMPP review. Procedures for hallux rigidus, hallux valgus, bunionette and lesser toe deformities – removed poor wound healing as a contraindication. Hallux valgus surgery – added allowance for pre-ulcer and criterion for simple exostectomy/resection medial eminence. Separated bunionette surgery indications from hallux valgus surgery; added indication for first MTP joint arthrodesis. Separated metatarsal osteotomy criteria into a standalone indication; added exclusion for improved cosmesis. Ankle arthritis – new indication for revision total ankle arthroplasty. Ankle arthroplasty – removed severe ankle deformity and peripheral neuropathy as contraindications. Added references. Added guidance for correct coding to code section.
Revised	05/09/2022, 11/11/2021	09/11/2022	IMPP review. Removed requirement for 6 months of symptoms from all indications. For Ankle Arthritis indications, reduced conservative management requirement to 3 months. Added peripheral neuropathy/Charcot joint exclusion for hallux rigidus surgery. In contraindications (all procedures), removed “with non-healing ulcerative wounds” for peripheral vascular disease.
Revised	11/11/2021	06/12/2022	IMPP review. New indication for first metatarsophalangeal joint arthroplasty with criteria for select implants. Hallux rigidus surgery exclusions: clarified specific types of excluded implants; excluded metatarsophalangeal joint arthroplasties for any other indications; removed exclusion for percutaneous osteotomy. Hallux valgus/bunionette: removed exclusion for implant arthroplasties. Lesser toe deformities: removed exclusions for implant arthroplasties and intramedullary fixation devices.
Revised	12/03/2020	03/14/2021	IMPP review. Clarified requirements for imaging reports. Removed radiographic requirement for confirmation of lesser toe deformities. Ankle arthrodesis and total ankle arthroplasty added as new indications for revision of failed previous reconstructions. Removed total ankle arthroplasty requirements for adjacent joint or inflammatory arthritis. Clarified contraindications only apply to total ankle arthroplasty.
Created	05/11/2020	11/01/2020	Original effective date. IMPP review.

Small Joint Surgery 2026-11-15

Clinical Appropriateness Guidelines

Table of Contents

Description and Application of the Guidelines

General Clinical Guideline

Clinical Appropriateness Framework

Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions

Repeat Diagnostic Intervention

Repeat Therapeutic Intervention

Small Joint Surgery of the Foot and Ankle

General Requirements and Documentation

General Recommendations

Hallux Rigidus Surgery

Description and Scope

Table 1. Grading Scales for Hallux Rigidus

Clinical Indications

Hallux Rigidus Surgery

First Metatarsophalangeal Joint Arthrodesis

First Metatarsophalangeal Joint Arthroplasty

Contraindications

All Hallux Rigidus Procedures

Exclusions

References

Hallux Valgus and Bunionette Surgery

Description and Scope

Clinical Indications

Hallux Valgus Surgery

First Metatarsophalangeal Joint Arthrodesis for Hallux Valgus

Bunionette Surgery

Sesamoid Surgery

Contraindications

All Hallux Valgus/Bunionette Procedures

Exclusions

References

Metatarsal Osteotomy

Clinical Indications

Contraindications

All Osteotomy Procedures

Exclusions

Lesser Toe Deformities

Description and Scope

Clinical Indications

Lesser Toe Deformity Surgery

Contraindications

All Lesser Toe Deformity Procedures

Exclusions

References

Ankle Arthritis

Description and Scope

Clinical Indications

Ankle Arthrodesis

Total Ankle Arthroplasty

Revision or Conversion of a Prior Ankle Arthroplasty

Contraindications

Ankle Arthrodesis

Ankle Arthroplasty Procedures

Exclusions for all ankle procedures

References

Bone Growth Stimulation of the Appendicular Skeleton: Noninvasive, Invasive, Semi-Invasive

Scope

Clinical Indications

Noninvasive Electrical Bone Growth Stimulation

Exclusions

Invasive and Semi-Invasive Bone Growth Stimulators

Ultrasound Bone Growth Stimulation (Low-Intensity Pulsed Ultrasound)

Exclusions

Exclusions

References

Codes

Appendix

Wagner classification of diabetic foot ulcers

History

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