Description

A bunion or hallux valgus deformity consists of a lateral deviation from a straight line of the great toe toward the other toes of the foot with medial deviation of the 1st metatarsophalangeal (MTP) joint. The tissues surrounding the joint may become inflamed and painful. However, not all bunion deformities may cause symptoms. A bunion has many etiologies including, but not limited to, arthritic conditions, heredity or trauma while aggravation to the deformity may occur due to faulty foot mechanics or tight fitting shoe wear. This progressive deformity is not a single disorder but a complex deformity of the 1st ray or the column of bones that form the medial border of the forefoot.

Bunion and Bunionette Surgical Treatments

Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Surgery may be recommended to correct the deformity and reconstruct the bones and joints, restoring normal pain-free function to individuals having difficulty walking and/or experiencing pain despite accepted conservative treatments.

Surgical repair of hallux valgus may include an osteotomy (cutting portions of bone on each side of the toe joint followed by realignment), shortening or lengthening tendons or ligaments, shaving tissue from the bunion, or arthrodesis (removing damaged portions of the joint and using screws, wires or a plate to hold the joint together). Several operative procedures and osteotomies have been devised and modified over time. The precise intervention employed depends on careful clinical and radiological evaluation and planning, as all hallux valgus deformities are unique and no single osteotomy procedure can treat them all.

Bunionette or tailor’s bunion

Is a bony prominence on the lateral side of the 5th metatarsal head (toe). A painful callus or a localized keratosis may form beneath the 5th metatarsal head along with the bursa on the lateral side of the toe. Surgical repair may be necessary when severe pain limits an individual’s ability to walk.

Hallux limitus

Refers to a great toe that lacks normal motion but does not demonstrate degenerative arthritic changes at the MTP joint. This condition may originate from inflammation, thickening of the joint capsule or from an unknown cause. Uncontrolled studies suggest that surgery provides long-term relief of pain and improved function.

Hallux rigidus

Is a progressive disorder characterized by limitation of movement along with a dorsal bunion at the MTP joint of the great toe most often caused in an adult by degenerative arthritis. An individual with hallux rigidus may have a history of pain and stiffness in the 1st MTP joint that increases with activity and is aggravated by shoes. Many surgical procedures for hallux rigidus have been recommended including, but not limited to, arthrodesis (fusion) or resection arthroplasty.

A 1st MTP joint replacement, also known as total prosthetic arthroplasty, is an alternative to an arthrodesis surgical procedure for those individuals with disabling pain and lack of motion in the 1st MTP joint not improved with conservative and/or surgical treatment due to degenerative or post traumatic arthritis (hallux rigidus). The US Food & Drug Administration (FDA) have approved both partial and full replacements.

Bunion and Bunionette Surgical Treatments

Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Replacement implants made of acrylic, biocompatible hydrogel, metal, metal alloys and silastic. Ceramic (eg, Moje implant) and modular (eg, Metis implant) 1st MTP joint total replacement implants are currently not approved by the FDA. (Refer to Coverage Limitations section)

A molded cylindrical 1st MTP joint implant, created from a biocompatible hydrogel made of polyvinyl alcohol and saline, purportedly has elastic and compressive mechanical properties similar to articular cartilage and maintains range of motion in the joint. An example of an FDA-approved molded cylindrical implant includes, but may not be limited to, Cartiva Synthetic Cartilage Implant (SCI).¹³ (Refer to Coverage Limitations section)

Coverage Bunion/Hallux Valgus Deformity

Bunion/Hallux Valgus Deformity Humana members may be eligible under the Plan for bony correction bunion or hallux valgus surgery (eg, osteotomy or resection procedures) when the following criteria are met:

Coverage Determination

• Radiographic* confirmation of an intermetatarsal (IM) angle greater than 9 degrees and/or hallux valgus (HV) angle greater than 20 degrees; AND
• Documentation of persistent pain and difficulty walking despite at least 3 months of conservative treatment under the direction of a healthcare professional with ALL of the following:
  • Alternative or modified footwear; AND
  • Corticosteroid injections if medically appropriate and not contraindicated. Intra-articular steroid injections should be avoided 3 months prior to planned bunion surgery; AND
  • Foot orthotics (shoe inserts) (generally certificate excluded); AND
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) or oral analgesics if medically appropriate and not contraindicated; AND
• Protective cushions/pads; AND any of the following:
  • Development of a neuroma secondary to the bunion; OR
  • Limited or painful range of motion and pain upon palpation at the 1st toe MTP joint; OR
  • Nonhealing ulceration caused by bunion; OR
  • Painful prominence of the dorsiflexed 2nd toe due to pressure from the 1st toe;

*Radiographic confirmation must include interpretation of weight bearing anterior/posterior and lateral views of the affected foot.

Humana members may be eligible under the Plan for simple bunionectomy or soft tissue correction of the hallux valgus when the following criteria are met:

• Radiographic* confirmation of an HV angle of 15 degrees or greater and no degenerative changes to the MTP joint; AND
• Documentation of persistent pain and difficulty walking despite at least 3 months of conservative treatment under the direction of a healthcare professional with ALL of the following:
  • Alternative or modified footwear; AND
  • Corticosteroid injections if medically appropriate and not contraindicated. Intra-articular steroid injections should be avoided 3 months prior to planned bunion surgery; AND
  • Foot orthotics (shoe inserts) (generally excluded by certificate); AND
  • NSAIDs or oral analgesics if medically appropriate and not contraindicated;

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Protective cushions/pads*Radiographic confirmation must include interpretation of weight-bearing anterior/posterior and lateral views of the affected foot.

Hallux Limitus/Rigidus

Humana members may be eligible under the Plan for surgical correction of the MTP joint (eg, hallux limitus or rigidus) when the following criteria are met:

• Radiographic* confirmation of osteoarthritis within the 1st MTP joint, when performing surgical procedures for hallux rigidus, as evidenced by any of the following:
  • Cysts in the metatarsal head; OR
  • Loss of the cartilage space between the bones; OR
  • Mild to moderate bony proliferative pathology; AND
• Documentation of persistent pain and difficulty walking despite at least months of conservative treatment under the direction of a healthcare professional with ALL of the following:
  • Alternative or modified footwear; AND
  • Corticosteroid injections if medically appropriate and not contraindicated. Intra-articular steroid injections should be avoided 3 months prior to planned surgical correction of the MTP joint; AND
  • Foot orthotics (shoe inserts) (generally excluded by certificate); AND
  • NSAIDs or oral analgesics if medically appropriate and not contraindicated; AND
  • Protective cushions/pads

Bunion and Bunionette Surgical Treatments
Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012
Page: 6 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Bunionette

Humana members may be eligible under the Plan for bunionette surgery (eg, osteotomy or resection procedures) when the following criteria are met:

• Radiographic* confirmation of an IM angle 10 degrees or greater and a lateral deviation angle 14 degrees or greater of the 5th MTP joint when performing an osteotomy; OR
• Radiographic* confirmation of bony prominence when performing a simple resection; AND
• Documentation of persistent pain and difficulty walking despite at least 3 months of conservative treatment under the direction of a healthcare professional with ALL of the following:
  • Alternative or modified footwear; AND
  • Corticosteroid injections if medically appropriate and not contraindicated. Intra-articular steroid injections should be avoided 3 months prior to planned bunionette surgery; AND
  • Foot orthotics (shoe inserts) (generally excluded by certificate); AND
  • NSAIDS or oral analgesics if medically appropriate and not contraindicated; AND
  • Protective cushions/pads

Radiographic confirmation must include interpretation of weight bearing anterior/posterior and lateral views of the affected foot.

Bunion and Bunionette Surgical Treatments
Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012
Page: 7 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Humana members may be eligible under the Plan for repeat bunion surgical treatment (eg, arthrodesis) following failure of a previous surgical procedure.

MTP Joint Replacement

Humana members may be eligible under the Plan for a partial or total replacement of the 1st MTP joint with an FDA-approved device when the following criteria are met:

• Absence of contraindications; AND
• Radiographic* confirmation of disabling hallux valgus or disabling degenerative or post traumatic arthritis (hallux rigidus stage three or four); AND
• Documentation of persistent pain and difficulty walking despite at least 3 months of conservative treatment under the direction of a healthcare professional with ALL of the following:
  1. Alternative or modified footwear; AND
  2. Corticosteroid injections if medically appropriate and not contraindicated. Intra-articular steroid injections should be avoided 3 months prior to planned MTP joint replacement surgery; AND
  3. Foot orthotics (shoe inserts) (generally excluded by certificate); AND
  4. NSAIDs or oral analgesics if medically appropriate and not contraindicated; AND
  5. Protective cushions/pads

*Radiographic confirmation must include interpretation of weight-bearing anterior/posterior and lateral views of the affected foot.

Humana members may be eligible under the Plan for total replacement of the 1st MTP joint following failure of a previous proximal phalanx resection (implant) surgical procedure.

Bunion and Bunionette Surgical Treatments
Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012
Page: 8 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. (Refer to the Coverage Limitations section)

Coverage Limitations

Humana members may NOT be eligible under the Plan for bunion, bunionette or hallux valgus surgery for any indications other than those listed above including, but may not be limited to, when performed for cosmetic purposes (to improve or change your appearance or self-esteem). All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for specific definition.

Humana members may NOT be eligible under the Plan for a MTP joint replacement for any indications other than those listed above including any joint other than the 1st MTP joint. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Contraindications to 1st MTP joint replacement include, but may not be limited to:

• Active infection of the foot; OR
• Allergy to polyvinyl alcohol; OR
• Inadequate bone stock due to:
  • Avascular necrosis
  • Congenital dislocation
  • Large osteochondral cyst (greater than 1 cm)
  • Malignancy
  • Osteoporosis; OR
• Lesions of the 1st MTP joint greater than 10 mm; OR

Bunion and Bunionette Surgical Treatments
Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012
Page: 9 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Systemic and metabolic disorders leading to progressive deterioration of bone and/or tumors of the supporting bone structures

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for replacement of the 1st MTP joint with the following implants/prosthesis:

• Ceramic prosthesis (eg, Moje); OR
• Modular implant (eg, Metis); OR
• Molded cylindrical implant (eg, Cartiva SCI)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about bunions, bunionette, hallux limitus or rigidus or MTP joint replacement may be found from the following websites:

• American College of Foot and Ankle Surgeons
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual's health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Provider Claims Codes

Bunion and Bunionette Surgical Treatments
Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

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26535	Arthroplasty, interphalangeal joint; each joint
26536	Arthroplasty, interphalangeal joint; with prosthetic implant, each joint
28110	Ostectomy, partial excision, fifth metatarsal head (bunionette) (separate procedure)
28240	Tenotomy, lengthening, or release, abductor hallucis muscle
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 (bunionectomy), with sesamoidectomy, when performed; with resection of proximal phalanx base, when performed, any method
28295	Correction, hallux valgus (bunionectomy), with sesamoidectomy, when performed; with proximal metatarsal osteotomy, any method Correction, hallux valgus (bunionectomy), with
28297	sesamoidectomy, when performed; with distal metatarsal osteotomy, any method Correction, hallux valgus (bunionectomy), with sesamoidectomy, when performed; with first metatarsal and
28298	medial cuneiform joint arthrodesis, any method Correction, hallux valgus (bunionectomy), with sesamoidectomy, when performed; with proximal phalanx
28299	osteotomy, any method Correction, hallux valgus (bunionectomy), with sesamoidectomy, when performed; with double osteotomy,
28308	any method Osteotomy, with or without lengthening, shortening or angular
28310	Osteotomy, shortening, angular or rotational correction; . proximal phalanx, first toe (separate procedure)
28740	Arthrodesis, midtarsal or tarsometatarsal, single joint
28750	Arthrodesis, great toe; metatarsophalangeal joint
28899	Unlisted procedure, foot or toes	Not Covered if used to report any treatment outlined in Coverage Limitations section
cPT® Category III Code(s)	Description	Comments
No code(s) identified
HCPCS Code(s)	Description	Comments
L8641	Metatarsal joint implant	Not Covered if used to report any implant outlined in Coverage Limitations section
L8642	Hallux implant	Not Covered if used to report any implant outlined in Coverage Limitations section
L8658 Interphalangeal joint spacer, silicone or equal, each
L8699	Prosthetic implant, not otherwise specified	Not Covered if used to report any implant outlined in Coverage Limitations section

Bunion and Bunionette Surgical Treatments
Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012
Page: 11 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.
Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

• American College of Foot and Ankle Surgeons (ACFAS). ACFAS position statement on cosmetic surgery. https://www.acfas.org. Published February 2020.

Bunion and Bunionette Surgical Treatments
Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012
Page: 12 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

American College of Foot and Ankle Surgeons (ACFAS). Clinical Practice Guideline (ARCHIVED). Diagnosis and treatment of forefoot disorders. https://www.acfas.org. Published March/April 2009. Accessed April 13, 2023.

American Orthopaedic Foot and Ankle Society (AOFAS). Position Statement. Cosmetic foot and ankle surgery. https://www.aofas.org. Published May 5, 2015. Updated October 12, 2021. Accessed April 13, 2023.

ClinicalKey. Murphy GA. Disorders of the hallux. In: Azar FM, Beaty JH. Campbell's Operative Orthopaedics, 14th ed. Elsevier; 2021:4041-4153.e7. https://www.clinicalkey.com. Accessed April 13, 2023.

ClinicalKey. Murphy GA. Lesser toe abnormalities. In: Azar FM, Beaty JH. Campbell's Operative Orthopaedics, 14th ed. Elsevier; 2021:4227-4283.e3. https://www.clinicalkey.com. Accessed April 13, 2023.

ECRI Institute. Clinical Evidence Assessment. Cartiva synthetic cartilage (Cartiva, Inc.) for treating arthritis of the first metatarsophalangeal joint. https://www.ecri.org. Published July 19, 2017. Updated January 15, 2020. Accessed June 3, 2022.

ECRI Institute. Clinical Evidence Assessment. Lapiplasty (Treace Medical Concepts, Inc.) for treating hallux valgus deformity (bunions). https://www.ecri.org. Published October 12, 2020. Accessed April 13, 2023.

ECRI Institute. Clinical Evidence Assessment. Lesser Hemi MPJ implant (BIOPRO) for treating metatarsophalangeal joint arthritis. https://www.ecri.org. Published March 11, 2021. Accessed April 13, 2023.

ECRI Institute. Hotline Response (ARCHIVED). Surgery for treating hallux rigidus. https://www.ecri.org. Published August 10, 2018. Accessed June 10, 2021.

ECRI Institute. Product Brief. HemiCAP MTP resurfacing hemi-arthroplasty implant (Arthrosurface, Inc.) for treating arthritis of the first metatarsophalangeal joint. https://www.ecri.org. Published September 9, 2019. Accessed June 3, 2022.

ECRI Institute. Product Brief. Minimally invasive bunion (MIB) plating system (Trlliant Surgical) for treating hallux valgus deformity. https://www.ecri.org. Published July 31, 2019. Accessed June 3, 2022.

ECRI Institute. Product Brief. Reference toe system (IN2Bones) for first metatarsophalangeal joint arthroplasty. https://www.ecri.org. Published January 1, 2019. Accessed June 10, 2021.

Hayes, Inc. Clinical Research Response. Lapiplasty (Treace Medical Concepts Inc.) for the correction of hallux valgus. https://evidence.hayesinc.com. Published January 23, 2023. Accessed April 17, 2023.

Hayes, Inc. Health Technology Brief (ARCHIVED). Cartiva synthetic cartilage implant (Wright Medical, Group) for treatment of first metatarsophalangeal joint arthritis. https://evidence.hayesinc.com. Published May 22, 2020. Updated Accessed April 18, 2023.

MCG Health. Bunionectomy. 26th edition. https://www.mcg.com. Accessed April 18, 2023.

UpToDate, Inc. Evaluation and diagnosis of common causes of forefoot pain in adults. https://www.uptodate.com. Updated March 2023. Accessed April 18, 2023.

UpToDate, Inc. Hallux valgus deformity (bunion).https://www.uptodate.com. Updated March 2023.

Accessed April 18, 2023.

US Food & Drug Administration (FDA). 510(k) summary: Arthrosurface Toemotion. https://www.fda.gov. Published February 26, 2014. Accessed June 10, 2021.

US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Cartiva Synthetic Cartilage Implant (SCI). https://www.fda.gov. Published April 20, 2016. Accessed May 28, 2019.

Bunion and Bunionette Surgical Treatments
Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0541-012
Page: 14 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

APPENDIX A Grading of Severity of Hallux Rigidus (Coughlin and Shurnas)

Grade	Radiograph	Pain	MTP joint motion
0	Normal		Stiffness or slight loss
1	Minor narrowing of MTP joint space	Intermittent	Mild restriction
2	Moderate joint space narrowing, osteophyte formation	More consistent	Moderate restriction
3	Severe joint space narrowing, extensive osteophyte formation	Constant (no pain at midrange of MTP joint motion)	Moderately severe restriction (less the 20 degrees total motion)
4	Same as grade 3	Pain at midrange of passive MTP	Same as grade 3