Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

Medical Policy: Foot Surgery- Bunion/Hammertoe/Metatarsophalangeal Joint (Commercial)

POLICY NUMBER LAST REVIEW DATE APPROVED BY

MG.MM.ME.SU.70v2a 05/07/2021 MPC (Medical Policy Committee) IMPORTANT NOTE ABOUT THIS MEDICAL POLICY: Property of ConnectiCare, Inc. All rights reserved. The treating physician or primary care provider must submit to ConnectiCare, Inc. the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, ConnectiCare will not be able to properly review the request for prior authorization. This clinical policy is not intended to pre-empt the judgment of the reviewing medical director or dictate to health care providers how to practice medicine. Health care providers are expected to exercise their medical judgment in rendering appropriate care. The clinical review criteria expressed below reflects how ConnectiCare determines whether certain services or supplies are medically necessary. ConnectiCare established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence- based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). ConnectiCare, Inc. expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Identification of selected brand names of devices, tests and procedures in a medical coverage policy is for reference only and is not an endorsement of any one device, test or procedure over another. Each benefit plan defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by ConnectiCare, as some plans exclude coverage for services or supplies that ConnectiCare considers medically necessary. If there is a discrepancy between this guideline and a member's benefits plan, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of the State of CT and/or the Federal Government. Coverage may also differ for our Medicare members based on any applicable Centers for Medicare & Medicaid Services (CMS) coverage statements including including National Coverage Determinations (NCD), Local Coverage Determinations (LCD) and/or Local Medical Review Policies(LMRP). All coding and web site links are accurate at time of publication.

Related Medical Guideline Cosmetic Surgery Procedures

Definitions Hallux valgus (HV) Painful bony bump that develops on the inside of the foot at the big (1ST) deformity (aka bunion) toe joint. Pressure on the joint causes the big (1ST) toe to lean toward the second toe. Over time, the normal structure of the bone changes, resulting in the bunion bump. The deformity gradually increases causing pain when wearing shoes and walking.

Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

Hallux rigidus (aka stiff A deformity in the joint located at the base of the big (1ST) toe. It causes big (1st) toe) pain and stiffness in the big toe and, over time, bending the toe becomes more and more difficult. This condition can cause discomfort and even disability, since this important toe is used to walk, lean, climb and even stand. Hallux Rigidus is a progressive condition in which foot mobility decreases over time. In its primary phases, the mobility of the big (1st) toe is only somewhat limited ("Hallux Limitus"); however, with progression, the range of motion of the toe decreases until it reaches the final state of "Rigidus," which is when the toe remains stiff or as "frozen." Bunionette (tailor’s Painful bony prominences that occur over the lateral aspect of the fifth bunion) (little toe) metatarsophalangeal (MTP) joint Hammertoe A contracture (bending) deformity of one or both joints of the second, third, fourth, or fifth (little) toes. This abnormal bending can put pressure on the toe when wearing shoes, causing problems to develop. Hammertoes usually start out as mild deformities and get progressively worse over time. In the earlier stages, hammertoes are flexible, and the symptoms can often be managed with noninvasive measures. But if left untreated, hammertoes can become more rigid and will not respond to nonsurgical treatment.

Guideline A. Bunionectomy B. Hammertoe Repair C. Metatarsophalangeal Joint Surgical Correction D. Metatarsophalangeal Joint Replacement

A. Bunionectomy (Bunionette, Simple and Bony Correction)

General Criteria 1. Skeletal maturity 2. Symptoms of pain and walking difficulty unresponsive to ≥ 6 months of conservative therapy (≥ 2 must be applicable): a. Change in footwear b. Padding or orthotics (shoe inserts) c. Nonsteroidal anti-inflammatory drugs (NSAIDS) d. Local injections to the first metatarsophalangeal joint (e.g., local anesthesia or steroid)

Bunion Considered medically necessary when the General Criteria above are met with radiologic imaging confirmation of a MTP joint of at least 16 degrees and an Intermetatarsal angle (IMA) of at least 10 degrees

Simple Bunionectomy (e.g., modified McBride, Silver Procedure) Considered medically necessary when the General Criteria above are met with radiologic imaging confirmation of a hallux valgus angle (HVA) of at least 15 degrees and one:

Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

1. Presence of diabetes and ulcers or infection originating from the bunion 2. Foot pain limiting everyday activity (walking, wearing reasonable shoes) 3. Chronic big toe inflammation and swelling that does not improve with rest and medications 4. Toe deformity that causes drifting in of the big (1st) toe toward smaller toes 5. Toe stiffness that causes inability to bend and straighten the big toe

Bony Correction Bunionectomy (e.g., Akin, Chevron, Keller, Lapidus, Mitchell, proximal metatarsal osteotomy procedures, etc.) Considered medically necessary when the General Criteria above are met and both:

1. Radiologic imaging confirmation of a hallux valgus angle (HVA) of at least 30 degrees 2. Intermetatarsal angle (IMA) of at least 13 degrees and one: i. Significant foot pain that limits everyday activities (walking, wearing reasonable shoes) ii. Chronic big (1st) toe inflammation and swelling that does not improve with rest or medications iii. Toe deformity that causes a drifting in of the big (1st) toe toward smaller toes iv. Toe stiffness that causes inability to bend and straighten the big (1st) toe Limitations/Exclusions A bilateral bunionectomy done at the same time generally not considered medically necessary unless extenuating circumstances are present Bony correction bunionectomy is considered experimental, investigational or unproven for all of the following: ▪ Foot ulcer(s) secondary to peripheral vascular disease ▪ Gangrene of the foot, ankle or lower leg ▪ Non-ambulatory members (unless surgery is to relieve ulceration due to prominence) ▪ Open blisters, pressure sores, and skin ulceration overlying the bunion when the bunion is not the cause of the skin lesion (bony correction may lead to osteomyelitis) ▪ Poor tissues at the operative site due to excessive scarring and multiple closely placed previous incisions ▪ Severe vascular insufficiency significantly impairing foot-circulation (e.g., absent foot pulses, intermittent claudication, ankle/arm ratio < 0.6) ▪ Cosmetic appearance of the foot

B. Hammertoe Repair (i.e., surgical correction of hammertoe, claw toe, or mallet toe) Hammertoe repair is considered medically necessary for members ≥ 18 years of age (or skeletally mature) when ≥ 1 of the following clinical indications is applicable: 1. Adventitious bursitis on the dorsal surface of the hammertoe 2. Ankylosis of the distal interphalangeal (DIP) joint or proximal interphalangeal (PIP) joint 3. Inter-digital neuroma caused by the deformity 4. Lateral metatarsophalangeal (MTP) capsular tear caused by the deformity Proprietary information of ConnectiCare. © 2021 ConnectiCare, Inc. & Ppage 3 of 14 Affiliates

Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

5. Painful nail conditions secondary to persistent trauma 6. Presence of co-existing or causative conditions (e.g., tendon contracture) that need repair 7. Subluxation or dislocation of the MTP joint 8. Synovitis/capsulitis of the MTP joint 9. Ulceration of the apices

Documentation should detail all: 1. Radiographic confirmation of deformity (i.e., interpretation and report of anterior/posterior and lateral views of the affected foot) 2. Skeletal maturity (epiphyseal closure) 3. Symptoms unresponsive to ≥ 3 months of conservative management directed by a healthcare professional (≥ 2 must be applicable): i. Corticosteroid injections ii. Debridement of associated hyperkeratotic lesions (e.g., corns, calluses) iii. Foot orthotics (e.g., adaptive footwear such as shoe inserts, footgear modifications, corrective splinting)/orthopedic shoes (i.e., wide/deep toe box) (Note: benefit exclusions may apply) iv. Oral analgesics and/or nonsteroidal anti-inflammatory drugs (NSAIDs) v. Protective padding vi. Taping or adhesive devices

Repeat hammer toe surgery is considered medically necessary following failure of a previous surgical procedure

Limitations/Exclusions Fixation implants are considered experimental, investigational or unproven (e.g., Acumed Hammertoe Fusion Set, BME Hammerlock Implant, CannuLink Intramedullary Fusion Device, CrossTie Intraosseous Fixation System, Futura Flexible Digital Implant, Futura LMP Lesser Phalangeal Joint Implant, HammerFix IP Fusion System, Integra Hammertoe Implant, OsteoMed Interflex IPG System, Pro-Toe Hammertoe Implant, Smart Toe, StayFuse Fusion Device, ToeGrip Device, Two-Step Hammer Toe Implant, Weil-Carver Hammertoe Implant and the Wright Cann Phalinx System)

C. Metatarsophalangeal (MTP) Joint — Surgical Correction Surgical correction (e.g., arthrodesis, cheilectomy, Keller procedure [resection arthroplasty]) of the first MTP joint (e.g., hallux rigidus) is considered medically necessary in skeletally mature members with osteoarthritis (OA). Documentation should detail all: 1. Skeletal maturity (epiphyseal closure) 2. Radiologic confirmation of OA as evidenced by any: i. Cysts in the metatarsal head ii. Loss of cartilage between bones iii. Mild to moderate bony proliferative pathology

Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

healthcare professional (≥ 2 must be applicable): i. Alternative or modified footwear ii. Corticosteroid injections iii. Debridement of associated hyperkeratotic lesions (e.g., corns, calluses) iv. Foot orthotics (e.g., adaptive footwear such as shoe inserts, footgear modifications, corrective splinting) (Note: benefit exclusions may apply) v. Oral analgesics or nonsteroidal anti-inflammatory drugs (NSAIDS) vi. Protective cushions/pads vii. Taping or adhesive devices

D. Metatarsophalangeal (MTP) Joint — Replacement Partial or total replacement of the first MTP (hallux rigidus) joint is considered medically necessary for disabling arthritis by either hemiarthroplasty or total prosthetic replacement arthroplasty with silastic or metallic implants.

Limitations/Exclusions The following services are considered experimental, investigational or unproven: ▪ MTP joint replacement for joints other than the first MTP joint ▪ Ceramic implants (e.g., Moje prosthesis) ▪ Synthetic implants (e.g., Cartiva Synthetic Cartilage Implant, METIS prosthesis, OsteoMed ReFlexion 1st MTP Implant System and the ToeFit-Plus prosthesis) ▪ Interpositional arthroplasty with biologic spacers for hallux rigidus, degenerative arthritis, and other indications involving the MTP joints

Applicable Procedure Codes

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 (bunionectomy), with sesamoidectomy, when performed; with resection of proximal phalanx base, when performed, any method 28296 Correction, hallux valgus (bunionectomy), with sesamoidectomy, when performed; with distal metatarsal osteotomy, any method 28297 Correction, hallux valgus (bunionectomy), with sesamoidectomy, when performed; with first metatarsal and medial cuneiform joint arthrodesis, any method 28298 Correction, hallux valgus (bunionectomy), with sesamoidectomy, when performed; with proximal phalanx osteotomy, any method 28299 Correction, hallux valgus (bunionectomy), with sesamoidectomy, when performed; with double osteotomy, any method Applicable Diagnosis Codes

G57.60 Lesion of plantar nerve, unspecified lower limb G57.61 Lesion of plantar nerve, right lower limb G57.62 Lesion of plantar nerve, left lower limb G57.63 Lesion of plantar nerve, bilateral lower limbs L97.501 Non-pressure chronic ulcer of other part of unspecified foot limited to breakdown of skin L97.502 Non-pressure chronic ulcer of other part of unspecified foot with fat layer exposed Proprietary information of ConnectiCare. © 2021 ConnectiCare, Inc. & Ppage 5 of 14 Affiliates

Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

L97.503 Non-pressure chronic ulcer of other part of unspecified foot with necrosis of muscle L97.504 Non-pressure chronic ulcer of other part of unspecified foot with necrosis of bone L97.505 Non-pressure chronic ulcer of other part of unspecified foot with muscle involvement without evidence of necrosis L97.506 Non-pressure chronic ulcer of other part of unspecified foot with bone involvement without evidence of necrosis L97.508 Non-pressure chronic ulcer of other part of unspecified foot with other specified severity L97.509 Non-pressure chronic ulcer of other part of unspecified foot with unspecified severity L97.511 Non-pressure chronic ulcer of other part of right foot limited to breakdown of skin L97.512 Non-pressure chronic ulcer of other part of right foot with fat layer exposed L97.513 Non-pressure chronic ulcer of other part of right foot with necrosis of muscle L97.514 Non-pressure chronic ulcer of other part of right foot with necrosis of bone L97.515 Non-pressure chronic ulcer of other part of right foot with muscle involvement without evidence of necrosis L97.516 Non-pressure chronic ulcer of other part of right foot with bone involvement without evidence of necrosis L97.518 Non-pressure chronic ulcer of other part of right foot with other specified severity L97.519 Non-pressure chronic ulcer of other part of right foot with unspecified severity L97.521 Non-pressure chronic ulcer of other part of left foot limited to breakdown of skin L97.522 Non-pressure chronic ulcer of other part of left foot with fat layer exposed L97.523 Non-pressure chronic ulcer of other part of left foot with necrosis of muscle L97.524 Non-pressure chronic ulcer of other part of left foot with necrosis of bone L97.525 Non-pressure chronic ulcer of other part of left foot with muscle involvement without evidence of necrosis L97.526 Non-pressure chronic ulcer of other part of left foot with bone involvement without evidence of necrosis L97.528 Non-pressure chronic ulcer of other part of left foot with other specified severity L97.529 Non-pressure chronic ulcer of other part of left foot with unspecified severity M12.271 Villonodular synovitis (pigmented), right ankle and foot M12.272 Villonodular synovitis (pigmented), left ankle and foot M12.279 Villonodular synovitis (pigmented), unspecified ankle and foot M19.071 Primary osteoarthritis, right ankle and foot M19.072 Primary osteoarthritis, left ankle and foot M19.079 Primary osteoarthritis, unspecified ankle and foot M19.171 Post-traumatic osteoarthritis, right ankle and foot M19.172 Post-traumatic osteoarthritis, left ankle and foot M19.179 Post-traumatic osteoarthritis, unspecified ankle and foot M20.10 Hallux valgus (acquired), unspecified foot M20.11 Hallux valgus (acquired), right foot M20.12 Hallux valgus (acquired), left foot M20.20 Hallux rigidus, unspecified foot M20.21 Hallux rigidus, right foot M20.22 Hallux rigidus, left foot M20.40 Other hammer toe(s) (acquired), unspecified foot M20.41 Other hammer toe(s) (acquired), right foot M20.42 Other hammer toe(s) (acquired), left foot M20.5x1 Other deformities of toe(s) (acquired), right foot M20.5X2 Other deformities of toe(s) (acquired), left foot M20.5X9 Other deformities of toe(s) (acquired), unspecified foot M20.60 Acquired deformities of toe(s), unspecified, unspecified foot M20.61 Acquired deformities of toe(s), unspecified, right foot M20.62 Acquired deformities of toe(s), unspecified, left foot M21.611 Bunion of right foot M21.612 Bunion of left foot

Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

M21.619 Bunion of unspecified foot M21.621 Bunionette of right foot M21.622 Bunionette of left foot M21.629 Bunionette of unspecified foot M21.6X1 Other acquired deformities of right foot M21.6X2 Other acquired deformities of left foot M21.6X9 Other acquired deformities of unspecified foot M24.69 Ankylosis, other specified joint (eff. 10/01/2020) M24.574 Contracture, right foot M24.575 Contracture, left foot M24.576 Contracture, unspecified foot M24.671 Ankylosis, right ankle M24.672 Ankylosis, left ankle M24.673 Ankylosis, unspecified ankle M24.674 Ankylosis, right foot M24.675 Ankylosis, left foot M24.676 Ankylosis, unspecified foot M65.871 Other synovitis and tenosynovitis, right ankle and foot M65.872 Other synovitis and tenosynovitis, left ankle and foot M65.879 Other synovitis and tenosynovitis, unspecified ankle and foot M67.00 Short Achilles tendon (acquired), unspecified ankle M67.01 Short Achilles tendon (acquired), right ankle M67.02 Short Achilles tendon (acquired), left ankle M77.50 Other enthesopathy of unspecified foot and ankle M77.51 Other enthesopathy of right foot and ankle M77.52 Other enthesopathy of left foot and ankle M77.9 Enthesopathy, unspecified [synovitis/capsulitis] Q66.6 Other congenital valgus deformities of feet Q66.7 Congenital pes cavus [claw toe, congenital] Q66.89 Other specified congenital deformities of feet Q74.2 Other congenital malformations of lower limb(s), including pelvic girdle [subluxation or dislocation MP joint] S93.101A Unspecified subluxation of right toe(s), initial encounter S93.101D Unspecified subluxation of right toe(s), subsequent encounter S93.101S Unspecified subluxation of right toe(s), sequela S93.102A Unspecified subluxation of left toe(s), initial encounter S93.102D Unspecified subluxation of left toe(s), subsequent encounter S93.102S Unspecified subluxation of left toe(s), sequela S93.103A Unspecified subluxation of unspecified toe(s), initial encounter S93.103D Unspecified subluxation of unspecified toe(s), subsequent encounter S93.103S Unspecified subluxation of unspecified toe(s), sequela S93.104A Unspecified dislocation of right toe(s), initial encounter S93.104D Unspecified dislocation of right toe(s), subsequent encounter S93.104S Unspecified dislocation of right toe(s), sequela S93.105A Unspecified dislocation of left toe(s), initial encounter S93.105D Unspecified dislocation of left toe(s), subsequent encounter S93.105S Unspecified dislocation of left toe(s), sequela S93.106A Unspecified dislocation of unspecified toe(s), initial encounter S93.106D Unspecified dislocation of unspecified toe(s), subsequent encounter S93.106S Unspecified dislocation of unspecified toe(s), sequela S93.111A Dislocation of interphalangeal joint of right great toe, initial encounter S93.111D Dislocation of interphalangeal joint of right great toe, subsequent encounter S93.111S Dislocation of interphalangeal joint of right great toe, sequela S93.121A Dislocation of metatarsophalangeal joint of right great toe, initial encounter S93.121D Dislocation of metatarsophalangeal joint of right great toe, subsequent encounter S93.121S Dislocation of metatarsophalangeal joint of right great toe, sequela Proprietary information of ConnectiCare. © 2021 ConnectiCare, Inc. & Ppage 7 of 14 Affiliates

Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

S93.122A Dislocation of metatarsophalangeal joint of left great toe, initial encounter S93.122D Dislocation of metatarsophalangeal joint of left great toe, subsequent encounter S93.122S Dislocation of metatarsophalangeal joint of left great toe, sequela S93.123A Dislocation of metatarsophalangeal joint of unspecified great toe, initial encounter S93.123D Dislocation of metatarsophalangeal joint of unspecified great toe, subsequent encounter S93.123S Dislocation of metatarsophalangeal joint of unspecified great toe, sequela S93.124A Dislocation of metatarsophalangeal joint of right lesser toe(s), initial encounter S93.124D Dislocation of metatarsophalangeal joint of right lesser toe(s), subsequent encounter S93.124S Dislocation of metatarsophalangeal joint of right lesser toe(s), sequela S93.125A Dislocation of metatarsophalangeal joint of left lesser toe(s), initial encounter S93.125D Dislocation of metatarsophalangeal joint of left lesser toe(s), subsequent encounter S93.125S Dislocation of metatarsophalangeal joint of left lesser toe(s), sequela S93.126A Dislocation of metatarsophalangeal joint of unspecified lesser toe(s), initial encounter S93.126D Dislocation of metatarsophalangeal joint of unspecified lesser toe(s), subsequent encounter S93.126S Dislocation of metatarsophalangeal joint of unspecified lesser toe(s), sequela S93.129A Dislocation of metatarsophalangeal joint of unspecified toe(s), initial encounter S93.129D Dislocation of metatarsophalangeal joint of unspecified toe(s), subsequent encounter S93.129S Dislocation of metatarsophalangeal joint of unspecified toe(s), sequela

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Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

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Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

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Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

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Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

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Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

ToeFit-Plus™ prosthesis. J Foot Ankle Surg. 2014;53(3):265-268.

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Medical Policy: Foot Surgery-Bunion/Hammertoe/ Metatarsophalangeal Joint(Commercial)

Ankle Int. 2017;38(1):107.

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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):374-383.

Specialty-matched clinical peer review.

Revision history

DATE REVISION 05/07/2021 • Minor descriptive edits (i.e., 1st toe, bunion section). • Removed Arthrex metatarsal phalangeal joint implant from Limitation/Exclusion section under D. Metatarsophalangeal (MTP) Joint-Replacement. 01/01/2020 • New policy