CurrentCignaPolicy 0446

First Metatarsophalangeal (MTP) Joint Replacement

Defines medical necessity and exclusions for partial or total replacement of the first MTP joint for severe hallux valgus or hallux rigidus and lists devices/procedures considered experimental or unproven; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyFirst Metatarsophalangeal (MTP) Joint Replacement

Policy CodePolicy 0446

Change TypeAnnual review — no clinical statement changes

Effective DateSep 15, 2025

Next Review DateSep 15, 2026

Key ActionDocument persistent disabling symptoms and failed conservative management when requesting coverage or prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

first MTPJoint(s) considered medically necessary for replacement

Class 2FDA recall classification referenced for Cartiva

PMA; recallCartiva regulatory note

510(k)restor3d clearance

152Baumhauer trial implant arm

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3Annual review entries

Coverage Criteria — First MTP Joint Replacement

inv-01: Medically necessary — first MTP joint replacement

Partial or total replacement of the first MTP joint is considered medically necessary as an alternative to arthrodesis when ALL of the following are met:

Medical necessity criteria: 1) Persistent severe disabling symptoms from hallux valgus or hallux rigidus due to degenerative joint disease of the first MTP joint; AND 2) Failure of conservative medical management.

inv-03: Medically necessary implant arthroplasty

Covered when ALL of the following are met

Implant arthroplasty coverage: Use of CPT 28291 or HCPCS L8641/L8642 for first MTP joint implant may be considered medically necessary when applicable policy criteria (e.g., diagnosis of hallux rigidus, documentation of symptoms and prior conservative management per policy) are met and provider documents informed consent including alternatives.

Policy references professional guidance recommending judicious use and patient counseling about alternatives

inv-02: Experimental, investigational, or unproven

The following are considered experimental, investigational or unproven (NOT covered):

Devices and implant types: Use of ceramic implants (e.g., Moje), synthetic cartilage implants (e.g., Cartiva Synthetic Cartilage Implant), and personalized (custom patient-specific 3D printed) implants for partial or total replacement of the first MTP joint.

Anatomic sites/procedures: MTP joint replacement for joints other than the first MTP joint (lesser toes), replacement of other toe joints (e.g., interphalangeal joints), and replacement of the tarsometatarsal (TMT) joint.

inv-04: Experimental / Investigational / Unproven

Not covered / considered experimental when ANY of the following apply

Synthetic cartilage implant and certain implants: Partial replacement of the first MTP joint using synthetic cartilage implant (e.g., Cartiva SCI), replacement of any toe joint other than the first MTP joint, replacement of the tarsometatarsal (TMT) joint, or use of ceramic or personalized (3D) implants is considered experimental, investigational, or unproven due to insufficient long-term evidence.

Multiple retrospective and small studies with limited long-term data and concerns about failure/revision rates inform this stance.

The policy excludes replacement procedures outside the first metatarsophalangeal (MTP) joint. Specifically, MTP joint replacement for joints other than the first MTP joint (i.e., lesser toes), replacement of other toe joints such as interphalangeal joints, and replacement of the tarsometatarsal (TMT) joint are considered experimental, investigational, or unproven and are not covered. The documented rationale is insufficient evidence in the published medical literature to support the safety and efficacy of implants at these anatomic sites.

The policy further excludes the use of certain implant types for partial or total first MTP joint replacement. Use of ceramic implants (e.g., Moje), synthetic cartilage implants (e.g., Cartiva SCI), and personalized, patient-specific 3D printed implants for first MTP joint arthroplasty is considered experimental, investigational, or unproven and therefore not eligible for coverage.

The National Institute for Health and Care Excellence (NICE) guidance (2022) on synthetic cartilage implant (SCI) for first MTP joint osteoarthritis recommends restricted use. For patients with advanced joint disease for whom arthrodesis is indicated, NICE states the procedure should be used only with special arrangements for clinical governance, consent, and audit or research. For other individuals with hallux rigidus, NICE recommends the procedure be used only in a research context. NICE further advises that the procedure should not be used in people with inflammatory arthritis or diabetic peripheral neuropathy and highlights limited evidence on which patients and OA stages are most appropriate for the implant.

The policy distinguishes implant types and provides guidance on evidence limitations. Ceramic implants (e.g., Moje), synthetic cartilage implants (Cartiva SCI), and personalized patient-specific 3D printed implants are listed as experimental, investigational, or unproven for first MTP joint replacement due to limited long-term data and uncertain comparative effectiveness.

Published literature specific to the Cartiva SCI is limited to retrospective series, small prospective cohorts, and a single randomized trial with inconsistent individual outcome measures and limitations in power and follow-up; reports cite concerns including implant failure, removal, fragmentation, displacement, pain, infection, and nerve injury. These evidence gaps inform the policy’s noncoverage stance for Cartiva and similar synthetic cartilage devices.

Evidence for personalized 3D-printed hemiarthroplasty implants is similarly limited to small case series and reports with inadequate long-term comparative data; therefore, patient-specific 3D implants are considered experimental and not medically necessary until larger controlled studies with extended follow-up demonstrate safety and effectiveness.

Given the current evidence and the regulatory context, the policy considers the Cartiva synthetic cartilage implant experimental, investigational, or unproven for partial first MTP joint replacement. Peer-reviewed studies are limited in number and quality, show inconsistent outcomes compared with arthrodesis, and report implant removals and conversions to arthrodesis in the follow-up period. The policy’s designation reflects these evidence limitations and device safety concerns.

Revision history notes for the policy indicate that during recent annual reviews there were no clinical policy statement changes. Annual review entries dated 9/15/2023, 9/15/2024, and 9/15/2025 summarize updates to formatting and confirm no changes to the clinical coverage statements.

Coding and Device Examples

Device examples and regulatory statusmixed

RTS Flexible 1st MPJ Implant (In2BonesUSA)	Example of Class II 510(k)-cleared first MTP device
BioPro MPJ Hemi Implant	Example of Class II 510(k)-cleared hemi implant
Cartiva SCI	Cartiva Synthetic Cartilage Implant — PMA-approved device for first MTP (note: Class II recall posted 12/4/2024)
restor3d MTP Implant	510(k) cleared restor3d MTP Implant (hemiarthroplasty) - cobalt-chromium LPBF printed

Considered Medically Necessary when criteria metCPTCovered

28291

Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; with implant

Considered Medically Necessary when criteria metHCPCSCovered

L8641	Metatarsal joint implant
L8642	Hallux implant

Experimental/Investigational/Unproven reporting codesmixedNot Covered

28899	Unlisted procedure, foot or toes
L8699	Prosthetic implant, not otherwise specified

Provider Actions, Documentation & Billing

Prior Authorization

Prior Authorization / Code-based Requirement

Prior authorization and code-based reporting: Procedures using CPT 28291 or HCPCS L8641/L8642 for hallux rigidus correction with implant may be considered medically necessary when the policy criteria are met. Providers should obtain any required prior authorization per the member's benefit plan and document the indication, prior conservative therapies, and rationale for implant arthroplasty.

Affected codes: CPT 28291; HCPCS L8641, L8642
Obtain prior authorization when required by the member's plan

Denial Risk

Claims Without Covered Codes Will Be Denied

Claims must include covered diagnosis and/or procedure codes described in this policy. Claims submitted without a covered code under this policy or billed for conditions not covered by the applicable benefit plan will be denied. When billing, providers must use the most appropriate codes as of the effective date of submission (Effective Date: 2025-09-15).

Background — Conditions and Evidence Summary

Hallux valgus is characterized by lateral deviation of the great toe often associated with a bunion and difficulty with footwear; it may cause pain and functional limitations. Hallux rigidus is degenerative arthritis of the first MTP joint leading to restricted range of motion (particularly dorsiflexion), joint pain, and functional impairment. Conservative management options cited in the policy include footwear modification, orthoses, exercise/therapy, nonsteroidal anti-inflammatory medications, and injections; surgical options range from less invasive procedures (e.g., cheilectomy, osteotomy) to definitive procedures such as arthrodesis (fusion) or implant arthroplasty.

The policy notes that arthrodesis (surgical fusion of the first MTP joint) is considered a standard treatment for advanced hallux rigidus and reliably improves pain and function though it eliminates joint motion. Implant arthroplasty (partial or total replacement) is described as an alternative for selected patients who desire retention of joint motion, but its use is subject to the policy’s medical necessity criteria and limitations related to implant type and supporting evidence.

Key Definitions

Arthrodesis — surgical fusion of the first MTP joint

DefinitionSurgical fusion of the first metatarsophalangeal (MTP) joint resulting in loss of joint motion.

Primary purposeProvide reliable improvements in function and symptoms for end‑stage first MTP joint osteoarthritis (hallux rigidus).

Expected outcomeConsistent pain relief and functional improvement though joint motion is sacrificed by fusion.

Implant arthroplasty — partial or total joint replacement intended to preserve motion

DefinitionPartial or total joint replacement of the MTP joint with an artificial implant intended to preserve joint motion.

Clinical roleOffered as an alternative for select patients who wish to retain first MTP joint mobility when arthrodesis would eliminate motion.

Revision History & Review Notes

2025-09-15Annual reviewLatest

Annual review completed; no clinical policy statement changes were made.

2024-09-15Annual review

Annual review completed; no clinical policy statement changes were made.

2023-09-15Annual review

Policy Summary

PayerCigna

PolicyFirst Metatarsophalangeal (MTP) Joint Replacement

Policy CodePolicy 0446

Change TypeAnnual review — no clinical statement changes

Effective DateSep 15, 2025

Next Review DateSep 15, 2026

Key ActionDocument persistent disabling symptoms and failed conservative management when requesting coverage or prior authorization.

SourceLink

On This Page

Claims without covered diagnosis/procedure codes will be denied
Use current codes as of the date of submission (do not use legacy/unlisted codes if a specific code applies)

Denial Risk

Experimental / Investigational Coding Denial Risk

Experimental/Investigational coding and denial risk: Procedures using unlisted or nonspecific prosthetic codes to report synthetic cartilage implants or other non-covered devices (for example, CPT 28899 or HCPCS L8699) may be coded but are considered experimental, investigational or unproven per this policy and are subject to denial.

Do not expect reimbursement for partial first MTP replacement with synthetic cartilage implants (e.g., Cartiva) or replacement of other toe joints or TMT joint
Unlisted codes: CPT 28899; HCPCS L8699 — denial risk for experimental/unproven procedures

Note

Policy Revision Details

No clinical policy statement changes noted in recent annual reviews. Review history indicates no change to the clinical policy statements for this topic as of the latest annual review date (2025-09-15).

Annual review summary: No clinical policy statement changes (9/15/2025)

Documentation Required

Coding and Documentation

Coding and documentation: When reporting hallux rigidus correction with implant, use CPT 28291 or HCPCS L8641/L8642 as appropriate and document the procedure performed, the clinical indication (e.g., persistent severe disabling symptoms from hallux valgus or hallux rigidus due to degenerative joint disease), and failed conservative management. If a ceramic or personalized implant is used, note that these are considered experimental/unproven and should be documented accordingly.

Report implant arthroplasty with CPT 28291 or HCPCS L8641/L8642 when criteria met
Document: diagnosis, specific procedure, device used, prior conservative treatments tried and failed, and clinical justification for implant versus arthrodesis

Note

References: FDA Premarket Approval & Safety Information

Device safety and regulatory references: Providers should reference FDA premarket approval, MAUDE reports, and recall information when planning care and obtaining informed consent. The Cartiva device has an FDA PMA (P150017) and a documented Class 2 device recall; these details should be considered in device selection and prior authorization discussions.

FDA Premarket Approval: Cartiva Synthetic Cartilage Implant (P150017)
FDA Class 2 Device Recall information and MAUDE reports (review prior to use)

Documentation Required

Conservative Treatments and Less Invasive Options

Conservative treatments and less invasive surgical options must be attempted and documented prior to considering implant arthroplasty. Conservative options include adaptive footwear, exercises, orthoses, physical therapy, NSAIDs, and intra-articular steroid injections. Documentation should include duration, response, and rationale for escalation to surgical intervention.

Adaptive footwear and orthoses
Exercises and physical therapy
NSAIDs and intra-articular steroid injections
Document failure of conservative management prior to implant arthroplasty

Documentation Required

Guideline-Informed Patient Selection

Guideline-informed patient selection and informed consent: Use judicious selection criteria for implant arthroplasty. Inform patients of alternatives (including arthrodesis and less invasive procedures), potential complications, device-specific safety history, and that evidence for some implants (e.g., synthetic cartilage) is limited. Avoid use in patients with contraindications noted by guidance (e.g., inflammatory arthritis, diabetic peripheral neuropathy when specified).

Inform patients of alternatives and obtain informed consent documenting discussion
Consider patient-specific factors and guideline recommendations when selecting candidates for implants

Note

Non-surgical Interventions for First MTP

Non-surgical interventions evidence: A recent Cochrane review (Munteanu et al., 2024) evaluated non-surgical interventions for first MTP osteoarthritis and found limited benefit from shoe inserts, arch-contouring foot inserts, and hyaluronic acid injections; nevertheless, non-surgical care should be attempted and documented before surgery.

Non-surgical options may have limited efficacy per recent evidence but remain first-line prior to surgical options
Document trial and outcome of non-surgical interventions

ConsiderationsSelection depends on joint condition, patient goals, and motivation; arthrodesis remains the gold standard for many cases.

Synthetic cartilage implant (Cartiva SCI) — PVA hydrogel interpositional implant

Device descriptionAn interpositional synthetic polyvinyl alcohol (PVA) hydrogel implant intended to preserve motion of the first MTP joint as an alternative to arthrodesis.

ExampleCartiva Synthetic Cartilage Implant (Cartiva SCI), evaluated in randomized and longer‑term follow‑up studies (Baumhauer et al.; Glazebrook et al.).

Evidence summaryRandomized trial (Baumhauer et al.) compared Cartiva to arthrodesis; longer‑term follow‑up showed maintained patient‑reported improvements but a proportion required implant removal and conversion to arthrodesis (e.g., 9.2% by 24 months).

Arthrodesis — reiterated definition as standard treatment for advanced hallux rigidus

Definition (reiterated)Surgical fusion of the first MTP joint, a joint‑destructive procedure that eliminates motion at the joint.

Standard treatment roleConsidered the gold standard for end‑stage first MTP osteoarthritis (hallux rigidus) with reliable fusion and pain outcomes.

TradeoffsPredictable symptom relief and functional improvement at the cost of permanent loss of MTP joint motion.

Cartiva Synthetic Cartilage Implant (SCI) — FDA PMA reference and device identification

Regulatory statusCartiva Synthetic Cartilage Implant (Cartiva SCI) has FDA premarket approval (PMA P150017).

Device typeSynthetic polyvinyl alcohol (PVA) hydrogel interpositional implant for first MTP joint arthroplasty.

Safety noticeA Class II device recall for the Cartiva SCI was posted (reference to Class 2 recall dated Oct 31, 2024).

Annual review completed; policy updated to new template and formatting standards (also prior minor wording update converting 'tarsal metatarsal' to 'tarsometatarsal').