CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Synthetic Cartilage Implants for Joint Pain

This policy governs coverage determinations for synthetic cartilage implants (e.g., Cartiva PVA hydrogel) for treatment of articular cartilage damage, primarily first metatarsophalangeal (MTP) joint osteoarthritis, for Blue Cross Blue Shield - Rhode Island products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySynthetic Cartilage Implants for Joint Pain

Policy CodePolicy N/A

Change TypeNo material change

Effective Date11|01

Next Review DateN/A

Key ActionFile claims for the Cartiva implant with unlisted code L8699; CPT 28291 is not covered when billed for implantation of a synthetic cartilage implant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2016FDA approval year

5 yrPost-approval follow-up

L8699, 28291Not covered codes

Jul 16, 2019Last updated

Coverage Determinations

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Overall coverage stance

Coverage determinations and concise rationale:

Coverage determinations: For BlueCHiP for Medicare products: synthetic cartilage implants are considered not covered. For Commercial products: synthetic cartilage implants are considered not medically necessary.

Rationale: evidence is insufficient to determine effects on health outcomes for first MTP joint and other joints; pivotal trial vs arthrodesis showed mixed results and long-term durability data are limited.

Evidence basis and limitations

Evidence basis, limitations, and regulatory constraints:

Evidence limitations for first MTP OA and other joints: Pivotal randomized controlled trial exists comparing the polyvinyl alcohol (PVA) synthetic implant (Cartiva) to arthrodesis for advanced first MTP osteoarthritis, with patient-reported scores slightly worse than arthrodesis and similar functional outcomes; long-term durability evidence is limited (only ~20% 5-year follow-up reported) and continued FDA approval depends on 5-year follow-up of the complete cohort.

High risk of bias favoring the novel device noted; corroboration from independent long-term studies is needed.

Evidence gaps: No randomized controlled trials were identified for synthetic cartilage implants in joints other than the first metatarsophalangeal (great toe) joint; available data are observational for other joints.

Insufficient evidence to determine effects on health outcomes for non-MTP joints.

Regulatory and labeling constraints: Cartiva (PVA hydrogel) was approved by the FDA in July 2016 for degenerative or posttraumatic arthritis of the first MTP joint; FDA labeling lists contraindications including lesions greater than 10 mm and insufficient quality or quantity of bone; the post-approval study requires 5-year follow-up to assess long-term safety and effectiveness.

Documentation of long-term follow-up is relevant to regulatory status and ongoing evaluation of implant durability.

For Commercial Products, synthetic cartilage implants are considered not medically necessary for the treatment of articular cartilage damage due to insufficient evidence of clinical benefit. Claims for the Cartiva hydrogel implant should be filed using unlisted HCPCS code L8699, and CPT code 28291 is specifically not covered when billed for implantation of a synthetic cartilage implant.

Provider Billing & Documentation Actions

Billing Rule

Filing & Coverage Codes — Benefits Vary by Contract

Benefits may vary between groups and contracts. Providers must confirm member benefits and coverage prior to services. Claims for synthetic cartilage implants should be filed using the unlisted prosthetic implant code L8699 when applicable. Note that CPT 28291 is not covered when billed for implantation of a synthetic cartilage implant.

File claims for the implant with HCPCS L8699 (Prosthetic Implant; not otherwise specified).
CPT 28291 is not covered when billed for implantation of a synthetic cartilage implant.
Verify member-specific benefits (Commercial vs BlueCHiP for Medicare) before scheduling.

Prior Authorization

Conservative Treatment Expectation

Conservative, nonoperative management is expected as first-line therapy for early-stage disease before considering a synthetic cartilage implant. Document prior conservative treatments tried and failed, and consider alternative surgical options where appropriate.

Document trials of conservative management (e.g., medications, orthotics, physical therapy, activity modification) and their duration/outcomes.
List and document reasons why conservative care failed or is not appropriate prior to implant consideration.
Consider and document discussion of alternative surgical options (debridement, abrasion, osteochondral grafting, autologous chondrocyte implantation, cheilectomy, interpositional grafts, arthrodesis).

Documentation Required

Post-Approval Follow-up Documentation

For procedures involving FDA-approved devices with post-approval study requirements, providers must document and maintain required follow-up data. Continued FDA approval for the Cartiva synthetic cartilage implant depends on 5-year follow-up of treated subjects; providers participating in post-approval studies must comply with study follow-up and reporting requirements.

Document patient enrollment in post-approval study and consent when applicable.
Maintain and submit scheduled follow-up assessments and outcomes for up to 5 years as required by the FDA post-approval study.
Include follow-up findings (symptoms, function, complications, imaging if required) in the medical record and in any study reporting.

Denial Risk

Coverage Denial Triggers

Situations that commonly trigger coverage denials are listed below — verify member coverage and document medical necessity carefully to reduce risk of denial.

BlueCHiP for Medicare members: Implantation of a synthetic cartilage implant is not covered.
Commercial members: Implantation is considered not medically necessary unless contract language states otherwise.
Failure to document prior conservative management attempts and reasons for failure may result in denial.
Billing with CPT 28291 for implantation of a synthetic cartilage implant may be denied — use L8699 when appropriate.
Lack of required post-approval follow-up documentation for patients enrolled in FDA-mandated studies may affect coverage determinations or reporting compliance.

Clinical Background

Articular cartilage damage may be focal or part of diffuse osteoarthritis and often does not heal spontaneously; involvement of the first metatarsophalangeal (MTP) joint (hallux rigidus) can cause significant pain and functional limitation. Treatment options range from conservative management to surgical procedures including cheilectomy, interpositional spacers, arthrodesis, and joint replacement, and synthetic polyvinyl alcohol (PVA) hydrogel implants have been developed to preserve motion by acting as a spacer in the first MTP joint.

The Cartiva PVA hydrogel implant received FDA premarket approval in July 2016 specifically for degenerative or posttraumatic arthritis of the first MTP joint. Evidence supporting the implant includes a pivotal trial comparing implantation to arthrodesis, but long-term durability and effectiveness data are limited and ongoing post-approval study follow-up is required.

Device Definition

Cartiva synthetic cartilage implant — key details

Implant materialPolyvinyl alcohol (PVA) hydrogel

Disc size8–10 mm diameter

Implantation protrusionSlight protrusion of 1–1.5 mm to act as a spacer in the first MTP joint

Packaging/instrumentationSupplied with dedicated reusable instrumentation (drill bit, introducer, and placer)

Regulatory statusFDA premarket approval (approved July 2016) for treatment of arthritis of the first MTP joint