CurrentAetnaPolicy 0364

Allograft Transplants of the Extremities

Defines Aetna's coverage and medical necessity criteria for allograft transplants of the extremities (knee ligaments, osteochondral, meniscus, and selected ankle procedures) and identifies experimental/investigational indications; intended for providers and review staff.

Policy Summary

PayerAetna

PolicyAllograft Transplants of the Extremities

Policy CodePolicy 0364

Change TypeNo material changes

Effective DateDec 3, 1999

Next Review DateApr 11, 2024

Key ActionObtain and document prior conservative management and lesion-specific imaging when seeking coverage for allograft procedures.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MultipleDistinct procedure categories

9+Experimental indications listed

<55Meniscal age limit

6 moFailed non‑op therapy (ankle)

18%OCA overall failure rate

86%

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Patient satisfaction (pooled OCA)

Coverage and Medical Necessity Criteria

Osteochondral (Femoral) — Medical Necessity

Covered when ALL of the following are met:

Osteochondral femoral lesion coverage criteria: Member has one of: avascular necrosis lesions of the femoral condyle; or osteochondral dissecans lesions of the distal femur; or otherwise healthy, active, non-elderly members with osteochondral dissecans of the distal femur who have failed earlier arthroscopic procedures or are not candidates due to size, shape, or location.

Lesion-specific criteria: Lesion meets all of the following: full-thickness depth (Outerbridge grade 3 or 4) and 2 cm or greater in diameter by MRI or arthroscopy; surrounded by normal, healthy (non-arthritic) cartilage; causing disabling localized knee pain unresponsive to conservative treatment (eg, medication, in-person physical therapy); normal knee alignment or alignment will be surgically corrected at time of allograft; stable and aligned knee with intact meniscus and normal joint space on X-ray; opposing articular surface generally free of disease or injury (no arthritis on corresponding tibial surface).

Meniscal Transplantation — Medical Necessity

Covered when ALL of the following are met:

Meniscal allograft criteria: Degenerative changes absent or minimal (Outerbridge grade II or less); knee stable prior to surgery or surgically corrected at time of allograft (eg, intact or reconstructed ACL); member under age 55 years; normal knee alignment or alignment will be surgically corrected at time of allograft; pre-operative MRI or prior arthroscopy demonstrates absence or near-absence of the meniscus; significant knee pain unresponsive to conservative treatment.

Knee Ligament Allografts — Medical Necessity

Covered when selection criteria are met:

Knee ligament allografts: Allografts of the knee ligaments (ACL, PCL, MCL, LCL, MPFL) are considered medically necessary as an alternative to autografts for knee ligament reconstruction.

Semitendinosus Allograft for Ankle — Medical Necessity

Covered when ALL of the following are met:

Semitendinosus allograft (ankle): Member has chronic ankle instability and has failed 6 months of non-operative treatments including braces, in-person physical therapy (balance and strength exercises), medication and taping.

Fast-Fix Meniscal Repair System

Fast-Fix meniscal repair system: The Fast-Fix meniscal repair system is considered medically necessary for repair of meniscal tears.

Experimental/Investigational (Not Covered)

The following are considered experimental and investigational (not covered) because safety and effectiveness have not been established:

Experimental/Investigational list: Allograft transplant of the knee for indications not listed as medically necessary; Cartiform viable osteochondral allograft; Cryopreserved arterial allografts for critical limb ischemia; Juvenile cartilage allograft tissue implantation (DeNovo ET/NT); Manipulated (decellularized) human tissue graft products (eg, Chondrofix); Osteochondral allografts of the talus; Osteochondral allografts for individuals with previous total meniscectomy or cartilaginous defects associated with osteoarthritis or inflammatory disease; synthetic resorbable polymers (eg, TruFit Plug, PolyGraft); vascularized bone graft for avascular necrosis of the talus; and other listed indications where effectiveness has not been established.

Coverage-related clinical criteria

Use of allograft tissue is discussed with specific recommended situations where it may be appropriate.

Situations where allograft may be considered: Reserve tendon allograft for revision ACL reconstruction when an autograft was already used, or for primary reconstruction in combined ligament injuries when an adequate autograft is not available.

Situations where allograft is discouraged: Routine primary isolated ACL reconstruction with allograft is discouraged due to higher failure and abnormal stability rates compared with autograft; avoid use when an adequate autograft is available.

Osteochondral and juvenile cartilage grafts: Osteochondral allografts and juvenile particulated cartilage (eg, DeNovo NT) may be considered for large, deep, or refractory osteochondral lesions or when other treatments have failed, but evidence is limited and risk of graft failure and reoperation should be weighed.

Processing/sterilization considerations:

Evidence‑based considerations for OCA use

Consider allograft transplantation when ALL of the following evidence-supported considerations apply:

General considerations: Patient has symptomatic focal or unipolar chondral/osteochondral defect with documented lesion size and etiology; nonoperative measures and standard reparative procedures are inappropriate or have failed; and patient counseling is documented regarding variable outcomes and potential for reoperation or conversion to arthroplasty.

Favorable prognostic factors: Etiologies such as osteochondritis dissecans, post-traumatic, or idiopathic lesions; younger patients; and unipolar lesions are associated with better outcomes.

Less favorable scenarios: End-stage or bipolar joint disease (eg, bipolar fresh OCA for knee) and large talar lesions requiring structural allograft have higher early failure and revision rates.

Evidence quality and consent: Recognize that most supporting studies are case series (Level IV) with limited sample sizes and methodological weaknesses; document informed consent reflecting uncertain long-term efficacy.

Evidence considerations (informational)

Evidence and practice points from the literature and guideline summaries (informational):

Evidence and patient selection considerations: Select patients based on lesion size, location, prior treatments, and activity level; counsel on realistic expectations for function and risk of failure; consider corrective osteotomy for malalignment and address concomitant instability.

Product-specific observations: Particulated juvenile cartilage (DeNovo NT/JACI-BMAC), cryopreserved viable allografts (Cartiform/CVOCA), and TruFit synthetic plugs have preliminary series showing functional improvements but varied radiographic repair quality and limited long-term data; comparative studies with microfracture show no clear superiority.

Failure/risk factors: Risk factors for poor outcome include large lesion size, graft resorption, smoking, avascular necrosis etiology, acetabular involvement, and high-demand patients; immunologic factors and graft storage/processing may influence outcomes.

The policy explicitly lists specific products and procedures that are considered experimental/investigational or otherwise not supported for the indications described. Examples called out in the source include Cartiform (a cryopreserved viable osteochondral allograft), DeNovo ET/DeNovo NT (juvenile cartilage allograft products), the TruFit Plug (a synthetic resorbable biphasic implant), PolyGraft, Chondrofix (manipulated/decellularized human tissue graft), and cryopreserved arterial allografts. The Fast-Fix meniscal repair system and a range of CPT/ICD-10 entries are also listed in the coding section for reference.

Use of tendon allograft for routine, primary isolated ACL reconstruction is discouraged in this policy because multiple studies and meta-analyses report lower normal stability and higher rates of abnormal stability (a proxy for graft failure) with allograft versus autograft. The document states that allografts should generally be reserved for revision ACL surgery or for primary reconstruction only when an adequate autograft is not available, and highlights concerns about disease transmission with processed allografts.

The policy describes bipolar fresh osteochondral allograft (BFOA) transplantation (resurfacing opposing joint compartments) for end‑stage knee arthritis as controversial. Small series report high early failure rates and frequent early conversion to arthroplasty — for example, one BFOA series had failure in 6 of 7 patients with mean revision to total knee arthroplasty at ~19.5 months — and patellar allograft series reported notable reoperation and failure rates over long-term follow-up. These outcomes counsel caution when considering bipolar fresh OCA for end‑stage knee disease.

The TruFit plug (a synthetic biphasic, resorbable scaffold) has mixed early clinical reports: systematic reviews and small series show short-term clinical improvement in some cohorts but deterioration or discordant imaging findings in longer follow-up. The policy notes there are no data demonstrating superiority or equivalence to established treatments (eg, microfracture or mosaicplasty) and calls for randomized controlled trials before continued broad clinical use can be endorsed.

Reports on Cartiform (a cryo‑preserved viable osteochondral allograft) note technical limitations including implant size restrictions: a single Cartiform implant is generally limited to defects of approximately ≤2‑cm diameter and therefore cannot restore large osseous defects; potential disadvantages and infection/disease transmission risks are also described.

The policy summarizes that vascularized composite allotransplantation (VCA) for face or upper extremity reconstruction is reserved for highly selected patients because of substantial morbidity and high complication rates. Reported outcomes include an overall surgical complication rate of 23%, acute rejection in 89%, opportunistic infection in 58%, and partial or complete allograft loss in 19%; the document emphasizes complex preoperative evaluation and detailed patient consent.

The policy states that allograft transplant of the knee for indications not specified as medically necessary in this CPB is considered experimental/investigational and therefore not covered. The exclusions list specifically names several procedures and products (eg, Cartiform, DeNovo ET/NT, TruFit Plug, PolyGraft, Chondrofix, cryopreserved arterial allografts) and also cites osteochondral allografts of the talus and other listed indications as not established.

Multiple sections and evidence summaries in the policy conclude that existing data for the TruFit plug are insufficient to establish clinical value. Systematic reviews and case series report early improvement for some patients but show inconsistent longer-term results and imaging; the document therefore indicates TruFit plug use has not been established as clinically valuable compared with established treatments.

The policy characterizes use of bipolar fresh OCA for post‑traumatic or end‑stage knee arthritis as controversial and high risk. Small case series report early graft failure, progressive chondrolysis, joint laxity, and frequent need for conversion to arthroplasty within months to a few years, supporting the policy’s cautionary stance for this application.

Within the excerpt provided, the policy does not state a specific list of additional "not medically necessary" determinations beyond the experimental/investigational exclusions and the named product-specific limitations. The document explicitly notes certain products and indications as experimental/investigational, but no additional explicit NMN determinations are given in these chunks.

Evidence for cryopreserved arterial allografts in critical limb ischemia is variable. Single-center series report declining primary patency over time (for example, primary patency estimates falling to ~26–38% at 5 years in different series) and mixed limb‑salvage outcomes; registry data and retrospective analyses described in the policy characterize results as sub‑optimal in some cohorts and advise cautious patient selection.

Procedure and Diagnosis Codes

Covered CPT Codes (when selection criteria are met)CPTCovered

20932	Allograft, includes templating, cutting, placement and internal fixation, when performed.
20933	Allograft (listed in series 20932-20934; exact descriptions in document).
20934	Allograft (listed in series 20932-20934; exact descriptions in document).
27427	Ligamentous reconstruction (augmentation), knee; extra-articular.
27428	Ligamentous reconstruction, intra-articular (open).
27429	Ligamentous reconstruction, intra-articular (open) and extra-articular.
29888	Arthroscopically aided anterior cruciate ligament repair/augmentation or reconstruction.
29889	Arthroscopically aided posterior cruciate ligament repair/augmentation or reconstruction.
27415	Osteochondral allograft, knee, open.
29867	Arthroscopy, knee, surgical; osteochondral allograft(s) (e.g., mosaicplasty).

1–10 of 14

1/2

Covered ICD-10 Codes (when selection criteria are met)ICD-10Covered

M87.051 - M87.059	Idiopathic aseptic necrosis of femur.
M87.151 - M87.159	Osteonecrosis due to drugs, femur.
M87.251 - M87.256	Osteonecrosis due to previous trauma, femur.
M87.351 - M87.353	Other secondary osteonecrosis, femur.
M87.851 - M87.859	Other osteonecrosis, right femur.
M93.961 - M93.969	Osteochondropathy, unspecified lower leg [osteochondral lesions of the distal femur].
M23.200 - M23.369	Derangement of medial and lateral meniscus.
Q68.6	Discoid meniscus.
S83.200+	Tear of unspecified meniscus, current injury.
M25.371 - M25.373	Other instability, ankle.

CPT Codes Not Covered for Specified IndicationsCPTNot Covered

20962	Bone graft with microvascular anastomosis; other than fibula, iliac crest, or metatarsal (not covered for listed indications).
28103	Excision or curettage of bone cyst or benign tumor, talus or calcaneus; with allograft (not covered for listed indications).
20957	Bone graft with microvascular anastomosis; metatarsal (not covered for listed indications).

HCPCS/Other not coveredmixedNot Covered

Cartiform	No specific HCPCS code; product listed as not covered for indications in the CPB.
Cryopreserved arterial allografts	No specific CPT/HCPCS code; listed as not covered for indications in the CPB.

Osteochondral lesion size — threshold

Size threshold>= 2 cm diameter (full-thickness grade 3 or 4) by MRI or arthroscopy

Depth requirementFull-thickness depth (Outerbridge grade 3 or 4)

Anatomic locationDistal femur (femoral articulation only)

Imaging confirmationLesion measured and confirmed by MRI or arthroscopy

Age for meniscal transplantation

Age limitMember must be under 55 years of age (< 55 years)

Prior Authorization, Documentation, and Clinical Requirements

Prior Authorization

Prior Authorization Recommended — Osteochondral / Juvenile Allograft

Prior authorization is recommended for osteochondral and juvenile allograft procedures. Requests should reference the main policy selection criteria for coverage determination.

Affected procedures include osteochondral allografts and juvenile cartilage allograft implants (eg, DeNovo NT/ET)
Prior authorization may be required to confirm selection criteria are met

Prior Authorization

Prior Authorization — See Main Policy

Prior authorization should follow the requirements and processes outlined in the main Aetna policy. Submit requests with the documentation listed below and consult plan-specific resources as needed.

See the main policy for operational prior authorization steps and available Aetna provider resources
Coordination with member’s specific plan may affect preauthorization routing and coverage review

Background and Scope

Background: Allografts are donor (cadaveric) tissues used as an alternative to autografts for ligament reconstruction and meniscal transplantation. Advantages include avoidance of donor‑site morbidity and shorter operative time; disadvantages include potentially higher failure rates (notably for ACL reconstruction), risk of disease transmission, and sensitivity of outcomes to processing/sterilization methods (eg, irradiation or chemical processing can alter graft mechanical properties and affect clinical results).

Key Definitions

Allograft — definition

DefinitionAllograft: graft between individuals of the same species but of dissimilar genotype; procured from cadaver donors

Processing/storageProcessed, stored and utilized according to FDA and AATB standards

Preservation methodsMay be preserved by freeze-drying or deep-freezing; sterilized by procurement screening or secondary methods (eg, ethylene oxide, gamma irradiation)

Revision reconstruction — definition

DefinitionRevision reconstruction: corrective surgery when the original ligament reconstruction has failed

ContextPerformed when primary reconstruction is unsuccessful or there is chronic insufficiency after prior procedures

Policy Summary

PayerAetna

PolicyAllograft Transplants of the Extremities

Policy CodePolicy 0364

Change TypeNo material changes

Effective DateDec 3, 1999

Next Review DateApr 11, 2024

Key ActionObtain and document prior conservative management and lesion-specific imaging when seeking coverage for allograft procedures.

SourceLink

On This Page

Sterilization and processing (eg, high-dose irradiation) can adversely affect graft mechanical properties and outcomes; very high irradiation doses (eg, >= 3 Mrad) are unacceptable.

Associated requirementsDegenerative changes absent or minimal (Outerbridge grade II or less)

Stability/alignmentKnee stable prior to surgery or surgically corrected at time of allograft

Denial Risk

Experimental / Investigational Exclusions

The following allograft transplants and related uses are considered experimental and investigational and are not covered because safety and effectiveness have not been established.

Allograft transplant of the knee for indications not listed as medically necessary
Cartiform viable osteochondral allograft for microfracture and other joint surgeries
Cryopreserved arterial allografts for critical limb ischemia
Juvenile cartilage allograft implantation (DeNovo ET/NT) for indications outside covered criteria
Manipulated (decellularized) human tissue graft products (eg, Chondrofix)
Osteochondral allografts of the talus for listed non-covered indications and other listed anatomic sites

Denial Risk

Allograft Discouraged for Primary ACL Reconstruction

Use of allograft for routine primary, isolated ACL reconstruction is discouraged due to higher failure rates compared with autograft. Allograft ACL reconstruction is generally reserved for revision cases or complex multi-ligament injuries where autograft is unavailable.

Document reasons autograft is not suitable when proposing allograft for ACL reconstruction
Evidence shows higher graft failure and lower stability rates for allograft in primary ACL reconstruction

Note

Evidence Quality May Affect Coverage

Evidence quality and study limitations may affect coverage decisions. Many indications have limited or low-methodological-quality evidence; reviewers may weigh this when determining medical necessity.

Ankle literature and many cartilage/osteochondral studies show low levels of evidence (eg, Level IV case series)
Heterogeneity and methodological weaknesses (small sample sizes, study design, inconsistent outcome measures) are common

Denial Risk

Evidence Limitations May Prompt Denial

Insufficient high-quality evidence or infrequent supporting clinical data for a requested indication may prompt denial of coverage. Provide robust supporting documentation to mitigate this risk.

Lack of comparative trials, small cohorts, short follow-up, or inconsistent outcomes are common denial triggers
Novel or uncommon indications without established effectiveness are at higher risk for denial

Denial Risk

VCA Complication Risk — Authorization Considerations

Vascularized composite allotransplantation (VCA) for the upper extremity and face carries substantial complication risks that can influence authorization decisions; document patient selection and informed consent discussions.

High rates of acute/chronic rejection and opportunistic infections reported in VCA series
Significant morbidity (eg, impaired glucose metabolism, partial/complete allograft loss) — emphasize strict selection and thorough preoperative counseling

Note

No Other Specific Provider Actions Stated Here

No additional specific provider actions or requirements are stated elsewhere in this supplemental section beyond the items listed here; follow the main policy for operative criteria and administrative processes.

Refer to the main policy for any additional provider obligations or plan-specific rules

Step Therapy

No Step Therapy Requirements Described

No distinct step-therapy programs are described in this section. Coverage determinations rely on documented medical necessity and adherence to the main policy criteria.

There are no explicit step-therapy requirements in these supplemental callouts
Providers should still document prior conservative treatments when clinically relevant

Documentation Required

Required Clinical Documentation

Required clinical documentation should be submitted with prior authorization requests to justify allograft use and to support medical necessity decisions.

Pre-operative imaging (MRI, X-rays, CT as applicable) showing lesion size, location, and cartilage status
Lesion characterization: size (cm or cm²), depth (full-thickness/grade 3–4), morphology, and surrounding cartilage health
Clinical history: symptoms, functional impact, duration, and failure of conservative therapy
Prior treatments and responses (eg, physical therapy, injections, microfracture)

Documentation Required

Documentation Expectations for Allograft Use

Documentation should specifically address why an allograft is indicated and, when applicable, why autograft is unavailable or inappropriate (eg, prior autograft used in revision cases or multi-ligament injuries requiring additional tissue).

Indication and rationale for allograft selection (including prior surgeries and grafts used)
Lesion characteristics and objective measurements (imaging and arthroscopic findings)
Functional scores and pain assessments when available (eg, AOFAS, IKDC, FAOS, HOOS)

Documentation Required

Cartiform / CVOCA Procedure Documentation

For Cartiform/CVOCA (cryo‑preserved osteochondral/chondral allografts), include procedure‑specific documentation noting implant limitations and suitability for the lesion.

Document implant technical limitations (eg, Cartiform/CVOCA single implant typically treats defects up to ~2 cm diameter; cannot reliably fill large osseous defects)
State whether marrow-stimulation augmentation or single-stage implantation is planned and why it is appropriate for the lesion
Provide imaging and lesion measurements demonstrating compatibility with implant size and intended repair strategy

Note

Reference Links for Documentation and Resources

Include links and references to Aetna resources and plan disclosures to guide documentation and administrative submissions.

Aetna Glossary and provider resources: https://www.aetna.com/glossary.html
Program provisions and plan disclosures: https://www.aetna.com/legal-notices/program-provisions.html and https://www.aetna.com/individuals-families/member-rights-resources/rights/disclosure-information.html
For additional administrative information (apps, FAQs, legal notices) see Aetna’s provider pages listed in the main policy

Reconstructive methodsMay involve intra-articular, extra-articular, or combined procedures using various graft sources

DeNovo NT and DeNovo ET — definitions

DeNovo NT (natural tissue)Particulated juvenile donor cartilage implanted with fibrin adhesive (minced juvenile cartilage graft)

DeNovo ET (engineered tissue)Engineered living tissue graft grown from juvenile chondrocytes, investigational and undergoing clinical study

Clinical statusDeNovo NT available in the U.S.; DeNovo ET is investigational/under clinical trial

TruFit plug / synthetic scaffold — definition

Product typeTruFit Plug: synthetic biphasic, resorbable polymer scaffold intended to support marrow elements and matrix ingrowth

Composition/indicationMade from polylactide-coglycolide copolymer, calcium sulfate, and polyglycolide; intended as scaffold for osteochondral defect repair

Regulatory noteApproved in Europe for focal defects; in the U.S. approved only for backfill of osteochondral autograft sites; clinical value not established

Osteochondral allograft transplantation (OCA) — definition

DefinitionOsteochondral allograft transplantation (OCA): replacement of damaged articular cartilage and underlying subchondral bone with donor osteochondral tissue

IndicationsUsed for focal and sometimes diffuse (single-compartment) chondral defects of the knee

Graft typesIncludes fresh, prolonged fresh, and fresh-frozen procurement and storage methods

Bipolar fresh osteochondral allograft (BFOA) — definition

DefinitionBipolar fresh osteochondral allograft (BFOA): transplantation of fresh osteochondral allograft tissue to resurface opposing joint compartments (eg, tibiofemoral and patellofemoral)

Outcome noteReported to have high early failure rates and frequent early conversion to arthroplasty in small series

Risk considerationConsidered high-risk application; clinicians should counsel regarding failure and revision likelihood

Osteochondral allograft (OCA) — general definition

General definitionOsteochondral allograft (OCA): transplantation of osteochondral tissue (bone and cartilage) from a donor to reconstruct large cartilage defects

Anatomic usesUsed in knee, talus, trochlea, and femoral head reconstruction depending on indication

Indication contextConsidered for large, deep, or refractory osteochondral lesions when other treatments have failed

JACI-BMAC / DeNovo NT — definition

JACI-BMAC / DeNovo NT descriptionParticulated juvenile allograft cartilage (DeNovo NT) implanted arthroscopically, sometimes with autologous bone marrow aspirate concentrate (BMAC)

Intended useUsed for treatment of critical-size osteochondral lesions (eg, talus) as a single-stage arthroscopic procedure

Outcomes noteEarly series report functional improvements but reparative tissue often appears fibrocartilaginous on MRI; long-term superiority over microfracture not established

CVOCA / Cartiform — definition

CVOCA / Cartiform descriptionCryopreserved viable osteochondral or chondral allografts preserving viable chondrocytes, growth factors, and extracellular matrix

MechanismIntended to augment marrow stimulation by providing viable chondrocytes and growth factors to promote hyaline-like repair

Processing/storageCryopreserved and stored at low temperatures (eg, -80°C) with pores/poration to enhance flexibility and growth factor release

CVOCA/Cartiform — shorthand

Shorthand termCVOCA/Cartiform: cryo-preserved viable osteochondral/chondral allograft

Clinical use noteUsed to augment marrow stimulation for focal full-thickness cartilage defects; single-implant size limits (~<=2 cm diameter) reported

Evidence statusEarly case-series and preclinical studies support biological plausibility but long-term clinical efficacy is limited

Outerbridge classification — reference

PurposeOuterbridge classification: facilitates objective description of chondral damage in the knee

Scale rangeGrades 0 through IV

Clinical useUsed to define lesion depth and guide treatment decisions (eg, Grade III–IV correspond to full-thickness defects)

Outerbridge classification — grading details

Grade 0Normal cartilage

Grade ICartilage with swelling and softening

Grade IIPartial-thickness defect with fissures not reaching subchondral bone or <= 1.5 cm diameter

Grade IIIFissuring to level of subchondral bone in area > 1.5 cm (full-thickness)

Grade IVExposed subchondral bone