Close Window
Aetna Aetna
Clinical Policy Bulletin:
Allograft Transplants of the Extremities
Number: 0364


Policy

  1. Aetna considers allograft transplant of the knee (knee ligaments, osteochondral, and meniscus) medically necessary when selection criteria are met.

    Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament, (MCL), and Lateral Collateral Ligament (LCL):

    1. Members with ligament deficiency who are not candidates for autogenous transplantation (e.g., individuals whose autogenous tissues have been compromised by previous surgery, previous injury), or 
    2. Members with pathology such as chronic patellar tendonitis, and hamstring injury, or
    3. Members with any other contra-indications to using their own tissue such as collagen disease or generalized ligamentous laxity.

    Osteochondral:

    1. Avascular necrosis lesions of the femoral condyle; or
    2. Non-repairable stage 3 or 4 osteochondritis dissecans; or
    3. Otherwise healthy, active, non-elderly members who have either failed earlier arthroscopic procedures or are not candidates for such procedures because of the size, shape, or location of the lesion; or
    4. Treatment of an isolated, traumatic injury that is full-thickness depth (grade 4, down to and/or including the bone) lesion, preferably surrounded by normal, healthy (non-arthritic) cartilage.  The opposing articular surface should be generally free of disease or injury.

    Meniscus:

    1. Degenerative changes must be absent or minimal, and
    2. Knee must be stable (i.e., intact or reconstructed ACL), and
    3. Members under the age of 55 years, and 
    4. Pre-operative studies (MRI or previous arthroscopy) reveal absence or near-absence of the meniscus.

    Aetna considers allograft transplant of the knee experimental and investigational for all other indications because its effectiveness for indications other than the ones listed above has not been established.

  2. Aetna considers osteochondral allograft of the talus experimental and investigational because there are unanswered questions regarding the clinical outcomes of this approach when compared with ankle arthrodesis, especially in terms of pain, disability, functionality and durability. 

    Aetna considers the use of vascularized bone graft for the treatment of avascular necrosis of the talus experimental and investigational because its effectiveness has not been established.

  3. Aetna considers osteochondral allograft experimental and investigational for ilio-tibial band repair, shoulder instability, tarso-metatarsal arthrodesis, repairing chondral defects/lesions of the elbow, patella, patello-femoral ligament, and shoulder (e.g., Hill Sachs lesions) because its effectiveness has not been established.

  4. Aetna considers the use of TruFit Plug (a synthetic resorbable biphasic implant) for osteochondral allografts of the knee experimental and investigational because its effectiveness has not been established.

  5. Aetna considers the Fast-Fix meniscal repair system experimental and investigational for repair of meniscal tears and other indications.

  6. Aetna considers the use of DeNovo ET engineered tissue graft and DeNovo NT tissue graft for repair of articular cartilage lesions experimental and investigational because its effectiveness has not been established.



Background

Repair of knee ligaments refers to surgical treatment of acute injuries (ruptures), whereas primary reconstruction usually refers to surgical intervention of ligamentous laxity (chronic insufficiency) several months following an injury.  Revision reconstruction means corrective surgery when the original reconstruction has failed.  The bulk of the literature on ligamentous reconstruction of the knee deals with the primary reconstruction of the anterior cruciate ligament (ACL).  Generally, there are 3 reconstructive methods for managing ACL insufficiency: (i) intra-articular replacements, (ii) extra-articular procedures, and (iii) combined procedures.  The first method is intended to replace the ACL, whereas the second method is intended to tighten the medial or lateral secondary restraints, or both in the third method.  The sources for intra-articular replacements are quadriceps tendon, patellar tendon, hamstring tendons, and iliotibial band or tract.  In particular, the bone-patellar tendon-bone autograft (the central one-third of the patellar tendon and its bony attachments to the patella and tibial tubercle) is the most common operation currently performed for reconstructing the ACL through arthroscopy.

Allograft, also known as allogeneic graft or homograft, is a graft between individuals of the same species, but of dissimilar genotype.  For tendon allografts, cadaver donors are usually used.  The donor tissues most commonly used are the patellar and Achilles tendons.  An allograft may be preserved by freeze-drying or deep-freezing and can be sterilized either by sterile procurement with careful donor screening or by secondary sterilization with gaseous ethylene oxide or gamma irradiation.  It is believed that freeze-drying or deep-freezing renders connective tissue allografts less immunogenic by killing the cells and denaturing surface histocompatibility antigens.  However, while some investigators have claimed that freeze-drying of the allograft does not significantly change the mechanical properties of the grafts compared with deep-freezing; others have reported frequent late failures of freeze-dried allograft tissues.  Fideler and co-workers (1994) concluded that a dose of 30,000 or 40,000 gray (3 or 4 megarad) of gamma radiation is necessary for the inactivation of the DNA of the human immunodeficiency virus in frozen bone-patellar ligament-bone allograft harvested from donors infected with the virus.

Tendon allograft has been used for the repair/reconstruction of the ACL in patients following major knee injury.  The advantages of using these allografts are a more abundant supply of tissue for multiple ligament and revision surgery, a shorter operative time, faster rehabilitation, avoidance of morbidity associated with autograft harvesting, as well as a lower incidence of stiff knee.  On the other hand, the disadvantages in employing allografts are a potentially increased failure rate, a risk of hepatitis or AIDS infection, as well as stimulation of an immune response.

Studies have shown high failure rates with use of allograft for ACL reconstruction (Gorschewsky et al, 2005; Pritchard et al, 1995; Roberts et al, 1991).  Prodromos et al (2007) performed a meta-analysis of autograft and allograft stability data.  Normal stability for all autografts was 72 % versus 59 % for all allografts (p < 0.01).  Abnormal stability was 5 % for all autografts versus 14 % for all allografts (p < 0.01).  Bone-patellar-tendon-bone (BPTB) autograft normal stability was 66 % versus 57 % for BPTB allografts (p < 0.01).  Abnormal BPTB autograft stability was 6 % versus 16 % for BPTB allograft.  Hamstring autograft normal or abnormal stability rates were 77 % and 4 % and were compared to soft tissue allografts as a group which were 64 % and 12 % (p < 0.01).  The investigators reported that allografts had significantly lower normal stability rates than autografts.  The investigators found that allograft abnormal stability rate, which usually represents graft failure, was nearly 3 times higher than that of autografts.  The investigators concluded that autografts are the graft of choice for routine ACL reconstruction with allografts better reserved for multiple ligament-injured knees where extra tissue may be required.

A meta-analysis of patellar autograft versus allograft for ACL reconstruction found better outcomes with autograft (Krych et al, 2008).  The investigators noted, however, that when irradiated and chemically processed allografts are excluded, the outcomes of autograft and allograft are more similar, but without the irradiation or chemical processing of allografts, there is an increased risk of transmission of infection.

A guidelines panel from the Italian National Guidelines System (Romanini et al, 2010) conducted a critical review of the literature of grafts for arthroscopic ACL reconstruction, and found that "[a]utograft shows moderate superiority compared with allograft" and that "[a]vailable evidence allows recommendation of use of autograft over allograft in arthroscopic ACL reconstruction."  The guidelines panel also found that, for autograft, patellar tendon has better performance than hamstring.  The guidelines panel also concluded that "[i]t is also appropriate to consider allograft and artificial ligaments only in very selected cases, discouraging widespread use, given the potential risks and paucity of well-performed, well-designed clinical studies."

Reinhard et al (2010) conducted a systematic review of the evidence for graft selection in ACL reconstruction.  The investigators found limited high-quality evidence comparing autograft to allograft.  Most case series include a smaller number of young patients (i.e., less than 30 years of age) and there have been early reports of unacceptably high failure rates in young patients.  The authors stated that procurement, storage, sterilization, and processing of allografts vary widely within the industry.  The investigators noted that the sterilization process may affect the mechanical characteristics of allografts, and that this process is necessary to decrease viral disease transmission and bacterial infection rate, but it may also adversely affect the quality of the tissue.  The review stated that several techniques have been used for this purpose.  The review found that, although ethylene oxide sterilization does not alter directly the mechanical properties of the graft, it has been shown to cause clinical failure because of persistent synovitis, and therefore is less favorable.  Another sterilization technique involves applying irradiation.  The authors stated that high-dose irradiation (3 Mrad or more) is unacceptable as it severely affects mechanical properties of the tissue.  The authors stated that lower doses of irradiation (2 to 2.5 Mrad) has also been shown in several studies to cause unacceptable inferior clinical outcomes and high failure rates..

Other more recent studies have found lower failure rates with patellar tendon autograft than allograft and/or hamstring autograft (Barrett et al, 2011; Barrett et al, 2010; Mehta et al, 2010).

Dopirak and colleagues (2008) noted that there has been substantial progress in the understanding of the medial patello-femoral ligament during the past 10 years.  This structure is the primary static soft-tissue restraint to lateral patellar displacement.  Substantial alteration of normal patellar tracking occurs after sectioning of the ligament.  Clinical studies have demonstrated the medial patello-femoral ligament is disrupted during acute patellar dislocation.  Recently, several medial patello-femoral ligament-based procedures have been developed for the treatment of patellar instability with good early results.  However, the authors stated that further studies are needed to define the exact role of these procedures in the treatment of patello-femoral instability.

Oro et al (2011) compared operating room time and costs associated with ACL reconstruction with either bone-patellar tendon-bone (BPTB) autograft or BPTB allograft.  The total mean cost per case was 25 % higher in the allograft group compared with the autograft group.  The mean operating room time was only 12 mins greater in autograft cases.  Other studies have found significantly higher costs with use of allograft than autograft in ACL reconstruction, with little differences in operating room costs (Cooper and Kaeding, 2010; Naqda et al, 2010).

There is inadequate evidence that the use of tendon allograft is equally effective as autograft in the primary reconstruction of ACL.  In addition, due to the risk of disease transmission, it should not be used for primary, isolated ACL reconstruction.  Tendon allograft for reconstruction of the ACL should only be employed when an adequate autologous graft is not available for (i) revision surgery (in knees in which a primary reconstruction of the ligament had failed and in which an autograft had already been used) or for (ii) primary reconstruction surgery for combined ligament injuries (ACL and either the posterior cruciate ligament, or medial collateral ligament) when an adequate autologous graft is not available.

There are relatively few studies comparing allograft to autograft in posterior cruciate ligament (PCL) reconstruction.  In an evidence review of outcomes of posterior collateral ligament treatment, Hammoud et al (2010) cited evidence of good results with Achilles allograft and hamstring autograft for posterior cruciate ligament reconstruction.  Hermans et al published a 6- to 12-year follow-up (mean 9.1 years) study of single bundle PCL reconstruction.  Twenty-two patients (88 % follow-up) with isolated PCL injuries underwent reconstruction using patellar tendon autograft (n = 9), 4-strand hamstring tendon autograft (n = 7), 2-strand hamstring tendon autograft plus Achilles tendon allograft (n = 8), or Achilles tendon allograft alone (n = 1).  The authors reported that there were no differences between grafts used in mean Lysholm score, Tegner score, or International Knee Documentation Committee (IKDC) rating between the patellar tendon and hamstring tendon reconstructions. 

Williams and Gamradt (2008) noted that the creation of cartilage repair tissue relies on the implantation or neosynthesis of cartilage matrix elements.  One cartilage repair strategy involves the implantation of bioabsorbable matrices that immediately fill a chondral or osteochondral defect.  Such matrices support the local migration of chondrogenic or osteogenic cells that ultimately synthesize new ground substance.  One such matrix scaffold, TruFit Plug, a synthetic resorbable biphasic implant, is a promising device for the treatment of osteochondral voids.  The implant is intended to serve as a scaffold for native marrow elements and matrix ingrowth in chondral defect repair.  The device is a resorbable tissue regeneration scaffold made predominantly from polylactide-coglycolide copolymer, calcium sulfate, and polyglycolide.  It is approved in Europe for the treatment of acute focal articular cartilage or osteochondral defects but is approved by the U.S. Food and Drug Administration only for backfill of osteochondral autograft sites.  Pre-clinical studies demonstrated restoration of hyaline-like cartilage in a goat model with subchondral bony incorporation at 12 months.  Early clinical results of patients enrolled in the Hospital for Special Surgery Cartilage Registry have been favorable, with a good safety profile.

Carmont et al (2009) stated that TruFit plugs are synthetic polymer scaffolds that are inserted into an articular surface to provide a stable scaffold to encourage the regeneration of a full thickness of articular cartilage to repair chondral defects.  These researchers reported promising early results for the repair of small articular cartilage defects within the knee.  Others have reported "failures" in which patients have complained of persistent symptoms and joint effusion at 6 months after plug insertion and arthroplasty has been undertaken.  These investigators reported a case of delayed incorporation of an articular cartilage defect of the lateral femoral condyle treated with 3 TruFit plugs.  The patient eventually reported symptom alleviation and resumption of functional activity after 24 months of continued rehabilitation.  The authors recommended that patients with continued symptoms persevere with rehabilitation and allow the regenerating articular cartilage time to mature fully before considering undertaking irreversible arthroplasty procedures.

The clinical value of TruFit Plug for osteochondral allografts of the knee has not been established.

Severe post-traumatic ankle arthritis poses a reconstructive challenge in the young and active patient.  Bipolar fresh osteochondral allograft (BFOA) may represent an intriguing alternative to arthrodesis and prosthetic replacement.  Giannini et al (2010) described a lateral trans-malleolar technique for BFOA, and evaluated the results in a case series.  A total of 32 patients, mean age of 36.8 +/- 8.4 years, affected by ankle arthritis underwent BFOA with a mean follow-up of 31.2 months.  The graft was prepared by specifically designed jigs, including the talus and the tibia with the medial malleolus.  The host surfaces were prepared by the same jigs through a lateral approach.  The graft was placed and fixed with twist-off screws.  Patients were evaluated clinically and radiographically at 2, 4, and 6 months after operation, and at a minimum 24 months follow-up.  A biopsy of the grafted areas was obtained from 7 patients at 1-year follow-up for histological as well as immunohistochemical examination.  Pre-operative AOFAS score was 33.1 +/- 10.9 and post-operatively 69.5 +/- 19.4 (p < 0.0005).  Six failures occurred.  Cartilage harvests showed hyaline-like histology with a normal collagen component but low proteoglycan presence and a disorganized structure.  Samples were positive for MMP-1, MMP-13 and Capsase-3.  The authors concluded that the use of BFOA represents an intriguing alternative to arthrodesis or arthroplasty; precise allograft sizing, stable fitting and fixation and delayed weight-bearing were key factors for a successful outcome.  They stated that further research regarding the immunological behavior of transplanted cartilage is needed.

Injury of articular cartilage due to trauma or pathological conditions is a major cause of disability worldwide.  There is extensive ongoing reseach focusing on strategies to repair and replace knee joint cartilage.  DeNovo NT Graft has been used to treat focal articular defects in a wide range of anatomical applications (e.g., ankle, elbow, great toe, hip, knee, and shoulder). DeNovo NT Natural Tissue Graft, a human tissue allograft, is an available cartilage repair treatment in the United States.  DeNovo ET Engineered Tissue Graft is undergoing a clinical study as an investigational biological product currently underoing clinical tials.  Moreover, there is a lack of evidence regarding the clinical value of DeNovo tissue graft.

Ahmed and Hincke (2010) discussed strategies to repair and replace knee joint cartilage.  Because of inadequacies associated with widely used approaches, the orthopedic community has an increasing tendency to develop biological strategies, which include transplantation of autologous (i.e., mosaicplasty) or allogeneic osteochondral grafts, autologous chondrocytes (autologous chondrocyte transplantation), or tissue-engineered cartilage substitutes.  Tissue-engineered cartilage constructs represent a highly promising treatment option for knee injury as they mimic the biomechanical environment of the native cartilage and have superior integration capabilities.  Currently, a wide range of tissue-engineering-based strategies are established and investigated clinically as an alternative to the routinely used techniques (i.e., knee replacement and autologous chondrocyte transplantation).  Tissue-engineering-based strategies include implantation of autologous chondrocytes in combination with collagen I, collagen I/III (matrix-induced autologous chondrocyte implantation), HYAFF 11 (Hyalograft C), and fibrin glue (Tissucol) or implantation of minced cartilage in combination with copolymers of polyglycolic acid along with polycaprolactone (cartilage autograft implantation system), and fibrin glue (DeNovo NT natural tissue graft).  Tissue-engineered cartilage replacements show better clinical outcomes in the short-term, and with advances that have been made in orthopedics they can be introduced arthroscopically in a minimally invasive fashion.  Thus, the future is bright for this innovative approach to restore function.

Kruse et al (2012) presented the findings of a new technique using DeNovo NT juvenile allograft cartilage implantation introduced into a talar lesion arthroscopically in a single procedure to repair a posterio-medial talar osteochondral defects in a healthy, active 30-year old female.  The patient tolerated the procedure well.  At the 6-month follow-up visit, the patient had returned to full activity, and at 24 months, she remained completely pain-free.  The findings of this case study need to be validated by well-designed studies.

Haene et al (2012) evaluated the intermediate outcomes of fresh osteochondral allografting for osteochondral lesions of the talus with use of validated outcome measures.  A total of 16 patients (17 ankles) received a fresh osteochondral allograft, and all 16 were available for follow-up.  Data were prospectively collected with use of the Ankle Osteoarthritis Scale (AOS), Short Form-36 (SF-36), and American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Module outcome measures.  Post-operative American Orthopaedic Foot & Ankle Society (AOFAS) hind-foot scale scores were also collected.  All 16 patients underwent radiographic and computed tomographic (CT) analyses pre-operatively, and 15 patients had these studies post-operatively.  The average duration of follow-up was 4.1 years.  The latest follow-up CT evaluation identified failure of graft incorporation in 2 of 16 ankles.  Osteolysis, subchondral cysts, and degenerative changes were found in 5, 8, and 7 ankles, respectively.  Five ankles were considered failures, and 2 required a re-operation because of ongoing symptoms.  The AOS Disability and the AAOS Foot and Ankle Core Scale scores significantly improved, but there was no significant change in the AOS Pain, AAOS Foot and Ankle Shoe Comfort Scale, or SF-36 scores.  Overall, 10 patients had a good or excellent result; however, persistent symptoms remained in 6 of these patients; only 4 were symptom-free.  The authors concluded that the use of a fresh osteochondral allograft is a reasonable option for the treatment of large talar osteochondral lesions.  Moreover, they stated that the high re-operation rate (2 of 17) and failure rate (5 of 17) must be taken into consideration when one is choosing this procedure for the management of these lesions.  The findings of this small case-series study need to be validated by well-designed studies with more patients and longer follow-up.

Gross et al (2012) performed a systematic review of clinical outcomes after cartilage restorative and reparative procedures in the glenohumeral joint to (i) identify prognostic factors that predict clinical outcomes, (ii) provide treatment recommendations based on the best available evidence, and (iii) highlight literature gaps that require future research.  These investigators searched Medline (1948 to week 1 of February 2012) and Embase (1980 to week 5 of 2012) for studies evaluating the results of arthroscopic debridement, microfracture, osteochondral autograft or allograft transplants, and autologous chondrocyte implantation for glenohumeral chondral lesions.  Other inclusion criteria included minimum 8 months' follow-up.  The Oxford Level of Evidence Guidelines and Grading of Recommendations Assessment, Development and Evaluation (GRADE) recommendations were used to rate the quality of evidence and to make treatment recommendations.  A total of 12 articles met inclusion criteria, which resulted in a total of 315 patients.  Six articles pertained to arthroscopic debridement (n = 249), 3 to microfracture (n = 47), 2 to osteochondral autograft transplantation (n = 15), and 1 to autologous chondrocyte implantation (n = 5).  Whereas most studies reported favorable results, sample heterogeneity and differences in the use of functional and radiographic outcomes precluded a meta-analysis.  Several positive and negative prognostic factors were identified.  All of the eligible studies were observational, retrospective case series without control groups; the quality of evidence available for the use of the afore-mentioned procedures is considered "very low" and "any estimate of effect is very uncertain".  The authors concluded that more research is needed to determine which treatment for chondral pathology in the shoulder provides the best long-term outcomes.  They encouraged centers to establish the necessary alliances to conduct blinded, randomized clinical trials and prospective, comparative cohort studies necessary to rigorously determine which treatments result in the most optimal outcomes.  At this time, high-quality evidence is lacking to make strong recommendations, and decision- making in this patient population is performed on a case-by-case basis.

Farr et al (2012) noted that Cartilage Autograft Implantation System (CAIS; DePuy/Mitek, Raynham, MA) and DeNovo Natural Tissue (NT; ISTO, St. Louis, MO) are novel treatment options for focal articular cartilage defects in the knee.  These methods involve the implantation of particulated articular cartilage from either autograft or juvenile allograft donor, respectively.  In the laboratory and in animal models, both CAIS and DeNovo NT have demonstrated the ability of the transplanted cartilage cells to "escape" from the extracellular matrix, migrate, multiply, and form a new hyaline-like cartilage tissue matrix that integrates with the surrounding host tissue.  In clinical practice, the technique for both CAIS and DeNovo NT is straightforward, requiring only a single surgery to affect cartilage repair.  Clinical experience is limited, with short-term studies demonstrating both procedures to be safe, feasible, and effective, with improvements in subjective patient scores, and with magnetic resonance imaging evidence of good defect fill.  The authors concluded that while these treatment options appear promising, prospective randomized controlled studies are needed to refine the indications and contraindications for both CAIS and DeNovo NT.

Petrera et al (2013) reported their experience with the use of fresh glenoid osteochondral allograft in the treatment of a chronic post-traumatic posterior subluxation of the shoulder associated with glenoid bone loss in a 54-year old recreational football player.  Based on the pathoanatomy of the lesion and availability of a bone bank providing fresh allograft, these researchers opted for an open anatomic reconstruction using a fresh glenoid allograft.  A posterior approach was used; the prepared allograft was placed in the appropriate anatomic position and fixed with 2 small fragment screws with washers.  At 2-year follow-up, the clinical outcome is excellent.  The authors noted that this procedure may represent an effective option for the treatment of chronic posterior shoulder instability due to glenoid bone loss.  However, they stated that the long-term effectiveness and the progression of glenohumeral osteoarthritis need to be evaluated.

DeNovo ET engineered tissue graft (ISTO Technologies, Inc. St. Louis, MO) is a scaffold-free hyaline cartilage implant designed for the repair and regeneration of knee cartilage.  It uses tissue-engineered juvenile cartilage cells applied to defects of the joint surface using a protein-based adhesive.  There is a lack of evidence regarding the clinical value of the DeNovo ET tissue graft.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Allograft transplant of the knee ligaments:
CPT codes covered if selection criteria are met:
27427
27428
27429
29888
29889
ICD-9 codes covered if selection criteria are met:
717.81 - 717.89 Other internal derangement of knee [including lateral, medial, anterior and posterior ligaments]
726.64 Patellar tendinitis
Other ICD-9 codes related to the CPB:
710.8, 710.9 Other specified and unspecified diffuse diseases of connective tissue
728.4 Laxity of ligament
844.2 Sprain and strain cruciate ligament of knee
959.7 Injury, other and unspecified, knee, leg, ankle, and foot
V15.5 Personal history of injury
V45.89 Other postprocedural status
Allograft transplant of the knee, osteochondral:
CPT codes covered if selection criteria are met:
27415
29867
ICD-9 codes covered if selection criteria are met:
715.16 Osteoarthrosis localized, primary, lower leg
715.26 Osteoarthrosis localized, secondary, lower leg
715.36 Osteoarthrosis localized, not specified whether primary or secondary, lower leg
715.96 Osteoarthrosis, unspecified whether generalized or localized, lower leg
732.7 Osteochondritis dissecans
733.43 Aseptic necrosis of medial femoral condyle
Other ICD-9 codes related to the CPB:
719.86, 719.96 Other specified and unspecified disorder of joint, lower leg
733.90 Disorder of bone and cartilage, unspecified
733.99 Other unspecified disorders of bone and cartilage
891.0 - 891.2 Open wound of knee, leg [except thigh], and ankle
Allograft transplant of the knee, meniscus:
CPT codes covered if selection criteria are met:
29868
Other CPT codes related to the CPB:
27427 - 27429
29870 - 29889
73721 - 73723
ICD-9 codes covered if selection criteria are met:
717.0 - 717.5 Derangement of medial and lateral meniscus
836.0 Tear of medial cartilage or meniscus of the knee, current
836.1 Tear of lateral cartilage or meniscus of the knee, current
836.2 Other tear of cartilage or meniscus of the knee, current
Osteochondral allograft of talus:
CPT codes not covered for indications listed in the CPB:
20962
28103
Other CPT codes related to the CPB:
28705 - 28725
ICD-9 codes not covered for indications listed in the CPB:
733.44 Aseptic necrosis of talus
Osteochondral allograft of tarsal-metatarsal:
CPT codes not covered for indications listed in theCPB:
20957
28107
Other CPT codes related to the CPB:
28730 - 28735


The above policy is based on the following references:
  1. Roberts TS, Drez D Jr, McCarthy W, Paine R. Anterior cruciate ligament reconstruction using freeze-dried, ethylene oxide-sterilized, bone-patellar tendon-bone allografts. Two year results in thirty-six patients. Am J Sports Med. 1991 Jan-Feb;19(1):35-41.
  2. Valenti JR, Sala D, Schweitzer D, et al. Anterior cruciate ligament reconstruction with fresh-frozen patellar tendon allografts. Int Orthop. 1994;18(4):210-214.  
  3. Levitt RL, Malinin T, Posada A, et al. Reconstruction of anterior cruciate ligaments with bone-patellar tendon-bone. Clin Orthop. 1994;303:67-78.
  4. Fideler BM, et al. Effects of gamma irradiation on the human immunodeficiency virus.  J Bone Joint Surg. 1994;76(7):1032-1035.
  5. Miller MD, Harner CD. The use of allograft: Techniques and results. Clin Sports Med. 1993;12(4):757-770.  
  6. Nin JR, Leyes M, Schweitzer D, et al. Anterior cruciate ligament reconstruction with fresh-frozen patellar tendon allografts: Sixty cases with 2 years' minimum follow-up. Knee Surg Sports Traumatol Arthrosc. 1996;4(3):137-142.  
  7. Shelton WR, Papendick L, Dukes AD, et al. Autograft versus allograft anterior cruciate ligament reconstruction. Arthroscopy. 1997;13(4):446-449.  
  8. van Arkel E, de Boer HH. Human meniscal transplantation: Preliminary results at 2 to 5 year follow-up. J Bone Joint Surg. 1995;77(4):589-595.  
  9. Pritchard JC, Drez D Jr, Moss M, Heck S. Long-term followup of anterior cruciate ligament reconstruction using freeze-dried fascia lata allografts. Am J Sports Med. 1995;23(5):593-596.
  10. Wilcox T, Goble EM. Indications for meniscal allograft reconstruction. Am J Knee Surg. 1996;9:35-36. 
  11. Goble EM, Kohn D, Verdonk R, et al. Meniscal substitutes -- human experience. Scand J Med Sci Sports. 1999;9(3):146-157.  
  12. Convey FR, Meyers MH, Akeson WH. Fresh osteochondral allografting of the femoral condyle. Clin Orthop. 1991;273:139-145.  
  13. Mahomed MN, Beaver RJ, Gross AE. The long-term success of fresh, small fragment osteochondral allografts used for intraarticular post-traumatic defects in the knee joint. Orthopedics. 1992;15(10):1191-1199. 
  14. Garrett JC. Fresh osteochondral allografts for treatment of articular defects in osteochondritis dissecans of the lateral femoral condyle in adults. Clin Orthop. 1994;303:33-37.  
  15. Ghazavi MT, Pritzker KP, Davis AM, et al. Fresh osteochondral allografts for post-traumatic osteochondral defects of the knee. J Bone Joint Surg Br. 1997;79(6):1008-1013.  
  16. Bakay A, Csonge L, Papp G, et al. Osteochondral resurfacing of the knee joint with allograft. Clinical analysis of 33 cases. Int Orthop. 1998;22(5):277-281.  
  17. Chu CR, Convery FR, Akeson WH, et al. Articular cartilage transplantation. Clinical results in the knee. Clin Orthop. 1999;360:159-168. 
  18. Noyes FR, Barber-Westin SD. Reconstruction of the lateral collateral ligament of the knee with patellar tendon allograft. Report of a new technique in combined ligament injuries. Am J Sports Med. 1999;27(2):269-270.
  19. Peterson RK, Shelton WR, Bomboy AL. Allograft versus autograft patellar tendon anterior cruciate ligament reconstruction: A 5-year follow-up. Arthroscopy. 2001;17(1):9-13.  
  20. Allum RL. BASK Instructional Lecture 1: Graft selection in anterior cruciate ligament reconstruction. Knee. 2001;8(1):69-72. 
  21. Felix NA, Paulos LE. Current status of meniscal transplantation. Knee. 2003;10(1):13-17.
  22. Washington State Department of Labor and Industries, Office of the Medical Director. Meniscal allograft. Health Technology Assessment. Olympia, WA: Washington State Department of Labor and Industries; revised October 22, 2002. Available at: http://www.lni.wa.gov/omd/TechAssessDocs.htm. Accessed August 7, 2003.
  23. Gross AE, Agnidis Z, Hutchison CR. Osteochondral defects of the talus treated with fresh osteochondral allograft transplantation. Foot Ankle Int. 2001;22(5):385-391. 
  24. Hayes DW Jr, Averett RK. Articular cartilage transplantation. Current and future limitations and solutions. Clin Podiatr Med Surg. 2001;18(1):161-176. 
  25. Tasto JP, Ostrander R, Bugbee W, Brage M. The diagnosis and management of osteochondral lesions of the talus: Osteochondral allograft update. Arthroscopy. 2003;19 Suppl 1:138-141.
  26. Graf KW Jr, Sekiya JK, Wojtys EM; et al. Long-term results after combined medial meniscal allograft transplantation and anterior cruciate ligament reconstruction: Minimum 8.5-year follow-up study. Arthroscopy. 2004;20(2):129-140.
  27. Raikin SM. Stage VI: Massive osteochondral defects of the talus. Foot Ankle Clin. 2004;9(4):737-744, vi.
  28. Noyes FR, Barber-Westin SD, Rankin M. Meniscal transplantation in symptomatic patients less than fifty years old. J Bone Joint Surg Am. 2005;87 Suppl 1(Pt.2):149-165.
  29. Caldwell PE 3rd, Shelton WR. Indications for allografts. Orthop Clin North Am. 2005;36(4):459-467.
  30. Chapovsky F, Kelly JD 4th. Osteochondral allograft transplantation for treatment of glenohumeral instability. Arthroscopy. 2005;21(8):1007.
  31. Gorschewsky O, Klakow A, Riechert K, et al. Clinical comparison of the Tutoplast allograft and autologous patellar tendon (bone-patellar tendon-bone) for the reconstruction of the anterior cruciate ligament: 2- and 6-year results. Am J Sports Med. 2005;33(8):1202-1209.
  32. Rodriguez EG, Hall JP, Smith RL, et al. Treatment of osteochondral lesions of the talus with cryopreserved talar allograft and ankle distraction with external fixation.Surg Technol Int. 2006;15:282-288.
  33. Moore DR, Cain EL, Schwartz ML, Clancy WG Jr. Allograft reconstruction for massive, irreparable rotator cuff tears. Am J Sports Med. 2006;34(3):392-396.
  34. Simon TM, Jackson DW. Articular cartilage: Injury pathways and treatment options. Sports Med Arthrosc. 2006;14(3):146-154.
  35. Schoenfeld AJ, Leeson MC, Grossman JP. Fresh-frozen osteochondral allograft reconstruction of a giant cell tumor of the talus. J Foot Ankle Surg. 2007;46(3):144-148.
  36. Colangeli M, Donati D, Benedetti MG, et al. Total knee replacement versus osteochondral allograft in proximal tibia bone tumours. Int Orthop. 2007;31(6):823-829.
  37. Prodromos C, Joyce B, Shi K. A meta-analysis of stability of autografts compared to allografts after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2007;15(7):851-856.
  38. Gross AE, Kim W, Las Heras F, et al. Fresh osteochondral allografts for posttraumatic knee defects: Long-term followup. Clin Orthop Relat Res. 2008;466(8):1863-1870.
  39. Krych AJ, Jackson JD, Hoskin TL, Dahm DL. A meta-analysis of patellar tendon autograft versus patellar tendon allograft in anterior cruciate ligament reconstruction. Arthroscopy 2008;24(3):292-298.
  40. Adelaar RS, Madrian JR. Avascular necrosis of the talus. Orthop Clin North Am. 2004;35(3):383-395, xi.
  41. Dopirak RM, Steensen RN, Maurus PB. The medial patellofemoral ligament. Orthopedics. 2008;31(4):331-338.
  42. Williams RJ, Gamradt SC. Articular cartilage repair using a resorbable matrix scaffold. Instr Course Lect. 2008;57:563-571.
  43. Carmont MR, Carey-Smith R, Saithna A, et al. Delayed incorporation of a TruFit plug: Perseverance is recommended. Arthroscopy. 2009 Jul;25(7):810-814.
  44. Giannini S, Buda R, Grigolo B, et al. Bipolar fresh osteochondral allograft of the ankle. Foot Ankle Int. 2010;31(1):38-46.
  45. Melton JT, Wilson AJ, Chapman-Sheath P, Cossey AJ. TruFit CB bone plug: Chondral repair, scaffold design, surgical technique and early experiences. Expert Rev Med Devices. 2010;7(3):333-341.
  46. Hermans S, Corten K, Bellemans J. Long-term results of isolated anterolateral bundle reconstructions of the posterior cruciate ligament: A 6- to 12-year follow-up study. Am J Sports Med. 2009;37(8):1499-1507.
  47. Romanini E, D'Angelo F, De Masi S, et al. Graft selection in arthroscopic anterior cruciate ligament reconstruction. J Orthop Traumatol. 2010;11(4):211-219.
  48. Hammoud S, Reinhardt KR, Marx RG. Outcomes of posterior cruciate ligament treatment: A review of the evidence. Sports Med Arthrosc. 2010;18(4):280-291.
  49. Barrett GR, Luber K, Replogle WH, Manley JL. Allograft anterior cruciate ligament reconstruction in the young, active patient: Tegner activity level and failure rate. Arthroscopy. 2010;26(12):1593-1601.
  50. Cooper MT, Kaeding C. Comparison of the hospital cost of autograft versus allograft soft-tissue anterior cruciate ligament reconstructions. Arthroscopy. 2010;26(11):1478-1482.
  51. Reinhardt KR, Hetsroni I, Marx RG. Graft selection for anterior cruciate ligament reconstruction: A level I systematic review comparing failure rates and functional outcomes. Orthop Clin North Am. 2010;41(2):249-262.
  52. Mehta VM, Mandala C, Foster D, Petsche TS. Comparison of revision rates in bone-patella tendon-bone autograft and allograft anterior cruciate ligament reconstruction. Orthopedics. 2010;33(1):12. 
  53. Nagda SH, Altobelli GG, Bowdry KA, Brewster CE, Lombardo SJ. Cost analysis of outpatient anterior cruciate ligament reconstruction: Autograft versus allograft. Clin Orthop Relat Res. 2010;468(5):1418-1422.
  54. Hospodar SJ, Miller MD. Controversies in ACL reconstruction: Bone-patellar tendon-bone anterior cruciate ligament reconstruction remains the gold standard. Sports Med Arthrosc. 2009;17(4):242-246.
  55. Barrett AM, Craft JA, Replogle WH, et al. Anterior cruciate ligament graft failure: A comparison of graft type based on age and Tegner activity level. Am J Sports Med. 2011;39(10):2194-2198.
  56. Oro FB, Sikka RS, Wolters B, et al. Autograft versus allograft: An economic cost comparison of anterior cruciate ligament reconstruction. Arthroscopy. 2011;27(9):1219-1225.
  57. Ahmed TA, Hincke MT. Strategies for articular cartilage lesion repair and functional restoration. Tissue Eng Part B Rev. 2010;16(3):305-329.
  58. Kruse DL, Ng A, Paden M, Stone PA. Arthroscopic De Novo NT(®) juvenile allograft cartilage implantation in the talus: A case presentation. J Foot Ankle Surg. 2012;51(2):218-221.
  59. Haene R, Qamirani E, Story RA, et al. Intermediate outcomes of fresh talar osteochondral allografts for treatment of large osteochondral lesions of the talus. J Bone Joint Surg Am. 2012;94(12):1105-1110.
  60. Gross CE, Chalmers PN, Chahal J, et al. Operative treatment of chondral defects in the glenohumeral joint. Arthroscopy. 2012;28(12):1889-1901.
  61. Farr J, Cole BJ, Sherman S, Karas V. Particulated articular cartilage: CAIS and DeNovo NT. J Knee Surg. 2012;25(1):23-29.
  62. Petrera M, Veillette CJ, Taylor DW, et al. Use of fresh osteochondral glenoid allograft to treat posteroinferior bone loss in chronic posterior shoulder instability. Am J Orthop (Belle Mead NJ). 2013;42(2):78-82.
  63. Coetzee JC, Giza E, Schon LC, et al. Treatment of osteochondral lesions of the talus with particulated juvenile cartilage. Foot Ankle Int. 2013 Apr 10. [Epub ahead of print].
  64. Tompkins M, Hamann JC, Diduch DR, et al. Preliminary results of a novel single-stage cartilage restoration technique: Particulated juvenile articular cartilage allograft for chondral defects of the patella. Arthroscopy. 2013 Jul 20. [Epub ahead of print]


email this page   


Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
Aetna
Back to top