National Medical Policy Subject:

Osteochondral Allograft Transplants of the Lower Extremity (OAG)

Policy Number:

NMP355

Effective Date*:

June 2007

Update:

August 2015

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use

X

Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other None

Reference/Website Link

Use Health Net Policy

Instructions  Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions.  Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2)  If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual.

Osteochondral Allograft Transplants of the Lower Extremity (OAG) Aug 15

1



If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement The Health Net Medical Policies on ACL Allograft Transplant and Meniscal Allograft Transplant have been incorporated into this one single policy. Refer to the policy on Oats and Mosaicplasty for the Osteochondral Autograft Transfer System. Health Net, Inc. considers allograft transplants of the knee (osteochondral, anterior cruciate ligament, and meniscal) medically necessary when any of the following specific criteria are met: 1. Osteochondral Defects 

Symptomatic and debilitating focal chondral lesions of an articular surface of the knee are present; or



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 health cartilage. The opposing articular surface should be generally disease free; or



Otherwise healthy, active, non-elderly members who have either failed previous medical and/or surgical management (e.g. failed earlier arthroscopic procedures because of the size, shape, or location of the lesion); or



Non-repairable stage 3 or 4 osteochondritis dissecans; or



The patient is not currently a candidate for total knee replacement.

2. Anterior Cruciate Ligament 

Revision of previous ACL reconstruction when autograft is not available due to deficient bone;



The surgical revision requires multiligament reconstruction and several grafts;



The patient has a medical condition (e.g., anatomic anomaly, prior knee injury or prior knee surgery) that precludes the use of autograft tissue.

NOTE: The Health Net Medical Policy on Anterior Cruciate Ligament (ACL) Allograft Transplantation, has been incorporated into this policy. 3. Meniscal Allograft Transplant is considered medically necessary for patients with a significant partial (more than 50%) or partial loss of the meniscus** when all of the criteria listed below are met: 

Physically active and physiologically young, under age 55; and



Documented mild to moderate articular damage (Outerbridge grade II or less); and



Disabling knee pain refractory to conservative treatment; and



Normal alignment without varus or valgus deformities.

Osteochondral Allograft Transplants of the Lower Extremity (OAG) Aug 15

2

**Absence of meniscus must be firmly established by previous operative reports, magnetic resonance imaging (MRI), or diagnostic arthroscopy. Note: The criteria for meniscus transplant is from the American Academy of Orthopedic Surgeons.

Contraindications to Meniscal Allograft Transplant include any of the following: 1. Systemic metabolic degenerative disease; (i.e., gout) or 2. Arthritis of the knees or rheumatoid arthritis; or 3. Flattening of the femoral condyles or severe degenerative changes (greater than 50% joint space narrowing, bone on bone, or erosion to subchondral bone); or 4. Patients who have undergone partial or total meniscectomy and do not presently have symptoms or problems with their knee; or 5. *Obese sedentary individuals pose a very poor risk for this procedure. (i.e. Transplants tend to fail in overweight patients because of excessive weight-bearing stress on the new cartilage). *Note – Obesity is defined as being 20% or more over the ideal weight and build with a body mass index (BMI) of 30 or higher.

Not Medically Necessary Health Net, Inc. considers 0steochondral allograft transplant of the knee for any indication, other than listed above, not medically necessary.

Investigational Health Net, Inc. considers either of the following indication investigational due to a lack of controlled prospective studies in the medical literature to validate their efficacy and safety: 

Osteochondral Allograft of the Talus - Additional clinical studies of this approach with comparison to ankle arthrodesis, especially in terms of pain, disability, functionality and durability are needed; or



The use of synthetic resorbable polymers (i.e. PolyGraft Bone Graft Substitute [BGS], TruFit, and TruGraft), to repair osteochondral articular cartilage defects.

Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date.

Osteochondral Allograft Transplants of the Lower Extremity (OAG) Aug 15

3

ICD-9 Codes 715.16 715. 26 715.9 717.0 717.1 717.2 717.3 717.40 717.41 717.42 717.43 717.5 717.7 717.83 719.86 730.1 732.7 733.9 733.90 733.99 836.0 836.1 836.2 891.0-891.2 959.7

Osteoarthrosis localized, primary, lower leg Osteoarthrosis localized, secondary, lower leg Osteoarthritis Old bucket handle tear of medial meniscus Derangement of anterior horn of medial meniscus Derangement of posterior horn of medial meniscus Other and unspecified derangement of medial meniscus Derangement of lateral meniscus, unspecified Bucket handle tear of lateral meniscus Derangement of anterior horn of lateral meniscus Derangement of posterior horn of lateral meniscus Derangement of meniscus, not elsewhere classified Chondromalacia patellae Old disruption of anterior cruciate ligament Other specified and unspecified disorder of joint, lower leg Osteonecrosis Osteochondritis dissecans Traumatic osteochondral injury Disorder of bone and cartilage, unspecified Other specified disorder of bone and cartilage Tear of medial cartilage or meniscus of the knee, current Tear of lateral cartilage or meniscus of the knee, current Other tear of cartilage or meniscus of the knee, current Open wound of knee, leg (except thigh), and ankle Injury, other and unspecified, knee, leg, ankle and foot

ICD- 10 Codes M17.10-M17.12 M17.5 M19.90-M19.93 M22.40-M22.42 M23.20-M23.269 M23.50-M23.52 M25.169 M25.869 M86.60 M89.8X9 M89.9 M94.9 M93.20 M93.261-M93.269 M94.8X9 S81.009 S81.029 S81.809 S81.829 S83.209 S91.029 S83.219 S83.249

Unilateral primary osteoarthritis of knee Other unilateral secondary osteoarthritis of knee Osteoarthritis, unspecified site Chondromalacia patellae Derangement of meniscus due to old tear or injury Chronic instability of knee Fistula, unspecified knee Other specified joint disorders, unspecified knee Other chronic osteomyelitis, unspecified site Other specified disorders of bone, unspecified site Disorder of bone, unspecified Disorder of cartilage, unspecified Osteochondritis dissecans of unspecified site Osteochondritis dissecans, knee Other specified disorders of cartilage, unspecified sites Unspecified open wound, unspecified knee Laceration with foreign body, unspecified knee Unspecified open wound, unspecified lower leg Laceration with foreign body, unspecified lower leg Unspecified tear of unspecified meniscus, current injury, unspecified knee Laceration with foreign body, unspecified ankle Bucket-handle tear of medial meniscus, current injury, unspecified knee Other tear of medial meniscus, current injury, unspecified knee

Osteochondral Allograft Transplants of the Lower Extremity (OAG) Aug 15

4

S83.289 S83.30X S86.929 S89.80X S89.90X S91.009 S96.929 S99.819 S99.919

Other tear of lateral meniscus, current injury, unspecified knee Tear of articular cartilage of unspecified knee, current, initial encounter Laceration of unspecified muscle(s) and tendon(s) at lower leg level, unspecified leg Other specified injuries of unspecified lower leg Unspecified injury of unspecified lower leg, initial encounter Unspecified open wound, unspecified ankle Laceration of unspecified muscle and tendon at ankle and foot level, unspecified foot Other specified injuries of unspecified ankle Unspecified injury of unspecified ankle

CPT Codes 27407 27415 27427 27428 27429 29867 29868

Repair, primary, torn ligament and or capsule, knee; cruciate Osteochondral allograft, knee, open Ligamentous reconstruction (augmentation), knee; extraarticular Ligamentous reconstruction (augmentation), knee intraarticular (open) Ligamentous reconstruction (augmentation), knee; intraarticular (open) and extra-articular Arthroscopy, knee, surgical; osteochondral allograft Arthroscopy, knee, surgical; meniscal transplantation (includes arthrotomy for meniscal), medial or lateral

HCPCS Codes NA

Scientific Rationale – Update August 2015 Gacitelli et al (2015) assessed the outcome of osteochondral allograft (OCA) transplantation as a salvage procedure after various cartilage repair surgeries. One hundred sixty-four knees in 163 patients (mean age = 32.6 years; range = 11-59 years; 55% males) were treated with OCA transplantation after subchondral marrow stimulation (SMS), osteochondral autograft transplantation (OAT), and autologous chondrocyte implantation (ACI). The majority of previous procedures were isolated SMS in 145 knees (88.4%). Mean allograft size was 8.5 ± 7.9 cm(2). The most common location was in femoral condyle. The number and type of reoperations on the operative knee were assessed. Failure of the OCA transplantation was defined as any reoperation resulting in removal of the allograft. Functional outcomes were evaluated. Sixty-eight knees had reoperations after OCA transplantation. Thirty-one knees (18.9%) were classified as allograft failures. The median time to failure was 2.6 ± 6.8 years (range = 0.7-23.4 years). Survivorship of the graft was 82% at 10 years and 74.9% at 15 years. Patients whose grafts were still in situ had a mean of 8.5 ± 5.6 years of follow-up. Scores on all functional outcomes scales improved significantly from preoperatively to latest follow-up. Eighty-nine percent of OCA transplantation patients reported being "extremely satisfied" or "satisfied." The authors concluded despite the high reoperation rate, OCA transplantation is a successful salvage surgical treatment after cartilage repair procedures. This cohort showed improved survivorship and functional outcomes of OCA transplantation after SMS, ACI, and OAT. Saltzman et al (2015) sought to synthesize, in a systematic review, the available clinical evidence of osteochondral allograft transplants for large osteochondral defects of the humeral head. The authors included 12 studies (8 case reports and 4 case series) in this

Osteochondral Allograft Transplants of the Lower Extremity (OAG) Aug 15

5

review. The study group consisted of 35 patients. The mean age was 35.4 ± 18.1 years; 77% of patients were male patients. Thirty-three patients had large Hill-Sachs lesions due to instability, 1 had an osteochondritis dissecans lesion, and 1 had an iatrogenic lesion after resection of synovial chondromatosis. The mean lesion size was 3 ± 1.4 cm (anteroposterior) by 2.25 ± 0.3 cm (medial-lateral), representing on average 40.5% ± 4.73% of the native articular surface. Of the 35 patients, 3 received a fresh graft, with all others receiving frozen grafts. Twenty-three femoral heads, 10 humeral heads, and 2 sets of osteochondral plugs were used. The mean length of follow-up was 57 months. Significant improvements were seen in forward flexion at 6 months (68° ± 18.1°, P < .001), forward flexion at 12 months (83.42° ± 18.3°, P < .001), and external rotation at 12 months (38.72° ± 18.8°, P < .001). American Shoulder and Elbow Surgeons scores improved by 14 points (P = .02). Radiographic studies at final follow-up showed allograft necrosis in 8.7% of cases, resorption in 36.2%, and glenohumeral arthritic changes in 35.7%. Complication rates were between 20% and 30%, and the reoperation rate was 26.67%. Although only 3 patients received fresh allografts, there were no reports of graft resorption, necrosis, or arthritic changes in these patients. The authors concluded humeral head allograft-most commonly used in the setting of large Hill-Sachs lesions due to instability-has shown significant improvements in shoulder motion and American Shoulder and Elbow Surgeons scores as far as 1 year postoperatively. Return-to-work rates and satisfaction levels are high after the intervention. Complication and reoperation rates are substantial, although it is possible that use of fresh allograft tissue may result in less resorption and necrosis. Getgood et al (2015) retrospectively reviewed patients who received simultaneous meniscal allograft transplantation (MAT) and osteochondral allografting (OCA) between 1983 and 2011. Forty-eight (twenty-nine male: nineteen female) patients with a median age of 35.8 years (15-66) received combined MAT and OCA procedures. Forty-three patients had received previous surgery with a median of 3 procedures (1-11 procedures). The underlying diagnosis was trauma (tibial plateau fracture) in 33 % with osteoarthritis predominating in 54.2 % of cases. Thirty-one patients received a lateral meniscus, 16 received a medial meniscus and one patient received bilateral MAT. The median number of OCAs was two per patient (1-5 grafts), with a median graft area of 15 cm(2) (0.7-41 cm(2)). There were 21 unipolar, 24 bipolar (tibiofemoral) and three multifocal lesions. Thirty-six MATs constituted a compound tibial plateau OCA with native meniscus attached. At follow-up, failure was defined as any procedure resulting in removal or revision of one or more of the grafts. Patients completed the modified Merle d'Aubigné and Postel (18-point) scale, Knee Society Function (KS-F) score, and subjective International Knee Documentation Committee (IKDC) scores. Patient satisfaction was also captured. Twenty-six of 48 patients (54.2 %) required reoperation, but only 11 patients (22.9 %) were noted to have failed (10 MAT and 11 OCA). The mean time to failure was 3.2 years (95 % CI 1.5-4.9 years) and 2.7 years (95 % CI 1.3-4.2 years) for MAT and OCA, respectively. The 5-year survivorship was 78 and 73 % for MAT and OCA respectively, and 69 and 68 % at 10 years. Six of the failures were in the OA cases and one was an OCD lesion where bipolar grafts were utilized. The OCD case underwent a revision OCA and remains intact. The others were converted to knee arthroplasty. One case failed due to early deep infection, ultimately requiring arthrodesis. Of those with grafts still intact, the mean clinical follow-up was 6.8 years (1.7-17.1 years). Statistically significant improvements in all outcome scores were noted between baseline and the latest follow-up. In total, 90 % of those responding would have the surgery again and 78 % were either extremely satisfied or satisfied with the outcome. The authors concluded the overall success rate of concomitant MAT and OCA was comparable with reported results for either procedure in isolation. A trend towards a worse outcome was observed with bipolar tibiofemoral grafts in the setting of OA. Comparatively better results

Osteochondral Allograft Transplants of the Lower Extremity (OAG) Aug 15

6

in less advanced, unipolar disease could suggest a benefit to early intervention that might merit a lower treatment threshold for combined MAT and OCA. Caravaggi et al (2015) reported severe ankle arthritis is a life-limiting condition which often requires surgery. Ankle arthroplasty via artificial or "biological" reconstruction is a viable option in those patients who are not comfortable with arthrodesis. More functional studies are needed to compare the performance and outcomes of the two function-preserving arthroplasties. In this study two groups of 10 patients affected by severe ankle arthritis were treated either with a 3-component ankle prosthesis or with bipolar fresh osteochondral allograft transplantation. Patients were evaluated pre-operatively and at 5-year follow-up. The American Orthopaedic Foot and Ankle Society score was used for clinical evaluation, and gait analysis for functional assessment. Activation pattern of lower limb muscles was obtained by surface electromyography (EMG). In each group, kinematic, kinetic, and EMG data were compared between pre-op and follow-up assessments, and also versus corresponding data from a 20 healthy subject control group. The median clinical score significantly increased between pre-op and follow-up from 53 to 74.5 in the transplantation and from 28.5 to 80 in the prosthesis group. Spatio-temporal parameters showed a statistically significant improvement in cadence and cycle time. Improvement of gait speed was also observed only in the prosthesis group. EMG patterns at follow-up were strongly correlated with the corresponding control data for both groups. Although no significant amelioration in the joints' range of motion was detected in either surgical procedure, preservation of the functional conditions at medium-term, along with significant improvement of the clinical score, may be considered a positive outcome for both techniques. At this time, the available evidence is insufficient to draw definitive conclusions regarding the comparative effectiveness, the durability, and the safety of osteochondral allograft transplantation for articular ankle disorders.

Scientific Rationale – Update August 2014 Rosso et al (2014) performed a systematic review to assess the quality of the published studies on meniscal allograft transplantation (MAT), the indications for surgery; the methods used for preservation, sizing, and fixation of the allograft; and the clinical and radiographic outcomes of this procedure and its role in preventing osteoarthritis. Inclusion criteria for the articles were English language, peer-reviewed clinical studies with evidence levels 1 to 4, reported clinical and/or radiological outcomes of MAT isolated or combined with other procedures, minimum 12-month follow-up, case series of at least 10 patients, and a follow-up rate of at least 80% (no more than 20% of patients lost to follow-up) A total of 55 studies matched the inclusion criteria (2 level 2, 7 level 3, and 46 level 4). The average Coleman methodology score was 49.73 ± 12.41 (range, 24-81). There was agreement in the literature regarding the indications for MAT: joint line pain and tenderness correlated with previous meniscectomy, young patients, without diffuse Outerbridge grade III and no grade IV cartilage damage, and a stable and well-aligned knee. Different graft types have been used: viable, fresh frozen, cryopreserved, and lyophilized. The most common method for graft sizing was plain radiography. Different fixation techniques have been described, with only a few studies comparing the clinical results of the different techniques and with no proven superiority of one method over the other. All the studies showed clinical improvement at last follow-up visit compared with preoperatively. The chondroprotective effect of MAT is still unclear. The reviewers concluded meniscal allograft transplantation seems to provide good clinical results at short-term and midterm follow-up, with improvement in knee function as well as acceptable complication and failure rates. Higher quality studies are necessary to better assess the potential chondroprotective effect

Osteochondral Allograft Transplants of the Lower Extremity (OAG) Aug 15

7

of MAT and to identify differences in terms of outcomes between different surgical techniques. Vundelinckx et al (2014) reported the long-term results of a patient cohort whose mediumterm results have been reported and to evaluate whether the results are maintained in the long term or deteriorate after a certain period. The hypothesis was that the subjective, clinical, and radiographic results are consistent in the long term without significant deterioration. Thirty patients from the original cohort of 49 patients (50 MATs) who underwent MAT at least 9 years before this study were evaluated with the Knee injury and Osteoarthritis Outcome Score (KOOS); Lysholm, Tegner, and Short Form-36 scores; and a visual analog score for pain. A standardized clinical examination was performed to objectively evaluate knee-related symptoms. Standard weightbearing radiographs, including a full-leg standing radiograph, were performed to evaluate joint space narrowing and any progression of osteoarthritis and malalignment. These results, at a mean follow-up time of 12 years and 8 months (152 months; range, 112-216 months), were compared with the preoperative data and the outcome results at medium-term follow-up (mean, 8 years and 9 months). Of the original 49 patients, 6 (12.2%) required conversion to a total knee arthroplasty during the study period and were considered failures, and 17 (34.7%) required a second surgical procedure during the study period. Excluding the 6 total knee arthroplasty cases, 90% of patients reported being very satisfied or satisfied and would undergo the procedure again. Only 1 patient reported not wanting to undergo the procedure again. Results of the visual analog score, KOOS and all KOOS subscales, Lysholm, and Short Form36 all showed a statistically significant improvement at estimated follow-up periods of 7.5 and 12.5 years compared with preoperative scores. There was no statistically significant difference for these scores between 7.5 and 12.5 years postoperatively. Despite the improvement in outcome scores, the Tegner activity level score remained unchanged during the entire follow-up period. Regarding radiographic outcomes, there was a progressive increase in the Kellgren-Lawrence rating over the study period. There was a statistically significant (P = .0208) progressive joint space narrowing between estimates at the 7.5-year (5.45 mm) and 12.5-year (4.95 mm) follow-up. However, there was no statistically significant (P = .6724) difference in absolute value of alignment deviation from the 0° mechanical axis between 7.5 years (2.32°) and 12.5 years (2.51°) postoperatively. There was no difference between medial and lateral transplants. The authors concluded, despite an increase in joint space narrowing, MAT resulted in significant improvements in pain and functional outcomes over the study period. There was no change in these improvements between the medium- and long-term follow-up period. This study confirms the good and consistent results found in the literature concerning satisfaction, pain resolution, and functional scores at long-term follow-up.

Scientific Rationale – Update August 2013 Montgomery et al (2013) evaluated trends in surgical treatment of articular cartilage defects of the knee in the United States. A total of 163,448 articular cartilage procedures of the knee were identified over a 6-year period. Microfracture and chondroplasty accounted for over 98 % of cases. There was no significant change in the incidence of cartilage procedures noted from 2004 (1.27 cases per 10,000 patients) to 2009 (1.53 cases per 10,000 patients) (p = 0.06). All procedures were performed more commonly in males (p < 0.001). This gender difference was smallest in patients undergoing chondroplasty (51 % males and 49 % females) and greatest for open osteochondral allograft (61 % males and 39 % females). Chondroplasty and microfracture were most commonly performed in patients aged 40-59, while all other procedures were performed most frequently in patients