Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 10|01|2022 POLICY LAST REVIEWED: 05|07|2025 OVERVIEW Osteochondral grafts are used to repair full-thickness chondral defects involving a joint. In the case of osteochondral autografts, 1 or more small osteochondral plugs are harvested from non-weight-bearing sites, usually from the knee, and press fit into a prepared site in the lesion. Osteochondral allografts are typically used for larger lesions. Autologous or allogeneic minced cartilage, decellularized osteochondral allograft plugs, and reduced osteochondral allograft discs are also being evaluated as a treatment of articular cartilage lesions. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION
Not applicable POLICY STATEMENT Medicare Advantage Plans and Commercial Products Allografting Fresh osteochondral allografting is covered as a technique to repair full-thickness chondral defects of the knee, large (area >1.5 cm2) or cystic (volume >3.0 cm3) osteochondral lesions of the talus or osteochondral lesions of the talus when autografting would be inadequate due to lesion size, depth or location.
Osteochondral allografting for all other joints are not covered for Medicare Advantage Plans and not medically necessary for Commercial Products as the evidence is insufficient to determine the effects of the technology on health outcomes.
Autografting Osteochondral autografting, using one or more cores of osteochondral tissue, is covered for full thickness cartilage defects of the knee or osteochondral lesions of the talus.
Osteochondral autografting for all other joints are not covered for Medicare Advantage Plans and not medically necessary Commercial Products as the evidence is insufficient to determine the effects of the technology on health outcomes. Other Treatments The following treatments of focal articular cartilage lesions are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products as the evidence is insufficient to determine the effects of the technology on health outcomes: • Autologous minced or particulated cartilage • Allogeneic minced or particulated cartilage • Decellularized osteochondral allograft plugs (eg, Chondrofix) • Reduced osteochondral allograft discs (eg, ProChondrix, Cartiform) COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable surgery benefits/coverage. Medical Coverage Policy | Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

BACKGROUND For individuals who have full-thickness articular cartilage lesions of the knee who receive an osteochondral autograft, the evidence includes randomized controlled trials (RCTs), systematic reviews of RCTs, and longer- term observational studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Several systematic reviews have evaluated osteochondral autografting for cartilage repair in the short- and mid-term. Compared with abrasion techniques (eg, microfracture, drilling), there is evidence that osteochondral autografting decreases failure rates and improves outcomes in patients with medium-size lesions (eg, 2-6 cm2) when measured at longer follow-up. This is believed to be due to the higher durability of hyaline cartilage compared with fibrocartilage from abrasion techniques. There appears to be a relatively narrow range of lesion size for which osteochondral autografting is most effective. The best results have also been observed with lesions on the femoral condyles, although treatment of lesions on the trochlea and patella may also improve outcomes. Correction of malalignment is important for the success of the procedure. The evidence suggests that osteochondral autografts may be considered an option for moderate- sized, symptomatic, full thickness, chondral lesions of the femoral condyle, trochlea, or patella. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have full-thickness articular cartilage lesions of the knee when autografting would be inadequate due to lesion size, location, or depth who receive a fresh osteochondral allograft, the evidence includes case series and systematic reviews of case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment related morbidity. Due to the lack of alternatives, this procedure may be considered a salvage operation in younger patients for full-thickness chondral defects of the knee caused by acute or repetitive trauma when other cartilage repair techniques (eg, microfracture, osteochondral autografting, autologous chondrocyte implantation) would be inadequate due to lesion size, location, or depth. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have full-thickness articular cartilage lesions of the knee, ankle, elbow, or shoulder who receive autologous or allogeneic minced or particulated articular cartilage, the evidence includes a small RCT and small case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment- related morbidity. The evidence on autologous minced cartilage includes a small RCT. The evidence on allogeneic juvenile minced cartilage includes a few small case series. The case series have suggested an improvement in outcomes compared with preoperative measures, but there is also evidence of subchondral edema, nonhomogeneous surface, graft hypertrophy, and delamination. For articular cartilage lesions of the knee, further evidence, preferably from RCTs, is needed to evaluate the effect on health outcomes compared with other procedures. There are fewer options for articular cartilage lesions of the ankle. However, further study in a larger number of patients is needed to assess the short- and long-term effectiveness of this technology. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have full-thickness articular cartilage lesions of the knee, ankle, elbow, or shoulder who receive decellularized osteochondral allograft plugs, the evidence includes small case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The case series reported delamination of the implants and high failure rates. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have full-thickness articular cartilage lesions of the knee, ankle, elbow, or shoulder who receive reduced osteochondral allograft discs, the evidence includes very small case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

CODING Medicare Advantage Plans and Commercial Products The following surgery code(s) are considered medically necessary when filed with any of the ICD-10 Diagnosis* codes listed below: 27415 Osteochondral allograft, knee, open

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

27416 Osteochondral autograft(s), knee, open (eg, mosaicplasty) (includes harvesting of autograft[s]) 28446 Open osteochondral autograft, talus (includes obtaining graft[s]) 29866 Arthroscopy, knee, surgical; osteochondral autograft(s) (eg, mosaicplasty) includes harvesting of the autograft[s]) 29867 Arthroscopy, knee, surgical; osteochondral allograft (eg, mosaicplasty)

*ICD-10 Diagnosis codes:
M12.561-M12.569 M17.0-M17.9
M23.8x1-M23.92 M25.861-M25.869 M85.671-M85.679 M89.8x6 M93.261-M93.269 M93.271-M93.279 M94.261-M94.269 M94.8x6 M94.9 S89.80xA-S89.82xS S89.90xA-S89.92xS

RELATED POLICIES Not Applicable PUBLISHED Provider Update, July 2025 Provider Update, December 2024 Provider Update, July 2023 Provider Update, August 2022 Provider Update, July 2021

REFERENCES

1. Durur-Subasi I, Durur-Karakaya A, Yildirim OS. Osteochondral Lesions of Major Joints. Eurasian J Med.Jun 2015; 47(2): 138-44. PMID 26180500
2. Fortin PT, Balazsy JE. Talus fractures: evaluation and treatment. J Am Acad Orthop Surg. Mar-Apr 2001;9(2): 114-27. PMID 11281635
3. Mithoefer K, McAdams T, Williams RJ, et al. Clinical efficacy of the microfracture technique for articularcartilage repair in the knee: an evidence-based systematic analysis. Am J Sports Med. Oct 2009;37(10): 2053-63. PMID 19251676
4. Solheim E, Hegna J, Inderhaug E, et al. Results at 10-14 years after microfracture treatment of articularcartilage defects in the knee. Knee Surg Sports Traumatol Arthrosc. May 2016; 24(5): 1587-93. PMID25416965
5. Reddy S, Pedowitz DI, Parekh SG, et al. The morbidity associated with osteochondral harvest fromasymptomatic knees for the treatment of osteochondral lesions of the talus. Am J Sports Med. Jan2007; 35(1): 80-5. PMID 16957009
6. Hangody L, Kish G, Modis L, et al. Mosaicplasty for the treatment of osteochondritis dissecans of thetalus: two to seven year results in 36 patients. Foot Ankle Int. Jul 2001; 22(7): 552-8. PMID 11503979
7. Zamborsky R, Danisovic L. Surgical Techniques for Knee Cartilage Repair: An Updated Large- ScaleSystematic Review and Network Meta-analysis of Randomized Controlled Trials. Arthroscopy. Mar2020; 36(3): 845-858. PMID 321390628.
8. Gracitelli GC, Moraes VY, Franciozi CE, et al. Surgical interventions (microfracture, drilling,mosaicplasty, and allograft transplantation) for treating isolated cartilage defects of the knee in adults.Cochrane Database Syst Rev. Sep 03 2016; 9: CD010675. PMID 27590275
9. Magnussen RA, Dunn WR, Carey JL, et al. Treatment of focal articular cartilage defects in the knee: asystematic review. Clin Orthop Relat Res. Apr 2008; 466(4): 952-62. PMID 18196358

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

10. Pareek A, Reardon PJ, Macalena JA, et al. Osteochondral Autograft Transfer Versus Microfracture inthe Knee: A Meta-analysis of Prospective Comparative Studies at Midterm. Arthroscopy. Oct 2016;32(10): 2118-2130. PMID 27487736
11. Harris JD, Cavo M, Brophy R, et al. Biological knee reconstruction: a systematic review of combinedmeniscal allograft transplantation and cartilage repair or restoration. Arthroscopy. Mar 2011; 27(3): 409-18. PMID 21030203
12. Hangody L, Kish G, Karpati Z, et al. Arthroscopic autogenous osteochondral mosaicplasty for the treatment of femoral condylar articular defects. A preliminary report. Knee Surg Sports TraumatolArthrosc. 1997; 5(4): 262-7. PMID 9430578
13. Hangody L, Kish G, Karpati Z, et al. Mosaicplasty for the treatment of articular cartilage defects:application in clinical practice. Orthopedics. Jul 1998; 21(7): 751-6. PMID 9672912
14. Hangody L, Vasarhelyi G, Hangody LR, et al. Autologous osteochondral grafting--technique and long- term results. Injury. Apr 2008; 39 Suppl 1: S32-9. PMID 18313470
15. Solheim E, Hegna J, Oyen J, et al. Osteochondral autografting (mosaicplasty) in articular cartilagedefects in the knee: results at 5 to 9 years. Knee. Jan 2010; 17(1): 84-7. PMID 19666226
16. Solheim E, Hegna J, Oyen J, et al. Results at 10 to 14 years after osteochondral autografting(mosaicplasty) in articular cartilage defects in the knee. Knee. Aug 2013; 20(4): 287-90. PMID23482060
17. Marcacci M, Kon E, Delcogliano M, et al. Arthroscopic autologous osteochondral grafting for cartilagedefects of the knee: prospective study results at a minimum 7-year follow-up. Am J Sports Med. Dec2007; 35(12): 2014-21. PMID 17724094
18. Astur DC, Arliani GG, Binz M, et al. Autologous osteochondral transplantation for treating patellarchondral injuries: evaluation, treatment, and outcomes of a two-year follow-up study. J Bone Joint SurgAm. May 21 2014; 96(10): 816-23. PMID 24875022
19. Nho SJ, Foo LF, Green DM, et al. Magnetic resonance imaging and clinical evaluation of patellarresurfacing with press-fit osteochondral autograft plugs. Am J Sports Med. Jun 2008; 36(6): 1101- 9.PMID 18337357
20. Kunze KN, Ramkumar PN, Manzi JE, et al. Risk Factors for Failure After Osteochondral AllograftTransplantation of the Knee: A Systematic Review and Exploratory Meta-analysis. Am J Sports Med.Jan 20 2022: 3635465211063901. PMID 35049404
21. Merkely G, Ogura T, Ackermann J, et al. Clinical Outcomes after Revision of Autologous ChondrocyteImplantation to Osteochondral Allograft Transplantation for Large Chondral Defects: A ComparativeMatched-Group Analysis. Cartilage. Apr 2021; 12(2): 155-161. PMID 30897940
22. De Caro F, Bisicchia S, Amendola A, et al. Large fresh osteochondral allografts of the knee: asystematic clinical and basic science review of the literature. Arthroscopy. Apr 2015; 31(4): 757-65.PMID 25660010
23. Chui K, Jeys L, Snow M. Knee salvage procedures: The indications, techniques and outcomes of largeosteochondral allografts. World J Orthop. Apr 18 2015; 6(3): 340-50. PMID 25893177

24. Nielsen ES, McCauley JC, Pulido PA, et al. Return to Sport and Recreational Activity AfterOsteochondral Allograft Transplantation in the Knee. Am J Sports Med. Jun 2017; 45(7): 1608- 1614.PMID 28375642 i

    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS