Humana Allograft Transplantation of the Knee Form

. Description This policy focuses on reconstruction of the meniscus and ligament structures of the knee. For information regarding articular cartilage and/or subchondral bone damage and repair with transplantation, please refer to Osteochondral and Subchondral Defects Surgery Medical Coverage Policy. Allografts may be used as an alternative to autografts for ligament reconstruction or meniscal transplantation of the knee. Allograft tissue is procured from genetically unrelated cadaver donors and processed, stored and utilized according to US Food & Drug Administration (FDA) and the American Association of Tissue Banks (AATB) standards. The advantages of allografts include no donor site morbidity, shorter Allograft Transplantation of the Knee Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0453-017 Page: 2 of 10 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. surgical time, smaller incisions and greater availability.7 Allograft transplants are not rejected by the body as with other organ transplants. Knee Ligaments Reconstruction with allograft tendons may be performed for the anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial or lateral collateral ligaments (MCL, LCL). These ligaments are strong fibrous bands of tissue that attach to the femur, fibula patella and tibia bones providing strength and stability to the joint. Allografts are commonly used for ACL reconstruction.17 Resorbable implant for ACL repair is a resorbable implant made of degradable material (bovine collagen) that allows healing of a torn ACL biomechanically stabilized by traditional suturing procedures at the torn ends of the tendon. Purportedly, the implant acts like a bridge scaffold. After suture stabilization, the individual’s blood is injected into the implant to form a protective clot to stimulate tissue healing to eventually replace the device. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. As the ACL heals, the implant is absorbed by the body, within approximately 8 weeks. An example of an FDA-approved ACL resorbable implant is the BEAR (Bridge-Enhanced ACL Repair). 10,20 (Refer to Coverage Limitations section) Meniscus Meniscal allograft transplantation (MAT) is a surgical technique for restoring knee function for an individual with a destroyed or absent menisci. The meniscus (or menisci) refers to the lateral and medial crescent shaped cartilaginous tissues that are located at the junction of the tibia and femur which provide structural integrity to the knee and absorbs shock. Allograft tissue is matched by size to the individual, inserted into the knee joint and anchored to supporting structures by hardware, soft tissue or bony tissue fixation. The procedure may be performed using an arthroscopic approach or by open incision and may be done alone or in tandem with other reconstructive knee procedures. Collagen meniscus implants (CMI), also known as collagen scaffolds or Menaflex, are implantable porous meniscus scaffolds composed of collagen fibers, enriched See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Allograft Transplantation of the Knee Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0453-017 Page: 3 of 10 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. with glycosaminoglycan, used as a template and support for generation of new tissue to replace the lost menisci. An example of an FDA-approved CMI is the Collagen Meniscus Implant XL.9,15 (Refer to Coverage Limitations section) For information regarding bone graft materials, please refer to Bone Graft Substitutes Medical Coverage Policy. For information regarding autograft reconstruction and knee arthroscopy, please refer to Hip, Knee and Shoulder Arthroscopic Surgeries Medical Coverage Policy. Coverage Determination Humana members may be eligible under the Plan for reconstruction of the knee ligaments using allograft tissue when ANY of the following criteria are met: • Existence of a medical condition that prevents the use of autograft tissue (eg, previous injury or surgery, anatomic abnormality); OR • Failed reconstruction or revision of a previous surgery; OR • Multiple ligament reconstruction Humana members may be eligible under the Plan for MAT when ALL of the following criteria are met: • Absence or near absence of the meniscus as documented by magnetic resonance imaging (MRI) or prior arthroscopy; AND • 50 years of age or younger; AND • Body mass index (BMI) less than or equal to 40; AND • Documentation of absent or minimal articular changes (Outerbridge grade II or less); AND • Knee joint must be stable prior to surgery or be surgically corrected at the time of the allograft; AND See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Allograft Transplantation of the Knee Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0453-017 Page: 4 of 10 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. • Normal knee alignment; AND • Significant knee pain with functional impairment interfering with activities of daily living (ADLs) (eg, dressing, driving, meal prep, walking) unresponsive to 3 months of conservative treatment* under the direction of a healthcare professional with ALL of the following: o Intra-articular steroid injection for individual with minimal articular changes (Outerbridge grade II or I) if medically appropriate and not contraindicated. Intra-articular steroid injections should be avoided absent of articular changes or 3 months prior to planned meniscal surgery; AND o Modification of pain inducing activities; AND o Nonsteroidal anti-inflammatory drugs (NSAIDs) if medically appropriate and not contraindicated; AND o Orthotics (knee brace) if medically appropriate; AND o Physical therapy including a home exercise program (HEP) *Failure of conservative treatment is not required in active infections or acute trauma with functional loss (effusion, focal tenderness, inability to bear weight, symptoms explained by radiographic findings [eg, fracture, soft tissue injury] or a visual deformity [eg, dislocation]). Functional impairment is defined as a direct and measurable reduction in physical performance of an organ or body part. Coverage Limitations Humana members may NOT be eligible under the Plan for reconstruction of the knee ligaments using allograft tissue or meniscal allograft transplantation for any indications other than those listed above. These are considered experimental/ investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer reviewed medical literature published in the English language. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Allograft Transplantation of the Knee Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0453-017 Page: 5 of 10 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Humana members may NOT be eligible under the Plan for ANY of the following when used alone or as part of a ligament or meniscus reconstruction, regeneration or transplantation: • Autologous platelet derived growth factors (eg, platelet rich plasma), (for information regarding coverage determination/limitations, please refer to Bone Graft Substitutes or Platelet-Derived Growth Factors for Wound Healing Medical Coverage Policies); OR • Collagen scaffolds (eg, BEAR [bridge enhanced ACL repair], Collagen Meniscus Implant XL, Menaflex); OR • Meniscal prosthesis; OR • Tissue engineered menisci; OR • Xenograft These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. Note: The criteria for collagen meniscus implants are consistent with the Medicare National Coverage Policy and therefore apply to Medicare members. Background Additional information about injuries to the ligaments of the knee and the meniscus may be found from the following websites: • American Academy of Orthopaedic Surgeons • National Library of Medicine Medical Alternatives Alternatives to reconstruction of the knee ligaments using allograft tissue include, but may not be limited to, the following: • Reconstruction of the knee ligaments using autograft tissue See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Allograft Transplantation of the Knee Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0453-017 Page: 6 of 10 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Alternatives to MAT include, but may not be limited to, the following: • Meniscal and ligament repair • Meniscectomy Physician consultation is advised to make an informed decision based on an individual’s health needs. Provider Claims Codes Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. CPT® Code(s) 27427 27428 27429 Description Comments Ligamentous reconstruction (augmentation), knee; extra- articular Ligamentous reconstruction (augmentation), knee; intra- articular (open) Ligamentous reconstruction (augmentation), knee; intra- articular (open) and extra-articular 27599 Unlisted procedure, femur or knee Not Covered if used to report any procedure outlined in Coverage Limitations section Arthroscopy, knee, surgical; meniscal transplantation (includes arthrotomy for meniscal insertion), medial or lateral Arthroscopically aided anterior cruciate ligament repair/augmentation or reconstruction Arthroscopically aided posterior cruciate ligament repair/augmentation or reconstruction Description Comments 29868 29888 29889 CPT® Category III Code(s) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Allograft Transplantation of the Knee Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0453-017 Page: 7 of 10 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. No code(s) identified HCPCS Code(s) G0428 Description Collagen meniscus implant procedure for filling meniscal defects (e.g., CMI, collagen scaffold, Menaflex) Comments Not Covered References 1. American Academy of Orthopaedic Surgeons (AAOS). Evidenced-based clinical practice guideline: management of anterior cruciate ligament injuries. https://www.aaos.org. Published August 22, 2022. Accessed December 5, 2022. 2. 3. 4. 5. 6. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Collagen meniscus implant (150.12). https://www.cms.gov. Published May 25, 2010. Accessed December 5, 2022. ClinicalKey. Cheung E, McAllister D, Petrigerani F. Anterior cruciate ligament injuries. In: DeLee JC, Drez D, Miller MD. DeLee, Drez, & Miller’s Orthopaedics Sports Medicine. 5th ed. Elsevier; 2020:1185-1198.e7. https://www.clinicalkey.com. Accessed December 5, 2022. ClinicalKey. Laidlaw M, Buyukdogan K, Miller M. Articular cartilage lesions. In: DeLee JC, Drez D, Miller M. DeLee, Drez, & Miller’s Orthopaedics Sports Medicine. 5th ed. Elsevier; 2020:1161-1177.e4. https://www.clinicalkey.com. Accessed December 5, 2022. ClinicalKey. Miller III RH, Azar FM. Knee injuries. In: Azar F, Beaty JH. Campbell’s Operative Orthopaedics. 14th ed. Elsevier; 2021:2198-2373.e18. https://www.clinicalkey.com. Accessed December 6, 2022. ClinicalKey. Phillips BB, Mihalko M. Arthroscopy of the lower extremity. In: Azar F, Beaty JH. Campbell’s Operative Orthopaedics. 14th ed. Elsevier; 2021:2576-2662.e8. https://www.clinicalkey.com. Accessed December 6, 2022. 7. ClinicalKey. Ruzbarsky J, Maak T, Rodeo S. Meniscal injuries. In: DeLee JC, Drez D, Miller M. DeLee, Drez, & Miller’s Orthopaedics Sports Medicine. 5th ed. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Allograft Transplantation of the Knee Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0453-017 Page: 8 of 10 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Elsevier; 2020:1132-1153.e6. https://www.clinicalkey.com. Accessed December 5, 2022. 8. 9. ClinicalKey. Wydra F, Axibal D, Vidal A. Meniscal transplantation. In: DeLee JC, Drez D, Miller M. DeLee, Drez, & Miller’s Orthopaedics Sports Medicine. 5th ed. Elsevier; 2020:1154-1160.e1. https://www.clinicalkey.com. Accessed December 5, 2022. ECRI Institute. Product Brief (ARCHIVED). Collagen meniscus implant XL (Stryker Corp.) for treating medial meniscus injuries. https://www.ecri.org. Published December 31, 2018. Accessed December 16, 2021. 10. Hayes, Inc. Emerging Technology Report (ARCHIVED). Bridge enhanced anterior cruciate ligament repair (BEAR) implant. https://evidence.hayesinc.com. Published December 20, 2020. Accessed December 13, 2022. 11. Hayes, Inc. Health Technology Brief (ARCHIVED). Collagen meniscus implant (CMI, Menaflex; Ivy Sports Medicine LLC) for meniscal tears. https://evidence.hayesinc.com. Published February 16, 2017. Updated January 9, 2019. Accessed December 12, 2022. 12. Hayes, Inc. Medical Technology Directory. Comparative effectiveness of irradiated allografts for primary anterior cruciate ligament reconstruction. https://evidence.hayesinc.com. Published March 6, 2018. Updated February 16, 2022. Accessed December 13, 2022. 13. Hayes, Inc. Medical Technology Directory (ARCHIVED). Comparative effectiveness of nonirradiated allografts for primary anterior cruciate ligament reconstruction. https://evidence.hayesinc.com. Published November 7, 2017. Updated March 18, 2021. Accessed December 13, 2022. 14. Hayes, Inc. Medical Technology Directory (ARCHIVED). Meniscal allograft transplantation. https://evidence.hayesinc.com. Published December 28, 2011. Updated November 5, 2015. Accessed December 12, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Allograft Transplantation of the Knee Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0453-017 Page: 9 of 10 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 15. MCG Health. Collagen meniscus implant. 26th edition. https://www.mcg.com. Accessed December 12, 2022. 16. MCG Health. Meniscal allograft transplant. 26th edition. https://www.mcg.com. Accessed December 12, 2022. 17. UpToDate, Inc. Anterior cruciate ligament injury. https://www.uptodate.com. Updated December 8, 2022. Accessed December 13, 2022. 18. UpToDate, Inc. Meniscal injury of the knee. https://www.uptodate.com. Updated November 14, 2022. Accessed December 13, 2022. 19. US Food & Drug Administration (FDA). 510(k) summary: Ivy Sports Medicine Collagen Meniscus Implant XL (CMI XL). https://www.fda.gov. Published May 2, 2017. Accessed December 28, 2021. 20. US Food & Drug Administration (FDA). De novo summary: BEAR (Bridge- Enhanced ACL Repair) implant. https://www.fda.gov. Published December 16, 2020. Accessed December 27, 2021. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Allograft Transplantation of the Knee Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0453-017 Page: 10 of 10 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Appendix A Outerbridge classification system4 Grade Grade 0 Grade I Grade II Grade III Grade IV Chondral Damage Normal cartilage Cartilage with swelling and softening Partial thickness defect with fissures on the surface that do not reach subchondral bone or exceed 1.5 centimeters (cm) in diameter Fissuring to the level of subchondral bone in an area with a diameter greater than 1.5 cm Exposed subchondral bone See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.