Humana Osteochondral and Subchondral Defects Surgery Form

Description Osteochondral Defect

An osteochondral defect is any type of damage to articular cartilage and underlying subchondral bone due to traumatic injury or degenerative changes (eg, osteochondritis dissecans (OCD), osteoarthritis, osteonecrosis). Due to the inability of the articular cartilage to heal itself efficiently, surgical procedures have been developed to stimulate new cartilage growth.

Description Autologous chondrocyte transplantation (ACT) or autologous chondrocyte implantation (ACI)

is a two-step procedure utilized to repair traumatic cartilage defects of the knee joint. First, autologous chondrocytes are collected during a cartilage biopsy performed as an arthroscopic procedure. The chondrocytes are then replicated in a cell culture and seeded on a porcine cellular membrane (eg, MACI) at a cell processing facility. After approximately 6 weeks, an arthrotomy is performed to debride the defect, trim the membrane to the size of the defect for complete coverage and then secure the membrane over the damaged area using a fibrin sealant.

Osteochondral allograft transplant refers to the replacement of damaged articular cartilage and bone with tissue from a cadaveric donor. These allografts can either be fresh or frozen. Osteochondral allograft transplantation is used predominantly in the treatment of large and deep osteochondral lesions resulting from conditions such as osteochondritis dissecans (OCD), osteonecrosis or traumatic osteochondral fractures.

Osteochondral autograft transplant (OAT) involves the transplantation of small plugs of healthy bone and hyaline cartilage from joint areas with less weight bearing. The most common donor sites are the areas of the knee or ankle (on the same side). Small holes are drilled through the lesion and the newly harvested plugs are inserted into the holes. The two most commonly performed types of OAT procedures are:

• Mosaicplasty – A technique that consists of removing small osteochondral cylinders from low weight bearing surfaces of the affected joint or another joint in the same individual and transplanting them in a mosaic-like formation into focal chondral or osteochondral defects in the knee. It is usually utilized to treat larger defects.
• Osteochondral Autograft Transfer System (OATS) procedure – This procedure is similar to mosaicplasty; however, it involves the use of a larger, single plug that usually fills an entire defect (eg, those associated with anterior cruciate ligament [ACL] tears).

Cryopreserved viable osteochondral allograft product (eg, Cartiform, CartiMax) is made of full-thickness articular cartilage and a thin layer of subchondral bone, harvested from a human cadaver, which maintains intact native cartilage architecture with viable chondrocytes, growth factors and extracellular matrix proteins to promote articular cartilage repair. The wafer thin, disc shaped graft is often used in conjunction with marrow stimulation (eg, microfracture) purportedly allowing the host mesenchymal stem cells to infiltrate the graft from the underlying bone.

Osteochondral and Subchondral Defects Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0494-019

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.bone marrow after stimulation to promote chondrogenesis or cartilage formation.16 (Refer to Coverage Limitations section)

Hybrid ACI performed with an OAT transfer system (hybrid ACI/OATS) provides an osteochondral core to immediately restore the condylar contour and mechanical function, while implanted chondrocytes have time to mature over several years. ACI is an established procedure for treating large defects, but the new cells may take several years to mature and produce native hyaline cartilage. OAT involves transfer of native hyaline cartilage, but the procedure cannot cover large defects without risking complications at the donor site. 14 (Refer to Coverage Limitations section)

Juvenile cartilage allograft tissue implantation (eg, DeNovo NT natural tissue graft, DeNovo ET engineered tissue graft) was developed to repair damaged articular cartilage. The living articular cartilage is obtained from juvenile donors and minced into small particles. The particles are then surgically implanted into the damaged cartilage defect and secured using a fibrin glue. Purportedly, transplanted juvenile cartilage cells can migrate, multiply and form new cartilage that combines with the host tissue. 16,24 (Refer to Coverage Limitations section)

Manipulated (decellularized) human tissue graft products (eg, Chondrofix osteochondral allograft) are made of bone and cartilage tissue that is harvested from a cadaveric donor that has been processed to remove blood, cells and fat from the tissue. It is sterilized to kill bacteria and other microorganisms while purportedly promoting bone integration and remodeling to reduce the risk of inflammation in repair of Outerbridge Grade 3 and Grade 4 osteochondral lesions. (Refer to Coverage Limitations section)

Minced cartilage or biopaste extracellular matrix products (eg, BioCartilage) are dehydrated micronized cartilage developed from allograft articular cartilage that when injected into an osteochondral defect, during a microfracture surgical procedure repair, provides a scaffold over the defect stimulating cartilage regrowth.14 (Refer to Coverage Limitations section)

Synthetic resorbable polymers (eg, Agili-C, PolyGraft, TruGraft granules, TruFit plugs) are polymer scaffolds that are being proposed for the repair of osteochondral articular cartilage defects. The implant functions as a scaffold for chondral andOsteochondral and Subchondral Defects Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0494-019 Page: 4 of 18

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.osteogenic cells with the synthetic polymer being resorbed as the cells produce their normal matrices.17 (Refer to Coverage Limitations section)

Xenograft transplantation is being proposed as a future alternative to osteochondral allografts or autografts for chondral defects in articular cartilage. Currently, xenogenic porcine chondrocytes are in the early stage of investigation to genetically engineer the cells to prevent an immune response or host rejection. (Refer to Coverage Limitations section)

Subchondral Defect Subchondroplasty is a minimally invasive procedure developed to treat chronic, nonhealing subchondral defects known as bone marrow lesions (BMLs) or bone marrow edema (BMEs). The procedure involves injecting calcium phosphate bone substitute percutaneously, under fluoroscopic guidance, into the region of the BML to fill the void left by the lesion and purportedly promote bone turnover. Subchondral bone refers to the epiphyseal bone directly underneath the area of articular cartilage.

Coverage Autologous Chondrocyte Transplantation

Autologous Chondrocyte Transplantation Humana members may be eligible under the Plan for ACT of the knee when ALL of the following criteria are met:

Coverage Determination

• Absence of contraindications; AND
• Body mass index (BMI) less than or equal to 35; AND
• Documentation including radiological interpretation and report for soft tissue pathology (eg, magnetic resonance imaging [MRI]) or arthroscopy of a focal chondral defect size of 1 to 10 square centimeters (cm2); AND
• Failure of 3 months of conservative treatment* under the direction of a healthcare professional with ALL of the following:
  • Intra-articular steroid injection if medically appropriate and not contraindicated. Intra-articular steroid injections should be avoided 3 months prior to planned ACT of the knee; AND
  • Modification of pain inducing activities; AND
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) if medically appropriate and not contraindicated; AND
  • Orthotics (knee brace) if medically appropriate; AND
  • Physical therapy including home exercise program (HEP) (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND
• *Failure of conservative treatments 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]).
• Full-thickness (Outerbridge grade 3 or 4) isolated cartilaginous defect of the knee involving the lateral or medial femoral condyle, the trochlear groove of the femur or patella caused by acute or repetitive trauma; AND
• Individual is expected to comply with prescribed postoperative rehabilitation program; AND
• Individual who is a smoker or nicotine user is provided assistance in developing a plan for quitting (cessation) that includes pharmacotherapy (eg, bupropion, varenicline) and/or referral to a smoking cessation program prior to the surgical procedure; AND
• Knee must be stable and aligned (a corrective procedure in combination with, or prior to, chondrocyte implantation may be necessary to ensure stability, alignment and normal weight distribution within the joint); AND
• Previous arthroscopic or surgical repair greater than 6 months prior to transplantation; AND
• Skeletally mature** to 55 years of age.

Osteochondral and Subchondral Defects Surgery Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 12/14/2023 Policy Number: HUM-0494-019 Page: 5 of 18

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.

• Symptoms such as lesion related pain, swelling or catching/locking which limits activities of daily living

Skeletally mature refers to a system of fused skeletal bones which occurs when bone growth ceases.

Coverage Autologous Chondrocyte Transplantation

Coverage Limitations

Autologous Chondrocyte Transplantation Humana members may NOT be eligible under the Plan for ACT for any indication not listed above including, but not limited to, the following:

• Cartilage defects in joints other than the knee; OR
• Initial or first line of surgical therapy; OR
• Osteochondritis dissecans (OCD) lesion; OR
• Previous total meniscectomy

This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for ACT in the presence of the following contraindications:

• History of hypersensitivity to gentamicin, other aminoglycosides or products of bovine or porcine origin; OR
• Inflammatory arthritis or joint disease (eg, rheumatoid arthritis); OR
• Prior knee surgery (preceding 6 months) excluding surgery to procure biopsy or accompanying procedure to prepare the knee for MACI implant; OR
• Severe osteoarthritis of the knee; OR
• Uncorrected congenital blood coagulation disorders

Osteochondral and Subchondral Defects Surgery Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0494-019 Page: 7 of 18

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.

Coverage Determination

Osteochondral Allograft/Autograft Transplantation Humana members may be eligible under the Plan for an osteochondral allograft OR osteochondral autograft transplant of the knee when ALL of the following criteria are met:

• BMI of less than or equal to 35; AND
• Disabling localized knee pain that is unresponsive to 3 months of conservative treatment* under the direction of a healthcare professional with ALL of the following:
  • Intra-articular steroid injection if medically appropriate and not contraindicated. Intra-articular steroid injections should be avoided 3 months prior to planned osteochondral allograft OR osteochondral autograft transplant; AND
  • Modification of pain inducing activities; AND
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) if medically appropriate and not contraindicated; AND
  • Orthotics (knee brace) if medically appropriate; AND
  • Physical therapy including home exercise program (HEP) (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND
• *Failure of conservative treatments 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]).

Osteochondral and Subchondral Defects Surgery Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0494-019 Page: 8 of 18

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.

• Focal, full thickness (Outerbridge grade 3 or 4) articular cartilage defects; AND
• Documentation including radiological interpretation and report for soft tissue pathology (eg, MRI) or arthroscopy of a chondral defect on the weight bearing portion of the lateral or medial femoral condyle, or trochlear region of the knee that is between 1-2.5 cm2 in diameter or less than 2.5 cm2 total for autograft transplants, or greater than 2 cm2 total for allograft transplants; AND
• Individual who is a smoker or nicotine user is provided assistance in developing a plan for quitting (cessation) that includes pharmacotherapy (eg, bupropion, varenicline) and/or referral to a smoking cessation program prior to the surgical procedure; AND
• No evidence of arthritis on the corresponding tibial surface; AND
• Normal appearing hyaline cartilage surrounds the borders of the defect; AND
• Normal knee alignment; AND
• Skeletally mature** to 55 years of age

Coverage Osteochondral Allograft/Autograft Transplantation

Coverage Limitations

Osteochondral Allograft/Autograft Transplantation Humana members may NOT be eligible under the Plan for osteochondral allograft OR osteochondral autograft transplant for any indications other than those listed above including, but not limited to, the following joints:

• Ankle; OR
• Elbow; OR
• Hip; OR
• Patella; OR
• Shoulder

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.

Humana members may NOT be eligible under the Plan for hybrid ACT/OATS for any indication. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Coverage Limitations

Other Miscellaneous Articular Cartilage and Subchondral Repair Procedures/Products Humana members may NOT be eligible under the Plan for articular cartilage repair using the following products:

• Cryopreserved viable osteochondral allograft product (eg, Cartiform, CartiMax); OR
• Juvenile cartilage allograft tissue implantation (eg, DeNovo NT natural tissue graft, DeNovo ET engineered tissue graft; OR
• Manipulated (decellularized) human tissue graft products (eg, Chondrofix osteochondral allograft); OR
• Minced cartilage/biopaste (eg, BioCartilage); OR
• Synthetic resorbable polymers (eg, Agili-C, PolyGraft, TruFit plugs); OR
• Xenograft transplantation

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.

Subchondroplasty Humana members may NOT be eligible under the Plan for subchondroplasty for any indication. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language

Additional information about articular cartilage defects, bone marrow lesions, osteoarthritis, osteochondritis dissecans or osteonecrosis may be found from the following websites:

Background

• American Academy of Orthopaedic Surgeons
• National Institutes of Arthritis and Musculoskeletal and Skin Diseases
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

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.