Description

Knee arthroplasty is a surgical procedure with the primary goal to relieve pain caused by severe arthritis with or without the presence of a deformity. Knee arthroplasty procedures may include a partial or total replacement or focal resurfacing of the knee.

Anatomically, the knee is formed by three bones:

• the lower end of the femur,
• the upper end of the tibia and
• the patella.

Articular cartilage is the smooth tissue that covers and protects the end of the bones to make movement of the knee easier by reducing friction. The bones are interconnected by ligaments, the collateral (medial and lateral) for sideways movement and the cruciate (anterior and posterior) for back and forth movement. A synovial membrane lines the joint forming the inner surface of articular capsule filled with synovial fluid.

Knee arthroplasty, partial or total replacement, is performed for destruction of articular cartilage from osteoarthritis, rheumatoid/inflammatory arthritis, posttraumatic degenerative joint disease or osteonecrosis/joint collapse with cartilage destruction. Arthritic damage may occur in one or more of the compartments of the knee. The compartments are the medial or inner, lateral or outer and patellofemoral (kneecap and thigh bone).

The arthroplasty/replacement procedures are described as follows:

• Total – (TKA) consists of resecting the entire knee by removing diseased articular surfaces of all three compartments of the knee, followed by resurfacing with metal and polyethylene prosthetic femoral, patellar and tibial components. Based on the design of the prosthesis, ligaments may be retained, released or resectioned. The patella may or may not be resurfaced.
• Unicompartmental – (UKA), also known as a partial knee replacement, resects and replaces one knee compartment, either the lateral, medial or patellofemoral.
• Bicompartmental – resurfaces the medial and patellofemoral compartments and replaces them with an implant. (Refer to Coverage Limitations Section)
• Bi-unicompartmental – a UKA performed on the contralateral or opposite compartments of a knee (eg, lateral and medial). (Refer to Coverage Limitations Section)

Focal resurfacing of a knee joint surgically removes a localized or limited amount of damaged bone from the surface of the joint. The damaged area is replaced with an implant. This technology is purportedly viewed as an early or bridging treatment before a total knee arthroplasty for an individual with the following conditions:

• Between 40 and 60 years of age
• Diagnosed with early-stage osteoarthritic damage which is confined to the inside of the knee
• Overweight
• Physically active

Examples of US Food & Drug Administration (FDA) approved focal knee resurfacing systems include, but may not be limited to, the HemiCAP patello-femoral resurfacing prosthesis and the UniCAP compartmental resurfacing implant system.

(Refer to Coverage Limitations section) Interpositional unicompartmental or unicondylar spacer device is a non-fixed or free floating concaved shaped metallic implant developed to treat isolated medial compartment osteoarthritis purportedly for an individual that has failed conservative treatments but is not a candidate for a TKA. Examples of FDA- approved interpositional unicompartmental or unicondylar devices include, but may not be limited to, the Orthoglide and the Unicondylar Interpositional Spacer (previously named Unispacer). (Refer to Coverage Limitations section)

Customized knee replacement implants are prostheses that are uniquely designed to copy an individual’s knee anatomy based on a computed tomography (CT) scan. A computer assisted design using digital formulas converts the CT scan into a 3-dimensional (3D) model of the knee that is used to make the customized prosthesis. Purportedly, the customized devices allow for greater knee flexion or motion, improved implant durability and surgical outcomes than conventional knee prostheses.

For information regarding anatomic 3D printing, please refer to Code Compendium (Miscellaneous) Medical Coverage Policy.

Coverage Determination

Total Knee Arthroplasty Humana members may be eligible under the Plan for TKA for the following indications:

• Absence of contraindications; AND
• Documentation of skeletal maturity; 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
• The device is FDA approved;
• AND ONE of the following:

• Angular deformity of greater than 20 degrees; OR
• Avascular necrosis with collapse of femoral or tibia condyle; OR
• Failure of previous femoral or tibial osteotomy; OR
• Failure of previous unicompartmental knee replacement with pain interfering ADLs; OR
• Distal femur or proximal tibial fracture with severe osteoporosis or concomitant degenerative joint disease; OR
• Hemophiliac arthropathy with contracture in the knee; OR
• Kellgren Lawrence Grade 4 osteoarthritis with bone-on-bone articulation in the weight-bearing portion of the joint (lateral, medial, patellofemoral); OR
• Malunion or nonunion of a distal femur or proximal tibia fracture; OR
• Post traumatic knee joint destruction; OR
• Progressive flexion contracture;
• OR Documentation of painful, disabling joint disease of the knee that interferes with activities of daily living (ADLs) resulting from non-inflammatory joint disease (avascular necrosis, osteoarthritis or traumatic arthritis), rheumatoid arthritis or post traumatic arthritis including:o Failure of at least 3 months of conservative treatment under the direction of a healthcare professional, which includes:

• Activity/lifestyle modifications; AND
• Ambulatory assistive device if medically appropriate; AND
• Individual with a BMI greater than 40 have documentation of attempted weight loss; AND
• Intra-articular injections when medically appropriate and not contraindicated.

• Intra-articular steroid injections should be avoided 3 months prior to TKA; AND
• Medications (eg, nonsteroidal anti-inflammatory drugs [NSAIDs] or non-narcotic analgesics) when medically appropriate and not contraindicated; 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
• Radiographic confirmation of bone and joint pathology of the knee joint as evidenced either of the following:
1. Exposed subchondral bone (Outerbridge Grade 4); OR
2. Large osteophytes, marked narrowing of joint space, definite deformity of bone ends, severe sclerosis (Kellgren Lawrence Grade 4); OR
• Radiological confirmation (magnetic resonance imaging [MRI] preferred if not contraindicated) of avascular necrosis of the femoral condyles or proximal tibia

Replacement/Revision of TKA

Humana members may be eligible under the Plan for replacement or revision of previous total arthroplasty for the following indications:

• Aseptic loosening of prosthetic components; OR
• Bearing surface wear leading to symptomatic synovitis; OR
• Dislocation of the patella; OR
• Fracture or mechanical failure of implant; OR
• Implant or knee misalignment; OR
• Knee stiffness (arthrofibrosis); OR
• Periprosthetic fracture of distal femur, proximal tibia or patella; OR
• Progressive or substantial periprosthetic bone loss (osteolysis); OR
• Prosthetic joint infection; OR
• Tissue or systemic reaction to metal implant; AND

AND the following:

• 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

Coverage Limitations

Total Knee Arthroplasty Humana members may NOT be eligible under the Plan for TKA for any indications other than those listed above including, but may not be limited to, the following contraindications:

• Active infection in the joint, unless carrying out a revision as either an immediate exchange or an interval procedure; OR

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

• Active skin infection or open wound at surgical site; OR
• Advanced neurodegenerative disease (eg, advanced Parkinson’s disease); OR
• Allergy to implant materials (eg, ceramic, cobalt, chromium, polyethylene, titanium); OR
• Bony abnormalities that cannot be managed prior to surgery which would increase the likelihood of a poor surgical outcome (eg, inadequate bone stock to support implant); OR
• Extensor mechanism dysfunction; OR
• Infections of the body or blood (eg, sepsis); OR
• Joint instability not able to be corrected by a constrained or hinged prosthesis; OR
• Malignant tumors that do not allow adequate fixation of the implant components; OR
• Multiple uncontrolled comorbid medical conditions; OR
• Neuropathic joint; OR
• Skeletally immature; OR
• Vascular insufficiency, muscular atrophy or neuromuscular disease severe enough to compromise implant stability or postoperative recovery

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.

Knee Arthroplasty Effective Date: 10/09/2023

Revision Date: 10/09/2023

Review Date: 07/27/2023

Policy Number: HUM-0591-005 Page: 8 of 15

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.

Coverage Determination

Unicompartmental Knee Arthroplasty

Humana members may be eligible under the Plan for unicompartmental knee arthroplasty (lateral, medial or patellofemoral) for the following indications:

• Absence of contraindications; 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
• The device is FDA approved;
• AND ONE of the following:

• Angular deformity that corrects to neutral; OR
• Partial resection of the knee required for treatment of malignancy; OR
• Unicompartmental post traumatic joint destruction; OR
• Replacement (revision) of previous arthroplasty needed (eg, infection, implant failure); OR
• Documentation of painful, disabling joint disease of the knee that interferes with activities of daily living (ADLs) resulting from non-inflammatory joint disease (avascular necrosis, osteoarthritis or traumatic arthritis) including:

• Failure of at least 3 months of conservative treatment under the direction of a healthcare professional, which includes:

• Activity/lifestyle modifications; AND
• Ambulatory assistive device if medically appropriate; AND
• Individual with a BMI greater than 40 have documentation of attempted weight loss; AND
• Intra-articular injections when medically appropriate and not contraindicated.

Knee Arthroplasty Effective Date: 10/09/2023

Revision Date: 10/09/2023

Review Date: 07/27/2023

Policy Number: HUM-0591-005 Page: 9 of 15

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.

• Intra-articular steroid injections should be avoided 3 months prior to unicompartmental knee arthroplasty; AND
• Medications (eg, nonsteroidal anti-inflammatory drugs [NSAIDs] or non-narcotic analgesics) when medically appropriate and not contraindicated; 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
• Radiographic confirmation of bone and joint pathology of the knee joint as evidenced one of the following:

1. Exposed subchondral bone (Outerbridge Grade 4); OR
2. Large osteophytes, marked narrowing of joint space, definite deformity of bone ends, severe sclerosis (Kellgren Lawrence Grade 4); OR

Radiological confirmation (magnetic resonance imaging [MRI] preferred if not contraindicated) of avascular necrosis of the femoral condyles or proximal tibia

Coverage Limitations

Unicompartmental Knee Arthroplasty Humana members may NOT be eligible under the Plan for unicompartmental knee arthroplasty (lateral, medial or patellofemoral) for any indication other than those listed above including, but may not be limited to, the following contraindications:

• Angular deformity of more than 5 degrees from the mechanical axis for valgus knees; OR
• Angular deformity of more than 10 degrees from the mechanical axis for varus knees; OR
• Anterior cruciate ligament deficiency not able to be corrected by a non-mobile bearing implant and the knee joint cannot be balanced at the time of surgery; OR
• Exposed subchondral bone beneath the patella; OR
• Flexion contracture of 10 degrees or more; OR
• Inflammatory arthritis (eg, rheumatoid arthritis); OR
• Lateral subluxation of patella or joint space loss along lateral patella facet; OR
• Preoperative arc of motion of less than 90 degrees; OR
• Significant cartilaginous erosion in the weight-bearing areas of the opposite compartment

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.

Coverage Other Miscellaneous Knee Procedures/Devices

Coverage Limitations

Other Miscellaneous Knee Procedures/Devices Humana members may NOT be eligible under the Plan for the following knee procedures or devices:

• Bicompartmental/bi-unicompartmental knee arthroplasty; OR
• Focal resurfacing; OR
• Interpositional unicompartmental device (eg, Orthoglide, Unicondylar Unispacer)

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.

Knee Arthroplasty Effective Date: 10/09/2023

Revision Date: 10/09/2023

Review Date: 07/27/2023

Policy Number: HUM-0591-005 Page: 10 of 15

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.

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

American Academy of Orthopaedic Surgeons

National Institute of Arthritis and Musculoskeletal and Skin Disease

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.