LCD L39911: Total Joint Arthroplasty

General Information

Arthroplasty entails replacing part or all the joint with an endoprosthesis: an implant constructed of non-biological materials such as metal, ceramic, or polyethylene. In total knee arthroplasty (TKA), diseased articular surfaces are replaced. In total hip arthroplasty (THA) both the femoral head and the acetabulum or socket are replaced.

Joint replacement surgery has been performed on millions of people over the past several decades. There are roughly over 1.2 million total knee and hip replacements performed annually in the Unites States and this number will continue to rise as our population ages. 20 Total joint replacement has proven to be an important medical advancement in the field of orthopedic surgery with the hip and the knee being the most commonly replaced joints. 5

The knee is the largest joint in the body and is vital to movement. It is made up of the lower end of the femur, upper end of the tibia, and the patella. The knee is comprised of 3 compartments, the medial, the lateral, and the patellofemoral. The ends of the femur and tibia are covered with articular cartilage that helps the knee bones to move smoothly across each other as you bend and straighten the leg. Between the femur and the tibia there are also 2 areas of meniscus cartilage which act to reduce shock between the bones and cushion and stabilize the joint.

The hip is the largest joint in your body after the knee. It functions to provide balance and support for your upper body, bear your body weight and move the upper leg. The hip is comprised of 2 compartments, the femoral head which is the ball, and the acetabulum which is the socket. These are covered with articular cartilage, the bursa, and are lubricated by synovial fluid produced by the synovial membrane.

The most common reason people seek knee replacement surgery is for arthritis of the knee joint. Types of arthritis include osteoarthritis (OA), rheumatoid arthritis (RA), and traumatic arthritis. Pain is most prevalent with activity, but immobility can cause difficulty in mobilizing after being seated for a long time. Arthritis can cause severe limitations when performing activities of daily living (ADL) such as but not limited to walking, squatting, and climbing stairs. Other findings that prompt consideration of TKA include chronic knee inflammation or swelling not relieved by rest, knee stiffness, lack of pain relief after taking non-steroidal anti-inflammatory medications, and failure to achieve symptom improvement with other conservative therapies such as steroid injections and physical therapy. Osteonecrosis (ON), fracture and malignancy are additional reasons to proceed with total knee replacement surgery. The goal of total knee replacement surgery is to relieve pain and improve or increase patient function.

Total hip replacement surgery is most often performed due to severe pain caused by OA of the hip joint. RA, traumatic arthritis, malignancy involving the hip joint, fracture and ON of the femoral head are also causes for hip replacement surgery. Pain from the damaged hip joint can cause disruption of sleep due to the inability to lie on the affected hip, and can also cause limitations to ADLs such as walking, bathing and cooking. When pain is not relieved with conservative therapies such as non-steroidal anti-inflammatories (NSAIDS), physical therapy, activity modification, or assistive devices, hip replacement may be indicated.

Occasionally, there can be failure in the prior total knee or hip replacement. Failure can be due but not limited to, an infection involving the joint, substantial bone loss in the structures supporting the prosthesis, aseptic loosening or wear of the prosthetic components, and fracture. When these circumstances occur, there may be a need to do a total knee or total hip revision.

Covered Indications

Total knee replacement surgery will be considered medically necessary when 1 or more of the following criteria are met:

• Total knee arthroplasty (TKA)

• Failure of previous osteotomy; 6,7 or

• Distal femur fracture; 6 or

• Proximal tibia fracture; 6 or

• Malignancy of the distal femur, proximal tibia, knee joint or adjacent soft tissues; 6,7 or

• Avascular necrosis of the knee; 6,7 or

• Advanced joint disease demonstrated by all the following:

• Radiographic supported evidence or when conventional radiography is not adequate, magnetic resonance imaging (MRI) and/or computed tomography (CT) (in situations when MRI is non-diagnostic or not able to be performed) supported evidence (subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis); 7 and

• Pain or functional disability attributable to the advanced joint disease, 6 and

• Unsuccessful history of appropriate conservative therapy (non-surgical medical management) that is clearly addressed in the pre-procedure medical record. Non-surgical medical management is usually implemented for 3-months or more to assess effectiveness. Conservative treatment as clinically appropriate for the patient’s current episode of care typically include 1 or more of the following: anti-inflammatory medications, analgesics, flexibility and muscle strengthening exercises, supervised physical therapy (ADLs diminished despite completing a plan of care), activity restrictions as is reasonable, assistive device use, weight reduction as appropriate, and/or therapeutic injections into the knee as appropriate. When non-surgical management is not appropriate, the medical record must clearly document the bases for that conclusion. 1,2,

• Replacement/Revision of TKA

• Disabling pain or functional disability; 9 or

• Progressive or substantial periprosthetic bone loss; 7 or

• Fracture or mechanic failure of 1 or more components; 7 or

• Infection; 7 or

• Aseptic loosening of 1 or more components; 7 or

• Failure and wear of the prosthetic components leading to symptomatic synovitis, 7 or

• Implant or knee misalignment; 9 or

• Extensor mechanism instability, 9 or

• Knee stiffness/arthrofibrosis 9

Total hip replacement surgery will be considered medically necessary when 1 or more of the following criteria are met:

• Total hip arthroplasty (THA)

• Malignancy of the joint involving the bones or soft tissues of the pelvis or proximal femur; 10 or

• Avascular necrosis (ON of femoral head); 10,15 or

• Fracture of the femoral neck; 10 or

• Acetabular fracture; 15 or

• Non-union or failure of previous hip fracture surgery; 14 or

• Mal-union of acetabular or proximal femur fracture; 10 or

• Advanced joint disease as evidenced by all the following:

• Radiographic, or MRI evidence supporting the advanced joint disease; 12 and

• Pain or functional disability attributable to the advanced joint disease, 12 and

• Unsuccessful history of appropriate conservative therapy (non-surgical medical management) that is clearly addressed in the pre-procedure medical record. Non-surgical medical management is usually implemented for 3 months or more to assess effectiveness. Conservative treatment as clinically appropriate for the patient’s current episode of care typically include 1 or more of the following: unsupervised exercise (i.e., aerobic, strengthening, stretching, Tai-chi, etc.) or completion of a supervised physical therapy program (land or aquatic based), topical or oral anti-inflammatory medications, analgesics, assistive device use, weight reduction as appropriate, acupuncture or therapeutic intraarticular injections as appropriate. When non-surgical management is not appropriate, the medical record must clearly document the basis for that conclusion. 1,10,19

• Replacement/Revision THA

• Instability of 1 or both components; 14 or

• Fracture or mechanical failure of the implant; 14 or

• Recurrent or irreducible dislocation; 14 or

• Infection; 14 or

• Clinically significant leg length inequality not amenable to conservative management; 10 or

• Treatment of a displaced periprosthetic fracture; 14 or

• Progressive or substantial bone loss; 14 or

• Clinically significant audible noise; 14 or

• Adverse local tissue reaction 10

Limitations

TKA or THA is not considered medically reasonable and necessary when any of the above criteria are not met.

TKA or THA is not considered medically reasonable and necessary when 1 or more of the following contraindications are present:

• Active infection of the hip or knee joint or active systemic bacteremia 7,10

• Active skin infection or open wound within the planned surgical site of the hip or knee 7

• Neuropathic arthritis 10

• Rapidly progressing neurological disease 10

This local coverage determination (LCD) is only addressing medical necessity criteria for performing total knee and hip replacement surgery. The indications in this LCD are not to be applied for unicompartmental knee replacement surgery which is only contained to 1 compartment of the knee. However, failed previous unicompartmental joint replacement is an indication for performing TKA.

The devices/implants for total knee and total hip replacement surgeries are regulated by the Food and Drug Administration (FDA) as medical devices. The devices used should be class II or class III devices that meet the requirements as outlined in the CFR, Title 21, Volume 8, Chapter I, Subchapter H, Part 888 Orthopedic Devices.

Please see the associated billing and coding article A59811 Billing and Coding: Total Joint Arthroplasty for information on documentation requirements.

Knee

The Osteoarthritis Research Society International conducted a systematic review of 23 existing guidelines published between 1945 and January of 2006, to develop concise recommendations for managing hip and knee OA. 1 Sixteen experts were gathered from primary care, rheumatology, orthopedics and evidence-based medicine to form a team to develop an expert consensus guideline. The existing literature was chosen based on the appraisal of guidelines research and evaluation (AGREE) instrument, and a Delphi exercise with confidence intervals (CI) at 95% was used to create 25 recommendations. The results included but are not limited to exercise, weight reduction, education, pharmacological therapy, physical therapy, bracing, ambulatory aids, and intraarticular or hyaluronan injections. The authors concluded that when these conservative measures do not adequately manage pain and improve function, joint arthroplasty is effective at improving quality of life (QOL) outcomes and pain.

Individuals with OA of the knee often report joint pain, stiffness, and difficulty with ambulation. The American Academy of Orthopedic Surgeons (AAOS) Appropriate Use Criteria (AUC) guideline gives recommendations for non-surgical treatment for OA of the knee. 2 These criteria were determined based on literature review combined with clinical expertise of physicians from diverse medical specialties. A writing panel developed clinical based scenarios which were then subject to 2 rounds of voting from a panel, first to rate the appropriateness of each treatment modality, and second to discuss disagreement from the first round of voting, clarification needed, and to then vote again. Voting consisted of rating appropriateness using a 9-point scale with 7-9 being appropriate, 4-6 being may be appropriate but more research is needed to remove uncertainty, and 1-3 being rarely appropriate. Like Osteoarthritis Research Society International (OARSI), 1 they concluded that appropriate non-surgical measures include but are not limited to, self-management that includes exercise, walking, and weight loss, physical therapy modalities, knee braces, assistive devices, NSAIDs and intraarticular corticosteroids. They determined platelet rich plasma was rarely indicated as a treatment for knee OA symptoms.

Knee OA more than any other disease in the elderly can hinder independence with tasks such as walking, stair climbing, and housekeeping. 3,4 It is common, especially in women, for those affected by knee OA to have knee extensor or quadricep weakness. The American College of Rheumatology recommends exercise as a non-surgical treatment for OA to improve strength. 4 Baker and colleagues conducted a randomized controlled trial (RTC) of 46 patients blinded into 2 groups. A total of 23 patients received exercise intervention alone and 22 received only nutrition education. Both groups received home visits once every 2 weeks over the 4-month period. The exercise group intervention consisted of a home-based progressive strength training program. The nutrition control group was provided with a booklet based on the USA food pyramid and asked to keep a good log on 3 nonconsecutive days of every 2 weeks. Primary and secondary outcomes were measured at baseline and at the end of 4-months of interventions. Primary outcome measurement used was the Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC) and secondary outcomes measured were clinical knee examination, strength, physical performance, QOL, nutrition, and adherence. In both groups, 19 participated in the trial until it’s completion. At the end of 4 months, the exercise group had a 71% improvement in knee extension strength, a 36% improvement in pain, and 38% improvement in physical function compared to the control group at 3%, 22% and 32% respectively. They concluded that substantial improvements in strength, pain, QOL, and ability to function physically result from participating in high intensity, home based exercise programs.