Lower Extremity Major Joint Replacement (Hip and Knee) Form

Summary Of Evidence

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Analysis of Evidence

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Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

For the purpose of this LCD, lower extremity major joint replacement or arthroplasty refers to the replacement of the hip or knee joint. The goal of total hip or knee replacement surgery is to relieve pain and improve or increase functional activity of the beneficiary.

Joint replacement, referred to as arthroplasty, has been performed with short and long term favorable outcome over the past several decades and has proven to be an important medical advancement in the field of orthopedic surgery. The hip and knee are the two most commonly replaced joints. The knee is the largest joint in the body and includes the lower end of the femur, the upper end of the tibia and the patella. The knee joint has three compartments, the medial, the lateral and the patellofemoral. The surfaces of these compartments are covered with articular cartilage and are bathed in synovial fluid. The bones of the knee joint work together, allowing the knee to move and function smoothly. The hip is a large weight bearing joint made up of two components: a ball (femoral head) and socket (acetabulum). These components are covered with articular cartilage and are bathed in synovial fluid produced by a synovial membrane.

The most common reason for total knee arthroplasty is arthritis of the knee joint. Types of arthritis include osteoarthritis, rheumatoid arthritis and traumatic arthritis (arthritis which occurs as a result of injury). This arthritis causes a severe limitation in the activities of daily living, including impaired ambulation, squatting, and climbing stairs. Pain is typically most severe with activity and patients often have difficulty mobilizing from a sitting position. Other findings include signs of chronic knee inflammation, swelling and stiffness not relieved by rest, non-steroidal anti-inflammatories, physical therapy or other non-surgical therapies such as intra articular injections.

Osteonecrosis and malignancy are additional reasons to proceed with arthroplasty or total joint replacement.

Total hip arthroplasty is most often performed due to severe pain caused by osteoarthritis of the hip joint. Rheumatoid arthritis, traumatic arthritis, malignancy involving the hip joint and osteonecrosis of the femoral head are also indications for hip replacement surgery. The pain from the damaged joint limits activities of daily living, such as walking, or causes disruption of sleep. Pain relief not achieved by taking non-steroidal anti-inflammatory medications and failure to achieve symptom improvement with other conservative therapies such as physical therapy, activity modification and assistive devices are reasons for proceeding with hip arthroplasty or replacement.

Circumstances that lead to revision or repeat procedure of a total hip or total knee arthroplasty can be necessary due to continued disabling pain or continued decline in function attributed to failure of the primary joint procedure. Failure can be due to infection involving the joint, substantial bone loss in the structures supporting the prosthesis, fracture, aseptic loosening of the components and wear of the prosthetic components. In revisional surgery it is important to provide replacement of the components of the previous surgery responsible for the failure. If either component of the joint remains viable and without infection or deterioration, it is expected that only those failed components will be replaced without injury to the indwelling viable components, e.g., the acetabulum is well seated and without deterioration, only the femoral component should be revised or replaced with a similar matching component. Unavailability of components of a previous arthroplasty requiring the replacement of both components, or failure due to the design of the original components should be clearly documented in the medical record.

Covered Indications

This LCD is only addressing medical necessity criteria for performing total hip and knee replacement surgery. With respect to knee replacement surgery, there is a form of knee joint replacement surgery called unicompartmental knee replacement. This is typically done for patients with osteoarthritis of the knee in which the damage is confined to one compartment of the knee. The indications outlined in this LCD are not to be applied for unicompartmental knee replacement surgery.

See Documentation Requirements section for additional information.

Medicare will consider Total Knee Arthroplasty (TKA) medically reasonable and necessary when three or more of the following criteria are met:

1. Advanced joint disease demonstrated by radiographic supported evidence or magnetic resonance imaging (MRI), e.g., fracture or deterioration, distortion of joint surfaces, subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis;
2. History of unsuccessful appropriate conservative therapy that is clearly documented 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 includes one or more of the following: anti-inflammatory medications; analgesics; flexibility and muscle strengthening exercises with supervised physical therapy.
3. Pain with functional disability due to arthritis or trauma to the knee joint; activities of daily living (ADLs) are diminished despite compliance with plan of care including activity restrictions as is reasonable, assistive device use, weight reduction as appropriate or therapeutic injections into the knee as appropriate;
4. Distinct structural abnormalities such as:
   • Distal femur fracture;
   • Proximal tibia fracture;
   • Malignancy of the distal femur, proximal tibia, knee joint or adjacent soft tissues;
   • Avascular or other form of osteonecrosis of the knee;
   • Rheumatologic changes precluding or inconsistent with rehabilitation
5. Failed previous joint replacement/arthroplasty necessitating revision as indicated by any of the following:
   • Loosening, fracture, or mechanical failure of one or more components;
   • Technical or functional failure of previous knee surgery, e.g. unicompartmental knee replacement;
   • Previous osteotomy or partial arthroplasty;
   • Infection;
   • Periprosthetic fracture or bone loss of distal femur, proximal tibia or patella; Implant or knee malalignment;
   • Bearing surface wear leading to symptomatic synovitis;
   • Tibiofemoral or extensor mechanism instability; or
   • Knee stiffness, arthrofibrosis or other destructive conditions that render the knee impaired to the extent to preclude employment or functional activities.

Medicare will consider Total Hip Arthroplasty (THA) medically reasonable and necessary when three or more of the following indications are met:

1. Advanced joint disease demonstrated by radiographic supported evidence or when conventional radiography is not adequate, magnetic resonance imaging (MRI) supported evidence (subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis);
2. Pain and functional disability from injury due to trauma or arthritis of the joint; activities of daily living (ADLs) are diminished despite completing a plan of care with activity restrictions as is reasonable, assistive device use, appropriate weight reduction, flexibility and muscle strengthening exercises with supervised physical therapy.
3. History of unsuccessful conservative treatment or non-surgical medical management that is clearly documented 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 includes one or more of the following: anti-inflammatory medications, analgesics, or therapeutic injections when appropriate, with physical therapy or assist devices.
4. Distinct structural abnormalities
   • Malignancy of the joint involving the bones or soft tissues of the pelvis or proximal femur;
   • Avascular necrosis (osteonecrosis of femoral head);
   • Fracture of the femoral neck; Acetabular fracture;
   • Non-union or failure of previous hip fracture surgery; Mal-union of acetabular or proximal femur fracture;
5. Failed previous Hip Arthroplasty necessitating revision as indicated by the following:
   • Loosening, fracture or mechanical failure of the implant;
   • Instability of one or more components;
   • Recurrent or irreducible dislocation;
   • Infection;
   • Displaced periprosthetic fracture;
   • Clinically significant leg length inequality;
   • Progressive soft tissue or bone reaction or substantial bone loss,
   • Clinically significant audible noise; or
   • Bearing surface wear leading to symptomatic synovitis
   • Other disease or destructive process that renders the hip impaired to the extent to preclude employment or functional activities

Limitations

The following are considered not reasonable and necessary and therefore will be denied:

1. TKA and THA will not be considered reasonable and necessary when the above indications are not met.
2. Medicare will consider a total knee replacement or total hip replacement not medically reasonable and necessary when the following contraindications are present:
   • Active infection of the hip or knee joint or active systemic bacteremia
   • Active skin infection or open wound within the planned surgical site of the hip or knee
   • Progressive neurological disease, etiologic for pain, instability or disability

Provider Qualifications

Services will be considered medically reasonable and necessary only if performed by appropriately trained providers. This training and expertise must have been acquired within the framework of an accredited residency or fellowship program in the applicable specialty/subspecialty or must reflect extensive continued medical education activities. If these skills have been acquired by way of continued medical education, the courses must be comprehensive, offered or sponsored or endorsed by an academic institution in the United States or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as Category 1 Credit. It is expected that these services would be performed as indicated by current medical literature or standards of practice by appropriately trained medical physicians (MD or DO) certified or eligible for certification by the American Board of Orthopaedic Surgery.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Refer to Billing and Coding: Lower Extremity Major Joint Replacement (Hip and Knee), A56796, for applicable CPT/HCPCS codes and diagnosis codes.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.