LCD L33618

Coverage Guidance

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Major Joint Replacement (Hip and Knee). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Major Joint Replacement (Hip and Knee) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

• CMS IOM Publication 100-08, Medicare Program Integrity Manual,

• Chapter 6, Section 6.5.2 Conducting Patient Status Reviews of Claims for Medicare Part A Payment for Inpatient Hospital Admissions

• Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Federal Register References:

• Code of Federal Regulations (CFR), Title 21, Volume 8, Chapter I, Subchapter H, Part 888 Orthopedic Devices.

Indications and Limitations of Coverage

History/Background and/or General Information

Joint replacement surgery has been performed on millions of people over the past several decades and has proved 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 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 replacement surgery 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 difficulty with walking, squatting, and climbing stairs. Pain is typically most severe with activity and patients often have difficulty getting mobilized when seated for a long time. Other findings 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 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 osteoarthritis of the hip joint. Rheumatoid arthritis, traumatic arthritis, malignancy involving the hip joint and osteonecrosis of the femoral head are also causes for hip replacement surgery. The pain from the damaged joint usually limits activities of daily living, such as walking, bathing and cooking. The pain can also cause disruption of sleep due to the inability to lie on the hip while in bed. 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 (in some patients) assistive device use are reasons for proceeding with a total hip replacement. The goal of total hip replacement surgery is to relieve pain and improve or increase patient function.

Occasionally, there may be a need to redo a total hip or total knee replacement. This is often referred to as a revision total knee or revision total hip. Circumstances that lead to the need for a revision total hip or knee are continued disabling pain, continued decline in function which can be attributed to failure of the primary joint replacement. 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.

Covered Indications

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

1. Total knee arthroplasty (TKA)

• Failure of a previous osteotomy; or

• Distal femur fracture; or

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

• Failure of previous unicompartmental knee replacement; or

• Avascular necrosis of the knee; or

• Proximal tibia fracture; or

• 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); and

• Pain or functional disability from injury due to trauma or arthritis of the joint; 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 one or more of the following: anti-inflammatory medications, analgesics, flexibility and muscle strengthening exercises, supervised physical therapy [Activities of daily living (ADLs) diminished despite completing a plan of care], activity restrictions as is reasonable, assistive device use, weight reduction as appropriate, therapeutic injections into the knee as appropriate.

2. Replacement/Revision total knee arthroplasty

• Disabling pain or functional disability; or

• Progressive and substantial bone loss; or

• Fracture or dislocation of the patella; or

• Infection; or

• Periprosthetic fracture or aseptic loosening; or

• Failure and wear of the prosthetic components; or

• Dislocation of the knee joint; or

• Instability of the knee joint

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

3. Total hip arthroplasty (THA)

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

• Avascular necrosis (osteonecrosis of femoral head); or

• Fracture of the femoral neck; or

• Acetabular fracture; or

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

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

• 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); and

• Pain or functional disability from injury due to trauma or arthritis of the joint); 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 one or more of the following:

• anti-inflammatory medications, analgesics, flexibility and muscle strengthening exercises, supervised physical therapy [Activities of daily living (ADLs) diminished despite completing a plan of care], activity restrictions as is reasonable, assistive device use, weight reduction as appropriate.

4. Replacement/Revision total hip arthroplasty

• Instability of one or both components; or

• Fracture or mechanical failure of the implant; or

• Recurrent or irreducible dislocation; or

• Infection; or

• Treatment of a displaced periprosthetic fracture; or

• Clinically significant leg length inequality; or

• Progressive or substantial bone loss; or

• Clinically significant audible noise; or

• Adverse local tissue reaction

Limitations

Total knee replacement or total hip replacement will NOT be considered medically 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

• Neuropathic arthritis

• Rapidly progressive neurological disease

This local coverage determination (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 contained to one compartment of the knee. The indications outlined in this LCD are not to be applied for unicompartmental knee replacement surgery. Failed previous unicompartmental joint replacement is an indication for performing a total knee arthroplasty.

Unsuccessful conservative therapy (non-surgical medical management). The documentation should demonstrate a history of a reasonable attempt (usually 3 months or more) at conservative therapy as appropriate for the patient in their current episode of care. For example, documented trial of NSAIDs or contraindication to such therapy and/or documented supervised physical therapy. Documentation should support that ADLs are diminished due to pain and/or disability despite non-surgical medical management.

The devices/implants for total knee and total hip replacement surgeries are regulated by the 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.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Provider Qualifications

The CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 outlines that “reasonable and necessary" services are "ordered and furnished by qualified personnel." 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 and/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 and/or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as Category 1 Credit.

Summary of Evidence

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Analysis of Evidence

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Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Major Joint Replacement (Hip and Knee) (A57765) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Major Joint Replacement (Hip and Knee) (A57765) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Bibliography

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