**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.