Total Joint Arthroplasty

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

21 CFR §888.1100 Arthroscope

42 CFR §482.24 Condition of participation: Medical record services

CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 6, §6.5.2 Conducting Patient Status Reviews of Claims for Medicare Part A Payment for Inpatient Hospital Admissions

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 2 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 3 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 2 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 (TKR) 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).

Arthritis causes a severe limitation in the activities of daily living (ADLs), 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 (NSAIDs) 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 TKR surgery. The use of TKR in patients with malignancy must be weighed against considerations of life expectancy and possible alternative procedures to relieve pain. The goal of TKR is to relieve pain and improve or increase patient function.

Total hip replacement (THR) 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 use of THR in patients with malignancy must be weighed against considerations of life expectancy and possible alternative procedures to relieve pain. The pain from the damaged joint usually limits ADLs, 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 NSAIDs 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 THR. The goal of THR surgery is to relieve pain and improve or increase patient function.

Occasionally, there may be a need to perform a reoperation on a previous THR or TKR. 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 and/or 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.

Total Knee Arthroplasty (TKA)

Indications:

This A/B MAC will consider TKR surgery medically necessary when 1 or more of the following criteria are met:

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); 
  
  
• Pain or functional disability from injury due to trauma or arthritis of the joint; and
  
  
• If appropriate, a history of unsuccessful conservative therapy (non-surgical medical management) that is clearly addressed in the pre-procedure medical record. (If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable.);  
  
  
• Failure of a previous osteotomy; 
  
  
• Distal femur fracture; 
  
  
• Malignancy of the distal femur, proximal tibia, knee joint or adjacent soft tissues; 
  
  
• Failure of previous unicompartmental knee replacement; 
  
  
• Avascular necrosis of the knee; or
  
  
• Proximal tibia fracture

Non-surgical medical management is usually, but not always, implemented prior to scheduling total joint surgery. Non-surgical treatment as clinically appropriate for the patient’s current episode of care typically includes 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), 
  
  
• Assistive device use, 
  
  
• Weight reduction as appropriate, or
  
  
• Therapeutic injections into the knee as appropriate.

In some circumstances, for example, if the patient has bone on bone articulation, severe deformity, or pain and significant disabling interference with ADLs, the surgeon may determine that non-surgical medical management would be ineffective or counterproductive, and that the best treatment option, after explaining the risks, is surgical. If medical management is deemed inappropriate, the medical record should indicate the rationale for and circumstances under which this is the case.

Indications for Replacement/Revision of TKA:

• Loosening of 1 or more components, 
  
  
• Fracture or mechanical failure of 1 or more components, 
  
  
• Infection, 
  
  
• Treatment of periprosthetic fracture of distal femur, proximal tibia or patella, 
  
  
• Progressive or substantial periprosthetic bone loss, 
  
  
• Bearing surface wear leading to symptomatic synovitis, 
  
  
• Implant or knee misalignment, 
  
  
• Knee stiffness/arthrofibrosis, 
  
  
• Tibiofemoral instability, or
  
  
• Extensor mechanism instability

Total Hip Arthroplasty (THA)

Indications:

This A/B MAC will consider THR surgery medically necessary when 1 or more of the following criteria are met:

Advanced joint disease demonstrated by:

• Radiographic supported evidence or when conventional radiography is not adequate, MRI supported evidence (subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis); 
  
  
• Pain that cannot be adequately controlled despite optimal conservation treatment or functional disability from injury due to trauma or arthritis of the joint; and
  
  
• If appropriate, a history of unsuccessful conservative therapy (non-surgical medical management) that is clearly addressed in the pre-procedure medical record. (If conservative therapy is not appropriate, the medical record must clearly document the rationale for why such approach is not reasonable.); 
  
  
• 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; 
  
  
• Nonunion or failure of previous hip fracture surgery; or
  
  
• Malunion of acetabular or proximal femur fracture

Non-surgical medical management is usually, but not always, implemented prior to scheduling total joint surgery. Non-surgical treatment as clinically appropriate for the patient’s current episode of care typically includes 1 or more of the following:

• Anti-inflammatory medications or analgesics, 
  
  
• Flexibility and muscle strengthening exercises, 
  
  
• Supervised physical therapy (ADLs diminished despite completing a plan of care), 
  
  
• Assistive device use, 
  
  
• Weight reduction as appropriate, or
  
  
• Therapeutic injections into the hip as appropriate.

Indications for Replacement/Revision of THA:

• Loosening of 1 or both components; 
  
  
• Fracture or mechanical failure of the implant; 
  
  
• Recurrent or irreducible dislocation; 
  
  
• Infection; 
  
  
• Treatment of a displaced periprosthetic fracture; 
  
  
• Clinically significant leg length inequality not amenable to conservative management; 
  
  
• Progressive or substantial bone loss; 
  
  
• Bearing surface wear leading to symptomatic synovitis or local bone or soft tissue reaction; 
  
  
• Clinically significant audible noise; or
  
  
• Adverse local tissue reaction.

Limitations:

This A/B MAC will not consider a TKR or THR medically necessary when the following contraindications are present:

• Active infection of the hip or knee joint or active systemic bacteremia
  
  
• Active skin infection (exception recurrent cutaneous staph infections) or open wound within the planned surgical site of the hip or knee
  
  
• Rapidly progressive neurological disease except in the clinical situation of a concomitant displaced femoral neck fracture

The following conditions are relative contraindications to TKR or THR and if such surgery is performed in the presence of these conditions, it is expected that the rationale for proceeding with the surgery under such circumstances is clearly documented in the medical record:

• Absence or relative insufficiency of abductor musculature
  
  
• Any process that is rapidly destroying bone
  
  
• Neurotrophic arthritis

This local coverage determination (LCD) is only addressing medical necessity criteria for performing THR and TKR 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 1 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 TKA.

N/A

N/A

Documentation Requirements

In order to qualify for coverage of both Medicare Part A inpatient services and Part B provider services, the medical record must contain documentation that fully supports the medical necessity and justification of the procedure performed and must be made available to this A/B MAC upon request. When the documentation does not meet the criteria for the service(s) rendered or the documentation does not establish the medical necessity for the service(s), such service(s) will be denied as not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act.

A history and physical, discharge summary, physician progress notes and an operative report are typically in the hospital record for the procedures in this LCD. Other relevant information addressing coverage criteria related to the patient’s episode of care prior to the hospitalization, should be included in the hospital record (see below). Failure to include this information in the hospital record may result in denial of coverage for Part A services and trigger a review of the Part B provider claim to determine whether the Part B service rendered was reasonable and necessary.

When the procedure is indicated for advanced joint disease, the following should be documented in the medical record:

• Arthritis of the knee or hip supported by X-ray or MRI. The X-ray or MRI should demonstrate 1 of the following:
  • Subchondral cysts,
  • Subchondral sclerosis,
  • Periarticular osteophytes,
  • Joint subluxation,
  • Joint space narrowing,
  • Avascular necrosis or
  • Bone on bone articulation

• Pain or functional disability at the hip or knee. For example, documented pain that interferes with ADLs (functional disability), or pain that is increased with initiation of activities or pain that increases with weight bearing.

• Unsuccessful conservative therapy (non-surgical medical management) if appropriate. The documentation should demonstrate a history of a reasonable attempt at conservative therapy as appropriate for the patient in their current episode of care. For example, a 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.
  
  
• For patients with significant conditions or co-morbidities, the risk/benefit of non-cardiac surgery, such as TKA or THA should be appropriately addressed in the medical record.

Medical record documentation for other TKA and THA indications outlined in the LCD should include the following, when indicated:

• Supporting evidence (e.g., pathology reports and referral from an oncologist for a malignancy of the joint or X-ray of a fracture).
  
  
• Pain at the hip or knee when indicated as a reason for the procedure (e.g., for revision/replacement TKA/THA). For example, documented pain that interferes with ADLs (functional disability), pain that is increased with initiation of activities or pain that increases with weight bearing.
  
  
• For patients with significant conditions or co-morbidities, the risk/benefit of non-cardiac surgery, such as TKA or THA should be appropriately addressed in the medical record.
  
  
• When infection is the reason for revision TKA or THA surgery, laboratory and/or pathology reports must be in the medical record and all documentation regarding treatment of the infection and a physician note indicating that it is appropriate to proceed with surgery.

In the instance that the patient is undergoing a bilateral knee or hip replacement, all criteria listed above would apply to the bilateral surgery when indicated. The medical record should also support the medical necessity for performing a bilateral THA or TKA.

The treating physician must discuss the significant benefits and risks with the patient. In order to meet Medicare’s reasonable and necessary (R&N) threshold for coverage of a procedure, the physician’s documentation for the case should clearly support both the diagnostic criteria for the indication (standard test results and/or clinical findings as applicable) and the medical need (the procedure does not exceed the medical need and is at least as beneficial as existing alternatives and the procedure is furnished with accepted standards of medical practice in a setting appropriate for the patient’s medical needs and condition). Lacking compelling arguments for an exception in the supporting documentation, the hospital (Fiscal Intermediary Standard System [FISS] claim) and physician services (Modernized Claim System [MCS] claim) can be denied.

If in certain circumstances the patient does not meet all of the required criteria outlined in the LCD for a procedure, but the treating physician feels that the procedure is a covered procedure given the current standards of care, then the documentation must clearly outline the patient’s episode of care that supports the major procedure and must clearly address the reason(s) for coverage. For example, if clinical findings (or lack of) for an indication are not consistent with the LCD criteria, it should be directly addressed in the pre-procedure documentation. For example, if certain conservative measures are not necessary or appropriate for a given patient, it should be directly noted in the pre-procedure documentation. The clinical judgment of the treating physician is always a consideration if clearly addressed in the pre-procedure record and if consistent with the episode of care for the patient as documented in patient records and claim history.

Review of the medical record must indicate that inpatient hospital care was medically necessary, reasonable, and appropriate for the diagnosis and condition of the beneficiary at any time during the stay. The beneficiary must demonstrate signs and/or symptoms severe enough to warrant the need for medical care and must receive services of such intensity that they can be furnished safely and effectively only on an inpatient basis.

Utilization Guidelines

It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

The devices/implants utilized for TKR and THR 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 outlined in CFR 21, Chapter 1, subchapter H, Part 888.

1. Ackerman IN, Bennell KL, Osborne RH. Decline in health-related quality of life reported by more than half of those waiting for joint replacement surgery: A prospective cohort study. BMC Musculoskeletal Disorders. 2011;12:108.
2. Kane RL, Saleh KJ, Wilt TJ, et al. Total Knee Replacement. Evidence Report/Technology Assessment No. 86. AHRQ Publication No. 04-E006-2. Published December 2003. Accessed 5/4/2023
3. American Academy of Orthopaedic Surgeons. Total Knee Replacement. Accessed 5/4/2023
4. Dennis DA, Berry DJ, Engh G, et al. Revision total knee arthroplasty. Journal of the American Academy of Orthopaedic Surgeons. 2008:16(8):442-454.
5. Emedicine. Total Knee Arthroplasty. Accessed 5/4/2023
   
6. Feeley BT, Gallo RA, Sherman S, Williams RJ. Management of osteoarthritis of the knee in the active patient. Journal of the American Academy of Orthopaedic Surgeons. 2010;18(7):406-416.
7. InterQual^® 2017 Procedures Adult Criteria, Total joint replacement, knee and hip & removal and replacement, total joint replacement knee and hip. McKesson Corporation.
   
8. Milliman Care Guidelines^® 2017. Inpatient and surgical care 15th edition. Knee arthroplasty and hip arthroplasty. Milliman Care Guidelines LLC.
9. O’Connor MI. Implant survival, knee function and pain relief after TKA: Are there differences between men and women? Clinical Orthopaedics & Related Research. 2011;469(7):1846-1851.
10. Richmond J, Hunter D, Irrgang J, et al. Treatment of osteoarthritis of the knee (non-arthroplasty). Journal of the American Academy of Orthopaedic Surgeons. 2009;17(9):591-600.
11. U.S. National Library of Medicine, National Insitute of Health. Hip Joint Replacement. Accessed 5/4/2023
    

• TJA
• THA
• TKA