Local Coverage Determination (LCD)

Total Joint Arthroplasty

L39911

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L39911
Original ICD-9 LCD ID
Not Applicable
LCD Title
Total Joint Arthroplasty
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL39911
Original Effective Date
For services performed on or after 10/13/2024
Revision Effective Date
For services performed on or after 02/28/2025
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
08/29/2024
Notice Period End Date
10/12/2024

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Issue

Issue Description

Limited coverage for total joint (knee and hip) arthroplasty and revisions as described in the coverage indications of the policy.

Issue - Explanation of Change Between Proposed LCD and Final LCD

The word gender was revised to sex.

CMS National Coverage Policy

Italicized font represents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national language/wording.

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.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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 (rheumatology.org/patients/joint-replacement-surgery). 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 is 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. Type of arthritis include osteoarthritis (OA), rheumatoid arthritis, 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 limitation when performing activities of daily living (ADL) such as but not limited to walking, squatting, and climbing stairs. Other findings that prompt consideration of total knee arthroplasty 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, 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. Rheumatoid Arthritis, traumatic arthritis, malignancy involving the hip joint, fracture and osteonecrosis 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 also cause limitation 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:

  1. Total knee arthroplasty (TKA)
    1. Failure of previous osteotomy;6,7 or
    2. Distal femur fracture;6 or
    3. Proximal tibia fracture;6 or
    4. Malignancy of the distal femur, proximal tibia, knee joint or adjacent soft tissues;6,7 or
    5. Avascular necrosis of the knee;6,7 or
    6. Advanced joint disease demonstrated by all of 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 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. When non-surgical management is not appropriate, the medical record must clearly document the bases for that conclusion.1,2,19
  2. Replacement/Revision of TKA
    1. Disabling pain or functional disability;9 or
    2. Progressive or substantial periprosthetic bone loss;7 or
    3. Fracture or mechanic failure of one or more components;7 or
    4. Infection;7 or
    5. Aseptic loosening of one or more components;7 or
    6. Failure and wear of the prosthetic components leading to symptomatic synovitis,7 or
    7. Implant or knee misalignment;9 or
    8. Extensor mechanism instability,9 or
    9. Knee stiffness/arthrofibrosis9

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

  1. Total hip arthroplasty (THA)
    1. Malignancy of the joint involving the bones or soft tissues of the pelvis or proximal femur;10 or
    2. Avascular necrosis (osteonecrosis of femoral head);10,15 or
    3. Fracture of the femoral neck;10 or
    4. Acetabular fracture;15 or
    5. Non-union or failure of previous hip fracture surgery;14 or
    6. Mal-union of acetabular or proximal femur fracture;10 or
    7. Advanced joint disease as evidenced by all of 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 one or more of the following: unsupervised exercise (ie: 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 bases for that conclusion.1,10,19
  2. Replacement/Revision THA
    1. Instability of one or both components;14 or
    2. Fracture or mechanical failure of the implant;14 or
    3. Recurrent or irreducible dislocation;14 or
    4. Infection;14 or
    5. Clinically significant leg length inequality not amenable to conservative management;10 or
    6. Treatment of a displaced periprosthetic fracture;14 or
    7. Progressive or substantial bone loss;14 or
    8. Clinically significant audible noise;14 or
    9. Adverse local tissue reaction10

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 one or more of the following contraindications are present:

  • Active infection of the hip or knee joint or active systemic bacteremia7,10
  • Active skin infection or open wound within the planned surgical site of the hip or knee7
  • Neuropathic arthritis10
  • Rapidly progressing neurological disease10

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 one 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 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.

Summary of Evidence

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 osteoarthritis (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 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 K Baker and colleagues conducted a 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 were provided 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, quality of life, 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.

M Fransen et al conducted a systemic review to determine the effect therapeutic exercise had on joint pain, physical function and QOL in patients with knee OA.3 They identified 54 randomized controlled trials (RCTs) from 5 electronic databases that compared various forms of land-based exercises against a non-exercise control group. The results of 44 trials were pooled and concluded that pain was significantly reduced with exercise and there was moderately improved physical function. Thirteen of the pooled study results showed a notable benefit on QOL immediately after treatment. These studies continued to show benefit at 2 and 6 months later, though declining. They authors concluded that land-based exercise gives short term benefit that lasts up to 2-6 months after treatment ends.

S Skou et al. conducted an RCT of 100 patients with moderate to severe knee OA who had met the criteria for total knee arthroplasty.5 Fifty patients were placed on 12 weeks of nonsurgical conservative treatment alone, and 50 underwent total knee replacement followed by 12 weeks of nonsurgical treatment. Nonsurgical treatment consisted of dietary guidance, insole use, exercise, pain medication and education. The primary outcome was to evaluate changes from the baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) in areas of pain, symptoms, activities of daily living, and quality of life over a 12-month period. Of the 100 patients, 95 completed the 12 month follow up with 13 of the nonsurgical group undergoing total knee replacement before 12 months. They concluded that the patients who underwent TKA had a greater improvement in KOOS score, though they did have a higher number of serious adverse events as well (24 vs. 6, P=0.005).

The American Academy of Orthopedic Surgeons (AAOS) developed an Appropriate Use Criteria for the surgical management of OA.6 They estimate that by 2024, the number of people over 65 years of age who have knee OA will be 77.2 million as people are living longer. To develop this appropriate use criteria, 2 expert panels in orthopedic surgery and other appropriate medical fields participated. A writing panel created a list of 864 scenarios and 3 treatments were offered. A voting panel then evaluated the appropriateness of the 3 treatments. Each scenario was subject to 3 rounds of voting. They determined pain that limits walking function, instability in function, 1 or more compartments, joint space narrowing visible on imaging and mechanical symptoms were appropriate for TKA.

G Martin et al. performed a topic review including indications and perioperative considerations for TKA.7 Osteoarthritis is the most common type of arthritis in adults and has led to TKA being performed in over 95% of patients in the United States. Other indications for performing TKA are destruction from disease such as but not limited to rheumatoid arthritis/inflammatory arthritis, posttraumatic degenerative joint disease, osteonecrosis, and congenital abnormalities of the joint. When knee pain is severe and is unresponsive to nonoperative treatment, TKA is indicated. The authors agree that a variety of nonsurgical treatment should be tried before proceeding with TKA. While TKA is relatively safe, there are contraindications where TKA should not be performed that include active infection, neurological disease that affects the extensor mechanism, chronic lower extremity ischemia, and in patients that are still growing. Operative risk should be thoroughly assessed prior to TKA such as physical assessment that includes a comprehensive knee exam, spine and hip exam, evaluating motor strength and tone especially in the quadriceps or extensor mechanism, deep tendon reflex, gait, pulses, and skin. A medical risk assessment should be performed. Patients undergoing TKA will be subject to blood loss, anesthesia as well as a postoperative rehabilitation program following joint replacement. With many patients being older, underlying comorbidities must also be considered. Radiographic images should support advanced arthritic changes and exclude other causes for pain and dysfunction.

The American College of Rheumatology (ACR) and the American Association of Hip and Knee Surgeons (AAHKS) developed a clinical practice guideline for determining the ideal time to perform hip and knee arthroplasty after a systematic review of literature.8 The used the population, intervention, comparator, outcomes (PICO) method to formulate 13 clinically relevant questions. Using a Grading Recommendations Assessment, Development and Evaluation (GRADE) approach, a panel of 13 physicians and patients rated the quality of evidence in 176 papers to determine their recommendations. The population included patients with moderate-to-severe pain, loss of function and imaging evidence of moderate-to-severe OA or Osteonecrosis (ON) with secondary arthritis, that have completed at least 1 trial of nonsurgical treatment. Nonsurgical therapy included but was not limited to analgesics (NSAIDs, acetaminophen, etc.), ambulatory assistive devices, weight loss, bracing, intraarticular injections, and modifying activity. The authors determined that in patients with OA or ON with secondary arthritis where nonsurgical treatment has failed, joint arthroplasty should be performed without delay for any additional treatments. They do not recommend delaying surgery for weight loss in patients to meet a specific weight or body mass index number. They conditionally recommended delaying joint arthroplasty in patients with uncontrolled diabetes until glycemic results are improved, and in those with nicotine dependence until nicotine use is either reduced or stopped entirely. They acknowledge a paucity of high-quality evidence to support the recommendations.

A Postler and colleagues conducted a retrospective case study to determine the major causes of TKA revisions.9 They looked at 402 TKA revision surgeries performed in their department from January 2010 to December 2015. They analyzed radiographic results, blood tests, joint aspiration, intraoperative findings, cultures and tissue sample results. The authors found the most frequent reasons for revision surgery was infection. Other reasons were aseptic loosening, periprosthetic fracture, instability, pain, arthrofibrosis, extensor mechanism insufficiency, and implant failure. Limitations in the study were a lack of baseline information for the initial TKA given that most patients were treated in the department cased on referral, and time between the initial TKA and the need for a revision was not known. The authors acknowledge that their department cases were probably more complicated than other joint replacement registries, however they believe the data is typical for tertiary care centers.

Hip

Authors aimed to consolidate best practice guidelines for total hip arthroplasty including indications, contraindications, and perioperative care.10 Indications for Total Hip Arthroplasty (THA) include patients that have failed conservative or other surgical options and have continued debilitating pain and interference in daily living. Deformity or limited motion can also be reasons for THA. Conditions affecting the hip include osteoarthritis, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, Femoroacetabular Impingement Syndrome (FAIS), developmental hip dysplasia, trauma, neoplasms, osteonecrosis, or childhood hip disorders. Providers should not proceed with THA if there are active infections, skeletal immaturity, quadriplegia, permanent or irreversible muscle weakness, or preexisting conditions such as recent myocardial infarction, unstable angina, heart failure or severe anemia. Conservative treatments include weight reduction, physical therapy, NSAIDs, assistive devices, intraarticular glucocorticoid injections, or addressing underlying inflammatory disorders. Post-operative rehabilitation and follow-up are important to ensure appropriate healing. Patients with high body mass index (BMI) have a higher risk of early revision due to infection.

J Hirvonen et al conducted a prospective multicenter study to assess the quality of life in patients awaiting a major joint replacement.11 Population controls were selected for comparison for 133 patients. Health Related Quality of Life (HRQoL) 15D questionnaires, which measures quality of movement, sleep, sexual activity, vitality, usual activity, discomfort and symptoms, and psychological factors were distributed to all participants. Matching was done on age, sex, housing, and home municipality to remove the bias of confounding variables. At baseline, there were statistically significant differences in the scores of patients and population controls. Patients reported worse scores in terms of moving (P < 0.001), sleeping (P < 0.001), sexual activity (P < 0.001), vitality (P <0.001), usual activities, (P < 0.001), and discomfort and symptoms (P < 0.001). Patients also reported worse scores than the population controls in psychological measures such as depression (P < 0.001) and distress (P = 0.004). Researchers concluded that a worse HRQoL was consistently noted in patients that were waiting to undergo major joint replacement, but scores did not worsen during the waiting period.

Researchers performed a systematic literature review to evaluate the indication for total hip or knee arthroplasty in patients with OA.12 Guidelines and research on indications published from orthopaedic and arthritis organizations were collected to synthesize data. A total of 18 papers were assessed including 6 original studies and 12 reviews. Pain indications for THA included hip pain during activities or at rest, pain refractory to non-surgical management, and incapacitating pain unresponsive to conservative therapy. Functional indications included constricted range of motion, functional impairment (substantial or other), and function limiting symptoms (major lifestyle changes or activities important to patient). Radiological indications included evidence of arthritis, findings of joint space narrowing, bone sclerosis, bone cysts femoral/acetabular osteophytes, and evidence of joint degeneration. Of the 5 hip only studies, 2 indicated failure of conservative therapy and 1 indicated conservative therapy should be the initial course of treatment. Three knee and hip articles were collected however, guidelines, criteria and recommendations remained unclear from these sources.

T Mok et al conducted a meta-analysis assessing THA versus conservative therapy.13 A total of 3 randomized clinical trials were collected after applying inclusion/exclusion criteria. The 3 articles assessed 650 FAIS patients. Using the Hip Outcome Score (HOS) sports scale to measure outcomes, authors concluded there was no significant difference between Arthroscopic Hip Surgery (AHS) or conservative treatment. Using the International Hip Outcome Total (iHOT) and Hip Outcome Score of Activities of Daily Living (HOS ADL) scales, AHS is presented more favorable outcomes in patients with FAIS. Other conditions were not assessed for the comparison or surgical versus conservative treatment.

A retrospective study was executed to assess causes of failure in 1100 THAs (1036 patients) and required revision surgeries.14 Patient data was collected was collected from 1985 to 2005 with a minimum follow-up period of 2 years. Of the 1100 THAs, the initial indication for revision was as follows: aseptic loosening (45%), instability (16%), osteolysis/wear (16%), deep periprosthetic infection (11%), periprosthetic fracture (6%), or other (7%). During follow-up, 141 patients required a second revision noting the following causes: instability (35%), aseptic loosening (30%), osteolysis/wear (12%), deep periprosthetic infection (12%), other (9%), periprosthetic fracture (2%). Overall survivorship was 82% at 10 years and 72.6% at 15 years. Instability and aseptic loosening attributed to 65% of failure of revisions. Survivorship was impacted by diagnosis and cause of revision.

P Kumar et al retrospectively investigated 118 hips (99 patients) to evaluate common hip conditions that require THA and post-operative outcomes.15 The Harris Hip Score (HHS) was used to assess dysfunction following THA. Males more frequently underwent hip arthroplasty in this sample of patients (3.1:1). Uncemented Total Hip Replacement (THR) was used in 75% of cases and cemented was used in patients with trauma sequelae with deficient acetabulum or poor bone density. The lowest scores were found in patients with inflammatory arthritis (IA) and best scores in non-traumatic avascular necrosis (AVN). Primary OA was also commonly found in patients.

I Ackerman et al conducted a prospective cohort study to measure the impact of waiting for TJA on HRQoL.16 The study comprised of 134 patients completing self-reported questionnaires including Assessment of Quality of Life (AQoL), WOMAC, and Kessler Psychological Distress Scale (K10). Scores were captured when patients were put on the orthopaedic waiting list and at preadmission for surgery. Approximately 69% of patients waited an average of 6 months or longer for Major Joint Replacement (MJR) surgery. About 25% of patients were on the waitlist for less than 6 months. Patients reported various conditions such as osteoarthritis (78%) or rheumatoid arthritis (18%). Other comorbidities included back pain (44%), osteoporosis (13%), gout (7%), fibromyalgia (<1%), hypertension (40%), diabetes (13%), coronary artery disease (13%), asthma (12%), anxiety/depression (11%), or cancer (4%). Previous joint replacement was reported in 20% of patients. Using the AQoL score, both knee (p=0.39) and hip (p=0.01) replacement patients showed a worse score at preadmission. Using the WOMAC score, knee (p=0.50) and hip (0.35) replacement patients showed worse scores at preadmission. In regard to the K10 scale, psychological distress was worse at preadmission in knee (p=0.33) and hip (p=0.50) patients.

J Evans et al performed a systematic review to evaluate the survivorship of hip replacements and causes of failure.17 A total of 44 articles were included in this study comprising of 13 212 THAs with 15 years of follow-up, 121 384 THAs from the Australian Orthopaedic Association National Joint Replacement Registry Annual Report, and 94 292 THAs from the Finnish Arthroplasty Report. More than half of all patients were female (56.2%, 55%, 58.5% respectively). Using pooling, the survivorship of 15 years was 89.4%. Survivorship at 20 years was 70.2% and 57.9% at 25 years. Researchers concluded that age, sex, and implant type directly correlated with the success and survivorship of the replacement.

AAHKS members developed guidelines, recommendations and indications for patients that require THA including both surgical and conservative recommendations.18 Authors follows PICO structure to refine literature supporting this document. Strong recommendations were made against the use of intraarticular hyaluronic acid to treat symptomatic hip osteoarthritis but supported the use of NSAIDs. Tranexamic Acid was strongly supported to reduce blood loss in those undergoing THA. Moderate recommendations were made for both physical therapy as a conservative treatment and post operatively. Corticosteroid injections were also moderately recommended for pain management and to improve function. Physicians moderately recommended the exposure approach for THA and for the use of cemented femoral stems. There was limited evidence supporting the impact of BMI on adverse events and clinical outcomes. There was also limited evidence supporting adverse events related to diabetes, tobacco use, or social determinants of health. The use of opioids and acetaminophen was unanimously rejected as pain management options. There was insufficient evidence to suggest an increased risk of stiff spine syndrome in conjunction with osteoarthritis. Limited evidence was available to support the use of Neuraxial to reduce adverse events.

Analysis of Evidence (Rationale for Determination)

The knee followed by the hip are the largest joints in the body. While there are many reasons patients seek joint replacement, osteoarthritis is one of the most prevalent causes of wearing of the knee and hip joints. The evidence of literature supports that knee arthroplasty and hip arthroplasty are safe and effective procedures in patients where conservative measures have failed to relieve symptoms and improves patient function, independence and quality of life.

Multiple organizations such as the AAOS, ACR, OARSI, and AAHKS, all have developed guidelines for non-surgical and surgical management of the knee and hip joints. While these guidelines slightly vary, they all support conservative measures to improve pain, mobility and function.

TKA is a common surgical procedure with various indications for necessity. Conditions requiring TKA vary, and conservative therapy may offer relief to patients. The literature supports conservative therapy is the first line of treatment included but not limited to physical therapy, corticosteroid injections, weight reduction and NSAIDs as appropriate. Failure to improve mobility, function or reduce pain using conservative measures are indications that a TKA may be appropriate. There are contraindications for TKA including but not limited to active infection, neurological disease that affects the extensor mechanism, chronic lower extremity ischemia. Both conservative and surgical treatments have shown to improve QOL in patients. A TKA revision or replacement may be required if there is infection, instability, pain, failure of implant or fracture.

THA is the second most common major joint replacement surgery with many of the same indications and treatment options as TKA. Patients requiring THA will be prescribed conservative measures similar to those of THA including physical therapy, corticosteroid injections, weight reduction and NSAIDs. Both treatments have shown improved HRQoL scores. THA eligibility is determined using lab studies, imaging, and function tests. Patients with comorbidities such as FAIS, osteoarthritis, developmental hip dysplasia, or childhood hip disorders, or neoplasms are also considered for eligibility. THA should not be performed if there is an active infection, skeletal immaturity, quadriplegia, permanent or irreversible muscle weakness, or preexisting conditions such as recent myocardial infarction, unstable angina, heart failure or severe anemia. Causes for THA revision or replacement include fracture, infection, instability, and aseptic loosening.

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Other Contractor’s policies: Noridian Healthcare Solutions, LLC LCD L33494, Total Joint Arthroplasty; National Government Services, Inc. LCD L36039, Total Joint Arthroplasty and First Coast Service Options, Inc. LCD L32078 for Major Joint Replacement (Hip and Knee)

Bibliography
  1. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137-162. doi:10.1016/j.joca.2007.12.013
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Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
02/28/2025 R2

Posted 02/27/2025 Under Summary of Evidence the word gender was revised to the word sex. This change is effective 02/28/2025.

  • Other
10/13/2024 R1

Posted 10/31/2024 Under Covered Indications for Total knee arthroplasty deleted line e. Failure of previous osteotomy as it is a duplicate of line a.

  • Other
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