Total Joint Arthroplasty

Jurisdiction: J15 MAC Part B. States: Kentucky, Ohio. Type: Active LCD

Total Knee Arthroplasty Primary total knee arthroplasty is considered reasonable and medically necessary if all of the following criteria have been met (1,2,3,4 and 5): 1. Advanced joint disease; 1-4 Osteoarthritis with joint destruction 1-4 OR Avascular necrosis (osteonecrosis) 5 OR Inflammatory arthritis when intractable to medical management 2 OR Traumatic with joint destruction (distal femur fracture, proximal tibia fracture) 6 OR Tumor (malignant and non-malignant) with joint destruction affecting the femur, proximal tibia, knee joint of adjacent soft tissues 2,7 OR Failed osteotomy or unicompartmental knee arthoplasty 8 2. Moderate to severe pain and loss of function using standardized pain and function scales* for assessment; 9 3. Radiographic findings demonstrating advanced arthritic changes; 1 X-ray assessments consistent with advanced arthritic changes i.e. a score of ≥2 on the Kellgren–Lawrence scale, with scores ranging from 0 to 4 and a score of ≥2 indicating definite osteoarthritis 3,9 OR Alternative radiographic measures (such as MRI or CT) when conventional radiographs are not adequate. 4. A trial of at least 1 or more conservative therapy without improvement in pain and function typically for a duration of a minimum of 3 months. In exceptional circumstances when conservative therapy is determined to not be appropriate, rationale must be documented in the medical record; 10-12 5. Optimization of co-morbidities if applicable Documentation of smoking history, and counselling on the effect of smoking on healing. Treatment for smoking cessation and outcome of counselling, if applicable. For patients with diabetes documentation of counseling of risk and efforts to optimize medical management and reduce blood sugars if applicable For obesity, risk counseling and efforts for weight reduction to optimize outcomes documented. Revision or replacement Revision or replacement TKA will be considered medically necessary if: 1. Documentation as to the cause of the failure of the primary procedure (such as infection, aseptic loosening , periprosthetic fracture, instability, moderate to severe pain and loss of function using standardized pain and function scales for assessment, polyethylene wear, restriction of motion/arthrofibrosis, extensor mechanism insufficiency, implant failure, and allergy). 13 AND 2. Modifiable factors are addressed prior to surgical intervention. Total Hip Arthroplasty Primary total hip arthroplasty is considered reasonable and medically necessary if all of the following criteria have been met (1,2,3,4&5): 1. Advanced joint disease; Osteoarthritis with joint destruction 1-4 OR Avascular necrosis of the hip (osteonecrosis of femoral head) 14,15 OR Femoroacetabular impingement syndrome 16 OR Developmental hip dysplasia or childhood hip disorders 14 OR Fracture of the femoral neck 15 OR Non-union or failure of previous hip fracture or malunion of acetabular or proximal femur fracture 14 OR Malignancy of the joint involving the bones or soft tissue of the pelvis or proximal femur 14 Acetabular fracture 14 2. Moderate to severe pain and loss of function using standardized pain and function scales* for assessment; 9 3. Radiographic findings demonstrating advanced arthritic changes; 1 X-ray assessments consistent with advanced arthritic changes e., a score of ≥2 on the Kellgren–Lawrence scale, with scores ranging from 0 to 4 and a score of ≥2 indicating definite osteoarthritis; 3,9 OR Alternative radiographic measures (such as MRI) when conventional radiographs are not adequate 4. A trial of at least 1 or more conservative therapy without improvement in pain and function typically for a duration of a minimum of 3 months. In exceptional circumstances when conservative therapy is determined to not be appropriate, rationale must be documented in the medical record. 11,12 5. Optimization of co-morbidities if applicable Documentation of smoking history, and counselling on the effect of smoking on healing. Treatment for smoking cessation and outcome of counselling, if applicable. For patients with diabetes documentation of counseling of risk and efforts to optimize medical management and reduce blood sugars if applicable For obesity, risk counseling and efforts for weight reduction to optimize outcomes documented. Revision or replacement Revision or replacement THA will be considered medically necessary if: 1. Documentation as to the cause of the failure of the primary procedure (such as instability, aseptic loosening, osteolysis and/or wear, infection, periprosthetic fracture, implant fracture, failed bipolar, periprosthetic bone loss, fracture, mechanic failure, and dislocation) 17 AND 2. Modifiable factors are addressed prior to surgical intervention. Limitations TJA should not be performed in presence of: Local or systemic active infection Neuropathic arthritis Rapidly progressive neurological disease Skeletal immaturity Quadriplegia Permanent or irreversible muscle weakness in the absence of pain Bilateral Surgery When bilateral TKA or bilateral THA is performed, the criteria listed above and documentation requirements below apply to each joint upon which surgery is performed. 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. Definitions Total Joint Arthroplasty (TJA) replacement of the joint with an endoprosthesis or implant. Total Knee Arthroplasty (TKA) also referred to as total knee replacement is a surgical procedure in which the diseased articular surface of the knee is resected followed by resurfacing with prosthetic components. 2 Total hip Arthroplasty (THA) also referred to as hip replacement is a surgical procedure in which the diseased portion of the hip is resected followed by artificial components. Conservative therapy- nonsurgical management which includes may physical therapy, non-steroidal anti-inflammatory drugs (NASIDS), braces, intraarticular injections, weight reduction, and smoking cessation. 9 Grading of Recommendations Assessment, Development and Evaluation (GRADE)- widely recognized system for assessing the quality of evidence and the strength of recommendations in healthcare. 18 *Scales 19 Standardized pain scales should be used for the evaluation. The specific scales are at the discretion of the provider but examples of standardized scales include but are not limited to: EuroQol-5 Dimension (EQ-5D) Hanover Functionality Status Questionnaire (FFbH) Harris Hip Score (HHS) Hip Disability and Osteoarthritis Outcome Score (HOOS) Hospital for Special Surgery Knee Score Insall Knee Score Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Society Score Numerical Rating Score (NRS) Oxford Knee questionnaires/ Oxford Hip Score Timed up-and-go test to assess Western Ontario and McMaster Universities (WOMAC) questionnaire Visual Analog Scale (VAS) 40-meter walk test, 30-second chair test, stair-climb test and six-minute walk test