Oscar Total Knee Arthroplasty (CG069) Form

The knee is composed of the lower end (distal) of the femur, the patella, and the upper end (proximal) of the tibia. There is a smooth cartilage surface at the distal end of the femur, proximal end of the tibia and undersurface of the patella. For various reasons these cartilage surfaces can wear down and sometimes erode away. In general terms this process is called arthritis, inflammation of a joint. Total knee arthroplasty (TKA) or total knee replacement is surgical reconstruction or replacement of the distal femur, and proximal tibia, and often the undersurface of the patella. Some of the knee ligaments are removed, and other ligaments retained. This guideline does not address partial knee arthroplasty, knee arthroscopy, or knee arthrotomy, please see MCG criteria. Definitions “Ambulatory” is a stay in a facility for up to 23 hours. “Avascular necrosis” is spontaneous osteonecrosis (bone death) when there is alteration of blood supply to the bone with unknown etiology. There are numerous causes for avascular necrosis, but in some cases the cause is unknown. 1 “Angular deformity” in the knees is a deviation from mechanical axis of the lower limb. The mechanical axis is a line from the center of the femoral head through the center of the knee joint to the center of the ankle joint. The usual angular deformities are bow-legs (genu varum), knock-knees (genu valgum), or hyperextension (genu recurvatum). “Kellgren-Lawrence System” is a five-grade classification system describing radiographic findings for osteoarthritis (Table 1). Table 1. Kellgren-Lawrence System for classifying osteoarthritis Grade Radiographic Findings 0 I II III No radiographic features of osteoarthritis are present Doubtful joint space narrowing and possible osteophytic lipping Definite osteophytes and possible joint space narrowing Moderate multiple osteophytes, definite joint space narrowing, some sclerosis, and possible deformity of bone contour IV Large osteophytes, marked joint space narrowing, severe sclerosis, and definite deformity of bone contour “Osteoarthritis” (degenerative joint disease) is the most common form of arthritis and occurs when cartilage gradually wears down and affected bones no longer have the cushion of protective tissue. The primary symptoms are joint pain, stiffness and movement restriction. “Revision” of total knee replacement is when surgery is needed to replace or reconstruct prior knee replacement due to failure, infection, instability or other indications. “Rheumatoid arthritis” is an autoimmune disease causing chronic inflammation in joints and tissue. Over long periods of time, the inflammation can cause joint deformity, bone and cartilage erosion. Clinical Indications General Clinical Indications (For partial knee arthroplasty, knee arthroscopy, or knee arthrotomy, please see MCG criteria) Total knee arthroplasty for a unilateral knee is considered medically necessary when ONE of the following criteria are met: 1. The member has advanced joint disease as indicated by ALL of the following: a. Radiologic or arthroscopic findings of advanced knee joint destruction documented by the treating surgeon and/or radiologist by of ONE of the following: i. Kellgren Lawrence Grade IV radiographic findings (Table 1); or 2 ii. Exposed subchondral bone, which is erosion of articular cartilage that exposes subchondral bone often designated as Modified Outerbridge Classification IV; or iii. iv. Symptomatic angular deformity with accompanying radiographic changes; or Symptomatic avascular necrosis of the femoral condyles or proximal tibia with accompanying radiographic changes; and b. Severe pain persisting in the affected knee that interferes with functional activity or age-appropriate activities for at least 3-months (e.g., ambulation, prolonged standing, ability to sleep); and c. There has been a failure to decrease pain or improve function after at least a 3-month trial of conservative treatment (non-surgical) which has included ALL of the following: i. Active and ongoing participation in a physical therapy (documented) or a well documented home exercise program under the supervision of a physical therapist or physician, (e.g., lower extremity flexibility and strengthening program), activity modification, and/or weight loss program); and ii. Oral/topical medications (e.g., analgesics, NSAIDs, serotonin/norepinephrine reuptake Inhibitor (duloxetine)), unless poorly tolerated or contraindicated; and iii. Therapeutic injections to the knee and not within three months before the surgery date (unless contraindicated, examples include, but not limited to as bone-on-bone, osteolytic cysts, osteophytes, and sclerosis) ; and d. If there is a separate request for the device, implant or prosthesis that will be inserted during surgery, it must be FDA approved (unless the member is enrolled in an approved clinical trial as defined by the plan benefit); and e. If the member is a smoker or nicotine product user, the member has stopped using within 4 weeks of surgery or has been provided a well documented education plan on options to quit such as referral to a cessation program, pharmacologic, and over the counter treatments have been documented; and f. No contraindication present or the request is not considered Experimental or Investigational, or Not Medically Necessary based on the indications listed below; or 2. Failure of previous surgical interventions such as ONE of the following: a. Previous proximal tibial or distal femoral osteotomy; or b. Previous unicompartmental knee replacement with continued pain interfering with ADLs; or 3. Post-traumatic injury (e.g., fracture, infection) causing debilitating knee joint destruction affecting movement, causing pain and stiffness; or 4. Bone tumor involving the knee that requires excision. 3 SimultaneousBilateralSurgery Total knee arthroplasty for simultaneous bilateral surgery is considered medically necessary if ALL of the following criteria are met: 1. Each knee meets medical necessity for criteria under General Clinical Indications; and 2. Meets the inpatient hospital Levels of Care criteria (see below). Removal or Revision of Total Knee Arthroplasty Removal(resectionwithsubsequentreimplantationatalatertimeorpermanentresectionarthroplasty withnoreimplantationplanned)orRevision(membersmayrequiremulti-stagedsurgeriestocomplete revisionovertime) The removal or revision of a total knee prosthesis is considered medically necessary when ALL of the following criteria are met: 1. No current or ongoing knee infection (e.g., supporting labs and cultures, no longer on antibiotics, assessment by treating surgeon); and 2. One of the following: a. Infected knee prosthesis;or b. Periprosthetic infection;or c. Prosthesis/hardware failure, damage or fracture;or d. Loosening of prosthesis, implant or components that is confirmed by imaging;or e. Periprosthetic Knee fracture;or f. Instability or dislocation of the knee;or g. The member has functional disability AND persistent pain for more than 6 months;or h. Bearing surface wear leading to symptomatic synovitis;or i. Significant limb malalignment post TKA; or 3. Additional staged surgery is needed as part of a multispecialty approach to any one of the conditions listed above. This could include, but is not limited to, the replacement of impregnated antibiotic spacers, additional joint washouts, and the removal or replacement of hardware. Levels of Care AmbulatorySurgicalCenter,OutpatientHospital The following indications are appropriate for ambulatory surgical centers and outpatient hospital level of care: ● Unilateral TKA ● Staged TKA on both knees (request for each knee still needs to meet medical necessity and staggered typically between 30-90 days following the first total knee joint replacement). ● An additional day as an ambulatory or observation level of care might be needed for a safe transition to oral pain medication. 4 InpatientHospital Inpatient hospital level of care for simultaneous bilateral total knee arthroplasty may be considered medically necessary if an ambulatory or outpatient hospital is unable to monitor the member’s needs. Furthermore, each knee must meet medical necessity. The member may also meet inpatient hospital level of care for unilateral or bilateral total knee replacement if ONE of the following are met: ● Non-elective surgery for unilateral or bilateral; or ● For members requesting unilateral or bilateral revision procedures that require an extended stay outside of the ambulatory or outpatient hospital timeframe, or are unable to be discharged and expected to be admitted/transferred to acute or subacute rehab facility (the member must also meet Oscar’s utilization review criteria for the rehabilitation facility); or ● The member requires more prolonged postoperative treatment or management for unilateral or bilateral due to comorbidities which may include ANY of the following: ○ need for parenteral bridging anticoagulation ○ NYHA class III or IV heart failure ○ pulmonary fibrosis ○ pulmonary hypertension ○ history of thromboembolism ○ extensive edema ○ chronic systemic corticosteroid use ○ severely reduced renal function ○ Poorly controlled type 1 diabetes ○ recent history of falls ○ Significant dementia ○ BMI > 40 ○ Age > 70 and an additional comorbidity as listed in this section ○ Significant movement abnormalities (eg, stroke, Parkinson disease, dependent functional status); or ● For a member to meet inpatient level of care for pain management after TKA surgery, the member must meet the criteria in MCG Pain Management GRG (PG-PM) criteria for unilateral or bilateral; or ● An inpatient admission for a unilateral or bilateral request may be considered medically necessary when the member meets MCG Ambulatory Surgery Exception Criteria (CG-AEC). ExtensionRequests The Plan considers extension requests for inpatient level of care medically necessary when the member continues to meet extension criteria in MCG Knee Arthroplasty, Total for milestones of recovery, clinical status is improving during IP stay, and is not ready to be transitioned to an alternative or lower level of care. Extension requests should be based on medical records of progress. 5 Experimental or Investigational / Not Medically Necessary The Plan considers the following conditions as contraindications: ● Generalized infection, active illness under medical management ● Active infection in the knee, unless surgery is for revision for TKA ● Active wound or skin infection at the planned knee joint for surgery ● The member has not reached skeletal maturity ● Allergy to components of the implant The following indications are considered not medically necessary: ● Customized total or partial knee implant ● Progressive neurologic disease affecting lower extremity and extensor mechanism ● Chronic lower extremity ischemia or vascular insufficiency severe enough to compromise recovery ● Anemia has not been investigated and managed ● Joint instability that has not been managed prior to TKA The following indications are considered experimental/investigational/unproven: ● UniSpacer interpositional spacer ● Persona IQ Smart Knee Implant (Zimmer Biomet) for Total Knee Arthroplasty