Medical Policy

Subject: Total Joint Replacement (Hip and Knee) for Medicare Medical Policy #: 20.13 Original Effective Date: 07/22/2020 Status: New Policy Last Review Date: N/A

Disclaimer

Refer to the member’s specific benefit plan and Schedule of Benefits to determine coverage. This may not be a benefit on all plans or the plan may have broader or more limited benefits than those listed in this Medical Policy.

Description

Lower Extremity Major Joint Replacement or Arthroplasty refers to the replacement of the hip or knee joint. The goal of total hip or knee replacement surgery is to relieve pain and improve or increase functional activity of the member.

The surgical treatment (arthroplasty) is the replacement of the damaged joint with a prosthesis. The chief reasons for joint arthroplasty (total joint replacement) are osteoarthritis, rheumatoid arthritis, traumatic arthritis (result of a fracture), osteonecrosis, malignancy, and revisions of previous surgery. Treatment options include physical therapy, analgesics or anti- inflammatory medications. The aim is to improve functional status and relieve pain. Arthroplasty failures are caused by trauma, chronic progressive joint disease, prosthetic loosening and infection of the prosthetic joint

Coverage Determination

Prior Authorization is required for 27130, 27132, 27134, 27447, 27486, and 27487. Logon to Pres Online to submit a request: https://ds.phs.org/preslogin/index.jsp PHP follows LCD (L36007) for Lower Extremity Major Joint Replacement for both Hip and Knee for Medicare members Note: In addition to the below items (for both knee or hip) further documentation requirements are listed in the documentation Requirement section below. Content: I. TOTAL KNEE REPLACEMENT II. KNEE REVISION or REPEAT procedure III. TOTAL HIP ARTHROPLASTY (THA) IV. HIP REVISION or REPEAT procedure

I. TOTAL KNEE REPLACEMENT The most common reason for total knee arthroplasty is arthritis of the knee joint. Types of arthritis include osteoarthritis, rheumatoid arthritis and traumatic arthritis (arthritis which occurs as a result of injury). Note: The following does not apply for unicompartmental knee replacement surgery. In the instance that the patient is undergoing a bilateral knee replacement, the criteria listed below would apply to the surgery of both knees when indicated. PHP will consider Total Knee Arthroplasty (TKA) medically reasonable and necessary when three or more of the following criteria are met: A. Radiographic evidence: Advanced joint disease validated by radiographic or magnetic resonance imaging (MRI), e.g., fracture or deterioration, distortion of joint surfaces, subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, narrowing, avascular necrosis; B. Unsuccessful therapy: Medical record shows unsuccessful conservative therapy clearly documented in the pre- procedure visits. 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

Not every Presbyterian health plan contains the same benefits. Please refer to the member’s specific benefit plan and Schedule of Benefits to determine coverage [MPMPPC051001] 1

includes one or more of the following: anti-inflammatory medications; analgesics; flexibility and muscle strengthening exercises with supervised physical therapy. C. Impaired ambulation continues: Pain with functional disability due to arthritis or trauma to the knee joint; activities of daily living (ADLs) are diminished despite compliance with plan of care including activity restrictions as is reasonable, assistive device use, weight reduction as appropriate or therapeutic injections into the knee as appropriate; D. Distinct structural abnormalities such as: • Distal femur fracture; • Proximal tibia fracture; • Malignancy of the distal femur, proximal tibia, knee joint or adjacent soft tissues; • Avascular or other form of osteonecrosis of the knee; • Rheumatologic changes precluding or inconsistent with rehabilitation

E. Revision or repeat procedure: Failed previous joint replacement/arthroplasty necessitating revision as indicated by any of the following: • Loosening, fracture, or mechanical failure of one or more components; • Technical or functional failure of previous knee surgery, e.g. unicompartmental knee replacement; • Previous osteotomy or partial arthroplasty; • Infection; • Periprosthetic fracture or bone loss of distal femur, proximal tibia or patella; Implant or knee malalignment; • Bearing surface wear leading to symptomatic synovitis; • Tibiofemoral or extensor mechanism instability; or • Knee stiffness, arthrofibrosis or other destructive conditions that render the knee impaired to the extent to preclude employment or functional activities.

*See below for additional information on revision or repeat procedure.

II. KNEE REVISION or REPEAT procedure Revision or repeat procedure: Failed previous knee arthroplasty necessitating revision as indicated by the following: • Loosening, fracture, or mechanical failure of one or more components; • Technical or functional failure of previous knee surgery, e.g. unicompartmental knee replacement; • Previous osteotomy or partial arthroplasty; • Infection; • Periprosthetic fracture or bone loss of distal femur, proximal tibia or patella; Implant or knee malalignment; • Bearing surface wear leading to symptomatic synovitis; • Tibiofemoral or extensor mechanism instability; or • Knee stiffness, arthrofibrosis or other destructive conditions that render the knee impaired to the extent to preclude employment or functional activities

III. TOTAL HIP ARTHROPLASTY (THA) Total hip arthroplasty 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 indications for hip replacement surgery.

NOTE: In the instance that the patient is undergoing a bilateral hip replacement, the criteria listed below would apply to the surgery of both hips when indicated.

PHP will consider Total Hip Arthroplasty (THA) medically reasonable and necessary when three or more of the following indications are met:

A. Radiographic evidence: 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); B. Impaired ambulation continues: Pain and functional disability from injury due to trauma or arthritis of the joint; activities of daily living (ADLs) are diminished despite completing a plan of care with activity restrictions as is reasonable, assistive device use, appropriate weight reduction, flexibility and muscle strengthening exercises with supervised physical therapy.

Not every Presbyterian health plan contains the same benefits. Please refer to the member’s specific benefit plan and Schedule of Benefits to determine coverage [MPMPPC051001] 2

C. Unsuccessful therapy: Medical record shows unsuccessful conservative therapy clearly documented in the pre- procedure visits. 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 includes one or more of the following: anti-inflammatory medications, analgesics, or therapeutic injections when appropriate, with physical therapy or assist devices. D. Distinct structural abnormalities 1. Malignancy of the joint involving the bones or soft tissues of the pelvis or proximal femur; 2. Avascular necrosis (osteonecrosis of femoral head); 3. Fracture of the femoral neck; Acetabular fracture; 4. Non-union or failure of previous hip fracture surgery; Mal-union of acetabular or proximal femur fracture;

IV. HIP REVISION or REPEAT procedure Failed previous Hip Arthroplasty necessitating revision as indicated by the following: • Loosening, fracture or mechanical failure of the implant; • Instability of one or more components; • Recurrent or irreducible dislocation; • Infection; • Displaced periprosthetic fracture; • Clinically significant leg length inequality; • Progressive soft tissue or bone reaction or substantial bone loss, • Clinically significant audible noise; or • Bearing surface wear leading to symptomatic synovitis • Other disease or destructive process that renders the hip impaired to the extent to preclude employment or functional activities

Limitations The following are considered not reasonable and necessary:

1. 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 • Progressive neurological disease, etiologic for pain, instability or disability

2. Unicompartmental Knee Replacement:

For knee joint replacement surgery specific to unicompartmental (damage confined to one compartment) knee replacement done for patients with osteoarthritis of the knee; the coverage outlined in this policy do not apply to unicompartmental knee replacement surgery

Documentation Requirements Note: The medical records should contain enough detailed information to support the determination that major joint replacement surgery was reasonable and necessary for the patient. Progress notes consisting of only conclusive statements should be avoided. See MLN # SE1236 for Documenting Medical Necessity for Major Joint Replacement (Hip an d Knee).

When the procedure is indicated for advanced joint disease, in addition to the above items, all the following shall be documented in the Medical Record. 1. Radiology: X-ray or MRI must support arthritis of the knee or hip. The X-ray or MRI must show one of the following: subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis or bone on bone articulations. 2. Impairment: Pain with functional disability at the hip or knee. For example, documented (specify) pain that interferes with ADLs (functional disability), or pain that is increased with initiation of activities or pain that increases with weight bearing, or pain precluding sleep. Description of the pain such as onset, duration, character, aggravating, and relieving factors. 3. Unsuccessful Therapy: The documentation should demonstrate a history of a reasonable attempt (typically 3 months or more) at conservative therapy as appropriate for the patient in the current episode of care. For example, documented trial of NSAIDs or contraindication to such therapy and documented supervised physical therapy. 4. Medical records support that ADLs are diminished due to pain or disability despite non-surgical medical management. 5. Other condition or co-morbidities: 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.

Not every Presbyterian health plan contains the same benefits. Please refer to the member’s specific benefit plan and Schedule of Benefits to determine coverage [MPMPPC051001] 3

When the procedure is indicated for other than advanced joint disease, the medical record documentation should include the following when specified:

1. Supporting evidence (e.g., pathology reports and referral from an Oncologist for a malignancy of the joint or X-ray of a fracture). 2. Hip or Knee Pain when indicated as a reason for the procedure (revision or replacement TKA/THA) should document the functional disability, e.g., pain that interferes with ADLs, that is increased with initiation of activities or pain that restricts weight bearing, impairs sleep and precludes that activity. 3. 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. 4. When infection is the reason for revision TKA or THA surgery, laboratory or pathology reports must be in the medical record. All documentation regarding treatment of the infection and a physician note indicating that it is appropriate to proceed with surgery, should be in the medical record as well

Coding

The coding listed in this medical policy is for reference only. Covered and non-covered codes are within this list.

CPT Codes Total Hip Arthroplasty 27130 Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft 27132 Conversion of previous hip surgery to total hip arthroplasty, with or without autograft or allograft 27134 Revision of total hip arthroplasty; both components, with or without autograft or allograft 27137 Revision of total hip arthroplasty; acetabular component only, with or without autograft or allograft 27138 Revision of total hip arthroplasty; femoral component only, with or without allograft

CPT Codes Total Knee Arthroplasty 27445 Arthroplasty, knee, hinge prosthesis (e.g., Walldius type) 27447 Arthroplasty, knee, condyle and plateau; medial AND lateral compartment with or without patella resurfacing (total knee arthroplasty) 27486 Revision of total knee arthroplasty, with or without allograft; 1 component 27487 Revision of total knee arthroplasty, with or without allograft; femoral and entire tibial component

ICD-10 CM See LCA A56796 for current list of Diagnosis Codes Note: There are over 1300 diagnosis that support the above listed procedure codes. Access Lower Extremity Major Joint Replacement (HIP and Knee) (A56796) for covered diagnoses.

Reviewed by / Approval Signatures

Clinical Quality & Utilization Mgmt. Committee: Howard Epstein MD Senior Medical Director: Norman White MD Date Approved: 07/22/2020

References

Not every Presbyterian health plan contains the same benefits. Please refer to the member’s specific benefit plan and Schedule of Benefits to determine coverage [MPMPPC051001] 4

1. CMS, Novitas Solutions, LCD (L36007), Lower Extremity Major Joint Replacement (Hip and Knee), Revision Seven, R10, revision date: 11-14-2019. [Cited 05-05-2020] 2. CMS, Local Coverage Article, Billing and Coding: Lower Extremity Major Joint Replacement, (Hip and Knee) (A56796), Effective: 11/14/2019, R1. [Cited 05/05/2020]. 3. American Academy of Orthopaedic Surgeons (AAOS). Treatment of osteoarthritis of the knee; evidence-based guideline. 2nd Ed. May 18, 2013. Available at: http://www.aaos.org/research/guidelines/TreatmentofOsteoarthritisoftheKneeGuideline.pdf 4. American Academy of Orthopaedic Surgeons, The Impact of Obesity on Total Joint Arthroplasty, Publication Date 06/01/2013. Accessed 10/25/2018. 5. American Academy of Orthopaedic Surgeons, Tobacco Use and Orthopaedic Surgery, February 2016. [Cited 09/03/2019] 6. AAOS, copyright 2012, The Musculoskeletal Effects of Perioperative Smoking, Jun 2012, vol 20, No6, page 359. [Cited 05/26/2020] 7. OrthoInfo, Copyright 1995-2020 by the American Academy of Orthopaedic Surgeons, Obesity, Weight Loss, and Joint Replacement Surgery, Last Reviewed July 2015. [Cited 05/26/2020] 8. CMS, IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 12, Section 40 – Surgeons and Global Surgery [Cited 06/15/2020] 9. MLN Matters Number: SE1236 Documenting Medical Necessity of Major Joint Replacement (Hip and Knees) www.cms.gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/SE1236.pdf. 10. MLN Booklet Major Joint Replacement (Hip or Knee) ICN 909065 May 2017. www.cms.gov/Outreach-and- Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/jointreplacement-ICN909065.pdf.

Publication History

07-22-20 New policy: Reviewed by PHP Medical Policy Committee on 06/30/20. New policy specific to Medicare. Prior authorization will apply to this policy for Total Hip Arthroplasty 27130, 27132, 27134; & Total Knee Arthroplasty 27447, 27486, and 27487.

This Medical Policy is intended to represent clinical guidelines describing medical appropriateness and is developed to assist Presbyterian Health Plan and Presbyterian Insurance Company, Inc. (Presbyterian) Health Services staff and Presbyterian medical directors in determination of coverage. The Medical Policy is not a treatment guide and should not be used as such. For those instances where a member does not meet the criteria described in these guidelines, additional information supporting medical necessity is welcome and may be utilized by the medical director in reviewing the case. Please note that all Presbyterian Medical Policies are available online at: Click here for Medical Policies

Web links: At any time during your visit to this policy and find the source material web links has been updated, retired or superseded, PHP is not responsible for the continued viability of websites listed in this policy.

When PHP follows a particular guideline such as LCDs, NCDs, MCG, NCCN etc., for the purposes of determining coverage; it is expected providers maintain or have access to appropriate documentation when requested to support coverage. See the References section to view the source materials used to develop this resource document.

Not every Presbyterian health plan contains the same benefits. Please refer to the member’s specific benefit plan and Schedule of Benefits to determine coverage [MPMPPC051001] 5