Lower Extremity Major Joint Replacement (Hip and Knee)

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for lower extremity major joint replacement (hip and knee). Federal statute and subsequent Medicare regulations are lengthy and they are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for lower extremity major joint replacement (hip and knee) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

IOM Citations:

• CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 12, Section 40 – Surgeons and Global Surgery
• CMS IOM Publication 100-08, Program Integrity Manual
  • Chapter 3, Section 3.3.2.4 – Signature Requirements
  • 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 Provisions in an LCD

Other:

• 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
• 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

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). This section states that no payment shall be made to any provider for any claims that lack the necessary information to process the claim.

Federal Register References:

• Title 21 Code of Federal Regulations (CFR), Chapter I, Subchapter H, Part 888 - Orthopedic Devices

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

For the purpose of this LCD, 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 beneficiary.

Joint replacement, referred to as arthroplasty, has been performed with short and long term favorable outcome over the past several decades and has proven to be an important medical advancement in the field of orthopedic surgery. The hip and knee are the two 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 three 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 move and function smoothly. The hip is a large weight bearing joint made up of two 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 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). This arthritis causes a severe limitation in the activities of daily living, including impaired ambulation, squatting, and climbing stairs. Pain is typically most severe with activity and patients often have difficulty mobilizing from a sitting position. Other findings include signs of chronic knee inflammation, swelling and stiffness not relieved by rest, non-steroidal anti-inflammatories, physical therapy or other non-surgical therapies such as intra articular injections.

Osteonecrosis and malignancy are additional reasons to proceed with arthroplasty or total joint replacement.

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. The pain from the damaged joint limits activities of daily living, such as walking, or causes disruption of sleep. Pain relief not achieved by taking non-steroidal anti-inflammatory medications and failure to achieve symptom improvement with other conservative therapies such as physical therapy, activity modification and assistive devices are reasons for proceeding with hip arthroplasty or replacement.

Circumstances that lead to revision or repeat procedure of a total hip or total knee arthroplasty can be necessary due to continued disabling pain or continued decline in function attributed to failure of the primary joint procedure. 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. In revisional surgery it is important to provide replacement of the components of the previous surgery responsible for the failure. If either component of the joint remains viable and without infection or deterioration, it is expected that only those failed components will be replaced without injury to the indwelling viable components, e.g., the acetabulum is well seated and without deterioration, only the femoral component should be revised or replaced with a similar matching component. Unavailability of components of a previous arthroplasty requiring the replacement of both components, or failure due to the design of the original components should be clearly documented in the medical record.

Covered Indications

This LCD is only addressing medical necessity criteria for performing total hip and knee replacement 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 confined to one compartment of the knee. The indications outlined in this LCD are not to be applied for unicompartmental knee replacement surgery.

See Documentation Requirements section for additional information.

Medicare will consider Total Knee Arthroplasty (TKA) medically reasonable and necessary when three or more of the following criteria are met:

1. Advanced joint disease demonstrated by radiographic supported evidence or magnetic resonance imaging (MRI), e.g., fracture or deterioration, distortion of joint surfaces, subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis;
2. History of unsuccessful appropriate conservative therapy that is clearly documented 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 includes one or more of the following: anti-inflammatory medications; analgesics; flexibility and muscle strengthening exercises with supervised physical therapy.
3. 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;
4. 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
5. 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.

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

1. 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);
2. 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.
3. History of unsuccessful conservative treatment or non-surgical medical management that is clearly documented 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 includes one or more of the following: anti-inflammatory medications, analgesics, or therapeutic injections when appropriate, with physical therapy or assist devices.
4. Distinct structural abnormalities
   • 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;
   • Non-union or failure of previous hip fracture surgery; Mal-union of acetabular or proximal femur fracture;
5. 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 and therefore will be denied:

1. TKA and THA will not be considered reasonable and necessary when the above indications are not met.
2. Medicare will consider a total knee replacement or total hip replacement not medically reasonable and necessary 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

Provider Qualifications

Services will be considered medically reasonable and necessary only if performed by appropriately trained providers. This training and expertise must have been acquired within the framework of an accredited residency or fellowship program in the applicable specialty/subspecialty or must reflect extensive continued medical education activities. If these skills have been acquired by way of continued medical education, the courses must be comprehensive, offered or sponsored or endorsed by an academic institution in the United States or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as Category 1 Credit. It is expected that these services would be performed as indicated by current medical literature or standards of practice by appropriately trained medical physicians (MD or DO) certified or eligible for certification by the American Board of Orthopaedic Surgery.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Refer to Billing and Coding: Lower Extremity Major Joint Replacement (Hip and Knee), A56796, for applicable CPT/HCPCS codes and diagnosis codes.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

N/A

N/A

Refer to the Local Coverage Article: Billing and Coding: Lower Extremity Major Joint Replacement (Hip and Knee), A56796, for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The medical record documentation must support the medical necessity of the services as directed in this policy.
4. In order to qualify for coverage of both Medicare Part A and Part B services, the medical record must contain documentation that fully supports the medical necessity of the procedure/service performed and must be made available to the Contractor upon request. (Please see below for additional information regarding specific documentation requirements)
5. Documentation must support CMS 'signature requirements' as described in the Medicare Program Integrity Manual (Pub. 100-08), Chapter 3.
6. When reviewing claims for procedures with DRGs, please refer to the CMS online Manual, Pub 100-08, Chapter 6, Section, 6.5.2.

Additional Documentation Requirements Specific to Joint Arthroplasty:

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.

Any major procedure has significant benefit and risk (injury or death) that the treating physician discusses with the patient. To meet Medicare’s reasonable and necessary threshold for coverage of a procedure, the physician’s documentation for the case should clearly support (1) the diagnostic criteria for the indication (standard test results, when appropriate, and clinical findings) (2) that the procedure does not exceed the medical need, (3) is at least as beneficial as existing alternatives, and (4) the procedure is furnished within 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, both the hospital (facility) and physician services claims may be denied.

When the procedure is indicated for advanced joint disease, in addition to the above items, all of the following shall be documented in the Medical Record.

1. Arthritis of the knee or hip supported by X-ray or MRI. The X-ray or MRI must demonstrate one of the following: subchondral cysts, subchondral sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, avascular necrosis or bone on bone articulations.
2. Pain with 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, or pain precluding sleep.
3. 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. Documentation should support that ADLs are diminished due to pain or disability despite non-surgical medical management.
5. 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 the procedure is for indications outlined in the LCD, other than advanced joint disease, the medical record documentation should include the following, when indicated:

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.

The Hospital Record for the procedures in this LCD must include the following:

1. A history and physical describing the present issue, the duration of the issue, current signs and symptoms, and any comorbidities;
2. Physician progress notes to include physical examination demonstrating any presence of deformity range of motion abnormalities, crepitus, effusion, tenderness, or gait abnormalities;
3. An operative report;
4. Any other relevant information addressing coverage criteria related to the patients episode of care prior to the hospitalization; and
5. Discharge summary;

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 THA or TKA bilaterally.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

When services are performed in excess of peer norm based on data analysis they may be subject to prepay or post pay medical review.

The devices/implants utilized 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 outlined in CFR 21, Chapter 1, subchapter H, Part 888 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=888)

Contractor is not responsible for the continued viability of websites listed.

Other Medicare Contractor's Local Coverage Determinations

Care Allies medical necessity guidelines: Knee arthroplasty, number 0347.

Cigna medical coverage policy: Knee arthroplasty/replacement, number 0347.

Cigna medical coverage policy: Total hip replacement with metal-on-metal and ceramic-on-ceramic prosthesis, number 0214.

Consultations with the representatives to the Carrier Advisory Committee and other Medicare Contractors.

Contractor Medical Directors

Original JH/JL ICD-9 Source LCD L35594, Lower Extremity Major Joint Replacement (Hip and Knee)

1. Ackerman, IN, Bennell, KL, and 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. Aetna Clinical Policy Bulletin: Total hip implants, number 0287.
3. Agency for Healthcare Research and Quality (AHRQ). Evidence Report/Technology Assessment: Number 86. Total Knee Replacement. Retrieved from https://www.ahrq.gov/clinical/epcsums/kneesum.htm
4. Agency for Healthcare Research and Quality (AHRQ). Evidence Report/Technology Assessment: Number 86. Total Knee Replacement. December 2003. Available at http://archive.ahrq.gov/clinic/epcsums/kneesum.htm
5. American Academy of Orthopaedic Surgeons (AAOS). Treatment of Osteoarthritis of the Knee (Non-Arthroplasty): Full Guideline. 2008: December 6.
6. AAOS – OrthoInfo: Joint Replacement; Accessed at http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd =1&cad=rja&uact=8&ved=0CDQQFjAA&url=http%3A% 2F%2Forthoinfo.aaos.org%2Fmenus%2Farthroplasty.cfm&ei= W8y3VNmUNIKZNv2JgIAK&usg= AFQjCNHLbaf3duXF0Hm4NkFjXqFJozHUMw.
7. American Academy of Orthopaedic Surgeons (AAOS) and the American Association of Hip and Knee Surgeons (AAHKS). Model Coverage Determination: Total Joint Arthroplasty. Available at http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm =1&source=web&cd=1&cad=rja&uact=8&ved= 0CB4QFjAA&url=http%3A%2F%2Fwww.aaos.org%2Fnews%2Faaosnow% 2Foct12%2Fadvocacy6.asp&ei=Qc23VNu_KIGjgwSg3IGoDA&usg= AFQjCNFeIwWZEf_jDYTMP2UQdsWW2HTA3w.
8. Dennis, DA, Berry, DJ, Engh, G, Fehring, T, MacDonald, SJ, Rosenberg, AG, Scuderi, G. AAOS Symposium: Revision Total Knee Arthroplasty. Journal of the American Academy of Orthopaedic Surgeons. 2008: 16:442-454.
9. 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. 2012: July; 18: 406-416.
10. InterQual® 2012.2 Procedures Adult Criteria: Total Joint Replacement (TJR), Hip; Removal and Replacement, Total Joint Replacement (TJR), Hip; Total Joint Replacement (TJR), Knee; Removal and Replacement, Total Joint Replacement (TJR), Knee. McKesson Corporation.
11. 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
12. Milliman Care Guidelines® 2011. Inpatient and Surgical Care 15th Edition. Knee Arthroplasty and Hip Arthroplasty. Milliman Care Guidelines LLC.
13. National Guideline Clearinghouse. Osteoarthritis. The care and management of osteoarthritis in adults. Retrieved from https://www.guideline.gov
14. O’Connor, MI. Implant Survival, Knee Function and Pain Relief After TKA. Are There Differences Between Men and Women? Clinical Orthopaedics and Related Research. 2011: 469(7);1846-1851.
15. U.S. National Library of Medicine, National Institute of Health. Hip joint replacement. Retrieved from https://www.nlm.nih.gov/medlineplus/ency/article/002975.htm
16. https://www.orthoinfo.aaos.org.