HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
S-261-001
Topic:
Knee Arthroplasty Total and Partial
Section:
Surgery
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
April 2018
Annual Review:
April 2018
 
 

Knee arthroplasty is a surgical procedure, which attempts to reconstruct or replace a malformed or degenerated knee joint with internal hardware. Total knee arthroplasty (TKA) involves surgical reconstruction or replacement of the entire knee joint as a result of bicompartmental or tricompartmental involvement. Partial knee arthroplasty involves surgical reconstruction or replacement of one joint surface of the knee joint as a result of unicompartmental involvement. Total or partial knee revision involves surgical reconstruction or replacement due to failure or complications of previous knee arthroplasty.

The Modified Outerbridge Classification is a system that has been developed for judging articular cartilage injury to the knee. This system allows delineation of varying areas of chondral pathology, based on the qualitative appearance of the cartilage surface, and can assist in identifying those injuries that are suitable for repair techniques. The characterization of cartilage in this system is as follows:

  • Grade I - Softening with swelling
  • Grade II - Fragmentation and fissuring less than one square centimeter (1 cm2)
  • Grade III - Fragmentation and fissuring greater than one square centimeter (1 cm2)
  • Grade IV - Subchondral bone exposed.

The Kellgren-Lawrence Grading System is a radiographic grading system that has been developed for describing osteoarthritic changes to the knee. When used, the radiographic findings are typically reported within one of the following categories:

  • Grade I – Doubtful narrowing of joint space and possible osteophytic lipping
  • Grade II – Definite osteophytes and possible narrowing of joint space
  • Grade III – Moderate multiple osteophytes, definite narrowing of joint space, some sclerosis, and possible deformity of bone contour
  • Grade IV – Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone contour.

Non-surgical care, with regard to the treatment of the knee, is defined as any non- surgical treatment, which has been demonstrated in the scientific literature as efficacious and/or is considered a standard of care in the treatment of knee pain. The types of treatment involved can include, but are not limited to: relative rest/activity modification, physiotherapy modalities, supervised therapeutic exercise, oral medications, bracing, and/or injections (steroid and/or viscosupplementation).

The UniSpacer is a small, kidney shaped insert made of cobalt chrome for patients with early stage osteoarthritis of the knee.The UniSpacer is said to treat isolated, moderate degeneration of the medial compartment (Grade III-IV chondromalacia) with no more than minimal degeneration (Grade I-II chondromalacia; no loss of joint space) in the lateral condyle or patellofemoral compartment. The proposed goals of UniSpacer surgery are to relieve pain and to improve joint stability by restoring ligament tension and normal knee alignment.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Partial Knee Arthroplasty

Partial (unicompartmental) knee arthroplasty may be considered medically necessary when ALL of the following criteria have been met:

·         Chronic, severe, disabling pain for at least six (6) months in duration; and

·         Loss of knee function which interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment; and

·         Unicompartmental degenerative arthritis (Kellgren- Lawrence Grade IV) with joint space narrowing on weight-bearing radiographs or Modified Outerbridge Classification Grade IV changes documented by arthroscopy; and

·         Intact, stable ligaments, in particular the a nterior cruciate ligament; and

·         Knee arc of motion (full extension to full flexion) greater than 90º; and

·         Failure of non-surgical management.

Partial (unicompartmental) knee arthroplasty is considered not medically necessary when ANY of the following criteria is present:

·         Severe Grade III or IV patellofemoral joint arthritis (when unicompartmental arthroplasty to be performed is medial or lateral); or

·         Prior high tibial osteotomy; or

·         Tibial or femoral shaft deformity; or

·          Radiographic evidence of medial or lateral subluxation; or

·         Flexion contracture greater than 15º; or

·         Varus deformity greater than 15º or a valgus deformity greater than 20º; or

·         Inflammatory arthropathy; or

·         Active local or systemic infection; or

·         Severe loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb, rendering the procedure unjustifiable; or

·          Osteoporosis or other osseous abnormalities which would make the likelihood of a poor outcome more probable; or

·         Severe lack of collateral ligament integrity leading to joint instability.

Bicompartmental knee arthroplasty and bi-unicompartmental knee arthroplasty as an alternative for total knee replacement is considered experimental/investigational and therefore non-covered as the safety and efficacy cannot be established by the available published peer reviewed literature.

Total Knee Arthroplasty

Total Knee Arthroplasty (Replacement) may be considered medically necessary when ALL of the following criteria have been met:

·         Chronic severe, disabling pain for at least 6 months in duration; and

·         Loss of knee function which interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment; and

·         Presence of bicompartmental or tricompartmental degenerative arthritis (Kellgren-Lawrence Grade IV) with joint space narrowing on weight-baring radiographs or Modified Outerbridge Classification Grade IV change documented by arthroscopy; and

·         Knee motion of greater than 50o; ; and

·         Failure of non-surgical management.

Total Knee Arthroplasty (Replacement) is considered not medically necessary when ANY of the following criteria are present:

·         Active local or systemic infection; or

·         Severe loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb, rendering the procedure unjustifiable; or

·         Osteoporosis or other osseous abnormalities which would make the likelihood of a poor outcome more probable; or

·         Joint instability due to a lack of collateral ligament integrity; or

·         Greater than 30 degrees of fixed varus or valgus deformity.

Total Knee Revision 

Total Knee Revision may be considered medically necessary for an individual who has previously undergone a partial or total knee arthroplasty when ALL of the following criteria have been met:

·         Chronic severe, disabling pain; and

·         Loss of knee function which interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment; and

·         Presence of ANY of the following:

o    Fracture or dislocation of the patella; or

o     Instability of the components; or

o    Aseptic loosening; or

o     Infection; or

o     Periprosthetic fracture; or

o     Unexplained pain for greater than six (6) months unresponsive to non- surgical management.

Total Knee Revision is considered not medically necessary when ANY of the following criteria is present:

·         Persistent infection

·         Poor bone quality

·         Limited quadriceps or extensor function

·         Poor skin coverage

·         Poor vascular status.

UniSpacer

Use of the UniSpacer device is considered experimental/investigational and therefore non-covered as the safety and efficacy cannot be established by the available published peer reviewed literature.

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Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.



The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

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