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.

Autologous Chondrocyte Implantation (ACI) (a.k.a. Autologous Chondrocyte Transplantation

(ACT)) is a surgical technique which utilizes an individual’s own cells in an effort to repair damage to articular cartilage with the goal of improving joint function and reducing pain. The procedure involves the collection and culture of articular cartilage cells (i.e., chondrocytes) that are then implanted into the cartilage defect with the intent that the cultured cells will contribute to the regeneration and repair of the articular surface.

Mosaicplasty (or osteochondral cylinder transplantation) is a surgical technique which consists of

harvesting cylindrical bone-cartilage grafts and transplanting them into focal chondral or osteochondral defects in the knee. After excision of the chondral lesion, an abrasion arthroplasty is performed to refresh the base of the defect. The grafting procedure involves collecting grafts from the posterior aspect of the distal femoral articular surfaces (medial condyle, lateral condyle or trochlea) and implanting the grafts in a mosaic-like pattern that will contribute to regeneration and repair the articular surface. A recipient tunnel is created and sized with a drill bit slightly larger than the length of the graft. The harvested graft is placed in the tunnel by a press-fit method. All subsequent grafts are inserted in a similar pattern.

The Osteochondral Allograft Transplantation (OATS Procedure) is similar to mosaicplasty, involving the use of a larger, single plug that usually fills an entire defect. It is often performed to graft chondral defects that are also associated with anterior cruciate ligament (ACL) tears. This method allows arthroscopic access to both the ACL and the chondral defect for the performance of a repair and the grafting procedure.

Subchondral Drilling or Microfracturing is a surgical procedure which is performed after the calcified cartilage is debrided and the surgeon creates tiny fractures in the adjacent bones (through the use of an awl). Blood and bone marrow (which contains stem cells) seep out of the fractures, creating a blood clot that releases cartilage-building cells. The microfractures are treated as an injury by the body, which is why the surgery results in new, replacement cartilage. Studies have shown that microfracturing techniques don’t fill the chondral defect fully and the repair material they form is fibrocartilage. Fibrocartilage is not as good mechanically as the original hyaline cartilage; it is much denser and isn’t able to withstand the demands of everyday activities as well as hyaline cartilage and is; therefore, a higher risk of breaking down. The procedure is less effective in treating older individuals, overweight individuals, or in larger cartilage lesions. Furthermore, chances are high that after only one or two years, symptoms start to return as the fibrocartilage wears away, forcing the individual to reengage in articular cartilage repair. This is not always the case and microfracture surgery is; therefore, considered to be an intermediate step.

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: ice, relative rest/activity modification, acupuncture, manual therapy, physiotherapy modalities, supervised therapeutic exercises, oral medications, bracing, and/or injections (steroid and/or viscosupplementation).

KT 1000 Arthrometer (used as an option to the Lachman test) was developed to provide objective measurement of the sagittal plane motions of the tibia relative to the femur. This motion, sometimes referred to as drawer motion, occurs when an examiner applies force to the lower limb or when the muscles of the quadriceps are contracted. The accuracy of the Lachman test is as good as the instrument evaluation if the end point is taken into consideration. Both measurements can help to improve the quality of the clinical examination if the examiners are inexperienced. Nevertheless, instrument measurements of anterior knee laxity are not necessary if a thorough clinical examination is performed, taking the end point of the Lachman test into considerations.

A knee arthroscopic or open procedure may be considered medically necessary in an individual in

whom surgery is being performed for fracture, tumor, infection or foreign body that has led to or

will likely lead to progressive destruction.

Diagnostic Arthroscopy

Diagnostic Arthroscopy may be considered medically necessary when ALL of the following criteria have been met:

·         Severe, disabling mechanical 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 for at least (six) 6 months in duration; and

·         All of the following criteria:

o    Failure of non-surgical management for at least three (3) months in duration; and

o    MRI is inconclusive for internal derangement/pathology; and

o    Any ONE of the following:

§  Limited range of motion; or

§  Evidence of joint swelling/effusion; or

§  Joint line tenderness.

Diagnostic Arthroscopy is considered not medically necessary when physical examination fails to document ALL of the following:

·         Limited range of motion; and

·         Evidence of ligamentous instability; and

·         Evidence of meniscal involvement; and

·         Evidence of joint swelling/effusion; and

·         Joint tenderness; and

·         MRI evaluation fails to demonstrate internal derangement/pathology.

Arthroscopic Lavage

Arthroscopic lavage, with and without chondroplasty, (debridement) may be considered medically necessary when ALL of the following criteria have been met:

·         Individual has 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

·         MRI demonstrates articular cartilage degeneration and ANY one of the following conditions:

o    Loose bodies within the joint; or

o    Unstable flaps of articular cartilage; or

o    Frank meniscal tear in conjunction with articular cartilage degeneration; or

o    Impinging osteophytes, which would be reasonably expected to result in mechanical symptoms and loss of knee joint function; and

·         Individual reports pain and ANY one of the following subjective complaints:

o    Knee range of motion is “blocked” due to pain; or

o    Giving way weakness/buckling of the knee; or

o    Painful locking, clicking or popping during weight bearing activities; and

·         Failure of non-surgical management for at least three (3) months in duration.

Arthroscopic lavage with or without chondroplasty is considered not medically necessary for osteoarthritis of the knee unless the above listed criteria are met.

Meniscectomy

Meniscectomy (partial or total) or meniscal repair may be considered medically necessary when ALL of the following criteria have been met:

·         Severe, disabling pain and a documented loss of knee function which interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment; and

·         MRI demonstrates a frank meniscal tear (not simply degenerative changes, i.e., fraying) that correlates with the individual’s reported symptoms and physical exam findings; and

·         Pain and at least ONE (1) of the following subjective complaints:

o    Knee range of motion is “blocked” due to pain; or

o    Giving way weakness/buckling of the knee; or

o    Painful locking, clicking or popping during weight bearing activities; and

·         Two (2) or more of the following on physical examination:

o    Limited range of motion; or

o    Evidence of joint swelling/effusion; or

o    Joint line tenderness; or

o    Positive McMurray test (or other equivalent tests for meniscal pathology); and

·         With the exception of the individual who experiences an acute meniscal tear with associated disabling pain and loss of function, failure of non-surgical management for at least three (3) months in duration.

Meniscal debridement may be considered medically necessary when performed in conjunction with other medically necessary arthroscopic procedures on the knee (e.g., anterior cruciate reconstruction).

Meniscectomy (partial or total) or meniscal repair is considered not medically necessary for any other indication.

Autologous Chondrocyte Implantation (Transplantation cartilage restoration procedures)

Autologous chondrocyte implantation may be considered medically necessary for the treatment of symptomatic cartilaginous defects of the distal femoral articular surface (i.e., medial condyle, lateral condyle or trochlea) caused by acute or repetitive trauma when ALL of the following criteria have been met:

·         Severe, disabling pain and a loss of knee function which interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment; and

·         A distal femoral articular surface (i.e., medial condyle, lateral condyle or trochlea) defect of one to ten (1-10) cm² in size has been identified during arthroscopy or during an MRI which is classified by the Modified Outerbridge Scale as Grade III or Grade IV or symptomatic, full- thickness articular cartilage lesions of the trochlea; and

·         Failure of non-surgical management for at least three (3) months in duration; and

·         Presence of ALL of the following on physical examination:

o    A stable knee with intact or reconstructed ligaments (ACL or PCL); and

o    Normal joint alignment; and

o    Normal joint space; and

·         Absence of osteoarthritis or generalized tibial chondromalacia; and

·         Normal articular cartilage at the lesion border (contained lesion); and

·         Absence of a corresponding tibial or patellar lesion (“kissing lesion”) with a Modified OuterbridgeScale of Grade III or Grade IV; and

·         Body Mass Index (BMI) 35 or less; and

·         Age 15 - 55 years; and

·         Individual must be capable and willing to participate in a supervised post-operative physical rehabilitation program.

Meniscal Allograft Transplantation

Meniscal allograft transplantation may be considered medically necessary when ALL of the following criteria have been met:

·         Severe, disabling pain and a loss of knee function which interferes with the ability to carry outage appropriate activities of daily living and/or demands or employment; and

·         Prior significant trauma resulting in a irreparable meniscal tear or has undergone a meniscectomy where at least one-half of the meniscus has been removed; and

·         MRI demonstrates articular cartilage degeneration in the affected compartment classified by the Modified Outerbridge Scale as Grade I or Grade II; and

·         Failure of non-surgical management for at least three (3) months in duration; and

·         Presence of ALL of the following on physical examination:

o    A stable knee with intact or reconstructed ligaments (ACL or PCL); and

o    Normal joint alignment; and

o    Normal joint space; and

·         Two (2) or more of the following:

o    Individual is not considered an appropriate candidate for total knee arthroplasty; or

o    Body Mass Index (BMI) 35 or less; or

o    Age 49 years or younger; or

o    Individual must be capable and willing to participate in a post-operative supervised physical rehabilitation program; or

o    Any one of the following:

§  Limited range of motion; or

§  Evidence of joint swelling/effusion; or

§  Joint line tenderness.

Meniscal allograft transplantation may be considered not medically necessary for any other indication

including, but not limited, to the following:

·         Upon standing radiographs, individual demonstrates osteoarthritic change in the knee and demonstrates joint space narrowing, osteophytes, or changes in the underlying bone

·         Upon MRI, individual demonstrates articular degeneration in affected compartment which is classified by Modified Outerbridge Scale as Grade III or IV.

Osteochondral Allograft/Autograft Transplantation Systems (OATS) /Mosaicplasty

Osteochondral allograft/autograft transplantation/mosaicplasty may be considered medically necessary when ALL of the following criteria have been met:

·         Severe, disabling pain and a loss of knee function which interferes with the ability to carry outage appropriate activities of daily living and/or demands of employment; and

·         Large, full-thickness chondral defect of the distal femoral articular surface (i.e., medial condyle, lateral condyle or trochlea), which has been identified during arthroscopy or during an MRI, classified by Modified Outerbridge Scale as Grade III or Grade IV; and

·         Osteochondral autograft transplants and mosaicplasty may be considered medically necessary in an individual with small (i.e., ≤ 2.5 cm² total) chondral defects with sharp, definite borders surrounded by normal-appearing hyaline cartilage; and

·         Osteochondral allograft transplants may be considered medically necessary an individual with larger (i.e., ≤ 10.0 cm² total) chondral defects with sharp definite borders surrounded by normal appearing hyaline cartilage; and

·         Previous arthroscopic or other traditional surgical procedure (i.e., microfracture, drilling, abrasion, osteochondral graft) which has resulted in an inadequate response; and

·         Failure of non-surgical management for at least three (3) months in duration; and

·         ALL of the following on physical examination:

o    stable knee with intact or reconstructed ligaments (ACL or PCL); and

o    Normal joint alignment; and

o    Normal joint space; and

·         Absence of osteoarthritis or generalized tibial chondromalacia, steroid-induced cartilage or bone disease, with normal articular cartilage at the lesion border; and

·         Absence of a corresponding tibial or patella lesion (“kissing lesion”) with a Modified Outerbridge Scale of Grade III or Grade IV; and

·         Individual is not a candidate for total knee arthroplasty; and

·         Body Mass Index (BMI) of less than 35; and

·         Age 49 years or younger; and

·         Individual must be capable and willing to participate in an extensive period of non-weight bearing and supervised post-operative physical rehabilitation program.

Anterior Cruciate Ligament Reconstruction

Allograft Knee Ligament Reconstruction - Knee ligament reconstruction (i.e., anterior cruciate) using

allograft tissue may be considered medically necessary for the treatment of ligament injury (e.g., rupture,

laxity) when ANY of the following conditions is met:

·         Previous reconstruction has failed and requires revision; or

·         Surgical reconstruction requires the use of multiple ligament transfers; or

·         Individual has a medical condition (e.g., anatomic anomaly, prior knee injury or prior knee surgery) that precludes the use of autograft tissue.

Knee ligament reconstruction (i.e., anterior cruciate) using allograft tissue for any other indication

not listed above is considered not medically necessary.

Anterior cruciate ligament reconstruction with allograft (see above for allograft specific criteria) or autograft may be considered medically necessary when ALL the following criteria have been met:

·         Severe, disabling pain and a documented loss of knee function which interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment; and

·         Knee instability which is noted as “giving way weakness”, or “buckling”; and

·         MRI, Arthroscopy, or Arthrogram demonstrates a tear/disruption or significant laxity of the anterior cruciate ligament; and

·         Positive Lachman’s Test; and

·         ANY of the following abnormal physical examination findings:

o    Positive Anterior Drawer Test; or

o     Positive Pivot Shift Test; or

o    Positive KT arthrometer (greater than three and a half [3.5] mm equals plus one [1], greater than five [5] to seven [7] mm equals plus two [2], greater than seven [7] mm equals plus three [3]); or

·         Failure of non-surgical management for at least three (3) months in duration.

Anterior cruciate ligament reconstruction with allograft (see above for allograft specific criteria) or autograft may be considered medically necessary in an acute injury setting where hemathrosis, effusion,

and joint instability have been documented. This may include ANY of the following:

·         A confirmed ACL tear and a repairable meniscus tear; or

·         Need to return to high demand activities that require cutting, pivoting, and/or agility activities in which ACL insufficiency may predispose to further instability episodes, that may result in new articular or meniscal cartilage injuries; or

·         Concomitant ligament injuries (i.e., multiligamentous knee injury) that require reconstruction to provide stability.

Posterior Cruciate Ligament Reconstruction

Allograft Knee Ligament Reconstruction - Knee ligament reconstruction (i.e., posterior cruciate) using allograft tissue may be considered medically necessary for the treatment of ligament injury (e.g., rupture, laxity) when ANY of the following conditions is met:

·         Previous reconstruction has failed and requires revision; or

·         Surgical reconstruction requires the use of multiple ligament transfers; or

·         Individual has a medical condition (e.g., anatomic anomaly, prior knee injury or prior knee surgery) that precludes the use of autograft tissue.

Knee ligament reconstruction (i.e., posterior cruciate) using allograft tissue for any other indication not listed above is considered not medically necessary.

Posterior cruciate ligament reconstruction with allograft (see above for allograft specific criteria) or

autograft may be considered medically necessary when ALL the following criteria have been met:

·         Severe, disabling pain and a documented loss of knee function to an extent which interferes with the ability to carry out the age appropriate activities of daily living and/or demands of employment; and

·         Individual has undergone an MRI or Arthroscopy or Arthrogram which demonstrates a tear/disruption or significant laxity of the posterior cruciate ligament; and

·         Individual demonstrates Positive Posterior Drawer Sign and/or positive Tibial Drop Back Test and/or Quadriceps Active Test either of the following abnormal physical examination findings:

o    Eight (8) millimeters or more of increased posterior translation on stress radiographs; or

o    Positive KT-1000 arthrometer (greater than 7.6 mm of increased posterior translation); and

·         Failure of non-surgical care for at least three (3) months in duration; and

·         Posterior cruciate ligament reconstruction with allograft (see above for allograft specific criteria) or autograft may be considered medically necessary in an acute injury setting where hemathrosis, effusion and joint instability have been documented. This may include instances where there are concomitant ligament injuries (i.e., multiligamentous knee) that require reconstruction.

Medial Collateral/Lateral Collateral Ligament Repair/Reconstruction

Allograft Knee Ligament Reconstruction - Knee ligament reconstruction (i.e., medial collateral, lateral collateral) using allograft tissue may be considered medically necessary for the treatment of ligament injury (e.g., rupture, laxity) when ANY of the following conditions is met:

·         Previous reconstruction has failed and requires revision; or

·         Surgical reconstruction requires the use of multiple ligament transfers; or

·         Individual has a medical condition (e.g., anatomic anomaly, prior knee injury or prior knee surgery) that precludes the use of autograft tissue.

Knee ligament reconstruction (i.e., medial collateral, lateral collateral) using allograft tissue for any

other indication not listed above is considered not medically necessary.

Medial collateral/lateral collateral ligament repair with allograft (see above for allograft specific

criteria) or autograft may be considered medically necessary when ALL of the following criteria have

been met:

·         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

·         Individual reports knee instability which is noted as “giving way weakness” or “buckling”; and

·         MRI or other diagnostic study demonstrates a tear/disruption of the medial or lateral collateral ligament; and

·         Positive Valgus Stress Test (Medial), or Varus Stress Test (Lateral); and

·         Failure of non-surgical management for at least six (6) weeks duration.

Medial collateral or lateral collateral ligament repair/reconstruction with allograft or autograft may be considered medically necessary in an acute injury setting where total disruption of the ligament (i.e., multi-ligamentous knee injury) is documented on MRI examination and effusion and joint instability

have been documented on physical examination.

Patella Tendon Re-Alignment (Lateral Retinacular Release, Elmslie-Trillat-Maquet, Fulkerson

Procedures)

Patella Tendon re-Alignment procedure(s) may be considered medically necessary when ALL of the following criteria have been met:

·         Severe anterior knee 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

·         Confirmed osteochondral defect of the patellofemoral joint (X-ray, CT scan, MRI or previous arthroscopic procedure); and

·         Failure of non-surgical management for at least three (3) months.

Patella Tendon re-Alignment procedure(s) as a treatment of recurrent patellar instability may be considered medically necessary when ALL of the following criteria have been met:

·         Recurrent patellar instability interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment; and

·         Positive Patellar Apprehension Test on examination; and

·         Increased Q angle of greater than 15 degrees or elevated TT-TG (tibial tubercle trochlear groove) distance; and

·         Failure of non-surgical management for at least three (3) months; and

·         Lateral retinacular release when the individual presents with an acute patellar dislocation with associated intra- articular fracture.

Subchondral Drilling or Microfracturing

Subchondral drilling or microfracturing may be considered medically necessary when ALL of the

following criteria have been met:

·         Severe, disabling pain and a loss of knee function interferes with the ability to carry out age

appropriate activities of daily living and/or demands of employment; and

·         Large, full-thickness distal femoral articular (medial condyle, lateral condyle or trochlea)

cartilage defect on the weight-bearing surface which has been identified during arthroscopy or during an MRI which is classified by the Modified Outerbridge Scale as Grade III or IV provided the lesion is less than or equal to cm ² total; and

·         All of the following physical examination findings:

o    Stable knee with intact ligaments and menisci; and

o    Normal joint alignment; and

o    Normal joint space; and

·         Failure of non-surgical management for at least three (3) months.

High Tibial Osteotomy

High tibial osteotomy may be considered medically necessary when ALL of the following criteria

have been met:

·         Severe, disabling pain and a loss of knee function interferes with the ability to carry out age appropriate activities of daily living and/or demands of employment; and

·         Unicompartmental osteoarthritis of the knee; and

·         All of the following on physical examination:

o    Less than 15 degrees of fixed varus deformity; and

o    The individual must be capable of at least 90 degrees of flexion; and

o    Joint stability in full extension; and

o     Intact anterior cruciate ligament (ACL); and

·         Failure of non-surgical management for at least three (3) months in duration; and

·         Individual must be capable and willing to participate in a period of non-weight bearing and a

post-operative physical rehabilitation program; and

·         Age 60 years or less; and

·         Individual is not a candidate for a knee arthroplasty.

High tibial osteotomy is considered not medically necessary for ANY of the following conditions:

·         Inflammatory arthritide (i.e., rheumatoid arthritis); or

·         Chondrocalcinosis; or

·         Anterior cruciate ligament tear; or

·         Involvement of more than 1/3 of the condylar surface; or

·         Osteochondral defect lesion of more than five (5) mm deep.