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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 04/14/2005 Title: Cartilage Transplants of Lower Extremity
Revision Date: 10/01/2018 Document: BI101:00
CPT Code(s): J7330; S2112; 27412; 27415-27416; 29866-29868
Public Statement

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1.       Cartilage transplant procedures of the knee require preauthorization, and are covered only in specific settings. Use of the Carticel or MACI product (autologous cultured chondrocytes), per FDA guidelines, is restricted to only those physicians who have completed Vericel’s Surgeon Training Program—validated by Vericel (http://carticel.com/office-locations-map ).

2.       Cartilage transplant procedures of other joints of the lower extremity are considered experimental and are not covered.


Medical Statement

1)    All cartilage transplant procedures require preauthorization.

2)    QualChoice considers allograft transplant of the knee (anterior cruciate ligament, osteochondral and meniscus) medically necessary when the following criteria are met:

a)    Anterior Cruciate Ligament (ACL):

i)     Members with ACL deficiency who are not candidates for autogenous transplantation (e.g., individuals whose autogenous tissues have been compromised by previous surgery, previous injury), or

ii)    Members with pathology such as chronic patellar tendonitis, and hamstring injury, or

iii)   Members with any other contra-indications to using their own tissue such as collagen disease or generalized ligamentous laxity.

b)    Osteochondral:

i)     Treatment of an isolated, traumatic injury that is full-thickness depth (grade 4, down to and/or including the bone) lesion, preferably surrounded by normal, healthy (non-arthritic) cartilage. The opposing articular surface should be generally free of disease or injury; or

ii)    Non-repairable stage 3 or 4 osteochondritis dissecans; or

iii)   Avascular necrosis lesions of the femoral condyle; or

iv)   Otherwise healthy, active members who have either failed earlier arthroscopic procedures or are not candidates for such procedures because of the size, shape, or location of the lesion.

c)    Meniscus:

i)     Members under the age of 45, and

ii)    Pre-operative studies (MRI or previous arthroscopy) reveal absence or near-absence of the meniscus, and

iii)   Degenerative changes must be absent or minimal, and

iv)   Knee must be stable (i.e., intact or reconstructed ACL).

3)    QualChoice considers autologous osteochondral Mosaicplasty (cartilage transfer from a non-weight bearing area) of the knee to be medically necessary for members who have a full thickness cartilage defect of a weight bearing area who meet all of the following criteria:

a)    Skeletally mature (age>15) and under the age of 50, AND

b)    Minimal underlying degenerative changes, AND

c)    BMI ≤30, AND

d)    The defect causes symptoms that significantly interfere with the member’s activities of daily living, AND

e)    EITHER

i)     Focal chondral defect between 1.0 and 3.0 sq. cm. in size OR

ii)    Osteochondritis dissecans defect between 1.0 and 5.0 sq. cm. in size

4)    QualChoice considers autologous chondrocyte implantation (e.g., Carticel®, MACI®)  of the knee to be medically necessary for members who have a single or (for MACI) multiple full thickness cartilage defect of the weight bearing surface of the femoral condyle, patella or trochlea, caused by acute or repetitive trauma who meet all the following criteria:

a)    Skeletally mature (age>15) under the age of 55, AND

b)    Minimal underlying degenerative changes, AND

c)    A stable knee with intact or reconstructed ligaments (ACL or PCL)

d)    Normal joint alignment OR plans for ensuring normal joint alignment through concurrent procedures such as tibial tubercle osteotomy.

e)    Normal joint space

f)     Absence of osteoarthritis or generalized tibial chondromalacia

g)    Normal articular cartilage at the lesion border (contained lesion)

h)   The defect causes symptoms that significantly interfere with the member’s activities of daily living, AND

i)     The defect is at least 1.5 to 10 sq. cm. in size, AND

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

k)    Previous surgical repair has failed

l)     BMI is less than 35

m)  Appropriate glycemic control with Hba1c of 8mg/dl or less, in members with diabetes.

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

Codes Used In This BI:

J7330     Autologous cultured chondrocytes, implant

S2112    Arthroscopy, knee, surgical, for harvesting of cartilage (chondrocytes)

27412    Autologous Chondrocyte Implantation, knee

27415    Ostrochondral Allograft, knee, open;

27416    Ostrochondral Auto graft, knee, open; (e.g., Mosaicplasty)

29866    Arthroscopy, Knee, Surgical; Osteochondral auto graft(s)

29867    Arthroscopy, knee, surgical; Osteochondral allograft;

29868    Arthroscopy, knee, surgical; meniscal transplantation, medial or lateral


Limits

1)    QualChoice considers Autologous chondrocyte implantation (e.g., Carticel®, MACI®) Experimental and Investigational because the effectiveness of autologous chondrocyte implants for these lesions has not been established including:

A.        alar lesions, or lesions of other joints (e.g., hip and shoulder);   or

B.        Individuals who have had a previous total meniscectomy; or

C.        Individuals with a cartilaginous defect associated with osteoarthritis, rheumatoid arthritis or inflammatory diseases or where an osteoarthritic or inflammatory process significantly and adversely affects the quality of the peri- lesional cartilage; or

D.        Individuals with known history of anaphylaxis to gentamicin or sensitivities to materials of bovine or porcine origin; or

E.        Individuals with osteochondritis dissecans (OCD) lesions; or

F.         Initial or first line of surgical therapy.

2)    When approved, only one MACI implant will be approved per surgical intervention.  Each MACI implant is 3 x 5 cm and repair of multiple defects (up to the 10 sq. cm. max.) can be performed using a single 15 sq.cm. MACI implant.

3)    QualChoice considers osteochondral allograft of talus experimental and investigational because there are unanswered questions regarding the clinical outcomes of this approach when compared with ankle arthrodesis, especially in terms of pain, disability, function and durability.

4)    QualChoice considers cartilage transplants of lower extremity joints in any other circumstance to be experimental and investigational.


Background

Allograft transplantation of knee defects (osteochondral, meniscal, and ACL) in patients without significant arthritic change is generally accepted practice.

The treatment of articular hyaline cartilage defects is an unsettled field, with multiple approaches advocated. Micro fracture surgery created tiny fractures in the underlying bone to encourage the formation of new cartilage. Mosaicplasty is a technique that consists of removing small osteochondral cylinders from low weight-bearing surfaces of the affected joint and inserting them into the affected area to create a mosaic of islands of hyaline cartilage in an area that would otherwise be filled with only fibrocartilage.  Autologous chondrocyte transplantation creates a graft from a patient’s own cartilage cells, previously harvested and expanded in vitro, to repair defects. 

Most studies of these techniques are observational, and provide little solid evidence of outcomes. Comparative trials, where they exist at all, are small and have limited term follow up. Trials comparing surgical approaches to conservative management are especially rare. Per Hayes June 2018 review: There was insufficient published evidence to assess the safety and/or impact of the MACI implant on health outcomes or management in patients requiring articular cartilage repair.

Surgical techniques are most likely to be successful in the treatment of isolated cartilage defects in patients with no underlying osteoarthritis.


Reference

1.    Bakay A, Csonge L, Papp G, et al. Osteochondral resurfacing of the knee joint with allograft. Clinical analysis of 33 cases. Int Orthop. 1998; 22(5):277-281.

2.    Chu CR, Convery FR, Akeson WH, et al. Articular cartilage transplantation. Clinical results in the knee. Clin Orthop. 1999; 360:159-168.

3.    Peterson RK, Shelton WR, Bomboy AL. Allograft versus auto graft patellar tendon anterior cruciate ligament reconstruction: A 5-year follow-up. Arthroscopy. 2001; 17(1):9-13.

4.    Allum RL. BASK Instructional Lecture 1: Graft selection in anterior cruciate ligament reconstruction. Knee. 2001; 8(1):69-72.

5.    Felix NA, Paulos LE. Current status of meniscal transplantation. Knee. 2003; 10(1):13-17.

6.    Washington State Department of Labor and Industries, Office of the Medical Director. Meniscal allograft. Health Technology Assessment. Olympia, WA: Washington State Department of Labor and Industries; revised October 22, 2002. Available at: http://www.lni.wa.gov/ClaimsIns/Files/OMD/AciUpdate.pdf.

7.    Gross AE, Agnidis Z, Hutchison CR. Osteochondral defects of the talus treated with fresh Osteochondral allograft transplantation. Foot Ankle Int. 2001; 22(5):385-391.

8.    Hayes DW Jr., Averett RK. Articular cartilage transplantation. Current and future limitations and solutions. Clin Podiatr Med Surg. 2001; 18(1):161-176.

9.    Tasto JP, Ostrander R, Bugbee W, Brage M. The diagnosis and management of Osteochondral lesions of the talus: Osteochondral allograft update. Arthroscopy. 2003; 19 Suppl 1:138-141.

10. Bentley G, et al.  A prospective, randomized comparison of autologous chondrocyte implantation versus Mosaicplasty for Osteochondral defects in the knee.  J Bone joint Surg Br.  2003; 85(2):223-230.

11. Dozin B, et al.  Comparative evaluation of autologous chondrocyte implantation and Mosaicplasty: a multicentered randomized clinical trial.  Clin J Sport Med. 2005; 15(4):220-226.

12. Gudas R, et al.  Osteochondral autologous transplantation versus micro fracture for the treatment of articular cartilage defects in the knee joint in athletes.  Knee Surg Sports Traumatol Arthroscopy. 2006; 14(9):834-342.

13. Hayes Medical Technology Directory.  Mosaicplasty Publication date April 13, 2012, accessed 7 July 2014.

14.   Horas U, et al.  Autologous chondrocyte implantation and Osteochondral cylinder transplantation in cartilage repair of the knee joint.  A prospective, comparative trial.  J Bone Joint Surg Am. 2003; 85-A (2):185-192.

15. Knutsen G, et al.  A randomized trial comparing autologous chondrocyte implantation with micro fracture. Findings at five years.  J Bone Joint Surg Am. 2007; 89(10):2105-2112.

16. Hayes Medical Technology Directory.  Autologous chondrocyte implantation of the knee.  Published June 2018MCG Health, Ambulatory Care 22nd edition. ACG A-0415(AC)


Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.


Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.