Printer Friendly Version
Printer Friendly Version
Printer Friendly Version
A.7.01.48
A variety of procedures are being developed to resurface articular cartilage defects. Autologous chondrocyte implantation involves harvesting chondrocytes from healthy tissue, expanding the cells in vitro, and implanting the expanded cells into the chondral defect. Second- and third-generation techniques include combinations of autologous chondrocytes, scaffolds, and growth factors.
Articular Cartilage Lesions
Damaged articular cartilage typically fails to heal on its own and can be associated with pain, loss of function, and disability, and may lead to debilitating osteoarthritis over time. These manifestations can severely impair a patient's activities of daily living and adversely affect quality of life.
Treatment
Conventional treatment options include debridement, subchondral drilling, microfracture, and abrasion arthroplasty. Debridement involves the removal of synovial membrane, osteophytes, loose articular debris, and diseased cartilage, and it is capable of producing symptomatic relief. Subchondral drilling, microfracture, and abrasion arthroplasty attempt to restore the articular surface by inducing the growth of fibrocartilage into the chondral defect. Compared with the original hyaline cartilage, fibrocartilage has less capability to withstand shock or shearing force and can degenerate over time, often resulting in the return of clinical symptoms. Osteochondral grafts and autologous chondrocyte implantation attempt to regenerate hyaline-like cartilage and thereby restore durable function. Osteochondral grafts for the treatment of articular cartilage defects are discussed in the Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions medical policy.
With autologous chondrocyte implantation, a region of healthy articular cartilage is identified and biopsied through arthroscopy. The tissue is sent to a facility licensed by the U.S. Food and Drug Administration (FDA) where it is minced and enzymatically digested, and the chondrocytes are separated by filtration. The isolated chondrocytes are cultured for 11 to 21 days to expand the cell population, tested, and then shipped back for implantation. With the patient under general anesthesia, an arthrotomy is performed, and the chondral lesion is excised up to the normal surrounding cartilage. Methods to improve the first-generation autologous chondrocyte implantation procedure have been developed, including the use of a scaffold or matrix-induced autologous chondrocyte implantation (MACI) composed of biocompatible carbohydrates, protein polymers, or synthetics. The only FDA-approved MACI product to date is supplied in a sheet, which is cut to size and fixed with fibrin glue. The amount of MACI implanted depends on the size and shape of the cartilage defect; multiple implants can be used if there is more than one defect. This procedure is considered technically easier and less time consuming than the first-generation technique, which required suturing of a periosteal or collagen patch and injection of chondrocytes under the patch.
Desired features of articular cartilage repair procedures are the ability 1) to be implanted easily, 2) to reduce surgical morbidity, 3) not to require harvesting of other tissues, 4) to enhance cell proliferation and maturation, 5) to maintain the phenotype, and 6) to integrate with the surrounding articular tissue. In addition to the potential to improve the formation and distribution of hyaline cartilage, use of a scaffold with MACI eliminates the need for harvesting and suture of a periosteal or collagen patch. A scaffold without cells may also support chondrocyte growth.
The culturing of chondrocytes is considered by the U.S. Food and Drug Administration (FDA) to fall into the category of manipulated autologous structural cells, which are subject to a biologic licensing requirement. In 1997, Carticel® (Genzyme; now Vericel) received the FDA approval for the repair of clinically significant, "...symptomatic cartilaginous defects of the femoral condyle (medial-lateral or trochlear) caused by acute or repetitive trauma.…"
In December 2016, MACI® (Vericel) received FDA approval for “the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.” MACI consists of autologous chondrocytes that are cultured onto a bioresorbable porcine-derived collagen membrane. In 2017, production of Carticel was phased out, and MACI is the only autologous chondrocyte implantation product available in the United States.
A number of other second-generation methods for implanting autologous chondrocytes in a biodegradable matrix are currently in development or testing or are available outside the United States. They include Atelocollagen (Koken), a collagen gel; Bioseed® C (BioTissue Technologies), a polymer scaffold; CaReS (Ars Arthro), collagen gel; Cartilix (Biomet), a polymer hydrogel; Chondron (Sewon Cellontech), a fibrin gel; Hyalograft C (Fidia Advanced Polymers), a hyaluronic acid-based scaffold; NeoCart (Histogenics), an autologous chondrocyte implantation with a 3-dimensional chondromatrix in a phase 3 trial; and Novocart®3D (Aesculap Biologics), a collagen-chondroitin sulfate scaffold in a phase 3 trial. ChondroCelect® (TiGenix), characterized as a chondrocyte implantation with a completed phase 3 trial, uses a gene marker profile to determine in vivo cartilage-forming potential and thereby optimizes the phenotype (eg, hyaline cartilage vs fibrocartilage) of the tissue produced with each autologous chondrocyte implantation cell batch. Each batch of chondrocytes is graded based on the quantitative gene expression of a selection of positive and negative markers for hyaline cartilage formation. Both Hyalograft C and ChondroCelect have been withdrawn from the market in Europe. In 2020, the FDA granted breakthrough status to Agili-C™ (CartiHeal, Ltd.), a proprietary cell-free biocompatible and biodegradable tapered-shape implant for the treatment of cartilage lesions in arthritic and non-arthritic joints that, when implanted into a pre-prepared osteochondral hole, acts as a 3-dimensional scaffold that potentially supports and promotes the regeneration of the articular cartilage and its underlying subchondral bone. Agili-C was FDA-approved in 2021 for treatment of knee-joint surface lesions with a treatable area of 1 to 7 cm2 without severe osteoarthritis.
Also, see the related medical policies, Continuous Passive Motion in the Home Setting and Meniscal Allografts and Other Meniscal Implants .
Autologous chondrocyte implantation may be considered medically necessary for the treatment of disabling full-thickness articular cartilage defects of the knee caused by acute or repetitive trauma, when all of the following criteria are met:
Autologous chondrocyte implantation for all other joints, including the talar, and any indications other than those listed above is considered investigational.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
For smaller lesions (e.g., smaller than 4 cm²), if debridement is the only prior surgical treatment, then consideration should be given to marrow-stimulating techniques before autologous chondrocyte implantation is performed.
The average defect size reported in the literature is about 5 cm²; many studies treated lesions as large as 15 cm².
Severe obesity (e.g., body mass index greater than 35 kg/m²) may affect outcomes due to the increased stress on weight-bearing surfaces of the joint.
Misalignment and instability of the joint are contraindications. Therefore, additional procedures, such as repair of ligaments or tendons or creation of an osteotomy for realignment of the joint, may be performed at the same time. In addition, meniscal allograft transplantation may be performed in combination, either concurrently or sequentially, with autologous chondrocyte implantation. The charges for the culturing component of the procedure are submitted as part of the hospital bill.
The entire matrix-induced autologous chondrocyte implantation procedure consists of 4 steps: (1) the initial arthroscopy and biopsy of normal cartilage, (2) culturing of chondrocytes on an absorbable collagen matrix, (3) a separate arthrotomy to place the implant, and (4) post-surgical rehabilitation. The initial arthroscopy may be scheduled as a diagnostic procedure; as part of this procedure, a cartilage defect may be identified, prompting biopsy of normal cartilage in anticipation of a possible chondrocyte transplant. The biopsied material is then sent for culturing and returned to the hospital when the implantation procedure (i.e., arthrotomy) is scheduled.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
4/1997: Approved by Medical Policy Advisory Committee (MPAC).
7/1998: FEP exception added effective January 1, 1998.
10/17/2000: TEC source added.
2/2001: Reviewed by MPAC; Mosaicplasty considered investigational, HCPCS J7330 added.
5/2001: Reviewed by MPAC; Mosaicplasty separated from ACT policy, investigational status maintained.
10/4/2001: Clarification of policy exceptions; Document # 00-07IHR takes precedence over Blue Cross Blue Shield Association policy # 7.01.48.
2/11/2002: Investigational definition added.
4/18/2002: Type of Service and Place of Service deleted.
1/17/2003: Policy reviewed; no changes based on Hayes report.
4/11/2003: Sources updated.
4/25/2003: Code Reference section updated, CPT code 27599 added.
8/8/2003: CPT code ranges 27330-27335, 27403, 29870-29887 listed separately, ICD-9 diagnosis code ranges 715-715.99, 717-719.99 listed separately, ICD-9 diagnosis code 715.99 is not a valid code and has been deleted.
7/15/2004: Reviewed by MPAC, remains investigational, Description and Policy Guidelines section aligned with BCBSA policy # 7.01.48, Sources updated.
10/5/2004: Code Reference section updated, CPT code 20999, 27330-27335, 27403, 29870-29887 deleted, CPT code 29999 added, ICD-9 procedure code 81.47 added, ICD-9 diagnosis code 715.00-715.98, 717.0-719.99, 732.7, 959.7 deleted, HCPCS S2113, S2113 added.
3/22/2005: Code Reference section updated, CPT code 27412 with effective date of 1/1/2005 added, CPT code 27599, 29999 Note: "To report services on and after 1/1/2005, see CPT code 27412" added, ICD-9 procedure code 80.16, 80.26 Note: "To report services on and after 1/1/2005, see ICD-9 procedure code 81.47" added, HCPCS S2113 deletion date of 12/31/2004 and Note: "See CPT code 27412" added.
3/22/2005: Code Reference section updated, CPT code 27412 with effective date of 1/1/2005 added, CPT code 27599, 29999 Note: "To report services on and after 1/1/2005, see CPT code 27412" added, ICD-9 procedure code 80.16, 80.26 Note: "To report services on and after 1/1/2005, see ICD-9 procedure code 81.47" added, HCPCS S2113 deletion date of 12/31/2004 and Note: "See CPT code 27412" added.
12/13/2006: Policy reviewed, no changes.
12/12/2007: Code reference section updated per the 2008 CPT/HCPCS revisions.
1/14/2008: Policy reviewed, no changes.
12/5/2008: Policy reviewed, policy statement re-written with medically necessary criteria.
12/18/2008: Code reference section updated, covered table added.
11/11/2009: Policy reviewed, no changes.
04/20/2010: Policy title changed from “Autologous Chondrocyte Transplantation” to “Autologous Chondrocyte Implantation and Other Cell-based Treatments of Focal Articular Cartilage Lesions.” Policy description and guidelines updated extensively due to this expansion. Two policy statements were added regarding the implantation of autologous minced cartilage, allogeneic minced cartilage, or allogeneic cartilage cells; these procedures are investigational. FEP verbiage added to the Policy Exceptions section. Outdated references deleted from the Sources section.
08/23/2011: Deleted "Absence of meniscal pathology" as a coverage criteria from the first policy statement.
07/17/2012: Policy reviewed; no changes.
11/15/2013: Deleted "Other Cell-based Treatments" from the policy statement. Policy statements regarding minced cartilage were moved to the Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions medical policy. Deleted outdated FEP statement from the Policy Exceptions section.
09/15/2014: Policy reviewed; no changes.
08/21/2015: Code Reference section updated to add ICD-10 codes and to remove ICD-9 procedure codes 80.16 and 80.26. Moved CPT code 28446 to the Investigational Codes table.
02/17/2016: Policy description updated regarding second-generation methods for implanting autologous chondrocytes. Autologous chondrocyte implantation of the patella changed from investigational to medically necessary. Medically necessary statement updated to remove the need for a prior surgical procedure. It previously stated: Autologous chondrocyte implantation may be considered medically necessary for the treatment of disabling full thickness articular cartilage defects of the knee caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior surgical procedure, when all of the following criteria are met. Policy guidelines updated regarding meniscal allograft transplantation. Added medically necessary and investigative definitions.
05/31/2016: Policy number A.7.01.48 added.
07/06/2017: Policy description updated regarding matrix-induced autologous chondrocyte implantation products. Removed the following policy statement: Matrix-induced autologous chondrocyte implantation is considered investigational. Policy Guidelines updated regarding four steps of matrix-induced autologous chondrocyte implantation.
01/19/2018: Medically necessary policy statement criteria updated to change "weight-bearing surface of the femoral condyles or trochlea" to "weight-bearing surface of the femoral condyles, trochlea, or patella."
05/03/2018: Policy description updated regarding methods for implanting autologous chondrocytes. Policy statements unchanged.
05/13/2019: Policy reviewed; no changes.
05/20/2020: Policy reviewed; no changes.
07/16/2021: Policy description updated regarding implants. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."
06/01/2022: Policy reviewed; no changes.
05/12/2023: Policy description updated regarding implants. Policy statements unchanged.
05/20/2024: Policy reviewed. Policy statements updated to change "patients" to "individuals."
05/13/2025: Policy description updated regarding matrix-induced autologous chondrocyte implantation. Policy statements unchanged.
Blue Cross Blue Shield Association policy # 7.01.48
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Code Number | Description | ||
CPT-4 | |||
27412 | Autologous chondrocyte implantation, knee | ||
27599 | Unlisted procedure, femur or knee | ||
29999 | Unlisted procedure, arthroscopy | ||
HCPCS | |||
J7330 | Autologous cultured chondrocytes, implant | ||
S2112 | Arthroscopy, knee, surgical for harvesting of cartilage (chondrocyte cells) | ||
ICD-9 Procedure | ICD-10 Procedure | ||
81.47 | Other repair of knee | 0SUC07Z, 0SUC37Z, 0SUD07Z, 0SUD37Z | Supplement of knee joint (right or left), by approach (open or percutaneous), with autologous tissue supplement |
0SUC47Z | Supplement right knee joint with autologous tissue substitute, percutaneous endoscopic approach | ||
0SUD47Z | Supplement left knee joint with autologous tissue substitute, percutaneous endoscopic approach | ||
ICD-9 Diagnosis | ICD-10 Diagnosis |
Code Number | Description |
CPT-4 | |
28446 | Open osteochondral autograft, talus (includes obtaining graft[s]) |
HCPCS | |
ICD-10 Procedure | |
ICD-10 Diagnosis |
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.