Medical Policy: 07.01.64
Original Effective Date: May 2014
Reviewed: June 2020
Revised: June 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Damage to the cartilage that covers the ends of the knee bones is common, especially in active individuals.. The ability of cartilage to repair itself is very limited. The damage may lead to later osteoarthritis and a need for knee replacements. Attempts to repair the damaged cartilage have mostly used a procedure called microfracture (MF), involving drilling small holes into the bone under the damaged area. A clot of blood then covers the damaged area and over time forms scar tissue called fibrocartilage. In the procedure called autologous chondrocyte implantation (ACI), a small piece of healthy cartilage is removed from the knee, and the cartilage-producing cells (chondrocytes) are cultured in the laboratory until there are many millions of them. They are then used to patch the area of damaged cartilage. The hope is that the chondrocytes will form natural cartilage, which will last longer than fibrocartilage. For smaller lesions consideration should be given to marrow-stimulating techniques before autologous chondrocyte implantation (ACI) is performed. The average defect size reported in the literature is about 5 cm2, and the support of ACI over bone stimulating techniques in smaller lesions is not proven at this time. Smaller defects not affecting the subchondral bone are usually treated with microfracturing while lesions with loss of subchondral bone can be managed with osteochondral transfer (OAT). There is no universally accepted algorithm for treatment of cartilage defects at this time.
ACI (Autologous Chondrocyte Implant): ACI is a two-step procedure. New cartilage cells are grown and then implanted in the cartilage defect.
ACI is most useful for younger patients who have single defects larger than 2 cm in diameter. ACI has the advantage of using the patient's own cells, so there is no danger of a patient rejecting the tissue. It does have the disadvantage of being a two-stage procedure that requires an open incision. It also takes several weeks to complete.
The culturing of chondrocytes is considered by the FDA to fall into the category of manipulated autologous structural (MAS) cells, which are subject to a biologic licensing requirement. In 2017, production of Carticel® was phased out and MACI® is the only ACI product that is available in the United States. In this policy: MACI is used both to refer to third-generation autologous chondrocyte implantation (ACI) and as a trade name (MACI®).
MACI®, (Vericel) autologous cultured chondrocytes on porcine collagen membrane), a product that was FDA approved in December 2016, an alternative to autologous cultured chondrocytes and growth with Carticel. MACI is intended for autologous use and must only be administered to the patient for whom it was manufactured.
Per the manufacturer, and FDA indications for use: The use of MACI® in pediatric patients or patients over 65 years of age has not been established or FDA approved. The use in this approved age group is directly from inclusion in the SUMMIT trial, which was used to gain FDA approval for MACI. The indications for use on product insert states "MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults." The manufacturer plans on studying the pediatric population with further studies. Vericel proposed the following timeline for the completion of the clinical pediatric study: Protocol submission, by June 30, 2017; study initiation, by June 30, 2018; study completion by June 30, 2025; and submission of the final report by December 31, 2025.
A number of second-generation methods for implanting autologous chondrocytes in a biodegradable matrix are currently in development/testing. These include Atelocollagen (collagen gel, Koken), BioCart II (ProChon Biotech, Phase II trial), Bioseed C (polymer scaffold, BioTissue Technologies) CaReS (collagen gel, Ars Arthro), Cartilix (polymer hydrogel, Cartilix), Cartipatch (solid scaffold with an agarose-alginate matrix, TBF Tissue Engineering, Phase III trial), Chondron (fibrin gel, Sewon Cellontech), Hyalograft C (hyaluronic acid-based scaffold, Fidia Advanced Polymers), NeoCart (ACI with a 3-dimensional chondromatrix, Histogenics. Phase III trial), and Novocart (collagen-chondroitin sulfate scaffold, B. Braun-Tetec). ChondroCelect (characterized chondrocyte implantation, TiGenex, Phase III trial completed) uses a gene marker profile to determine in vivo cartilage-forming potential and thereby optimizes the phenotype (e.g., hyaline cartilage vs. fibrocartilage) of the tissue produced with each ACI 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. Although clinical use of these second-generation ACI products has been reported in Europe and Asia, nly MACI is approved for use in the U.S. at this time.
The available evidence reports that ACI for the treatment of clinically significant, focal defects of the femoral condyle is associated with improved health outcomes such as diminished pain and improved joint function over the short term. However, the available evidence is not sufficient to determine if the improvements are caused by the use of autologous chondrocytes or how the outcomes compare to the outcomes achievable simply by use of debridement with rehabilitation.
Practice Guidelines and Position Statements
American Academy of Orthopaedic Surgeons (AAOS)
In a 2010 clinical practice guideline on the diagnosis and treatment of osteochondritis dissecans (OCD), the American Academy of Orthopaedic Surgeons (AAOS) was unable to recommend for or against a specific cartilage repair technique in symptomatic skeletally immature or mature patients with an unsalvageable osteochondritis dissecans lesion.
National Institute for Health and Clinical Excellence (NICE)
NICE issued an updated Technology Appraisal Guidance (2018). The NICE guidance cited the most accurate cost-effectiveness estimate for ACI compared with microfracture is uncertain. The committee published the consensus of surgeons with specialist knowledge of surgical repair techniques for articular chondrocyte defects of the knee. The following recommendations are based on the consensus of specialist.
Autologous chondrocyte implantation (ACI) is recommended as an option for treating symptomatic articular cartilage defects of the knee, only if:
- the person has not had previous surgery to repair articular cartilage defects
- there is minimal osteoarthritic damage to the knee (as assessed by clinicians experienced in investigating knee cartilage damage using a validated measure for knee osteoarthritis)
- the defect is over 2 cm² and
- the procedure is done at a tertiary referral centre.
German Society of Orthopaedics and Trauma
In a 2016 guideline by the working group "Clinical Tissue Regeneration" of the German Society of Orthopaedics and Trauma entitled "Autologous chondrocyte implantation (ACI) for cartilage defects of the Knee" indications for ACI include:
- Defect stage: Full-thickness, symptomatic cartilage defect grades 3 and 4 as per ICRS and osteochondritis dissecans stages III and IV as per ICRS-OCD, possibly in combination with subchondral bone reconstruction
- Defect size: Minimum: 2.5 to 3 cm²; Maximum: no limit
- Defect localization: No limitation: Medial and lateral femoral condyle; Medial and lateral tibial plateau; Patellar bearing surface (trochlea); Patella
- Age: Typically up to about 55 years of age; higher age is however not a contraindication with relevant defect morphology and primarily intact joint conditions. Children and adolescents possible
- Concomitant pathologies which cause it, which cannot be treated in parallel (e.g., misalignment)
- Advanced arthritis
- Subtotal resected meniscus in an impacted compartment
- Rheumatoid arthritis with relevant synovitis
- Hemophilia-associated arthropathy
The British Association for Surgery of the Knee (BASK)
The British Association for Surgery of the Knee (BASK) UK Consensus recommends that all patients being considered for ACI should have had physical therapy first, as that may relieve symptoms.
Emergency Care Research Institute (ECRI Institute)
A recently published evidence report on MACI® (2018) Conclusions: Available evidence is too limited in quantity and quality to determine whether MACI works as well as or better than other ACIs for improving pain and functional status. Larger, blinded randomized controlled trials (RCTs) comparing MACI with microfracture and other ACIs and reporting longer-term outcomes (e.g., quality of life, pain) are needed to assess MACI's comparative safety and effectiveness; however, the only ongoing trial (addressing pediatric patients) will not address the evidence gaps.
A published report on Combined Autologous Chondrocyte Implantation and Osteochondral Autograft for Repairing Osteochondral Knee Defects (2019) found the following conclusions: Evidence from 2 very small case series and 3 case reports at very high risk of bias is insufficient to determine hybrid ACI-OAT’s safety and efficacy. Randomized controlled trials (RCTs) that compare hybrid ACI-OAT to ACI alone and OAT alone, as well as to other cartilage defect treatments, are needed.
The MACI package insert is noted below:
Indications and Usage
- MACI® is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.
Dosage and Administration
- For autologous implantation only.
- The amount of MACI implanted depends on the size (surface area in cm2) of the cartilage defect.
- MACI should be trimmed to the size and shape of the defect and implanted with the cell-side down.
Dosage Forms and Strengths
- Each 3 x 5 cm cellular sheet (MACI implant) consists of autologous cultured chondrocytes on a resorbable porcine Type I/III collagen membrane, at a density of at least 500,000 cells per cm2
- Known history of hypersensitivity to gentamicin, other aminoglycosides,or products of porcine or bovine origin.
- Severe osteoarthritis of the knee.
- Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders.
- Prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant.
- Inability to cooperate with a physician-prescribed post-surgical rehabilitation program.
Warnings and Precautions
- Safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. Expansion of malignant or dysplastic cells present in biopsy tissue during manufacture and subsequent implantation may be possible.
- Because patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases, cartilage biopsy and MACI implant may carry risk of transmitting infectious diseases.
- Local inflammation or active infection in the bone, joint, and surrounding soft tissue, meniscal pathology, cruciate ligament instability, and misalignment should be assessed and treated prior to or concurrent with MACI implantation.
- Final sterility test results are not available at the time of shipping.
The FDA approval was supported by the results of SUMMIT trial (Superiority of MACI implant versus Microfracture Treatment in patients with symptomatic articular cartilage defects in the knee), a Phase 3 two-year, prospective, multicenter, randomized, open-label, parallel-group study that enrolled a total of 144 patients, ages 18 to 54 years, with at least one symptomatic Outerbridge Grade III or IV focal cartilage defect on the medial femoral condyle, lateral femoral condyle, and/or the trochlea co-primary efficacy endpoint was change from baseline to Week 104 for the subject's Knee injury and Osteoarthritis Outcome Score (KOOS) in 2 subscales: Pain and Function (Sports and Recreational Activities [SRA]). At Week 104, KOOS pain and function (SRA) had improved from baseline in both treatment groups, but the improvement was statistically significantly (p<0.001) greater in the MACI group compared with the microfracture group. In a responder analysis, the proportion of subjects with at least a 10-point improvement in both KOOS pain and function (SRA) was greater in the MACI group (63/72 = 87.5%; 95% CI [77.6%, 94.6%]) compared with the microfracture group (49/72 = 68.1%; 95% CI [56.0%, 78.6%]). Patients from the two-year SUMMIT study had the option to enroll in a three-year follow-up study (extension study). A majority of the patients who completed the SUMMIT study also participated in a three-year extension study. The FDA concluded that the overall efficacy data support a long-term clinical benefit from the use of the Maci implant in patients with cartilage defects of the knee. There is a paucity in recent evidence in superiority of autologous chondrocyte implantation versus microfracture or osteochondral transplant. The gaps in data is not being addressed in current clinical trials.
For information on Osteochondral Transplants see policy 07.01.65
In this policy: (*MACI is used both to refer to third-generation autologous chondrocyte implantation (ACI) and as a trade name (MACI®).
Autologous chondrocyte implantation (also referred to as autologous chondrocyte transplant/ACT), or matrix induced chondrocyte implantation (MACI) with the MACI® product, may be considered medically necessary for the treatment of articular cartilage defects of single joints of the femoral condyle (medial, lateral, or trochlear) or patella caused by acute or repetitive trauma, in the following patients:
ALL of the following criteria must first be met:
- Patient is between the ages of 15 and 55 years old (for an adolescent member 15-18 years old, s/he should be skeletally mature with documented closure of growth plates) and
- Presence of disabling pain and/or knee locking which limits activities of daily living and
- Patient has failed to respond to conservative treatment for at least two months (such as physical therapy, braces, ice/heat, injections) and
- No history of hypersensitivity to gentamyacin or products of porcine or bovine origin and
- Body mass index of less than 35 kg/m2 and
- Focal articular cartilage defect down to but not through the subchondral bone (grade III or IV) on a load bearing surface of the femoral condyle (medial, lateral, trochlear) or the patella and
- Size of defect measures area ranging from 2 square cm to 10 square cm and
- Patient should not be considered a candidate for total knee replacement and
- Documented minimal to absent degenerative changes in the surrounding articular cartilage, with normal appearing hyaline cartilage surrounding the border of the defect, and
- Lack of degenerative joint disease (e.g., osteoartritis (OA), rheumatoid arthritis (RA) or inflammatory disease[s]) and
- Current normal knee mechanics and alignment, or plan to concurrently repair during autologous chondrocyte implantation and
- No history of total meniscectomy and
- No prior knee surgery (within 6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant
If ALL of the above criteria are met, the additional surgical considerations are as follows:
As a first line surgical treatment: For surgical repair of the defect greater than 4 cm²
As a second line surgical treatment: Previous inadequate response to arthroscopic or other surgical repair of the defect (microfracture, drilling) for all defects 2 cm2-4 cm2
The use of MACI for individuals less than 18 years of age without closure of growth plates has not been proven, per FDA product indications “The safety and effectiveness of MACI in pediatric patients have not been established”. The use in pediatric individuals will be considered investigational.
Repeat autologous chondrocyte implantation is considered not medically necessary.
If the procedure does not meet all the medical criteria above, the culturing of chondrocytes will not meet medical criteria.
Autologous chondrocyte implantation for treatment of, but not limited to the following conditions/scenarios is considered investigational:
- osteochondral dissecans (OCD) lesion
- inflammatory disease of the joints
- in combination with osteochondral autograft transfer system (OATS, mosaicplasty)
- history of multiple defects or ACI repair
Autologous chondrocyte implants are investigational for talar lesions or lesions of other joints (e.g., hip and shoulder) because the effectiveness of autologous chondrocyte implants for these lesions has not been established or FDA approved.
The use of non-FDA approved second-generation methods for implanting autologous chondrocytes in a biodegradable matrix is investigational for the treatment of osteochondral defects/lesions and all other indications because their effectiveness has not been established. This includes second generation products: ChondroCelect, Novocart, NeoCart, Hyalograft C, Chondron, Cartilix and Bioseed. The main deficiency of the existing evidence is that there are no published controlled studies that compare the outcomes of autologous chondrocyte implant with any other treatments or with the natural progression of the disease. The available studies do report the proportions of patients treated with ACT who achieved various levels of outcomes, but there is no way to determine if those outcomes are better than, the same as, or worse than, the outcomes that would have occurred with other treatments.
The use of autologous chondrocyte implantation and the MACI® (autologous cultured chondrocytes on porcine collagen membrane) procedure as a first line treatment is considered investigational for smaller defects (<4 cm2). Although the studies show promise that the procedures may be more beneficial than microfracture, only short-term outcomes are available, longer term outcomes fail to show superiority of autologous chondrocyte transplant currently. Additional well-designed studies involving larger study populations and long-term follow-up are needed to determine the role of ACI/MACI relative to microfracture or other surgical interventions (microfracture, drilling, osteochondral transplant, allograft transplantation) for the treatment of isolated cartilage defects of the knee in adults. The evidence is considered of very low quality with high or unclear risk of bias.
- Progress report, history, and/or operative notes confirming injury and prior treatments/therapies; AND
- Report(s) documenting normal alignment and stability of the knee and the absence of osteoarthritis (OA) or rheumatoid arthritis (RA); AND
- Report from the knee arthroscopy documenting/showing the presence of the cartilage defect (with measurements obtained during imaging or debridement) and normal cartilage surrounding the defect.
Classifications of Articular Cartilage Lesions by Severity
Softening and swelling
Fragmentation and fissures in area less than 0.5 inch in diameter
Fragmentation and fissures in area larger than 0.5 inch in diameter
Exposed subchondral bone
Modified Classifications of Articular Cartilage Lesions by Severity
|MRI Results||Arthroscopy Results
||focal areas of hyperintensity with normal contour
||cartilabe with softening and swelling
||blister-like swelling/fraying of articular cartilage extending to surface
||fragmentation and fissuring within soft areas of articular cartilage
||partial thickness cartilage loss with focal ulceration
||partial thickness cartilage loss with fibrillation
||full thickness cartilage loss with underlying bone reactive changes
||cartilage destruction with exposed subchondral bone*
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 27412 Autologous chondrocyte implantation, knee
- J7330 Autologus cultured chondrocytes, implant
- S2112 Arthroscopy, knee, surgical, for harvesting of cartilage (chondrocyte cells)
- 27599 Unlisted procedure, femur or knee
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- Pestka JM, Bode G, Salzmann G, et al. Clinical outcome of autologous chondrocyte implantation for failed microfracture treatment of full-thickness cartilage defects of the knee joint. Am J Sports Med. 2012;40(2):325-331.
- Benthien JP, Schwaninger M, Behrens P. We do not have evidence based methods for the treatment of cartilage defects in the knee. Knee Surg Sports Traumatol Arthrosc. 2011;19(4):543-552.
- Zaslav K, Cole B, Brewster R, et al. A prospective study of autologus chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee. Am J Sports Med. 2009;37(1):42-55.
- Wasiak J, Clar C, Villanueva E. Autologous cartilage implantation for full thickness articular cartilage defects of the knee. Cochrane Database Syst Rev. 2006;(3):CD003323.
- BlueCross BlueShield Association (BCBSA), Technology Evaluation Center (TEC). Autologous chondrocyte transplantation of the knee. TEC Assessment Program. Chicago IL: BCBSA; June 2003; 18(2).
- National Institute for Clinical Excellence (NICE). Guidance on the use of autologous cartilage transplantation for full thickness cartilage defects in knee joints. Technology Appraisal Guidance No. 89. London, UK: NICE; 2005, reviewed 2008.
- American Academy of Orthopaedic Surgeons. Clinical practice guideline on the diagnosis and treatment of osteochondritis dissecans 2010.
- ECRI Institute. Osteochondral Autograft Transplantation for the Ankle. Plymouth Meeting (PA): ECRI Institute 2009 October 27. 8 p. [ECRI hotline response].
- Washington State Health Care Authority, Health Technology Assessment Program. Osteochondral allograft transplantation and autograft transfer system (OATS/mosaicplasty). Final Key Questions. Olympia, WA: Washington State Health Care Authority; August 10, 2011.
- Banke IJ, Vogt S, Buchmann S, Imhoff AB. Arthroscopic options for regenerative treatment of cartilage defects in the shoulder. Orthopade. 2011;40(1):85-92.
- Ebert JR, Robertson WB, Woodhouse J, Fallon M, Zheng MH, Ackland T, Wood DJ. Clinical and magnetic resonance imaging-based outcomes to 5 years after matrix-induced autologous chondrocyte implantation to address articular cartilage defects in the knee. Am J Sports Med. 2011 Apr;39(4):753-63.
- Carticel [package insert]. Cambridge, MA: Genzyme; 1997.
- Schmitt LC, Quatman CE, Paterno MV, et al. Functional outcomes after surgical management of articular cartilage lesions in the knee: A systematic literature review to guide postoperative rehabilitation. J Orthop Sports Phys Ther. 2014;44(8):565-A10.
- Solheim E, Hegna J, Inderhaug E, et al. Results at 10-14 years after microfracture treatment of articular cartilage defects in the knee. Knee Surg Sports Traumatol Arthrosc. Nov 23 2014. PMID 25416965
- Montgomery SR, Foster BD, Ngo SS, et al. Trends in the surgical treatment of articular cartilage defects of the knee in the United States. Knee Surg Sports Traumatol Arthrosc. Sep 2014;22(9):2070-2075. PMID 23896943
- Mundi R, Bedi A, Chow L, et al. Cartilage Restoration of the Knee: A Systematic Review and Meta-Analysis of Level 1 Studies. Am J Sports Med. Jul 2 2015. PMID 26138733
- Trinh TQ, Harris JD, Siston RA, et al. Improved outcomes with combined autologous chondrocyte implantation and patellofemoral osteotomy versus isolated autologous chondrocyte implantation. Arthroscopy. Mar 2013;29(3):566-574. PMID 23312875
- Biant LC, Bentley G, Vijayan S, et al. Long-term results of autologous chondrocyte implantation in the knee for chronic chondral and osteochondral defects. Am J Sports Med. Sep 2014;42(9):2178-2183. PMID 25002462
- Bhattacharjee A, McCarthy HS, Tins B, et al. Autologous bone plug supplemented with autologous chondrocyte implantation in osteochondral defects of the knee. Am J Sports Med. 2016;44(5):1249-1259.
- Ebert JR, Fallon M, Smith A, et al. Prospective clinical and radiologic evaluation of patello-femoral matrix-induced autologous chondrocyte implantation. Am J Sports Med. 2015;43(6):1362-1372.
- Kon E, Filardo G, Gobbi A, et al. Long-term results after hyaluronan-based MACT for the treatment of cartilage lesions of the patello-femoral joint. Am J Sports Med. 2016;44(3):602-608.
- Niemeyer P, Feucht MJ, Fritz J, et al. Cartilage repair surgery for full-thickness defects of the knee in Germany: Indications and epidemiological data from the German Cartilage Registry (KnorpelRegister DGOU). Arch Orthop Trauma Surg. 2016;136(7):891-897.
- Hergenroeder AC, Harvey BS. Management of osteochondritis dissecans (OCD). UpToDate Inc., Waltham, MA. Last reviewed July 2016.
- Chambers HG, Shea KG, Anderson AF, et al.; American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons clinical practice guideline on: The diagnosis and treatment of osteochondritis dissecans. J Bone Joint Surg Am. 2012;94(14):1322-1324.
- Schuette HB, Kraeutler MJ, McCarty EC. Matrix-Assisted Autologous Chondrocyte Transplantation in the Knee: A Systematic Review of Mid- to Long-Term Clinical Outcomes. Orthop J Sports Med. 2017 Jun 6;5(6)
- Niemeyer P, Albrecht D, Andereya S, et al. Autologous chondrocyte implantation (ACI) for cartilage defects of the knee: A guideline by the working group "Clinical Tissue Regeneration" of the German Society of Orthopaedics and Trauma (DGOU). Knee. 2016 Jun; 23(3):426-35.
- Von Keudell A, Han R, Bryant T, Minas T. Autologous Chondrocyte Implantation to Isolated Patella Cartilage Defects. Cartilage. 2017 Apr;8(2):146-154
- Ebert JR, Schneider A, Fallon M, et al. A comparison of 2-year outcomes in patients undergoing tibiofemoral or patellofemoral matrix-induced autologous chondrocyte implantation. Am J Sports Med. Sep 01 2017:363546517724761. PMID 28910133
- Meyerkort D, Ebert JR, Ackland TR, et al. Matrix-induced autologous chondrocyte implantation (MACI) for chondral defects in the patellofemoral joint. Knee Surg Sports Traumatol Arthrosc. Oct 2014;22(10):2522-2530. PMID 24817164
- Riboh JC, Cvetanovich GL, Cole BJ, et al. Comparative efficacy of cartilage repair procedures in the knee: a network meta-analysis. Knee Surg Sports Traumatol Arthrosc. Dec 2017;25(12):3786-3799. PMID 27605128
- Mistry, H. Connock, M. et al. (2017) National Institute of Health Research (NHS) Autologous chondrocyte implantation in the knee: ststemic review and economic evaluation. Health Technology Assessment 21 (6) February 2017. Doi: 10.3310/hta21060
- Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, Emans P, Podskubka A, Tsuchida A, Kili S, Levine D, Brittberg M; SUMMIT study group. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2014 Jun;42(6):1384-94. doi: 10.1177/0363546514528093. Epub 2014 Apr 8.
- FDA Full Prescribing Information MACI.
- ECRI Institute. MACI Autologous Chondrocyte Implant (Vericel Corp.) for Repairing Knee Cartilage Defects in Adults. Plymouth Meeting (PA): ECRI Institute; 2018 Nov 27. (Custom Product Brief).
- National consensus on the definition, investigation, and classification of meniscal lesions of the knee Abram, S.G.F. et al. The Knee , Volume 25 , Issue 5 , 834 - 840
- National Institute for Health and Care Excellence (NICE). Autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee [TA477]. 2017;
- Brittberg, M, Recker, D, Ilgenfritz, J, and Saris, DBF. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2018;46(6):1343-1351
- Collarile, M, Sambri, A, Lullini, G, Cadossi, M, and Zorzi, C. Biophysical stimulation improves clinical results of matrix-assisted autologous chondrocyte implantation in the treatment of chondral lesions of the knee. Knee Surg Sports Traumatol Arthrosc. 2018;26(4):1223-1229. PubMed abstract | Full text
- Kraeutler, MJ, Belk, JW, Carver, TJ, and McCarty, EC. Is Delayed Weightbearing After Matrix-Associated Autologous Chondrocyte Implantation in the Knee Associated With Better Outcomes? A Systematic Review of Randomized Controlled Trials. Orthop J Sports Med. 2018;6(5):2325967118770986.
- Riboh JC, Cvetanovich GL, Cole BJ, et al. Comparative efficacy of cartilage repair procedures in the knee: a network meta-analysis. Knee Surg Sports Traumatol Arthrosc. Dec 2017;25(12):3786-3799. PMID 27605128
- Krill M, Early N, Everhart JS, et al. Autologous chondrocyte implantation (ACI) for knee cartilage defects: A review of indications, technique, and outcomes. JBJS Rev. 2018;6(2):e5.
- DeSandis BA, Haleem AM, Sofka CM, et al. Arthroscopic treatment of osteochondral lesions of the talus using juvenile articular cartilage allograft and autologous bone marrow aspirate concentration. J Foot Ankle Surg. 2018 Jan 2 [Epub ahead of print]
- Kato, Y, Chavez, J, Yamada, S, Hattori, S, Takazawa, S, and Ohuchi, H. A large knee osteochondral lesion treated using a combination of osteochondral autograft transfer and second-generation autologous chondrocyte implantation: A case report. Regenerative Therapy. 2019;10:10-16.
- National Institute for Health and Care Excellence (NICE). Autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee [TA508]. 2018;
- ECRI Institute, Hotline Response: Combined Autologous Chondrocyte Implantation and Osteochondral Autograft for Repairing Osteochondral Knee Defects. (2019)
- Von Keudell A, Han R, Bryant T, Minas T. Autologous chondrocyte implantation to isolated patella cartilage defects: Two- to 15-year follow-up. Cartilage. 2017;8(2):146-154.
- Mandl LA, Martin GM. Overview of surgical therapy of knee and hip osteoarthritis. UpToDate Inc., Waltham, MA. Last reviewed January 2020.
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- Gudas R, Maciulaitis J, Staskunas M, Smailys A. Clinical outcome after treatment of single and multiple cartilage defects by autologous matrix-induced chondrogenesis. J Orthop Surg (Hong Kong). 2019;27(2):2309499019851011.
- Niemeyer, P., Laute, V., Zinser, W. et al. Safety and efficacy of matrix-associated autologous chondrocyte implantation with spheroid technology is independent of spheroid dose after 4 years. Knee Surg Sports Traumatol Arthrosc 28, 1130–1143 (2020).
- Pareek, A, Carey, JL, Reardon, PJ, Peterson, L, Stuart, MJ, Krych, AJ. Long-term outcomes after autologous chondrocyte implantation: a systematic review at mean follow-up of 11.4 years. Cartilage. 2016;7(4):298–308
- Gursoy S, Akkaya M, Simsek ME, Gursoy M, Dogan M, Bozkurt M. Factors Influencing the Results in Matrix-Associated Autologous Chondrocyte Implantation: A 2 - 5 Year Follow-Up Study. J Clin Med Res. 2019;11(2):137â€144. doi:10.14740/jocmr3711
- June 2020 - Interim Review, Policy Revised
- February 2020 - Annual Review, Policy Renewed
- February 2019 - Annual Review, Policy Revised
- February 2018 - Annual Review, Policy Revised
- March 2017 - Annual Review, Policy Revised
- March 2016 - Annual Review, Policy Revised
- April 2015 - Annual Review, Policy Revised
- May 2014 - New Policy
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.