Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Knee Pain
Treatment: MACI surgery
The insurer denied the MACI surgery.
The determination is upheld.


This is a patient with right knee pain. She had sustained a prior patella fracture that required open reduction and internal fixation surgery. Plain radiographs were obtained and confirmed a healed fracture of the patella. A magnetic resonance imaging (MRI) scan of the right knee was also obtained which confirmed a healed patella fracture and chondromalacia of the patella. The current provider performed a removal of hardware from the right knee and chondroplasty of the patella undersurface. A cartilage autograft harvest was also performed for a later matrix autologous chondrocyte implantation. At issue in this case is the medical necessity of the proposed autologous cultured chondrocytes on porcine collagen membrane (MACI) cartilage restoration surgery.

The requested health service/treatment of MACI surgery is not medically necessary for this patient. The medical records document a Grade 3 lesion of the medial facet of the patella which measure 1.2 x 1.7 cm in size. The current, peer-reviewed literature does not support the performance of MACI cartilage restoration surgery for a Grade 3 cartilage lesion of this size. Thus, the medical necessity of the proposed MACI knee surgery is not established in this case.
The medical records document that this patient had persistent pain after an open reduction and internal fixation of a patella fracture in the right knee. Due to painful hardware, the current orthopedic provider performed removal of hardware from the right knee and diagnostic arthroscopy. The arthroscopy revealed a 1.2 x 1.7 centimeter (cm) cartilage lesion on the medial facet of the patella. The operative report documented that the cartilage lesion was a grade 3 lesion. The report does not document that this was a full thickness area of cartilage loss and the arthroscopic photos confirm that a full thickness lesion was not present. Thus, the medical records in this case do not support the medical necessity of the proposed MACI surgery for this patient's right knee.
In addition, the current, peer-reviewed orthopedic literature does not support the performance of a MACI cartilage restoration procedure for the medial facet cartilage lesion identified in this patient's right knee. This determination is based upon articles published by Brittberg and colleagues and by Saris and associates. The article published by Brittberg and colleagues in the American Journal of Sports Medicine in 2018 concluded that "Symptomatic cartilage knee defects 3 square centimeters (cm2) or larger treated with MACI were clinically and statistically significantly improved at 5 years compared with microfracture treatment. No remarkable adverse events or safety issues were noted in this heterogeneous patient population." A second article published by Saris and associates in the American Journal of Sports Medicine in 2014 concluded that " The treatment of symptomatic cartilage knee defects greater than or equal to (>=) 3 cm(2) in size using MACI was clinically and statistically significantly better than with microfracture, with similar structural repair tissue and safety, in this heterogeneous patient population. Moreover, MACI offers a more efficacious alternative than microfracture with a similar safety profile for the treatment of symptomatic articular cartilage defects of the knee." Since the cartilage lesion in this case measured 1.2 x 1.7 cm in size, it does not meet the criteria for medical necessity for MACI surgery based on the conclusions of these two peer-reviewed articles. Thus, the medical necessity of the proposed MACI surgery for the patient in question is not established.