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Use of MACI in pediatric patients (younger than 18 years of age) or patients over 65 years of age has not been established. For implantations post-pregnancy, the safety of breast feeding to infant has not been determined.
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The MACI implant is not recommended during pregnancy. Use in patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery. Local treatment guidelines regarding the use of thromboprophylaxis and antibiotic prophylaxis around orthopaedic surgery should be followed. To create a favorable environment for healing, concomitant pathologies that include meniscal pathology, cruciate ligament instability and joint misalignment, must be addressed prior to or concurrent with the implantation of MACI. In the case of positive sterility results, health care provider(s) will be contacted. Universal precautions should be employed when handling the biopsy samples and the MACI product.įinal sterility test results are not available at the time of shipping. A cartilage biopsy and MACI implant may carry the risk of transmitting infectious diseases to healthcare providers handling the tissue.
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Patients undergoing procedures associated with MACI are not routinely tested for transmissible infectious diseases. Expansion of present malignant or dysplastic cells during the culturing process or implantation is possible. The safety of MACI in patients with malignancy in the area of cartilage biopsy or implant is unknown. MACI is contraindicated in patients who are unable to follow a physician-prescribed post-surgical rehabilitation program. MACI is also not indicated for use in patients who have undergone prior knee surgery in the past 6 months, excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant. MACI is also contraindicated for patients with severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. Providers are responsible for selecting coding options that most accurately reflect a patient's condition, the provider's system guidelines, payer requirements and services rendered. This list is not all-inclusive, and physician and staff may deem other codes more appropriate. This document is not intended to be a directive, nor is it a suggestion about the likelihood of obtaining reimbursement. Providers are encouraged to contact third-party payers for specific information on their coverage, coding, and payment policies. Third-party payment for medical products and services is affected by numerous factors.
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Providers should exercise independent clinical judgment when selecting codes and submitting claims to reflect accurately the services rendered to individual patients. The information has been compiled from various resources and is subject to change. The following coverage, coding, and payment information is provided for informational purposes only and should not be construed as legal advice. The majority of plans routinely reimburse fully for this treatment option using HCPCS code J7330 for autologous cultured chondrocytes and CPT code 27412 for autologous chondrocyte implantation Contact a M圜artilageCare Representative for reimbursement support at: 87