№ files_lp_3_process_7_071546
File format: docx Character count: 5701 File size: 28 KB
Guidance document and sample correspondence outlining clinical indication, safety information, and supporting rationale for prior authorization requests for MACI in adult patients with symptomatic full-thickness cartilage defects of the knee.
Year: 2025
Product Name: MACI® (autologous cultured chondrocytes on porcine collagen membrane)
Document Type: Guidance and sample Letter of Medical Necessity
Subject: Prior authorization request for autologous chondrocyte implantation
Indication: Repair of symptomatic, full-thickness cartilage defects of the knee in adults
Limitations of Use: Effectiveness not established for joints other than the knee or for certain age groups
Safety Information: Contraindications, warnings, precautions, and adverse reactions detailed
Manufacturer: Vericel Corporation
Related Program: MyCartilageCare®
Regulatory Reporting Authority: U.S. Food and Drug Administration
Intended Audience: Healthcare providers and medical directors of insurance payor plans
Geographic Scope: United States
Copyright Holder: Vericel Corporation
Version: PP.US.MAC.0479 v3.0
Price: 8 / 10 USD
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Topics: MACI Chondrocytes Cultured