An Overview of Reimbursement and Coverage Basics for Medical Devices

• 1 Difference between FDA safety and effectiveness review and CMS reasonable and necessary economic coverage focus
• 2 When to pursue an NCD versus an LCD and how MAC regional LCD processes affect coverage timing
• 3 Which devices get separate payment versus bundled DRG payment and implications of ASP reporting, DME fees, pass-through, and NTAP
• 4 How software and remote-monitoring apps affect coverage and billing and that remote monitoring CPT codes require clinician review

Based on transcript analysis and 32 reviews