Industry Insights & Trends

Reimbursement and Approval Processes for Medical Devices


Below are overviews of the approval and reimbursement processes of medical devices in the U.S. A graphical representation of the processes involved is included in the attached Google Presentation document. The Google Slide features additional notes highlighting the process flow and what is required or expected.

FDA Approval for Medical Devices

FDA Reimbursement Process for Medical Devices

  • Medical device reimbursement approval in the U.S. focuses on three core areas, namely coding, coverage, and payment. The three elements must be addresses in the reimbursement strategy to avoid compromising the overall strength of the plan.
  • Coding — clarify the right coding system (CPT, HCPCS or ICD-10-PCS), identify applicable coverage policies, appropriate type of payment mechanisms, “(MS-DRG, APC and different fee-for-service fee schedules),” and payment rates for the device.
  • Coverage — provide evidence demonstrating that the new device/technologies are effective and have the potential to advance medical practice.
  • Payment — shows what is covered whether it is the full cost of the service or treatment, or partial because payers can ask providers for pricing specific to their overall plan by optimizing payment to maximize returns.

New Technology Add-on Payment (NTAP) Program Reimbursement Process

Glenn is the Lead Operations Research Analyst at Simple Manifestation with experience in research, statistical data analysis and interview techniques. A holder of degree in Economics. A true specialist in quantitative and qualitative research.

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