Needs and Opportunities (Problem/Challenge):
- Identify opportunities with and blockers of simultaneous regulatory and private payer evidence gathering in the IDE process
- Determine where evidence development should/should not be combined between reimbursement and other activities (e.g. clinical trials)
- De-risk participation in existing CDRH Payer Communication Task Force (PCTF) programs
- Clarify links between business decisions (to conduct a trial in a given geography) and early reimbursement and regulatory determinations (e.g. LDTs = local coverage approvals, facilitate nationwide sales)
- Identify & Summarize evidence development synergies and gaps with specific focus on regulatory and reimbursement considerations
- Leverage Case Examples to answer the following questions:
- Potential benefits from doing one study (cost, time savings)?
- Challenges and concerns related to protocol development and study implementation?
- Potential benefits of simultaneous FDA and payer input (e.g. business case predictability, product launch planning)?
- Evidence gaps in the IDE study from the payer’s perspective for reimbursement purposes
- Determine: Efficiency gained from conducting one study for both Market Clearance (FDA) and Reimbursement evidence requirements (ideal state)