What committees need
Concise clinical rationale
Two-page summary of clinical problem, device mechanism, patient population, expected outcomes, and supporting evidence. No marketing fluff—just clinical facts.
Coverage and coding brief
Current CPT/HCPCS codes, DRG assignment, payer coverage policies, reimbursement rates, and any coverage gaps. Committees need reimbursement certainty before approval.
Economic summary
Cost per case, annual budget impact, cost-offset opportunities, ROI timeline. Include sensitivity analysis for different volume scenarios.
References and evidence
Peer-reviewed publications, FDA clearance/approval documentation, real-world data, and competitor comparisons. Committees verify claims independently.
Implementation plan
Timeline, training requirements, supply chain logistics, EMR integration needs, and go-live support. Feasibility matters as much as clinical benefit.
Common pitfalls
Overpromising outcomes
Committees see hundreds of submissions. Exaggerated claims trigger skepticism and delay. Stick to what the evidence supports.
Ignoring reimbursement
Clinical benefit alone doesn't secure approval. If the hospital loses money on every case, the device won't get adopted—no matter how good it is.
Skipping the champion
Value analysis committees need internal advocates. Without a clinician champion to answer questions and vouch for the device, submissions often stall.
Submission process
Pre-submission
Meet with supply chain and clinical stakeholders to understand priorities and concerns. Tailor your dossier to address their specific needs.
Formal submission
Submit complete dossier through hospital's vendor portal. Follow formatting requirements exactly—incomplete submissions get rejected without review.
Committee presentation
Expect 15-20 minutes for presentation and Q&A. Bring clinical champion, be ready for tough questions, and provide follow-up materials promptly.
Post-decision
If approved, coordinate implementation quickly. If denied, request feedback, address concerns, and resubmit when ready. Persistence pays off.