Video: How Much Data and Which Endpoints Are Needed for CMS/Payers vs. Regulators?

In this expert-led video, Dr. Adam Saltman, Chief Medical Officer at NAMSA, explains how startups can strategically design clinical studies to meet the needs of both regulators and payers. He outlines how adding targeted endpoints can help satisfy FDA requirements for safety and effectiveness while also addressing CMS criteria for medical necessity and reasonableness.

What You’ll Learn:

Dual-Purpose Study Design: How to align regulatory and reimbursement goals in one trial
Stakeholder Engagement: Best practices for approaching FDA and CMS with study proposals
Efficiency Strategies: How to reduce the need for multiple studies by telescoping evidence generation

Whether you’re preparing for FDA submission or planning your reimbursement strategy, this video offers practical guidance for maximizing impact with minimal duplication.

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Video: How Much Data and Which Endpoints Are Needed for CMS/Payers vs. Regulators?

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What You’ll Learn:

Let’s Talk About Your Project