First Do No Harm: Ensuring the Safe and Effective Use of Health IT (Text Version)

On September 14, 2009, David Matchar made this presentation at the 2009 Annual Conference. Select to access the PowerPoint® presentation (145 KB).

Slide 1

Where we'd like to be

This slide shows a flow chart of how Coverage with Evidence Development (CED) potentially fits into the coverage decision making process. The key concept is that evidence development under CED be designed to address the information needs of decision makers directly and efficiently as possible. For this to happen, alternative designs should be matched to decision making circumstance and stakeholders should be in agreement about what constitutes "adequate evidence" in support of an informed decision. Which CED approach is selected (if any) should be based on a qualitative or quantitative value of information exercise, which explicitly considers the likely impact of alternative study outcomes.

Slide 2

CED and PET/AD

• Based on analysis, CMS made a national non-coverage decision
• Pressure led to conditional coverage
• Meeting convened with CMS, NIA, FDA, ADA, and other stakeholders
• Commissioned design of a PCT

Slide 3

The challenge for CED

• Truly compelling research designs
• Timely
• Engages relevant stakeholders
• A robust decision-making machinery