Relearning English When it Comes to FDA and CMS Jargon

MedTech company: Please cover our technology. It works!

Payer: The data is insufficient for coverage. It's experimental/ investigational.

MedTech company: How can that be? It's approved by the FDA!

Payer: Yes, but we weren't able to determine its value.

MedTech company: But its value proposition has been vetted extensively by providers all over the country.

*head scratch*

The Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS)/ commercial health plans use similar terminology yet mean very different things, which can leave even the most cutting-edge AI MedTech companies confused. Let's decode some key terms and shed light on how different healthcare stakeholder entities use them for their own distinct purposes.

The claims where communication wires get crossed tend to be:

"The device is experimental/ investigational."

"The device works."

"The device has a strong value proposition."

Check out the table below to see how FDA, payers, and MedTech developers might be using the same terms but not meaning the same thing.

If you'd like to know how to parse out these terms for your tech, let's speak directly with the type of stakeholder who can teach you Reimbursementglish and in just one hour, get you speaking with enough confidence for your next round of funding!