As I try to keep up with all things diabetes, I was a surprised to recently read that CMS (Centers for Medicare & Medicaid Services) is considering a new, more relaxed analysis of HbA1C. In a time where other metrics are becoming noticeable, like “time in range” and “biochemical hypoglycemia,” we are looking at relaxing the gold standard for assessing glucose levels to be less accurate. It’s mind boggling to me that this is even a consideration, as it would seem in the aftermath of the Theranos FDA investigation that we should demand higher standards, not lower.
A change to the lab standard can mean an A1C of 8.0% can read out between 7.2%-8.8%
To me the analogy is quite simple, you’ve spent years practicing hitting a target — let’s say with a bow and arrow, because diabetes isn’t just pulling a trigger — it takes real skill to manage. Let’s say you are competing and practicing daily to hit that bulls eye and you can see where you were landing so you know how to judge the next try. This is helpful feedback, otherwise, how would you know how close to the target you are? Now imagine someone hid the target — you can’t see it anymore. It’s there somewhere, but you are not able to visualize what you need to do in order to hit the target anymore- how likely are you to keep practicing and trying? What is the incentive to get it right if you don’t know where you are aiming anymore?
Luckily, CMS is allowing for comment on the situation here. If you would like to leave your feedback you are encouraged to do so. After all, what is the point of having a target if you don’t even know where it is?
About the Author:
Molly McElwee-Malloy is the Clinical Services Manager for Tandem Diabetes Care. She previously worked for TypeZero Technologies and UVA's Center for Diabetes Technology. Molly is the chair of the technology workgroup for AADE. She's active in the diabetes online peer support community: @MollyMacT1D.
Disclaimer: The views and opinions expressed in this blog are those of the author and do not necessarily reflect the views of Tandem.