CMS S&C 15-11 Off-Label/Modified Use of Waived BGMS

This is my latest understanding: Last November there was a joint webinar from CMS and CAP about this. The bottom line was that CMS retracted the "withdrawal of the letter" and stated that it was intended for the manufctuerers only. CMS fully intended to enforce the off-label use of the glucose meters if not cleared for critically ill patients. Fingerstick samples are still not cleared for any glucose meter.

Do you know if there's a way to directly access the notes or slides from this webinar?

This is what I found in my notes:

"Thank you for participating in our webinar series, Managing Compliance at the Point of Care, and our first event focused on Achieving Care Goals. If you'd like to listen to a replay of the webinar, you can access it at:"

go.roche.com/webinars

I think you may stil be able to get to it there. Administration found it very enlightening and were not happy with the result....

I don't think you can access the Roche webinar this way- is there another link?

Hello all,

I don't have an update (March 29) but I was made aware on Friday that CLSI is giving a recently published White Paper on the glucose meter/critically ill topic free of charge, free of membership. You must use their store to 'order' but there is no charge. I saw it on the store webpage listed for $0.

You receive a copy via 'download' in an email.

FYI only.

Thanks Peggy!!! I'm still looking through it but looks like lots of good info. there

Agreed Charles!

Maybe this is a good place to ask: What is everyone doing to define critically ill?

Here is our definition:

·        Critically
Ill Patients:

o        Patients
undergoing a cardiac and/or pulmonary event with life support in progress.

James,  are BS performed on a lab specimen for these critically ill patients?

For patients fitting the critically ill definition a venous sample  must be collected.

Testing can be performed either in the lab on the chemistry analyzer or performed

at bedside using an iSTAT.

We are debating if we are going to define critically ill or if we are going to leave it to the physician to determine if their patient is critically ill.

Best practice is to formulate one definition for critically ill which is agreed to by 

and signed off by clinicians. Leaving it to each physician could develop into

a confusing situation for staff. For standardization purposes one definition 

would be most beneficial.