Sanofi appreciates the opportunity for public comment relative to measure development and note we have been supportive in previous efforts by CMS to include measures to encourage good glycemic control in the hospital setting.

Our initial comment is that referring to this as a measure for “severe hypoglycemia" would be more appropriate, since hypoglycemia here is defined as less than 40mg/dL. We would suggest recommending a change in the name of the measure to “Hospital Harm - Severe Hypoglycemia”, as well as referring to the construct being measured as “severe hypoglycemia” throughout the framing documents. Another consideration: The ADA defines hypoglycemia as blood glucose less than 70mg/dL - so if CMS want a measure of hypoglycemia - not specifically severe in nature - then an optional numerator might be: hypoglycemic events as defined by blood glucose less than 70 mg/dL (vs. severe hypoglycemia defined as less than 40mg/dL).

Finally, as part of our continued efforts to encourage good glycemic control in the inpatient setting, we would suggest consideration of a hyperglycemia measure as well. NQF does have a hyperglycemia measure #2362 and suggests that the measures be paired (hypo and hyper) to “serve as a balancing measure and avoid unintended consequences”.