CMS Draft Interpretive Guidance Addresses Off-Label Uses of Blood Glucose Monitoring Devices by Hospitals and Other Providers

After receiving "considerable feedback" from providers about its interpretive guidance to state surveyors on off-label use of blood glucose monitoring devices, the Centers for Medicare and Medicaid Services (CMS) has replaced it with draft guidance and is seeking comments on the document. In its draft guidance, CMS says that the devices are approved by the U.S. Food and Drug Administration (FDA) for home monitoring of individuals with diabetes but that their use has expanded to hospitals and other provider settings where they are sometimes applied to patient populations whose blood chemistry and general medical condition are outside of the range of the FDA-approved indications for the devices.