On January 13, the New York State (NYS) Department of Health issued a directive limiting the ways in which NYS medical laboratories can use blood glucose meters to help patients. Although AACC shares the Department’s desire to ensure that blood glucose devices are used safely and appropriately, the association is concerned that this policy may impede the delivery of quality patient care and advises the Department to rescind it.
Blood glucose meters are currently designed to help many of the 19 million Americans with diabetes to monitor the effectiveness of their diabetes control programs. These devices have also become essential for managing care of non-diabetic patients in hospitals, including those who are critically ill, as studies have uncovered a connection between high blood sugar and poor outcomes. However, the Food and Drug Administration (FDA) has become increasingly concerned about this practice, referred to as off-label use, because critically ill patients may present with physiological variables that can interfere with the accuracy of blood glucose meters.
On January 7, FDA released draft guidance with suggestions for remedying this issue. In response to this draft guidance, the NYS Department of Health informed NYS laboratory directors that any lab engaging in off-label use of glucose meters must have a NYS clinical laboratory permit in the category of clinical chemistry and that only personnel licensed by the NYS Education Department are eligible to perform off-label testing. Additionally, the new NYS policy requires labs to perform studies showing that their blood glucose meters perform with an acceptable level of precision when used for off-label purposes. Until a lab meets these requirements, it must stop using glucose meters in critical care settings and/or at health fairs and other community events to screen the public for diabetes (which is considered off-label usage).
After reviewing the NYS Department of Health’s directive, AACC urges the Department to rescind or temporarily suspend the directive until the federal guidelines regulating off-label use of blood glucose meters are finalized. FDA has received extensive comments on its blood glucose meter draft guidance that it must review, and based on expert input, agencies frequently make substantive changes to draft guidance. AACC is concerned that NYS has acted prematurely by making and enforcing policy decisions based on a draft FDA document that is likely to change.
“AACC recognizes that there are many complicated and difficult decisions that must be made related to the use of blood glucose meters in off-label situations, such as who can perform the tests, the settings in which these tests can be performed, and what types of studies are required,” said AACC CEO Janet B. Kreizman. “We believe these are important issues that must be discussed and dealt with collaboratively within the healthcare community. We recommend New York wait and consider the efforts to review this issue by FDA, as well as the Centers for Medicare and Medicaid Services, before making and implementing policy changes that will significantly impact hospitals within their state and possibly nationwide.”