WASHINGTON – Today AACC sent formal comments to the Centers for Medicare and Medicaid Services (CMS) addressing CMS’ proposal to enforce more stringent regulatory requirements for testing with blood glucose monitors. AACC endorses CMS’ effort to improve patient care by ensuring these devices are used appropriately, but recommends creating a transition period that would give hospitals sufficient time to adjust to the new requirements and prevent the disruption of rapid, point-of-care blood glucose results for patients.

Blood glucose monitors are best known for their role in helping many of the 19 million Americans with diabetes to manage their illness at home. These devices have been approved for patients who, aside from having diabetes, are healthy. Blood glucose monitors are also used in diabetes and insulin management programs in intensive care units, emergency departments, operating rooms, and other settings in which active monitoring of critically ill patients through bedside testing is vital to getting them the treatment they need. Critically ill patients, however, can present with extreme physiological variables that might cause the blood sample normally drawn for these blood glucose monitors to be inadequate, resulting in inaccurate glucose values.

In response to concerns about the limitations of blood glucose monitors, CMS released draft guidance on March 13 stating the agency’s intent to begin enforcing the blood glucose monitor regulations that are required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), but that have not previously been implemented. Under these regulations, laboratories would not be able to use a blood glucose monitor on critically ill patients without first confirming that the device is accurate and effective in this patient population through their own studies or studies performed by the manufacturer of the device.

After reviewing CMS’ draft guidance, AACC recommends that the agency grant hospitals a transition period to ensure their practices comply with the CLIA regulations and to address the issues that will inevitably arise as they implement these new standards. Otherwise, AACC is concerned that immediate enforcement of these regulations will unnecessarily disrupt and jeopardize patient care by triggering a shift away from bedside glucose testing. This change could significantly impede the ability of healthcare practitioners to rapidly diagnose and treat hyperglycemia and hypoglycemia.

Additionally, many of the nurses, patient care technicians, and medical assistants who currently conduct blood glucose monitor testing would not be qualified to perform this testing under CLIA’s regulations. To prevent a shortage of healthcare personnel who can perform blood glucose testing on critically ill patients, hospitals will need time to assess and adjust their workforce as necessary to ensure they have enough personnel who meet the CLIA qualifications.

“AACC recognizes that CMS must enforce the CLIA regulations, and we support these efforts,” said AACC President Dr. David D. Koch. “This new draft guidance, however, is producing much confusion within hospitals regarding on which patients blood glucose monitors can be used and who can perform this testing. AACC urges the agency to take a pragmatic, educational approach to this situation.”

Read AACC’s comment letter here.


About AACC

Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.