The American Association for Clinical Chemistry (AACC) has sent a formal comment letter to the Centers for Medicare and Medicaid Services (CMS) addressing CMS’ proposal to enforce more stringent regulatory requirements for in-patient and outpatient hospital 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 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 capillary blood sample (finger stick) 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In response to concerns about the limitations of blood glucose monitors, CMS released draft guidance on March 13, 2015, stating the agency’s intent to begin enforcing the blood glucose monitor regulations that are required by the Clinical Laboratory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 blood glucose monitors 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After reviewing CMS’ draft guidance, AACC has recommended that the agency grant hospitals a transition period to ensure their practices comply with the CLIA regulations and to address the issues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.
That is, the change would suddenly make many hospitals’ use of the glucose monitor an “off-label” use, and thus turn glucose monitoring into a high-complexity test that could not be performed by nurses and other bedside caregivers. Faced with this situation, hospitals might have little choice but to discontinue the point-of-care testing procedure altogether. That would cause the kind of unintended bad consequence that sudden changes in the enforcement of regulations often create; and, in a painful irony, CMS’ action, taken to protect patients, would actually threaten the quality of care.
Speaking with MLO, AACC president David D. Koch, PhD, commented, “It would dramatically impact patient care if hospital laboratories chose not to use glucose meters in critically ill patients, and all the glucose results that the doctors desired on their patients would need to be ordered from the main laboratory.” He adds that, even in non-diabetic patients, “it’s been shown in numerous studies that regular and quick monitoring of glucose, and doing what’s called intensive control of glucose, will help the patient recover.” Without bedside monitoring, doctors might not have the timely information they need, and patients might not get the therapy they need as promptly as they should.
In the comment letter, AACC asserts that a transitional period will allow hospitals to adjust policies, procedures, and workforce to ensure compliance with the new regulatory requirements. Moreover, if the crux of avoiding the “off-label” designation is rigorous adherence to manufacturer instructions for using the monitors, the transition period would give manufacturers time to reexamine and clarify those instructions and work with hospitals.
None of which is to imply that hospitals have been cutting corners in ways that have endangered patients or compromised their care. They haven’t. But during the long period of non-enforcement, entirely safe procedures that do not conform to the letter of CLIA may have evolved. So, now that the more stringent regulations are apparently going to be enforced, hospitals need time to work with manufacturers to do what is necessary. When a procedure has been allowed to operate by “house rules” for quite some time, it can be difficult to make the necessary adjustments all at once—in this case, to make sure that the glucose meters are qualified properly for critically ill patients.
“AACC recognizes that CMS must enforce the CLIA regulations, and we support these efforts,” says Dr. Koch. “This new draft guidance, however, is producing much confusion within hospitals regarding which patients can be tested using blood glucose monitors and who can perform this testing. AACC urges the agency to take a pragmatic, educational approach to this situation.”
What next? The CMS did not specify a timetable; in fact, the comment period itself was not delineated by CMS, for example, as the typical 120 days. The possibility of some sudden action by the agency is a real one; or there might be staging; or it might be some while before anything happens at all. In the meantime, AACC and other stakeholders are continuing to monitor the situation.