CMS Pulls Back on Blood Glucose Monitor Regs

The Centers for Medicare & Medicaid Services (CMS) has backed off on some of its CLIA mandates regarding blood glucose monitors in the hospital setting, although inpatient providers say the new proposal remains too strict. CMS had issued draft guidelines last year regarding the point-of-care use for such monitors, which are relatively low-cost devices that are nearly ubiquitous in hospitals. The original regulations pertained to the use of such monitors for off-label uses, which implicate virtually every hospital use of such monitors (the monitors are mostly designed and marketed for personal use). Under the proposed guidelines, hospitals that deployed monitors in situations considered off-label would have to operate laboratories that qualified under CLIA as high-complexity laboratories. The Food and Drug Administration has proposed similar guidelines for use for any device that does not have pre-clearance for use in a hospital. Concerns have been raised by the hospital community that the regulations are too onerous, and would prompt many hospitals instead to turn to blood gas monitors, which are much more costly instruments. CMS met with representatives from both the American Hospital Association and state hospital lobbies on Jan. 28, and reissued guidance last month. In that new memorandum, CMS officials observed that “there may be significant confusion as to what hospitals, or other providers, must do to meet the CLIA requirements for off-label use of a (sic) waived test systems.” Perhaps the most significant change to the proposed regulations is an acknowledgement that “using a device within the limitations or precautions and intended use indicated by the manufacturer would not constitute off-label use, and not cause such use to constitute high complexity under CLIA,” with a change later in the proposed regulations that under such conditions the device would maintain its CLIA waiver status. Nevertheless, some officials remain concerned about how the regulations dictate the day-to-day use of blood glucose monitors. For example, the revised regulations concede that neither CMS nor the FDA shall define a critically ill patient, and that some monitors have not been evaluated or cleared for use with such patients. “What that does from our perspective is that it is asking a lab to use a waived test and ask hospitals to come up with definition of critically ill patients,” said Alyssa Keefe, vice president of federal regulatory affairs for the California Hospital Association (CHA), which represents about 350 hospitals and has been pushing for changes in the proposed regulations. Keefe said each hospital making such a determination would be extraordinarily difficult, and such a lack of clarity could prompt some to back away from using the monitors on their most acute patients, “limiting the use of a valuable tool.” The American Association of Clinical Chemistry (AACC) has struck a more cautious note on the matter, issuing a statement from President David Koch, M.D., that reads in part “no device is fool-proof, and every laboratory test has limitations. As clinical laboratory directors, point-of-care coordinators, and operators of point-of-care testing devices, AACC members work to always be aware of a device’s limitations and ensure that the test results contribute favorably to patient care.” There had also been concerns about some states jumping the gun on enforcing the regulations. For example, the New York Department of Health (NYDH) last year started to promulgate its own regulations that would limit off-label uses of the monitors, prompting the AACC to ask that agency to slow its efforts. The NYDH did not respond to a request asking if it had imposed that regulation. However, both the CHA and AACC say they expect to continue to work with CMS to obtain further clarification in the regulations before they’re finalized. “We’ve been really pleased that they have taken an opportunity to be very receptive to listening to many points of view,” Keefe said. Takeaway: Although federal regulators are yielding on how blood glucose monitors should be used in the hospital setting, constituents affected by the change are pushing for more changes.