The Centers for Medicare & Medicaid Services (CMS) has backed off on some of its CLIA mandates regarding blood glucose monitoring systems (BGMS) for off-label use. CMS issued a memorandum in November 2014 addressing point-of-care use of BGMS, which it has now withdrawn, revised and re-issued in draft form for public comment. That memorandum pertained to the use of such monitors for off-label uses, which implicates virtually every hospital use of such monitors (the monitors are mostly designed and marketed for personal use).
According to the memo, hospitals that deployed monitors in situations considered off-label would have to operate laboratories that qualified under CLIA as high-complexity laboratories. The Clinical Laboratory Management Association reported in a January article in
CLMA Advocacy that the memorandum affects “every CLIA licensed laboratory using glucose strip meters in nursing homes, provider offices, urgent cares, clinics and in hospitals whose staff use them in their intensive care units, patient units or emergency rooms for patient assessments.”
As we reported in our sister publication,
Laboratory Industry Report (LIR), concerns have been raised by the hospital community that the requirements 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, 2015.
CMS officials observed in the reissued memorandum 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.” CMS found this “particularly concerning” because it explains there have been no new CLIA policies and the regulations and statute remain unchanged. So, CMS described the two-fold purpose of its revised draft, released in March:
- Gather additional feedback regarding use of Waived BGMS, “environments in which BGMS are currently used,” and any issues with their use.
- “Promote added education regarding the current CLIA requirements.”
CMS acknowledged and clarified in the revision 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,” and thus under such conditions the device would maintain its CLIA waiver status. However, CMS explains that there is a risk to patients when BGMS are used off label—in other words, outside the manufacturer’s limitations, precautions and intended use—“without the necessary performance specifications” for that use.
CMS cites a common limitation set by manufacturers affecting critically ill patients and acknowledges that “[n]either the FDA nor CMS define the term ‘critically ill.’” CMS indicates when hospital laboratories want to use waived BGMS for such patients they need to set performance specifications for that use, such as identifying who is critically ill. Alyssa Keefe, vice president of federal regulatory affairs for the California Hospital Association (CHA), which represents about 350 hospitals, told LIR that having each hospital define who is critically ill 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.”
Keefe also said CHA expects to continue working 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.” The American Hospital Association also indicated in a news release that it plans to submit comments on the draft guidance. Comments regarding the BGMS guidelines should be submitted to LabExcellence@cms.hhs.gov. CMS indicates they will hold forums for additional discussion as well.
Source: Centers for Medicare & Medicaid Services, Survey & Certification Group, Memorandum,
Reissue of S & C 15-11 as DRAFT ONLY FOR COMMENT Off Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS), 3/13/15.
Takeaway: Although CMS withdrew its blood glucose monitoring guidelines and made some revisions, the conversation is not over and difficulties, such as defining critically ill patients, remain.
