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CLIA Final Rule

CMS goes off-off-label

CMS took an unusual step on March 13th, 2015. They temporarily withdrew a memorandum they had issued in November 21, 2014 on the Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS). But then this withdrawn memo was also reissued as a draft, with additional draft clarifications. What's going on?

CMS goes off-off-label on BGMS

(Some "off-the-cuff" remarks on the new Off-Label draft)

Sten Westgard, MS
April 2015

[please note: obviously, these comments are not truly off-the-cuff – but are definitely opinionated. We don't mean to offend the good-intentioned regulators at CMS. We are aiming at the policy, not the people involved.]


S&C Memorandum 15-11, issued on November 21,2014, served notice to laboratories in the US that any use of BGMS on critically ill patients was considered off-label use and had to cease (or if it continued, it had to be validated as an off-label use). The memorandum directed laboratories and hospitals that wanted to continue testing critically ill patients to meet the standards for high complexity testing and laboratory-developed tests, a much higher bar for validation and personnel. This came as a shock to many and generated a good deal of feedback / backlash. So the old memo was withdrawn, and a new draft memo was issued

The furor was such that CMS stated:

"We are temporarily withdrawing S&C Memorandum 15-11, which was issued on November 21, 2014, and reissuing it in draft-only form in order to:

  • "Obtain more feedback regarding the use of waived BGMS, the environments in which BGMS are currently used, and any issues that hospitals and other providers have identified with such use;
  • "Promote added education regarding the current CLIA requirements."

The off-the-record translation: CMS doesn't need more feedback, they already got PLENTY of feedback. And that feedback was very negative about this new memo. The labs they've heard from don't want any more education; they want the memo spiked. They want to keep using BGMS in all kinds of settings.

Just to prove that CMS already has plenty of feedback, the new memo then states "From those comments, it is apparent that:

  • "Waived BGMS are being used in a variety of settings and applications, which may indicate diverse clinical utility.
  • "Some of these uses may constitute off-label applications (i.e. applications outside the intended uses and limitations specified in the manufacturers' instructions).
  • "There is risk of patient harm when off-label use has occurred without the necessary performance specifications being in place for such off-label [editor's note: is a word missing here? Perhaps "use"].
  • "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 waived test systems [editor's note: "system"?] This is particularly concerning as S&C Memorandum 15-11 contained no new CLIA policies – the underlying CLIA Statute and regulations have not changed."

The off-the-record translation: this is really a defense of the CMS policy and memorandum. On the listservs, the reaction to the CMS memo has been far more blunt. Labs and hospitals have been using their BGMS off-label for years and no one has bothered them about it before. They have grown accustomed to this use and don't want to give it up, even if it is off-label. Furthermore, there is little chance that labs and hospitals would be able to meet the high-complexity bar even if they wanted to validate a BGMS for off-label use. The personnel requirements alone are so high that most of the staff currently using BGMS off-label would be disqualified.

Sounding off on "Critically Ill"

One of the great sources of frustration with the BGMS memo is the new terminology about the "critically ill." Since most BGMS devices obtained their waived clearance from the FDA through testing on normal patients, their intended use is restricted to that normal patient population. The devices were never validated by the manufacturer for the critically ill, and thus their labels must restrict the use. However, "critically ill" has not really been defined by the FDA or CMS, which makes it difficult to know when a laboratory is going "off-label" and when it isn't. The new draft doesn't attempt to clarify the situation:

"Neither the FDA nor CMS define the term 'critically ill.' CMS recognizes the tremendous variation of testing environments, technology, and patient clinical circumstances where BGMS devices are used. A hospital laboratory wishing to use a waived BGMS test in an off-label application must establish performance specifications for such use. This includes determining who is eligible for such testing (such as who, for the purposes of the laboratory-developed performance specifications required for off-label application, is considered in or outside the hospital's definition of 'critically ill'), based on what the laboratory knows about the test system, the patients, the environments within which the testing will be conducted, and the personnel using the test."


In other words, each laboratory is going to have to develop its own definition of "critically ill." Neither the FDA nor CMS are going to help. This compounds the challenge for the laboratory: not only must they meet the high complexity requirements, they must also define 'critically ill' as well as the set of performance specifications that must be met to use the test on the 'critically ill.'

CMS, in other words, is letting itself off the hook, but leaving the lab responsible.

On again, Off again, On again?

The bigger problem in this off-label discussion is the fact that this practice has existed for years and been unrestrained. Inspectors weren't enforcing this off-label violation, which over time became an implicit endorsement. Similar to the CMS problems with QC regulations for point-of-care devices (witness the EQA debacle, followed by the impending IQCP confusion), off-label use is a horse that has already left the barn. The practice is long-established, and CMS is late in trying to curtail it.

The real solution will involve more effort from the manufacturers, not the laboratories. If manufacturers can get FDA waived clearance for "critically ill" patients, labs won't need to do anything more. Unfortunately, all the devices on the market are not waived for critically ill. Even though CMS goes out of its way to point out that the Nova Statstrip has received waived clearance on critically ill patients, this is only for venous, arterial, neonatal arterial, or neonatal heelstick whole blood samples. "[N]o glucose meters are cleared to use fingerstick capillary samples in critically ill patients."

Labs are, as usual, caught between a regulation and a hard place. Eventually, some manufacturers will get the additional clearances, but even those are unlikely to make all the current off-label practices legal. BGMS devices were designed for different uses and different patients. If these devices can't meet the same quality standards as the central laboratory (and most of them don't, if we're honest about their performance), then we need to change our testing practices.

In the short run, the immediate effect of this withdrawal and re-drafting of the memo means that the worst consequences are postponed. In "educational" periods, labs may be cited and warned, but it's not a real error until the memo and policy become official and final. So this postponement gives labs a little breathing room, but they are still likely to hear from inspectors whenever an improper off-label use on the critically ill is observed. Labs that want to be in the clear will need to go ahead and define their critically ill population and validate their off-label use of their BGMS device. Labs can hope that their BGMS manufacturers are scrambling to quickly get the new FDA clearance for the critically ill. But if the Statstrip is any example, it looks like some uses (capillary samples) will remain be out of bounds in the future. And labs will still face the need to validate off-label use if they want all the flexibility of their current usage of BGMS devices.

No one's getting off easy on this one.