This month, I will be presenting a series of webinars organized by Nova Biomedical aimed to educate healthcare practitioners on what constitutes off-label use of blood-glucose meters (BGM). My part of the presentation will focus on the risks associated with the off-label use of BMGs and the ways to avoid potential liabilities.
Why did we choose this topic?
According to the FDA’s statistics there were thousands of serious injuries in critically ill patients due to the erroneous glucose meters’ readings. During the most recent FDA’s public meeting on BGM, FDA stated that BGM have one of the highest number of device adverse events reported per year.
A number of adverse events reported to the FDA resulted in deaths in the healthcare settings. The investigations showed that most of these patients were acutely ill, medically fragile, and were taking medications that interfered with glucose measurements (e.g. some patients were receiving Extraneal, and some were on maltose-containing substances). Patients were treated with insulin doses that were guided by falsely elevated results. Insulin is a high-alert medication, meaning that it bears a heightened risk of causing significant patient harm when used in error. Inappropriate insulin dosing may result in hypoglycemia, coma, and even death.
A part of the problem is that healthcare providers are using glucose meters, which are unable to distinguish between glucose and other sugars. As a result, in 2008 – after receiving a report of a patient who suffered irreversible brain damage following an aggressive insulin treatment – FDA mandated that BGM labels state that the product was not evaluated for use with the critically ill (if that’s the case). FDA issued warning letters to manufacturers reminding of this new labeling requirement.
In 2016, FDA issued a guidance differentiating between self-monitoring blood glucose test systems for over-the-counter (OTC) use and point of care use of the meters in the professional healthcare settings.
Following FDA’s recommendations, the New York State Department of Health, the Veteran’s Health Administration (VHA), and CMS each issued communications alerting labs, the public, and others of the patient safety and regulatory consequences of the off-label use of point-of-care BGM on critically ill patients. New York initially got involved because two patients died in the state’s hospital based on erroneous glucose reading.
What’s the problem with the off-label use of BGM?
The problem with BGM is that most of OTC meters migrated into the clinical setting,
but the manufacturers continued to seek FDA clearance for these devices as intended for home use. By obtaining OTC clearance, the BGMS devices were automatically waived (under CLIA). However, manufacturers generally performed accuracy studies more suited to an OTC population rather than a sicker hospitalized population. Accuracy studies were performed in a relatively healthy, ambulatory population even though the devices were used in a wide variety of patient populations.
Therefore, FDA created two classes of GM with two different classification codes. And FDA encouraged manufacturers of hospital use BGMS to seek FDA clearance and CLIA waiver for use in all hospital patient populations. As FDA stated in its guidance, self-monitoring readers are intended for use at home not in healthcare settings. And FDA requires an additional warning on the self-monitoring meters that they are not intended for use in professional settings. Self-use meters should not be used on critically ill patients in healthcare setting due to a high risk of error. Continuing to use meters that were intended and designed for self-monitoring may subject healthcare providers to unnecessary legal exposure.
What is off-label use of a medical device?
In a nutshell, using a device for a non-cleared indication constitutes an off-label use. If you use BGM for purposes or in populations beyond the “Intended Use,” you are using it off-label. Intended use is what had been cleared or approved by the FDA and you can usually find it in the package inserts or device manual.
FDA’s 2016 guidance reemphasized the need for clinical testing in “vulnerable” patient populations to support clearance for use of glucose meters in such populations. Manufacturers of blood glucose meters should study their devices in each sub-population for whom the device is labeled. And the meters should be used only in those sub-populations in which the device has been studied and for which the device has a labeled indication. Otherwise, the devices are used off-label.
CLIA requirements
The CMS administers CLIA and has delegated the authority to FDA to assign all in vitro diagnostic tests to one of three CLIA complexity categories: high complexity, moderate complexity, and waived.
Glucose blood reading is a waived test if you follow the manufacturers’ instructions. All testing should strictly adhere to “intended use” or “limitations of the procedure,” which are described in the device’s manual or the insert. If a device has “Intended use” or “limitations” that state that the product has not been evaluated on critically ill patients and you are using it in a healthcare setting on critically ill patients, you are engaging in a non-waived testing or off-label. You are modifying the test. By default, it becomes a high complexity test and you must meet additional CLIA regulatory requirements.
What are some other legal consequences when you use BGM off-label?
If off-label use results in patient’s injury, the patient or the estate is likely to bring a legal action against the healthcare provider for medical malpractice (also called negligence). Patient’s attorney will analyze and scrutinize the standard of care used. When the device was used off-label when other safer alternatives existed, the patient will argue that the provider breached the standard of care (especially considering FDA’s guidance on the topic as well as CMS, VA, and some state health departments’ warnings regarding inaccurate BGM reading in healthcare settings).
To succeed under a negligence theory for off-label use, a patient must establish that the prescriber has deviated from the standard of practice. As far as I know, more and more hospitals and providers stopped using BGM not intended for critically ill patients due to the error rate. We also have guidance from federal and state agencies to stop using GM which are not specifically intended for vulnerable population groups. All these makes plaintiff’s job of proving a deviation from the standard of care much easier.
Additionally, the doctrine of informed consent requires that health care providers disclose the nature of a proposed procedure, its benefits and risks, as well as any feasible alternatives. If a health care provider uses a BGMS off-label and does not inform a patient of the known risks of an inaccurate glucose reading, there is a risk that the patient’s consent does not meet the informed consent standard.
Physicians usually do not disclose to patients if a drug or device prescribed is for off-label use. As a result, patients often bring claims for lack of informed consent arguing that if they knew that the drug was not approved for a particular use – they would not had taken it in the first place.
Courts, however, do not require physicians to disclose, through an informed consent process, the off-label use of a drug or device. Courts usually hold that off-label prescribing is a “matter of medical judgment.” This position was confirmed by the U.S. Supreme Court, holding that “physicians can prescribe approved items for any use they deem reasonable.”
But, if a patient can establish that the non-disclosure was material to the patient’s decision, the patient may prevail under the informed consent theory. And under the theory of respondeat superior or vicarious liability, the medical facility could be liable for these and other actions of its physicians, nurses, staff or laboratories with respect to the off- label use of BGMS in critically ill patients.
Some other compliance risks associated with the off-label use of BGM in critically ill population:
– potential issues with CLIA-waived status;
– losing Medicare reimbursement because you are not properly performing a high complexity testing;
– issues with state agencies (e.g. Medicaid’s reimbursements and citations).
To recoup all the above, using a device off label when there is no justification and where there is evidence that using such device may lead to serious injuries, may cause legal actions and Board’s investigations. It may also affect federal accreditation and reimbursements. To learn more about the webinars and how you can join, please contact our office.