Cardiovascular Business hosted a roundtable discussion on the medico-legal considerations of the remote monitoring of patients with cardiac implantable electronic devices (CIEDs) with wireless capabilities. Despite data supporting its clinical benefits, some practices are resisting adoption due to the potential liability of receiving continual alerts. Here, four experts share opinions on how practices can navigate these waters.
- Victor R. Cotton, MD, JD, Healthcare Attorney, Hershey, Pa.Anne M. Gillis, MD, President-elect of the Heart Rhythm Society (HRS) and Professor of Medicine, University of Calgary, Alberta, Canada
- Debra Halligan, RN, BSN, Clinical Leader, Pacemaker/ICD Clinic, North Shore Medical Center, Salem, Mass.
- Colin M. Movsowitz, MD, Cardiac Electrophysiologist, Cardiology Consultants of Philadelphia
Beyond the hearsay
Remote monitoring of wireless devices allows for web-based access to critical clinical information, including system integrity, arrhythmias and heart failure parameters, through daily remote interrogations. Thus, these remote interrogations often negate the need for patients to make in-person visits to their clinic. Due to benefits demonstrated in such trials as CONNECT, TRUST and ALTITUDE, facilities have begun remotely monitoring patients with CIEDs as “the standard of care,” says Gillis.
“From the patient satisfaction and quality-of-life perspectives, remote monitoring has been enormously valuable, especially due to the elderly nature of this population,” says Gillis, who adds that remote monitoring allows for the capability to program in specific alerts to detect certain events earlier than can be detected within the typical in-person 90-day or six-month follow-up.
However, the responsibility of monitoring these alerts has led to legal questions. The law typically follows the data, says Cotton. “Because the current findings are strong, there appears to be no downside to using the technology, as there is no apparent risk to the patient and insurers are reimbursing for its use.”
However, some practices are hesitant to adopt the technology, says Movsowitz, because they are uncertain about liabilities.
From “a lawyer’s perspective,” Cotton says that practices cannot absolve themselves of liability by simply not adopting the technology, especially when the clinical data associated with wireless pacemakers and CIEDs “are all leaning toward benefit.” Physicians cannot acknowledge the clinical benefits of remote monitoring on one hand, and then simply not provide the service to their patients on the other hand, he says. When assessing the legal considerations with not implanting a wireless device, Cotton says it’s “more of a gray area.” A clinical argument can be made, says Cotton, that not implanting a wireless device could cause harm because an event might have been detected earlier. However, the legal argument for not implanting a wireless device “may be more difficult to sell to a jury, as it requires a series of if-then scenarios.”
However, if a practice uses a wireless device in which data are being generated, and a patient's arrhythmic event is ignored for too long, Cotton says this case may be more challenging to defend in court, “as it's a clearer case.” Thus, facilities should establish protocols for regularly tracking the data, he adds.
This uncertainty, Movsowitz says, may be one of the reasons that practices shy away from adopting the technology, in spite of its benefits. However, Cotton stresses that this is “not really acceptable,” and it presents an example of “medico-legal paranoia pointed in the wrong direction.” He also recommends that those practitioners consider the opposing argument in court, as it could be damning if someone suggests there is technology available to detect events sooner—at no risk or inconvenience to the patient.
In fact, from a clinical standpoint, practices are alerted to events sooner with remote monitoring, says Gillis. “There are unexpected, but critical alerts [that get automatically transmitted to an online dashboard] indicating evidence of a lead malfunction or a lead fracture. We can review the data and then decide whether we need to see the patient immediately or can a visit be scheduled that’s more convenient for the patient.”
As for industry’s role, Gillis says that the companies’ responsibility is “to produce technology that works and it's our responsibility to implement the technology, to follow patients and to treat them