Aetna will now reimburse for iRhythm's ZIO Patch, a continuous long-term heart monitor worn on an adhesive patch. The insurer recently updated its Clinical Policy Bulletin on cardiac event monitors, upgrading the ZIO Patch from "experimental and investigational" to "medically necessary" for certain conditions.
In particular, Aetna will reimburse for the ZIO Patch either "to evaluate syncope or light-headedness" or "to document an arrhythmia" in situations where a patient's symptoms are too infrequent to be detected by a traditional 24-hour Holter monitor. This suggests that the patch is still not reimbursable as a replacement for the Holter monitor in all circumstances.
The ZIO Patch is a smaller adhesive device worn on the patient’s chest. The ZIO patch has the advantage of being less cumbersome than a Holter monitor and can be worn for up to two weeks. However, it does not have any sort of wireless or Bluetooth connectivity — the readings are simply stored in the water-resistant device, which the patient mails to iRhythm at the end of the monitoring period.
Dr. Eric Topol at the Scripps Translational Science Institute published research just this month that compared the ZIO Patch to traditional Holter monitors. Topol found that the devices performed comparably and the ZIO patch was preferred by patients and doctors.
"To me, it signifies the beginning of the end of the Holter," he told MobiHealthNews at the time. "It's something that I grew up with for three decades of cardiology. For me that's been a reference standard. But I think there's little reason to use a Holter when you have technologies like this that are going to be much more useful and much more powerful."
Topol also said that reimbursement would be a major hurdle for the technology to overcome before it could become standard.
"These are really inexpensive to make,” he said. “The question is, can these be more palatable for patients, but also for a fraction of the cost we would attribute to a Holter monitor? [...] It’s disruptive and challenging to the current reimbursement system. The current model is the Holter, and the question is ‘Can we come up with a whole new model?’”
Aetna's policy bulletin doesn't mention the Scripps study, but it does have two new studies listed in the background section that weren't listed as of June, and therefore may have tipped the scales for demonstrating the ZIO Patch's clinical value: a study published in May in Future Cardiology and one published in August in the American Journal of Cardiology.
“This new policy further reinforces the clinical validity and clinical utility of using the ZIO Service for long-term continuous monitoring of patients with suspected heart arrhythmias,” Kevin King, president and chief executive officer of iRhythm, said in a statement. “We are pleased that Aetna’s members can now benefit from this coverage, which we believe will help improve patient outcomes and reduce healthcare costs.”
CardioNet, one of the first wireless health companies to secure any kind of reimbursement, is listed in the same bulletin. Aetna's policy bulletin also mentions AliveCor's ECG monitor, but under the same description it previously listed for ZIO: "Aetna considers the AliveCor Heart Monitor (iPhoneECG) experimental and investigational because its clinical value has not been established."