Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Arrhythmia/Irregular Heart Rhythm
Treatment: Heart Monitor Implant Replacement 
The health plan denied: Heart Monitor Implant Replacement 
The determination is: Upheld

The patient is a female who was evaluated previously for palpitations and two episodes of syncope. Her family history is remarkable for a sister who died suddenly as an adult. Resting and stress echocardiograms performed previously were unremarkable. The patient had continued complaints of palpitations despite nondiagnostic ambulatory electrocardiographic monitoring. A LINQ implantable loop recorder (ILR) was implanted. The battery ran out previously. The records provided do not indicate whether the patient had any symptoms during the time period that the device was functional or if any significant arrhythmias were documented. The patient was seen and reported "rare intermittent" palpitations. The character and specific frequency of these palpitations was not documented. The previously implanted ILR was removed, and a new device was implanted.
At issue is the medical necessity of the heart monitor implant replacement for the treatment of palpitations.
The health plan's determination of medical necessity is upheld in whole.
The documentation provided is insufficient to allow a determination that this service, in this instance, was medically necessary.
When symptoms are thought to be due to a cardiac arrhythmia, an important step in diagnosis is documentation of the rhythm at the time the symptoms occur. There are a variety of tools with which one can do this. Holter monitors record the rhythm for 24-48 hours and are useful in patients with daily symptoms. For patients with less frequent symptoms, event monitors are more useful. These can be worn externally, or implanted. In patients with symptoms that occur as frequently as weekly or once to twice a month, a diagnosis can often be made with an external monitor. If symptoms occur less frequently than every four to six weeks, external monitoring becomes impractical and less likely to be of benefit, and implantable recorders have a higher diagnostic yield. Per the 2017 International Society for Holter and Noninvasive Electrocardiology - Heart Rhythm Society (ISHNE-HRS) expert consensus statement on ambulatory electrocardiogram (ECG) and external cardiac monitoring/telemetry, "Frequency of symptoms should dictate the type of recording: longer term ECG monitoring is required for more infrequent events. Correlation (or lack) of symptoms and arrhythmias is key. The most appropriate clinical workflow may include a continuous (short-term 24 hour and up to 7 days) ambulatory electrocardiograph (AECG) monitoring, which if unsuccessful, is followed by intermittent external loop recording (long-term from weeks to months). For those patients remaining undiagnosed after prolonged noninvasive monitoring, implantable loop recorders (ILR) may be necessary."
Since no specific information was provided as to the frequency of this patient's current symptoms, an implantable monitor cannot be determined to be medically necessary in this instance. Moreover, this patient previously had an implantable loop recorder that was implanted in previously. No information was provided as to whether she had any symptoms during the time period that the device was functional or if any significant arrhythmias were documented. This information would be important in determining the need for, and likely yield of, further monitoring. For example, if she had her typical symptoms and no corresponding arrhythmias were documented, the yield of additional monitoring would likely be low. If arrhythmias were documented, then future monitoring might be useful in determining their frequency and/or response to treatment. Therefore, the requested service is not medically necessary.