CMS Cardiac Rhythm Device Evaluation Form

Summary Of Evidence

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Analysis of Evidence

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 Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Electronic analysis to monitor the patient’s pacemaker or cardioverter-defibrillator is medically necessary on a regular basis to evaluate the device. Pre and postoperative evaluation of the cardiac rhythm device in patients with implantable cardioverter-defibrillators (ICDs) or who are pacer dependent may be necessary because electromagnetic interference can alter the function of these devices, especially ICDs, in unpredictable ways. They may need to be re-programmed before and after a surgical procedure.

Covered Indications and Limitations

Please refer to NCD 20.8.1 Cardiac Pacemaker Evaluation Services for indications and limitations of coverage for the post-implant follow-up and evaluation of implanted cardiac pacemakers.

Transtelephonic Monitoring of Cardiac Pacemakers

Please refer to NCD 20.8.1.1 Transtelephonic Monitoring of Cardiac Pacemakers for general information, definition of transtelephonic monitoring, frequency guidelines for transtelephonic monitoring, and pacemaker clinic services.

For instances where a patient is monitored both during clinic visits and remotely or transtelephonically, the combined frequency of monitoring will be considered in evaluating the reasonableness of the frequency of monitoring services received by the patient.

Note: Payment for dual-chamber pacemakers operating in single-chamber mode should be made at the same frequency as monitoring of a single-chamber pacemaker.

Local Medicare Frequency Guidelines for Monitoring of Cardioverter-Defibrillators

Electronic analysis of a pacing cardioverter-defibrillator is performed in an office or outpatient hospital setting. It involves the interrogation and evaluation of the pulse generator status in addition to evaluation of the programmable parameters, analysis of event markers, and device response during periods of rest and activity. The monitoring of these complex devices requires more frequent monitoring than a single- or dual-chamber pacemaker. Therefore, Medicare will allow routine electronic analysis of a pacing cardioverter-defibrillator (single- and dual-chamber) within one month following implantation and then every three months thereafter. More frequent testing may be necessary to evaluate patient symptoms suggestive of pacing cardioverter-defibrillator involvement/origin.

Wearable Defibrillator System

Payment for wearable defibrillators is made by Durable Medical Equipment (DME) contractors and is subject to the indications and limitations in the DME Local Coverage Determination “Automatic External Defibrillators.”

Coverage (including frequency) for monitoring the wearable system is identical to that of implantable defibrillator devices.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.