LCD L34833

Coverage Guidance

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for cardiac rhythm device evaluation services. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for cardiac rhythm device evaluation services and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

IOM Citations:

• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 1,

• Section 20.8.1 Cardiac Pacemaker Evaluation Services

• Section 20.8.1.1 Transtelephonic Monitoring of Cardiac Pacemakers

• CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in LCDs

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Indications and Limitations of Coverage

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.

Summary of Evidence

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Analysis of Evidence

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Associated Information

Refer to the related Local Coverage Article: Billing and Coding: Cardiac Rhythm Device Evaluation, A56602, for all coding information.

Documentation Requirements

• All documentation must be maintained in the patient’s medical record and made available to the contractor upon request.

• Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The record must include the legible signature of the physician or non-physician practitioner responsible for and providing the care of the patient.

• The medical record documentation must support the medical necessity of the services as stated in this policy.

• When services are performed by entities other than the attending physician, such as monitoring services and pacemaker clinics, it is expected that the information obtained from these monitoring activities be communicated to the attending physician for use in the management of the patient's condition. This information must be documented in the patient's medical record.

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

Please refer to NCD 20.8.1 for national frequency guidelines for transtelephonic monitoring of cardiac pacemakers.

Please refer to the "Covered Indications and Limitations" section of this LCD for local frequency guidelines for monitoring of cardioverter-defibrillators.

Bibliography

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