Cardiac Event Detection Monitoring

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 event detection 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 event detection 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 100-02, Medicare Benefit Policy Manual,Chapter 15, Section 80 - Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
• CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual , Chapter 1, Part 1, Section 20.15 for Electrocardiographic Services
• CMS IOM 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD.

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.
• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Federal Register References:

• Title 42 Code of Federal Regulations (CFR) section 410.32(d)(3) indicates diagnostic tests are payable only when ordered by the physician or non-physician practitioner (NPP) who is treating the beneficiary for a specific medical problem and who uses the results in such treatment.

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

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

Cardiac Event Detection involves the use of a long-term monitor by patients to document a suspected or paroxysmal dysrhythmia. Following the recording of events, the patient transmits data via telephone to a physician’s office or a specified station that is equipped and staffed to assess electrocardiographic data and to initiate appropriate management action. The device must be patient-activated.

The CPT/HCPCS codes that follow have two key distinguishing features:

• The distinction between a monitor with and without pre-symptom loop.
• The availability of full 24-hour attended coverage for certain specified services.

Covered Indications

1. To detect, characterize and document symptomatic transient arrhythmias.
2. To aid in regulating anti-arrhythmic drug dosage.
3. To aid in the search for the cause of unexplained syncope, dizziness or giddiness.

Based on the above covered indications, the following clinical scenarios would be considered consistent with the above indications:

• To detect the presence of symptomatic transient arrhythmias (the frequency of the symptom would make a 24-hour ambulatory electrocardiogram [Holter], or even lengthier, but still intermediate [e.g., up to 14-day monitoring], not useful in documenting the rhythm).
• To monitor for the purpose of regulating anti-arrhythmic drug dosages.
• To monitor patients who have had surgical or ablative procedures for arrhythmias.

Limitations

The following are considered not reasonable and necessary and therefore will be denied:

1. A Cardiac Event Detection service is medically unnecessary if it offers little or no potential for new clinical data beyond that which has been obtained from a previous test or if other tests are better suited to obtain the clinical data relevant to the patient’s condition. The Cardiac Event Detection should be coordinated with results from standard EKGs, Holter monitor, along with more intermediate (e.g., up to 14-day) monitoring tests and stress tests.
2. For 24-hour attended monitoring services, the receiving station must be staffed on a 24-hour basis and should be able to direct the patient for the management of all emergencies. An answering service/answering machine would not fulfill this requirement.
3. In addition, systems utilizing computers to dial the physician’s office so the physician receives transmission by way of a relay is not a covered service since there is no attendance.
4. Cardiac event monitoring must be 24 hours a day, seven days a week attended for reimbursement.
5. Although the service is a 30-day service, it is recognized that the event recorder may be discontinued once the symptom-producing arrhythmia has been documented and diagnosed or following multiple transmissions during symptoms, without arrhythmia. It is unlikely that the arrhythmias would always be diagnosed on the first day of recording or that the service would always last only one day. The average duration of monitoring is anticipated to last 10–14 days or more.
6. The Cardiac Event Detection service is justified by the pre-test incidence of symptoms related to arrhythmias and is considered not medically necessary for those patients who are not having significant recurrent arrhythmias that are anticipated to require treatment.
7. Testing for more than 30 consecutive days is rarely medically necessary and the need for the continued monitoring must be justified by the treating physician. Failure to document an arrhythmia during a 30-day test period is not sufficient justification to reimburse a second or subsequent test. It is unlikely to be medically necessary to repeat a second test within a year in the absence of new or recurrent undiagnosed symptoms.
8. Event recorders must be patient-activated and may not use time-sampling technology. Accordingly, this test will be considered medically unnecessary for any patient who is unresponsive, comatose, severely confused or otherwise unable to recognize symptoms or activate the recorder.
9. Refer to the National Coverage Determination NCD 20.15 - Electrocardiographic Services for monitoring after post-infarct guidelines.
10. Because the Cardiac Event Detection service requires the diagnosis and evaluation of intermittent arrhythmias and patients must be continuously attached to pre-symptom loop recorders or be able to be attached at the start of symptoms to post-symptom loop recorders, each patient is required to have a recorder for his/her own exclusive use throughout the duration of the monitoring period. Recorders may not be “shared” amongst two or more patients, regardless of the environment or site of the service. It will be deemed medically unnecessary to perform cardiac event recording services when patients do not have exclusive use of a recorder for the entire service period (30 days).
11. Cardiac Event Detection is a 30-day packaged service. Tests may not be billed within 30 days of each other, even if the earlier of the tests was discontinued when arrhythmias were documented and the patient is now reconnected for follow-up of therapy or intervention.

Provider Qualifications

A test may be ordered only by a physician or qualified non-physician practitioner treating the beneficiary.

Place of Services (POS)

For additional information on services performed in an Independent Diagnostic Testing Facility (IDTF), please refer to Local Coverage Determination (LCD) L35448 Independent Diagnostic Testing Facility (IDTF) and Local Coverage Article A53252 Independent Diagnostic Testing Facility (IDTF).

This LCD imposes frequency limitations. For frequency limitations please refer to the Utilization Guidelines section below.

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. Please refer to the Local Coverage Article: Billing and Coding: Cardiac Event Detection Monitoring, A56600 for applicable CPT and ICD-10 codes. 

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

N/A

N/A

Refer to the Local Coverage Article: Billing and Coding: Cardiac Event Detection Monitoring, A56600,for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient's medical record and available to the contractor upon request.
2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
3. The medical record documentation must support the medical necessity of the services as stated in this policy.
4. When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request.
5. Records must include ECG rhythm strips with interpretation for each transmission, the date and time of each transmission, when the symptoms occurred and what the symptoms were must be documented for each transmission. The medical record should also include when the reviewing physician and the ordering physician were notified of the transmission and its results.
6. The Cardiac Event Detection provider's records must include the referring physician's request for the test and the indications for the test. This information should be incorporated into a formal report (interpretation) of the test.
7. Documentation of the necessity should include the referring physician's diagnostic impression and an indication of relevant signs and symptoms.
8. It is not enough to link the procedure code to a correct, payable ICD-10-CM diagnosis code. the diagnosis or clinical suspicion must be present and documented in the clinical record for the procedure to be paid.

Utilization Guidelines

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

In a symptomatic patient, it is expected that it would not be common to perform a Cardiac Event Detection service (one 30-day service) more frequently than once every six months unless assessing atrial fibrillation or post-intervention heart rate control. Such event detection frequency should be chosen by a physician based on a sound history and physical examination, and most importantly, according to symptom frequency and characteristics.

Contractor is not responsible for the continued viability of websites listed.

Other Contractor Local Coverage Determinations

“Cardiac Event Detection Monitoring,” TrailBlazer LCD, (00400) L16986, (00900) L17010.

“Cardiac Event Detection (CED) Policy,” Noridian Administrative Services, LLC LCD, (CO) L23703.

“Transtelephonic Electrocardiographic Transmission / Monitoring,” Arkansas BlueCross BlueShield (Pinnacle) LCD, (NM and OK) L9464, L11847.
“Patient-Activated EKG Recorders,” Arkansas BlueCross BlueShield (Pinnacle) LCD, (NM and OK) L9386, L11805.

Contractor Medical Directors

Novitas Solutions, Inc. – JH Local Coverage Determination (LCD) Consolidation Narrative Justification – Most Clinically Appropriate LCD

LCDs Compared:
L26748, Cardiac Event Detection Monitoring, TrailBlazer/CO, NM, OK, TX, Indian Health Service, ESRD, SNF, RHC, WPS legacy - A/B
L30620, Long-Term Wearable Electrocardiographic Monitoring (WEM), Cahaba, MS - B

CMD Rationale:
This is a relatively new service and often gets used for screening. A policy helps to give guidance.
Cahaba has mention of this type of monitoring but it is not as extensive as the TrailBlazer policy.
I would retain the TrailBlazer policy for JH.
L26748 is the most clinically appropriate LCD.

N/A