Indications and Limitations of Coverage and/or Medical Necessity
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 (see "Coding Guidelines" section in the attached article for instructions).
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 presymptom loop.
- The availability of full 24-hour attended coverage for certain specified services.
Indications The covered indications are:
- To detect, characterize and document symptomatic transient arrhythmias.
- To aid in regulating anti-arrhythmic drug dosage.
- 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) 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 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 tests and stress tests.
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.
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.
Cardiac event monitoring
must be 24 hours a day, seven days a week attended for reimbursement.
A test may be ordered only by a physician or qualified non-physician practitioner treating the beneficiary.
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.
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.
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.
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.
Event recorders are not covered for outpatient monitoring of recently discharged postinfarct patients.
Because the Cardiac Event Detection service requires the diagnosis and evaluation of intermittent arrhythmias and patients must be continuously attached to presymptom loop recorders or be able to be attached at the start of symptoms to postsymptom 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). 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.
Compliance with the provisions in this policy is subject to monitoring by postpayment data analysis and subsequent medical review.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, 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.
As published in CMS IOM 100-08, Section
13.5.1, in order to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
- Safe and effective.
- Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, that meet the requirements of the Clinical Trials NCD are considered reasonable and necessary).
- Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
- Furnished in accordance with accepted standards of medical
practice for the diagnosis or treatment of the patient's
condition or to improve the function of a malformed body
member.
- Furnished in a setting appropriate to the patient's medical needs
and condition.
- Ordered and furnished by qualified personnel.
- One that meets, but does not exceed, the patient's medical needs.
- At least as beneficial as an existing and available medically
appropriate alternative.
CMS National Coverage Policy:
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 regarding cardiac event detection services are found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:
- Medicare Benefit Policy Manual - Pub. 100-02.
- Medicare National Coverage Determinations Manual - Pub. 100-03.
- Correct Coding Initiative - Medicare Contractor Beneficiary and Provider Communications Manual - Pub. 100-09, Chapter 5.
- Social Security Act (Title XVIII) Standard References, Sections:
- 1862(a)(1)(A) Medically Reasonable & Necessary.
- 1862(a)(1)(D) Investigational or Experimental.
- 1833(e) Incomplete Claim.
Documentation supporting medical necessity should be legible, maintained in the patient's medical record and made available to Medicare upon request.
When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request.
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.
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.
Documentation of the necessity should include the referring physician's diagnostic impression and an indication of relevant signs and symptoms.
It is not enough to link the procedure code to a correct, payable ICD-9-CM diagnosis code. The diagnosis or clinical suspicion must be present and documented in the clinical record for the procedure to be paid.
In a symptomatic patient, it is expected that it would not be necessary to perform a Cardiac Event Detection service (one 30-day service) more frequently than once every six months.
Notice: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient's condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient's medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.
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