CLINICAL MEDICAL POLICY

Policy Name: Policy Number: Responsible Department(s): CLINICAL MEDICAL POLICY Cardiac Event Detection Monitoring (L34953) MP-054-MC-PA Medical Management Provider Notice Date: 05/01/2018 Issue Date: 06/01/2018 Effective Date: 06/01/2018 Annual Approval Date: 03/21/2019 Revision Date: Products: Application: N/A Page Number(s): 1 of 10 Pennsylvania Medicare Assured All participating and nonparticipating hospitals and providers DISCLAIMER Gateway Health (Gateway) medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions. POLICY STATEMENT Gateway Health may provide coverage under the medical-surgical benefits of the Company s Medicare products for medically necessary Cardiac Event Detection Monitoring. This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records. Policy No. MP-054-MC-PA Page 1 of 10

PROCEDURES 1. CMS National Coverage Policy This medical policy 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 (reference: NCD 20.15). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this medical policy. Neither Medicare payment policy rules nor this medical policy 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 website: 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 1862(a)(1)(D) states that no payment shall be made for services considered Investigational or Experimental. 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. 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. 2. Coverage Guidance A. Coverage Indications, Limitations, and/or Medical Necessity Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire medical policy) 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 postpayment data analysis and subsequent medical review audits. 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: Policy No. MP-054-MC-PA Page 2 of 10

The distinction between a monitor with and without pre-symptom loop. The availability of full 24-hour attended coverage for certain specified services. B. Indications 1) The covered indications are: a. To detect, characterize, and document symptomatic transient arrhythmias. b. To aid in regulating anti-arrhythmic drug dosage. c. To aid in the search for the cause of unexplained syncope, dizziness, or giddiness. 2) Based on the above covered indications, the following clinical scenarios would be considered consistent with the above indications: a. 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). b. To monitor for the purpose of regulating anti-arrhythmic drug dosages. c. To monitor patients who have had surgical or ablative procedures for arrhythmias. C. 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, along with more intermediate (e.g., up to 14-day) monitoring 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. Policy No. MP-054-MC-PA Page 3 of 10

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 post-infarct patients. 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 among 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. Notice: This medical policy 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, Chapter 13, 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: Policy No. MP-054-MC-PA Page 4 of 10

o o o o o 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. 3. Post-payment Audit Statement The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Gateway Health at any time pursuant to the terms of your provider agreement. COVERAGE DETERMINATION Gateway Health follows the coverage determinations made by CMS as outlined in either the national coverage determinations (NCD) or the state-specific local carrier determination (LCD). There is no NCD that is specific to the Cardiac Event Detection Monitoring policy. This policy supplements the existing and related NCDs but does not repeat the existing NCDs. Please follow the Novitas Solutions LCD (L34953) for Cardiac Event Detection Monitoring: S:\Medical Policy Development\MEDICARE POLICIES\PA Medicare Medical Policies\2018 PA Medicare Medical Policies\MP-054-MC-PA Cardiac Event Detection\Research and Information\Local Coverage Determination for Cardiac Event Detection Monitoring (L34953)_aspx.mht Related NCDs: Electrocardiographic Services (20.15): https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=179&ncdver=2&docid=20.15&from2=search.asp&bc=gaaaaagaaaaaaa%3d%3d& Transtelephonic Monitoring of Cardiac Pacemakers (20.8.1.1): https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=345&ncdver=1&bc=aaaagaaaaaaaaa%3d%3d& Cardiac Pacemaker Evaluation Services (20.8.1): https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=160&ncdver=1&bc=aaaagaaaaaaaaa%3d%3d& CODING REQUIREMENTS Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. Policy No. MP-054-MC-PA Page 5 of 10

012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient 018x Hospital - Swing Beds 021x Skilled Nursing - Inpatient (Including Medicare Part A) 022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient 071x Clinic - Rural Health 073x Clinic - Freestanding 075x Clinic - Comprehensive Outpatient Rehabilitation Facility (CORF) 077x Clinic - Federally Qualified Health Center (FQHC) 085x Critical Access Hospital Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. Note: The contractor has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this medical policy. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet- Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance. 073X EKG/ECG (Electrocardiogram) - General Classification Group 1 Paragraph Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. 93268 and 93270 (Non-OPPS only) Covered Procedure Codes CPT Codes Description 93268 ECG record/review 93270 Remote 30 day ECG rev/report 93271 ECG/monitoring and analysis 93272 ECG/review interpret only Group 1 Paragraph Note: It is the provider's responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted. Providers should continue to submit ICD-10-CM diagnosis codes without decimals on their claim forms and electronic claims. Policy No. MP-054-MC-PA Page 6 of 10

The CPT/HCPCS codes included in this medical policy will be subjected to procedure to diagnosis editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary. Medicare is establishing the following limited coverage for CPT codes 93268, 93270, 93271 and 93272: Covered Diagnosis Codes ICD-10 Codes Description G45.9 Transient cerebral ischemic attack, unspecified I25.82 Chronic total occlusion of coronary artery I44.0 Atrioventricular block, first degree I44.1 Atrioventricular block, second degree I44.2 Atrioventricular block, complete I44.30 Unspecified atrioventricular block I45.5 Other specified heart block I45.6 Pre-excitation syndrome I45.81 Long QT syndrome I45.89 Other specified conduction disorders I45.9 Conduction disorder, unspecified I46.2 Cardiac arrest due to underlying cardiac condition I46.8 Cardiac arrest due to other underlying condition I46.9 Cardiac arrest, cause unspecified I47.0 Re-entry ventricular arrhythmia I47.1 Supraventricular tachycardia I47.2 Ventricular tachycardia I47.9 Paroxysmal tachycardia, unspecified I48.0 Paroxysmal atrial fibrillation I48.1 Persistent atrial fibrillation I48.2 Chronic atrial fibrillation I48.3 Typical atrial flutter I48.4 Atypical atrial flutter I48.91 Unspecified atrial fibrillation I48.92 Unspecified atrial flutter I49.01 Ventricular fibrillation I49.02 Ventricular flutter I49.1 Atrial premature depolarization I49.2 Junctional premature depolarization I49.3 Ventricular premature depolarization I49.40 Unspecified premature depolarization I49.49 Other premature depolarization I49.5 Sick sinus syndrome I49.8 Other specified cardiac arrhythmias I67.841 Reversible cerebrovascular vasoconstriction syndrome I67.848 Other cerebrovascular vasospasm and vasoconstriction Policy No. MP-054-MC-PA Page 7 of 10

R00.0 Tachycardia, unspecified R00.1 Bradycardia, unspecified R00.2 Palpitations R06.00 Dyspnea, unspecified R06.09 Other forms of dyspnea R06.3 Periodic breathing R42 Dizziness and giddiness R55 Z09 Syncope and collapse Encounter for follow-up examination after completed treatment for conditions other than malignant neoplasm Z86.74 Personal history of sudden cardiac arrest GENERAL INFORMATION Associated 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 submitted medical record should support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code should describe the service performed. 4. The medical record documentation must support the medical necessity of the services as directed in this policy. 5. When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request. 6. 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. 7. 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. 8. 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-10-CM diagnosis code. The diagnosis or clinical suspicion must be present and documented in the clinical record for the procedure to be paid. Policy No. MP-054-MC-PA Page 8 of 10

Sources of Information and Basis for Decision 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. REIMBURSEMENT Participating facilities will be reimbursed per their Gateway Health contract. POLICY SOURCE(S) Centers for Medicare and Medicaid Services (CMS), Local Coverage Determination (LCD). No. L34953: Cardiac Event Detection Monitoring. Effective 10/01/2015. Accessed on March 6, 2018 and available at: S:\Medical Policy Development\MEDICARE POLICIES\PA Medicare Medical Policies\2018 PA Medicare Medical Policies\MP-054-MC-PA Cardiac Event Detection\Research and Information\Local Coverage Determination for Cardiac Event Detection Monitoring (L34953)_aspx.mht Centers for Medicare and Medicaid Services (CMS), National Coverage Determination (NCD). No. 20.15: Electrocardiographic Services. Effective 08/26/2015. Accessed on March 7, 2018 and available at: https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=179&ncdver=2&bc=aaaaqaaaaaaa& Policy No. MP-054-MC-PA Page 9 of 10

Policy History Date Activity 03/06/2018 Initial policy developed 03/21/2018 QI/UM Committee approval 06/01/2018 Provider effective date Policy No. MP-054-MC-PA Page 10 of 10