CLINICAL MEDICAL POLICY

Transcription

1 CLINICAL MEDICAL POLICY Surveillance of Implantable or Wearable Cardioverter Policy Name: Defibrillators (ICDs): Office, Hospital, Web, or Non-Web Based (L34087) Policy Number: MP-052-MC-KY Responsible Department(s): Medical Management Provider Notice Date: 03/15/2018 Issue Date: 04/15/2018 Original Effective Date: 04/15/2018 Annual Approval Date: 03/01/2019 Revision Date: N/A Products: Kentucky Medicare Assured Application: All participating and nonparticipating hospitals and providers Page Number(s): 1 of 10 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 provides coverage under the DME benefits of the Company s Medicare products for medically necessary surveillance of implantable or wearable cardioverter defibrillators. 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-052-MC-KY Page 1 of 10

2 COVERAGE GUIDANCE 1. Coverage Indications, Limitations, and/or Medical Necessity A. Abstract Implanted cardioverter-defibrillators require periodic evaluation of function and reprogramming based upon the patient's medical condition. Interrogation may be provided during a face-to-face encounter or remotely. The interrogation and evaluation may be provided as routine follow-up in an asymptomatic patient without device discharge, or for symptoms, with device discharge. Reprogramming should be reflected by a need for change in the patient's medical condition. Remote interrogation is a 90-day service, inclusive of all transmissions during that period which are then billed as a single service. A provider may not bill a remote service and a face-to-face service on the same day. Medicare will cover surveillance of ICDs as a face-to-face or remote service to monitor behavior of the device, to investigate symptoms such as post-event shock, and syncope, ICD malfunction or device failure. Surveillance of ICDs is also indicated to program device evaluation and adjustment and for patients prior to surgery or other procedures to modify or disable the device during the procedure. Remote interrogation is a single 90- day service, while in-person interrogation can be reported for each day it is performed. Peri-procedural device evaluation and programming before and/or after a procedure or test may be reported separately. B. Indications and Limitations: Surveillance of an ICD is indicated to monitor the behavior of the device and to assess the patient with intervening symptoms. The frequency and need for both face-to-face and remote interrogation should be coordinated so that there is no unnecessary duplication of the interrogation services. The symptoms requiring unscheduled investigation by both remote and face-to-face modalities should be discrete symptoms such as post-shock events, syncope/nearsyncope and palpitations. Remote and face-to-face interrogations may be performed for suspected malfunction or device failure. In-person evaluation/interrogation services (93287, 93289, and 93292) may be reported each time they are provided (reimbursement is dependent upon documentation of medical necessity). Remote interrogation services and are 90-day services, and may only be reported once during that period regardless of the number of interrogations performed. The 90-day period begins with the initiation of remote monitoring or the 91st day of the implantable defibrillator. In-person interrogation occurring during the same 90-day period as remote interrogation is included in the remote interrogation service. If there is no interrogation Policy No. MP-052-MC-KY Page 2 of 10

3 service provided within a 90-day period then the service should not be billed for that period. Programming services may be reported separately. In-person interrogation performed on the same day as the programming of the device is included in the programming service. Interrogation and reprogramming of defibrillators prior to and after a surgical procedure or test (93287) is covered as a separate procedure when it is necessary to modify how the device would function during the procedure/test (e.g., to avoid interference by an electrical cautery during the procedure, to disable during cardiac surgery, etc). When performing program device evaluation with iterative adjustment of the device to test function and select optimal programmed parameters, the final parameters may or may not change from previous parameters. Documentation of each parameter tested and the result should be maintained in the record. For physician billing, each interrogation, with/without reprogramming must be provided under personal supervision of the physician in a hospital or other facility setting and at least direct supervision in the office or private clinic setting. The physician must personally review and analyze the data, and generate a report. For hospital billing, each interrogation, with/without reprogramming must be provided under direct supervision of a qualified physician in the hospital. A qualified physician must personally review and analyze the data, and generate a report. When the technical portion of interrogation services are provided by a service center (IDTF, hospital based laboratory, etc), or physician other than the one analyzing and interpreting the results (93296), the physician performing the review, analysis and report must generate his/her own interpretation and report (with signature) and not just countersign the technical review and distribution of results. These evaluation/interrogation services should not be billed when implanting or replacing an ICD. The service must be prescribed by a physician or a qualified non-physician practitioner. An evaluation and management (E&M) service provided on the same day as in-person interrogation/programming must be a significant and separately identifiable face-toface service. No part of the ICD surveillance (face-to-face or Internet based) may be reported as an E&M service. A brief history to ascertain whether the device has discharged or patient has had symptoms relevant to the need for the device (and therefore function) is considered part of the surveillance service. EKG rhythm strips ( ) are included in these evaluation/interrogation services and should not be billed separately. Coverage is limited to system(s) approved by the FDA for patients with a specific implanted ICD model. Policy No. MP-052-MC-KY Page 3 of 10

4 Only physicians who have expertise and/or training in reprogramming of ICDs may bill the interrogation with or without reprogramming services. 2. Other Comments: For claims submitted to the Part A MAC: This coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators to process their claims. Bill type codes only apply to providers who bill these services to the Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC. Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes. For dates of service prior to April 1, 2010, FQHC services should be reported with bill type 73X. For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services. For outpatient settings other than CORFs, references to "physicians" throughout this policy include non-physicians, such as nurse practitioners, clinical nurse specialists and physician assistants. Such non-physician practitioners, with certain exceptions, may certify, order and establish the plan of care as authorized by State law. (See Sections 1861[s][2] and 1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections , , and ; 58 FR 18543, April 7, 2000.) 3. General Information Associated Information The patient's medical record must contain documentation that fully supports the medical necessity for services included within this medical policy. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. An Internet based service may require a signed service agreement between the manufacturer and the physician. This agreement should be kept on file and be available upon request. When the technical portion of interrogation services are provided by a service center (IDTF, hospital based laboratory, etc), or physician other than the one analyzing and interpreting the results (93296), the physician performing the review, analysis and report must generate his/her own interpretation and report (with signature) and not just countersign the technical review and distribution of results. Policy No. MP-052-MC-KY Page 4 of 10

5 All of the following must be maintained in the patient s medical record in the physician s office: date(s) of device implant and identification of device, a copy of the physician s order for the service, all transmissions, formal interpretations, reports, information relating the reason for the service: routine follow-up versus specific symptoms. If the reason for the service is that the patient was symptomatic, then the nature of the symptoms must be documented. Not applicable The frequency and need for both face-to-face and web-based modalities should be coordinated so that there are no unnecessary duplications of the interrogation services. When the in-person service is rendered for monitoring purposes only, in the absence of symptoms or discharge of the device (ICD-10-CM code Z95.810), it is expected that the service be performed no more frequently than once every three months. Remote interrogation services may be billed no more often than once every 90 calendar days. When the in-person service is rendered for other indications, it may be performed as appropriate based on clinical symptomatology. Sources of Information This bibliography presents those sources that were obtained during the development of this policy. CIGNA Government Services is not responsible for the continuing viability of Web site addresses listed below. American Medical Association, CPT 2009 Professional Edition, pages Medtronic CareLink Network, Fact Sheet, Press Release, Backgrounder by Medtronic, Inc. Medtronic completes Phase One of its Medtronic CareLink Patient Management Network Rollout, Company Press Release, Atlanta-March 18, FDA approves Web-based heart monitoring system by Alicia Ault, New York, Jan 03 (2002), Reuters Health / elin021.htm New Smart Pacemakers, ICDs Will Even Contact Your Doctor For You, News and Press Releases, San Diego Tuesday, May 07, 2002, North American Society of Pacing and Electrophysiology Bibliography N/A 4. 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. Policy No. MP-052-MC-KY Page 5 of 10

6 5. Place of Service The place of service for surveillance of implantable or wearable cardioverter defibrillators are outpatient. 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. 011x Hospital Inpatient (Including Medicare Part A) 012x 013x 022x 023x 071x 073x 077x 085x Hospital Inpatient (Medicare Part B only) Hospital Outpatient Skilled Nursing - Inpatient (Medicare Part B only) Skilled Nursing - Outpatient Clinic - Rural Health Clinic - Freestanding Clinic - Federally Qualified Health Center (FQHC) 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. Revenue codes only apply to providers who bill these services to the Part A MAC. Revenue codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC. Please note that not all revenue codes apply to every type of bill code. Providers are encouraged to refer to the FISS revenue code file for allowable bill types. Similarly, not all revenue codes apply to each CPT/HCPCS code. Providers are encouraged to refer to the FISS HCPCS file for allowable revenue codes. All revenue codes billed on the inpatient claim for the dates of service in question may be subject to review Cardiology - General Classification 0489 Cardiology - Other Cardiology Policy No. MP-052-MC-KY Page 6 of 10

7 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 for Surveillance of Implantable or Wearable Cardioverter Defibrillators. There is a CGS LCD for Surveillance of Implantable or Wearable Cardioverter Defibrillators. Please see the link below to see the CGS LCD: There is no NCD for Automatic External Defibrillators. There is a CGS DME LCD for Automatic External Defibrillators. Please refer to the link below to see the CGS LCD L33690: There is an NCD (20.4) for implantable Cardioverter-Defibrillators (ICDs) but there is no NCD or LCD for subcutaneous implantable cardioverter-defibrillators (S-ICDs). REIMBURSEMENT Participating facilities will be reimbursed per their Gateway Health contract. CODING REQUIREMENTS Procedure Codes CPT Codes Description PROGRAMMING DEVICE EVALUATION (IN PERSON) WITH ITERATIVE ADJUSTMENT OF THE IMPLANTABLE DEVICE TO TEST THE FUNCTION OF THE DEVICE AND SELECT OPTIMAL PERMANENT PROGRAMMED VALUES WITH ANALYSIS, REVIEW AND REPORT BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL; SINGLE LEAD TRANSVENOUS IMPLANTABLE DEFIBRILLATOR SYSTEM PROGRAMMING DEVICE EVALUATION (IN PERSON) WITH ITERATIVE ADJUSTMENT OF THE IMPLANTABLE DEVICE TO TEST THE FUNCTION OF THE DEVICE AND SELECT OPTIMAL PERMANENT PROGRAMMED VALUES WITH ANALYSIS, REVIEW AND REPORT BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL; DUAL LEAD TRANSVENOUS IMPLANTABLE DEFIBRILLATOR SYSTEM PROGRAMMING DEVICE EVALUATION (IN PERSON) WITH ITERATIVE ADJUSTMENT OF THE IMPLANTABLE DEVICE TO TEST THE FUNCTION OF THE DEVICE AND SELECT OPTIMAL PERMANENT PROGRAMMED VALUES WITH ANALYSIS, REVIEW AND REPORT BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL; MULTIPLE LEAD TRANSVENOUS IMPLANTABLE DEFIBRILLATOR SYSTEM PERI-PROCEDURAL DEVICE EVALUATION (IN PERSON) AND PROGRAMMING OF DEVICE SYSTEM PARAMETERS BEFORE OR AFTER A SURGERY, PROCEDURE, OR TEST WITH ANALYSIS, REVIEW AND REPORT BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL; SINGLE, DUAL, OR MULTIPLE LEAD IMPLANTABLE DEFIBRILLATOR SYSTEM INTERROGATION DEVICE EVALUATION (IN PERSON) WITH ANALYSIS, REVIEW AND REPORT BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL, INCLUDES CONNECTION, Policy No. MP-052-MC-KY Page 7 of 10

8 RECORDING AND DISCONNECTION PER PATIENT ENCOUNTER; SINGLE, DUAL, OR MULTIPLE LEAD TRANSVENOUS IMPLANTABLE DEFIBRILLATOR SYSTEM, INCLUDING ANALYSIS OF HEART RHYTHM DERIVED DATA ELEMENTS INTERROGATION DEVICE EVALUATION (IN PERSON) WITH ANALYSIS, REVIEW AND REPORT BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL, INCLUDES CONNECTION, RECORDING AND DISCONNECTION PER PATIENT ENCOUNTER; WEARABLE DEFIBRILLATOR SYSTEM INTERROGATION DEVICE EVALUATION(S) (REMOTE), UP TO 90 DAYS; SINGLE, DUAL, OR MULTIPLE LEAD IMPLANTABLE DEFIBRILLATOR SYSTEM WITH INTERIM ANALYSIS, REVIEW(S) AND REPORT(S) BY A PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL INTERROGATION DEVICE EVALUATION(S) (REMOTE), UP TO 90 DAYS; SINGLE, DUAL, OR MULTIPLE LEAD PACEMAKER SYSTEM OR IMPLANTABLE DEFIBRILLATOR SYSTEM, REMOTE DATA ACQUISITION(S), RECEIPT OF TRANSMISSIONS AND TECHNICIAN REVIEW, TECHNICAL SUPPORT AND DISTRIBUTION OF RESULTS Diagnosis Codes ICD-10 Codes Description I46.2 Cardiac arrest due to underlying cardiac condition I46.8 Cardiac arrest due to other underlying condition I47.0 Re-entry ventricular arrhythmia I47.2 Ventricular tachycardia I47.9 Paroxysmal tachycardia, unspecified I49.01 Ventricular fibrillation I49.02 Ventricular flutter R00.0 Tachycardia, unspecified R00.2 Palpitations R42 Dizziness and giddiness R55 Syncope and collapse T82.110A* Breakdown (mechanical) of cardiac electrode, initial encounter T82.111A* Breakdown (mechanical) of cardiac pulse generator (battery), initial encounter T82.118A* Breakdown (mechanical) of other cardiac electronic device, initial encounter T82.120A* Displacement of cardiac electrode, initial encounter T82.121A* Displacement of cardiac pulse generator (battery), initial encounter T82.128A* Displacement of other cardiac electronic device, initial encounter T82.190A* Other mechanical complication of cardiac electrode, initial encounter T82.191A* Other mechanical complication of cardiac pulse generator (battery), initial encounter T82.198A* Other mechanical complication of other cardiac electronic device, initial encounter T82.817A* Embolism due to cardiac prosthetic devices, implants and grafts, initial encounter T82.827A* Fibrosis due to cardiac prosthetic devices, implants and grafts, initial encounter T82.837A* Hemorrhage due to cardiac prosthetic devices, implants and grafts, initial encounter T82.847A* Pain due to cardiac prosthetic devices, implants and grafts, initial encounter T82.857A* Stenosis of other cardiac prosthetic devices, implants and grafts, initial encounter T82.867A* Thrombosis due to cardiac prosthetic devices, implants and grafts, initial encounter Policy No. MP-052-MC-KY Page 8 of 10

9 T82.897A* Z45.010* Z45.018* Z45.02* Z48.03* Z48.89* Z95.0* Z95.810* Other specified complication of cardiac prosthetic devices, implants and grafts, initial encounter Encounter for checking and testing of cardiac pacemaker pulse generator [battery] Encounter for adjustment and management of other part of cardiac pacemaker Encounter for adjustment and management of automatic implantable cardiac defibrillator Encounter for change or removal of drains Encounter for other specified surgical aftercare Presence of cardiac pacemaker Presence of automatic (implantable) cardiac defibrillator Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: *Use Z45.02 for interrogation and reprogramming of defibrillator prior to undergoing a surgical procedure unrelated to defibrillator. *Use Z48.03 or Z48.89 for interrogation and/or reprogramming of defibrillator following surgical procedure unrelated to defibrillator. *ICD-10 codes Z95.0, Z45.010, Z45.018, T82.110A,T82.111A, T82.118A, T82.120A,T82.121A, T82.128A, T82.190A,T82.191A, and T82.198A are payable only for CPT code These ICD-10 codes have been added to this list only because CPT code refers to pacemaker systems in addition to implantable cardiac defibrillator systems in its descriptor. When this CPT code is reported for services for implantable or wearable cardioverter defibrillators, coverage defined in this LCD applies. POLICY SOURCE(S) Centers for Medicare and Medicaid Services (CMS), Local Coverage Determination (LCD). No. L34087: Surveillance of Implantable or Wearable Cardioverter Defibrillators (ICDs): Office, Hospital, Web, or Non-Web Based. Effective on October 05, Accessed on February 6, 2018 and available at: Centers for Medicare and Medicaid Services (CMS), National Coverage Determination (NCD). No. 20.4: Implantable Automatic Defibrillators. Effective January 27, Accessed on February 7, 2018 and available at: Centers for Medicare and Medicaid Services (CMS), Local Coverage Determination (LCD). No. L34833 Cardiac Rhythm Device Evaluation. Effective on October 01, Accessed on November 7, 2017 and available at: Centers for Medicare and Medicaid Services (CMS), Local Coverage Determination (LCD). No. L33690: Automatic External Defibrillators. October 1, Accessed on February 06, 2018 and available at: Policy No. MP-052-MC-KY Page 9 of 10

10 Policy History Date Activity 02/06/2018 Initial policy developed 02/21/2018 QI/UM Committee approval 04/15/2018 Provider effective date Policy No. MP-052-MC-KY Page 10 of 10