Surveillance of Implantable or Wearable Cardioverter Defibrillators (ICDs): Office, Hospital, Web, or Non-Web Based

Language quoted from Centers for Medicare and Medicaid Services (CMS). National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Section 1862 (a)(7) excludes routine physical examinations, unless otherwise covered by statute.

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.

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/near-syncope 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 93295 and 93296 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 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-to-face 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 (93040-93042) 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.

Only physicians who have expertise and/or training in reprogramming of ICDs may bill the interrogation with or without reprogramming services.

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 410.74, 410.75, 410.76 and 419.22; 58 FR 18543, April 7, 2000.)

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The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (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.

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.


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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.

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 408-411.

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, 2002 @ http://www.cathlab.com.ar/revista/industrial/industria.htm FDA approves Web-based heart monitoring system by Alicia Ault, New York, Jan 03 (2002), Reuters Health Information @http://www.reutershealth.com/archive/2002/01/03/e…/20020103elin021.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 (NASPE) @http://www.naspe.org/.

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