Highmark Medicare Services

12102, 12202, 12302, 12501, 12301, 12201

MAC Part A & B

L27533

Surveillance of Implantable Cardioverter-Defibrillator (ICD), Office, Internet or Non-Internet Based

L27533

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

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.

CMS Internet On-Line Manual Publication 100-3, Chapter 1, Section 20.8. This section is specific to the coverage of Cardiac Pacemakers.

CMS Internet On-Line Manual Publication 100-3, Chapter 1, Sections 20.8.1 and 20.8.1.1. These sections are specific to Cardiac Pacemaker Evaluation Services and Transtelephonic Monitoring of Cardiac Pacemakers.

CMS Internet On-Line Manual Publication 100-3, Chapter 1, Section 20.4. This section is specific to the coverage of Implantable Automatic Defibrillators.

CMS Transmittal 29 and 497, Change Request 3604

CMS Transmittal 979, Change Request 5048

Pennsylvania, Maryland, District of Columbia, Delaware

Central Office

For services performed on or after 07/11/2008

N/A

For services performed on or after 08/01/2008

08/31/2008

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

Traditional follow-up of an implanted cardioverter-defibrillator (ICD) is done by way of a compatible programmer in a face-to-face encounter. Intervening symptoms, event markers and device responses are evaluated and, if necessary, reprogramming of the device is initiated.

The Internet now provides a medium through which a physician can acquire device information from a patient's implanted defibrillator (ICD) without face-to-face contact. The patient may use a manufacturer's specific transmitter to send data to a central service station. The physician, in turn, retrieves the data with an office computer. This information is identical to a face-to-face ICD interrogation without reprogramming.

Covered Indications

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 Internet based modalities should be coordinated so that there are no unnecessary duplications of the interrogation services.

The symptoms requiring unscheduled investigation by Internet or face-to-face modalities should be discrete symptoms such as post-shock events, syncope, near-syncope or palpitations.

Coverage Limitations

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 the analysis must be a separate and distinct face-to-face service. No part of the ICD surveillance (face-to-face or Internet based) may be reported as an E&M service.

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 report the interrogation with or without reprogramming services.

A global service may be reported for Internet based monitoring when the physician and his/her staff perform the technical and professional component of the service.

The technical portion of the service may be reported when the physician has the equipment, software, supplies and Internet connections sufficient to access and use the network services (i.e., to receive, review and/or manipulate the transmitted device data). The physician and his/her staff are solely responsible for scheduling of device evaluations, printing, storing and maintaining patient device data, and communications with the patient regarding device monitoring.

The professional component of the service includes complete analysis of the device data, final interpretation of the transmission, generation of a complete report, and communication with the patient, referring physician, etc. as appropriate.

Diagnostic Tests and X-Rays

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.

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.

N/A

All those not listed under the “ICD-9 Codes that Support Medical Necessity” section of this policy.

Conditions that are not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy.

1. All documentation must be maintained in the patient's medical record and be 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 record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
   
3. The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed.

Documentation must support the medical necessity of this service as outlined in the "Indications and Limitations of Coverage and/or Medical Necessity" section of this policy.

The 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.

All of the following must be maintained in the patient's medical record in the physician's office:

• A copy of the physician's order for the service
• All transmissions
• Formal interpretations
• Reports
• Information relating the reason for the service (i.e., routine follow-up versus symptomatic)
• The nature of the symptoms

Documentation must include a current, pertinent history and physical examination, and progress notes describing and supporting the covered indication.

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

The frequency and need for both face-to-face and Internet based modalities should be coordinated so that there are no unnecessary duplications of the interrogation services.

When the service is rendered for remote monitoring purposes for single, dual or multiple lead implantable cardioverter defibrillator systems with interim physician analysis and physician review and report, it is expected that the service will be performed no more often than once every 90 days.

When the service is rendered for other indications, it may be performed as appropriate based on clinical symptomatology.

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/

Other Contractor's policies

Highmark Medicare Services Contractor Medical Directors

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups that include representatives from the appropriate specialty(ies).

CAC/IAC Distribution:  04/01/2008

05/15/2008

05/23/2008

L27533

07/31/2008

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