L29304-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Vagal Nerve Stimulation (VNS) for Intractable Depression (L29304)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29304

LCD Title Vagal Nerve Stimulation (VNS) for Intractable Depression

Contractor's Determination Number 61885

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2012

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the 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 §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: CMS Manual System, Pub. 100-03, Medicare National Coverage Determination Manual, Chapter 1, Part 2,

Sections 160.7 and 160.18

CMS Transmittal 70 & 1271, Change Request 5612

Indications and Limitations of Coverage and/or Medical Necessity

Vagus Nerve stimulator (VNS) therapy involves the direct delivery of intermittent retrograde electrical impulses to the left vagus nerve via a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest with an electrical lead (wire) connected from the generator to the left vagus nerve. Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead. These signals are in turn sent to

the brain. This device was initially approved in 1997 for epilepsy and there is a Medicare National Coverage Decision (NCD) for that indication.

In 2005, the FDA approved this device for the treatment of patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

At present, the available evidence based on publications in peer-reviewed literature and other pertinent sources, is not sufficient to support VNS therapy for depression. Therefore, this Local Coverage Determination (LCD) finds VNS therapy as not reasonable and necessary and not eligible for reimbursement at this time.

Effective for services performed on or after May 4, 2007, VNS is not reasonable and necessary for resistant depression. (CMS Manual System, Pub. 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, Section 160.18C)

Coding Information

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.

999x Not Applicable

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.

99999 Not Applicable

CPT/HCPCS Codes

61885 INSERTION OR REPLACEMENT OF CRANIAL NEUROSTIMULATOR PULSE GENERATOR OR RECEIVER, DIRECT OR INDUCTIVE COUPLING; WITH CONNECTION TO A SINGLE ELECTRODE ARRAY

61888 REVISION OR REMOVAL OF CRANIAL NEUROSTIMULATOR PULSE GENERATOR OR RECEIVER

64568 INCISION FOR IMPLANTATION OF CRANIAL NERVE (EG, VAGUS NERVE) NEUROSTIMULATOR ELECTRODE ARRAY AND PULSE GENERATOR

64569 REVISION OR REPLACEMENT OF CRANIAL NERVE (EG, VAGUS NERVE) NEUROSTIMULATOR ELECTRODE ARRAY, INCLUDING CONNECTION TO EXISTING PULSE GENERATOR

64570 REMOVAL OF CRANIAL NERVE (EG, VAGUS NERVE) NEUROSTIMULATOR ELECTRODE ARRAY AND PULSE GENERATOR

64585 REVISION OR REMOVAL OF PERIPHERAL NEUROSTIMULATOR ELECTRODE ARRAY

95970

ELECTRONIC ANALYSIS OF IMPLANTED NEUROSTIMULATOR PULSE GENERATOR SYSTEM (EG, RATE, PULSE AMPLITUDE, PULSE DURATION, CONFIGURATION OF WAVE FORM, BATTERY STATUS, ELECTRODE SELECTABILITY, OUTPUT MODULATION, CYCLING, IMPEDANCE AND PATIENT COMPLIANCE MEASUREMENTS); SIMPLE OR COMPLEX BRAIN, SPINAL CORD, OR PERIPHERAL (IE, CRANIAL NERVE, PERIPHERAL NERVE, SACRAL NERVE, NEUROMUSCULAR) NEUROSTIMULATOR PULSE GENERATOR/TRANSMITTER, WITHOUT REPROGRAMMING

ELECTRONIC ANALYSIS OF IMPLANTED NEUROSTIMULATOR PULSE GENERATOR SYSTEM (EG, RATE, PULSE AMPLITUDE, PULSE DURATION, CONFIGURATION OF WAVE FORM, BATTERY STATUS, ELECTRODE

95974 SELECTABILITY, OUTPUT MODULATION, CYCLING, IMPEDANCE AND PATIENT COMPLIANCE MEASUREMENTS); COMPLEX CRANIAL NERVE NEUROSTIMULATOR PULSE GENERATOR/TRANSMITTER,

WITH INTRAOPERATIVE OR SUBSEQUENT PROGRAMMING, WITH OR WITHOUT NERVE INTERFACE TESTING, FIRST HOUR

ELECTRONIC ANALYSIS OF IMPLANTED NEUROSTIMULATOR PULSE GENERATOR SYSTEM (EG, RATE, PULSE AMPLITUDE, PULSE DURATION, CONFIGURATION OF WAVE FORM, BATTERY STATUS, ELECTRODE

95975 SELECTABILITY, OUTPUT MODULATION, CYCLING, IMPEDANCE AND PATIENT COMPLIANCE MEASUREMENTS); COMPLEX CRANIAL NERVE NEUROSTIMULATOR PULSE GENERATOR/TRANSMITTER,

WITH INTRAOPERATIVE OR SUBSEQUENT PROGRAMMING, EACH ADDITIONAL 30 MINUTES AFTER FIRST HOUR (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

ICD-9 Codes that Support Medical Necessity XX000 Not Applicable

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity

296.00 - 296.99 BIPOLAR I DISORDER, SINGLE MANIC EPISODE, UNSPECIFIED - OTHER SPECIFIED EPISODIC MOOD DISORDER

298.0 DEPRESSIVE TYPE PSYCHOSIS

300.4 DYSTHYMIC DISORDER

309.1 ADJUSTMENT DISORDER WITH DEPRESSED MOOD

309.2 ADJUSTMENT REACTION WITH PROLONGED DEPRESSIVE REACTION

309.28 ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSED MOOD

311 DEPRESSIVE DISORDER NOT ELSEWHERE CLASSIFIED

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical necessity for vagal nerve stimulation must be supported in the medical record and not be related to intractable depression. Documentation must be available to Medicare upon request.

Appendices

Utilization Guidelines N/A

Sources of Information and Basis for Decision

Blue Cross Blue Shield Association, Technology Evaluation Center, Assessment Program. (2005). Vagus Nerve Stimulation for Treatment-Resistant Depression, 20 (8).

Department of Health and Human Services, U.S. Food and Drug Administration. (2005). VNS Therapy System – P970003s050. Center for Devices and Radiological Health.

FDA approval letter, July 15, 2005, and other FDA documents.

Nahas, Z., Marangell, L.B., Husain, M.M., Rush, A.J., Sackeim, H.A., Lisanby, S.H., et al. (2005). Two-year outcome of vagus nerve stimulation (VNS) for treatment of major depressive episodes. Journal of Clinical Psychiatry, 66(9), 1097-1104.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2011

Revision History Number 2

Revision History Explanation Revision Number:2 Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2012 Revised Effective Date: 01/01/2012

LCR B2012-006

December 2011 Connection

Explanation of Revision: Annual 2012 HCPCS Update. Descriptors revised for CPT codes 64585, 95970, 95974, & 95975. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2011 Revised Effective Date 01/01/2011

LCR B2011-006

December 2011 Update

Explanation of Revision: Annual 2011 HCPCS Update. CPT code 64573 was deleted. In addition, added CPT codes 64568, 64569, and 64570. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29304) replaces LCD L23157 as the policy in notice. This document (L29304) is effective on 02/02/2009.

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

95970 descriptor was changed in Group 1

95974 descriptor was changed in Group 1 95975 descriptor was changed in Group 1

11/21/2010 - The following CPT/HCPCS codes were deleted: 64573 was deleted from Group 1

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

64585 descriptor was changed in Group 1 95970 descriptor was changed in Group 1 95974 descriptor was changed in Group 1 95975 descriptor was changed in Group 1

Reason for Change