LCD/NCD Portal

L29304

 

VAGAL NERVE STIMULATION (VNS) FOR INTRACTABLE DEPRESSION

 

 

01/01/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

• 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.

o 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)

 

 

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

95974 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); COMPLEX CRANIAL NERVE NEUROSTIMULATOR PULSE GENERATOR/TRANSMITTER, WITH INTRAOPERATIVE OR SUBSEQUENT PROGRAMMING, WITH OR WITHOUT NERVE INTERFACE TESTING, FIRST HOUR

95975 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); 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 DO NOT Support Medical Necessity

 

296.00 BIPOLAR I DISORDER, SINGLE MANIC EPISODE, UNSPECIFIED

296.01 BIPOLAR I DISORDER, SINGLE MANIC EPISODE, MILD

296.02 BIPOLAR I DISORDER, SINGLE MANIC EPISODE, MODERATE

296.03 BIPOLAR I DISORDER, SINGLE MANIC EPISODE, SEVERE, WITHOUT MENTION OF PSYCHOTIC BEHAVIOR

296.04 BIPOLAR I DISORDER, SINGLE MANIC EPISODE, SEVERE, SPECIFIED AS WITH PSYCHOTIC BEHAVIOR

296.05 BIPOLAR I DISORDER, SINGLE MANIC EPISODE, IN PARTIAL OR UNSPECIFIED REMISSION

296.06 BIPOLAR I DISORDER, SINGLE MANIC EPISODE, IN FULL REMISSION

296.10 MANIC AFFECTIVE DISORDER RECURRENT EPISODE UNSPECIFIED DEGREE

296.11 MANIC AFFECTIVE DISORDER RECURRENT EPISODE MILD DEGREE

296.12 MANIC AFFECTIVE DISORDER RECURRENT EPISODE MODERATE DEGREE

296.13 MANIC AFFECTIVE DISORDER RECURRENT EPISODE SEVERE DEGREE WITHOUT PSYCHOTIC BEHAVIOR

296.14 MANIC AFFECTIVE DISORDER RECURRENT EPISODE SEVERE DEGREE SPECIFIED AS WITH PSYCHOTIC BEHAVIOR

296.15 MANIC AFFECTIVE DISORDER RECURRENT EPISODE IN PARTIAL OR UNSPECIFIED REMISSION

296.16 MANIC AFFECTIVE DISORDER RECURRENT EPISODE IN FULL REMISSION

296.20 MAJOR DEPRESSIVE AFFECTIVE DISORDER SINGLE EPISODE UNSPECIFIED DEGREE

296.21 MAJOR DEPRESSIVE AFFECTIVE DISORDER SINGLE EPISODE MILD DEGREE

296.22 MAJOR DEPRESSIVE AFFECTIVE DISORDER SINGLE EPISODE MODERATE DEGREE

296.23 MAJOR DEPRESSIVE AFFECTIVE DISORDER SINGLE EPISODE SEVERE DEGREE WITHOUT PSYCHOTIC BEHAVIOR

296.24 MAJOR DEPRESSIVE AFFECTIVE DISORDER SINGLE EPISODE SEVERE DEGREE SPECIFIED AS WITH PSYCHOTIC BEHAVIOR

296.25 MAJOR DEPRESSIVE AFFECTIVE DISORDER SINGLE EPISODE IN PARTIAL OR UNSPECIFIED REMISSION

296.26 MAJOR DEPRESSIVE AFFECTIVE DISORDER SINGLE EPISODE IN FULL REMISSION

296.30 MAJOR DEPRESSIVE AFFECTIVE DISORDER RECURRENT EPISODE UNSPECIFIED DEGREE

296.31 MAJOR DEPRESSIVE AFFECTIVE DISORDER RECURRENT EPISODE MILD DEGREE

296.32 MAJOR DEPRESSIVE AFFECTIVE DISORDER RECURRENT EPISODE MODERATE DEGREE

296.33 MAJOR DEPRESSIVE AFFECTIVE DISORDER RECURRENT EPISODE SEVERE DEGREE WITHOUT PSYCHOTIC BEHAVIOR

296.34 MAJOR DEPRESSIVE AFFECTIVE DISORDER RECURRENT EPISODE SEVERE DEGREE SPECIFIED AS WITH PSYCHOTIC BEHAVIOR

296.35 MAJOR DEPRESSIVE AFFECTIVE DISORDER RECURRENT EPISODE IN PARTIAL OR UNSPECIFIED REMISSION

296.36 MAJOR DEPRESSIVE AFFECTIVE DISORDER RECURRENT EPISODE IN FULL REMISSION

296.40 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MANIC, UNSPECIFIED

296.41 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MANIC, MILD

296.42 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MANIC, MODERATE

296.43 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MANIC, SEVERE, WITHOUT MENTION OF PSYCHOTIC BEHAVIOR

296.44 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MANIC, SEVERE, SPECIFIED AS WITH PSYCHOTIC BEHAVIOR

296.45 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MANIC, IN PARTIAL OR UNSPECIFIED REMISSION

296.46 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MANIC, IN FULL REMISSION

296.50 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) DEPRESSED, UNSPECIFIED

296.51 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) DEPRESSED, MILD

296.52 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) DEPRESSED, MODERATE

296.53 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) DEPRESSED, SEVERE, WITHOUT MENTION OF PSYCHOTIC BEHAVIOR

296.54 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) DEPRESSED, SEVERE, SPECIFIED AS WITH PSYCHOTIC BEHAVIOR

296.55 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) DEPRESSED, IN PARTIAL OR UNSPECIFIED REMISSION

296.56 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) DEPRESSED, IN FULL REMISSION

296.60 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MIXED, UNSPECIFIED

296.61 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MIXED, MILD

296.62 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MIXED, MODERATE

296.63 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MIXED, SEVERE, WITHOUT MENTION OF PSYCHOTIC BEHAVIOR

296.64 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MIXED, SEVERE, SPECIFIED AS WITH PSYCHOTIC BEHAVIOR

296.65 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MIXED, IN PARTIAL OR UNSPECIFIED REMISSION

296.66 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) MIXED, IN FULL REMISSION

296.7 BIPOLAR I DISORDER, MOST RECENT EPISODE (OR CURRENT) UNSPECIFIED

296.80 BIPOLAR DISORDER, UNSPECIFIED

296.81 ATYPICAL MANIC DISORDER

296.82 ATYPICAL DEPRESSIVE DISORDER

296.89 OTHER AND UNSPECIFIED BIPOLAR DISORDERS, OTHER

296.90 UNSPECIFIED EPISODIC MOOD DISORDER

296.99 OTHER SPECIFIED EPISODIC MOOD DISORDER

298.0 DEPRESSIVE TYPE PSYCHOSIS

300.4 DYSTHYMIC DISORDER

309.0 ADJUSTMENT DISORDER WITH DEPRESSED MOOD

309.1 ADJUSTMENT REACTION WITH PROLONGED DEPRESSIVE REACTION

309.28 ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSED MOOD

311 DEPRESSIVE DISORDER NOT ELSEWHERE CLASSIFIED

 

 

Documentation 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.

 

Treatment Logic

• 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.

 

 

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.

 

01/01/2012

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 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.

 

 

CMS LCD VAGAL NERVE STIMULATION (VNS) FOR INTRACTABLE DEPRESSION