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Stimulation of the vagus nerve can be performed by means of an implantable stimulator within the carotid artery sheath. This technique has been proposed as a treatment for refractory seizures, depression, and other disorders.
Significant advances have occurred in surgical treatment for epilepsy and in medical treatment of epilepsy with newly developed and approved medications. Despite these advances, however, 25%-50% of patients with epilepsy experience breakthrough seizures or suffer from debilitating adverse effects of antiepileptic drugs. Vagus nerve stimulation (VNS) has been investigated as a treatment alternative in patients with medically refractory partial-onset seizures for whom surgery is not recommended or for whom surgery has failed.
While the mechanisms for the therapeutic effects of vagal nerve stimulation are not fully understood, the basic premise of VNS in the treatment of various conditions is that vagal visceral afferents have a diffuse central nervous system projection, and activation of these pathways has a widespread effect on neuronal excitability. Surgery for implantation of a vagal nerve stimulator involves wrapping 2 spiral electrodes around the left vagus nerve within the carotid sheath. The electrodes are connected to an infraclavicular generator pack. The programmable stimulator may be programmed in advance to stimulate at regular times or on demand by patients or family by placing a magnet against the sublacvicular implant site. In 1997, the U.S. Food and Drug administration (FDA) approved a vagus nerve stimulation device called the NeuroCybernetic Prosthesis (NCP®) system through the Premarket Approval (PMA) process. The device was approved for use in conjunction with drugs or surgery "as an adjuctive treatment of adults and adolescents over 12 years of age with medically refractory partial onset seizures."
Since 1997, it has been reported that recipients of a vagus nerve stimulator have experienced improvements in mood. Therefore, there has been research interest in VNS as a treatment of refractory depression. On July 15, 2005, Cyberonics received PMA approval by the FDA for the VNS TherapyTM System "for the adjunctive long-term treatment of chronic or recurrent depression for 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."
VNS therapy has also been investigated for use in other conditions such as headaches, obesity, and essential tremors.
Cerbomed has developed a transcutaneous VNS (t-VNS®) system that uses a combined stimulation unit and ear electrode to stimulate the auricular branch of the vagus nerve, which supplies the skin over the concha of the ear. Patients self-administer electric stimulation for several hours a day; no surgical procedure is required. The device received the CE mark in Europe in 2011, but has not been FDA approved for use in the U.S. Electrocore has developed a noninvasive VNS (gammaCore®) that is currently being investigated for headache; the device does not have FDA approval.
Vagus nerve stimulation (VNS) may be considered medically necessary as a treatment of medically refractory seizures defined as:
Vagus nerve stimulation is considered investigational as a treatment of all other conditions, including but not limited to heart failure, fibromyalgia, essential tremors, obesity, depression, headaches, tinnitus, and traumatic brain injury.
Non implantable vagus nerve stimulation devices are considered investigational for all indications.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
2/1999: Approved by Medical Policy Advisory Committee (MPAC)
2/9/2000: Note POLICY change regarding device coverage
8/9/2001: Policy Guidelines section revised; all references to coding included under "Code Reference" section
2/13/2002: Investigational definition added
4/18/2002: Type of Service and Place of Service deleted
5/8/2002: Code Reference section updated
5/16/2002: Reviewed by MPAC; age restriction deleted, Sources updated
2/13/2004: Code Reference section updated, CPT code 61885, 63690, 63691 deleted
11/18/2004: Reviewed by MPAC, policy title "Chronic Vagus Nerve Stimulation for Treatment of Seizures" renamed "Vagus Nerve Stimulation," vagus nerve stimulation is considered investigational for treatment of essential tremors, CPT 64590, 95970, 95974, 95975 description revised, ICD-9 procedure code 04.92, 04.93 description revised, HCPCS E0753 deleted 2002
4/22/2005: Code Reference section reviewed, no changes
7/21/2005: Reviewed by MPAC: added "Vagus nerve stimulation for the treatment of depression is considered investigational."
10/27/2005: Code Reference section reviewed, no changes
11/15/2005: ICD9 procedure codes 86.97, 86.98 added
3/13/06: Policy updated, "NeuroCybernetic Prosthesis (NCP®) Model 101 is the only covered device." removed from policy as multiple devices are appropriate.
3/20/2006: Coding updated. HCPCS 2005 & 2006 revisions added to policy.
7/24/2006: Investigational conditions rewritten for clarification and headaches added.
9/19/2006: Coding updated. ICD9 2006 revisions added to policy. Coding revised. ICD9 2006 revisions added to policy
12/13/06: Policy reviewed, no changes
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
1/14/2008: Policy reviewed, policy statement clarified but no changes to intent
12/5/2008: Policy reviewed, policy statement revised to include all seizure disorders that are medically refractory. Obesity added to the investigational statement.
12/16/2008: Code reference section updated. Added ICD-9 diagnosis codes 345.01, 345.11, 345.21, 345.31, 345.61, 345.71, 345.81 and 345.91 as covered codes.
12/31/2008: Code reference section updated per the 2009 CPT/HCPCS revisions
12/10/2009: Policy Description revised to remove principal subtypes of partial-onset seizures. Policy Statement updated with definition of refractory seizures. Policy Exceptions revised to add FEP verbiage. Coding Section revised as follows: CPT4 codes 61885 and 61886 added to Covered Codes Table. CPT4 codes 64585, 64590, 64595, 95970 removed from Covered Codes Table. ICD9 procedure codes 02.93, 86.94, 86.95, and 86.96 added to Covered Codes Table. ICD9 procedure codes 04.92, 04.93, 04.99, and 86.09 removed from Covered Codes Table. Corrected ICD9 diagnosis codes 345.2 and 345.3 by removing incorrect 5th digit. HCPCS code L8689 added to Covered Codes Table. HCPCS codes E0752, E0754, E0756, E0757, and E0758 removed from Covered Codes Table. Verbiage added, "*Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement section". Coding requirement information added.
10/14/2010: Annual ICD-9 code update: Added new ICD-9 code 780.33 to the Covered Codes table.
03/07/2011: Added new CPT codes 64568, 64569, and 64570 to the Code Reference section.
04/26/2012: Investigational policy statement revised to add heart failure and fibromyalgia as investigational conditions. Deleted outdated references from the Sources section. Removed deleted CPT code 64573 from the Code Reference section.
07/19/2013: Policy reviewed; no changes.
05/02/2014: Policy reviewed; description updated regarding VNS devices. Investigational policy statement revised to add tinnitus and traumatic brain injury as investigational conditions. Added investigational policy statement that non implantable vagus nerve stimulation devices are considered investigational for all indications.
Blue Cross Blue Shield Association policy # 7.01.20
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Vagal nerve stimulation requires not only the surgical implantation of the device, but also subsequent neurostimulator programming, which occurs intraoperatively and typically during additional outpatient visits.