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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. There are also devices available that are implanted at different areas of the vagus nerve. This policy also addresses devices that stimulate the vagus nerve transcutaneously.
Vagus Nerve Stimulation
Vagus nerve stimulation (VNS) was initially 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. Over time, the use of VNS has expanded to generalized seizures, and it has been investigated for a range of other conditions.
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. Electrical stimulus is applied to axons of the vagus nerve, which have their cell bodies in the nodose and junctional ganglia and synapse on the nucleus of the solitary tract in the brainstem. From the solitary tract nucleus, vagal afferent pathways project to multiple areas of the brain. There are also vagal efferent pathways that innervate the heart, vocal cords, and other laryngeal and pharyngeal muscles, and provide parasympathetic innervation to the gastrointestinal tract that may also be stimulated by VNS.
The type of VNS device addressed in this policy consists of an implantable, programmable electronic pulse generator that delivers stimulation to the left vagus nerve at the carotid sheath. The pulse generator is connected to the vagus nerve via a bipolar electrical lead. Surgery for implantation of a vagal nerve stimulator involves implantation of the pulse generator in the infraclavicular region and wrapping 2 spiral electrodes around the left vagus nerve within the carotid sheath. 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 subclavicular implant site.
Various types of devices that stimulate the vagus nerve transcutaneously have been developed as well. One device made by Cerbomed stimulates the auricular branch of the vagus nerve. Some devices used in studies are not well characterized as to the specific manufacturer or type of device used. The U.S. Food and Drug Administration has not approved any transcutaneous VNS devices.
Other types of vagus nerve stimulators are also available. The Maestro® System (EnteroMedics, St. Paul, MN) consists of a subcutaneously-implanted pulse generator and electrodes that are placed in contact with the trunks of the vagus nerve at the gastroesophageal junction. These types of stimulators differ in the location of the pulse generator and electrodes and the stimulation programming settings, and are not addressed in this policy.
Potential Indications for VNS
VNS was originally approved for the treatment of medically refractory epilepsy. Significant advances have been made since then in the surgical and medical treatment of epilepsy, and newer, more recently approved medications are available. Despite these advances, however, 25%-50% of patients with epilepsy experience breakthrough seizures or suffer from debilitating adverse effects of antiepileptic drugs. For patients such as these, VNS therapy has been used as an alternative to or adjunct to epilepsy surgery or medications.
Based on observations that patients treated with VNS experienced improvements in mood, VNS has been evaluated for the treatment of refractory depression. VNS has been investigated for multiple other conditions which may be affected by either the afferent or efferent stimulation of the vagus nerve, including headaches, tremor, obesity, heart failure, fibromyalgia, tinnitus, and traumatic brain injury.
In 1997, the U.S. Food and Drug administration (FDA) approved a vagus nerve stimulation device called the NeuroCybernetic Prosthesis (NCP®) System (Cyberonics) 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."
On July 15, 2005, Cyberonics received PMA supplement 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."
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 Medical has developed a noninvasive VNS (gammaCore®) that is currently being investigated for headache; the device has not been FDA approved for use in the United States.
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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
04/06/2015: Policy description updated regarding devices and potential indications for VNS. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
08/26/2015: Code Reference section updated for ICD-10. Updated the code descriptions for 61885 and 61886.
03/31/2016: Policy description updated regarding devices. Policy statements unchanged.
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.