This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions


This Medical Policy is provided for informational purposes only.

If Members have any questions about the medical necessity of a service or procedure, they should discuss the question with their Network Provider or call a member of our Customer Service Team.

MEDICAL POLICY USE DISCLAIMER

  1. Medical Policy is used by Blue Cross & Blue Shield of Mississippi, A Mutual Insurance Company ("BCBSMS") as one set of guidelines (among other sets of guidelines) to assist BCBSMS in making benefit coverage decisions. BCBSMS utilizes Medical Policy adopted by our Medical Policy Advisory Committee ("MPAC") which is supported by the Blue Cross and Blue Shield Association Medical Policy, research and development. Medical Policies are the property of BCBSMS and any use of Medical Policy not agreed to by BCBSMS is strictly prohibited. The use of Medical Policy for purposes related to the health care of a BCBSMS plan member is permitted and is not a violation of the proprietary rights of BCBSMS.
  2. These Medical Policies are based on scientifically meritorious evidence provided through research for a particular medical technology. Medical Policy is also based on data from peer-reviewed scientific literature, from criteria developed by specialty societies and from guidelines adopted by other health care organizations.
  3. These Medical Policies apply to members/subscribers who have health insurance through BCBSMS. This Medical Policy also applies to persons covered by the Mississippi Children's Health Insurance Program, Members of a self-insured group health plan for which Blue Cross & Blue Shield of Mississippi provides claims administration and persons covered by a Medicare Supplement policy offered by BCBSMS. This Medical Policy does not apply to any other individuals. Medical Policies may differ for Federal employees covered under the Federal Employees Health Benefits Plan.
  4. In the event of any conflict between this Medical Policy and any benefit plan, Summary Plan Description or other coverage document, the benefit plan, Summary Plan Description or other coverage document will govern.
  5. Medical technology is rapidly changing and these Medical Policies are subject to change without notice. Also, please be aware that as a result of ongoing changes being made to Medical Policy, BCBSMS cannot and does not guarantee that these Medical Policies are current.

BCBSMS Medical Policies are Subject to the Following Restrictions

Medical Policy Search
Printer Friendly Version Vagus Nerve Stimulation

Vagus Nerve Stimulation

 

DESCRIPTION

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 antiepileptic 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 upon 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.

 

POLICY

Vagus nerve stimulation (VNS) may be considered medically necessary as a treatment of medically refractory seizures defined as:
  • Seizures that occur in spite of therapeutic levels of antiepileptic drugs, or
  • Seizures that cannot be treated with therapeutic levels of antiepileptic drugs because of intolerable adverse effects of these drugs

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 and headaches.

 

POLICY EXCEPTIONS

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.

 

POLICY GUIDELINES

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.

 

POLICY HISTORY

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.

 

SOURCE(S)

Hayes Medical Technology Directory

Blue Cross Blue Shield Association policy # 7.01.20

 

CODE REFERENCE

This is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

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.

Code Number

Description

CPT-4

61885

Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array

61886

Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays

64553

Percutaneous implantation of neurostimulator electrodes; cranial nerve

64568Incision for implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator  (New 01-01-2011)
64569Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generator (New 01-01-2011)
64570Removal of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator  (New 01-01-2011)

95974

Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and 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 and 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 Procedure

02.93

Implantation or replacement of intracranial neurostimulator lead(s)

89.15

Other nonoperative neurologic function tests

86.94

Insertion or replacement of single array neurostimulator pulse generator, not specified as rechargeable

86.95

Insertion or replacement of dual array neurostimulator pulse generator, not specified as rechargeable

86.96

Insertion or replacement of other neurostimulator pulse generator

86.97

Insertion or replacement of single array rechargeable neurostimulator pulse generator

86.98

Insertion or replacement of dual array rechargeable neurostimulator pulse generator

ICD-9 Diagnosis

345.01

Generalized nonconvulsive epilepsy with intractable epilepsy

345.11

Generalized convulsive epilepsy with intractable epilepsy

345.2

Petit mal status

345.3

Grand mal status 

345.41

Localization-related (focal) (partial) epilepsy and epileptic syndromes with simple partial seizures, with intractable epilepsy 

345.51

Localization-related (focal) (partial) epilepsy and epileptic syndromes with simple partial seizures, with intractable epilepsy 

345.61

Infantile spasms with intractable epilepsy

345.71

Epilepsia partalis continua with intractable epilepsy

345.81

Other forms of epilepsy and recurrent seizures with intractable epilepsy

345.91

Epilepsy, unspecified with intractable epilepsy

780.32

Complex febrile convulsions. 

780.33Post traumatic seizures (New 10-01-2010)

780.39

Other convulsions

HCPCS

L8680

Implantable neurostimulator electrode, each

L8681

Patient programmer (external), for use with implantable programmable neurostimulator pulse generator, replacement only 

L8682

Implantable neurostimulator radiofrequency receiver

L8683

Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver

L8685

Implantable neurostimulator pulse generator, single array, rechargeable, includes extension

L8686

Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension

L8687

Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension

L8688

Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

L8689

External recharging system for battery (internal) for use with implantable Neurostimulator, replacement only

 

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