Friday, November 16, 2018

CPT 61885, 61886, 64553, 64568, 64569 - Cranial neurostimulator pulse generator

Coding Code Description CPT

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

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

HCPCS

L8680 Implantable neurostimulator electrode, each

L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator

L8682 Implantable neurostimulator radiofrequency receiver

L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver

L8684 Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement

L8685 Implantable eurostimulator 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


Introduction

The vagus nerve starts in the brain stem and runs down the neck, into the chest, and then down to the stomach area. Stimulating this nerve has been studied as a way to treat several different types of conditions. A small device that generates electricity is surgically placed in a person’s chest. A thin wire leads from the device to the vagus nerve. Vagus nerve stimulation may be used to treat seizures that don’t respond to medication. However, for other conditions it’s considered investigational (unproven). There is not yet enough information in published medical studies to show how well it works for other conditions. Similarly, non-implanted devices to stimulate the vagus nerve for treatment of any condition are also investigational due to lack of evidence that they improve one’s health.

Policy Coverage Criteria Service Medical Necessity Vagus nerve stimulation eg, NeuroCybernetic Prosthesis (NCP®) (Cyberonics)

Vagus nerve stimulation may be considered medically necessary as a treatment of medically refractory seizures*. *Medically refractory seizures are defined as seizures that occur despite therapeutic levels of antiepileptic drugs or seizures that cannot be treated with therapeutic levels of antiepileptic drugs because of intolerable adverse events of these drugs. This indication is applicable for both pediatric and adult patients.

Service Investigational
Vagus nerve stimulation Vagus nerve stimulation is considered investigational as a treatment of other conditions, including but not limited to:

* depression
* essential tremor
* fibromyalgia
* headaches
* heart failure
* obesity (see Related Policy 7.01.150)
* tinnitus
* traumatic brain injury
* upper-limb impairment due to stroke

Non-implantable vagus nerve stimulation devices eg, gammaCore® (ElectroCore)

Non-implantable (transcutaneous) vagus nerve stimulation devices are considered investigational for all indications.

Documentation Requirements

The medical records submitted for review should document that medical necessity criteria are met. The record should include documentation that member has medically refractory seizures as evidenced by:
* Persistent seizures in spite of therapeutic levels of antiepileptic medications



Documentation Requirements OR

* Member has intolerable side effects of drug therapy Vagus nerve stimulation has been evaluated for the treatment of obesity. This indication is addressed in a separate policy (see Related Policies).




Related Information

Definition of Terms


Medically refractory seizures are 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.

Evidence Review Description Stimulation of the vagus nerve can be performed by using a pulsed electrical stimulator implanted 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 through the skin (transcutaneously).


Background Vagus Nerve Stimulation (VNS)

VNS was initially investigated as a possible 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 VNS 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. An 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. VNS may also stimulate vagal efferent pathways that innervate the heart, vocal cords, and other laryngeal and pharyngeal muscles, and provide parasympathetic innervation to the gastrointestinal tract.

A 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 two spiral electrodes around the left vagus nerve within the carotid sheath. The programmable stimulator may be programmed in advance to stimulate at regular intervals or on demand by patients or family by placing a magnet against the infraclavicular implant site.

Various types of devices that transcutaneously stimulate the vagus nerve have been developed as well. The U.S. Food and Drug Administration (FDA) has not approved any transcutaneous VNS devices.

Other types of implantable vagus nerve stimulators that are placed in contact with the trunks of the vagus nerve at the gastroesophageal junction are not addressed in this policy.


Indications
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% to 50% of patients with epilepsy experience breakthrough seizures or suffer from debilitating adverse effects of antiepileptic drugs. For these patients, VNS therapy has been used as an alternative or adjunct to epilepsy surgery or medications. Based on observations that patients treated with VNS experience 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, heart failure, fibromyalgia, tinnitus, and traumatic brain injury.

Summary of Evidence

Vagus Nerve Stimulation


For individuals who have seizures refractory to medical treatment who receive VNS, the evidence includes RCTs and multiple observational studies. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The RCTs reported significant reductions in seizure frequency for patients with partial-onset seizures. The uncontrolled studies have consistently  reported large reductions in a broader range of seizure types in both adults and children. The evidence is sufficient to determine that the technology results in a meaningful improvement inthe net health outcome.

For individuals who have treatment-resistant depression who receive VNS, the evidence includes an RCT, other nonrandomized comparative studies, and case series. Relevant outcomes are  symptoms, change in disease status, and functional outcomes. The RCT only reported shortterm  results and found no significant improvement for the primary outcome. Other available studies are limited by small sample sizes, potential selection bias, and lack of a control group in the case series. The evidence is insufficient to determine the effects of the technology on health outcomes.

Other Conditions

For individuals who have chronic heart failure who receive VNS, the evidence includes RCTs and case series. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The RCTs evaluating chronic heart failure did not show significant improvements in the primary outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have upper-limb impairment due to stroke who receive VNS, the evidence includes a single pilot study. Relevant outcomes are symptoms, change in disease status, and functional outcomes. This pilot study has provided preliminary support for improvement in functional outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have other neurologic conditions (eg, essential tremor, headache, fibromyalgia, tinnitus, or autism) who receive VNS, the evidence includes case series. Relevant outcomes are symptoms, change in disease status, and functional outcomes. Case series are insufficient to draw conclusions regarding efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

Transcutaneous Vagus Nerve Stimulation


For individuals with episodic cluster headaches who receive transcutaneous VNS, the evidence includes 3 RCTs. One RCT for a cluster headache showed a reduction in headache frequency but did not include a sham treatment group. Two randomized, double-blind, sham-controlled studies showed efficacy of achieving pain-free status within 15 minutes of treatment with noninvasive VNS in patients with episodic cluster headaches but not in patients with chronic cluster headaches. The RCTs for episodic cluster headaches are promising, however, additional studies with larger relevant populations are required to establish the treatment efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have other neurologic, psychiatric, or metabolic disorders (eg, epilepsy, depression, schizophrenia, headache, impaired glucose tolerance) who receive transcutaneous VNS, the evidence includes RCTs and case series for some of the conditions. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The RCTs are all small and have various methodologic problems. None showed definitive efficacy of transcutaneous VNS in improving patient outcomes. No controlled trials are published to date evaluating gammaCore for the acute treatment of migraine headache. The evidence is insufficient to determine the effects of the technology on health outcomes.

1 comment:

  1. Very interesting website I am so looking forward to reading more posts. Well, Vagus Nerve Stimulation is a form of treatment for people whose seizures are not controlled with medications alone. Read more about Neurostimulation, here: href="https://novelaneuro.com/blog/a-brief-overview-of-deep-brain-stimulation

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