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.

Coding Code Description CPT

61850 Twist drill or burr hole(s) for implantation of neurostimulator or electrodes, cortical.

61860 Craniectomy or craniotomy for implantation of neurostimulator electrodes, cerebral, cortical

61863 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), without use of intraoperative microelectrode recording; first array

61864 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), without use of


61867 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), with use of intraoperative microelectrode recording; first array

61868 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (eg, thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), with use of intraoperative microelectrode recording; each additional array (List separately in addition to primary procedure)

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

HCPCS

L8680 Implantable neurostimulator electrode, each
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



Introduction

Deep brain stimulation (DBS) can be used to treat essential tremor, Parkinson disease, and a movement disorder called dystonia. Deep brain stimulation is used when drugs aren’t able to control symptoms. It works by blocking electrical signals in specific areas of the brain that control movement. Surgery is needed to place a thin metal rod, called an electrode, in the brain.(When severe movement affects both sides of the body, an electrode may be implanted on each side of the brain.) The electrode is attached to a small device called a neurostimulator, which is placed under the skin below the collar bone. Batteries power the neurostimulator to send electrical signals to the electrode. This policy describes when deep brain stimulation may be considered medicall necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Policy Coverage Criteria Application Medical Necessity DBS of the thalamus Deep brain stimulation of the thalamus may be considered medically necessary for:
* Unilateral treatment of disabling, medically unresponsive tremor* due to:
o Parkinson’s disease OR
o Essential Tremor
* Bilateral treatment of disabling, medically unresponsive tremor* in both upper limbs due to:
o Parkinson’s disease OR
o Essential tremor
*See Definition of Terms DBS of the globus pallidus or subthalamic nucleus (unilateral or bilateral) Deep brain stimulation of the globus pallidus or subthalamic nucleus may be considered medically necessary for:
* Parkinson’s disease with ALL of the following:
o A good response to levodopa
o Motor complications not controlled by drug treatment AND
o One of the following:
* A minimum score of 30 points on the motor portion of the Unified Parkinson Disease Rating Scale (UPDRS) when the patient has been without medication for approximately 12 hours OR
* Parkinson’s disease for at least 4 years
* Primary dystonia** with ALL of the following:
o Patients older than 7 years of age AND
o Chronic, intractable (drug refractory)
**Note: may include generalized and/or segmental dystonia, hemidystonia, and


Application Medical Necessity cervical dystonia (torticollis) Application Investigational

DBS for other disorders Deep brain stimulation is considered investigational for:
* Other disorders, including but not limited to:
o Multiple sclerosis
o Post-traumatic dyskinesia
o Tardive dyskinesia
o Chronic cluster headaches
* Other psychiatric or neurologic diagnoses, including but not limited to:
o Alcohol addiction
o Alzheimer disease
o Anorexia nervosa
o Chronic pain
o Depression
o Epilepsy
o Obsessive-compulsive disorder
o Tourette syndrome

Definition of Terms

Disabling, medically unresponsive tremor is defined as all of the following:

* Tremor causing significant limitation in daily activities
* Inadequate control by maximal dosage of medication for at least 3 months before implant Contraindications to deep brain stimulation include:
* Patients who are not good surgical risks because of unstable medical problems or because of the presence of a cardiac pacemaker
* Patients who have medical conditions that require repeated magnetic resonance imaging
* Patients who have dementia that may interfere with the ability to cooperate
* Patients who have had botulinum toxin injections within the last 6 months

Evidence Review Background

Deep brain stimulation (DBS) is used as an alternative to permanent neuroablative proceduresfor control of essential tremor and Parkinson disease. DBS is also being evaluated for the treatment of a variety of other neurologic and psychiatric disorders.

Deep Brain Stimulation

Deep brain stimulation involves the stereotactic placement of an electrode into the brain (ie, hypothalamus, thalamus, globus pallidus, or subthalamic nucleus). The electrode is initially attached to a temporary transcutaneous cable for short-term stimulation to validate treatment effectiveness. Several days later, the patient returns for permanent subcutaneous implantation of the cable and a radiofrequency-coupled or battery-powered programmable stimulator. The electrode is typically implanted unilaterally on the side corresponding to the most severe symptoms. However, use of bilateral stimulation using 2 electrode arrays has also been investigated in patients with bilateral, severe symptoms. After implantation, noninvasive programming of the neurostimulator can be adjusted to the patient’s symptoms. This feature may be important for patients with Parkinson disease (PD), whose disease may progress over time, requiring different neurostimulation parameters. Setting the optimal neurostimulation parameters may involve the balance between optimal symptom control and appearance of adverse effects of neurostimulation such as dysarthria, disequilibrium, or involuntary movements.

Essential Tremor and PD

DBS has been investigated as an alternative to permanent neuroablative procedures, such as thalamotomy and pallidotomy. DBS has been most thoroughly investigated as an alternative to thalamotomy for unilateral control of essential tremor (ET) and tremor associated with Parkinson’s disease (PD). More recently, there has been research interest in the use of DBS of the globus pallidus or subthalamic nucleus as a treatment of other parkinsonian symptoms, such as rigidity, bradykinesia, or akinesia. Another common morbidity associated with PD is the occurrence of motor fluctuations, referred to as an "on and off" phenomena, related to the maximum effectiveness of drugs (ie, “on” state) and the nadir response during drug troughs (ie, “off” state). In addition, levodopa, the most commonly used anti-Parkinson drug, may be associated with disabling drug-induced dyskinesias. Therefore, the optimal pharmacologic treatment of PD may involve a balance between optimal effects on PD symptoms versus the appearance of drug-induced dyskinesias. The effect of DBS on both PD symptoms and druginduced dyskinesias has also been studied.

Primary and Secondary Dystonia

DBS has also been investigated in patients with primary and secondary dystonia, defined as a neurologic movement disorder characterized by involuntary muscle contractions, which force certain parts of the body into abnormal, contorted, and painful movements or postures. Dystonia can be classified according to age of onset, bodily distribution of symptoms, and cause. Age of onset can occur during childhood or during adulthood. Dystonia can affect certain portions of the body (focal dystonia and multifocal dystonia) or the entire body (generalized dystonia). Torticollis is an example of a focal dystonia. Primary dystonia is defined when dystonia is the only symptom unassociated with other pathology. Treatment options for dystonia include oral or injectable medications (ie, botulinum toxin) and destructive surgical or neurosurgical interventions (ie, thalamotomies or pallidotomies) when conservative therapies fail. Secondary dystonia is a dystonia brought on by an inciting event, such as a stroke, trauma, or drugs.

Tardive dystonia is a form of drug-induced secondary dystonia.

Cluster Headaches
DBS has been investigated in patients with chronic cluster headaches. Cluster headaches occur as episodic attacks of severe pain lasting from 30 minutes to several hours. The pain is usually unilateral and localized to the eye, temple, forehead, and side of the face. Autonomic symptoms that occur with cluster headaches include ipsilateral facial sweating, flushing, tearing, and rhinorrhea. Cluster headaches occur primarily in men and have been classified as vascular headaches that have been associated with high blood pressure, smoking, and alcohol use. However, the exact pathogenesis of cluster headaches is uncertain. Positron emission tomography (PET) scanning and magnetic resonance imaging(MRI) have shown the hypothalamic region may be important in the pathogenesis of cluster headaches. Alterations in hormonal or serotonergic function may also play a role. Treatment of cluster headaches includes pharmacologic interventions for acute episodes and prophylaxis, sphenopalatine ganglion(SPG) blockade, and surgical procedures such as percutaneous sphenopalatine ganglion radiofrequency rhizotomy, and gamma knife radiosurgery of the trigeminal nerve.

Neurologic and Psychiatric Disorders

The role of DBS in treatment of other treatment-resistant neurologic and psychiatric disorders, particularly Tourette syndrome, epilepsy, major depressive disorders, and obsessive-compulsive disorder (OCD), is also being investigated. Ablative procedures are irreversible and, though they have been refined, remain controversial treatments for intractable illness. Interest has shifted to neuromodulation through DBS of nodes or targets within neural circuits involved in these disorders. Currently, a variety of target areas are being studied.

Summary of Evidence

For individuals who have essential tremor or tremor in PD who receive DBS of the thalamus, the evidence includes a systematic review and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The systematic review (a TEC Assessment) concluded that there was sufficient evidence that DBS of the thalamus results in clinically significant tremor suppression and that outcomes after DBS were at least as good as thalamotomy. Subsequent studies reporting long-term follow-up have supported the conclusions of the TEC Assessment and found that tremors were effectively controlled 5 to 6 years after DBS. The evidence is sufficient to determine thatthe technology results in a meaningful improvement in the net health outcome.


For individuals who have symptoms (eg, speech, motor fluctuations) associated with PD (advanced or >4 years in duration with early motor symptoms) who receive DBS of the globus pallidus interna (GPi) or subthalamic nucleus (STN), the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatmentrelated morbidity. One of the systematic reviews (a TEC Assessment) concluded that studies on DBS of the GPi or STN have consistently demonstrated clinically significant improvements in outcomes (eg, neurologic function). Other systematic reviews also found significantly better outcomes after DBS than after a control intervention. An RCT in patients with levodoparesponsive PD of at least 4 years in duration and uncontrolled motor symptoms found that quality of life at 2 years was significantly higher when DBS was provided in addition to medical therapy. Meta-analyses of RCTs comparing DBS of the GPi and STN have reported mixed findings and have not shown that 1 type of stimulation is clearly superior to the other. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have primary dystonia who receive DBS of the GPi or STN, the evidence includes systematic reviews, an RCT, and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. A pooled analysis of 24 studies, mainly uncontrolled, found improvements in motor scores and disability scores after 6 months and at the last follow-up (mean, 32 months). A double-blind RCT found that severity scores improved more after active than after sham stimulation. The evidence is sufficient todetermine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have tardive dyskinesia or tardive dystonia who receive DBS, the evidence includes case series, one of which included a double-blind comparison of outcomes when the DBS device was turned on versus off. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Few studies were identified and they had small sample sizes (range, 9-19 patients). Additional studies, especially RCTs or other controlled studies, are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have epilepsy who receive DBS, the evidence includes 2 systematic reviews of RCTs and many observational studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Two RCTs were identified. The larger reported that DBS had a positive impact during some parts of the blinded trial phase but not others, and a substantial number of adverse events (in >30% of patients). The smaller RCT (N=16) showed a benefit with DBS. Many small observational studies reported fewer seizures compared with baseline, however, without control groups, interpretation of these results is limited. Additional trials are required to determine the impact of DBS on patient outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have multiple sclerosis (MS) who receive DBS, the evidence includes an RCT.

Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. One RCT with 10 multiple sclerosis patients is insufficient evidence on which to draw conclusions about the impact of DBS in this population. Additional trials are required. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have Tourette syndrome who receive DBS, the evidence includes crossover RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Several small (=15 patients) crossover studies and a 2015 meta-analysis have suggested that DBS may improve outcomes in patients with Tourette syndrome. However, the optimal target of the brain for DBS is unknown, so additional controlled studies in larger numbers of patients are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have cluster headaches or facial pain who receive DBS, the evidence includes a randomized crossover study and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. In the randomized study, the between-group difference in response rates did not differ significantly between active and sham stimulation phases. Additional RCTs or controlled studies are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have treatment-resistant depression who receive DBS, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The only double-blind, parallel-group RCT in patients with depression did not find that DBS significantly increased the response rate compared with sham; 2 other RCTs were stopped due to futility. A crossover controlled trial randomized patients to active or to sham stimulation after a year of open-label stimulation. There was a greater reduction in symptom scores after active stimulation, but only in patients who were responders in the open-label phase; these findings may not be generalizable. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have obsessive-compulsive disorder who receive DBS, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Among the RCTs on DBS for obsessive-compulsive disorder, only 1 has reported the outcome of greatest clinical interest (therapeutic response rate), and that trial did not find a statistically significant benefit for DBS compared to sham treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have anorexia nervosa, alcohol addiction, Alzheimer disease, Huntington disease, or chronic pain who receive DBS, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. RCTs are needed to evaluate the efficacy of DBS for these conditions. The evidence is insufficient to determine the effects of the technology on health outcomes.

Introduction

The brain communicates with the body by sending electrical signals along nerves. When it comes time to go to the bathroom, the brain sends signals to specific nerves that travel throughthe lower back to the muscles that control the opening and closing of the bladder and bowel.

Weak electrical signals may be used to address certain kinds of bowel and bladder problems that have not responded to other treatments. This procedure is known as sacral nerve neuromodulation. Another name for it is sacral nerve stimulation. This procedure involves implanting a small device under the skin in the lower back area. Small wires are also implanted so that the electric current activates the nerve important to either bladder or bowel function. This treatment usually is done in two steps. The first is a temporary placement to find out if sacral nerve stimulation works. The second is surgery to place the permanent implant. This policy describes when sacral nerve stimulation may be considered medically necessary.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Service Medical Necessity Urinary Incontinence and Non-obstructive Retention Sacral nerve neuromodulation

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted lead may be considered medically necessary in patients who meet ALL of the following criteria:
* There is a diagnosis of at least one of the following:
o Urge incontinence
o Urgency-frequency syndrome
o Nonobstructive urinary retention
o Overactive bladder AND

* There is documented failure or intolerance to at least 2 conventional conservative therapies (eg, behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment for at least a sufficient duration to fully assess its efficacy, and/or surgical corrective therapy) AND

* The patient is an appropriate surgical candidate (see Definition of Terms) AND

* Incontinence is not related to a spinal cord injury or progressive, systemic neurologic condition (such as multiple sclerosis or diabetic neuropathy) Permanent implantation, sacral nerve neuromodulation device Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in patients who meet ALL of the following criteria:

* All of the criteria above are met AND

* A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours

Fecal Incontinence

Sacral nerve neuromodulation

A trial period of sacral nerve neuromodulation with either percutaneous nerve stimulation or a temporarily implanted


Service Medical Necessity lead may be considered medically necessary in patients who meet all of the following criteria:

* There is a diagnosis of chronic fecal incontinence of more than 2 incontinent episodes on average per week for more than 6 months, or for more than 12 months after vaginal childbirth AND
* There is documented failure or intolerance to conventional conservative therapy (eg, dietary modification, the addition of bulking and pharmacologic treatment) for at least a sufficient duration to fully assess its efficacy AND
* The patient is an appropriate surgical candidate (see Definition of Terms) AND
* The condition is not related to an anorectal malformation (eg, congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) or chronic inflammatory bowel disease AND
* Incontinence is not related to a spinal cord injury or progressive, systemic neurologic condition (such as multiple sclerosis or diabetic neuropathy) AND
* The patient has not had rectal surgery in the previous 12 months, or in the case of rectal cancer, the patient has not had rectal surgery in the past 24 months Permanent implantation, sacral nerve neuromodulation device Permanent implantation of a sacral nerve neuromodulation device may be considered medically necessary in patients who meet all of the following criteria:
* All of the criteria above are met AND
* A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.


Service Investigational

Other applications, urinary incontinence and nonobstructive retention Other urinary/voiding applications of sacral nerve neuromodulation are considered investigational, including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition (eg, detrusor hyperreflexia, multiple sclerosis, spinal cord injury or other types of chronic voiding dysfunction). Other applications, chronic constipation or chronic pelvic pain Sacral nerve neuromodulation is investigational in the treatment of chronic constipation or chronic pelvic pain. Coding Sacral nerve neuromodulation involves several steps that are identified by the following codes.

Code Description CPT

64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)

64581 Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement)

A4290 Sacral nerve stimulation test lead, each
E0745 Stimulator electronic shock unit
L8679 Implantable neurostimulator, pulse generator, any type
L8680 Implantable neurostimulator electrode each (Note: Reported with 1-unit for each contact point on the implanted lead)
L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes


Related Information Definition of Terms

Inappropriate surgical candidates: Includes patients with bleeding disorders, anatomical limitations, skin disease at risk for infection, psychiatric disease, or patients who are pregnant.30 Overactive bladder (OAB): The International Continence Society has defined that overactive bladder syndrome as “urinary urgency, with or without urgency urinary incontinence, usually with increased daytime frequency and nocturia…” (available online at http://wiki.ics.org/Overactive+Bladder, Accessed May 2018).

Evidence Review Description

Sacral nerve neuromodulation (SNM), also known as sacral nerve stimulation, involves the implantation of a permanent device that modulates the neural pathways controlling bladder or rectal function. This policy addresses use of SNM in the treatment of urinary or fecal incontinence, urinary or fecal nonobstructive retention, an


Background

Urinary and Fecal Incontinence

Urge incontinence is defined as leakage of urine when there is a strong urge to void. Urgencyfrequency is an uncontrollable urge to urinate, resulting in very frequent, small volumes and is a prominent symptom of interstitial cystitis (also called bladder pain syndrome). Urinary retention is the inability to empty the bladder of urine completely. Fecal incontinence can arise from a variety of mechanisms, including rectal wall compliance, efferent and afferent neural pathways,  central and peripheral nervous systems, and voluntary and involuntary muscles. Fecal incontinence is more common in women, due mainly to muscular and neural damage that may occur during vaginal delivery.

Treatment

Treatment using sacral nerve neuromodulation, also known as indirect sacral nerve stimulation, is one of several alternative modalities for patients with urinary or fecal incontinence (urge incontinence, significant symptoms of urgency-frequency, nonobstructive urinary retention) who have failed behavioral (eg, prompted voiding) and/or pharmacologic therapies.

The sacral nerve neuromodulation device consists of an implantable pulse generator that delivers controlled electrical impulses. This pulse generator is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root. Two external components of the system help control the electrical stimulation. A control magnet, kept by the patient, is used to turn the device on or off. A console programmer is kept by the physician and used to adjust the settings of the pulse generator.

Before implantation of the permanent device, patients undergo an initial testing phase to estimate potential response to treatment. The first type of testing developed was percutaneous nerve evaluation (PNE). This procedure is done with the patient under local anesthesia, using a test needle to identify the appropriate sacral nerve(s). Once identified, a temporary wire lead is inserted through the test needle and left in place for 4 to 7 days. This lead is connected to an external stimulator, which is carried by patients in their pocket or on their belt. The results of this test phase are used to determine whether patients are appropriate candidates for the permanent device. If patients show a 50% or greater reduction in symptom frequency, they are deemed eligible for the permanent device.

The second type of testing is a 2-stage surgical procedure. In the first stage, a quadripolar-tined lead is implanted (stage 1). The testing phase can last as long as several weeks, and if patient  show a 50% or greater reduction in symptom frequency, they can proceed to stage 2 of the surgery, which is permanent implantation of the neuromodulation device. The 2-stage surgical procedure has been used in various ways. They include its use instead of PNE, for patients who failed PNE, for patients with an inconclusive PNE, or for patients who had a successful PNE to refine patient selection further.

The permanent device is implanted with the patient under general anesthesia. The electrical leads are placed in contact with the sacral nerve root(s) via an incision in the lower back, and the wire leads are extended through a second incision underneath the skin, across the flank to the  lower abdomen. Finally, a third incision is made in the lower abdomen where the pulse generator is inserted and connected to the wire leads. Following implantation, the physician programs the pulse generator to the optimal settings for that patient. The patient can switch the pulse generator between on and off by placing the control magnet over the area of the pulse generator for 1 to 2 seconds.

Summary of Evidence

For individuals with urinary incontinence who have failed conservative treatment who receive SNM, the evidence includes randomized controlled trials (RCTs), systematic reviews, and case series. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity.

Results from the RCTs and case series with long-term follow-up have suggested that SNM reduces symptoms of urge incontinence, urgency-frequency syndrome, nonobstructive urinary retention, and overactive bladder in selected patients. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. For individuals with fecal incontinence who have failed conservative treatment who receive SNM, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. Although relatively small, the available trials had a low risk of bias and demonstrated improvements in incontinence relative to alternatives. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with constipation who have failed conservative treatment who receive SNM, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. The available trials have not consistently reported improvements in outcomes with SNM. Additional studies are needed to demonstrate the health benefits of this technology. The evidence is insufficient to determine the effects of the technology on health outcomes.


For individuals with chronic pelvic pain who receive SNM, the evidence is limited to case series. Relevant outcomes are symptoms, morbid events, and treatment-related morbidity. The

Clinical Input Received from Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

In response to requests, input was received from 4 physician specialty societies and 2 academic medical centers while this policy was under review in 2012. Reviewers from 2 specialty societies and 2 academic medical centers provided opinions on the possible medical necessity of implantable leads for test stimulation, as part of a 2-stage process for device implantation. All 4 respondents supported the use of implantable leads for test stimulation as an alternative to percutaneous test stimulation for patients who had failed percutaneous test stimulation and/or for patients with inconclusive percutaneous test stimulation. Reasons for support included a longer period of interrupted treatment with stage-1 stimulation due to less lead migration and a higher rate of positive tests compared with percutaneous test stimulation.

Code Description CPT
21299 Unlisted craniofacial and maxillofacial procedure

21499 Unlisted musculoskeletal procedure, head

26989 Unlisted procedure, hands or fingers


Introduction

A face or hand transplant involves transferring many different types of tissue such as bone, blood vessels, muscle, nerve tissue, and skin from one person to another.

The donor’s family is consulted and the tissue is gathered only after the family agrees that their loved one’s tissues may be used in this way. Face or hand transplant surgeries often last many hours. A face transplant takes at least 12 hours and may last up to 36 hours. A hand transplant takes between 8 to 15 hours. (By comparison, a heart transplant usually takes between 6 and 8 hours.) Because this surgery is so extensive and involves many different types of tissue, the risks are considered to be high. While these surgeries have been done, they have only been done on a very small number of people. There is not enough medical evidence to determine if the benefits to a patient outweigh the risk of complications, infections, tissue rejection, and problems with the immune system from long-term use of anti-rejection drugs. For these reasons, face and hand transplants are considered investigational (unproven). 


Policy Coverage Criteria 

Procedure Investigational  Composite tissue allotransplantation, hand and/or face

Coding 

Composite tissue allotransplantation of the hand and/or face is considered investigational.

There are no specific CPT codes for the composite tissue allotransplantation procedure. It would be reported using combinations of existing codes or the unlisted code for the anatomic area. See the coding table below for possible code options.


.

Related Information 

Description

Composite tissue allotransplantation (also referred to as vascularized composite allotransplantation) is defined as transplantation of histologically different tissues. This type of transplantation is being proposed for facial transplants in patients with severely disfigured faces and for hand transplants in patients unsatisfied with prosthetic hands. The treatment has potential benefits in terms of improving functional status and psychosocial well-being. It also has potential risks, most notably those associated with a lifelong regimen of immunosuppressive drugs.


Background

Composite Tissue Allotransplantation

Composite tissue allotransplantation refers to the transplantation of histologically different tissue, which may include skin, connective tissue, blood vessels, muscle, bone, and nerve tissue. The procedure is also known as reconstructive transplantation. To date, primary applications of this type of transplantation have been of the hand and face (partial and full), although there are also reported cases of several other composite tissue allotransplantations, including that of the larynx, knee, and abdominal wall. 

Hand and face transplants have been shown to be technically feasible. The first successful partial face transplant was performed in France in 2005, and the first complete facial transplant was performed in Spain in 2010. In the United States, the first facial transplant was done in 2008; it was a near-total face transplant and included the midface, nose, and bone. The first hand transplant with short-term success occurred in 1998 in France. However, the patient failed to follow the immunosuppressive regimen, which led to graft failure and removal of the hand 29 months after transplantation. The first hand transplantation in the United States took place in 1999.

The most commonly performed face transplant procedure has been to restore the lower twothirds of facial structure, especially the perioral area (ie, lips, cheeks, chin) and in some cases the forehead, eyelids and scalp.

Facial transplantation has been performed on patients whose faces have been disfigured by trauma, burns, disease, or birth defects and who are unable to benefit from traditional surgical reconstruction. Hand transplantations have been done in patients who lost a hand due to trauma or life-saving interventions that caused permanent injury to the hand.

To date, hand transplants have not been performed for congenital anomalies or loss of a limb due to cancer. 

Composite tissue allotransplantation procedures are complex and involve a series of operations using a rotating team of specialists. For face transplantation, the surgery may last 8 to 15 hours. Hand transplant surgery has typically lasted between 8 and 12 hours. Bone fixation occurs first, and this is generally followed by the artery and venous repair and then by suture of nerves and/or tendons. In all surgeries performed to date, the median and ulnar nerves were repaired. The radial nerve was reconstructed in about half of the procedures.

Unlike most solid organ transplantations (eg, kidney and heart transplants), composite tissue allotransplantation is not life-saving, and its primary aim rests mainly in a patient’s cosmetic satisfaction and quality of life. In the case of facial transplantations, there is immense potential for the psychosocial benefits when a surgery is successful. Moreover, that the goal of composite tissue transplantation is to improve function (eg, grasping and lifting after hand transplants, blinking and mouth closure after face transplants) without alternative interventions such as prosthetics. Additionally, in the case of face transplantation, the procedure may be less traumatic than “traditional” facial reconstructive surgery using the patient’s own tissue. For example, traditional procedures often involve dozens of operations, whereas facial transplantation involves only a few operations.

Adverse Events
Composite tissue allotransplantation is associated with potential risks and benefits, and patients who undergo face or hand transplantation must adhere to a lifelong regimen of immunosuppressive drugs. Risks of immunosuppression include acute and chronic rejection, opportunistic infection that may be life-threatening, and metabolic disorders such as diabetes, kidney damage, and lymphoma. Other challenges include the need to participate actively in intensive physical therapy to restore functionality and the potential for frustration and disappointment if functional improvement does not meet expectations. Moreover, there is the potential for allograft loss, which would lead to additional procedures in hand transplant patients, and there are limited reconstructive options for facial transplantation. Furthermore, in the case of hand transplants, there is a risk that functional ability (eg, grasping and lifting objects) may be lower than with a prosthetic hand, especially compared with newer electronic prosthetic devices. Due to the importance of selecting candidates who can withstand these physical and mental challenges, potential hand and face transplant recipients undergo extensive screening for both medical and psychosocial suitability.

Coding 

Autologous and allogeneic hematopoietic cell transplants are considered investigational to treat advanced stage epithelial ovarian cancer.

Code Description CPT

38232 Bone marrow harvesting for transplantation; autologous

38240 Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor

38241 Hematopoietic progenitor cell (HPC); autologous transplantation

38242 Allogeneic lymphocyte infusions

S2140 Cord blood harvesting for transplantation, allogeneic

S2142 Cord blood-derived stem-cell transplantation, allogeneic

S2150 Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre and post transplant care in the global definition



Hematopoietic Cell Transplantation for Epithelial Ovarian Cancer


Introduction

Hematopoietic stem cells are cells that form within the bone marrow and can become many different types of blood cells. In a hematopoietic stem cell transplant, stem cells can be taken from a donor’s bone marrow, peripheral blood, or from a newborn baby’s umbilical cord blood or placenta shortly after the baby was delivered. The stem cells can also be harvested from the patient herself before she is given any high dose chemotherapy. If the stem cells are harvested from another person, it is called an allogeneic stem cell transplant. If the stem cells come from the patient herself before her high dose chemotherapy is given, it is called an autologous stem cell transplant. 

Hematopoietic stem cell transplants are sometimes given to patients who have epithelial ovarian cancer. These transplants are considered investigational. This policy explains why it is considered to be investigational.

Policy Coverage Criteria 

Condition Investigational  Advanced stage epithelial ovarian cancer




Evidence Review 

Description

Use of hematopoietic cell transplantation (HCT) has been investigated for treatment of patients with epithelial ovarian cancer. Hematopoietic stem cells are infused to restore bone marrow function after cytotoxic doses of chemotherapeutic agents with or without whole body radiotherapy.

Background

Epithelial Ovarian Cancer 

Several types of malignancies can arise in the ovary, and epithelial carcinoma is the most common. Epithelial ovarian cancer is the fifth most common cause of cancer death in women. For 2016, new cases and deaths from ovarian cancer in the United States were estimated at 22,280 and 14,240, respectively.

Most ovarian cancer patients present with widespread disease, and the National Cancer Institute Surveillance, Epidemiology and Results Program reported a 46.5% five-year survival for all cases between 2007 and 2013.

Treatment

Current management for advanced epithelial ovarian cancer is cytoreductive surgery with chemotherapy.

Approximately 75% of patients present with International Federation of Gynecology and Obstetrics stage III to IV ovarian cancer and are treated with paclitaxel plus a platinum analogue, the preferred regimen for the newly diagnosed advanced disease. Use of platinum and taxanes has improved progression-free survival and overall survival in advanced disease to between 16 and 21 months and 32 and 57 months, respectively.

However, cancer recurs in most women, and they die of the disease because chemotherapy drug resistance leads to uncontrolled cancer growth.


Hematopoietic Cell Transplantation

Hematopoietic cell transplantation (HCT) is a procedure in which hematopoietic stem cells are infused to restore bone marrow function in cancer patients who receive bone-marrow-toxic doses of drugs with or without whole body radiotherapy. Bone marrow stem cells may be obtained from the transplant recipient (autologous HCT) or from a donor (allogeneic HCT). They can be harvested from bone marrow, peripheral blood, or umbilical cord blood and placenta shortly after delivery of neonates. Although cord blood is an allogeneic source, the stem cells in it are antigenically “naive” and thus are associated with a lower incidence of rejection or graftversus-host disease. Cord blood is discussed in greater detail in a separate medical policy (see Related Policies).
HCT is an established treatment for certain hematologic malignancies; however, its use in solid tumors in adults is largely experimental. 

HCT for Epithelial Ovarian Cancer 

HCT has been investigated as a therapy to overcome drug resistance. However, limited data exist on this treatment approach, and the ideal patient population and best treatment regimen remain to be established.

 HCT has been tested in various patient groups with ovarian cancer: 
* To consolidate remission after induction therapy
* To treat relapse after a durable response to platinum-based chemotherapy
* To treat tumors that relapse after less than 6 months
* To treat refractory tumors

SPECIAL SITUATIONS on Ambulance billing

INTERCEPTS

In situations where a BLS vehicle intercepts with an ALS vehicle, each provider may bill for the appropriate base rate and for the loaded mileage they provided (if any).

 BRIDGE/TUNNEL TOLL

Bridge and tunnel toll charges are reimbursable to the ambulance provider, both loaded and return trip.

Billing instructions:

* The Unlisted Ambulance Service code must be used.

* All toll charges must be combined on one claim line.

* The Remarks section must contain the bridge or tunnel name and the number of times used.



3.3 CONTINUOUS OR ROUND TRIP TRANSPORT

This type of transport is considered to be one run. The base rate code for the highest level of service performed during transport should be billed on one claim line. Loaded mileage is also billed on one claim line with the total number of whole (loaded) miles indicated as the quantity.

Refer to the Waiting Time subsection of this chapter in cases where waiting time exceeds 30 minutes.


NURSING FACILITIES

Routine, non-emergency medical transportation provided for NF residents in a van or other nonemergency vehicle is included in the facility's per diem rate. This includes transportation for medical appointments, dialysis, therapies, or other treatments not available in the facility.

When the resident’s attending physician orders non-emergency transportation by ambulance (due to the need for a stretcher or other emergency equipment), the ambulance provider may bill MDHHS directly.

The ambulance provider must maintain the physician's written order as documentation of medical necessity.

If the resident’s attending physician does not order non-emergency ambulance transport, arrangements for payment must be between the facility and the ambulance provider, and cannot be charged to the resident, the resident's family, or used to offset the patient-pay amount. This cost may not be claimed as a routine cost on Michigan’s Medicaid cost report. The cost of non-emergency ambulance transports not ordered by the resident’s physician must be identified and removed on Worksheet 1-B by the NF. For direct reimbursement by MDHHS to an enrolled ambulance provider for services provided to a Medicaid beneficiary who is a resident of a NF, refer to the Ambulance Quick Reference Guide Section of this chapter.


 MULTIPLE ARRIVALS

When multiple units respond to a call for services, only the entity that actually provides services for the beneficiary may bill and be paid. The entity that rendered service/care should bill for all services furnished.

 MULTIPLE BENEFICIARIES PER TRANSPORT

When more than one eligible beneficiary is transported at the same time, the only acceptable duplication of charges is half of the base rate. Separate claims must be submitted for each beneficiary. The first claim is completed in the usual mannerand the base rate billed must reflect the highest level of service performed.

Claims for additional beneficiaries must indicate the U&C base rate charge. The appropriate modifier must be reported. Providers should refer to the Billing & Reimbursement for Professionals or the Billing & Reimbursement for Institutional Providers chapters of this manual, as appropriate, for a list of modifiers.

Payment is made at 50 percent of Medicaid's reimbursement rate or 50 percent of the provider's charge (whichever is less).



 MULTIPLE TRANSPORTS PER BENEFICIARY

Multiple ambulance transports rendered to the same beneficiary on the same date of service are covered under certain conditions. Information regarding billing and PA for multiple transports for the same beneficiary on the same date of service is contained in the Billing & Reimbursement for Institutional Providers and the Billing & Reimbursement for Professionals
Chapters of this manual.


OUT OF STATE NONBORDERLAND TRANSPORTS

Except for emergencies, out of state, nonborderland transports require PA. (Refer to the General Information for Providers chapter of this manual for additional information.) The ambulance provider, home health agency (HHA), hospital, NF, physician, or social worker may request this authorization. The ambulance provider must retain documentation of medical necessity (physician's order) in the beneficiary's file to support the need for ambulance transportation. To request
authorization, the requestor must call or write the MDHHS Program Review Division before services are rendered. (Refer to the Directory Appendix for contact information.) The request must include:

* Point of pick-up

* Beneficiary's name and Medicaid ID number

* Diagnosis

* Service to be provided

* Destination point

* Reason why the ambulance transport was medically necessary

* Reason why the beneficiary cannot be transported by any other means

* Name and address of the ambulance provider

* Requestor's name


Based on the authorization requested, MDHHS approves or denies the request. The ambulance provider may render the service upon receipt of verbal approval. A copy of the approval authorization letter is mailed to the ambulance provider following the verbal authorization. The ambulance provider may not bill Medicaid until he has received the authorization letter. The ambulance provider must keep a copy of the authorization letter in the beneficiary's file.

The requestor must notify the MDHHS Program Review Division of any changes to the approved PA (e.g., change in service date or ambulance provider, etc.).

When seeking reimbursement for out of state transports, the PA number must be entered on the claim, except in the case of emergency transports.

Coding Code Description

CPT 0335T Extra-osseous subtalar joint implant for talotarsal stabilization

HCPCS

S2117 Arthroereisis, subtalar



Introduction

The talus bone is the bone in the foot that joins with the two leg bones. It is commonly called the ankle bone. The talus sits on top of the heel bone (calcaneus), and the joint between the talus and calcaneus is called the subtalar joint. This joint is quite complex because it’s responsible for moving the foot in several different directions. If this joint is too flexible, it could result in conditions known as flat feet and talotarsal dislocation. Having flat feet means that when the foot is on the ground there is no space between the middle of the foot — the arch — and the ground. All of the foot touches the ground. Talotarsal joint dislocation causes the middle of the foot to roll inward during walking. In surgery to restrict the movement of the subtalar joint, a small piece of metal is screwed into the naturally occurring small channel between the ankle bone and the heel bone. The implant keeps the subtalar joint from moving too much. The studies on this surgery are small and don’t show how well this procedure works over the long term. Published studies also report problems from the surgery and a high number of implants being removed after they were put in. For these reasons, subtalar arthroereisis is considered investigational (unproven).

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Policy Coverage Criteria Service Investigational

Subtalar arthroereisis Subtalar arthroereisis is considered investigational. Note: This policy only applies to subtalar arthroereisis (sinus tarsi implant or stent) surgery, a corrective operation to limit range of motion at the subtalar joint in cases of excessive mobility. Arthrodesis describes a surgical fusion of a joint so that the bones grow together. Subtalar arthrodesis (joint fusion) surgery is not addressed in this policy.



Description

Arthroereisis is a surgical procedure that purposely limits movement across a joint. Subtalar arthroereisis (STA) or extraosseous talotarsal stabilization is designed to correct excessive talar displacement and calcaneal eversion by reducing pronation across the subtalar joint. Extraosseous talotarsal stabilization is also being evaluated as a treatment of talotarsal joint dislocation. It is performed by placing an implant in the sinus tarsi, which is a canal located between the talus and the calcaneus.

Background

Flatfoot

Flexible flatfoot is a common disorder, anatomically described as excessive pronation during weight-bearing due to anterior and medial displacement of the talus. It may be congenital in nature, or it may be acquired in adulthood due to posterior tibial tendon dysfunction, which in turn may be caused by trauma, overuse, inflammatory disorders, and other factors. Symptoms include dull, aching pain, which in children may be described as growing pains. Additional symptoms include refusal to participate in athletics or walking long distances.

Treatment

Conservative treatments include orthotics or shoe modifications. Surgical approaches for painful flatfoot deformities include tendon transfers, osteotomy, and arthrodesis. Arthroereisis with a variety of implant designs has also been investigated.

Subtalar arthroereisis has been performed for more than 50 years, with a variety of implant designs and compositions. The Maxwell-Brancheau Arthroereisis (MBA) implant is the most frequently reported, although other devices such as the HyProCure, subtalar arthroereisis peg, and Kalix are also described in the medical literature. The MBA implant is described as reversible and easy to insert, with the additional advantage that it does not require bone cement. In children, insertion of the MBA implant may be offered as a stand-alone procedure, although children and adults often require adjunctive surgical procedures on bone and soft tissue to correct additional deformities.


Flatfoot

Arthroereisis is the limitation of movement across a joint. Subtalar arthroereisis (also called extraosseous talotarsal stabilization) is designed to correct excessive talar displacement and calcaneal eversion by reducing pronation across the subtalar joint.

Talotarsal Joint Dislocation

Extraosseous talotarsal stabilization is also being evaluated as a treatment of talotarsal joint dislocation. The stabilization procedure is performed by placing an implant in the sinus tarsi, which is a canal located between the talus and the calcaneus.

Summary of Evidence

For individuals who have flatfoot or talotarsal joint dislocation who receive subtalar arthroereisis (STA), the evidence includes mainly single-arm case series and a small nonrandomized controlled trial comparing STA with lateral column calcaneal lengthening. Relevant outcomes are symptoms, functional outcomes, and quality of life. The small nonrandomized comparative trial (N=24 feet) is considered preliminary, and interpretation of the case series evidence is limited by the use of adjunctive procedures in addition to STA, creating difficulties in determining the extent to which each modality contributed to the outcomes. Another limitation of the published data is the lack of long-term outcomes, which is of particular importance because the procedure is often performed in growing children. Also, some studies have reported high rates of complications and implant removal. The evidence is insufficient to determine the effects of the technology on health outcomes.

Coding Code Description CPT

62287 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method, single or multiple levels, lumbar (eg, manual or automated percutaneous discectomy, percutaneous laser discectomy)

HCPCS

S2348 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar




Introduction
Between each bone of the spine is a round, flat disc. The discs act as cushions between the bones of the spine and help hold them together, while also providing stability and allowing a wide range of motion. Should the discs break down, pain and nerve problems may result. Typical treatment includes physical therapy and/or pain medications. In more severe cases, surgery may be needed. In recent years, using heat from either lasers or radio waves to remove or destroy parts of the discs has been studied as a way to try to treat pain. These techniques are investigational (unproven). More studies are needed to find out if they are safe and effective.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Policy Coverage Criteria Service Investigational Laser discectomy and radiofrequency coblation Laser discectomy and radiofrequency coblation (disc nucleoplasty) are considered investigational as techniques of disc decompression and treatment of associated pain.




Description

Laser energy (laser discectomy) and radiofrequency (RF) coblation (nucleoplasty) are being evaluated for decompression of the intervertebral disc. For laser discectomy under fluoroscopic guidance, a needle or catheter is inserted into the disc nucleus, and a laser beam is directed through it to vaporize tissue. For disc nucleoplasty, bipolar RF energy is directed into the disc to ablate tissue. These minimally invasive procedures are being evaluated for the treatment of discogenic back pain.

Background

Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptom findings, in conjunction with radiologically confirmed degenerative disc disease.

Treatment

Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases.

A variety of minimally invasive techniques have been investigated as treatment of low back pain related to disc disease. Techniques can be broadly divided into those designed to remove or ablate disc material, and thus decompress the disc, and those designed to alter the biomechanics of the disc annulus. The former category includes chymopapain injection, automated percutaneous lumbar discectomy, laser discectomy, and most recently, disc decompression using radiofrequency (RF) energy, referred to as a disc nucleoplasty. Techniques that alter the biomechanics of the disc (disc annulus) include a variety of intradiscal electrothermal procedures, which are discussed in another policy (see Related Medical Policies).

A variety of different lasers have been investigated for laser discectomy, including YAG, KTP, holmium, argon, and carbon dioxide lasers. Due to differences in absorption, the energy requirements and the rate of application differ among the lasers. In addition, it is unknown how much disc material must be removed to achieve decompression. Therefore, protocols vary according to the length of treatment, but typically the laser is activated for brief periods only.


RF coblation uses bipolar low-frequency energy in an electrical conductive fluid (eg, saline) to generate a high-density plasma field around the energy source. This creates a low-temperature field of ionizing particles that break organic bonds within the target tissue. Coblation technology is used in a variety of surgical procedures, particularly related to otolaryngology. The disc nucleoplasty procedure is accomplished with a probe mounted with a RF coblation source. The proposed advantage of coblation is that the procedure provides for controlled and highly localized ablation, resulting in minimal damage to surrounding tissue.

Summary of Evidence

For individuals with discogenic back pain or radiculopathy who receive laser discectomy, the evidence includes systematic reviews of observational studies. Relevant outcomes are symptoms, functional outcomes, and treatment-related morbidity. While numerous case series and uncontrolled studies have reported improvements in pain levels and functioning following laser discectomy, the lack of well-designed and well-conducted controlled trials limits interpretation of reported data. The evidence is insufficient to determine the effect of the technology on health outcomes.

For individuals with discogenic back pain or radiculopathy who receive disc nucleoplasty with radiofrequency coblation, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and treatmentrelated morbidity. For nucleoplasty, there are 2 RCTs in addition to several uncontrolled studies.

These RCTs are limited by the lack of blinding, an inadequate control condition in one, and inadequate data reporting in the second. The available evidence is insufficient to permit conclusions concerning the effect of these procedures on health outcomes due to multiple confounding factors that may bias results. High-quality randomized trials with adequate followup (at least 1 year), which control for selection bias, the placebo effect, and variability in the natural history of low back pain, are needed. The evidence is insufficient to determine the effect of the technology on health outcomes.  Subtalar Arthroereisis