Coverage of electrical nerve stimulation is limited to those stimulators and situations defined within this policy when used to alleviate chronic intractable pain, unless otherwise stated.

Use of electrical nerve stimulators and related services other than those specifically addressed within this policy, e.g., percutaneous neuromodulation therapy (PNT), or for conditions other than those addressed within this policy (e.g., multiple sclerosis, muscular dystrophy, or other motor function disorders), is considered experimental/investigational. It is not eligible for reimbursement. The medical efficacy for alternate use of electrical nerve stimulation has not been established. A participating, preferred, or network provider can bill the member for the denied service.

CENTRAL NERVOUS SYSTEM

Dorsal Column Stimulator (63650, 63655, 63685)

Dorsal column stimulation is considered experimental/investigational when used as a treatment for conditions other than chronic intractable pain. The medical efficacy for alternate use of this treatment has not been established.

Dorsal column stimulation is considered medically necessary when used as treatment for intractable pain caused by nerve root injuries, post-surgical or post-traumatic including post-laminectomy syndrome (failed back syndrome), complex regional pain syndrome I and II, causalgia, phantom limb pain, peripheral vascular disease, arachnoiditis lumbosacral, post herpetic neuralgia, plexopathy, cauda equine injury, incomplete spinal cord injury, neuritis or radiculitis. 

FREQUENCY:  As required by failure or malfunction of equipment, intolerance by patient, infection related to device components or loss of effectiveness, migration of lead(s) and justified by the following documentation:

• Spinal cord stimulation should be considered when other treatments of extremity, back or neck pain have failed or are not acceptable to the patient,  (i.e. surgical pharmacological, physical, psychologic).
• Spinal cord stimulation should be considered only after careful physical and psychological screening has been undertaken.  A psychological evaluation should be given, prior to implant, to rule out any untreated psychological problems.
• Spinal cord stimulation should be performed only facilities with a physician trained in residency or by hands on CME training to perform the procedure.  All technical support, computers and ancillary personnel should be available.
• A trial spinal cord stimulation lead should be placed prior to permanent implantation.  During the trial period the patient should sustain at least 50% pain relief and objective functional improvement (i.e. range of motion).
• A documented physiologic problem must exist prior to implementation,  (i.e. physical exam, diagnostic study).
• No untreated drug addiction problem should exist prior to implementation.
• The patient should not be implemented if:
  • less than 50% relief is seen with trial stimulation,
  • the patient does not perceive stimulation as pleasant,
  • the patient has an active coagulopathy,
  • the patient has a localized or disseminated infection,
  • the patient has a demand cardiac pacer or may need one relatively soon,
  • the patient has untreated drug addictions,
  • no physiologic problem can be identified,
  • the physician does not have adequate training and experience.
• A second opinion (when required) should be performed by a physician with credentials to implant like devices.  Second opinions may be performed by chart review.
• Spinal cord stimulation: The use of new dual lead systems have made  possible the treatment of bilateral extremity pain syndromes such as diabetic   neuropathies.  The use of dual lead stimulators will be approved if the criteria  for single lead systems are met and the pain syndrome is bilateral.  Psychological approval is also required.

Date Last Reviewed - 08/2007

Deep Brain Neurostimulation (61863, 61864, 61867, 61868, 61885, 61886)

Deep Brain Stimulation (DBS) is eligible to control tremors due to essential tremor (333.1) or Parkinson's Disease (332.0), when medication has failed. Payment will be allowed for DBS using a stimulator implanted on one side of the brain (unilaterally) or on both sides of the brain (bilaterally), and for the subcutaneous implantation of the pulse generator(s) within the patient's chest.

Deep brain stimulation is eligible when used as a treatment for chronic intractable (drug refractory) primary dystonia (333.6), including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age or above.

The DBS should be a last resort when all other treatments, including medications, have failed to control the tremors. Further, the patient should receive medical and neurophysiological monitoring before and after the implantation.

Date Last Reviewed - 08/2007

PERIPHERAL NERVOUS SYSTEM

Transcutaneous Electrical Nerve Stimulation (TENS)(64550)
Percutaneous Electrical Nerve Stimulation (PENS)(64555)

Transcutaneous Electrical Nerve Stimulation (TENS) is not an eligible service under the UCR and Fee Schedule programs except as identified in the benefits schedule.

When a covered benefit, both TENS and PENS are reimbursed when used to assess a patient's suitability for continued treatment with an electrical nerve stimulator.

Generally, a physician or physical therapist should be able to determine within a trial period of two months whether the patient is likely to derive a significant therapeutic benefit from the continued use of electrical stimulation. Once this is determined, the patient should use the TENS at home, or if PENS was used, a stimulator should be implanted. Consequently, continued treatments (64550), rather than assessment services, furnished by a physician in his office, by a physical therapist (applicable to TENS only) or outpatient clinic should be denied.

Claims for the TENS or PENS assessment services should be reported under code 95999 with payment equated to the level of reimbursement for an intermediate office visit.

Usually, the physician or physical therapist providing the TENS assessment service will provide the necessary equipment. If the patient rents the stimulator from a supplier during the trial period, payment may be made for the rental of the unit as well as the physician's or physical therapist's service, when a benefit. However, the combined payment may not exceed the amount which would have been payable to the physician or physical therapist alone for the total assessment service.

If the services continue for longer than two months, the claim should be evaluated to determine if the patient's condition is chronic, in which case the TENS would be covered as a prosthetic device.

Date Last Reviewed - 08/2007

Implanted Peripheral Nerve Stimulator (64575, 64590)

The implantation of a peripheral nerve stimulator is eligible when used to alleviate chronic intractable pain.

Date Last Reviewed - 08/2007

Implanted Autonomic Nerve Stimulator (64577)

This procedure is eligible only for the implantation of a phrenic nerve stimulator for treatment of patients with partial or complete respiratory insufficiency (518.5, 518.82). Implantation of an autonomic nerve stimulator other than phrenic is not eligible for payment. In addition, treatment for conditions other than partial or complete respiratory insufficiency is considered experimental/investigational. It is not eligible for reimbursement. The medical efficacy for alternate use of this treatment has not been established. A participating, preferred, or network provider can bill the member for the denied service.

Date Last Reviewed - 08/2007

See Medical Policy Bulletin O-9 for information on the phrenic nerve stimulator device.

Vagus Nerve Stimulation (61885, 61886, 64573)

The implantation of a vagus nerve stimulator for seizure control is eligible only when used as a last resort for patients with epilepsy with partial onset seizures (345.40-345.51). Eligibility is limited to those cases where the seizures cannot be controlled by any other method, i.e., surgery or medication.

The use of vagus nerve stimulation for treatment of refractory depression is considered experimental/investigational.  It is not eligible for payment.  Scientific evidence has not demonstrated the long-term clinical efficacy of VNS and its impact on treatment-resistant depression.  A participating, preferred, or network provider can bill the member for the denied service.

Date Last Reviewed - 01/2008

Implanted Neuromuscular Neurostimulator (64580)

The implantation of neuromuscular neurostimulator electrodes for chronic pain relief is considered experimental/investigational, and is not eligible for payment.  The clinical value of intramuscular stimulation for pain relief has not been validated by randomized controlled studies.  A participating, preferred, or network provider can bill the member for the denied service.

Date Last Reviewed - 08/2006

Claims for the removal of an implanted stimulator should be reported under the appropriate code (63660, 63688, 64585, 64595, 64999). If a second stimulator is implanted (e.g., because of infection or malfunction), payment should be made only for the reimplantation under the appropriate implantation code. No additional allowance should be made for the removal of the first unit.

Nerve stimulators are not covered except under those groups that provide coverage for durable medical equipment (e.g., TENS stimulators - E0720 and E0730) and prosthetic devices (implanted stimulators).

NOTE:

See Medical Policy Bulletin S-131 for guidelines on sacral nerve stimulation.

See Medical Policy Bulletin Y-16 for guidelines on electrical stimulation for wound healing.

See Medical Policy Bulletin E-45 for guidelines on interferential stimulators.

Description

CENTRAL NERVOUS SYSTEM

Dorsal Column Stimulator

Dorsal column stimulation involves the surgical implantation of neurostimulator electrodes within the dura mater (via laminectomy) or the percutaneous insertion of electrodes in the epidural space, often referred to as the PICES (Percutaneous Implantation of Spinal Column Electrical Stimulator) system.

Deep Brain Neurostimulation

Deep brain stimulation (DBS) involves the stereotactic implantation of electrodes in the deep brain (e.g., thalamus and periaqueductal gray matter).

Deep brain stimulation for the control of tremors consists of an electrode(s) implanted into the thalamus, and connected by lead wire(s) under the skin to a pulse generator(s) implanted in the chest. When activated, the device(s) sends a constant stream of tiny electrical pulses to the brain, blocking tremors. To turn the stimulator(s) on or off, the patient passes a handheld magnet over the pulse generator(s).

PERIPHERAL NERVOUS SYSTEM

Transcutaneous Electrical Nerve Stimulation (TENS)

This is a non-invasive technique where the stimulator is attached to the surface of the skin over the peripheral nerve to be stimulated.

Percutaneous Electrical Nerve Stimulation (PENS)

This procedure involves stimulation of the peripheral nerves by a needle electrode inserted through the skin.

Implanted Peripheral Nerve Stimulator

This procedure involves the implantation of electrodes around a selected peripheral nerve.  The stimulating electrode is connected by an insulated lead to a receiver unit which is implanted under the skin at a depth not greater than 1/2 inch. Stimulation is induced by a generator which is connected to an antenna which is attached to the skin surface over the receiver unit.  Sciatic and ulnar nerves are often the sites of such an implant.

Implanted Autonomic Nerve Stimulator

The phrenic nerve stimulator is a type of autonomic nerve stimulator which provides electrical stimulation of the patient's phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation.

Vagus Nerve Stimulator

The implantation of a vagus nerve stimulator consists of a generator which is implanted under the collar bone and connected by wire to the vagus nerve in the neck, where it delivers electrical signals to the brain to control seizures. It includes an external programming system which is used by the physician to change stimulation settings. Patients can turn the stimulator on and off with a hand-held magnet by holding it over the stimulator.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP.  Medical policy is not an authorization, certification, explanation of benefits or a contract.  Benefits are determined by the Federal Employee Program.

Long-Term Transcutaneous Electrical Nerve Stimulation (TENS) Use: Impact on Medication Utilization and Physical Therapy Costs, Clin J Pain, Vol. 14, Issue 1, 03/1998

Deep Brain Stimulation for Movement Disorders, Neurosurg Clin N Am, Vol. 9, Issue 2, 04/1998

Diaphragm Pacing, Chest Surg Clin N Am, Vol. 8, Issue 2, 05/1998

Vagus Nerve Stimulation Therapy for Partial-Onset Seizures, A Randomized Active-Control Trial, Neurology, Vol. 51, July 1998

Unilateral Thalamic Deep Brain Stimulation for Refractory Essential Tremor and Parkinson's Disease Tremor, Neurology, Vol. 51, Issue 4, 10/1998

Percutaneous Electrical Nerve Stimulation (PENS): A Complementary Therapy for the Management of Pain Secondary to Bony Metastasis, Clin J Pain, Vol. 14, Issue 4, 12/1998

Vagus Nerve Stimulation, Epilepsia, Vol. 39, No. 7, 1998

Percutaneous Electrical Nerve Stimulation for Low Back Pain, A Randomized Crossover Study, Journal of the American Medical Association, Vol. 281, No. 9, 03/1999

The Effects of Epimysial Electrode Location on Phrenic Nerve Recruitment and the Relation Between Tidal Volume and Interpulse Interval, IEEE Trans Rehabil Eng, Vol. 7, Issue 2, 06/1999

Treatment of Neuropathic Pain in a Patient with Diabetic Neuropathy Using Transcutaneous Electrical Nerve Stimulation Applied to the Skin of the Lumbar Region, Physical Therapy, Vol. 79, Issue 8, 08/1999

Neuropsychological and Quality of Life Outcome After Thalamic Stimulation for Essential Tremor, Neurology, Vol. 53, Issue 8, 11/1999

Percutaneous Electrical Nerve Stimulation: An Alternative to TENS in the Management of Sciatica, Pain, Vol. 83, Issue 2, 11/1999

Use of Transcutaneous Electrical Nerve Stimulation in a Young Child with Pain from Open Perineal Lesions, J Pain Symptom Manage, Vol. 18, Issue 5, 11/1999

Vagus Nerve Stimulation for Treatment-Resistant Depression: A Randomized, Controlled Acute Phase Trial, Biological Psychiatry, Vol. 58 (5), 09/2005

Effects of 12 Months of Vagus Nerve Stimulation in Treatment-Resistant Depression: A Naturalistic Study, Biological Psychiatry, Vol. 58 (5), 09/2005

A One-Year Comparison of Vagus Nerve Stimulation with Treatment as Usual for Treatment-Resistant Depression, Biological Psychiatry, Vol. 58 (5), 09/2005

Two-Year Outcome of Vagus Nerve Stimulation (VNS) for Treatment of Major Depressive Episodes, Journal of Clinical Psychiatry, Vol. 66 (9), 09/2005

Peripheral Nerve Stimulation for the Treatment of Chronic Pain, Journal of Clinical Neuroscience, Volume 14 (3), March 2007

Neurostimulation Technology for the Treatment of Chronic Pain: A Focus on Spinal Cord Stimulation, Expert Reveiw of Medical Devices, Volume 4 (2), March 2007