Description

A spinal cord stimulator (SCS), also known as a dorsal column stimulator (DCS), is an implantable medical device used to treat chronic pain. The most common indications for a SCS include the management of failed back surgery syndrome (FBSS) and the treatment of complex regional pain syndrome (CRPS) (also known as reflex sympathetic dystrophy [RSD]), though it has also been proposed for other uses.

Spinal cord stimulation requires a surgical procedure, conducted in two phases, to place an electrode into the epidural space of the spinal column. The electrode is connected to a surgically implanted pulse generator (which contains the battery). An electrical impulse generated by the device travels to the electrode(s) where it creates a paresthesia (tingling sensation) which is thought to alter the perception of pain by the individual.

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Spinal Cord Stimulators

Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0306-026

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Temporary Percutaneous Electrode Placement

In the first phase of the spinal cord stimulation process, a local anesthetic is injected near the insertion site and an electrode is placed with the assistance of fluoroscopy to guide it to the desired level in the spinal column. Over the next 2 to 3 days, extensive testing with the temporary electrode is performed as an outpatient to measure the effectiveness and determine adequate positioning. If at least a 50% reduction in pain is reported, the individual returns for placement of permanent electrodes and a generator device.

Permanent Electrode Placement and Implantation of a Pulse Generator

In the second phase of the process, the individual is kept awake, though sedated, during the surgical procedure to help guide electrode placement and ensure that the SCS provides adequate parasthetic sensation over the intended affected area. Permanent electrodes are placed; a connector wire is tunneled under the skin and connected to an implantable pulse generator (IPG) which is inserted into a surgically prepared pocket in the abdomen.

Examples of SCS include, but may not be limited to, Precision Novi SCS System, Precision Plus SCS System and Precision Spectra System. The Precision Montage MRI SCS, PrimeAdvanced SureScan, Prospera, RestoreAdvanced SureScan, RestoreSensor SureScan and RestoreUltra SureScan are examples of SCS that have been approved by the US Food & Drug Administration (FDA) for use in a magnetic resonance imaging (MRI) scanner.

The Evoke Spinal Cord Stimulation (SCS) System is designed to operate in either of two modes: an evoked compound action potential (ECAP) controlled closed-loop stimulation mode, or an open-loop (fixed output) stimulation mode. The open-loop stimulation mode is said to be equivalent to that of traditional SCS and the closed- loop purportedly is able to provide real-time measurement as well as automatic adjustment of the strength of the stimulation based on the reading, recording and response to the ECAP. (Refer to Coverage Limitations section)

The Freedom Spinal Cord Stimulator System is the first FDA-approved device to have the impulse generator/battery enclosed within the lead body/electrodes. The stimulator/electrodes are inserted percutaneously via a needle into the lumbar or thoracic epidural space.

(Refer to Coverage Limitations section)Spinal Cord Stimulators

Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0306-026

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The Intellis Spinal Cord Stimulator platform system, in addition to being MRI compatible, is also FDA-approved to be controlled by an application (app) interface with an Android tablet. This, in theory, eliminates the need for device replacement when technology updates are developed, and also allows the physician or other healthcare professionals to monitor the usage of the SCS, as the app also records/tracks its activity. A similar device, the Intellis with AdaptiveStim stimulator has the added ability to automatically adjust the therapy waveform as the individual moves. Their newest version is the Vanta with AdaptiveStim Implantable Neurostimulator. In addition to the AdaptiveStim capability, this stimulator is recharge-free, and also has a feature called differential target multiplexed (DTM) stimulation, a proprietary waveform that allows further individualization of the treatment.

The Nalu Neurostimulation System has been approved by the FDA for use as either a spinal cord stimulator or as a peripheral nerve stimulator. This system is described as a partially implanted, battery-free neurostimulation device. The pulse generator and leads are implanted, but the energy source is an externally worn radiofrequency generator battery (referred to as a therapy disc); it is controlled through a smartphone-based remote control app. (Refer to Coverage Limitations section)

For information regarding use of the Nalu Neurostimulation System for peripheral nerve stimulation, please refer to Electrical Stimulators for Pain and Nausea/Vomiting Medical Coverage Policy.

The Proclaim Elite Recharge-Free SCS System with BurstDR stimulation, in addition to being MRI compatible, emulates the natural firing patterns in the brain, thereby modulating both the sensory and emotional pathways. This type of stimulation is theorized to give an individual relief from painful sensations and their conscious attention to pain, and also reduce or eliminate the paresthesia that is felt with traditional spinal cord stimulation. This SCS is controlled by an app on Apple mobile digital devices which, in theory, eliminates the need for regular recharging or replacement when technology updates are developed. The Proclaim XR has the same capabilities as the Proclaim Elite, however it has a battery life of up to 10 years at low dose settings. An additional variation of the Proclaim system is the Proclaim Plus; it utilizes FlexBurst360 therapy (their next generation of BurstDR therapy) which allows treatment of multisite pain. The Prodigy MRI IPG with BurstDRSpinal Cord Stimulators

Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0306-026

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

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The Senza HF-10 SCS was the first, and remains the only, device to receive FDA approval to treat chronic pain without creating/causing paresthesia, with a subsequent label expansion approval indicating MRI compatibility. Their newest version, the Senza Omnia, allows delivery of the HF-10 high-frequency wavelength as well as the option for delivery of other conventional stimulation frequencies. As with the other Senza devices, it is also MRI compatible.

The Spectra WaveWriter Spinal Cord Stimulator System delivers paresthesia-based and subperception (no paresthesia) therapy simultaneously; this may also be described as dual-wave stimulation. This may allow customization of the therapy dependent on the individual and theoretically may be used in one of two ways: both therapy types can be combined to treat a specific area or used separately for managing multiple pain areas. Two newer versions, the WaveWriter Alpha and the WaveWriter Alpha-Prime are both MRI compatible; the WaveWriter Alpha has a rechargeable battery, while the WaveWriter Alpha-Prime has a nonrechargeable battery.

The Wavegate StimuLux has been granted an FDA Breakthrough Device Designation; it is described as a system for closed-loop adaptive modulation of spinal cord stimulation. According to the manufacturer, it integrates optoelectronic components and optical fiber to measure the distance between the spinal cord and the epidural electrode array. This purportedly allows real-time stimulus modulation to ensure consistent and effective adaptive stimulation. Currently this device is only available in clinical trials. (Refer to Coverage Limitations section)

Dorsal root ganglion stimulation differs slightly from traditional spinal cord stimulation and is proposed as a treatment of moderate to severe chronic intractable pain of the lower extremities in an adult with chronic CRPS. The Proclaim DRG Neurostimulation System (formerly the Axium Neurostimulator System) is an example of an FDA-approved dorsal root ganglion stimulator; it is also MRI compatible and uses wireless technology control via an Apple mobile digital device. (Refer to Coverage Limitations section)

Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0306-026

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Determination

Services provided by a psychiatrist, psychologist or other behavioral health professionals are subject to the provisions of the applicable behavioral health benefit.

Humana members may be eligible under the Plan for lumbar or thoracic spinal cord stimulation for the following conditions AND when the criteria corresponding to temporary trial or permanent placement are met:

• Complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD); OR
• Failed back surgery syndrome (FBSS) with primarily radicular pain; OR
• Inoperable chronic limb ischemia

Temporary Trial

A temporary trial of lumbar or thoracic spinal cord stimulation may be covered for any of the conditions listed above when ALL of the following criteria are met:

• Absence of contraindications; AND
• Implantation of the stimulator is used only as a late (if not last) resort for individuals with chronic intractable pain related to the conditions listed above; AND
• Other treatment modalities, under the direction of a healthcare professional, have been tried for 6 consecutive months within the past 12 months and failed to provide satisfactory pain control, to include ALL of the following:
  • Interventional spinal procedure (eg, epidural steroid injections, facet blocks, medial branch blocks, facet joint denervation) if medically appropriate and not contraindicated, was tried and failed (for information regarding coverage determination/limitations, please refer to Injections for Chronic Pain Conditions or Neuroablative Techniques for Chronic Pain Medical Coverage Policies; AND
  • Pharmacological management if medically appropriate and not contraindicated; AND
• Individual failed or could not tolerate the side effects of pain medications (eg, systemic opioids, non-narcotic analgesics); AND
• Medications were prescribed and taken via oral or transdermal routes of administration per a fixed schedule (not on an as needed basis [PRN]); AND
• Records are submitted documenting compliance with attempted pharmacological management; AND
• Physical therapy, including a home exercise program (HEP) (for information regarding coverage determination/limitations, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy); AND
• Surgical procedures:
  • If appropriate for the medical condition, surgery has been tried and failed OR the individual is not a candidate for surgical interventions; AND
  • For an individual with failed back surgery syndrome, they are not a candidate for further surgical intervention; AND
• Pain-focused psychological evaluation by a licensed mental health professional has been obtained within the past 12 months and indicates that the individual is a favorable candidate for permanent spinal cord stimulation; AND
• The individual has undergone screening, physical evaluation and diagnosis by a multidisciplinary team prior to implantation

Permanent Implantation

Permanent implantation of a lumbar or thoracic SCS may be covered when a temporary trial has been successful.

Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0306-026

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Successful is defined as:

• A temporary trial of at least 2 days duration has been completed, AND ALL of the criteria listed above have been met; AND
• Demonstration of at least 50% reduction in pain and improved function with the temporary implanted electrode prior to the permanent implantation

Spinal Cord Stimulators Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0306-026

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Replacement

Replacement/upgrade of a spinal cord stimulator may be considered medically necessary IF the existing device is no longer under manufacturer warranty, malfunctions (including impending end of battery life) and cannot be repaired OR replacement is required due to a change in the individual’s condition that makes the present device nonfunctional.

Lead and electrode replacement are not generally required at the time of generator replacement due to end of battery life.

Revision or Removal

Revision or removal of a spinal cord stimulator may be considered medically necessary for the following indications:

• Inadequate pain relief; OR
• Infection; OR
• Intolerance of paresthesia; OR
• Lead fracture; OR
• Lead migration; OR
• Loss of effectiveness/tolerance; OR
• Painful generator site; OR
• Seroma

Note: The criteria for spinal cord stimulators (dorsal column stimulators) are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for lumbar or thoracic spinal cord stimulation for any indications other than those listed above including, but not limited to:

• Chronic stable angina pectoris; OR
• Chronic visceral abdominal pain; OR

Spinal Cord Stimulators Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0306-026

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Low back pain with radicular pain to the lower extremities in the absence of failed back surgery syndrome; OR
• Pain and ischemia from peripheral vascular disease (PVD); OR
• Peripheral neuropathy including, but not limited to, diabetic neuropathy; OR
• Phantom limb pain (also referred to as post-amputation pain); OR
• Post-herpetic neuralgia; OR
• Replacement/upgrade of a functioning SCS that is not MRI compatible to one that is MRI compatible; OR
• Replacement/upgrade of a functioning SCS to a BurstDR or high-frequency SCS; OR
• Replacement/upgrade of a SCS when requested for convenience or to upgrade to a newer technology when the current device remains functional.

Lead and electrode replacement are NOT generally required at the time of a generator replacement due to end of battery life

All other indications are considered not medically necessary as defined in the member’s individual certificate.

Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for the following SCS or spinal cord stimulation for any indication:

• Cervical level spinal cord stimulation; OR
• Dorsal root ganglion stimulation; OR
• Evoke Spinal Cord Stimulation System (generator, neurostimulator [implantable], with closed feedback loop); OR

Spinal Cord Stimulators Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0306-026

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Freedom SCS System; OR
• Nalu Neurostimulation System; OR
• Proclaim DRG Neurostimulation System (formerly Axium); OR
• Simultaneous use of a SCS and intrathecal opioid therapy/implantable infusion pump; OR
• Wavegate StimuLux System (generator, neurostimulator [implantable], with closed feedback loop)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Contraindications

Spinal cord stimulators are contraindicated in the following individuals:

• Active infection; OR
• Body size is insufficient to support the weight and bulk of the device; OR
• Individual who has other implanted programmable devices (including cardiac pacemakers and/or defibrillators)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about chronic pain may be found from the following websites:

• Merck Manual
• National Library of Medicine

Spinal Cord Stimulators Effective Date: 08/24/2023

Revision Date: 08/24/2023

Review Date: 08/24/2023

Policy Number: HUM-0306-026

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.