Spinal Cord Stimulators - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.

Type: Internet-Only, Manuals (IOMs), NCD, LCD LCA

Title: Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 120 - Prosthetic Devices, Medicare Benefit Policy Manual, Electrical Nerve Stimulators, spinal Core Stimulators for, Spinal Cord Stimulators for Chronic Pain, cet 'er

ID Number: 160.7, 135136 A57791, L36204 A57792, 137632 A56876

Medicare Administrative Contractors (MACs): Noridian Healthcare Solutions, LLC, Palmetto GBA

Applicable States/Territories: CA, HI, NV, American Samoa, Guam, Northern Mariana Islands, AL, GA, TN, NC, SC, VA, WV

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.

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.

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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.

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.

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.

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 BurstDR stimulation is a similar device to the , using the same type of stimulation patterns, but does not have the capability to be controlled with any digital devices.

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

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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 non-rechargeable 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.

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.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

Please refer to the above CMS guidance for Spinal Cord Stimulators

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the criteria contained in the following:

Spinal Cord Stimulators

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

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US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage