History/Background and/or General Information
Spinal cord (dorsal column) stimulation (SCS) is a pain relief technique that delivers a low-voltage electrical current to the spinal cord to block the sensation of pain. This technique is best suited for pain that is neuropathic in nature i.e., resulting from actual damage to the peripheral nerves. Common indications include, but are not limited to, failed back syndrome, complex regional pain syndrome (i.e., reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy. SCS is generally not effective in treating nociceptive pain (resulting from irritation, not damage to the nerves) and central deafferentation pain (related to central nervous system damage from a stroke or spinal cord injury).
Two stages are involved in SCS implantation. In both stages, a physician, guided by an x-ray, places a lead into the epidural space located within the bony spinal canal.
The first stage consists of a short trial (e.g., 3-14 days) with a temporary percutaneous implantation of neurostimulator electrode(s) and external generator for assessing the patient’s suitability for ongoing treatment with a permanent surgically implanted nerve stimulator. During the trial phase, one or two leads are placed via an epidural needle in the appropriate position. This can be done under light sedation in an office setting if all the sterility, equipment, professional training and support personnel required for the proper surgery and follow up of the patient are available. If at least 50% pain relief is achieved during the trial phase, the temporary system may be transitioned to a permanent system. Performance and documentation of an effective trial is a prerequisite for permanent nerve stimulation.
In the permanent implantation stage, there are two different SCS systems routinely used. The first system uses percutaneous insertion of electrodes into the epidural space and subcutaneous connection to a neurostimulator. The second system involves the implantation of paddle-type leads into the epidural space after laminectomy and subcutaneous connection to a neurostimulator. Neurostimulators may be either Implantable Pulse Generators (IPGs), which use either a non-rechargeable or a rechargeable internal battery, or radio frequency devices, which receive energy in the form of radio frequency pulses from an external device powered by a rechargeable battery. The appropriate SCS system with up to 16 contacts/electrodes will depend on the underlying condition, the patient’s pain patterns, the area of body affected, and the amount and intensity of stimulation required. Permanent neurostimulators must be placed in an Ambulatory Surgical Center (ASC) or hospital.
Covered Indications
SCS may be covered for the relief of chronic intractable pain under the following circumstances:
- To treat chronic pain caused by lumbosacral arachnoiditis that has not responded to medical management including physical therapy. (Presence of arachnoiditis is usually documented by presence of high levels of proteins in the Cerebrospinal Fluid (CSF) and/or by myelography or Magnetic Resonance Imaging (MRI)
- To treat intractable pain caused by nerve root injuries, post-surgical or post-traumatic including that of post-laminectomy syndrome (failed back syndrome).
- To treat intractable pain caused by complex regional pain syndrome I & II.
- To treat intractable pain caused by phantom limb syndrome that has not responded to medical management.
- To treat intractable pain caused by end-stage peripheral vascular disease, when the patient cannot undergo revascularization or when revascularization has failed to relieve painful symptoms and the pain has not responded to medical management.
- To treat intractable pain caused by post-herpetic neuralgia.
- To treat intractable pain caused by cauda equina injury.
- To treat intractable pain caused by incomplete spinal cord injury.
- To treat intractable pain caused by plexopathy.
Limitations
SCS is considered experimental or investigational for all other indications including, but not limited to, treatment for refractory angina pectoris and treatment of cancer-related pain. There is insufficient evidence to conclude that SCS improves net health outcomes.
Selection of patients for implantation of spinal cord stimulators is critical to success of this therapy. No payment may be made for the implantation of spinal cord (dorsal column) stimulators or services and supplies related to such implantation, unless all of the conditions listed below have been met:
- Patients being selected for a trial must not have current substance abuse;
- Patients must undergo proper patient education, discussion, and disclosure including an extensive discussion of the risks and benefits of this therapy; and
- Only patients who experience a positive response to a trial should proceed to a permanent implantation. All trials which proceed to permanent implant must have adequate documentation in the chart to support that decision. A successful trial should be associated with at least a 50% reduction of target pain, or 50% reduction of analgesic medications, and show some element of functional improvement. (Patients with reflex sympathetic dystrophy may show lower levels of improvement since it takes longer periods for improvement than the typical 1-2 week trial). Physician judgment and experience will also be taken into account.
- Please refer to CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual; Chapter 1, Part 2, Section 160.2 Treatment of Motor Function Disorders with Electric Nerve Stimulation, Section 160.7 Electrical Nerve Stimulators for additional limitations.
Percutaneous implantation of neurostimulator electrode array, epidural - Two temporary spinal cord stimulator trials per anatomic spinal region (two per DOS) or (four units) per patient per lifetime, in place of service office, ASC, out-patient hospital, or hospital. Since permanent neurostimulator arrays can also be placed percutaneously, percutaneous implantation of neurostimulator electrode array, epidural can be covered more often in place of service ASC, outpatient hospital, or hospital.
Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural - One permanent spinal cord stimulator per patient per lifetime performed in an ASC, outpatient hospital, or hospital.
Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed and Revision Including Replacement, When Performed, of Spinal Neurostimulator Electrode Percutaneous Array(S), Including Fluoroscopy, When Performed will not be reimbursed in the office setting since they are included in Percutaneous Implantation of Neurostimulator Electrode Array, Epidural.
If a trial fails, a repeat trial is not appropriate unless there are extenuating circumstances that lead to trial failure.
Generally, electronic analysis is not considered medically necessary when provided at a frequency more often than once every 30 days. More frequent analysis may be necessary in the first month after implantation.
Relative Contraindication to SCS:
- The presence of other stimulation devices with sensing capacities (e.g., pacemakers or implantable cardiac defibrillators could be interfered by a spinal cord stimulator). This is a relative contraindication that may be covered when the patient has indications for a SCS and the documentation entails that the beneficiary was informed of their treatment options and explained the risks/benefits of SCS.
Contraindications to SCS:
- Major psychiatric disorders, including somatization;
- No partial sparing of the dorsal column fibers (e.g., total paraplegia) of the treated area;
- Severe diseases likely to interfere with neuromodulation procedures (e.g., coagulopathies and immunodeficiency diseases);
- An active and untreated substance abuse disorder;
- Ongoing requirement for therapeutic diathermy; or
- Severe cognitive impairment rendering a patient incapable of giving informed consent for the procedure and/or operating the device.
As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.
Provider Qualifications
The CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, outlines that “reasonable and necessary” services are “ordered and furnished by qualified personnel.” Services will be considered medically reasonable and necessary only if performed by appropriately trained providers. A qualified physician for this service/procedure is defined as follows: A) Physician is properly enrolled in Medicare. B) Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.
Permanent neurostimulators must be placed in an ASC or hospital. Physicians performing SCS trials in the office setting will be considered qualified if they have like privileges at a local hospital or ASC, or the providers have one of the following applicable specialty/subspecialty; Pain Medicine, Interventional Pain, Neurosurgery, Physical Medicine and Rehabilitation, Orthopedic Surgery. It is preferable that physicians performing the SCS trial will also perform the permanent implant. If the physician implanting the trial neurostimulator does not or cannot implant the permanent neurostimulator, the patient should be informed of this in writing and given the name of the referral surgeon who will implant the permanent neurostimulator(s).
Physicians with a low trial to permanent implant ratio (less than 50%) may be subject to post-payment review and may be asked to submit documentation as to the patient selection criteria, the radiologic imaging demonstrating proper lead placement, and the medical necessity of the trials. Failure to provide this documentation will be cause for post-payment denial and recoupment of reimbursement. It is understood that all patients may not have a favorable result of the trial implant; but careful selection should find the most appropriate patients.
