Title XVIII of the Social Security Act (SSA), §1862(a)(1)(A), states that no Medicare payment shall be made for items or services that “are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

CMS Manual System, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, §160.7, Electrical Nerve Stimulators.

The implantation of spinal cord stimulators (SCS) may be covered as therapies for the relief of chronic intractable pain. SCS is best suited for neuropathic pain but may have some limited value in other types of nociceptive severe, intractable pain. Therapy consists of a short trial with a percutaneous implantation of neurostimulator electrode(s) in the epidural space for assessing a patient’s suitability for ongoing treatment with a permanent surgically implanted nerve stimulator. Performance and documentation of an effective trial is a prerequisite for permanent nerve stimulation. In situations where the spinal cord stimulator has been working well but is in need of replacement for battery change, malfunction or end of stimulator life, a new trial is not needed to replace the stimulator.

Selection of patients for implantation of spinal cord stimulators is critical to success of this therapy. SCS therapy should be considered as a late option after more conservative attempts such as medications, physical therapy, psychological therapy or other modalities have been tried.

Patients must have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as physical evaluation). Documentation of the history and careful screening must be available in the patient chart if requested. Patients being selected for a trial

• Must not have active substance abuse issues.
• Must undergo proper patient education, discussion, and disclosure including an extensive discussion of the risks and benefits of this therapy.
• Must undergo appropriate psychological screening

Many experts recommend that the temporary neurostimulator be placed in an ASC or outpatient hospital setting. However, the temporary neurostimulator trial can be done 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. Permanent neurostimulators must be placed in an ASC or hospital. Physicians performing SCS trials in the office setting must have like privileges at a local hospital or ASC, or the providers must be subspecialty boarded in Pain Medicine by the American Board of Anesthesiology.

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).

It is expected that accurate patient selection will lead to most patients going on to receive permanent implants. 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.

Physicians with a low trial to permanent implant ratio (less than 50%) will 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.

Noridian will reimburse for placement of a maximum of 2 leads or 16 “contacts,” and for 2 SCS trials per anatomic spinal region per patient per lifetime (with exceptions allowed for technical limitations for the initial trials or for use of different modalities of stimulation, including new technology). More than 2 SCS trials per anatomic spinal region per patient per lifetime is not considered reasonable and necessary.

If a trial fails, a repeat trial is not appropriate unless there are extenuating circumstances that lead to trial failure.

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