LCD L37632

Coverage Guidance

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §160.7 Electrical Nerve Stimulators

Indications and Limitations of Coverage

Background

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.

Selection of patients for implantation of SCS 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.

Many experts recommend that the temporary neurostimulator be placed in an Ambulatory Surgical Center (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 to 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%) may/can/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. 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.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Documentation Requirements

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this Local Coverage Determination (LCD). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Documentation supporting medical necessity should be legible, maintained in the patient’s medical record, and made available to A/B MAC upon request.

The clinical record should include the elements leading to the diagnosis and the therapies tried before the decision to use SCS.

When the documentation does not meet the criteria for the service rendered, or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary.

Bibliography

McIntyre PJ, Bedder MD. Complications of spinal cord stimulation. In: Deer TR, Ed. Neurostimulation for the Treatment of Chronic Pain: Interventional and Neuromodulatory Techniques for Pain Management Series. Vol 1. 1st ed. Philadelphia, PA: Elsevier Saunders;2011.

Rauck RL, Nagel S, North JL, Machado AG. Spinal cord stimulation: Implantation techniques. In: Deer TR, Ed. Neurostimulation for the Treatment of Chronic Pain: Interventional and Neuromodulatory Techniques for Pain Management Series. Vol 1. 1st ed. Philadelphia, PA: Elsevier Saunders;2011.

Shah BJ, Hayek SM, Khalil AA. Medical considerations in spinal cord stimulation. In: Deer TR, Ed. Neurostimulation for the Treatment of Chronic Pain: Interventional and Neuromodulatory Techniques for Pain Management Series. Vol 1. 1st ed. Philadelphia, PA: Elsevier Saunders;2011.

Shahbazian MS, Richeimer SH. Implant technologies for severe pain: Why, when, and the outcomes. Practical Pain Management.2011;11(8):73-79.

Wu C, Falowksi SM, Sharan A. Spinal cord stimulation: General indications. In: Deer TR, Ed. Neurostimulation for the Treatment of Chronic Pain: Interventional and Neuromodulatory Techniques for Pain Management Series. Vol 1. 1st ed. Philadelphia, PA: Elsevier Saunders;2011.