NCD 160.7

Indications and Limitations of Coverage

Two general classifications of electrical nerve stimulators are employed to treat chronic intractable pain: peripheral nerve stimulators and central nervous system stimulators.

A. Implanted Peripheral Nerve Stimulators

Payment may be made under the prosthetic device benefit for implanted peripheral nerve stimulators. Use of this stimulator involves implantation of electrodes around a selected peripheral nerve. The stimulating electrode is connected by an insulated lead to a receiver unit which is implanted under the skin at a depth not greater than 1/2 inch.

Stimulation is induced by a generator connected to an antenna unit which is attached to the skin surface over the receiver unit. Implantation of electrodes requires surgery and usually necessitates an operating room.

NOTE: Peripheral nerve stimulators may also be employed to assess a patient’s suitability for continued treatment with an electric nerve stimulator. As explained in §160.7.1, such use of the stimulator is covered as part of the total diagnostic service furnished to the beneficiary rather than as a prosthesis.

B. Central Nervous System Stimulators (Dorsal Column and Depth Brain Stimulators)

The implantation of central nervous system stimulators may be covered as therapies for the relief of chronic intractable pain, subject to the following conditions:

1. Types of Implantations

There are two types of implantations covered by this instruction:

• Dorsal Column (Spinal Cord) Neurostimulation - The surgical implantation of neurostimulator electrodes within the dura mater (endodural) or the percutaneous insertion of electrodes in the epidural space is covered.

• Depth Brain Neurostimulation - The stereotactic implantation of electrodes in the deep brain (e.g., thalamus and periaqueductal gray matter) is covered.

2. Conditions for Coverage

No payment may be made for the implantation of dorsal column or depth brain stimulators or services and supplies related to such implantation, unless all of the conditions listed below have been met:

• The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain;

• With respect to item a, other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, or are judged to be unsuitable or contraindicated for the given patient;

• Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as physical evaluation);

• All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment training, and follow up of the patient (including that required to satisfy item c) must be available; and

• Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation.

Medicare Administrative Contractors may find it helpful to work with Quality Improvement Organizations to obtain the information needed to apply these conditions to claims.

Cross Reference

Medicare Benefit Policy Manual, Chapter 15, “Covered Medical and Other Health Services,” §120, and the following sections in this manual, §§160.2 and 30.1

Revision History

07/1995 - Determined that TENS covered under durable medical equipment benefit rather than prosthetic device benefit. Effective date 08/07/1995. (TN 78)

06/1988 - Added cross-references to section 45-25. Effective date 07/14/1988. (TN 26)