CMS Pub. 100-03, ch. 1, § 160.7.1

Therapy

(Rev. 149, Issued: 11-30-12, Effective: 06-08-12, Implementation: 01-07-13)

Electrical nerve stimulation is an accepted modality for assessing a patient’s suitability

for ongoing treatment with a transcutaneous or an implanted nerve stimulator.

Accordingly, program payment may be made for the following techniques when used to

determine the potential therapeutic usefulness of an electrical nerve stimulator:

A. Transcutaneous Electrical Nerve Stimulation (TENS)

This technique involves attachment of a transcutaneous nerve stimulator to the surface of

the skin over the peripheral nerve to be stimulated. It is used by the patient on a trial

basis and its effectiveness in modulating pain is monitored by the physician, or physical

therapist. Generally, the physician or physical therapist is able to determine whether the

patient is likely to derive a significant therapeutic benefit from continuous use of a

transcutaneous stimulator within a trial period of one month; in a few cases this

determination may take longer to make. Document the medical necessity for such

services which are furnished beyond the first month. (See §160.13 for an explanation of

coverage of medically necessary supplies for the effective use of TENS.)

If TENS significantly alleviates pain, it may be considered as primary treatment; if it

produces no relief or greater discomfort than the original pain electrical nerve stimulation

therapy is ruled out. However, where TENS produces incomplete relief, further

evaluation with percutaneous electrical nerve stimulation may be considered to determine

whether an implanted peripheral nerve stimulator would provide significant relief from

pain.

Usually, the physician or physical therapist providing the services will furnish the

equipment necessary for assessment. Where the physician or physical therapist advises

the patient to rent the TENS from a supplier during the trial period rather than supplying

it himself/herself, program payment may be made for rental of the TENS as well as for

the services of the physician or physical therapist who is evaluating its use. However, the

combined program payment which is made for the physician’s or physical therapist’s

services and the rental of the stimulator from a supplier should not exceed the amount

which would be payable for the total service, including the stimulator, furnished by the

physician or physical therapist alone.

B. Percutaneous Electrical Nerve Stimulation (PENS)

This diagnostic procedure which involves stimulation of peripheral nerves by a needle

electrode inserted through the skin is performed only in a physician’s office, clinic, or

hospital outpatient department. Therefore, it is covered only when performed by a

physician or incident to physician’s service. If pain is effectively controlled by

percutaneous stimulation, implantation of electrodes is warranted.

As in the case of TENS (described in subsection A), generally the physician should be

able to determine whether the patient is likely to derive a significant therapeutic benefit

from continuing use of an implanted nerve stimulator within a trial period of 1 month. In

a few cases, this determination may take longer to make. The medical necessity for such

diagnostic services which are furnished beyond the first month must be documented.

NOTE: Electrical nerve stimulators do not prevent pain but only alleviate pain as it

occurs. A patient can be taught how to employ the stimulator, and once this is done, can

use it safely and effectively without direct physician supervision. Consequently, it is

inappropriate for a patient to visit his/her physician, physical therapist, or an outpatient

clinic on a continuing basis for treatment of pain with electrical nerve stimulation. Once

it is determined that electrical nerve stimulation should be continued as therapy and the

patient has been trained to use the stimulator, it is expected that a stimulator will be

implanted or the patient will employ the TENS on a continual basis in his/her home.

Electrical nerve stimulation treatments furnished by a physician in his/her office, by a

physical therapist or outpatient clinic are excluded from coverage by §1862(a)(1) of the

Act. (See §160.7 for an explanation of coverage of the therapeutic use of implanted

peripheral nerve stimulators under the prosthetic devices benefit.) See §160.27 for an

explanation of coverage of the therapeutic use of TENS under the durable medical

equipment benefit.