A transcutaneous electrical nerve stimulator (TENS)(E0720, E0730) is a device which utilizes electrical current delivered through electrodes placed on the surface of the skin to decrease the patient's perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphins. A TENS unit must be distinguished from other electrical stimulators (e.g., neuromuscular stimulators) which are used to directly stimulate muscles and/or motor nerves.

For any item to be covered, it must:

1. be eligible for a defined Medicare benefit category;
2. be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; and,
3. meet all other applicable statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary", based on Social Security Act 1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage.

A transcutaneous electrical nerve stimulator (TENS) is covered for the treatment of patients with chronic, intractable pain or acute post-operative pain who meet the coverage rules listed below. The physician ordering the TENS unit must be the attending physician or a consulting physician for the disease or condition resulting in the need for the TENS unit.

Acute Post-Operative Pain
When a TENS unit is used for acute post-operative pain, the medical necessity is usually limited to 30 days from the day of surgery. Payment for more than one month is determined by individual consideration based upon supportive documentation provided by the attending physician. Payment will be made only as a rental. A TENS unit will be denied as not medically necessary for acute pain (less than three months duration) other than post-operative pain.

Chronic Pain
For chronic pain, the medical record must document the location of the pain, the duration of time the patient has had the pain, and the presumed etiology of the pain. The pain must have been present for at least three months. Other appropriate treatment modalities must have been tried and failed, and the medical record must document what treatment modalities have been used. The presumed etiology of the pain must be a type that is accepted as responding to TENS therapy. Examples of conditions for which a TENS unit are not considered to be medically necessary are (not all-inclusive): headache, visceral abdominal pain, pelvic pain, and temporomandibular joint (TMJ) pain. 

When used for the treatment of chronic, intractable pain, the TENS unit must be used by the patient on a trial basis for a minimum of one month (30 days), but not to exceed two months. The trial period will be paid as a rental. The trial period must be monitored by the physician to determine the effectiveness of the TENS unit in modulating the pain. For coverage of a purchase, the physician must determine that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time. The physician's records must document a re-evaluation of the patient at the end of the trial period, must indicate how often the patient used the TENS unit, the typical duration of use each time, and the results.

A 4 lead TENS unit may be used with either 2 leads or 4 leads, depending on the characteristics of the patient's pain. If it is ordered for use with 4 leads, the medical record must document why 2 leads are insufficient to meet the patient’s needs.

Supplies
Separate allowance will be made for replacement supplies when they are medically necessary and are used with a TENS unit that has been purchased and/or approved. If 2 TENS leads are medically necessary, then a maximum of one unit of code A4595 would be allowed per month; if 4 TENS leads are necessary, a maximum of two units per month would be allowed. If the use of the TENS unit is less than daily, the frequency of billing for the TENS supply code should be reduced proportionally.

Replacement of lead wires (A4557) more often than every 12 months would rarely be medically necessary.

Quantities of supplies greater than those described in the policy as the usual maximum amounts, in the absence of documentation clearly explaining the medical necessity of the excess quantities, will be denied as not medically necessary. 

Conductive Garment (E0731)
A conductive garment (E0731) used with a TENS unit is rarely medically necessary, but may be covered if all of the following conditions are met:

1. It has been prescribed by a physician for use in delivering covered TENS treatment; and
2. One of the medical indications outlined below is met:
    
   

   1. the patient cannot manage without the conductive garment because there is such a large area or so many sites to be stimulated and the stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes, and lead wires; or
   2. the patient cannot manage without the conductive garment for the treatment of chronic intractable pain because the areas or sites to be stimulated are inaccessible with the use of conventional electrodes, adhesive tapes, and lead wires; or
   3. the patient has a documented medical condition, such as skin problems, that preclude the application of conventional electrodes, adhesive tapes, and lead wires; or
   4. the patient requires electrical stimulation beneath a cast to treat chronic intractable pain.

A conductive garment is not covered for use with a TENS device during the trial period unless:

1. The patient has a documented skin problem prior to the start of the trial period; and
2. The item is medically necessary for the patient.

If the criteria above are not met for E0731, it will be denied as not medically necessary. 

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Reasons for Noncoverage

Transcutaneous electrical nerve stimulation equipment is covered under the Durable Medical Equipment benefit. In order for a member's equipment to be eligible for reimbursement, the medical necessity requirements documented in this medical policy must be met.

For an item addressed in this policy to be covered, a written signed and dated order must be received by the supplier prior to delivery of the item. If the supplier delivers the item prior to receipt of a written order, it will be denied as non-covered. If the written order is not obtained prior to delivery, payment will not be made for that item even if a written order is subsequently obtained. If a similar item is subsequently provided by an unrelated supplier who has obtained a written order prior to delivery, it will be eligible for coverage.

During the rental of a TENS unit, supplies for the unit are included in the rental allowance; there is no additional allowance for electrodes, lead wires, batteries, etc. If a TENS unit (E0720 or E0730) is purchased, the allowance includes lead wires and one month's supply of electrodes, conductive paste or gel (if needed), and batteries.

Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items delivered before a signed written order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

For a purchased TENS unit, a Certificate of Medical Necessity (CMN), which has been completed, signed and dated by the treating physician, must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for a written order if it contains all the required elements of an order. The initial claim must include an electronic copy of the CMN.

A CMN is not needed for a TENS rental.

A claim for code E0731 must be accompanied by the brand name and model number of the conductive garment. Documentation supporting the medical necessity for the E0731 must be kept in the supplier’s files and be available upon request.

KX, GA, AND GZ MODIFIERS: 

Suppliers must add a KX modifier to code E0731 only if all of the criteria in the Indications and Limitations of Coverage section of this policy have been met.

If all of the criteria in the Indications and Limitations of Coverage section have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Pre-Service Denial Notice or the GZ modifier if they have not obtained a valid Pre-Service Denial Notice. Services submitted with a GA modifier will be denied as not medically necessary and are billable to the member. Services submitted with a GZ modifier will be denied as not medically necessary and are not billable to the member.

Claim lines billed for E0731 without a GA, GZ or KX modifier will be rejected as missing information.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

A TENS supply allowance (A4595) includes electrodes (any type), conductive paste or gel (if needed, depending on the type of electrode), tape or other adhesive (if needed, depending on the type of electrode), adhesive remover, skin preparation materials, batteries (9 volt or AA, single use or rechargeable), and a battery charger (if rechargeable batteries are used).

Codes A4556 (Electrodes, [e.g., apnea monitor], per pair), A4558 (Conductive paste or gel), and A4630 (Replacement batteries, medically necessary TENS owned by patient) are not valid for claim submission. The provider cannot bill the member for the denied service. A4595 should be used instead. 

For code A4557, one unit of service is for lead wires going to two electrodes. If all the lead wires of a 4 lead TENS unit needed to be replaced, billing would be for two units of service.

There should be no billing and there will be no separate allowance for replacement electrodes (A4556), conductive paste or gel (A4558), replacement batteries (A4630), or a battery charger used with a TENS unit.

Other supplies, including but not limited to the following, will not be separately allowed: adapters (snap, banana, alligator, tab, button, clip), belt clips, adhesive remover, additional connecting cable for lead wires, carrying pouches, or covers.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items. https://www.dmepdac.com/

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider."  It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 10.2, 160.7.1, 160.13, 280.13

Equipment

Supplies