5160-10-15. DMEPOS: transcutaneous electrical nerve stimulation (TENS) units

(A) Definitions.

(1) "Accessories" is a collective term that encompasses but is not necessarily limited to the following items:

(a) Adapters;

(b) Clips;

(c) Additional connecting cable for lead wires;

(d) Carrying pouches; and

(e) Covers.

(2) "Supplies" is a collective term that encompasses but is not necessarily limited to the following items:

(a) Electrodes of any type;

(b) Lead wires;

(c) Conductive paste or gel;

(d) Adhesive;

(e) Adhesive remover;

(f) Skin preparation materials;

(g) Batteries; and

(h) Battery charger for rechargeable batteries.

(B) Provider requirement. A provider of transcutaneous electrical nerve stimulation (TENS) units must have a physical location available for face-to-face fitting and instruction purposes.

(C) Coverage.

(1) Payment may be made for a TENS unit on a rental/purchase basis.

(2) The default certificate of medical necessity (CMN) form is the ODM 03402, "Certificate of Medical Necessity: Transcutaneous Electrical Nerve Stimulation (TENS) Units" (rev. 7/2018). The CMN must include one of the following statements of need:

(a) For neurogenic pain, the following information:

(i) An attestation that the individual is experiencing intractable, nerve-related pain that has lasted at least six months;

(ii) An appropriate supporting diagnosis; and

(iii) An attestation that the use of a comparable TENS unit for a trial period of at least thirty days produced substantial relief from pain and, if applicable, enabled a significant reduction in medication (e.g., muscle relaxants, narcotics, analgesics); or

(b) For post-operative pain, the following information:

(i) An attestation that treatment lasting no longer than thirty days is needed for acute pain following surgery; and

(ii) The date of surgery.

(3) Payment may be made for the purchase of a TENS unit if the prescriber attests to the medical necessity of continued treatment.

(4) After a TENS unit has been purchased for an individual, regardless of payment source, separate payment may be made for necessary supplies, which must be dispensed only when they are needed, at a frequency not to exceed once per month. The payment made for supplies is an all-inclusive lump sum and does not depend on the number or nature of items in a particular shipment. No separate payment is allowed for individual supply items.

(5) After a TENS unit has been purchased, no separate payment is allowed for accessories.

(D) Requirements, constraints, and limitations.

(1) A diagnosis of "chronic intractable pain" is not in itself sufficient to warrant coverage.

(2) Rental of a TENS unit to treat intractable, nerve-related pain is limited to four months.

(3) Rental of a TENS unit to treat post-operative pain is limited to a single thirty-day period and may not be extended.

(4) The warranty period for a purchased TENS unit is two years from the date of delivery.

(5) Payment may be made for the rental or purchase of a used TENS unit only if the particular unit was previously used by the individual for whom it is currently prescribed.

(6) Payment for a TENS unit does not indicate or imply coverage of a conductive TENS garment.

(7) Payment is limited to the maximum amount for a two-lead unit unless the provider obtains and maintains documentation in the individual's file establishing the medical necessity of a four-lead unit.

(8) The medical necessity of a TENS unit not purchased by the department must be established before payment is made for supplies or repair.

(E) Claim payment. The lump-sum payment for TENS supplies is twenty-five dollars.

Replaces: 5160-10-15

Effective: 7/16/2018
Five Year Review (FYR) Dates: 07/16/2023
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 04/04/1977, 12/21/1977, 12/30/1977, 01/01/1980, 03/01/1984, 05/01/1990, 06/20/1990 (Emer), 09/05/1990, 04/16/2007, 04/01/2009