NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES
For any item to be covered by Medicare, 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 Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).
Transcutaneous electrical nerve stimulation (TENS) equipment is covered under the Durable Medical Equipment benefit (Social Security Act §1861(s)(6)). In order for a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.
During the rental of a TENS unit, supplies for the unit are included in the rental allowance; there is no additional allowance for items such as electrodes, lead wires, and batteries. If a TENS unit (E0720 or E0730) is purchased, the allowance is all-inclusive of items such as lead wires and one month's supply of items such as electrodes, conductive paste or gel (if needed), and batteries.
Refer to the COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY section of the LCD for additional information about coverage criteria and associated documentation.
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)
Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The link will be located here once it is available.
Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.
If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS
In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.
Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.
For all claims for TENS and related supplies there must be information in the medical record demonstrating that the coverage criteria are met.
For acute post-operative pain covered under criterion I of the related LCD, there must be information about:
- The date of surgery
- The nature of the surgery
- The location and severity of the pain
For chronic pain covered under criterion II of the related LCD, there must be information in the medical record describing:
- The location of the pain
- The severity of the pain
- The duration of time the beneficiary has had the pain
- The presumed etiology of the pain
- Prior treatment and results of that treatment
- Reevaluation of the beneficiary at the end of the trial period, must indicate
- How often the beneficiary used the TENS unit
- The typical duration of use each time
- The results (effectiveness of therapy)
Each claim for code E0731 must be accompanied by the brand, name and model number of the conductive garment.
CERTIFICATE OF MEDICAL NECESSITY (CMN)
For TENS provided under criteria I and II in the Coverage Indications, Limitations, and/or Medical Necessity of the related LCD, a Certificate of Medical Necessity (CMN), which has been completed, signed, and dated by the treating practitioner, must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for the Standard Written Order (SWO) if it contains the same information as required in a SWO. The CMN for TENS is CMS Form 848. In addition to the information that the treating practitioner enters in Section B, the supplier can use the space in Section C for a written confirmation of other details of the order or the treating practitioner can enter the other details directly.
A new CMN is not required just because the supplier changes assignment status on the submitted claim.
A CMN is not needed for a TENS rental.
KX, GA, GZ AND Q0 (zero) MODIFIERS:
Suppliers must add a KX modifier to codes E0720, E0730, and E0731 only if all of the criteria in the COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY section of the related LCD have been met.
For the situation where a KX modifier is required, if all of the criteria in the COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY section of the related LCD have not been met, the GA or GZ modifier must be added to these codes. When there is an expectation of a reasonable and necessary denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.
Claim lines billed for E0720, E0730, and E0731 without a GA, GZ or KX modifier as specified above will be rejected as missing information.
A transcutaneous electrical nerve stimulator (TENS) (E0720, E0730) is a device that 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.
A TENS supply allowance (A4595), is an all-inclusive code and includes items such as 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 to the DME MAC. 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.