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”).
A Transcutaneous Electrical Joint Stimulation Device (TEJSD) 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.
The DME benefit limits the coverage of DME items to those used the beneficiary’s home. Provision of TEJSD to beneficiaries in a Place of Service or facility considered to be other than home will be denied as statutorily non-covered. This includes a TEJSD incorporated into or used with any type brace (see below).
Braces are covered under the Braces benefit (Social Security Act § 1861(s)(9)). Coverage of items under the Braces benefit is not limited to the home.
Use of a TEJSD with a brace does not change the benefit category for the TEJSD device or of the brace. A TEJSD/brace combination does not extend the DME Benefit limitation of use in the home.
Refer to the applicable brace Local Coverage Determination and related Policy Article for information about coverage requirements for braces.
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.
A transcutaneous electrical joint stimulation device (TEJSD) coded (E0762) is a noninvasive device that delivers electrical stimulation intended to reduce the level of pain and symptoms associated with arthritis in a joint. TEJSD may have variation in the parameters of the current, how the current is applied, etc.
A TEJSD coded E0762 must be distinguished from other electrical stimulators (e.g., neuromuscular stimulators, functional electrical stimulators and transcutaneous electrical nerve stimulators, etc.) which also have unique HCPCS codes and are used to directly stimulate muscles and/or nerves. The appropriate applicable HCPCS code for these devices must be used.
TEJSD is sometimes provided in combination with an orthosis (brace). When these items are provided in combination, the TEJSD and brace are always coded separately, using the codes assigned to each individual product. Braces designed to accommodate placement of electrodes and/or lead wires, that contain integrated electrodes and/or lead wires, storage for the TEJSD, etc. are considered braces, not supplies or accessories to the TEJSD and must be coded with the HCPCS code that appropriately describes the brace.
If the electronics are incorporated into a brace, the item is no longer considered a brace. Rather it is DME if it meets the benefit requirements for the DME Benefit or is statutorily non-covered (no benefit) if it does not.
Code A4465 is used for replacement only of any wrap/strap used to position and hold electrodes used with TEJSD in place. Use of this code for replacement of wraps/straps used with a brace is incorrect coding.
The 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 (any type, single use or rechargeable), and a battery charger (if rechargeable batteries are used). One unit of service includes all necessary supplies for one month’s prescribed use of the device. Separate billing for individual supplies is considered unbundling.
Codes A4556 (Electrodes, [e.g., apnea monitor], per pair) and A4558 (Conductive paste or gel), are not valid for claim submission to the DME MAC. Code A4595 should be used instead.
For code A4557, one unit of service is for lead wires going to two electrodes.
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.
The only products which may be billed using code E0762 are those for which a written Coding Verification Review has been made by the Pricing, Data Analysis and Coding (PDAC) Contractor and subsequently published on the appropriate Product Classification List. Suppliers may not submit claims using E0762 for any other item.
Claims for unlisted items using HCPCS code E0762 will be denied as incorrect coding.
Suppliers should contact the PDAC for guidance on the correct coding of these items.