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”).
External upper limb tremor stimulators and related supplies and accessories meet the benefit requirements for Durable Medical Equipment (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.
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 required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.
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 prior to delivery, 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.
The medical records must include all of the following documentation to support initial coverage of an external upper limb tremor stimulator of the peripheral nerves of the wrist (E0734) and associated supplies (A4542):
- The beneficiary is 18 years or older with a diagnosis of essential tremor (ET) with symptoms affecting their dominant upper limb, and has no contraindications to external upper limb tremor stimulator therapy; and,
- The external upper limb tremor stimulator is being prescribed to treat severe ET symptoms in the beneficiary’s dominant upper limb that impairs their ability to perform upper-limb-related (i.e., eating, drinking, self-care, writing) activities of daily living (ADLs). Severe ET symptoms are indicated by a score of greater than or equal to 3 on the Bain & Findley Tremor ADL Scale (BF-ADL) for any upper-limb-related assessment item; and,
- If medically appropriate, tremor exacerbating medications (e.g., stimulants, beta agonists) have been reduced or eliminated; and,
- At least two (2) pharmacological treatment options for the management of ET symptoms have been either tried and failed at maximal tolerable treatment dosages (i.e., no or limited effect, intolerable side effects) or considered and ruled out (e.g., not appropriate in the context of the beneficiary’s medical history); and,
- The external upper limb tremor stimulator therapy is being prescribed as an alternative to invasive and/or permanent surgical treatment options (e.g., deep brain stimulation, magnetic resonance guided focused ultrasound, radiosurgery).
MODIFIERS
GA, GZ, KX, LT, and RT MODIFIERS:
Suppliers must add the KX modifier to claim lines billed for an external upper limb tremor stimulator, and related supplies and accessories, only if all of the coverage criteria in the “Coverage Indications, Limitations, and/or Medical Necessity” section in the related LCD have been met and evidence of such is retained in the supplier’s files and available to the DME MAC upon request.
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 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 Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.
Claim lines billed without a KX, GA, or GZ modifier will be rejected as missing information.
An external upper limb tremor stimulator of the peripheral nerves of the wrist (E0734) and associated supplies (A4542) are limb-specific (i.e., right or left upper extremity). The RT (right) and LT (left) modifiers must be used when billing codes E0734 and A4542. When bilateral (left and right) upper limb tremor stimulators or supplies are billed on the same date of service, bill each item on separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line with 2 UOS. Claim lines billed without the RT and/or LT modifiers, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.
CODING GUIDELINES
Code E0734 describes an external upper limb tremor stimulator that delivers customized electrical stimulation transcutaneously to the nerves of the upper extremity.
Code A4542 describes related accessories and supplies used with an external upper limb tremor stimulator and includes, but is not limited to, the wrist band with integrated electrodes. Code A4542 is separately billed at initial issue of the external upper limb tremor stimulator of the peripheral nerves of the wrist (E0734) and can be billed every ninety (90) days thereafter.
Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.
