A4557 Medicare coverage

Local coverage indication

Replacement of lead wires (A4557) more often than every 12 months would rarely be reasonable and necessary. A conductive garment (E0731) used with a TENS unit is rarely reasonable and necessary, but is covered only if all of the following conditions are met: It has been prescribed by the treating practitioner for use in delivering covered TENS treatment. One of the medical indications outlined below is met: The beneficiary 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. The beneficiary 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. The beneficiary has a documented medical condition, such as skin problems, that preclude the application of conventional electrodes, adhesive tapes, and lead wires. The beneficiary 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: The beneficiary has a documented skin problem prior to the start of the trial period, and The TENS is reasonable and necessary for the beneficiary.

Excerpt from LCD L33802 version 35, effective 01/01/2024. CMS LCD L33802.

National coverage indication, NCD 10.2

The use of transcutaneous electrical nerve stimulation (TENS) for the relief of acute post-operative pain is covered under Medicare. TENS may be covered whether used as an adjunct to the use of drugs, or as an alternative to drugs, in the treatment of acute pain resulting from surgery. The TENS devices, whether durable or disposable, may be used in furnishing this service. When used for the purpose of treating acute post-operative pain, TENS devices are considered supplies. As such they may be hospital supplies furnished inpatients covered under Part A, or supplies incident to a physician’s service when furnished in connection with surgery done on an outpatient basis, and covered under Part B. It is expected that TENS, when used for acute post-operative pain, will be necessary for relatively short periods of time, usually 30 days or less. In cases when TENS is used for longer periods, contractors should attempt to ascertain whether TENS is no longer being used for acute pain but rather for chronic pain, in which case the TENS device may be covered as durable medical equipment as described in § 160.27 .

Excerpt from NCD 10.2 version 2. CMS NCD 10.2.

National coverage indication, NCD 160.7.1

Electrical nerve stimulation is an accepted modality for assessing a patient's suitability for ongoing treatment with a transcutaneous or an implanted nerve stimulator. Accordingly, program payment may be made for the following techniques when used to determine the potential therapeutic usefulness of an electrical nerve stimulator: A. Transcutaneous Electrical Nerve Stimulation (TENS) This technique involves attachment of a transcutaneous nerve stimulator to the surface of the skin over the peripheral nerve to be stimulated. It is used by the patient on a trial basis and its effectiveness in modulating pain is monitored by the physician, or physical therapist. Generally, the physician or physical therapist is able to determine whether the patient is likely to derive a significant therapeutic benefit from continuous use of a transcutaneous stimulator within a trial period of 1 month; in a few cases this determination may take longer to make. Document the medical necessity for such services which are furnished beyond the first month. (See § 160.13 for an explanation of coverage of medically necessary supplies for the effective use of TENS.

Excerpt from NCD 160.7.1 version 2. CMS NCD 160.7.1.

What NCD 160.13 says the item is

Transcutaneous Electrical Nerve Stimulation (TENS) and/or Neuromuscular Electrical Stimulation (NMES) can ordinarily be delivered to patients through the use of conventional electrodes, adhesive tapes and lead wires. There may be times, however, where it might be medically necessary for certain patients receiving TENS or NMES treatment to use, as an alternative to conventional electrodes, adhesive tapes and lead wires, a form-fitting conductive garment (i.e., a garment with conductive fibers which are separated from the patients’ skin by layers of fabric).

What NCD 160.27 says the item is

The TENS is a type of electrical nerve stimulator that is employed to treat chronic intractable pain. This stimulator is attached to the surface of the patient’s skin over the peripheral nerve to be stimulated. It may be applied in a variety of settings (in the patient’s home, a physician’s office, or in an outpatient clinic). Payment for TENS may be made under the durable medical equipment benefit. A. General For the purposes of this decision chronic low back pain (CLBP) is defined as: an episode of low back pain that has persisted for three months or longer; and is not a manifestation of a clearly defined and generally recognizable primary disease entity.

National coverage indication, NCD 160.27

B. Nationally Covered Indications Effective June 8, 2012, the Centers for Medicare & Medicaid Services (CMS) will allow coverage for Transcutaneous Electrical Nerve Stimulation (TENS) for CLBP only when all of the following conditions are met. In order to support additional research on the use of TENS for CLBP, we will cover this item under section 1862(a)(1)(E) of the Social Security Act (the Act) subject to all of the following conditions: Coverage under this section expires three years after the publication of this decision on the CMS website. The beneficiary is enrolled in an approved clinical study meeting all of the requirements below. The study must address one or more aspects of the following questions in a randomized, controlled design using validated and reliable instruments. This can include randomized crossover designs when the impact of prior TENS use is appropriately accounted for in the study protocol.

Excerpt from NCD 160.27 version 1. CMS NCD 160.27.

Local coverage indication

ACCCESSORIES / SUPPLIES Claims for supplies used with a base item are not payable when the base item is not covered. Since code E0762 is not considered to be reasonable and necessary (see above), claims for codes A4465, A4495, A4557, and A4595 to be used with code E0762 will be denied as not reasonable and necessary.

Excerpt from LCD L34821 version 21, effective 01/01/2020. CMS LCD L34821.

From L33802

Items covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement. Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

CMS source L33802

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426

From A52713

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.

CMS source A52713

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426