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.

The purpose of a Local Coverage Determination (LCD) is to provide information
regarding "reasonable and necessary" criteria based on Social Security Act 
1862(a)(1)(A) provisions.

In addition to the "reasonable and necessary" criteria contained in this LCD
there are other payment rules, which are discussed in the following documents,
that must also be met prior to Medicare reimbursement:

  * The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  * The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  * Refer to the Supplier Manual for additional information on documentation requirements.
  * Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the "reasonable and necessary" criteria,
based on Social Security Act  1862(a)(1)(A) provisions, are defined by the
following coverage indications, limitations and/or medical necessity.

The practitioner ordering the Transcutaneous Electrical Nerve Stimulators
(TENS) unit and related supplies must be the treating practitioner for the
disease or condition justifying the need for the TENS unit.

A TENS is covered for the treatment of beneficiaries with chronic, intractable
pain or acute post-operative pain when one of the following coverage criteria,
I or II, are met.

  * _Acute Post-operative Pain_  
  
TENS is covered for acute post-operative pain. Coverage is limited to 30 days
(one month's rental) from the day of surgery. Payment will be made only as a
rental.  
  
A TENS unit will be denied as not reasonable and necessary for acute pain
(less than three months duration) other than for post-operative pain.  
  

  * _Chronic Pain Other than Low Back Pain_  
  
TENS is covered for chronic, intractable pain other than chronic low back pain
when all of the following criteria must be met:

    * The presumed etiology of the pain must be a type that is accepted as responding to TENS therapy. Examples of conditions for which TENS therapy is not considered to be reasonable and necessary are (not all-inclusive): 
      * headache
      * visceral abdominal pain
      * pelvic pain
      * temporomandibular joint (TMJ) pain
    * The pain must have been present for at least three months.
    * Other appropriate treatment modalities must have been tried and failed.
  
TENS therapy for chronic pain that does not meet these criteria will be denied
as not reasonable and necessary.

TENS therapy for Chronic Low Back Pain (CLBP) will be denied as not reasonable
and necessary.

_General Requirements for chronic pain (II)_

When used for the treatment of chronic, intractable pain described in section
II, the TENS unit must be used by the beneficiary on a trial basis for a
minimum of one month (30 days), but not to exceed two months. The trial period
will be paid as a rental. The trial period must be monitored by the treating
practitioner to determine the effectiveness of the TENS unit in modulating the
pain. For coverage of a purchase, the treating practitioner must determine
that the beneficiary is likely to derive significant therapeutic benefit from
continuous use of the unit over a long period of time.

A 4-lead TENS unit may be used with either 2 leads or 4 leads, depending on
the characteristics of the beneficiary's pain. If it is ordered for use with 4
leads, the medical record must document why 2 leads are insufficient to meet
the beneficiary's needs.

_Supplies_

Separate allowance will be made for replacement supplies when they are
reasonable and necessary and are used with a covered TENS. Usual maximum
utilization is:

  * 2 TENS leads - a maximum of one unit of A4595 per month.
  * 4 TENS leads - a maximum of two units of A4595 per month.

If the use of the TENS unit is less than daily, the frequency of billing for
the TENS supply code should be reduced proportionally.

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.

If the criteria above are not met for E0731, it will be denied as not
reasonable and necessary.

Reimbursement for supplies is contingent upon use with a covered TENS unit.
Claims for TENS supplies provided when there is no covered TENS unit will be
denied as not reasonable and necessary.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a
claim is submitted. If the supplier bills for an item addressed in this policy
without first receiving a completed SWO, the claim shall be denied as not
reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
base items that require a Written Order Prior to Delivery (WOPD), the supplier
must have received a signed SWO before the DMEPOS item is delivered to a
beneficiary. If a supplier delivers a DMEPOS item without first receiving a
WOPD, the claim shall be denied as not reasonable and necessary. Refer to the
LCD-related Policy Article, located at the bottom of this policy under the
Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed
associated options, accessories, and/or supplies, the supplier must have
received a WOPD which lists the base item and which may list all the
associated options, accessories, and/or supplies that are separately billed
prior to the delivery of the items. In this scenario, if the supplier
separately bills for associated options, accessories, and/or supplies without
first receiving a completed and signed WOPD of the base item prior to
delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines
listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC
articles. Claims that do not meet coding guidelines shall be denied as not
reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are
required to maintain POD documentation in their files. Proof of delivery
documentation must be made available to the Medicare contractor upon request.
All services that do not have appropriate proof of delivery from the supplier
shall be denied as not reasonable and necessary

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be
based on prospective, not retrospective use. For DMEPOS products that are
supplied as refills to the original order, suppliers must contact the
beneficiary, and document an affirmative response, prior to dispensing the
refill and not automatically ship on a pre-determined basis, even if
authorized by the beneficiary. This shall be done to ensure that the refilled
item remains reasonable and necessary, existing supplies are expected to end,
and to confirm any changes or modifications to the order. Contact with the
beneficiary or designee regarding refills must take place no sooner than 30
calendar days prior to the expected end of the current supply. For delivery of
refills, the supplier must deliver the DMEPOS product no sooner than 10
calendar days prior to the expected end of the current supply. This is
regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are
required to have contact with the beneficiary or caregiver/designee and
document an affirmative response, prior to dispensing a new supply of items.
Suppliers must not deliver refills without a refill request and an affirmative
response from a beneficiary. Items delivered without a valid, documented
refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's
expected utilization. Suppliers must stay attuned to changed or atypical
utilization patterns on the part of their clients. Suppliers must verify with
the treating practitioners that any changed or atypical utilization is
warranted. Regardless of utilization, a supplier must not dispense more than a
three (3) - month quantity at a time.