LCD for Transcutaneous Electrical Nerve Stimulators (TENS) (L11506)

LCD for Transcutaneous Electrical Nerve Stimulators (TENS) (L11506)

Contractor Information

Contractor Name

TriCenturion

Contractor Number

77011

Contractor Type

DME PSC

DME MAC this DME PSC is affiliated with

AdminaStar Federal, Inc., National Heritage Insurance Co.

LCD Information

LCD ID Number

L11506

LCD Title

Transcutaneous Electrical Nerve Stimulators (TENS)

Contractor's Determination Number

TENS20070101

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 10.2, 160.7.1, 160.13, 280.13

Primary Geographic Jurisdiction

Connecticut
District of Columbia
Delaware
Illinois
Indiana
Kentucky
Massachusetts
Maryland
Maine
Michigan
Minnesota
New Hampshire
New Jersey
New York - Entire State
Ohio
Pennsylvania
Rhode Island
Virginia
Vermont
Wisconsin
West Virginia

Oversight Region

Central Office

DME Region LCD Covers

Jurisdiction A/B

Original Determination Effective Date

For services performed on or after 10/01/1993

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2007

Revision Ending Date

Indications and Limitations of Coverage and/or Medical Necessity

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. For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

A transcutaneous electrical nerve stimulator (TENS) is covered for the treatment of patients with chronic, intractable pain or acute post-operative pain who meet the coverage rules listed below.

When a TENS unit is used for acute post-operative pain, the medical necessity is usually limited to 30 days from the day of surgery. Payment for more than one month is determined by individual consideration based upon supportive documentation provided by the attending physician. Payment will be made only as a rental. A TENS unit will be denied as not medically necessary for acute pain (less than three months duration) other than post-operative pain.

For chronic pain, the medical record must document the location of the pain, the duration of time the patient has had the pain, and the presumed etiology of the pain. The pain must have been present for at least three months. Other appropriate treatment modalities must have been tried and failed, and the medical record must document what treatment modalities have been used. The presumed etiology of the pain must be a type that is accepted as responding to TENS therapy. Examples of conditions for which a TENS unit are not considered to be medically necessary are (not all-inclusive): headache, visceral abdominal pain, pelvic pain, and temporomandibular joint (TMJ) pain.

When used for the treatment of chronic, intractable pain, the TENS unit must be used by the patient 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 physician to determine the effectiveness of the TENS unit in modulating the pain. For coverage of a purchase, the physician must determine that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time. The physician's records must document a reevaluation of the patient at the end of the trial period, must indicate how often the patient used the TENS unit, the typical duration of use each time, and the results.

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

Separate allowance will be made for replacement supplies when they are medically necessary and are used with a TENS unit that has been purchased and/or approved by Medicare. If 2 TENS leads are medically necessary, then a maximum of one unit of Code A4595 would be allowed per month; if 4 TENS leads are necessary, a maximum of two units per month would be allowed. 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 medically necessary.

Quantities of supplies greater than those described in the policy as the usual maximum amounts, in the absence of documentation clearly explaining the medical necessity of the excess quantities, will be denied as not medically necessary.

A conductive garment (E0731) used with a TENS unit is rarely medically necessary, but may be covered if all of the following conditions are met:

It has been prescribed by a physician for use in delivering covered TENS treatment; and
One of the medical indications outlined below is met:

the patient 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; or
the patient 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; or
the patient has a documented medical condition, such as skin problems, that preclude the application of conventional electrodes, adhesive tapes, and lead wires; or
the patient 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 patient has a documented skin problem prior to the start of the trial period; and
The item is medically necessary for the patient.

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

The physician ordering the TENS unit must be the attending physician or a consulting physician for the disease or condition resulting in the need for the TENS unit.

Coverage Topic

Transcutaneous Electrical Nerve Stimulators (TENS)

Coding Information

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other health care provider order for this item or service

KX – Specified required documentation on file

EQUIPMENT

E0720	TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DEVICE, TWO LEAD, LOCALIZED STIMULATION
E0730	TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DEVICE, FOUR OR MORE LEADS, FOR MULTIPLE NERVE STIMULATION
E0731	FORM FITTING CONDUCTIVE GARMENT FOR DELIVERY OF TENS OR NMES (WITH CONDUCTIVE FIBERS SEPARATED FROM THE PATIENT'S SKIN BY LAYERS OF FABRIC)

SUPPLIES

A4557	LEAD WIRES, (E.G., APNEA MONITOR), PER PAIR
A4595	ELECTRICAL STIMULATOR SUPPLIES, 2 LEAD, PER MONTH, (E.G. TENS, NMES)

ICD-9 Codes that Support Medical Necessity

Not specified.

Diagnoses that Support Medical Necessity

Not specified.

ICD-9 Codes that DO NOT Support Medical Necessity

Not specified.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

Not specified.

General Information

Documentation Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider" (42 U.S.C. section 1395l (e)). It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items delivered before a signed written order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

A Certificate of Medical Necessity (CMN), which has been completed, signed and dated by the treating physician, must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for a written order if it contains all the required elements of an order. The CMN for TENS is CMS Form 848 (DME Form 06.03B). The initial claim must include an electronic copy of the CMN.

A CMN is not needed for a TENS rental.

A claim for Code E0731 must be accompanied by the brand name and model number of the conductive garment. Documentation supporting the medical necessity for the E0731 must be kept in the supplier’s files and be available upon request. If all the coverage criteria described in the Indications and Limitations of Coverage section have been met for E0731, a KX modifier must be added to the code.

When billing for quantities of supplies greater than those described in the policy as the usual maximum amounts, there must be clear documentation in the patient's medical records corroborating the medical necessity of this amount. The patient's medical records that corroborate the order and any additional documentation that pertains to the medical necessity of items and quantities billed must be provided upon request.

Refer to the Supplier Manual for more information on documentation requirements.

Appendices

Utilization Guidelines

Refer to Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for Decision

Reserved for future use.

Advisory Committee Meeting Notes

Start Date of Comment Period

04/16/1993

End Date of Comment Period

05/31/1993

Start Date of Notice Period

08/01/1993

Revision History Number

TENS006

Revision History Explanation

Revision effective date: 01/01/2007
HCPCS CODES:
Revised: E0720, E0730
DOCUMENTATION REQUIREMENTS:
Removed DMERC references.
Removed reference to HCFA CMN Form; changed to read CMS Form.
Provided new DME Form number.
Revised instructions for use of CMN.
LCD ATTACHMENTS:
Attached newly revised CMN Form for TENS.

03/01/2006 - In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TriCenturion (77011) from DMERC Tricenturion (77011).

Revision Effective Date: 01/01/2006
LMRP converted to an LCD and Policy Article
INDICATIONS AND LIMITATIONS OF COVERAGE:
Added Medical Necessity denial if criteria for E0731 are not met.
DOCUMENTATIONS REQUIREMENT:
Added KX modifier to be used with E0731 if criteria are met.
Removed requirement to submit additional documentation with claim.

Revision effective date: 04/01/2003
HCPCS CODES AND MODIFIERS:
Revised: A4595 and E0730 effective 01/01/2003.
Added EY modifier
INDICATIONS AND LIMITATIONS OF COVREAGE:
Added: Standard language concerning coverage of items without an order.
Added: Language regarding the medical necessity for use of a greater quantity of supplies and the need for the items being documentated in patient’s medical records.
DOCUMENTATION REQUIREMENTS:
Added: Standard language concerning use of EY modifier for items without an order.
Added: Items billed in excess quantities and the requirement.

The revision dates listed below are the dates the revisions were published and not necessarily the effective dates for the revisions.

01/01/2002 - The revisions include changes in coverage and payment rules, coding guidelines, and documentation requirements, as well as elimination of availability for prior authorization for this item.

10/01/1996 – HCPCS code K0118 crosswalked to A4595. Incorporated Indications section into Coverage and Payment Rules section. Revised Coverage and Payment Rules section.

12/01/1993 – Corrected HAO to HA0 in Documentation section.

Last Reviewed On Date

Related Documents

Article(s)
A37219 - Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article - Effective January 2006

LCD Attachments

TENS CMN CMS-848 (42,305 bytes)

Article for Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article - Effective January 2006 (A37219)

Contractor Information

Contractor Name
TriCenturion
Contractor Number
77011
Contractor Type
DME PSC
DME MAC this DME PSC is affiliated with	AdminaStar Federal, Inc., National Heritage Insurance Co.

Article Information

Article ID Number

A37219

Article Type

Article

Key Article

Yes

Article Title

Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article - Effective January 2006

Primary Geographic Jurisdiction

DME Region Article Covers

Jurisdiction A/B

Original Article Effective Date

01/01/2006

Article Revision Effective Date

03/01/2006

Article Text

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

For an item addressed in this policy to be covered by Medicare, a written signed and dated order must be received by the supplier prior to delivery of the item. If the supplier delivers the item prior to receipt of a written order, it will be denied as noncovered. If the written order is not obtained prior to delivery, payment will not be made for that item even if a written order is subsequently obtained. If a similar item is subsequently provided by an unrelated supplier who has obtained a written order prior to delivery, it will be eligible for coverage.

During the rental of a TENS unit, supplies for the unit are included in the rental allowance; there is no additional allowance for electrodes, lead wires, batteries, etc. If a TENS unit (E0720 or E0730) is purchased, the allowance includes lead wires and one month's supply of electrodes, conductive paste or gel (if needed), and batteries.

CODING GUIDELINES

A transcutaneous electrical nerve stimulator (TENS) (E0720, E0730) is a device which 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) 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 (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 DMERC. 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 Statistical Analysis Durable Medical Equipment Regional Carrier (SADMERC) for guidance on the correct coding of these items.

Coverage Topic

Durable Medical Equipment
Transcutaneous Electrical Nerve Stimulators (TENS)

Coding Information

No Coding Information has been entered in this section of the article.

Other Information

Revision History Explanation
Effective Date: 01/01/2006 LMRP converted to an LCD and Policy Article 03/01/2006 - In accordance with Section 911 of the Medicare Modernization Act of 2003, this article was transitioned to DME PSC TriCenturion (77011) from DMERC Tricenturion (77011).

Related Documents
LCD(s) L11506 - Transcutaneous Electrical Nerve Stimulators (TENS)