LCD L34821

Indications and Limitations of Coverage

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.

DEFINITIONS

For purposes of this LCD the terms “arthritis”, “degenerative joint disease”, and “osteoarthritis” are used interchangeably and refer to the disease osteoarthritis. Arthritis due to other etiologies such as rheumatoid disease, gout, psoriasis, etc. (not all-inclusive) is not included by the use of these terms.

Transcutaneous electrical joint stimulation is administered by a noninvasive device that delivers electrical stimulation intended to reduce the level of pain and symptoms associated with arthritis in a joint. Devices that provide electrical stimulation have considerable variation in the parameters of the current, how the current is applied, etc. This LCD is applicable regardless of the individual characteristics of any given device.

INDICATIONS

There is insufficient published clinical evidence to establish that treatment with Transcutaneous Electrical Joint Stimulation Devices (TEJSD) (HCPCS code E0762) meets the requirements to be considered reasonable and necessary for the treatment of osteoarthritis or any other condition. Claims for TEJSD (code E0762) will be denied as not reasonable and necessary.

There is insufficient published clinical evidence to establish that treatment with other electro-magnetic devices such as transcutaneous electrical stimulation devices (TENS), neuromuscular stimulators (NMES), functional electrical stimulators (FES), light treatment devices (any type), infrared treatment devices (any type), etc. (not all-inclusive), singly or in any combination, meet the requirements to be considered reasonable and necessary for the treatment of osteoarthritis. Claims for these items will be denied as not reasonable and necessary.

TEJSD COMBINED WITH AN ORTHOSIS (Brace)

TEJSD is currently supplied as a stand-alone device or for use concurrently or in combination with a brace. Braces are separate DMEPOS items with independent coverage requirements that are unrelated to the coverage of TEJSD. When TEJSD is used concurrently or in combination with any type of brace, there no reimbursement possible for the TEJSD device. Refer to the applicable LCD and related Policy Article for information about the payment requirements for reimbursement of braces.

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.

There is no evidence of effectiveness of a TEJSD (E0762) when used with a conductive garment (E0731). Claims for code E0731 billed for use with an E0762 will be denied as not reasonable and necessary.

CODING

Refer to the related Policy Article CODING GUIDELINES section for additional information regarding coding of E0762.

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.

Summary of Evidence

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Analysis of Evidence

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Associated 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". It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner’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.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

• SWO

• Medical Record Information (including continued need/use if applicable)

• Correct Coding

• Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

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.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

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.

Miscellaneous

Appendices

Utilization Guidelines

Refer to Coverage Indications, Limitations and/or Medical Necessity

Bibliography

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