Local Coverage Determination (LCD)

Speech Generating Devices (SGD)

L33739

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Contractor Information

LCD Information

Document Information

LCD ID
L33739
LCD Title
Speech Generating Devices (SGD)
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 01/01/2020
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2020 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2020 American Dental Association. All rights reserved.

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CMS National Coverage Policy

CMS Pub. 100-03, (Medicare National Coverage Determinations Manual), Chapter 1, Section 50.1

Coverage Guidance

Coverage Indications, Limitations, 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.

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.

For the purposes of this policy, speech generation is defined as audible generation of words or phrases and in addition, may include:

  1. Communication via written text (i.e., email or text (SMS) messaging); or,

  2. Communication via phone messaging.

Speech generating devices are defined as durable medical equipment that provides an individual who has a severe speech impairment with the ability to meet his or her functional, speaking needs. Speech generating devices are speech aids consisting of devices or software that generate speech (as defined above) and are used solely by the individual who has a severe speech impairment. The speech is generated using one of the following methods:

  • Digitized audible/verbal speech output, using prerecorded messages;

  • Synthesized audible/verbal speech output which requires message formulation by spelling and device access by physical contact with the device-direct selection techniques;

  • Synthesized audible/verbal speech output which permits multiple methods of message formulation and multiple methods of device access; or

  • Software that allows a computer or other electronic device to generate speech.

A speech generating device (SGD) (E2500, E2502, E2504, E2506, E2508, E2510, E2511) is covered when all of the following criteria (1-7) are met:

  1. Prior to the delivery of the SGD, the beneficiary has had a formal evaluation of their cognitive and communication abilities by a speech-language pathologist (SLP). The formal, written evaluation must include, at a minimum, the following elements:
    1. Current communication impairment, including the type, severity, language skills, cognitive ability, and anticipated course of the impairment;

    2. An assessment of whether the individual's daily communication needs could be met using other natural modes of communication;

    3. A description of the functional communication goals expected to be achieved and treatment options;

    4. Rationale for selection of a specific device and any accessories;

    5. Demonstration that the beneficiary possesses a treatment plan that includes a training schedule for the selected device;

    6. The cognitive and physical abilities to effectively use the selected device and any accessories to communicate;

    7. For a subsequent upgrade to a previously issued SGD, information regarding the functional benefit to the beneficiary of the upgrade compared to the initially provided SGD; and

  2. The beneficiary's medical condition is one resulting in a severe expressive speech impairment; and

  3. The beneficiary's speaking needs cannot be met using natural communication methods; and

  4. Other forms of treatment have been considered and ruled out; and

  5. The beneficiary's speech impairment will benefit from the device ordered; and

  6. A copy of the SLP's written evaluation and recommendation have been forwarded to the beneficiary's treating practitioner prior to ordering the device; and

  7. The SLP performing the beneficiary evaluation may not be an employee of or have a financial relationship with the supplier of the SGD.

If one or more of the SGD coverage criteria 1-7 is not met, the SGD will be denied as not reasonable and necessary.

Codes E2500, E2502, E2504, E2506, E2508, E2510, E2511 perform the same essential function - speech generation. Therefore, claims for more than one SGD will be denied as not reasonable and necessary.

The capability to download updates to the covered features of the device from the manufacturer or supplier of the device is covered. See related Policy Article for additional Non-Medical Necessity Coverage and Payment Rules.

ACCESSORIES:

Claims for accessories to SGDs must meet the general coverage requirements for the base SGD described in criteria 1-7 above. Claims for SGD accessories for beneficiaries who do not meet criteria 1-7 above will be denied as not reasonable and necessary.

Alternative input devices are covered when a beneficiary is unable to use standard input devices. Claims for alternative input devices for beneficiaries who are able to use standard input devices will be denied as not reasonable and necessary.

Eye tracking and gaze interaction accessories for speech generating devices are covered when furnished to individuals with a demonstrated medical need for such accessories.

If the SGD is denied as not reasonable and necessary, any related accessories 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.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Coding Information

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

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

HCPCS MODIFIERS:

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

GA – Waiver of liability statement issued as required by payer policy, individual case

GZ – Item or service expected to be denied as not reasonable and necessary

KX - Requirements specified in the medical policy have been met

HCPCS CODES:

Group 1 Codes
CodeDescription
E2500 SPEECH GENERATING DEVICE, DIGITIZED SPEECH, USING PRE-RECORDED MESSAGES, LESS THAN OR EQUAL TO 8 MINUTES RECORDING TIME
E2502 SPEECH GENERATING DEVICE, DIGITIZED SPEECH, USING PRE-RECORDED MESSAGES, GREATER THAN 8 MINUTES BUT LESS THAN OR EQUAL TO 20 MINUTES RECORDING TIME
E2504 SPEECH GENERATING DEVICE, DIGITIZED SPEECH, USING PRE-RECORDED MESSAGES, GREATER THAN 20 MINUTES BUT LESS THAN OR EQUAL TO 40 MINUTES RECORDING TIME
E2506 SPEECH GENERATING DEVICE, DIGITIZED SPEECH, USING PRE-RECORDED MESSAGES, GREATER THAN 40 MINUTES RECORDING TIME
E2508 SPEECH GENERATING DEVICE, SYNTHESIZED SPEECH, REQUIRING MESSAGE FORMULATION BY SPELLING AND ACCESS BY PHYSICAL CONTACT WITH THE DEVICE
E2510 SPEECH GENERATING DEVICE, SYNTHESIZED SPEECH, PERMITTING MULTIPLE METHODS OF MESSAGE FORMULATION AND MULTIPLE METHODS OF DEVICE ACCESS
E2511 SPEECH GENERATING SOFTWARE PROGRAM, FOR PERSONAL COMPUTER OR PERSONAL DIGITAL ASSISTANT
E2512 ACCESSORY FOR SPEECH GENERATING DEVICE, MOUNTING SYSTEM
E2599 ACCESSORY FOR SPEECH GENERATING DEVICE, NOT OTHERWISE CLASSIFIED

General Information

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

Sources of Information
N/A
Bibliography

N/A

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
01/01/2020 R6

Revision Effective Date: 01/01/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Format of HCPCS code references, from code spans to individually-listed HCPCS
Revised: “physician” to “practitioner”
Revised: Order information as a result of Final Rule 1713
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
DOCUMENTATION REQUIREMENTS:
Revised: “physician’s” to “ treating practitioner’s”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: Prescriptions (orders) to SWO

02/27/2020: Pursuant to the 21st Century Cures Act , these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713, HCPCS code changes, and non-substantive corrections (listing individual HCPCS codes instead of a HCPCS code-span).

  • Provider Education/Guidance
  • Other
01/01/2017 R5

No changes have been made to this LCD.

04/05/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other
01/01/2017 R4 Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and directions to Standard Documentation Requirements
Added: General Requirements
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Direction to Standard Documentation Requirements
Removed: Supplier Manual reference from Miscellaneous
Removed: PIM reference from Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
07/01/2016 R3 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.
  • Change in Assigned States or Affiliated Contract Numbers
10/01/2015 R2 Revision Effective Date: 07/29/2015 (October 2015 Publication)
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: SGD definitional language from NCD 50.1
Added: Capability to download updates
Added: Gleason Act language for eye gaze accessories
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Documentation requirement for SGD and accessories
  • NCD Supplementation
10/01/2015 R1 Revision Effective Date: 10/31/2014
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
Added: Instructions for Equipment Retained from a Prior Payer
Revised: Repair to beneficiary-owned DMEPOS
  • Provider Education/Guidance

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
02/21/2020 01/01/2020 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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