• Digitized SGDs are those that deliver “whole message” speech output. These devices deliver words or phrases that have been pre-recorded by an individual other than the user of the speech generating device for playback upon command of the SGD user.
  
• Synthesized SGDs are those that translate the user’s input into device-generated speech using algorithms representing linguistic rules. Users are not limited to pre-recorded messages but rather can independently create messages as their communication needs dictate. These devices may also be called text to speech systems.

I. A speech generating device (SGD) is considered medically necessary durable medical equipment in the treatment of the functional disability caused by a speech impairment when ALL of the following criteria are met:

A. Prior to the delivery of the SGD, the member 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, all of 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. A treatment plan that includes a training schedule for the selected device;

6. Demonstration that the member possesses 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 patient of the upgrade compared to the initially provided SGD.

and

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

C. The member's speaking needs cannot be met using natural communication methods; and

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

E. The member's speech impairment will benefit from the device ordered; and

F. A copy of the SLP's written evaluation and recommendation have been forwarded to the member's treating physician prior to ordering the device.

• devices that are not dedicated speech devices, but are devices that are capable of running software for purposes other than for speech generation (e.g., devices that can also run a word processing package, an accounting program, or perform other non-medical function).
• Laptop computers, desktop computers, iPods, iPads or other devices that are not dedicated SGDs are not covered as they do not meet the definition of durable medical equipment (DME) as they are not primarily medical in nature and are devices that are useful to someone without severe speech impediment.

• Inability of repair; or
• Inability to apply either software or hardware to bring the device back to its useful state.

Digitized speech generating devices using pre-recorded messages - < 4 minutes:

Device Name	Manufacturer
ActionVoice 2	Enabling Devices
Bigmack	AbleNet, Inc.
Cheap Talk 8	Enabling Devices
Fifteen Talker	The Attainment Company
Five Talker	The Attainment Company
Hawk II	Adam Lab, Inc.
Hip Talker	Enabling Devices
MessageMate 20/60	Words+, Inc.
MessageMate 20-120	Words+ Inc.
One Step Communicator	AbleNet, Inc.
SpeakEasy	AbleNet, Inc.
Step-by-Step Communicator	AbleNet, Inc.
Step Talk Switch Plate	Enabling Devices
Talk Back 24	Crestwood Company
Tech/Speak 2 x 32	Advanced Multimedia Devices, Inc.
Tech/TALK 6x8	Advanced Multimedia Devices, Inc.
Ultimate 4	Tash, Inc.
VoicePal	Adaptivations
VoicePal Max	Adaptivations
VoicePal Pro	Adaptivations

Digitized speech generating devices using pre-recorded messages – 4 to 8 minutes:

Device Name	Manufacturer
6 Level Communicator	Enabling Devices
Black Hawk	Adam Lab, Inc.
Hand Held Voice	Mayer Johnson Co.
MessageMate 40/300	Words+, Inc.
SpeakEasy	AbleNet, Inc.
Talk Back 24	Crestwood Company
Tech/Speak 4 x 32	Advanced Multimedia Device, Inc.
Tech/Speak 6 x 32	Advanced Multimedia Device, Inc.
Tech/TALK 8 x 8	Advanced Multimedia Device, Inc.
Tech/TALK 12 x 8	Advanced Multimedia Device, Inc.


Digitized speech generating devices using pre-recorded messages – 9 to 16 minutes:

Device Name	Manufacturer
Digivox2	DynaVox Technologies
EasyTalk	The Great Talking Box Co.
Hand Held Voice	Mayer Johnson Co.
Macaw3	Zygo Industries
MessageMate 40/600	Words+, Inc.
SideKick	Prentke Romich Company
QuickTalker	AbleNet


Digitized speech generating devices using pre-recorded messages – ≥ 17 minutes:

Device Name	Manufacturer
Alpha Talker	Prentke Romich Company
DigiVox	DynaVox Technologies
Dynamo	DynaVox Technologies
Macaw3+	Zygo Industries
MACAW5	Zygo Industries
MACAW Green	Zygo Industries
DACtyl MACAW5	Zygo Industries
Talara	Zygo Industries


Synthesized speech generating devices requiring message formulation by spelling and access by physical contact with the device:

Device Name	Manufacturer
LightWRITER SL25, SL35, SL35/Cherry, SL35/BigKeys, SL38, SL56, SL85, SL87, SL88	DynaVox Technologies
Dubby II	Zygo Industries


Synthesized speech generating devices permitting multiple methods of message formulation and multiple methods of device access:

Device Name	Manufacturer
Axis 1600/Vanguard	Prentke Romich Company
Axis 1600/Scan/Wivox	Prentke Romich Company
Dynamite 3100 (replaced by DynaVox MT4)	DynaVox Technologies
DynaVox 3100 (replaced by DynaVox DV4)	DynaVox Technologies
Freedom 2000	Words+, Inc.
Freestyle	Assistive Technology, Inc.
Liberator	Prentke Romich Company
Optimist 100	Zygo Industries
Optimist 160	Zygo Industries
Pegasus Lite	Words+, Inc.
Synergy mAAC 2	Synergy
Vanguard	Prentke Romich Company

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Speech Generating Devices
Augmentative Communication Devices
Alternative Communication Devices
Augmentative and Alternative Communication Devices
DynaVox

References:
1. Centers for Medicare and Medicaid Services (CMS). NCD for Speech Generating Devices (50.1). Available at:https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=274&ncdver=2&bc=AAAAgAAAAEAAAA%3d%3d&

2. Centers for Medicare and Medicaid Services (CMS). Decision Memo for Augmentative and Alternative communication (AAC) Devices for Speech Impairment (CAG-00055N). April 26, 2000. Available at: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=8

3. NHIC, Corp. LCD for Speech Generating Devices (#L11534). Revision effective date: 07/01/2013. Available at: http://www.medicarenhic.com/viewdoc.aspx?id=2602

4. Formal Request for National Coverage Decision for Augmentative and Alternative Communication Devices. Submitted by various organizations. December 30, 1999. Available at: http://www.augcominc.com/whatsnew/medicare.html.

5. ECRI Institute. Custom Hotline Response: Augmentatvie Communication Devices for Non-Speaking Individuals. Updated: 11/30/04.

6. United Cerebral Palsy. Selecting an Augmentative and Alternative Communication (ACC) Device for Your Child by Kari Jaehnert. (cited 08/11/08). Available at: http://www.ucp.org/ucp_channeldoc.cfm/1/14/86/86-86/3916.

7. American Speech-Language Association (ASHA). Adult Speech and Language: Speech Disorders. Available at: http://www.asha.org/public/speech/disorders/AdultSandL.htm.

8. Communication Devices. Assistive Technology Quick Reference Series. Tech Connections. Available at: http://www.assistivetech.net/at_reports/guides/CommDevices-LP.pdf.

9. American Speech-Language Association (ASHA). Medicare Coverage Policy on Speech-Generating Devices. Available at: http://www.asha.org/practice/reimbursement/medicare/sgd_policy/

10. CMS Final Decision Memorandum. Final Scope of Benefit NCD: Speech Generating Devices. Available at: https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=26

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

E2500
E2502
E2504
E2506
E2508
E2510
E2511
E2512
E2599