Latest Review Date: October 2024

Category: Durable Medical Equipment (DME)                                                                  

POLICY:

Effective dates of service September 15, 2024, and after:

I.Speech generating devices (E2500-E2506, E2508, E2510) and speech generating software programs (E2511) may be considered medically necessary when ALL the following criteria are met:

1. Individual’s medical condition is one resulting in a severe expressive speech impairment, AND
2. Individual’s speaking needs cannot be met using natural communication methods AND
3. Other forms of treatment have been considered and ruled out AND
4. Individual’s speech impairment will benefit from the device ordered AND
5. Formal written evaluation of cognitive and communication abilities by a Speech Language Pathologist (SLP) including:
   1. Current communication impairment – type, severity, language skills, cognitive ability and anticipated course of impairment AND
   2. An assessment of whether the individual’s daily communication needs could be met using other natural modes of communication AND
   3. Description of functional communication goals and treatment options AND
   4. Rationale for selection of specific device and/or accessories.

Speech generating devices are considered investigational when ALL the above criteria are not met.

II.Accessories and upgrades for the Speech Generating Device (SGD) may be considered medically necessary if the basic medical necessity criteria above are met and the medical necessity for each accessory is clearly documented in the formal evaluation by the Speech Language Pathologist (SLP) including but not limited to:

• Eye Gaze Technology (including corresponding mount*) must meet ALL the following requirements:

  • Individual has met requirements for an SGD above (Section I)
  • Individual has limited head movement/control (cannot use head switches)
  • Individual has limited use of extremities and is unable to control or sustain fine/gross movements to use switches or touch methods
  • Individual has direct vision in one or both eyes
  • Individual has full control over system during trial
  • Individual has the ability to look up, down, left and right
  • Individual has adequate vision to view the screen and ability to focus on one spot for brief periods of time.
  • Contraindications include, but may not be limited to, those individuals with the following conditions: continuous, uncontrolled head movement; nystagmus. It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage for eye gaze access devices.
• Optimal Head Pointer Mouse (including corresponding mount*)
• Keyguards/Keyguides/Touchguides
  • when individual has limited fine motor skills, functional impairment or spasticity

*SGD mount is limited to one (1) mount, table top or clamp mount. Floor stand mounts and custom mounts are non-covered.

Convenience and other non DME items such as, but not limited to, carrying case and mounting device (other than for eye gaze/head switch/head pointer) are non-covered.

Previously covered devices may be considered medically necessary to be replaced when the following criteria are met:

• The equipment is non-functioning and repairs would cost more than to replace,  and has been in the home for five years or longer; and
• The equipment is out of warranty; and
• The individual owns the equipment; and
• The replacement is not result of malicious damage, culpable neglect, or wrongful disposition of the equipment.

Replacement or upgrade of existing, properly functioning equipment, even if warranty has expired, is considered investigational.

Coverage is limited to one speech-generating device per 5-year period when the above criteria is met. 

Software required to enable a laptop computer, desktop computer or PDA to function as a speech generating device may be covered when medical criteria noted above is met, however, charges for installation or technical support are not separately reimbursable.

Coverage for non-medical items, even when the items may be used to serve a medical purpose, such as smart devices (iPads, smart phones, tablets, personal computers, etc.) are non-covered. This includes smart devices/iPads billed separately from speech generating devices.

Refer to medical policy 352: Repair of Durable Medical Equipment (DME) and External Prosthetic Devices

Effective dates of service prior to September 15, 2024:

Speech generating devices (E2500-E2506, E2508, E2510) and speech generating software programs (E2511) may be considered medically necessary when ALL the following criteria are met:

1. Member’s medical condition is one resulting in a severe expressive speech impairment, AND
2. Member’s speaking needs cannot be met using natural communication methods AND
3. Other forms of treatment have been considered and ruled out AND
4. Member’s speech impairment will benefit from the device ordered AND
5. Formal written evaluation of cognitive and communication abilities by a speech language pathologist including:
   1. Current communication impairment – type, severity, language skills, cognitive ability and anticipated course of impairment AND
   2. An assessment of whether the member’s daily communication needs could be met using other natural modes of communication AND
   3. Description of functional communication goals and treatment options AND
   4. Rationale for selection of specific device and/or accessories.

Speech generating devices are considered investigational when ALL the above criteria are not met.

Accessories and upgrades for the Speech Generating Device (SGD) may be considered medically necessary if the basic medical necessity criteria above are met and the medical necessity for each accessory is clearly documented in the formal evaluation by the Speech Language Pathologist (SLP) including but not limited to:

• Eye Gaze Technology (including corresponding mount*)
  • when member has limited head movement/control
• Optimal Head Pointer Mouse (including corresponding mount*)
• Keyguards/Keyguides/Touchguides
  • when member has limited fine motor skills, functional impairment or spasticity

*SGD mount is limited to one (1) mount, table top or clamp mount. Floor stand mounts and custom mounts are non-covered.

Convenience and other non DME items such as, but not limited to, carrying case and mounting device (other than for eye gaze/head switch/head pointer) are non-covered.

Previously covered devices may be considered medically necessary to be replaced when the following criteria are met:

• The equipment is non-functioning and repairs would cost more than to replace,  and has been in the home for five years or longer; and
• The equipment is out of warranty; and
• The individual owns the equipment; and
• The replacement is not result of malicious damage, culpable neglect, or wrongful disposition of the equipment.

Replacement or upgrade of existing, properly functioning equipment, even if warranty has expired, is considered investigational.

Coverage is limited to one speech-generating device per 5-year period when the above criteria is met. 

Software required to enable a laptop computer, desktop computer or PDA to function as a speech generating device may be covered when medical criteria noted above is met, however, charges for installation or technical support are not separately reimbursable.

Coverage for non-medical items, even when the items may be used to serve a medical purpose, such as smart devices (iPads, smart phones, tablets, personal computers, etc.) are non-covered. This includes smart devices/iPads billed separately from speech generating devices.

Refer to medical policy 352: Repair of Durable Medical Equipment (DME) and External Prosthetic Devices

DESCRIPTION OF PROCEDURE OR SERVICE:

Speech generating devices (SGD’s), also known as voice output communication aids, are electronic augmentative and alternative communication systems used to supplement or replace speech or writing for individuals with severe speech impairments who are unable to communicate with speech or alternatives methods such as writing and sign language. These allow for improved communication to assist in meeting the individual’s needs and are referred to as augmentative and alternative communication (AAC) devices.

Digitized speech devices, referred to as devices with “whole message” speech output, use words or phrases that have been prerecorded for replay upon command of the SGD user. Synthesized speech translates a user’s input into device-generated speech. Users of synthesized speech SGDs can create messages to address their communication needs. Some SGDs require message formulation by spelling and access physical contact with a keyboard, touch screen, or other display containing letters. Speech generating software programs permit a laptop computer, desktop computer or personal digital assistant (PDA) to function as an SGD.

Individuals with impaired communication requiring AAC devices are carefully evaluated by a Speech-language pathologist (SLP) to identify the type of system which will meet the communication need. Speech-language pathologists assist the individual in learning a variety of skills and strategies to maximum the functional use of this equipment.

Motor speech disorders cause significant adverse impacts on an individual’s ability to communicate needs and achieve activities of daily living. Personal independence and family life are severely impacted and can lead to isolation through lack of interaction.

According to the American Speech-Language-Hearing Association (ASHA), there are two primary methods that users access an AAC device. The first direct selection involves pointing with a body part or using a pointing device or switch that is turned on with a body part, air puff or eyebrow movement. Another method, scanning, involves lights that pass over each choice and the user activates a switch to stop the light and make a choice. Scanning typically requires less motor control but higher cognitive functioning than direct selection.

The ASHA details three basic ways language is represented in augmentative and alternative communication (AAC):

• Single-meaning pictures – does not require reading, uses symbols or pictures;
• Alphabet-based systems – requires reading, symbol sequences are long and symbols can predict words after several letters are selected;
• Semantic compaction – does not require reading, symbol sequences are short and typically between one and two symbols per word, and symbol set is small. This type of system is the most commonly used.

This policy does not apply to electronic speech aids that are used by laryngectomized persons and persons with a permanently inoperative larynx. These are considered prosthetics.

KEY POINTS:

This evidence has been updated with a literature review using the PubMed database. The most recent literature review was performed through October 16, 2024.

Summary of Evidence:

Speech generating devices are defined as durable medical equipment that provides an individual who has a severe speech impairment with the ability to meet their functional, speaking needs. Speech generating devices are speech aids consisting of devices or software that generate speech and are used solely by the individual who has a severe speech impairment.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Speech generating device, SGD, digitized speech, synthesized speech, augmentative and alternative communication, AAC, Tobii Dynavox, Xpress, LightWriter SL40, Maestro, Vmax+, Tobii Dynavox T10, T15, I12, I15, PRIO, INDI 7, I110-Device, SC tablet, SC pro tablet, EM-12, I12+, I15+, I-13, I-16, gaze interaction, eye gaze, optimal head pointer mouse, mounting device, Keyguards, Keyguides, Touchguides, Prentke Romich, PRC, Freedom, Say it!, AbleNet QuickTalker Freestyle, Forbes ProSlate, Smartbox

APPROVED BY GOVERNING BODIES:

Speech generating devices are Food and Drug Administration (FDA) Class II devices.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

HCPCS Codes:

REFERENCES:

1. Agency for HealthCare Research and Quality (AHRQ). Evidence report/technology assessment no. 52.  Criteria for determining disability in speech-language disorders (summary). Available at: archive.ahrq.gov/clinic/tp/spdistp.htm.
2. Almirall D, DiStefano C, Chang YC, et al. Longitudinal effects of adaptive interventions with a speech-generating device in minimally verbal children with ASD. J Clin Child Adolesc Psychol. 2016;45(4):442-456.
3. American Speech-Language-Hearing Association (ASHA), Introduction to augmentative and alternative communication. Available at: www.asha.org/public/speech/disorders.
4. Frampton SE, Shillingsburg MA, Simeone PJ. Feasibility and preliminary efficacy of direct instruction for individuals with autism utilizing speech-generating devices. Behav Anal Pract. 2020;13(3):648-658.
5. Gevarter C, Zamora C. Naturalistic Speech-Generating Device Interventions for Children With Complex Communication Needs: A Systematic Review of Single-Subject Studies. Am J Speech Lang Pathol. 2018 Aug 6;27(3):1073-1090. doi: 10.1044/2018_AJSLP-17-0128.
6. Gevarter C, O'Reilly MF, Kuhn M, et al. Assessing the acquisition of requesting a variety of preferred items using different speech generating device formats for children with autism spectrum disorder. Assist Technol. 2017;29(3):153-160.
7. Gilroy SP, Leader G, McCleery JP. A pilot community-based randomized comparison of speech generating devices and the picture exchange communication system for children diagnosed with autism spectrum disorder. Autism Res. 2018;11(12):1701-1711.
8. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
9. Karlsson P, Allsop A, Dee-Price BJ, Wallen M. Eye-gaze control technology for children, adolescents and adults with cerebral palsy with significant physical disability: Findings from a systematic review. Dev Neurorehabil. 2018 Nov;21(8):497-505. doi: 10.1080/17518423.2017.1362057. Epub 2017 Sep 1.
10. Lorah ER, Parnell A, Whitby PS, Hantula D. A systematic review of tablet computers and portable media players as speech generating devices for individuals with autism spectrum disorder. J Autism Dev Disord. 2015;45(12):3792-3804.
11. Rispoli MJ, Franco JH, van der Meer L, et al. The use of speech generating devices in communication interventions for individuals with developmental disabilities: A review of the literature. Dev Neurorehabil. 2010;13(4):276-293.
12. Sterrett K, Holbrook A, Landa R, Kaiser A, Kasari C. The effect of responsiveness to speech-generating device input on spoken language in children with autism spectrum disorder who are minimally verbal†. Augment Altern Commun. 2022 Oct 20:1-10. doi: 10.1080/07434618.2022.2120070. Epub ahead of print.
13. Thiemann-Bourque K, Feldmiller S, Hoffman L, Johner S. Incorporating a peer-mediated approach into speech-generating device intervention: Effects on communication of preschoolers with autism spectrum disorder. J Speech Lang Hear Res. 2018;61(8):2045-2061.
14. van der Meer L, Kagohara D, Achmadi D, et al. Speech-generating devices versus manual signing for children with developmental disabilities. Res Dev Disabil. 2012;33(5):1658-1669.
15. Wendt O, Hsu N, Simon K, et al. Effects of an iPad-based speech-generating device infused into instruction with the picture exchange communication system for adolescents and young adults with severe autism spectrum disorder. Behav Modif. 2019;43(6):898-932.

POLICY HISTORY:

Medical Policy Group, July 2015 (6): Newly adopted policy; no change to review process.

Medical Policy Administration Committee, July 2015

Available for comment July 15 through August 28, 2015

Medical Policy Group, August 2015 (6): Clarification statement regarding speech generating input devices added to policy section; no change to policy intent.

Medical Policy Group, March 2016 (6): Change in policy statement to remove criteria specific to E2506, E2508 and E2510 models; added policy statement with criteria for input accessories for integration into speech generating devices, replacement devices and related software.

Medical Policy Group, October 2017 (6): Updates to Key Words.

Medical Policy Group, May 2018 (6): No literature review, updated policy to include non-coverage of smart devices.

Medical Policy Group, February 2019 (6): No literature review, clarified policy statement, added Key Word “PRIO”.

Medical Policy Group, October 2019 (6): Updates to Description, Key Points, and Key Words ( INDI 7, I110-Device, SC tablet, SC pro tablet, EM-12, I12+, I15+, I-13, I-16, gaze interaction). No change to policy intent.

Medical Policy Group, February 2020 (6): Updates to Policy Statement to include criteria for mounting device, added Key Words ( eye gaze, optimal head pointer, mounting device).

Medical Policy Group, October 2020 (6): Updates to Key Points and Coding (E2508 added). No change to policy intent.

Medical Policy Group, May 2021(6): Clarified Policy statement to include “keyguides and touchguides” and added Key Words (Keyguards, Keyguides, Touchguides).

Medical Policy Group, October 2021 (6): Updates to Key Points, USPSTF and References. No change to policy intent.

Medical Policy Group, February 2022 (6): Clarification to SGD mount policy section.

Medical Policy Group, October 2022 (6): Updates to Key Points, and References. No change to Policy Statement.

Medical Policy Goup, October 2023 (6): Updates to Policy and Key Points.  Removed policy statements effective for dates of service prior to 2/1/20.  No other changes to policy section.

Medical Policy Group, August 2024 (6): Updates to Policy section to include criteria for eye gaze accessory. Policy on draft 8/1/24-9/15/24.

Medical Policy Group, October 2024 (6): Updates to Policy statement to incorporate existing DME repair verbiage, Key Points, Key Words and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.