Description
Speech generating devices, or augmentative communication equipment, are durable medical equipment used for communication by individuals with severe speech impairment who do not have the ability to communicate with speech or alternatives to speech, such as writing and sign language.

Speech generating devices provide multiple methods of message formulation and are used therapeutically to establish, develop, or maintain the ability to communicate functional needs. These devices or aids are electronic and computer based and can generate synthesized (computer-generated) and/or digitized (natural human) speech output. Speech may be generated using one of the following methods:

• Digitized audible/verbal speech output, using prerecorded messages
• Synthesized audible/verbal speech output that requires message formulation by spelling and device access by physical contact with the device-direct selection techniques
• Synthesized audible/verbal speech output that permits multiple methods of message formation and multiple methods of device access
• Software that allows a computer or other electronic device to generate speech

Note: 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.

Policy
Speech generating devices are considered MEDICALLY NECESSARY when the medical criteria and guidelines shown below are met.

Speech generating devices and augmentative communication equipment are covered when all the following criteria are met: 

1. Prior to the delivery of the device, the member has had a formal evaluation of their cognitive and communication abilities by a speech-language pathologist. 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 member’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 patient 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 device, information regarding the functional benefit to the patient of the upgrade compared to the initially provided device
2. The member’s medical condition is one resulting in a severe expressive speech impairment 
3. The member’s speaking needs cannot be met using natural communication methods
4. Other forms of treatment have been considered and ruled out
5. The member’s speech impairment will benefit from the device ordered
6. A copy of the speech-language pathologist’s written evaluation and recommendation have been signed by the member’s treating physician and provided for review 
7. The speech-language pathologist performing the evaluation is not an employee of or has a financial relationship with the supplier of the device

Speech generating devices may be considered NOT MEDICALLY NECESSARY when the criteria listed above are not met, or if the device or software is not primarily and customarily used to serve a medical purpose. 

The following devices would not meet the definition of Speech Generating Devices and would also be considered not medically necessary:

• Devices or software applications that are not dedicated to speech generation. A device or software that is useful to someone without severe speech impairment is not considered Durable Medical Equipment.

• Laptop or desktop computers, smart phones, tablet PCs, software installation, and hardware or software accessories are non-covered since they are not primarily medical in nature and do not meet the definition of DME. They are not considered Speech Generating Devices.

Policy Guidelines
Accessories may be considered medically necessary if criteria for the base device are met and the medical necessity for each accessory is clearly documented in the formal evaluation by the speech-language pathologist. For any subsequent upgrade of equipment or software, or accessories to a previously issued device, information regarding the functional benefit to the member of the upgrade compared to the initially provided device must be submitted to demonstrate medical necessity. Only one device or software application at a time is considered medically necessary per member.

References 

1. Centers for Medicare & Medicaid Services. National Coverage Determination for Speech Generating Devices. Manual Section Number 50.1. Retrieved 8/17/06 from http://www.cms.hhs.gov
2. Region C DMERC. Local Coverage Determination for Speech Generating Devices L11524.
3. The Centers for Medicare & Medicaid, Local Coverage Determination LCD L33739 Speech Generating Devices, effective date 7/1/16, reviewed on August 23, 2016 from https://www.cms.gov/medicare-coverage-database
4. The Centers for Medicare & Medicaid, Local Coverage Determination LCD L33739 Speech Generating Devices, effective date 1/1/17, reviewed on September 6, 2017 from https://www.cms.gov/medicare-coverage-database
5. American Speech-Language-Hearing Association. Speech and Language Disorders. [http://www.asha.org/public/speech/disorders/] accessed 11/18/18.
6. Baxter S, et al. The state of art in the non-pharmacological interventions for developmental stuttering. Part 1: a systematic review of effectiveness. Int J Lang Commun Disord 2015 Sep;50(5):676-718.
7. Gevarter C, et al. Comparing communication systems for individuals with developmental disabilities: a review of single-case research studies. Res Dev Disabil 2013 Dec;34(12):4415-32.
8. Iacono T, et al. The role of augmentative and alternative communication for children with autism: current status and future trends. Neuropsychiatr Dis Treat. 2016 Sep 19;12:2349-2361.
9. Light J, et al. The changing face of augmentative and alternative communication: past, present, and future challenges. Augment Altern Commun 2012 Dec;28(4):197-204.
10. Linske A, et al. Communication Matters-Pitfalls and Promise of Hightech Communication Devices in Palliative Care of Severely Physically Disabled Patients With Amyotrophic Lateral Sclerosis. Front Neurol. 2018 Jul 27;9:603
11. McNaughton D, et al. "Augmentative and Alternative Communication (AAC) Will Give You a Voice": Key Practices in AAC Assessment and Intervention as Described by Persons with Amyotrophic Lateral Sclerosis. Semin Speech Lang. 2018 Nov;39(5):399-415.
12. Romski MA, et al. Communication patterns of youth with mental retardation with and without their speech-output communication devices. Amer J Mental Retardation 1999;104(3):249-59.
13. Russo MJ, et al. High-technology augmentative communication for adults with post-stroke aphasia: a systematic review. Expert Rev Med Devices 2017 May;14(5):355-30.
14. Sevcik RA, et al. Issues in augmentative and alternative communication in child psychiatry. Child Adolesc Psychiatric Clin N Am 1999 Jan;8(1):77-87.

Coding Section 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community,  and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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