CMS Pub. 100-03, ch. 1, § 50.1

A. General

Speech generating devices are considered to fall within the durable medical equipment

(DME) benefit category established by §1861(n) of the Social Security Act. They are

covered for patients who suffer from a severe speech impairment and have a medical

condition that warrants the use of a device based on the following definitions.

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 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

audible/verbal speech.

Other covered features of the device include the capability to generate email, text, or

phone messages to allow the patient to “speak” or communicate remotely, as well as the

capability to download updates to the covered features of the device from the

manufacturer or supplier of the device.

If a speech generating device is limited to use by a patient with a severe speech

impairment and is primarily used for the purpose of generating speech, it is not necessary

for the device to be dedicated only to audible/verbal speech output to be considered

DME. Computers and tablets are generally not considered DME because they are useful

in the absence of an illness or injury.

B. Nationally Covered Indications

N/A

C. Nationally Non-Covered Indications

Internet or phone services or any modification to a patient’s home to allow use of the

speech generating device are not covered by Medicare because such services or

modifications could be used for non-medical equipment such as standard phones or

personal computers. In addition, specific features of a speech generating device that are

not used by the individual who has a severe speech impairment to meet his or her

functional speaking needs are not covered. This would include any computing hardware

or software not necessary to allow for generation of audible/verbal speech, email, text or

phone messages, such as hardware or software used to create documents and spreadsheets

or play games or music, and any other function a computer can perform that is not

directly related to meeting the functional speaking communication needs of the patient,

including video communications or conferencing. These features of a speech generating

device do not fall within the scope of § 1861(n) of the Social Security Act and the cost of

these features are the responsibility of the beneficiary. Suppliers of speech generating

devices are encouraged to furnish the beneficiary with a voluntary Advance Beneficiary

Notice (ABN), or similar notice, which informs that these features are not covered and to

alert the beneficiary of the expense of these features.

D. Other

A/B MACs acting within their respective jurisdictions have discretion to cover or not

cover speech generating devices based on their individual reasonable and necessary

determinations.

(This NCD last reviewed July 2015.)