NCD 50.1

Item/Service Description

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.

Indications and Limitations of Coverage

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.)

Revision History

08/2015 - This Change Request (CR) provides updates to add a revised scope of benefit national coverage determination for speech generating devices (SGDs) covered under the Medicare benefit category for Durable Medical Equipment (DME). Implementation date: 09/21/2015 Effective date: 07/29/2015 (TN 184)(CR9281)

09/2002 - Corrected section to include material that was inadvertently deleted via transmittal 150. Effective date NA. (TN 158) (No change request number.)

11/2000 - Added new section, and defined speech generating devices. Effective and implementation dates January 1, 2001. (TN 132) (CR 1328)