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National Coverage Determination (NCD)

Speech Generating Devices

50.1

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Tracking Information

Publication Number
100-3
Manual Section Number
50.1
Manual Section Title
Speech Generating Devices
Version Number
2
Effective Date of this Version
07/29/2015
Ending Effective Date of this Version
Implementation Date
09/21/2015
Implementation QR Modifier Date

Description Information

Benefit Category
Durable Medical Equipment


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

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.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
184
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R184NCD.pdf
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)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Speech Generating Devices 2 07/29/2015 - N/A You are here
Speech Generating Devices 1 01/01/2001 - 07/29/2015 View
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CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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