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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
1
Effective Date of this Version
01/01/2001
Ending Effective Date of this Version
07/29/2015
Implementation Date
01/01/2001
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
Indications and Limitations of Coverage

Effective January 1, 2001, augmentative and alternative communication devices or communicators which are hereafter referred to as “speech generating devices” are now considered to fall within the durable medical equipment (DME) benefit category established by §1861(n) of the Social Security Act (the Act). They may be covered if the Medicare Administrative Contractor medical staff determines that the patient suffers from a severe speech impairment and that the medical condition warrants the use of a device based on the following definitions.

Definition of Speech Generating Devices

Speech generating devices are defined as speech aids that provide an individual who has a severe speech impairment with the ability to meet his functional speaking needs. Speech generating devices are characterized by:

  • Being a dedicated speech device, used solely by the individual who has a severe speech impairment;
  • May have digitized speech output, using prerecorded messages, less than or equal to 8 minutes recording time;
  • May have digitized speech output, using prerecorded messages, greater than 8 minutes recording time;
  • May have synthesized speech output which requires message formulation by spelling and device access by physical contact with the device-direct selection techniques;
  • May have synthesized speech output which permits multiple methods of message formulation and multiple methods of device access; or
  • May be software that allows a laptop computer, desktop computer or personal digital assistant (PDA) to function as a speech generating device.

Devices that would not meet the definition of speech generating devices and therefore, do not fall within the scope of §1861(n) of the Act are characterized by:

  • Devices that are not dedicated speech devices, but are devices that are capable of running software for purposes other than for speech generation, e.g., devices that can also run a word processing package, an accounting program, or perform other than non-medical function.
  • Laptop computers, desktop computers, or PDA’s which may be programmed to perform the same function as a speech generating device, are noncovered since they are not primarily medical in nature and do not meet the definition of DME. For this reason, they cannot be considered speech-generating devices for Medicare coverage purposes.
  • A device that is useful to someone without severe speech impairment is not considered a speech-generating device for Medicare coverage purposes.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
158
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R158CIM.pdf
Revision History

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 View
Speech Generating Devices 1 01/01/2001 - 07/29/2015 You are here
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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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