Speech Generating Devices

Affected Providers

Treating practitioners and DME suppliers who bill for speech generating devices (SGDs).

Local Coverage Determination (LCD): Speech Generating Devices (SGD) (L33739) has the current HCPCS and CPT codes.

Background

According to the 2024 Medicare Fee-for-Service Supplemental Improper Payment Data, the improper payment rate for SGDs is 18.1%, with a projected improper payment amount of $2.6 million.

You must meet the provisions in: 

• National Coverage Determination (NCD): Speech Generating Devices (50.1)
• Article: Speech Generating Devices (A52469)
• LCD L33739

Preventing Denials

SGDs are DME that enable a patient with a severe speech impairment to meet their functional speaking needs. SGDs are speech aids consisting of devices or software that generate speech and are used solely by the patient who has a severe speech impairment. The audible/verbal speech output is generated in 1 of these ways:

• Digitized, using prerecorded messages
• Synthesized, requiring message formulation by spelling and device access by physical contact with the device-direct selection techniques
• Synthesized, permitting multiple methods of message formulation and multiple methods of device access
• Generated by software that allows a computer or other electronic device to generate speech

Other covered features of the device include the capability to generate email, text, or phone messages, which allow the patient to speak or communicate remotely, and the capability to download updates to the covered features from the manufacturer or supplier of the device.

If a patient with a severe speech impairment uses an SGD primarily for generating speech, it doesn’t need to be dedicated only to audible/verbal speech output to be considered DME. We generally don’t consider computers and tablets to be DME because they’re useful without illness or injury.

We cover an SGD (HCPCS codes E2500, E2502, E2504, E2506, E2508, E2510, and E2511) when criteria 1–7 are met:

1. Before the SGD is delivered, a speech-language pathologist (SLP) formally evaluates the patient’s cognitive and communication abilities. The formal, written evaluation must include, at a minimum, these elements:
   • Current communication impairment, including the type, severity, and anticipated course of the impairment as well as language skills and cognitive ability
   • An assessment of whether the patient’s daily communication needs could be met using other, natural modes of communication
   • A description of the functional communication goals expected to be achieved and of the treatment options
   • Rationale for selection of a specific device and any accessories
   • Demonstration that the patient possesses a treatment plan that includes a training schedule for the selected device
   • The cognitive and physical abilities needed to effectively use the selected device and any accessories to communicate
   • For an upgrade to a previously issued SGD, information regarding the upgrade’s functional benefit to the patient compared with the initially provided SGD
2. The patient’s medical condition resulted in a severe expressive speech impairment
3. Natural communication methods can’t meet the patient’s speaking needs
4. Other forms of treatment were considered and ruled out
5. The patient’s speech impairment will benefit from the device ordered
6. A copy of the SLP’s written evaluation and recommendation were forwarded to the patient’s treating practitioner before ordering the device
7. The SLP performing the patient’s evaluation can’t be an employee of, or have a financial relationship with, the supplier of the SGD

We deny the SGD coverage as not reasonable and necessary if 1 or more of criteria 1–7 isn’t met.

To meet the DME benefit category requirements, the SGD must:

1. Be able to withstand repeated use
2. Have an expected life of at least 3 years
3. Be primarily and customarily used to serve a medical purpose
4. Generally not be useful to a person without illness or injury
5. Be appropriate to use in the home
6. Be limited to use by a patient with a severe speech impairment
7. Be primarily used for generating speech

Desktop computers, laptop computers, tablets, smartphones, and other hand-held computers (general computing devices) aren’t considered DME because they don’t meet requirements 3, 4, 6, and 7, even though they may serve a medical purpose. We reimburse for speech generating software only (HCPCS code E2511) when it’s installed on a general computing device. Use HCPCS code A9270 to bill for the device itself.

Non-Covered

We don’t cover these features of an SGD because they don’t fall within the scope of the DME benefit:

• Specific features of an SGD that aren’t used by the person who has a severe speech impairment to meet their functional speaking needs.
• Video communications or conferencing.
• Any computing hardware or software not needed to generate speech, emails, or text or phone messages. Examples include, but aren’t limited to, hardware or software used to:
  • Create documents or spreadsheets
  • Play games or music
• Internet service provider, phone service subscriptions, or any modification to a patient’s home to allow them to use an SGD. We don’t cover these services or modifications because they could be used for non-medical equipment like standard phones or general computing devices.
• A carrying case (including shoulder strap or carrying handle, any type) (HCPCS code E2599), which is a convenience item.
• Accessories used with non-covered devices.
• Upgrades to SGDs or software programs that are provided within the 5-year useful lifetime of the device

Documentation Requirements

To justify payment, you must meet specific requirements when ordering DMEPOS.

For SGDs, we require a face-to-face encounter and written order prior to delivery before you deliver items to the patient.

Example of Improper Payments Due to Insufficient Documentation for SGDs

A supplier bills the claim for E2500 (Speech generating device, digitized speech, using pre-recorded messages, less than or equal to 8 minutes recording time) and submits the following documentation per the review contractor’s request:

• Standard written order with correct HCPCS coding
• Treating practitioner’s medical record that doesn’t have a complete assessment of whether the patient’s daily communication needs could be met using other natural modes of communication
• Proof of delivery

What Documentation Was Missing?

The treating practitioner’s medical record documentation is missing a complete assessment of whether other natural methods of communication could meet the patient’s daily communication needs. The patient’s medical documentation doesn’t meet the requirements of medical necessity for an SGD.

What Happens Next?

The review contractor completes the claim as an insufficient documentation error, and the Medicare Administrative Contractor recoups payment.

Recommendation

To justify payment, the certifying physician must collect and submit proper documentation, including an assessment of whether other natural methods of communication could meet the patient’s daily communication needs.

For specific policy requirements, see NCD 50.1.