Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Speech and Non-Speech Generating Devices

Policy #:05.00.32i

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Speech-generating devices (SGDs) are considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has a permanent and/or progressive condition (e.g., traumatic brain injury, muscular dystrophy) resulting in severe expressive speech impairment (an inability or the limited ability to communicate wants, needs, and thoughts via the spoken or printed word).
  • The individual has been evaluated by a speech language pathologist (SLP) who has documented the individual's functional abilities to use the requested SGD. The written evaluation must include, at minimum, a description of the following:
    • Current communication impairment, including the type, severity, language skills, cognitive ability, and anticipated course of the impairment
    • An assessment of whether the individual's daily communication needs could be met using other natural modes of communication
    • A description of the functional communication goals to be achieved and treatment options
    • The rationale for the selection of a specific device and any accessories for communication
    • A demonstration that the individual possesses a treatment plan that includes a training schedule for the selected SGD
    • A demonstrated ability by the individual (e.g., cognitive and physical) to effectively use the level of technology provided by the requested SGD and any accessories for communication
      • It is recommended that a documented successful one-month trial be performed prior to submitting a request for an SGD.
    • For a subsequent upgrade to a previously issued SGD, information regarding the functional benefit of the upgrade to the individual compared to the initially issued SGD
  • Other forms of treatment have been considered and ruled out.
  • The individual's speech impairment will benefit from the selected device.
  • The SGD must be a dedicated speech device used solely by the individual who has the speech impairment.
  • The SGD must be characterized by one of the following:
    • Digitized speech output using pre-recorded messages
    • Synthesized speech output permitting message formulation by spelling and device access by physical contact with the device-direct selection techniques
    • Synthesized speech output permitting multiple methods of message formulation and multiple methods of device access
    • Software that allows a laptop, desktop, or handheld computer to function as an SGD

Upgrades to SGDs and/or speech-generating software programs functioning as SGDs are considered medically necessary and, therefore, covered when all of the following are met:
  • The above criteria are met
  • Medical necessity is clearly documented in a formal evaluation by the SLP
  • The upgrade is on or after the manufacturer's lifetime warranty.

Mounting systems are considered medically necessary and, therefore, covered when documentation of medical necessity is provided in a formal evaluation by the SLP.

Accessories for SGDs, including access devices, eye tracking and gaze interaction devices, replacement batteries, replacement battery chargers, and replacement adapters, are considered medically necessary and, therefore, covered when the medical necessity criteria for the device are met and documentation of medical necessity for each accessory is provided in a formal evaluation by the SLP. Codes for SGDs include the device as well as any applicable software, batteries, battery chargers, and AC adapters. These items are not eligible for separate reimbursement at the time of initial issue of the SGD.

BENEFIT CONTRACT EXCLUSION

A device-utilizing tablet, smartphone, or computer hardware must be designed by the manufacturer to function solely as a speech-generation device, at the time of initial issue. Desktop, laptop, tablet, smartphone, and other hand-held computers (i.e., general computing devices) are not covered, because they are not primarily medical in nature. The Company will cover speech-generating software only when installed on a general computing device.

The following features of a SGD are not covered by the Company because they are not primarily medical in nature. Therefore, they are not eligible for reimbursement consideration.
  • 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
  • Video communications or conferencing
  • Any computing hardware or software not necessary to allow for generation of speech, email, text, or phone messages. Examples include, but are not limited to:
    • Hardware or software used to create documents and spreadsheets; or,
    • Hardware or software used to play games or music

Internet service provider (ISP), phone service subscriptions, or any modification to an individual's home to allow use of the speech generating device is not covered by the Company because these are benefit exclusions. Therefore, these are is not eligible for reimbursement consideration.

A carrying case (including shoulder strap or carrying handle, any type) is not covered by the Company because it is considered a comfort or convenience item. Therefore, it is not eligible for reimbursement consideration.

Accessories used with non-covered devices are not covered by the Company. Therefore, they are not eligible for reimbursement consideration.

Upgrades to speech-generating devices and/or software programs provided within the manufacturer's useful lifetime warranty of the device are not covered by the Company. Therefore, they are not eligible for reimbursement consideration.

Computers, or other devices that are not defined as SGDs do not meet the Company's definition of durable medical equipment (DME); therefore, they are a benefit contract exclusion and are neither covered nor eligible for reimbursement.

Non-speech-generating devices are not covered by the Company because they are a benefit contract exclusion. Therefore, they are not eligible for reimbursement consideration.
  • Equipment that is primarily and customarily used for a non-medical purpose may or may not be considered “medical” in nature. This is true even though the item may have some medically related use.

ADDITIONAL REIMBURSEMENT INFORMATION
The following items are included in the reimbursement for the SGD:
  • Any software, interfaces, cables, adapters, interconnects, or switches necessary for the access device to interface with the SGD.
  • A protective case or cover, any type, since it is required to make the device durable.

FACE-TO-FACE REQUIREMENTS
As a condition for payment, a professional provider must have a face-to-face examination with the individual for whom the item is ordered that meets all of the following requirements:
  • The treating professional provider must have an in-person examination with the individual within the six (6) months prior to the date of the written order prior to delivery.
  • This examination must document that the individual was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.

A new face-to-face examination is required each time a new prescription for one of the specified items is ordered. A new prescription is required:
  • For all claims for purchases or initial rentals
  • When there is a change in the prescription for the accessory, supply, drug, etc.
  • If periodic prescription renewal required per medical policy
  • When an item is replaced
  • When there is a change in the supplier
  • When required by state law

In this policy the specified items are:

Code
Narrative
E2502Speech generating device, digitized speech, using prerecorded messages, greater than eight minutes but less than or equal to 20 minutes recording time
E2506Speech generating device, digitized speech, using prerecorded messages, greater than 40 minutes recording time
E2508Speech generating device, synthesized speech, requiring message formulation by spelling and access by physical contact with the device
E2510Speech generating device, synthesized speech, permitting multiple methods of message formulation and multiple methods of device access


REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, speech-generating devices are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in the medical policy are met.

However, services that are identified in this policy as a benefit contract exclusion are not eligible for coverage or reimbursement by the Company. Therefore, they are not eligible for reimbursement consideration.

BILLING GUIDELINES

SGDs and speech-generating software programs perform the same essential function (i.e., speech generation); therefore, only one is eligible for reimbursement.

An upgrade to an SGD should be coded as an accessory, whereas an upgrade to a speech-generating software program should be coded as a speech-generating software program.

Any type of software installation or technical support is not eligible for separate reimbursement.

Description

SPEECH-GENERATING DEVICES

A speech-generating device (SGD) is a type of durable medical equipment (DME) defined as an augmentative or alternative communication aid that provides individuals who have severe expressive speech disability the ability to meet functional speaking though audible generation of words and possibly written text or phone messaging. Severe expressive speech disability is an inability, or the limited ability, to communicate daily wants, needs, and thoughts via the spoken or printed word. This disability is diagnosed by a speech language pathologist (SLP) during a formal evaluation. The SLP determines which type of SGD would be most beneficial to the individual.

Speech produced by SGDs can be either digitized or synthesized. Digitized SGDs, sometimes referred to as devices with "whole message" speech output, utilize words and phrases that have been recorded for playback upon command of the user. Because the messages are pre-recorded, digitized SGDs limit an individual's fringe vocabulary (user specific words that allow for personalized expression). In contrast, synthesized SGDs translate the user’s input into device generated speech. Synthesized SGDs often have "text to speech" capabilities that allow the user to create messages with extensive fringe vocabulary.

Speech-generating software programs enable a laptop computer, desktop computer, or handheld computer to function as an SGD; therefore, speech-generating software programs can also be defined as SGDs. Upgrades to SGDs and/or speech-generating software programs functioning as SGDs are subsequent versions of the existing software program or memory modules that may include enhanced features or other improvements.

The two ways of accessing SGDs are direct selection and indirect selection. Direct selection requires physical contact with the device to produce communication; therefore, it is only appropriate for individuals who have reliable fine motor skills. Indirect selection is better suited for individuals who may have reliable gross motor skills but lack reliable fine motor skills. Indirect selection allows for message formulation through access devices such as, but not limited to, a head mouse, joysticks, infrared pointers, headpointers, lightpointers, switches, wheelchair integration devices, and scanning devices.

Mounting systems may be necessary to position the SGD, switches, and other access devices within reach of the individual. Accessories for SGDs include, but are not limited to, access devices, batteries, battery chargers, and adapters.

NON-SPEECH-GENERATING DEVICES (LOW TECH COMMUNICATION DEVICES)

Non-speech-generating devices are exclusive low technology devices where language selections are interpreted by the communication partner, without the benefit of auditory output. These communication devices do not need batteries or the use of electronics. An example of a non-speech-generating device is a communication board, which is a single- or multi-page display with letters, words, and/or symbols. Non-speech-generating devices are not defined as DME and do not qualify as a digitized or synthesized SGD.
References


Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).50.1: Speech generating devices. [CMS Web site] 07/29/15. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=274&ncdver=2&bc=AAAAgAAAAAAAAA%3d%3d&. Accessed January 25, 2019.

Centers for Medicare & Medicaid Services (CMS) CMS.GOV Final Decision Memo. Speech Generating Devices. Available at: https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=26&mcdtypename=National+Benefit+Category+Analyses&MCDIndexType=3&bc=AgAEAAAAAAAAAA%3d%3d& Accessed January 25, 2019.

Cheslock MA, Barton-Hulsey A, Romski M, Sevcik RA. Using a speech-generating device to enhance communicative abilities for an adult with moderate intellectual disability. Intellect Dev Disabil. 2008;46(5):376-86.

Code of Federal Regulations. Title 21, Volume 8. Subpart D--Physical Medicine Prosthetic Devices Sec. 890.3710 Powered communication system. Revised as of April 1, 2016. Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.3710. Accessed January 25, 2019.

Company Benefit Contracts.

Ganz JB, Earles-Vollrath TL, Heath AK, et al. A meta-analysis of single case research studies on aided augmentative and alternative communication systems with individuals with autism spectrum disorders. J Autism Dev Disord. 2012;42(1):60-74.

Govtrack.us Text of the Steve Gleason Act of 2015. Available at: https://www.govtrack.us/congress/bills/114/s984/text Accessed January 25, 2019.

Kagohara DM, van der Meer L, Ramdoss S, et al. Using iPods() and iPads() in teaching programs for individuals with developmental disabilities: A systematic review. Res Dev Disabil. 2013;34(1):147-56. Epub 2012 Aug 30.

Noridian Healthcare Solutions, LLC. Local Coverage DeterminationL33739: Speech generating devices (SGD). [Noridian Healthcare Web site]. Original: 10/01/2015. (Revised: 01/01/2017). Available at :
https://med.noridianmedicare.com/documents/2230703/7218263/Speech+Generating+Devices+%28SGD%29%20LCD+and+PA/7973cdbc-c335-47bb-91ca-ad8385830086. Accessed January 25, 2019.

Noridian Healthcare Solutions, LLC. Policy Article (A53469): Speech generating devices (SGD). [Noridian Healthcare Web site]. Original: 10/01/2015. (Revised: 01/01/2017). Available at :
https://med.noridianmedicare.com/documents/2230703/7218263/Speech+Generating+Devices+%28SGD%29%20LCD+and+PA/7973cdbc-c335-47bb-91ca-ad8385830086. Accessed January 25, 2019.

Rispoli MJ, Franco JH, van der Meer L, et al. The use of speech generating devices in communication interventions for individuals with developmental disabilities: a review of the literature. Dev Neurorehabil. 2010;13(4):276-93.

Shepherd TA, Campbell KA, Renzoni AM, Sloan N. Reliability of speech generating devices: a 5-year review. Augment Altern Commun. 2009;25(3):145-53.

United States Society for Augmentative and Alternative Communication (USSAAC). AAC Devices. [USSAAC Web site]. 2018. Available at: https://ussaac.org/aac-info/aac-devices. Accessed January 25, 2019.

van der Meer L, Kagohara D, Achmadi D, et al. Speech-generating devices versus manual signing for children with developmental disabilities. Res Dev Disabil. 2012;33(5):1658-69.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medical necessity as listed in the policy.




HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

E2500 Speech generating device, digitized speech, using pre-recorded messages, less than or equal to eight minutes recording time

E2502 Speech generating device, digitized speech, using prerecorded messages, greater than eight minutes but less than or equal to 20 minutes recording time

E2504 Speech generating device, digitized speech, using prerecorded messages, greater than 20 minutes but less than or equal to 40 minutes recording time

E2506 Speech generating device, digitized speech, using prerecorded messages, greater than 40 minutes recording time

E2508 Speech generating device, synthesized speech, requiring message formulation by spelling and access by physical contact with the device

E2510 Speech generating device, synthesized speech, permitting multiple methods of message formulation and multiple methods of device access

E2511 Speech generating software program, for personal computer or personal digital assistant

E2512 Accessory for speech generating device, mounting system

V5336 Repair/modification of augmentative communicative system or device (excludes adaptive hearing aid)


THE FOLLOWING CODE IS USED TO REPRESENT SPEECH GENERATING DEVICE (SGD) EYE TRACKING AND GAZE INTERACTION ACCESSORIES:

E2599 Accessory for speech generating device, not otherwise classified


BENEFIT CONTRACT EXCLUSION

E1902 Communication board, non-electronic augmentative or alternative communication device


THE FOLLOWING CODE IS USED TO REPRESENT A SGD CARRYING CASE:

E2599 Accessory for speech generating device, not otherwise classified


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

05.00.32i
03/13/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Speech and Non-Speech Generating Devices.
03/28/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Speech and Non-Speech Generating Devices.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 07/28/2017
Version Issued Date: 07/28/2017
Version Reissued Date: 03/13/2019

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.