Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Speech and Non-Speech Generating Devices
Policy #:MA05.003d

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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


Refer to the following News Article: Waiver of certain requirements during COVID-19 outbreak related to Durable Medical Equipment (DME), prosthetics, orthotics, and supplies for Medicare Advantage members (updated June 30, 2020)

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.

NOT COVERED

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, even though they may serve a medical purpose. 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 items not covered by Medicare. 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 it is a service not covered by Medicare, because such services or modifications could be used for non-medical purposes. Therefore, these are 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 an item not covered by Medicare because it is considered a convenience item. Therefore, it is not eligible for reimbursement consideration.

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

Computers, or other devices that are not defined as SGDs are not covered by the Company because they are not covered by Medicare. These items do not meet Medicare's definition of durable medical equipment (DME) because they are useful in the absence of illness or injury. Therefore, computers or other devices that are not defined as SGDs are not eligible for reimbursement consideration.

Non-speech-generating devices are not covered by the Company because they are items not covered by Medicare. 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

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:

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written 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 standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
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 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 DME supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

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

However, services that are identified in this policy as not covered are not eligible for coverage or reimbursement by the Company.

Refer to the policy that addresses the repair and replacement of durable medical equipment (DME) for information on that specific topic.

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] 07/29/2015. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=274&ncdver=2&bc=AAAAgAAAAAAAAA%3d%3d&. Accessed April 30, 2020.

Centers for Medicare & Medicaid Services (CMS) CMS.GOV Final Decision Memo. Speech Generating Devices. [CMS Web site]. 07/29/2015. 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& April 30, 2020.

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):376-386.

Code of Federal Regulations. Title 21, Volume 8. Subpart D--Physical Medicine Prosthetic Devices Sec. 890.3710 Powered communication system. [FDA Web site]. 09/19/2019. Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.3710. Accessed April 30, 2020.

Evidence of Coverage

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. {Govtrack.us Web site]. 10/11/2016. Available at: https://www.govtrack.us/congress/bills/114/s984/textAccessed April 30, 2020.

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.

Noridian Healthcare Solutions, LLC. Local Coverage DeterminationL33739: Speech generating devices (SGD). [Noridian Healthcare Web site]. Original: 10/01/2015. (Revised: 01/01/2020). Available at:
https://med.noridianmedicare.com/documents/2230703/7218263/Speech+Generating+Devices+%28SGD%29%20LCD+and+PA/7973cdbc-c335-47bb-91ca-ad8385830086. Accessed April 30, 2020.

Noridian Healthcare Solutions, LLC. Policy Article (A53469): Speech generating devices (SGD). [Noridian Healthcare Web site]. Original: 10/01/2015. (Revised: 01/01/2020). Available at:
https://med.noridianmedicare.com/documents/2230703/7218263/Speech+Generating+Devices+%28SGD%29%20LCD+and+PA/7973cdbc-c335-47bb-91ca-ad8385830086. Accessed April 30, 2020.

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):276-293.

Shepherd TA, Campbell KA, Renzoni AM, Sloan N. Reliability of speech generating devices: a 5-year review. Augment Altern Commun. 2009;25(3):145-153.

Swenson JR, Barnett LL, Pond B, Schoenberg A. Assistive technology for rehabilitation and reduction of disability. In: DeLisa JA, Gans BM, Bockeneck WL, eds. Rehabilitation Medicine: Principles and Practice.3rd ed. Philadelphia, PA: Lippincott-Raven; 1998:751-754.

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 April 30, 2020.

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):1658-1669.


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 SGD EYE TRACKING AND GAZE INTERACTION ACCESSORIES:

E2599 Accessory for speech generating device, not otherwise classified


NOT COVERED

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


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

E2599 Accessory for speech generating device, not otherwise classified


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

REVISIONS FROM MA05.003d:
07/06/2020This version of the policy will become effective 07/06/2020.

In accordance with the Final Rule 1713 (84 Fed. Reg Vol 217), a face-to-face encounter is no longer required for specified HCPCS codes:

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


REVISIONS FROM MA05.003c:
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.
07/28/2017The policy criteria that define the characteristics of a Speech generating device (SGD) have been updated.

The following not covered statements have been added to the policy.

NOT COVERED
    • Computers, tablets, and smartphones with non-covered features or other devices that are not defined by a manufacturer to solely function as a Speech Generating Device (SGD), are not considered a SGD.
    • Internet service provider (ISP), phone service subscriptions or any modification to an individuals home to allow use of the speech generating device is not covered by the Company because it is service not covered by Medicare, because such services or modifications could be used for non-medical purposes. Therefore, these are is not eligible for reimbursement consideration.
    • A carrying case (including shoulder strap or carrying handle, any type) (E2599) is not covered by the Company because it is an item not covered by Medicare because it is considered a convenience item. Therefore, it is not eligible for reimbursement consideration.
    • Accessories used with non-covered devices are not covered by the Company because they are items not covered by Medicare. 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, because it is an item not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

The following statements were added to the policy section:

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.

The following HCPCS code has been deleted from this policy:

L8510 Voice amplifier

REVISIONS FROM MA05.003b:
03/09/2016This version of the policy will become effective 03/09/2016.

The policy section has been updated to include new coverage for eye tracking and gaze interaction devices.

REVISIONS FROM MA05.003a:
02/11/2015This version of the policy will become effective 02/11/2015.

The policy has been updated to communicate the Company's continuing position on speech and non-speech generating devices.

The following CPT codes have been removed from the policy: 92605, 92606, 92607, 92608, 92609 & 92618

REVISIONS FROM MA05.003:
01/01/2015This is a new policy.




Version Effective Date: 07/06/2020
Version Issued Date: 07/07/2020
Version Reissued Date: N/A