Subject: Speech-Generating Devices
Date: June 5, 2012
This Clinical Policy Bulletin expresses our determination of whether certain services or supplies are medically necessary. We have reached these conclusions based on a review of currently available clinical information including:
- Clinical outcome studies in the peer-reviewed published medical and dental literature
- Regulatory status of the technology
- Evidence-based guidelines of public health and health research agencies
- Evidence-based guidelines and positions of leading national health professional organizations
- Views of physicians and dentists practicing in relevant clinical areas
- Other relevant factors
We expressly reserve the right to revise these conclusions as clinical information changes, and welcome further relevant information.
Each benefits plan defines which services are covered, excluded and subject to dollar caps or other limits. Members and their dentists will need to consult the member's benefits plan to determine if any exclusions or other benefits limitations apply to this service or supply.
The conclusion that a particular service or supply is medically necessary does not guarantee that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that we consider medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members.
- Aetna considers speech generating devices as medically necessary durable medical equipment (DME) for members who meet all of the following criteria:
- Prior to the delivery of the speech-generating device (SGD), the member has had a formal evaluation of his or her cognitive and language abilities by a speech-language pathologist (SLP). The formal, written evaluation must include, at a minimum, all of the following elements:
- Evaluation of 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 expected to be achieved and treatment options
- Rationale for selection of a specific device and accessories
- A treatment plan that includes a training schedule for the selected device
- Demonstration that the member has the cognitive and physical abilities to effectively use the selected device and any accessories to communicate
- For a subsequent upgrade to a previously issued SGD, information for the member comparing its benefits to the older SGD
- The members medical condition is one resulting in a permanent severe expressive speech disability
- The member's speaking needs cannot be met using natural communication methods
- Other forms of treatment have been considered and ruled out
- The member's speech disability will benefit from the device ordered
- A copy of the SLP's written evaluation and recommendation have been forwarded to the member's treating physician prior to ordering the device
- The SLP performing the evaluation of the member may not be an employee or have a financial relationship with the supplier of the SGD.
- Aetna considers SGDs experimental and investigational when criteria are not met.
Accessories and upgrades for the SGD are considered medically necessary if the basic medical necessity criteria are met and the medical necessity for each accessory is clearly documented in the formal evaluation by the SLP.
Only one speech generating device or speech generating software program at a time is considered medically necessary per member.
Multilingual modules for SGDs are considered not medically necessary.
Laptop computers, desktop computers, personal digital assistants (PDAs), or other devices that are not dedicated SGDs are not covered because they do not meet the definition of durable medical equipment. Please check benefits plan descriptions for details.
Software that enables a laptop computer, desktop computer, or PDA to function as a SGD is considered an SGD. However, installation of the program or technical support is not separately reimbursable.
There should be no separate billing of any software, interfaces, cables, adapters, interconnects and switches necessary for the accessory to interface with the SGD.
Speech-generating devices, as described above, are considered medically necessary regardless of whether the plan has an exclusion for "communication aids." Communication aids that are not speech-generating devices are not covered under plans that exclude communication aids. Please check benefit plan descriptions for details.
This CPB does not apply to electronic speech aids that are used by laryngectomized persons and persons with a permanently inoperative larynx. These are considered prosthetics. There are two types of electronic speech aids. One operates by placing a vibrating head against the throat. The other amplifies sound waves through a tube inserted into the user's mouth. A person who has had radical neck surgery and/or extensive radiation to the anterior part of the neck would generally be able to use only the "oral tube" model or one of the sensitive and more expensive "throat contact" devices.
This policy is based on Medicare DMERC criteria for speech-generating devices. Speech-generating devices (SGDs) are speech aids that provide individuals with severe speech impairment the ability to meet their functional speaking needs. Digitized speech, sometimes referred to as devices with "whole message" speech output, use words or phrases that have been recorded by an individual other than the SGD user for playback upon command of the SGD user.
Synthesized speech, unlike prerecorded messages of digitized speech, is a technology that translates a user's input into device-generated speech using algorithms representing linguistic rules. Users of synthesized speech SGDs are not limited to prerecorded messages but they can create messages independently as their communication needs dictate. Some SGDs require message formulation by spelling and access by physical contact with a keyboard, touch screen or other display containing letters. Speech-generating software programs enable a laptop computer, desktop computer or personal digital assistant (PDA) to function as an SGD. Within this policy, the term SGD also describes these speech-generating software programs. Speech-generating devices may permit multiple methods of message formulation and multiple methods of device access. For purposes of this policy, an SGD with multiple methods of message formulation should include message selection by two or more of the following methods: letters, words, pictures, and symbols. An SGD with multiple methods of access should include the capability to access the device by two or more of the following: direct physical contact with a keyboard or touch screen, indirect selection techniques and a specialized access device such as a joystick, head mouse, optical head pointer, light pointer, infrared pointer, scanning device or Morse code.
Upgrades of an SGD are subsequent versions of an SGD's software program or memory modules that may include enhanced features or other improvements. Mounting switches are devices necessary to place the SGD, switches, and other access devices within the reach of the patient.
Accessories for SGDs include, but are not limited to, access devices that enable selection of letters, words, or symbols via direct or indirect selection techniques. Examples of access devices include, but are not limited to, optical head pointers, joysticks, and SGD scanning devices. The assessment of need for an SGD should be performed by a qualified speech-language pathologist (SLP). For purposes of this policy, SLPs are licensed health professionals trained in the diagnosis and treatment of speech and language disorders. The SLP should hold a Certificate of Clinical Competence from the American Speech and Hearing Association.
Communication aids that do not generate speech are not covered under most Aetna benefits plans, as most plans have a specific contractual exclusion of communication aids. Please check benefits plan descriptions for details. In addition, communication aids that are not SGDs are not considered prosthetics for speech, as they do not replace internal or external body parts lost or impaired by disease or injury. Examples of non-covered communication aids include the following: picture books; flashcards; Braille typewriters; TTY (text telephone or TDD) devices; devices that allow the patient to communicate messages to others with writing (for example, a display screen or printout) rather than with synthesized speech; and devices that allow the user to communicate with a computer rather than with another person. Although communication aids that do not generate (synthesize) speech may be useful to patients who otherwise cannot communicate, they do not meet the definition of a prosthetic device under Aetna's benefits plans.
In addition, these communication aids that are not speech-generating devices do not meet the definition of covered durable medical or surgical equipment under Aetna's benefits plans. Aetna's DME benefit covers medical or surgical equipment for treatment of disease or injury; or for the purpose of improving body function lost or impaired by disease or injury; or to enable the patient to perform essential activities of daily living related to the patient's health and hygiene, within or outside the home, with minimal or no assistance from others. Aetna does not consider communication to be a bodily function. Although communication may be considered an activity of daily living, it is an activity that is not related to the patient's health and hygiene. Examples of functions and essential activities of daily living for which Aetna covers durable medical equipment include bathing; feeding; toileting; walking; and transferring from bed to chair, wheelchair or walker. Aetna does not consider communication to be an activity of this type. Furthermore, patients requiring a communication aid are usually unable to perform any of these functions without assistance from others, with or without a communication aid.
The literature for some communication aids emphasize their value in expanding vocabulary skills, for use in business and for report preparation, and their ability to be connected to a personal computer. This goes beyond what is considered to be an essential medical device. For similar reasons, Aetna does not cover visual alert systems for the deaf or special controls on cars for people who need them to drive.
Speech may gradually improve after head trauma or stroke. For these acquired disorders, SGDs are used as a last option. Therefore, use of an SGD is not usually initiated less than four to six months after trauma or stroke.
Medicare classifies SGDs as durable medical equipment (DME). To be eligible for an SGD, Medicare requires that the beneficiary is enrolled in Medicare Part B; the beneficiary lives in his/her family home, or an assisted living facility (but not in a hospital, skilled nursing facility or hospice); the beneficiary is determined, following an assessment by a SLP, to require an SGD to meet daily functional communication needs; and the beneficiary's physician prescribes the SGD.
|CPT codes covered if selection criteria are met:
||Evaluation of speech, language, voice, communication, and/or auditory processing
||Evaluation for prescription for speech-generating augmentative and alternative communication device, face-to-face with the patient; first hour
||Each additional 30 minutes (List separately in addition to code for primary procedure)
||Therapeutic services for the use of speech-generating device, including programming and modification
codes covered if selection criteria are met:
||Speech-generating device, digitized speech, using prerecorded messages, less than or equal to 8 minutes recording time
||Speech-generating device, digitized speech, using prerecorded messages, greater than 8 minutes but less than or equal to 20 minutes recording time
||Speech-generating device, digitized speech, using prerecorded messages, greater than 20 minutes but less than or equal to 40 minutes recording time
||Speech-generating device, digitized speech, using prerecorded messages, greater than 40 minutes recording time
||Speech-generating device, synthesized speech, requiring message formulation by spelling and access by physical contact with the device
||Speech-generating device, synthesized speech, permitting multiple methods of message formulation and multiple methods of device access
||Speech-generating software program, for personal computer or personal digital assistant
||Accessory for speech-generating device, mounting system
||Accessory for speech-generating device, not otherwise classified
||Services of a speech and language pathologist in home health setting, each 15 minutes
||Repair/modification of augmentative communicative system or device (excludes adaptive hearing aid)
|HCPCS codes not covered for indications listed in the CPB:
||Communication board, nonelectronic augmentative or alternative communication device
|Other HCPCS codes related to the CPB:
||Artificial larynx, any type
||Artificial larynx replacement battery/accessory, any type
|ICD-9 codes covered if selection criteria are met:
|315.31 - 315.39
||Developmental speech or language disorder
||Late effects of cerebrovascular disease, speech and language deficits
||Other speech disturbance
|Other ICD-9 codes related to the CPB:
|161.0 - 161.9
||Malignant neoplasm of larynx
|191.0 - 191.9
||Malignant neoplasm of brain
|433.00 - 436
||Occlusion and stenosis of precerebral or cerebral arteries, transient cerebral ischemia, and acute, but ill-defined, cerebrovascular disease
|800.00 - 801.99
||Fracture of vault of skull, base of skull
|850.00 - 854.19
||Intracranial injury, excluding those with skull fracture
||Late effect of fracture of skull and face bones
||Late effect of intracranial injury without mention of skull fracture
||Personal history of malignant neoplasm of other and unspecified oral cavity and pharynx
||Personal history of malignant neoplasm of brain
The above policy is based on the following references:
- U.S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Speech generating devices. Medicare Coverage Issues Manual §60-23. HCFA Pub. 6. Baltimore, MD: HCFA; 2001.
- TriCenturion LLC. Speech generating devices. Medicare Local Coverage Determination (LCD). DMERC Region A. LCD Database ID No. L11534. Contractors Determination No. SGD20050701. Columbia, SC: TriCenturion; effective July 1, 2005.
- TriCenturion LLC. Speech generating devices. Policy Article. DMERC Region A. Article Database ID No. A33770. Columbia, SC: TriCenturion; effective July 1, 2005.
- U.S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Durable medical equipment reference list. Medicare Coverage Issues Manual §60-9. HCFA Pub. 6. Baltimore, MD: HCFA; 2001.
- Poole CJ, Millman A. ABC of medical computing. Adaptive computer technology. Br Med J. 1995;311(7013):1149-1151.
- Tolley K, Leese B, Wright K, et al. Communication aids for the speech impaired: Cost and quality-of-life outcomes of assessment programs provided by specialist communication aids centers in the United Kingdom. Int J Technol Assess Health Care. 1995;11(2):196-213.
- Pehringer JL. Assistive devices: Technology to improve communication. Otolaryngol Clin North Am. 1989;22(1):143-174.
- Redford JB. Assistive devices. In: Practice of Geriatrics. 3rd Ed. EH Duthie, JR Katz, eds. Philadelphia, PA: W.B. Saunders Co.; 1998: 173-186.
- Rostron A, Ward S, Plant R. Computerized augmentative communication devices for people with dysphasia: Design and evaluation. Eur J Discord Commun. 1996;31(1):11-30.
- Beukelman DR, Mirenda P. Augmentative and alternative communication: Management of severe communication disorders in children and adults. Baltimore, MD: P.H. Brookes Publishers; 1998.
- Lloyd LL, Fuller DR, Arvidson HH. Augmentative and alternative communication: A handbook of principles and practices. Boston, MA: Allyn and Bacon; 1997.
- Bergen AF. Assistive technology for disabled clients. Caring. 1998;17(1):18-27.
- Wood D. Talking again with the help of a communication device. EBSCO Health Library. Ipswich, MA: EBSCO Publishing; 2005.
- Schlosser RW, Sigafoos J. Augmentative and alternative communication interventions for persons with developmental disabilities: Narrative review of comparative single-subject experimental studies. Res Develop Disabil. 2006;27(1):1-29.
- Millar DC, Light JC, Schlosser RW. The impact of augmentative and alternative communication intervention on the speech production of individuals with developmental disabilities: A research review. J Speech Lang Hear Res. 2006;49(2):248-264.
- Bruno J, Trembath D. Use of aided language stimulation to improve syntactic performance during a weeklong intervention program. Augment Altern Commun. 2006;22(4):300-313.
- Saito Y, Turnbull A. Augmentative and alternative communication practice in the pursuit of family quality of life: A review of the literature. Res Pract Severe Disabil. 2007;32(1):50-65.
- Olive ML, de la Cruz B, Davis TN, et al. The effects of enhanced milieu teaching and a voice output communication aid on the requesting of three children with autism. J Autism Dev Disord. 2007;37(8):1505-1513.
- Thunberg G, Ahlsén E, Sandberg AD. Children with autistic spectrum disorders and speech-generating devices: Communication in different activities at home. Clin Linguist Phon. 2007;21(6):457-479.
- Tack JW, Qiu Q, Schutte HK, et al. Clinical evaluation of a membrane-based voice-producing element for laryngectomized women. Head Neck. 2008;30(9):1156-1166.
- 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.
Rodriguez C, Rowe M. Use of a speech-generating device for hospitalized postoperative patients with head and neck cancer experiencing speechlessness. Oncol Nurs Forum. 2010;37(2):199-205.
Original policy: November 4, 2004
Updated: September 25, 2006; August 26, 2008; January 20, 2011; June 5, 2012
Revised: November 16, 2009
Medical Policy Bulletin #0437
: March 15, 2012, updated with additional coding.