This is a Formal Request for an Augmentative and Alternative Communication (AAC) Devices National Coverage Decision (NCD). These materials demonstrate that the past Medicare noncoverage decision related to AAC devices should be withdrawn and replaced with this proposed AAC Device NCD, which is based on professionally and programmatically sound criteria. As discussed below, the Health Care Financing Administration (HCFA) has no records of the basis or rationale for the noncoverage decision, and the noncoverage decision is inconsistent with 1) Medicare coverage policy and practices for items and services that treat the same conditions and address identical treatment goals (e.g., SLP services; laryngoplasty; artificial larynx; tracheostomy speaking valves); 2) a substantial volume of peer reviewed professional literature, policy and clinical practice; and 3) policies and practices of all state Medicaid programs and an overwhelming number of other public as well as private third party reimbursement programs. This Formal Request consists of six sections and three Appendices.
II. USE OF AAC DEVICES
AAC devices fall within a class of durable medical equipment that generally is recognized as appropriate treatment for, and has become the standard practice in, the treatment of individuals with severe communication impairments, such as dysarthria, apraxia, and aphasia. The Food and Drug Administration (FDA) classifies AAC devices as powered communication systems. AAC devices are reasonable and necessary treatment for individuals with dysarthria, apraxia, and/or aphasia, when these conditions are of such severity that, without an AAC device, the individual will lack functional or meaningful communication, i.e. when these speech (dysarthria, apraxia) and language (aphasia) disabilities interfere with the individuals ability to meet the communication needs arising in the course of current and projected daily activities through natural communication techniques, such as speech, writing, and/or gestures. These severe communication disabilities arise among small numbers of individuals with primary physical impairments of amyotrophic lateral sclerosis, also known as ALS or Lou Gehrigs Disease; cerebral palsy; locked-in-syndrome; multiple sclerosis; Parkinson disease; brain-stem stroke; cortical stroke; progressive aphasia; and traumatic brain injury. Based on demographic studies of individuals with severe communication impairment, approximately 47,000 Medicare beneficiaries require AAC devices because natural communication methods insufficiently meet their daily communication needs.
When, due to disability, effective natural communication is not possible, AAC devices provide individuals with severe communication impairments the access to life that professional literature identifies as being lost or denied. (Beukelman & Garrett, 1988). AAC devices provide opportunities to lead extraordinary lives: for example, world-renowned physicist Dr. Stephen Hawking and Bob Williams, the Deputy Assistant Secretary of Health & Human Services for Planning and Analysis, use AAC devices to communicate. Certain individuals using AAC devices such as Julia Tavalaro and Ruth Sienkiewicz-Mercer, discussed later in more detail, have made a remarkable transformations from being considered brain-dead or hopeless institutional cases to being recognized as intelligent, highly capable individuals and authors. Among other accomplishments, Ms. Sienkiewicz-Mercer married and successfully advocated for the closure of the institution where her needs and abilities had been neglected for many years. More typical cases include individuals such as Celia Cooper, who has ALS. Having lost the ability to speak due to ALS, Mrs. Cooper also lost the ability to communicate with her husband, children, grandchildren and friends, to run her household, to be left alone, or to negotiate community-based activities. Through the use of an AAC device, she regained the ability to perform these quite ordinary activities that adults without communication disabilities take for granted.
AAC devices are very effective in providing functional communication when speech is no longer intelligible. Users of AAC devices have a high degree of satisfaction with the communication opportunities they provide. AAC devices enable individuals to engage in the ordinary communication that arises in the course of their daily activities, which is consistent with the Medicare coverage requirements for all other forms of speech related services. Medicares speech-language pathology services guidance recognizes that an individuals functional goals may range from speech that permits expressions of wants and needs to a caregiver to full conversational communication.
AAC devices are recognized as appropriate treatment for, and have become standard practice in treatment of, individuals with severe dysarthria, apraxia, and aphasia. These speech (dysarthria, apraxia) and language (aphasia) conditions each produce a wide range of adverse effects on the ability to communicate. For the vast majority of individuals with these conditions, traditional speech-language pathology treatment techniques directed toward improving natural speech methods will be sufficient to enable them to meet daily communication needs. For a small number of individuals with these conditions however, estimated to be fewer than 47,000 Medicare beneficiaries, natural communication methods are insufficient to meet their daily communication needs, and for them, AAC treatment techniques, including AAC devices are necessary.
Dysarthria: The dysarthrias are a group of motor disorders that affect the ability of the vocal organs to execute the motor instructions required to produce intelligible speech. As a result, dysarthric speech is characterized by problems with articulation (production of speech sounds), voicing (volume and quality of speech), and prosody (speech rate, rhythm and naturalness), which interfere with speech intelligibility. Dysarthria is associated with many neurologic conditions including amyotrophic lateral sclerosis (also known as ALS or Lou Gehrigs disease), cerebral palsy, Parkinson disease, locked-in-syndrome, multiple sclerosis, and traumatic brain injury. For some individuals with severe dysarthria or anarthria (the complete lack of speech), the use of natural speech is not a realistic goal of intervention. (Yorkston, et al. 1999). For this small number of individuals, AAC devices are appropriate. An individual with severe dysarthria is able to formulate an intent to communicate, i.e., formulate a thought, linguistically encode it appropriately as a message, and program the motor sequence necessary to produce the message as speech, but the body is unable, due to disability, to execute those commands that control speech production. An AAC device permits the individuals intent to speak to be fulfilled. It is generally accepted in professional practice that carefully selected AAC devices are critical in offering an effective means for persons with severe dysarthria to meet the communication needs arising in their daily activities.
Apraxia: Acquired apraxia of speech is a term used to refer to a speech disorder, resulting from brain injury, that is characterized by changes in articulation and prosody. The disorder stems from a deficit in the planning and programming of the sequence of movements for speech and occurs despite the normal movement of the same muscles when speech is not involved. The most common cause of apraxia is stroke, although it also may occur with tumor or traumatic brain injury. Apraxia rarely occurs as an isolated disorder. When severe apraxia is present, it almost always co-exists with aphasia. It co-exists with dysarthria far less frequently. An individual with severe apraxia may produce no speech or perhaps a few stereotypical utterances that may or may not be meaningful. Imitation of even very simple utterances (me, no, bye) is difficult. AAC devices are recognized in the professional literature and practice as appropriate treatment for severe apraxia, particularly those devices that are easily transported by ambulatory individuals, those that do not require spontaneous spelling skills to prepare messages, and those that allow individualized rates of speech, vocabulary, and symbol sets.
Aphasia: Aphasia is the impairment of an individuals ability to understand and formulate language as a result of brain damage, typically involving the language-dominant cerebral hemisphere. Depending on its severity, aphasia can significantly affect an individuals ability to converse, exchange information, and in some cases, to communicate basic needs. With aphasia, language and often communication are permanently altered. By far the most common cause of aphasia is stroke, although aphasia may also result from brain tumors, head injuries, or other insults to the areas of the brain that mediate language processing. AAC devices enable individuals with severe aphasia to express basic needs, to communicate functional needs more specifically, to participate more fully in social exchanges, to become more independent in the community, and to talk on the telephone. In a smaller number of cases, aphasic individuals with cognitive-linguistic abilities, partner support, and extensive vocabulary needs will require AAC devices with synthesized speech output and that permit multiple means of message generation.
Selecting the appropriate AAC device for an individual requires an understanding of the technology as well as expertise in the types of speech and language impairments that interfere with functional communication. A comprehensive assessment is conducted by a speech language pathologist (SLP), with as needed input from other allied health professionals. The assessment is the mechanism utilized to identify a need for an AAC device, and to confirm that the most appropriate AAC device is recommended, so that the individual will be able to meet his or her daily communication needs. The AAC assessment involves six steps:
The outcome of the assessment process is a narrative report that includes an AAC treatment plan identifying the functional communication goals the individual is expected to achieve with the AAC device. The treatment plan and functional communication goals are based on the clinical factors presented and the application of the SLPs professional judgment. After completing the assessment, and reviewing nine clinical indicators, which address the need for treatment and device selection, the SLP may recommend, where indicated, an AAC device from one of the three categories of devices, and as needed, AAC accessories. The SLP then sends the narrative report to the individuals treating physician, who then prescribes AAC treatment and completes the certificate of medical necessity.
III. MEDICARE COVERAGE OF AAC DEVICES AS ITEMS OF DURABLE MEDICAL EQUIPMENT IS APPROPRIATE
AAC devices meet the Medicare statutory standard as reasonable and necessary to treat individuals with severe communication impairments. The devices are already deemed reasonable and necessary by every state Medicaid program, as well as by the Veterans Administration, TriCare, and countless private insurers.
AAC devices further meet the Medicare regulatory requirements to be classified as items of durable medical equipment (DME). Indeed, they are already so classified by numerous Medicaid programs which employ DME definitions identical to Medicares definition. First, AAC devices are durable. Second, AAC intervention serves a medical purpose. AAC devices are long recognized as a speech-language pathology treatment technique or methodology, and use of AAC devices serves the medical purpose of treating severe dysarthria, apraxia and/or asphasia when it is determined that other speech-language pathology treatment techniques directed to natural communication methods will not be sufficient to enable the individual to meet daily communication needs.
Third, AAC devices are not useful absent an illness or injury. Communicating with an AAC device provides profound benefits to an individual with severe communication disabilities, but it is much slower and less efficient than verbal communication. In short, no one uses an AAC device in the absence of severe communication disability. AAC devices are designed, marketed, and sold exclusively to individuals with severe communication disabilities. Fourth, and finally, AAC devices are intended for home use, permitting an individual with severe communication disability to meet daily communication needs at home and wherever else those needs arise.
By contrast, the current Medicare guidance related to AAC devices states that they are not durable medical equipment and should be denied as convenience items. CIM § 60-9. This guidance is ripe for re-review, as HCFA staff acknowledged in June 1999 during early discussions on this Formal Request.
First, the basis for the noncoverage decision is not known. After multiple searches for records, HCFA staff has reported that none can be found. Moreover, the conclusions stated in this guidance are profoundly flawed:
For all of these reasons, it is appropriate for Medicare to re-review the existing AAC device guidance and to withdraw and replace it. Medicare should replace the existing guidance with professionally and programmatically sound guidance that will establish a national coverage standard for AAC devices.
IV. TYPES OF AAC DEVICES
A variety of AAC device designs/configurations exist because individuals with severe communication disabilities present a wide range of physical cognitive, linguistic, sensory, and motor deficits, as well as different daily communication needs. As a practical matter, no single device can offer the number of features required to enable all individuals with AAC device needs to achieve effective and efficient communication. To address the varied needs of individuals with severe communication disabilities, AAC devices are divided into three technologically and clinically distinct categories:
The key distinguishing features among the categories of AAC devices are the type of speech output (which may be either digitized or synthesized) and, among synthesized speech output devices, the methods of message generation and device access. These design characteristics of AAC devices make each category of devices unique technologically and clinically, in that each offers features that can be matched by use of distinct clinical indicators to individuals profiles of physical, cognitive, linguistic, sensory and motor deficits, and to individuals communication needs.
Whole message or digitized speech output AAC devices are needed by individuals with cognitive and/or language impairments, which cause them to be unable to generate messages through spelling and/or by word-by-word development of their messages, such as those with severe aphasia due to cortical stroke. Digitized speech output is essentially natural speech -- of an individual other than the AAC device user, such as a spouse, SLP, or other person selected by the user -- that has been recorded, stored, and reproduced. AAC devices with digitized speech output are recognized in the professional literature as closed systems because they reproduce only those words or messages that have been pre-stored for their user. Digitized speech devices also are called whole message systems because they provide the user with an entire phrase, sentence, or message that can be accessed by a single selection on the AAC device. Examples of AAC devices with digitized speech output are shown in Figure 2. (A complete list of AAC devices with digitized speech output is found in Tables 8-11 in Section 5.)
As shown in Figure 5, among the category of AAC devices with digitized speech output are those with dynamic displays (e.g., Dynamo) and static displays (e.g., Message Mate, Macaw, Digivox), and devices that can be accessed with the use of accessories (access technologies) that offer different selection techniques such as physical contact direct selection, direct selection with an electronic accessory, or switch controlled indirect selection (e.g., scanning or Morse Code). Although AAC devices with digitized speech output require messages to be pre-stored, the amount of language (words, phrases, sentences or messages) that can be stored in the device, and thus be available to the user, varies greatly. In addition, the memory capacity of AAC devices with digitized speech output ranges from devices that offer a minute or two of speech, to devices that can store an hour or more of speech.
Individuals who have the cognitive and linguistic ability to formulate messages independently require AAC devices with synthesized speech output. Speech synthesis is a technology that transfers text input into device-generated speech using algorithms representing linguistic rules, including rules for pronunciation, pronunciation exceptions, voice inflections, and accents of the language. Stated another way, synthesized speech AAC devices translate the users input into speech. Thus, unlike AAC devices with digitized speech output, there is no pre-recording of specific words, phrases, sentences, or messages by another person, and there is no time-limit or message length limit to the speech that can be produced. This characteristic leads synthesized speech AAC devices to be described as offering generative speech capability or as being open systems because users can construct original messages as their communication needs dictate.
During the clinical decision making process, once the determination is made that an individual requires a synthesized speech AAC device, the focus of the inquiry turns to identifying the individuals most effective and efficient methods of formulating messages and accessing the device. The SLP must match the users linguistic skills to the message formulation, storage, and retrieval features available in a particular AAC device and match the users access-related physical abilities and limitations to the access capabilities of the device.
Synthesized speech AAC devices in this category permit individuals to construct messages only by spelling and the use of physical contact direct selection techniques, such as use of a finger, hand-held stylus, head-stick, or mouth-stick. Devices in this category have a keyboard for message formulation and do not offer users alternative methods of access. They do not have extensive language storage or rate enhancement features that would support their users ability to construct, store, and retrieve lengthy messages. Figure 3 provides examples of AAC devices with synthesized speech output that require message formulation by spelling and access by physical contact direct selection.
The AAC devices in this category are appropriate for individuals whose communication needs do not require production of lengthy messages, who can spell sufficiently well to generate their messages, and who will be able to make direct contact with the keyboard. An example is a person with ALS or cerebral palsy, who does not have very extensive communication needs and who has lost the ability to speak but who is a good speller and retains fine motor dexterity.
This category of synthesized speech AAC devices permits multiple methods of message formulation and access and allows users to take advantage of text, words, and/or pictographic symbols to formulate some messages or parts of messages and to spell others. AAC devices in this category also aid individuals who are non-literate but who have the cognitive and linguistic abilities to generate messages independently. Finally, they permit an individual to store and retrieve efficiently a large number of lengthy messages.
By offering multiple access methods, this category of synthesized speech devices can be used by individuals with a very wide range of physical limitations. Individuals can access the devices by physical contact direct selection, but if that is not an effective or efficient means of access, due to quadriplegia or locked-in-syndrome, for example, individuals can use an electronic accessory, such as a head mouse, optical head pointer, light pointer, infra-red pointer, eye-gaze, or joystick. If none of those accessories is appropriate, the devices in this category also will support access by indirect selection methods, such as switch-based scanning techniques and Morse code. As shown in Figure 5, this category of AAC devices consists of devices that have dynamic displays, for which the Editorial Panel awarded HCPCS code, E 1900, on October 28, 1999, and devices that have static displays.
AAC accessories support effective and efficient access to and proper positioning of an AAC device, safety during transport, and adequate power supply to meet an individuals communication needs throughout the day. AAC accessories also include specific AAC software that enable caregivers to more efficiently create new overlays to facilitate communication of new messages, and for some individuals, who have access to specially adapted laptop or desktop computers, (with a speech synthesizer, adequate speakers, sufficient power, and access aids) to use these devices as AAC devices.
An SLP will recommend AAC device accessories only when the individual is not capable of effectively or efficiently using the device without these adaptations. For some individuals, such as those with locked-in-syndrome and ALS, alternative methods of access are required because of the severe physical limitations imposed by these conditions. Other individuals may be able to make physical contact with the AAC device, but may not be able to generate sufficient force to consistently operate the keys, thus increasing the number of errors in construction of their messages, the time and energy required to construct messages, and the frustration associated with communicating, all of which decrease the effectiveness and efficiency of communication.
Three types of alternative access accessories exist: accessories that are non-electronic and support direct selection; electronic aids that support direct selection; and switches that facilitate indirect selection techniques. Table 14 identifies examples of AAC device accessories in each of these categories. When considering any AAC accessories, the goal is to match the users physical abilities and limitations with the accessory most likely to allow the individual to achieve effective and efficient communication with the AAC device. The assessment process related to AAC accessories is sequential. The simplest solutions, i.e., the non-electronic aids for direct selection, are considered first. If the individual does not have the hand, arm, or head control required for these aids, consideration is then given to the electronic direct selection aids. Finally, if neither direct selection technique will enable the individual to use the AAC device effectively and efficiently, consideration is given to switch-operated, indirect selection techniques (e.g., scanning, Morse Code).
V. PROPOSED NATIONAL COVERAGE DECISION
Stated below is the text of a proposed National Coverage Decision for AAC Devices. In addition, Appendix I, Tab C, lists the names, addresses and other contact information for a group of AAC professionals who have volunteered to provide advice and counsel to HCFA, the DMERC medical directors, and other Medicare decision makers regarding AAC device claims.
Augmentative & Alternative Communication Devices
E xxx 1 AAC devices with digitized speech output
E xxx 2 AAC devices with synthesized speech output, which require message formulation by spelling and device access by physical contact direct selection techniques
E xxx 3 AAC devices with synthesized speech output, which permit multiple methods of message formulation and multiple methods of device access
E xxx 4-1 AAC Accessories: access technologies, direct and indirect
E xxx 4-2 AAC Accessories: mounting systems
E xxx 4-3 AAC Accessories: carrying cases
E xxx 4-4 AAC Accessories: power supplies
E xxx 4-5 AAC Software
HCPCS Modifiers for AAC devices with digitized speech output
ZV AAC devices with digitized speech output with less than 4 minutes recording time
ZW AAC devices with digitized speech output with 4- 8 minutes recording time
ZX AAC devices with digitized speech output with 9-16 minutes recording time
ZY AAC devices with digitized speech output with 17-32 minutes recording time
ZZ AAC devices with digitized speech output with more than 32 minutes recording time
Benefit Category Durable Medical Equipment
Augmentative & Alternative Communication (AAC) devices are electronic devices that provide treatment for severe dysarthria, apraxia of speech, or aphasia, when, due to those communication impairments, an individual is not able to meet the communication needs that arise in the course of current and projected future daily activities. AAC devices are covered as durable medical equipment when incorporated into a speech language pathology treatment plan, and when it is determined by a speech-language pathology assessment that an individual is unable to meet the communication needs arising in the course of daily activities using natural communication techniques.
AAC devices include electronic devices that are: a) dedicated communication devices; and b) portable computers that have been modified to serve as an individuals communication device. The term AAC accessories means device-related components, software, and accessories that are necessary additions to an AAC device, based on the nature and severity of the beneficiarys disability, to permit its effective and efficient use.
An AAC device will be covered by Medicare as an item of durable medical equipment when all of the following are met: a) the AAC device is recommended by a speech-language pathologist in a narrative report based on a complete assessment; b) it is incorporated into a speech-language pathology treatment plan stating the functional communication goals to be achieved with the AAC device; c) it is prescribed by the beneficiarys physician; and d) it is supported by a completed certificate of medical necessity.
Coverage and Payment Rules
Code E xxx1 is covered if the patient meets:
a. criteria 1-3 but not
b. criteria 4, 5 and 6
Code E xxx2 is covered if the patient meets:
a. criteria 1-5 and 7 but not
b. criteria 6, 8, and 9
Code E xxx3 is covered if the patient meets:
a. criteria 1-3 and
b. criteria 4 and 6
The speech-language pathologists narrative report also must establish whether an individual for whom HCPCS Code E xxx 1-3 will require any AAC accessories.
For accessory code E xxx 4-5 to be covered, the patient must meet criteria 4 and 6 as listed above, and the certificate of medical necessity must specifically establish that the individual has access to specially adapted computer components and adaptations that will permit the individuals needs to be met solely by the use of AAC software.
Appropriate use of the Z_ modifier is the responsibility of the supplier billing the DMERC. This modifier identifies the device that fits within the HCPCS code Exxx1.
This Formal Request for an AAC Device National Coverage Decision provides the information HCFA staff identified in mid-August as necessary to permit review of the existing Medicare AAC device guidance. This Executive Summary and the detailed narrative sections and appendices that follow support AAC device classification by Medicare as frequently purchased DME. In addition, this Formal Request supports a determination by HCFA to withdraw and replace the existing AAC device guidance with the proposed National Coverage Decision that is enclosed.
As the HCFA review of this Formal Request proceeds, the AAC professionals who prepared these materials remain ready to respond to questions, participate in discussions, provide additional information, and otherwise facilitate HCFA staffs understanding of these materials and its determination to adopt the proposed AAC Device National Coverage. For any additional information or assistance, Lewis Golinker, Esq., will serve as the point of contact. Lewis Golinker is the Director, Assistive Technology Law Center, 202 East State Street, Suite 507, Ithaca, New York 14850, tele: 607-277-7286(v); 607-277-5239(fax); firstname.lastname@example.org (e-mail).
In June 1999, HCFA staff provided notice that Medicare was prepared to review its non-coverage policy for AAC devices and requested that concerned parties submit information to assist with that task. This Formal Request for an AAC Device National Coverage Decision was prepared by the nations leading AAC professionals, identified below in Section A, and it is submitted on behalf of the thirteen organizations identified below in Section B. These organizations represent the interests of Medicare beneficiaries, assessment and treatment professionals, AAC device manufacturers, and other advocates for those with speech impairments. All of these organizations and the individuals they serve have direct interests in the reversal of HCFAs non-coverage policy. This Formal Request provides the information and analyses that HCFA staff has requested and which will permit the expeditious decision to withdraw and replace the existing Medicare AAC device guidance with a set of professionally sound coverage criteria.