AAC devices meet the Medicare statutory standard as ‘reasonable and necessary’ to treat individuals with severe communication impairments. Like Medicare, the Medicaid programs focus on ‘medical necessity’ to determine coverage and payment of items and services. At present, AAC devices are covered by every state Medicaid program. In addition, the Veterans Administration (now the Department of Veterans Affairs), CHAMPUS (now TriCare), and hundreds of commercial health insurance providers adopted coverage policies for AAC devices. (See Myers v. State of Mississippi, 1995).

    AAC devices also meet the Medicare regulatory requirements for classification as items of durable medical equipment (DME) and are already so classified by numerous Medicaid programs which employ DME definitions identical to Medicare’s definition. First, AAC devices are durable. Second, AAC intervention serves a medical purpose. Third, AAC devices are not useful absent an illness or injury, and 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. In short, no one uses an AAC device in the absence of severe communication disability. Even the Food and Drug Administration (FDA) classifies AAC devices, which it describes as ‘powered communication systems,’ as ‘medical devices’ within the category Physical Medicine Prosthetic Devices. 44 Fed. Reg. 50,458, 50,489-90, (August 1979).

    By contrast, Medicare currently does not cover AAC devices. Some time during the late 1980s, HCFA issued a National Coverage Decision (NCD), which appears as part of the ‘DME Reference List.’ The NCD states that coverage for Augmentative Communication Devices is denied because such devices are convenience items that are not primarily medical in nature as defined in section 1861(n) of the Social Security Act. Coverage Issues Manual, (HCFA Pub. 6)(‘CIM’) § 60-9. Given the wealth of technical information provided in this Formal Request, the numerous professionals available for clarification, as well as past assurances by HCFA staff that further review would be unnecessary, we submit that HCFA can adopt the proposed NCD without referring it to the Medicare Coverage Advisory Committee (MCAC) or undertaking a technology assessment to review the findings presented.

    Subpart I of this section describes how AAC devices meet Medicare’s ‘reasonable and necessary’ coverage standard and meet the Medicare regulatory requirements for classification as DME and proposes Medicare coverage and payment categories for AAC devices. Subpart II describes the current coverage status of AAC devices including the history of the Medicare national coverage decision and explains why the current policy of non-coverage is erroneous and wholly inappropriate.

      1. AAC Devices Meet The Medicare Statutory Standard As Reasonable And Necessary
      2. The Medicare Act only pays for items or services that are ‘reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body member.’ 42 U.S.C. § 1395y(a)(1). There are no Medicare Act regulations further defining the terms ‘reasonable’ and ‘necessary.’ In the 1987 Federal Register notice regarding NCDs, HCFA stated that a request for a NCD must show that the item or service is reasonable and necessary, which would require proof that the item or service is: a) safe and effective, b) not experimental or investigational, c) cost effective, and d) appropriate. 52 Fed. Reg. 15,560 (April 27, 1987). Although HCFA never published final regulations, these factors continue to be appropriate benchmarks. On December 6, 1999, Dr. Jeffrey Kang, M.D., Director of the HCFA Office of Clinical Standards and Quality, while speaking at the Medical Device Manufacturer’s Association Second Annual Coverage and Reimbursement Conference in Philadelphia, referred to these four factors as general coverage factors, stating that the first two (safe and effective/not experimental or investigational) and last two (cost effective and appropriate) could be viewed as ‘related’ categories of information.

        The Medicare program has not previously considered whether AAC devices are ‘reasonable and necessary.’ The existing Medicare AAC device guidance was not based on a review of medical literature or application of the ‘reasonable and necessary’ standard. AAC devices satisfy all the specific criteria HCFA has set for coverage. They provide treatment for specific, severe communication disabilities, and provide significant functional improvements in individuals’ communication abilities. With AAC devices, individuals with severe dysarthria, apraxia and aphasia are able to meet the communication needs arising in their daily activities, and thereby are better able to participate more fully in their families and communities -- normal activities of daily living -- and to protect and improve their general health status. In addition, for those individuals who can achieve these functional outcomes through AAC device use, there is no alternate means of treatment that offers comparable benefits.

        1. AAC Devices are Safe and Effective
        2. In his December 6, 1999 presentation, Dr. Kang further clarified how HCFA determines an item or service is ‘safe and effective.’ He stated the term ‘effective’ means the item or service improves the health outcome of the patient as compared with the natural history of the disease. He also stated that HCFA would find an item or service to be effective based on proof that ‘the item or service improves a health outcome or provides an intermediate outcome with known links to a desired outcome and there is no medically effective alternative to compare the item or service with.’ Dr. Kang then distinguished this description of ‘effective’ from the FDA standard of ‘efficacy,’ which he described as meaning that the item or service does what it is diagnostically or therapeutically designed to do. Medicare’s requirement for effectiveness, in contrast, he explained, requires proof that the treatment provides health benefits, not merely that it works. Thus, FDA classification of AAC devices merely is the starting point for the HCFA coverage process.

          AAC devices, as a class of medical devices, are safe, effective, and efficacious. 48 Fed. Reg. 53,032, 53,049 (1983). For the past 16 years, AAC devices have been classified by the FDA as ‘powered communication systems’ and thus meet its standards for safety and effectiveness, or ‘efficacy.’ 21 C.F.R. § 890.3710. AAC devices, as a class of medical devices, also meet the additional proof required by Medicare to be effective. First, as explained in Section 3, the primary purpose of AAC devices is to provide treatment for severe dysarthria, apraxia, and aphasia and to improve the health outcomes of individuals with these severe communication disabilities. AAC devices provide a ‘meaningful contribution’ to the treatment of these severe communication disabilities, enabling individuals both to overcome the adverse effects of these severe communication impairments, and to meet the communication needs arising in their daily activities. See MCM § 2100.2.

          Second, as explained in Section 3, the speech-language pathology assessment process considers AAC interventions only after a determination has been made that treatment related to improved natural communication methods will not be effective. Thus, when an AAC device is recommended for an individual, there is no medically effective alternative form of treatment that will be of benefit.

          Finally, effective communication is essential for an individual to successfully negotiate routine daily activities, particularly when other physical or mental disabilities are present in addition to a severe communication impairment. In order to obtain medical care for those other conditions, AAC devices provide an effective way to communicate about these topics and access effective treatment for any other health conditions. This is an example of providing, in the words of Dr. Kang, ‘intermediate outcomes -- with known links to desired outcomes.’ As explained in Section 3, severe communication disabilities can disrupt every facet of an individual’s life. Also, because individuals with severe communication disabilities may not be able to accurately express symptoms or effectively respond to care providers, medical care can be delayed or mis-directed.

        3. AAC Devices are not Experimental
        4. Under the Medicare statute, an item or service is considered experimental when it ‘is not yet generally accepted, is rarely used, novel or relatively unknown.’ An item or service is no longer considered experimental when it ‘has come to be generally accepted by the professional medical community as an effective and proven treatment for the condition for which it is being used.’ AAC devices are not experimental. The general medical community views AAC devices as an effective and proven treatment for severe communication disabilities.

          The clinical professionals who provide other rehabilitation services to and who advocate for individuals with severe disabilities also recognize AAC interventions that enable effective communication as essential treatment tools . Neurologists, as the physicians most directly responsible for managing the care of individuals with ALS, recognize AAC intervention as the appropriate standard of care for individuals who have developed severe dysarthria or anarthria secondary to ALS. (Sufit 1997, Mitsumoto, Chad, & Pioo 1998). As described in greater detail in Section 3, SLPs recognize AAC intervention as the appropriate standard of care for individuals with severe dysarthria, apraxia, and aphasia, regardless of etiology. In addition, the American Medical Association’s, ‘Guidelines for the Use of Assistive Technology: Evaluation, Referral, Prescription’ incorporate AAC interventions as treatment options that must be considered for these individuals. (AMA, 1994).

          The general acceptance of AAC interventions by the professional medical community is further demonstrated by the volume of research and clinical practice research that has been published in peer-reviewed journals. AAC interventions also are a common seminar topic at continuing professional education conferences sponsored by international, national, regional, state and local organizations, including USSAAC, ASHA, RESNA, and UCPA. In addition, AAC interventions are the subject of numerous books and treatises used by practicing professionals. They are also used as teaching aids in both undergraduate and graduate level courses in pre-professional training programs for SLPs and other disciplines which provide treat individuals with severe disabilities.

        5. AAC Devices Are Cost Effective And Appropriate

Dr. Kang stated that to support coverage, HCFA seeks to identify the patients for whom the item or service is appropriate, the settings in which it is appropriately provided, and the professionals who are appropriate to provide it. As explained in Section 3, there are an estimated 47,000 Medicare beneficiaries with dysarthria, apraxia, and aphasia at a level of severity sufficient to require use of AAC devices. These individuals are given an assessment by an SLP and, at times, by other relevant professionals, such as an occupational or physical therapist. These assessments are conducted according to well-established data-gathering and decision making procedures and yield recommendations for specific AAC devices, and as necessary, accessories, from one of the three categories of AAC devices.

SLPs conduct functional assessments of an individual’s ability to meet the communication needs arising in the course of daily activities. They recommend AAC interventions only when a) some type of treatment is necessary to achieve that goal; and b) treatment intended to improve natural speech methods will not be sufficient. In addition, the assessments are conducted independent of any AAC device vendor or supplier and are then submitted to an individual’s treating physicians for review. AAC assessments, as well as the subsequent training and support for AAC device usage, are not setting-dependent. These tasks may be conducted at the individual’s home or in a professional office setting.

The appropriateness of AAC devices also can be measured by the existing Medicare standards for ‘reasonableness.’ According to Medicare guidance, the reasonableness of an item or device is based on the following factors:

    1. Would the expense of the item to the program be clearly disproportionate to the therapeutic benefits which could ordinarily be derived from use of the equipment?
    2. Is the item substantially more costly than a medically appropriate and realistically feasible alternative pattern of care?
    3. Does the item serve essentially the same purpose as equipment already available to the beneficiary?

MCM, § 2100.2. AAC devices satisfy all of these ‘reasonableness’ criteria. First, as discussed above and in greater detail in Section 3, the assessment and clinical decision making process related to AAC intervention is sequential: an SLP will consider AAC interventions only after the assessment determines that AAC treatment is needed to enable the individual to meet the communication needs arising in daily activities and that SLP treatment intended to improve natural communication methods will not be sufficient to achieve that goal. Thus, AAC interventions are recommended and prescribed only when there is no medically appropriate or realistically feasible alternative pattern of care.

Because of the nature of severe communication disabilities, the ‘substantial increases’ achieved by individuals who use AAC devices incorporate a wide range of functional communication abilities. Such range is identical to the range expected for all recipients of Medicare funded speech-language pathology services, i.e., AAC device use enables individuals to achieve the functional outcomes that are associated with Medicare-funded SLP services:

MIM § 3905.3, MHM§ 446(a)(1)(A).

      1. AAC Devices Meet the Medicare Regulatory Definition of DME

This Formal Request seeks classification of AAC devices as DME. 42 U.S.C.
§ 1395x(n). DME is defined as equipment furnished by a supplier or home health agency that has the following four characteristics:

    1. can withstand repeated use;
    2. is primarily and customarily used to serve a medical purpose;
    3. generally is not useful to an individual in the absence of illness or injury; and
    4. is appropriate for use in the home.

42 C.F.R. § 414.202. Based upon the treatment role of AAC devices described in Section 3, and the specific device characteristics described in Section 5, we submit that AAC devices meet all of these criteria.

Peggy Locke, President of the Communication Aid Manufacturers Association, stated in a recent letter:

AAC devices allow their users to achieve [their communication] goals by providing a functional substitute for body organs and structures that are necessary for the production of speech but which are non-functioning or mal-functioning due to illness, injury, disease or condition. Another way to describe the purpose of AAC devices is as a functional by-pass of these non- or mal-functioning body structures, i.e., they allow the AAC device user to express a thought (message) as speech, by by-passing the nerves, muscles, and organs of speech which, due to impairment, make natural speech ineffective. The AAC device is the by-pass. Viewed in this way, AAC devices provide the same benefits and serve the same functional purposes as power wheelchairs. A person with quadriplegia or other severe mobility impairment is unable to implement the desire to move from place to place. With a power wheelchair, however, the person is able to by-pass his or her no-working spinal column or other non- or malfunctioning body structures to accomplish the goal of mobility.

Stated more simply, every aspect of AAC device design, manufacture, marketing and sales is directed exclusively to people with severe communication disabilities. Knowledge of the unmet needs of people with disabilities drives the AAC device design process so that new devices and related products can meet those needs. AAC device marketing is directed exclusively to people with severe communication disabilities. And, the augmentative communication devices and related products manufactured and distributed by CAMA members have been and continue to be sold exclusively for use by persons with severe speech and language disabilities.

Letter dated October 23, 1999 to Lewis Golinker, from Peggy Locke, attached at Appendix III, Tab A.

The Medicare program has established seven payment categories for DME. 42 U.S.C.
§ 1395m; 42 C.F.R. §§ 414.220-.232. AAC devices qualify under the first category as ‘routinely purchased’ items. See 42 U.S.C. § 1395m(a)(2)(A)(ii); see also 42 C.F.R. § 414.220(a)(2). The Communication Aid Manufacturers Association, whose members include almost every company that manufactures and distributes AAC devices in the United States, recently surveyed its members to learn of their rental and sales practices. The result of that survey, reported by CAMA president Peggy Locke, was that:

I am able to report that with almost no exceptions, AAC devices are acquired by their users by sale. This represents far more than the 75 % of all devices; it is almost 100 percent of all AAC devices. The availability of long-term rental of AAC devices is the exceedingly rare exception; far more common is a limited rental option of 30-90 days, which is intended solely to permit trial periods. In addition, the CAMA members reported that this practice has been consistent throughout their existence as AAC device manufacturers and distributors.

Letter dated October 23, 1999 to Lewis Golinker, from Peggy Locke, President, Communication Aid Manufacturers Association, attached , attached at Appendix III, Tab A.

Assigning AAC devices to the ‘routinely purchased DME’ payment category is consistent with all the information herein.

      1. State Medicaid Coverage Of AAC Devices
      2. All state Medicaid programs cover AAC devices, with approximately half of all state Medicaid programs classifying AAC devices as items of DME. Of these, eight programs utilize a definition of DME that is identical or substantially identical to the Medicare DME definition and also classify, cover, and pay for AAC devices under the DME benefit. Table 5 lists these states and identifies their Medicaid DME definitions. Private health insurers also generally cover AAC devices as within policy or benefits plans’ DME benefit.

        Table 5: State Medicaid Coverage Of AAC Devices


        Citation To Medicaid DME Definition


        Dept. of Public Aid, Medical Assistance Provider Manual, §II-M-3, M-201.2 (Dec. 1992).


        470 IAC 1-7, § 27(g), at p. A2-49 (Oct. 1, 1994).


        Iowa Dept. of Human Serv., Coverage & Limitations, Medical Equipment and Supply Dealer, Chapt. E, page 2(b)(Jan 1, 1994), see also Iowa Medicaid Augmentative Communication Device Funding Criteria, Medical Equipment and Supply Dealer Manual, Chapt. E, p. 12, § D (Oct. 1, 1988).

        New Jersey

        N.J. Medicaid, Medical Equipment and Supplies Supplier Manual, Sub-Chapt. I, § 1.2 (Nov. 1979).

        New York

        18 N.Y.Code of Rules and Regulations, § 505.5(a)(1).



        Citation To Medicaid DME Definition

        North Dakota

        N.D. Dept. of Human Serv., Medical Assistance Program, DME Supplies and Guidelines, § 1.

        South Carolina

        S.C. Medicaid Home Health Serv. Manual, at p. 2-1.


        Wisc. Admin. Code, HSS, § 101.03(50).

        Both ‘dedicated’ AAC devices and AAC devices that are ‘computer-based’ are appropriately classified as DME. Although computers in general are not considered DME, when ‘the primary use of the computer will be as [an individual’s] communication device,’ there is general acceptance that these devices are DME. (USSAAC, Medicaid Model AAC Device Coverage Policy, 1995). All state Medicaid programs cover both dedicated and computer-based AAC devices, and at least seven states make express reference to computer-based AAC devices in their AAC coverage criteria. Two states, Delaware and Louisiana, have formally adopted the Medicaid Model Policy, referenced above. The other five states are identified in Table 6.

        Table 6: State Medicaid AAC Device Leverage Criteria Including Computer-Based Devices





        ‘If authorization is requested for a computer or computerized device, the intended use of the computer or computerized device must be compensation for loss or impairment of communication function.’

        470 Indiana Admin. Code § 5-8-12(q)(5)


        ‘Includes: methods that use communication boards, charts and mechanical or electrical aids, or computerized devices.’

        Maine Medical Assistance Manual, § 60, App. 3, § XI(A)

        New Hampshire

        ‘Any device which results in improved communication for persons with severe communication disabilities. AAC equipment may include, but is not limited to the following: picture/symbol/letter/word board/book/wallet; electronic device; computer hardware, software, adaptive input/output devices; mounting hardware; environmental control devices; telecommunications equipment.’

        New Hampshire Medicaid AAC Criteria (Definitions)





        New York

        ‘These components include, but are not limited to, communication devices, manual signs and communication strategies. Communication devices may be comprised of a primary unit such as a computer, dedicated device, manual board, electrolarynx, or amplifier and accessories which may include but are not limited to output peripherals such as printers, communication application programs, language symbols, interfaces, overlays, cables and mounts.’

        New York Dept. Of Health, Guidelines: Augmentative and Alternative Communication Systems (Definitions)


        ‘Personal computers and related hardware, unless components of a personal-computer based systems that has been adapted for use as a communication device.’

        Ohio Admin. Code, § 5101:3-10-24(K)(3)

      3. Medicare ALJ Decisions Recognizing Coverage For AAC Devices
      4. In five of the six known Medicare AAC administrative law judge (ALJ) decisions, where non-coverage of AAC devices was challenged, the ALJ approved the requested AAC device under the Medicare DME benefit. The sixth Medicare AAC ALJ decision awarded the device but concluded the device was within the Medicare prosthetic device benefit. Table 7 lists those decisions, which also are included in Appendix III at Tab A.

        Table 7: Medicare AAC ALJ Decisions

        Case Name


        In Re: Donald S.

        Dkt No. 000-89-3072 (Social Security Admin. Office of Hrgs & Appeals October 1, 1999)

        In re: Bernadine A.

        Dkt No. 000-86-0336 (Social Security Admin. Office of Hrgs & Appeals April 27, 1999)

        In re: Celia C.

        Dkt No. 196-14-0195 (Social Security Admin. Office of Hrgs & Appeals December 2, 1998)

        In re: Richard A.

        Dkt No. 000-06-0110 (Social Security Admin. Office of Hrgs & Appeals March 24, 1997)

        In re: Blanche B.

        Dkt No. 000-24-0399 (Social Security Admin. Office of Hrgs & Appeals May 8, 1995)

      5. FDA Status Of AAC Devices
      6. This subsection addresses three issues identified in the April 27, 1999 Federal Register notice which must be addressed in Formal Requests for National Coverage Decisions: 1) the FDA classification of AAC devices; 2) the proposed Medicare benefits classification for AAC devices; and 3) the proposed reimbursement category for AAC devices. Each of these points is discussed below.

          1. FDA Classification Of AAC Devices as Medical Equipment

Under the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 301 et. seq, the term ‘device’ is defined as:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is -

    1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

21 U.S.C. §321(h). FDA regulations define ‘device family’ as:

a group of one or more devices manufactured by or for the same manufacturer and having the same:

    1. Basic design and performance characteristics related to device safety and effectiveness,
    2. Intended use and function, and
    3. Device classification and product code.

Devices that differ only in minor ways not related to safety or effectiveness can be considered to be in the same device family. Factors such as brand name and common name of the device and whether the devices were introduced into commercial distribution under the same 510(k) or premarket approval application (PMA), may be considered in grouping products into device families.

21 C.F.R. § 803.3(e).

The FDA recognizes AAC devices as medical ‘devices’ within the ‘physical medicine devices intended for human use’ category. 21 C.F.R. §§ 890,3700, 890, 3710. The FDA further sub-divides AAC devices as two types of devices: powered communication systems and non-powered communication systems. The FDA classifies powered communication systems as Class II devices and identifies them as:

an AC- or battery-powered device intended for medical purposes that is used to transmit or receive information. It is used by persons unable to use normal communication methods because of physical impairment. Examples of powered communication systems include the following: a specialized typewriter, a reading machine, and a video picture and word screen.

21 C.F.R. § 890.3710. The FDA classifies nonpowered communication systems as Class I devices and identifies them as:

a nonpowered communication system is a mechanical device intended for medical purposes that is used to assist a patient in communicating when physical impairment prevents writing, telephone use, reading, or talking. Examples of nonpowered communications systems include an alphabet board and a page turner.

21 C.F.R. § 890.3700. This Formal Request for AAC Device National Coverage Decision addresses only the family of medical devices in the ‘powered communication device’ category.

    2. Medicare currently does not cover AAC devices. Some time during the late 1980s, HCFA issued a National Coverage Decision (NCD), which appears as part of the ‘DME Reference List.’ The NCD states that coverage for Augmentative Communication Devices is denied because such devices are convenience items that are not primarily medical in nature as defined in section 1861(n) of the Social Security Act. CIM § 60-9.

      At the time we believe HCFA developed the NCD, there was no information from any reliable source that supported HCFA’s conclusion that an AAC device did not provide treatment for expressive communication impairments. Likewise, there was no basis at that time, or ever, to conclude AAC devices served as a mere convenience to the individuals who require them. To the contrary, by the mid-to-late 1980s, there was an existing body of professional literature describing AAC intervention, as well as professional statements of policy and practice guidelines, a wide range of AAC devices, and a foundation of coverage practices and policies among federal and private payors. The types of information available in the 1980s mirror the information about AAC intervention available today and on which this Formal Request is based.

      1. History Of The Medicare Augmentative Communication Device National Coverage Decision
      2. It is estimated that HCFA developed the Medicare Augmentative Communication Device NCD between late-1986 and 1989. We support this estimate with the following information. First, there was no reference to AAC devices on a 1984 Medicare ‘DME Screening List,’ which appears to be the pre-cursor of the ‘DME Reference List.’ Second, on October 15, 1986, the HCFA Region V office wrote to a fiscal intermediary about Medicare AAC device coverage, but no reference was made to any applicable Medicare guidance about AAC devices. Third, the NCD appeared in the August 21, 1989 Federal Register as part of a general disclosure of existing Medicare National Coverage Decisions. 54 Fed.Reg. 34,555, 34,597 (Aug. 21, 1989). However, no additional information about the development of or the basis for this NCD was provided in the Federal Register. There are no records that explain its history, and HCFA staff acknowledge that the decision is ‘poorly documented.’ (email correspondence with S. Olshan, 8/18/99). HCFA staff have stated that the agency has no records related to this guidance.

        Among the information that does not exist is what initially prompted HCFA to develop this NCD; when was it written; what information was considered; and who was involved with its issuance. Notwithstanding these limitations, some information about the AAC Device guidance does exist, and this is provided below. HCFA’s own attempts to trace the foundation and development of the Augmentative Communication Device NCD have been unsuccessful. In 1998, HCFA staff searched its records and reported that none existed. HCFA undertook the additional searches in 1999, which also yielded no records. Little is known about this AAC Device NCD except that HCFA staff developed the NCD without input from any of the individuals who prepared this Formal Request or from any of the organizations on whose behalf this Formal Request is being submitted.

        Less is known about the information HCFA staff considered in developing the Augmentative Communication Device NCD. HCFA acknowledged that it did not conduct an extensive medical literature search nor did it seek the advice of knowledgeable medical professionals in developing this guidance -- two procedures it was required to undertake in developing NCDs as set forth by the Medicare Act’s ‘reasonable and necessary’ provision. See 42 U.S.C. § 1395y(a)(1). However, HCFA staff reported that these procedures were not followed for NCDs for items falling under the Medicare DME definition, such as AAC devices. See 42 U.S.C. § 1395x(n).

        Grant Bagley, M.D., a former HCFA official, explained in a Medicare appeal several years ago that no medical literature review ever was conducted, and no staff-prepared background paper exists for AAC devices. In response to an inquiry related to another item on the DME Reference List, which, like the AAC device, is based on the Medicare DME definition, Dr. Bagley stated:

        QUESTION: When and for what NCDs [National Coverage Decisions] did you first use the April 1987 process in making any NCD?

        RESPONSE: The April 29, 1987 Federal Register Notice described the existing procedures for making national coverage decisions under section 1862(a)91)(A) of the Social Security Act. . . . NCDs that are made based on provisions of the Social Security Act other than section 1862(a)(1)(A) are not subject to the process described in the Federal Register Notice. Thus, provisions such as the definition of DME made under section 1861(n) would not be subject to the ‘1987 process.’

      3. Extensive Medical & Professional Information About AAC Intervention Strategies Was Available During The Development Of The NCD

It is impossible to speculate whether HCFA would have issued the Augmentative Communication device NCD in its present form had it prepared a professional literature-based staff background paper, but it is without question that by 1989, there was a substantial body of professional medical literature addressing the policy and practice related to AAC intervention and the use of AAC devices. In addition, during the time HCFA issued the NCD, a wide range of AAC devices was available with capabilities comparable to those which are in use today. Moreover, at that time most third party payors including Medicaid, private insurance providers, CHAMPUS (now Tri-Care), and the Veterans Administration (now the Department of Veterans Affairs), reimbursed for AAC devices as either DME or prosthetic devices.

As discussed above in Section 3, researchers at the Mayo Clinic first recognized the role of AAC intervention as treatment for dysarthria in the 1960s (Darley, Aronson & Brown, 1969a; 1969b; 1975). Subsequent AAC intervention research, clinical practice, and professional literature are all built upon this foundation. During the 1970s, AAC intervention emerged as an area of specialization within the practice of speech-language pathology, and American and European peer-reviewed journals contained numerous articles on the subject (Zangari, Lloyd & Vicker, 1994).

Developments related to AAC professional literature, practice, and policy continued throughout the 1980s. AAC transitioned from a ‘pioneering phase,’ in which successful AAC interventions were viewed as the exception rather than the rule, to one of ‘public policy,’ where AAC devices are accepted as appropriate clinical intervention for individuals with severe communication disabilities. Further, payment for AAC devices became based on practice guidelines, rather than ad-hoc decision making. (Beukelman, 1990; Beukelman & Mirenda, 1998). The 1980s also heralded the birth of several organizations devoted to AAC issues including the International Society for Augmentative and Alternative Communication (ISAAC) in 1983. Publication of AAC research findings and clinical practice techniques continued throughout the 1980s in a variety of peer-reviewed journals, textbooks, and newsletters. By 1987, the volume of professional literature had expanded to permit ISAAC to publish a ‘Core Reference List’ for professionals interested in clinical practice in AAC (Windsor & Lloyd, 1987). The entry into a ‘public policy’ phase for AAC intervention also coincided with the development of guidelines for the field, i.e., ‘best practices’ recommendations for AAC assessment, intervention, delivery.

The AAC devices available at that time included devices that produced digitized speech and those that produced synthesized speech, permitting multiple methods of language (message) formulation and multiple methods of access.


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