This Formal Request for Issuance of an Alternative and Augmentative (AAC) Device National Coverage Determination is submitted by the following 12 organizations, which represent the interests of Medicare beneficiaries, assessment and treatment professionals, AAC device manufacturers, and advocates. These organizations and the individuals they serve have direct interests in the withdrawal of the current Medicare coverage policy for AAC devices and its replacement by a set of professionally sound criteria. In addition, these organizations’ numerous newsletters, conferences, journals, and other publications are among the primary means by which information is disseminated about public policy developments affecting people with disabilities. Through these means, any substantive or procedural changes in Medicare coverage policy toward AAC device coverage and reimbursement will be provided directly to the persons and organizations that will be most greatly affected. For these reasons, these organizations now join as one to request that the Health Care Financing Administration (HCFA) withdraw the existing Medicare guidance related to AAC devices and in its place, to adopt the proposed national coverage determination presented herein.

The American-Speech-Language-Hearing Association, with headquarters in Rockville, Maryland, is the national professional, scientific and credentialing association for speech-language pathologists (SLPs) and audiologists. ASHA’s membership consists of almost 90,000 SLPs, audiologists, and speech-language-hearing scientists. ASHA’s mission is to ensure that all individuals with speech, language and hearing disorders have access to quality services to help them communicate more effectively. ASHA is the principal certifying organization in the United States for speech-language 1) and audiologists. HCFA identifies the ASHA Certificate of Clinical Competence, granted to more than 77,000 SLPs and more than 13,000 audiologists, as the primary indicator of minimum professional competence to participate as a Medicaid provider of these services. 42 C.F.R. § 440.110(c)(2).

Since 1981, ASHA has recognized AAC assessment and treatment services as within the scope of practice of SLPs. ASHA’s members and certificate holders provide clinical assessment and treatment services, conduct research, publish professional journal articles, texts, course curricula, and other professional educational resources regarding AAC intervention, including both AAC devices and services for people with severe communication disabilities. In addition, pursuant to the ASHA Code of Ethics, ASHA members and certificate holders advocate on behalf of Medicare beneficiaries who require Medicare payment for AAC devices.

ASHA’s interest in Medicare coverage policy for AAC devices and services spans more than a decade. It repeatedly has expressed its disagreement with and concern about the content and effect of the AAC device national coverage decision, which calls AAC devices "convenience items" and directs all claims for AAC devices to be denied. ASHA believes the withdrawal of the existing guidance and its replacement with a professionally sound Medicare national coverage determination will make a significant difference in the abilities and opportunities for Medicare beneficiaries with severe dysarthria, apraxia, and aphasia who require AAC devices.

The Amyotrophic Lateral Sclerosis Association is the only national not-for-profit voluntary health organization dedicated solely to the fight against Amyotrophic Lateral Sclerosis, also known as ALS or Lou Gehrig’s Disease. From its founding in 1972, the organization, which is based in Calabasas Hills, California, has grown to include 32 chapters and 55 free standing support groups throughout the United States. The ALS Association encourages and provides financial and other support for research related to better understanding of and a cure for ALS and assists families through referrals and a variety of services, including information about payment assistance for assistive devices, such as Medicare payment for AAC devices. ALSA is one of the sponsors of a video-teleconference training series, to be led by the National Center on Disability Services and the Assistive Technology Law Center in early 2000, that is directed at providing information about Medicare payment for AAC devices.

ALS is a rare, progressive, fatal neuromuscular disease with an incidence of approximately 5,000 cases per year. It affects adults almost exclusively, and the average life expectancy after diagnosis for an individual with ALS is 2-5 years. ALS attacks nerve cells, causing the steady loss of voluntary muscle control, which affects mobility, chewing, swallowing, speech, and breathing. In the later stages of the disease, people with ALS are completely paralyzed, yet through it all their minds remain unaffected. It is estimated that approximately 75 % of all persons with ALS will lose the ability to communicate effectively. As a result, use of AAC devices as part of the standard treatment for the speech disabilities associated with ALS.

The high percentage of need for AAC intervention and the rapid pace of the condition make it essential that individuals with ALS have ready access to AAC devices. However, for many individuals with ALS, payment assistance is essential if AAC devices are to be of benefit. Because Medicare coverage criteria currently will not provide for efficient payment of AAC device claims, many individuals with ALS have struggled and suffered without the means to communicate with their families, friends, or health care providers. For these reasons, it is essential that Medicare coverage policy toward AAC devices be replaced so that individuals with ALS have a meaningful opportunity to obtain Medicare payment and reimbursement for these necessary communication aids.

Founded in 1980 as the National Head Injury Association, the Brain Injury Association (BIA) is a not-for-profit organization, based in Alexandria, Virginia, which supports research into brain injury prevention and treatment and provides a wide array of education and advocacy assistance to the 5.3 million Americans living with disability caused by brain injury through 43 state associations, contacts in every state, and a network of more than 800 support groups. For individuals with communication impairments from brain injury, BIA provides information and advocacy assistance for treatment and payment for AAC devices and services. The ability to communicate effectively is of great importance to individuals with brain injury, and it is essential that Medicare, a major payment source for the health care needs of people with brain injury, have appropriate coverage policy and payment criteria for AAC device claims.

The Center on Disability and Health is a not-for-profit Washington, D.C. based research, education, and advocacy organization founded in 1994, which is devoted to health care reform from a disability perspective. The Center explores changes needed in Medicare and other health-based benefits programs to ensure that persons with disabilities receive appropriate care and have an equal opportunity to benefit from covered services.

Consistent with this mission, since early 1997 the Center has participated in the effort to develop a strategy to persuade Medicare to withdraw and/or replace the AAC device national coverage determination. In early 1999, the Center coordinated the efforts of the Health Task Force of the Consortium for Citizens with Disabilities to request that HCFA withdraw and/or replace the existing Medicare AAC device national coverage determination. Based on its parallel experiences with the Medicaid program, the Center is aware that AAC device coverage policy reviews can serve to illustrate broader issues, and thereby be a catalyst for a more general policy review concerning other types of treatment and devices needed by people with disabilities.

The Communication Aid Manufacturers Association (CAMA), founded in 1992 and headquartered in Evanston, Illinois, is a national trade association for 22 companies based in the United States, Canada, and England, that manufacture and distribute almost all of the AAC devices, software, and accessories used by individuals with communication disabilities. CAMA’s mission is to provide information to professionals and individuals with disabilities about AAC and related devices and to keep its member companies informed of public policy and other developments relevant to their businesses. Among its activities is the long-standing CAMA Tour, consisting, annually, of approximately 40 one-day educational workshops, which travel to cities throughout the United States, offering assessment and treatment professionals as well as individuals with communication disabilities detailed information about product characteristics and improvements.

CAMA members are aware of the importance to individuals with communication disabilities of payment and benefits program guidance that facilitate access to AAC and related devices. They know of the extraordinary benefits their AAC devices and related products can provide and of the devastating harm that can arise when the ability to communicate effectively is absent. CAMA members recognize the exclusionary effects of the current Medicare AAC device guidance, which precludes the practice of accepting Medicare assignment. They seek instead, that Medicare create a system based on three principles: a) in which review of AAC device claims is based on clear and professionally sound criteria; b) that Medicare payment of AAC device claims be based on adequate levels of reimbursement; and c) that the system yields sufficient predictability of reimbursement so that the practice of accepting Medicare assignment can occur.

Communication Independence for the Neurologically Impaired (CINI), established in 1993, is a national, not-for-profit services and advocacy organization, headquartered in New York City. CINI is dedicated to assuring persons with severe neurological impairment, such as ALS, are able to obtain necessary AAC devices and services so that they will be able to maintain the ability to communicate throughout the process of their disease. CINI provides direct augmentative communication services to individuals with ALS as well as information and referral assistance to help individuals with ALS to find sources of health care and payment for AAC devices. To further its mission, CINI has provided financial and staff support for the efforts to develop and implement the strategy to persuade or compel HCFA to withdraw and/or replace its AAC device coverage policy so that Medicare beneficiaries with severe communication disabilities who require AAC devices will be able to obtain payment and reimbursement for them.

The National Association of Protection & Advocacy Systems (NAPAS) is a non-profit organization founded in 1983 and based in Washington, D.C. NAPAS is a national voluntary membership organization for the federally mandated nationwide network of disability rights agencies, consisting of protection and advocacy agencies (P&As) and client assistance programs (CAPs). Various Federal statutes mandate NAPAS member organizations provide legal representation and other advocacy services to all persons with disabilities. The P&As collectively are the largest providers of legally based advocacy services to people with disabilities in the United States.

Among the services provided by the P&As are advocacy services directed to obtaining Medicare payment for AAC devices. In support of that role, during the past 3 years, all the P&As have been provided with information about Medicare coverage and payment issues related to AAC devices, through the distribution of research memoranda, newsletter articles, informational booklets, tele-conferences, and annual conference presentations. Based on this information, to date, P&A attorneys have represented half of all the Medicare beneficiaries who have obtained Medicare payment for AAC devices. One of the P&As also is pursuing an administrative complaint directed to the current Medicare AAC device national coverage determination with the USDHHS Office of Civil Rights.

Under current Medicare policy, substantive decisions on AAC device claims are precluded until the beneficiary appeals to the administrative law judge level of review. This causes unconscionable delay: one P&A client with ALS, who was a Medicare HMO participant, died without an ever getting either an AAC device or individualized review of her need for a device, due to the length of time lost in the Medicare administrative appeal process. As this experience illustrates, the success of the P&As in individual appeals is by no means assured and in any event can never be an appropriate substitute for professionally and programmatically sound Medicare AAC device coverage and payment guidance.

The National Multiple Sclerosis Society is a not-for-profit organization, founded in 1946, and headquartered in New York City, which is devoted to finding effective treatments for, and supporting the health and welfare of the more than 300,000 Americans with Multiple Sclerosis, one of the two most common neurological diseases affecting young adults. Multiple Sclerosis is a chronic, often disabling disease of the central nervous system. It can cause loss of vision, speech disabilities, and impaired motor skills. The mission of the National Multiple Sclerosis Society is to end the devastating effects of MS. Through its fifty-state network of 135 chapters and divisions, the Society funds research, provides programs, furthers education, and promotes public policy development. The Society has over 660,000 members and provides services to more than one million persons each year.

The speech-related impacts of MS can give rise to a need for AAC devices, and when that need arises, it is essential that health-benefits payment programs, such as Medicare, have professionally sound AAC device coverage and reimbursement policies. Access to AAC devices will enable people with MS to participate fully in their health care, family lives, and in their communities. Such opportunities never were properly characterized as "conveniences."

RESNA, the Rehabilitation Engineering and Assistive Technology Society of North America, was founded in 1979 and is based in Arlington, Virginia. RESNA is an inter-disciplinary association comprised of more than 1,600 individuals and 150 organizations with a common interest in the use of technology to overcome disability. RESNA’s membership includes individuals with disabilities as well as professional services providers, such as occupational therapists, physical therapists, SLPs, and rehabilitation engineers.

RESNA provides information to professionals and public policy makers about the benefits and importance of assistive technology devices and services, including the importance of appropriate coverage and payment criteria by health focused benefits programs such as Medicare.

Sunrise Medical, Inc., headquartered in Carlsbad, California, is a world leader in the design and manufacture of medical products and assistive technology devices that address the recovery, rehabilitation, and respiratory needs of individuals in institutional and homecare settings. Sunrise products are manufactured in the United States, Mexico and Europe, and are distributed in more than 100 countries around the world. Sunrise Medical’s Dynavox division, headquartered and with its manufacturing site in Pittsburgh, Pennsylvania, is the world’s leading manufacturer of augmentative communication devices. The Dynavox family of products incorporates innovative designs and features and includes the Dynamo, a digitized speech output device with a dynamic screen and which offers 30 minutes of recording time, and the Dynavox and Dynamyte, both of which offer predictive natural language software that speeds sentence formation and which have the industry standard’s, life-like voice synthesizer.

United Cerebral Palsy Associations, UCPA, founded in 1949, is a not-for-profit organization based in Washington, D.C. Operating through a network of 140 affiliates in 48 states, UCPA provides information and advocacy services to more than 1,000,000 persons annually, so that children and adults with cerebral palsy and other disabilities will be able to maximize their opportunities for education, independence, and productivity. For more than a decade, UCPA has been at the forefront of legislative and public policy developments that promote the use of assistive devices by people with disabilities, including AAC devices.

Because dysarthria is commonly associated with cerebral palsy, UCPA is acutely aware of the impacts of communication disabilities and the essential benefits provided by AAC devices. In 1990, 1992, and 1995, the UCPA Board of Directors unanimously adopted Policy Statements on communication and access to AAC. Based on its leadership in this field, from 1994-1999, UCPA’s Assistive Technology Funding & Systems Change Project (ATFSCP) was designated by the U.S. Department of Education, National Institute on Disability and Rehabilitation as one of two providers of national technical assistance regarding access to and payment of assistive technology devices and services. As part of that role, the ATFSCP has been a primary source of support for the efforts of the Assistive Technology Law Center to develop information for families and services providers about Medicare payment for AAC devices and information and legal assistance to advocates representing Medicare beneficiaries who seek AAC devices. The ATFSCP also directly supported the efforts, culminating in this Formal Request, to persuade Medicare to withdraw and replace its long-standing AAC device guidance.

The United States Society for Augmentative and Alternative Communication (USSAAC) is the only national association with a specific commitment to enhancing the lives of individuals whose ability to speak and to be understood in normal conversation is severely impaired by disability and who can benefit by AAC interventions. USSAAC is the United States chapter of the International Society for Augmentative and Alternative Communication (ISAAC). USSAAC is a comprehensive, multi-disciplinary association devoted to expanding the base of knowledge about expressive communication disabilities, developing effective means of assessment and treatment for those disabilities, and assisting persons who need AAC intervention to obtain appropriate devices, services, and as necessary, payment assistance. USSAAC’s members come from every state and include individuals who use AAC interventions and their families, assessment and treatment professionals, educators, physicians, researchers, advocates, and AAC device manufacturers and vendors.

The inability to communicate one’s thoughts, needs and wishes is one of the most devastating of all functional impairments, affecting every aspect of a person’s life. AAC devices and services provide effective treatment that will overcome those limitations. For these reasons, USSAAC has supported efforts to ensure that all payment programs, including Medicare, develop and apply professionally sound criteria governing their coverage and payment for AAC devices and services.