Secretary Paige and Members of the Working Group:

This testimony is submitted on behalf of a new national, consumer-led coalition known as the “ITEM” Coalition, which is an acronym for Independence Through Enhancement of Medicare and Medicaid. The Coalition’s work is just getting started and, indeed, this Coalition is scheduled to be launched in June. However, when the opportunity presented itself to submit testimony to this Interagency Working Group on Assistive Technology Mobility Devices, the Coalition’s participants simply could not pass on the opportunity to raise awareness of our cause and offer comments for the record. On behalf of the ITEM Coalition, therefore, we thank you for the opportunity to testify before this important Interagency Working Group. We commend President Bush and this Administration for forming this Work Group to examine and make recommendations on the intractable problems associated with access to assistive technology mobility devices for people with disabilities.

The ITEM Coalition comprises nonprofit consumer and provider organizations interested in advancing awareness and public policy changes that will lead to improvements in access to assistive devices, technologies and related services for people with disabilities and chronic conditions of all ages. Our coalition is focused on raising awareness about the full complement of assistive devices, technologies, and related services, including what is commonly defined as durable medical equipment, orthotics (orthopedic braces), prosthetics (artificial limbs), supplies, and a whole host of aids and other devices. This includes everything from the “lowest tech” grab bar for seniors with orthopedic impairments to the “highest tech” screen readers for people with vision impairments. It also includes the myriad devices that improve the function, independence, health status, and quality of life of people with disabilities and chronic conditions.

Assistive technology mobility devices are some of the most common devices that assist people with disabilities to perform everyday activities, interact with their communities, and function in the employment and other settings. As assistive technology mobility devices are the specific focus of this Interagency Working Group, our testimony will primarily address this issue, but we would also like to take this opportunity to suggest that the charge of this Work Group is, in our view, too limited in scope. While improvement of access to mobility devices deserves serious attention, there is a wide range of equally important assistive devices, technologies and related services that are simply not accessible to the vast majority of people who need them. As such, we would like to take this opportunity to also address some of the broader issues involving the lack of access to assistive devices, technologies and related services for people with disabilities of all ages.

Contents:
Background
Assessing the Need for Better Access
An Endorsement of the Assistive Technology Act
Promising Developments
Problems with Third-Party Payment for Assistive Technology
Health Programs and Plans
Recognizing Functionality and Quality of Life
Medicare’s “In the Home” Restriction on DME
Conflicting Federal Policies
Restrictions in Access to Power Mobility
The Challenge of Covering New Technologies
Gaps in Medicare Assistive Device and Technology Coverage
Medicaid
The DME Problem for Dual Eligibles
Summary Recommendations
Submitted by the Undersigned Members of the ITEM Coalition
Endnotes

Background

Technology has the potential to unleash unprecedented levels of independent living and community participation among the population of people with physical, cognitive, sensory and communication disabilities. Assistive devices and technologies, both in the research and development pipeline and available on the market today, can vastly improve functional levels of people with disabilities and improve their quality of life. For both children and adults with disabilities, assistive technology can lead to greater participation, independence, productivity, and integration in the home, in the classroom, in the workplace and in the community. Access to assistive technologies and related services, however, is severely restricted for a number of reasons. These reasons include the lack of adequate funding sources, a lack of awareness of what is available given the fast pace of technological advancements, a lack of expertise by therapists and other service providers, uncoordinated and often outdated federal and state public policy, and economic barriers generally applicable to the disability community.

Assessing the Need for Better Access

The need for access to assistive devices, technologies and related services has been clearly demonstrated. Over fifteen million Americans with disabilities reported using assistive devices or technologies in recent surveys. (1) Based on 1994-95 data, it has been estimated that 6.8 million Americans used some kind of assistive device for mobility, including approximately 1.7 million who used wheelchairs or scooters. (2) The number of wheelchair users today has grown to approximately 2.1 million. (3) Millions of Americans report living in homes and using cars or vans that have been modified to meet their special needs. (4) More than 2.5 million Americans report they need assistive technology that they do not have, with about 70% citing cost as the primary reason. (5) Less than 20% of the estimated 28 million Americans who could benefit from hearing devices currently have them. (6) In fact, 50% of assistive technology users and 75% of those with home modifications paid for this assistive technology themselves or with the help of family members, with no help from third party payers. (7) The barriers to access to assistive devices, technologies and related services have been documented to result in physical consequences, such as a general deterioration in health and a risk of secondary injuries, as well as strained relationships with family, friends, and colleagues, financial strain, decreased independence, and limitations in social participation. (8)

An Endorsement of the Assistive Technology Act

For the past 15 years, the Technology Related Assistance for Individuals with Disabilities Act, as amended (“Tech Act”) state programs have worked hard to address this need with significant success. But the demand for access to assistive technologies continues to grow and the need for the state Tech Act programs has intensified, not diminished, over the years. It is difficult to reconcile the Administration’s FY 2004 budget request for the AT Act programs (i.e., zero funding except for the Protection and Advocacy for Assistive Technology program) with this Working Group’s charge and the demonstrated interest in assistive technology from the highest levels of the Bush Administration. In fact, the state Tech Act programs will likely be well-suited to implement some of the very recommendations that derive from the Working Group. The ITEM Coalition, therefore, recommends that this Working Group include a strong endorsement to fund the state Tech Act programs in FY 2004 and work with Congress to enact a strong, effective AT Act Reauthorization.

Promising Developments

A great deal of activity has occurred in recent years at the national level that demonstrates the high level of interest in improving access to assistive devices, technologies and related services. First and foremost, President Bush’s New Freedom Initiative (“NFI”) focused heavily on assistive technology issues, but the proposals within the NFI were limited to funding increases in research and development of assistive technologies and alternative financing mechanisms administered through the state Tech Act programs which were designed to make the purchase of assistive technologies less onerous on individuals with disabilities. Missing from the NFI was any proposal to coordinate vocational rehabilitation programs with other education, labor, and health programs to enhance access to assistive technologies. This Working Group obviously addresses that need and we commend the Department of Education for taking the lead on this important component of improving public policy related to assistive technologies.

Also missing from the NFI was a serious assessment and process for making recommendations to improve third party payer coverage of health-related assistive devices, technologies, and related services. Many publicly financed health programs (Medicare, Medicaid, the VA, FEHBP, and TRICARE) as well as private health plans routinely cover varying amounts of durable medical equipment, orthotics, prosthetics and supplies, but coverage policies are in need of review and revision. In addition, coverage policies need to be created for many health-related assistive, sensory and communication technologies, such as hearing aids, and other devices and related services.

It is the ITEM Coalition’s strong recommendation that this Interagency Working Group take this historic opportunity to launch a comprehensive review of health program and plan coverage of assistive devices, technologies and related services, whether related to mobility or other functional limitations, and recommend a process for assessing deficiencies in third party coverage of these vital devices and services for people with disabilities and chronic conditions. The ITEM Coalition also believes that the Working Group should not wait for a more comprehensive review to deliver recommendations on third party health coverage of assistive technology mobility devices. As such, we have made several recommendations later in this testimony related to mobility devices.

In addition to the NFI, a number of other developments have signaled a robust interest in addressing the deficiencies in access to assistive devices, technologies and related services. For instance:

* Healthy People 2010 includes a recommendation to reduce the proportion of people with disabilities who report not having the assistive devices and technology they need; (9)

* In January, 2003, the National Academy of Social Insurance published its report Medicare in the 21st Century: Building a Better Chronic Care System, which recommended that the longstanding need to improve assistive device benefits for Medicare beneficiaries be addressed. The report specifically recommended that Medicare “[c]over durable medical equipment with the specific intent of maintaining or restoring function” and “[p]rovide for assistive devices that compensate for sensory or neurological deficits.” (10)

* The AARP released in April 2003 a major publication entitled Beyond 50: A Report to the Nation on Disability and Long Term Care. The report examines the lack of access by seniors and people with disabilities to assistive devices and technologies, recommending that “coverage for the equipment and therapies often needed by persons with disabilities should be expanded in both private and public insurance program.” (11)

* The federal implementation of the Olmstead Supreme Court case has prompted a systematic review of barriers to community living in a whole host of government programs. Unfortunately, to date, the Olmstead decision has not prompted a comprehensive review of federal health program coverage policies on assistive devices and technologies for people with disabilities;

* Three years ago, CMS lifted Medicare’s national “non-coverage” determination for augmentative communication devices (AACs) and began covering these devices as durable medical equipment (“DME”) after decades of denials. However, CMS’ coverage criteria for DME required AAC manufacturers to disable the regular computer functions of a device before selling the device as an AAC. These functions can then be sold separately to the beneficiary but not reimbursed by Medicare;

* The Department of Defense Reauthorization Act of 2001 included a significant expansion of its DME and orthotics/prosthetics (O&P) benefit package for all TRICARE/CHAMPUS enrollees. As a result of this new law, TRICARE now covers any DME that maximizes a person’s function as long as it is consistent with that person’s physiological needs. The new law also expands coverage of orthotics, prosthetics, and the accessories and supplies that make these devices functional. Hearing aids are covered for the first time for TRICARE enrollees with hearing loss, and AAC’s are covered in a manner that is consistent with Medicare policy. Public comments on a proposed regulation regarding these benefit expansions are due June 16, 2003; and, finally,

* The U.S. Office of Personnel Management (“OPM”), which administers the Federal Employee Health Benefits Program, instructed the private health plans that serve federal employees to maximize their coverage of durable medical equipment (“DME”) in their 2002 benefit packages.

Problems with Third-Party Payment for Assistive Technology

Existing laws and policies that fund assistive devices, technologies, and related services have significant gaps that leave people with disabilities to either go without or face tremendous hurdles to secure funding. As the National Council on Disability’s Report, Federal Policy Barriers to Assistive Technology, (May 2000) states, “Today’s policies are a maze of conflicting definitions, eligibility criteria, philosophical models, and requirements for access to assistive technology. Consumers are left with the daunting task of learning each system’s policies to be able to advocate for the assistive technology they need.” The report also validates through stakeholder surveys that “the overarching barriers that continue to limit access to assistive technology are lack of awareness, lack of access to expertise, and lack of funding.” (12)

The primary third-party payers of devices, technologies and related services that assist people with disabilities and chronic conditions consist of health programs and plans, a variety of disability services programs such as vocational rehabilitation and special education, and the private sector. While this Working Group is focused on coordination of vocational rehabilitation and education programs, an important component of the overall problem, health program and health plan coverage of assistive devices, technologies and related services is viewed by many as the most fertile ground to plow. Indeed, if the Medicare and Medicaid programs assumed a greater role in covering assistive devices, technologies, and related services, and private health plans followed this lead, vocational rehabilitation and special education programs could be more focused on providing the services necessary to obtain meaningful education and employment.

Health Programs and Plans

Most often, coverage for assistive devices, technologies, and services across federal and state programs conforms to the requirements of the funding source rather than the functional needs of the individual with the disability. In this respect, the Working Group’s effort to coordinate programs designed to improve access to mobility devices for purposes of employment and education is well placed.

But in the health care area, there is one primary impediment to greater coverage of assistive devices, technologies, and related services by health care programs and plans. The term “assistive technology” is not generally recognized by the “medical model” on which virtually all health insurance programs and plans operate. Health programs and plans refer to many of the devices that would be considered “assistive technology” under the benefit category of durable medical equipment, prosthetics, orthotics, and supplies (referred to hereinafter as “DMEPOS”).(13) This translates into a requirement to squeeze the square peg of assistive technology into the round hole of DMEPOS. It requires, above all, that “assistive technologies” be primarily used for a medical purpose, something that is arguable for some assistive technologies. Health programs and plans operationalize this by applying the concept of “medical necessity” to the DMEPOS benefit category. (14)

This impediment derives from the original purpose of health insurance, which was to protect against unforeseen illness or injury. But as advances in medicine enabled a large percentage of consumers with disabilities and chronic conditions to survive and thrive, the demand on health care programs and plans to cover an ever-expanding breadth of devices and services for people with foreseeable, life-long health care needs has increased dramatically.

Recognizing Functionality and Quality of Life

This problem can be viewed as a lack of recognition of the value of “functionality” and “quality of life” in the concept of “medical necessity.” These factors often translate into the ability of the individual to participate fully in community and society. (15) In the DMEPOS area, this often results in exclusions of coverage of devices because they are considered “convenience” or “luxury” items. What this coverage policy exposes is the lack of recognition of the relative needs of people with varying levels of impairment brought on by the particular circumstances of the individual. What may be a “convenience item” for one person may be the key to full functioning, independent living, improved health, and ability to work, for someone else.

For instance, in the category of ultra lightweight wheelchairs, which enable manual users to propel themselves easier than with a standard wheelchair, Medicare claims in 2001 totaled approximately 2,463 out of 42 million Medicare beneficiaries (1999).(16) Of this remarkably low number, only 33% were approved for payment. (17) These numbers may suggest that providers are familiar with the restrictive coverage policies of wheeled mobility and do not even try to press Medicare to cover the most functional devices for the beneficiary. Even when claims are submitted for highly functional DME, the rates of denial are very discouraging.

Technology has blurred the line between what can legitimately be called a convenience or luxury and what improves the functionality or quality of life of the person, thereby improving his or her health status. The Veterans Administration has made significant progress in this area, permitting coverage of up to three mobility devices for each mobility-impaired veteran in order to satisfy various activity demands. Recognition of the value of community participation and full function should not be considered a luxury or a convenience but often is under current Medicare and Medicaid law and by other federal payers and private plans.

Medicare’s “In the Home” Restriction on DME

The Medicare program further limits access to DME through its “In the home” restriction, which provides that Medicare will only cover a mobility device if it is medically necessary “in the patient's home.” The “In the home” restriction is a major barrier to appropriate access to assistive technology mobility devices and should be revised to enhance access for people with disabilities. This restriction does not appear in the Medicare statute but has been a longstanding regulation that applies to the Medicare DME benefit. (18) The restriction was originally intended to define DME as devices that were provided outside of an institution such as a hospital or skilled nursing facility (“SNF”) and, therefore, warranted separate reimbursement. DME provided in these settings is covered under the global hospital or SNF rates.

But over time, this regulation was interpreted to restrict coverage only to DME that was medically necessary within the four walls of the beneficiary's home. In the early 1990's, this restriction was slightly modified by the Health Care Financing Administration (“HCFA”), now CMS, to cover DME that could also be useful outside of the home, but DME coverage will still be denied to this day if the device cannot be shown to be medically necessary in the patient's home. This limitation constitutes a major barrier to accessing assistive technology mobility devices that are appropriate for active participation in community and employment activities, and full functioning.

Conflicting Federal Policies

What is most disturbing about the “In the Home” requirement under Medicare is the disincentive it presents to Medicare beneficiaries with disabilities (particularly the 5 million under age 65) who would prefer to return to work but who cannot obtain coverage for mobility devices with functions that are most useful outside of the home. In 1999, Congress passed the Ticket to Work and Workforce Incentives Act, Public Law 106-170 (the “Ticket Law”), which significantly extended the time period that a person on the Social Security Disability Insurance (“SSDI”) program could keep their Medicare coverage if they returned to work and ceased taking income support payments from the federal government. The Ticket Law was designed to remove the disincentives that the loss of Medicare and/or Medicaid coverage posed to people with disabilities who wished to get back into the workforce.

Unfortunately, the Medicare benefit was never reviewed and modified to comport to these new incentives. Therefore, federal law now encourages people with disabilities to return to work but only covers assistive technology mobility devices that are useful “In the home” rather than providing full function in the community and, by extension, the workplace. The same can be said about other assistive devices, technologies and related services such as sensory devices that would enable people with vision and hearing impairments to more fully participate in the community, in educational settings and in the workplace.

Restrictions in Access to Power Mobility

Another Medicare (and other private payer) restriction on assistive technology mobility devices involves access to power mobility. The Medicare Manual's Certificate of Medical Necessity for power mobility devices asks physicians, among other things, to certify that the patient “is unable to operate any type of manual wheelchair.” (19) This policy is a severe limitation on access to power mobility for people who are long term manual wheelchair users and are at risk of developing secondary conditions as a result of such wheelchair use.

Many clinical studies have shown that prolonged manual wheelchair use is a major factor in the high incidence of secondary injuries to the upper limbs among wheelchair users, resulting in shoulder, elbow, and/or wrist pain. (20) Unlike most injuries, injuries to the upper limbs among manual wheelchair users are both relatively predictable and avoidable. The injuries are predictable because incidence of upper limb pain has been directly correlated with the time of use of the wheelchair. (21)

Additionally, it is known that certain patient populations, such as tetraplegics and quadriplegics, individuals with degenerative neurological conditions, and individuals with poliomyelitis, are at an increased risk of experiencing upper limb pain due to manual wheelchair use. (22) Accordingly, the research supports increasingly prescribing power wheelchairs to individuals with a high risk of upper limb pain due to prolonged manual wheelchair use.

Based on the extensive clinical data involving secondary injury from manual wheelchair use, Medicare should consider modifying its policy with respect to when a manual wheelchair user may access power mobility. Power mobility devices should be available to a portion of the manual wheelchair population that is at imminent risk of significant secondary injury due to prolonged manual wheelchair use. This policy would very likely decrease the incidence and prevalence of secondary injury, which oftentimes manifests itself in costly medical/surgical corrective interventions. A sister agency of CMS, the VA, permits access to power mobility at age 55, for instance. An age threshold is one way to address this problem, but a clinical assessment, based on the individual condition of each wheelchair user, may be more appropriate.

The Challenge of Covering New Technologies

New and innovative assistive devices and technologies enter the marketplace each year, posing a major challenge for third-party payers in assessing the benefit to the individual and determining whether coverage should ensue. It is not surprising, therefore, that many payers are slow to adopt coverage for innovative devices, technologies and related services. Health care payers, such as Medicare, are requiring greater levels of clinical data and outcomes studies before coverage is granted for innovative assistive technologies. In fact, CMS has recently instituted new mechanisms to refer certain medical devices to a “technology assessment” prior to making a coverage determination.

Assistive device and technology manufacturers, of course, are not accustomed to this level of rigor in demonstrating the clinical and scientific efficacy of their products. This is, in part, due to the fact that most assistive devices are not invasive and, therefore, do not require large-scale, double-blind clinical trials in order to show that they are “safe and effective,” which is the general standard required by the Food and Drug Administration (FDA). If the level of FDA review for assistive technology were comparable to that of new medications, most assistive device innovations would never make it to market due to the unsustainable costs incurred in conducting clinical trials and similar outcome studies, without the widespread application and financial reward that new drugs often bring. Still, when assistive device and technology manufacturers approach payers such as CMS with little more than anecdotal evidence to support coverage of their innovations, one cannot blame the agency for being reluctant to determine coverage.

What is needed at the payer level is an awareness of this problem and a willingness to consider all types of data, not just clinical trial data, to determine coverage of new and innovative assistive devices, technologies and related services. For instance, CMS and other payers should specifically recognize improvements in function that an assistive device brings to various populations of people with disabilities, so that specifically drawn coverage criteria might make a new device or technology available to those most able to maximize their function with the assistance of that particular device or technology.

Gaps in Medicare Assistive Device and Technology Coverage

The Medicare benefit package is viewed by many as the standard upon which most federal programs and private health plans base their coverage determinations. While the existing Medicare DMEPOS benefit category covers a fair amount of very useful types of assistive devices, technologies and related services for beneficiaries with disabilities, there are a number of glaring omissions in coverage. For instance, hearing aids, eyeglasses (except in limited circumstances), white canes for people with vision impairments, safety devices such as grab bars, and a host of assistive devices and technologies that enhance sensory and communication function are excluded from coverage under the program. (23)

Inexpensive grab bars can prevent costly hip fractures caused by falls, eyeglasses can assist in preventing medication mistakes, and hearing aid use has been shown to have a positive impact on physical, emotional, mental, and social well-being. (24) These and other assistive devices are “medical” in nature and should not be excluded from coverage under a typical health program or plan, but they are typically denied for coverage. Other examples include environmental control units for people with severe mobility limitations, computer screen readers, air conditioners for people with respiratory illnesses, and other assistive technologies that can vastly improve function and quality of life.

CMS has recently signaled its willingness to consider coverage of this type of assistive technology as long as it can be shown through clinical data that the device or technology in question produces good outcomes for beneficiaries with disabilities. A prime example of this involves CMS’s treatment of Augmentative and Alternative Communication Devices (“AACs”), powered communication systems that enable people with severely impaired speech to communicate. Conditions typically requiring AACs include ALS, cerebral palsy, multiple sclerosis, progressive aphasia, and traumatic brain injury. After decades of no coverage by the Medicare program, and after extensive pressure from outside interest groups, CMS relented to the multiple reversals of coverage denials for AACs by Administrative Law Judges and lifted a coverage determination that considered AACs as “convenience items.” (25)

Effective January 1, 2001, the Medicare Coverage Issues Manual included a coverage policy on AAC coverage, stating that “speech generating devices are now considered to fall within the DME benefit category…” (26) It is estimated that 47,000 Medicare beneficiaries are eligible to receive AAC coverage. This decision was considered a major victory by the disability community and has significant implications on private health insurance coverage of AACs. It should be noted, however, that a variety of other government programs already cover AACs including Medicaid (under the “home health care services” benefit) and vocational rehabilitation and special education (under the “assistive technology” benefit). The Department of Defense’s health care program, TRICARE, is the only federal program to cover AACs by name.

Medicaid

While Medicare is the largest payer of mobility devices in the country, the Medicaid program is another federal program that covers a large percentage of assistive devices for people with disabilities. Because Medicaid is a federal/state program, states have significant flexibility to design their own benefit packages and delivery models. All assistive devices and related services are provided under Medicaid as “optional services.” This means that various limitations can be easily imposed on assistive device benefits from year to year, and often are.

The introduction of Medicaid waivers, in the early 1980’s, where a state may target services to specific populations, has created a significant increase in access to a broader array of assistive technologies and devices, home modifications, and personal assistant services designed to allow people with disabilities to stay in their homes and communities, rather than in institutions. In addition, the Early Periodic Screening Diagnosis and Treatment (EPSDT) program within Medicaid has been of benefit to children with disabilities who need assistive technology. But state-based fiscal pressures continually threaten access to these important devices and services.

Eligibility to Medicaid programs is also inconsistent from state to state and arbitrary exclusions and benefit limitations often constitute barriers to access. For instance, in some states, when Medicaid beneficiaries turn 21 years of age, they lose coverage for all assistive technologies, such as leg prostheses and hearing aids that are covered under EPSDT. Some states impose unrealistically low benefit caps such as $500 for all durable medical equipment annually. CMS, however, has taken some steps to enhance Medicaid beneficiaries’ access to assistive devices and related services. In 1998, CMS issued a policy directive to state Medicaid programs that prohibited them from denying coverage of “equipment” that was not on a state’s “exclusive list” of covered durable medical equipment. This has provided beneficiaries with an important tool to use in attempting to secure the assistive technology needed by particular individuals with disabilities. But the chasm between the need and the level of coverage remains great.

The DME Problem for Dual Eligibles

Finally, we recommend that this Interagency Working Group examine and make recommendations designed to improve coordination of coverage of assistive technology mobility devices between the Medicare and Medicaid programs for beneficiaries who are dually eligible for both of these programs. In many states, including the State of New York, Medicaid covers mobility devices and technologies for people with disabilities of all ages more generously than does the national Medicare program. However, dual eligibles are required to submit their claims for benefits to Medicare first, with Medicaid covering the copayment for whatever the Medicare program's coverage criteria permits. As Medicaid is the payer of last resort and often does not restrict DME to that which is medically necessary "in the patient's home" as Medicare does, states like New York cover a wide range of assistive technology mobility devices that Medicare simply does not provide.

This creates a highly inequitable situation where Medicaid-only beneficiaries in some states receive the assistive technology mobility devices that best meet their needs, while dually eligible beneficiaries must settle for whatever the more restrictive Medicare coverage criteria will allow. This is a policy issue that cries out for coordination between the Medicare and Medicaid programs, especially in the area of assistive devices and technologies, including mobility devices. There are several policy alternatives that have the potential to resolve this problem. The Medicare program could revise it’s "in the home" restriction for DME which would largely solve the problem in the mobility device area. Alternatively, Medicare could adopt state Medicaid coverage criteria for dual eligibles or restructure the cost-sharing arrangement between the two programs for assistive devices and technologies to achieve a more equitable result. The ITEM Coalition does not recommend a particular solution, but simply offers this problem as one that this Interagency Working Group is ideally suited to resolve. We encourage the Working Group to address this problem and include a solution in the recommendations it will provide to the President.

Summary Recommendations

1. Launch a comprehensive review of health program and plan coverage of assistive devices, technologies and related services, whether related to mobility or other functional limitations, and recommend a process for assessing deficiencies in third party coverage of these vital devices and services for people with disabilities and chronic conditions.

2. The Working Group should not wait for a more comprehensive review to deliver recommendations on third party health coverage of assistive technology mobility devices.

3. The “In the home” restriction is a major barrier to appropriate access to assistive technology mobility devices and should be revised to enhance access for people with disabilities.

4. Based on the extensive clinical data involving secondary injury from manual wheelchair use, Medicare should consider modifying its policy with respect to when a manual wheelchair user may access power mobility. Power mobility devices should probably be available to a portion of the manual wheelchair population that is at imminent risk of significant secondary injury due to prolonged manual wheelchair use.

5. Payers, such as CMS, should consider all types of data, not just clinical trial data, in determining coverage of new and innovative assistive devices, technologies and related services and specifically recognize improvements in function that an assistive device brings to various populations of people with disabilities.

6. CMS should better coordinate coverage of assistive devices, technologies and related services of people who are dually eligible for both Medicare and Medicaid coverage so that dual eligibles are not placed at a disadvantage in those states where Medicaid covers a broader array of assistive devices and technologies.

Submitted by the undersigned members of the ITEM Coalition:

Adapted Physical Activity Council
Advancing Independence: Modernizing Medicare and Medicaid
Alexander Graham Bell Association for the Deaf and Hard of Hearing
American Academy of Audiology
American Academy of Physical Medicine and Rehabilitation
American Association for Homecare
American Association of People with Disabilities
American Congress of Community Support and Employment Services
American Foundation for the Blind
American Medical Rehabilitation Providers Association
American Music Therapy Association
American Network of Community Options and Resources
American Occupational Therapy Association
American Speech-Language-Hearing Association
American Therapeutic Recreation Association
Amputee Coalition of America
Assistive Technology Industry Association
Association for Persons in Supported Employment
Association of Tech Act Projects
Association of University Centers on Disability
Blinded Veterans of America
Brain Injury Association of America
Center for Medicare Advocacy
Christopher Reeve Paralysis Foundation
Consortium of Developmental Disabilities Councils
Council of Citizens with Low Vision International
Disability Service Providers of America
Eastern Paralyzed Veterans of America
Families USA
Helen Keller National Center
Long Island Center for Independent Living
Medicare Rights Center
Miami Project to Cure Paralysis
National Association for Home Care and Hospice
National Association for the Advancement of Orthotics and Prosthetics
National Association of Developmental Disabilities Councils
National Association of Research and Training Centers
National Campaign for Hearing Health
National Organization on Disability
National Rehabilitation Hospital
National Spinal Cord Injury Association
NISH
Paralyzed Veterans of America
Rehabilitation Engineering and Assistive Technology Society of North America
Research Institute for Independent Living
Self Help for Hard of Hearing People
Service Employees International Union
Spina Bifida Association of America
The Arc
United Cerebral Palsy Associations

Endnotes

(1) Carlson, D., Ehrlich, N., Berland, B.J., and Bailey, N., Assistive Technology Survey Results: Continued Benefits and Needs Reported by Americans with Disabilities, National Institute on Disability and Rehabilitation Research (NIDRR), 2001.

(2) National Health Interview Survey on Disability, Phase I file, National Center for Health Statistics, 1994-1995.

(3) United States Census Bureau, Americans with Disabilities: Household Economic Studies, 2001 (using 1997 data).

(4) Carlson, et al., 2001.

(5) LaPlante, M.P., Hendershot, G.E., and Moss, A.J., Assistive Technology Devices and Home Accessibility, National Center for Health Statistics, 1992.

(6) Kochkin, S. and Rogin, C., Quantifying the Obvious: The Impact of Hearing Instruments on Quality of Life, The Hearing Review 7(1): 6-35 (2000).

(7) See id.

(8) Neri, M.T., and Kroll, T., Understanding the Consequences of Access Barriers to Health Care: Experiences of Adults with Disabilities, Disability and Rehabilitation 25(2): 85-96 (2003).

(9) National Center on Birth Defects and Developmental Disabilities, Healthy People 2010 Chapter 6, Vision for the Decade: Proceedings and Recommendations of a Symposium, Centers for Disease Control and Prevention, 2001.

(10) National Academy of Social Insurance, Medicare in the 21st Century: Building a Better Chronic Care System, 2003, at p. v.

(11) AARP, Beyond 50: A Report to the Nation on Disability and Long Term Care, 2003, at p. 12.

(12) See id. at p. 15.

(13) DME is defined as “equipment, furnished by a supplier or a home health agency that (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 an illness or injury; and (4) Is appropriate for use in the home. 42 C.F.R. § 414.202.
Prosthetic and Orthotic devices are defined as
(1) Devices that replace all or part of an internal body organ, including ostomy bags and supplies directly related to ostomy care, and replacement of such devices and supplies;
(2) One pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens; and
(3) Leg, arm, back, and neck braces, and artificial legs, arms, and eyes, including replacements if required because of a change in the beneficiary’s physical condition.
42 C.F.R. § 412.202.

(14) Scheer, J., Kroll, T., Neri, M.T., and Beatty, P., Access Barriers for Persons with Disabilities, Journal of Disability Policy Studies 13(4):221-230 (2003).

(15) See id. A relatively new measure of society participation that may help quantify the concept of “functionality” and “quality of life” can be found in the World Health Organization’s International Classification of Functioning Disability and Health.

(16) Medicare claims data.

(17) See id.

(18) 42 C.F.R. § 402.212. The “In the Home” requirement is not applicable to orthotics, prosthetics, or supplies.

(19) HCFA Form 843 (5/97), Certificate of Medical Necessity, Motorized Wheelchairs, Question 7.

(20) Pentland, W. E. and Twomey, L. T., Upper Limb Function in Persons with Long Term Paraplegia and Implications for Independence: Part I, Paraplegia 32: 211-18 (1994) (finding the following pain prevalence among paraplegics: shoulder 39%, elbow 31%, and wrist/hand 40%); Cooper, Rory A., et al., Research on Physical Activity and Health Among People with Disabilities: a Consensus Statement, J. Rehabil. Res. Dev. 36(2): 142-54 (1999) (“Manual wheelchair users are particularly susceptible to rotator cuff tears, lateral epicondylitis, and cubital tunnel or carpal tunnel neuropathies due to micro-injury caused by the repetitive motions required to propel themselves.”); Dalyan M., et al., Upper Extremity Pain After Spinal Cord Injury, Spinal Cord 37(3): 191-5 (1999) (based on study of patients with spinal cord injury, 71% reported shoulder pain, 53% wrist pain, 43% hand pain, and 35% elbow pain).

(21) Nichols, P.J.R., et al., Wheelchair User’s Shoulder?, Scand. J. Rehabil. Med. 11: 29-32 (1979) (“One-third had at least one attack of cervico-brachial pain within one year. The frequency [and] duration of the attack tending to increase as time passes. . . . After ten years, 54% have cervico-brachial pain.”)

(22) Curtis, Kathleen, et al., Shoulder Pain in Wheelchair Users with Tetraplegia and Paraplegia, Arch. Phys. Med. Rehabil. 80: 453-57 (1999) (“In the current cross-sectional study, both the prevalence and intensity of shoulder pain during the performance of functional activities was significantly higher in subjects with tetraplegia than in subjects with paraplegia.”); Pentland, W. E. and Twomey, L. T., supra note 20 (“Wheelchair users whose extremities are already compromised by weakness and muscle imbalance (e.g. quadriplegia, poliomyelitis, degenerative neurological conditions) may be especially at risk [for upper limb pain].”).

(23) 42 U.S.C. § 1395y.

(24) National Council On Aging, The Consequences of Untreated Hearing Loss in Older Persons, 1999.

(25) Durable Medical Equipment Reference List, National Coverage Decision 60-9, April 2000.

(26) Speech Generating Devices, National Coverage Decision 60-23, November 2000.