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Dear Dr. McClellan:
The ITEM Coalition would like to focus our comments on the
DMEPOS Competitive Acquisition Proposed Rule issued May 1, 2006 to the “low vision
aid exclusion.” This provision is
completely unrelated to competitive bidding and is the only part of this
proposed rule that directly impacts coverage of assistive devices for Medicare
beneficiaries with disabilities. We take strong exception to the proposed “low vision aid exclusion” for
the reasons outlined in this response. The ITEM Coalition strongly urges
CMS to reconsider this proposed rule and to evaluate the medical/functional
purpose of each assistive device and technology at issue and establish
individualized coverage decisions.
The ITEM Coalition is a consumer-led coalition of 75
disability-related organizations with the purpose of raising awareness and
building support for policies that will improve coverage of assistive devices,
technologies, and related services for people of all ages with disabilities and
chronic conditions. From coverage for
hearing aids to augmentative communications devices (AACs) to advanced
artificial limbs to screen readers for people with vision impairments, the
Coalition’s mission is a broad one with implications for virtually every person
with a disability who relies on assistive devices to be healthy, functional,
and independent.
Members of the ITEM Coalition are extremely concerned by the
"low vision aid exclusion" segment of the
regulation. The proposed exclusion
states that all devices, “irrespective of their size, form, or technological
features that use one or more lens to aid vision or provide magnification of
images for impaired vision” will be
hereafter excluded from Medicare coverage based on the statutory “eyeglass”
exclusion. The ITEM Coalition believes
that this extremely expansive exclusion would decrease access to
important assistive technology for people with vision impairments now and in
the future, as well as perpetuate a harmful precedent that impacts access to
assistive technology for all people with disabilities.
Impact of “Low
Vision Aid Exclusion” on Individuals with Vision Impairments:
The ITEM Coalition believes that this proposal will have a
significant impact on beneficiaries with vision impairments who depend on
assistive technology that incorporates “one or more lens” to aid in their
vision. This represents a preemptive
wholesale denial of benefits for an entire subpopulation of people with
disabilities.
Initially, the expansion of the eyeglass exclusion would
prevent access to devices such as hand-held magnifiers, video monitors, and
other such technologies that utilize lens to enhance vision. These tools are often essential for
individuals with low vision who, without the aid of assistive technology,
cannot read prescriptions, financial documents, mail, recipes, and other important
materials. In short, these devices allow
individuals with low vision to live independently and safely.
While the immediate impact this expansive interpretation of
the eyeglass exclusion may be a decrease in access to current devices for individuals
with low vision, the proposal will have an even more detrimental impact in the term.
The expansion of the statutory eyeglass exclusion to include any technology that uses “one or more
lens for the primary purpose of aiding vision,” serves as a preemptive and
unwarranted coverage denial for any new technology designed to assist
individuals with vision impairments.
The ITEM Coalition believes that this preemptive coverage
denial is particularly problematic because it serves as a tremendous disincentive
to manufacturers and innovators to develop new and progressive vision
technology. Not only does Medicare
provide health care coverage for its beneficiaries, but it also serves to
influence to private health insurers, impacting a much larger population. Therefore, Medicare coverage policies are indicative
of the market for devices and technologies and influential when it comes to
investments in research and development.
If Medicare establishes this broad coverage exclusion for low vision
aids, we would undoubtedly see a decrease in innovation in this area – harmful
effects on those currently experiencing vision impairments or who will
experience such impairments in the future.
Recommendations:
The ITEM Coalition recommends that rather than establishing
preemptive coverage denials for all devices that utilize a lens to aid in
vision, CMS instead evaluate the medical/functional purpose of each assistive
device and technology at issue and establish individualized coverage decisions.
Although we recognize that the Centers for Medicare and
Medicaid Services (CMS) has the authority to reasonably interpret the Medicare
statute, the ITEM Coalition believes this broad exclusion to be unreasonable
and unsupported by the facts and circumstances surrounding the low vision aid
issue. In fact, the proposed decision,
if left intact, is harmful to the health and independence of Medicare
beneficiaries.
The ITEM Coalition believes that if the Congress had
originally intended the eyeglass exclusion to apply to all devices with “one or more lens” to aid in vision, it would have
explicitly expressed that with statutory language. However, nowhere in the statute or legislative
history does Congress suggest anything but a plain reading of the term
“eyeglasses.” Instead, we believe that
Congress’ use of the term “eyeglasses” was simply meant to apply to traditional
eyeglasses that fit on one’s nose and around one’s ears.
This interpretation has been supported by several federal courts. In one relevant case, Currier v. Thompson, 369 F. Supp.
2d 65 (D. Me. 2005), the U.S. District Court
for the District of Maine found that a video monitor
is not excluded from Medicare
coverage based on the “eyeglass” exclusion and remanded the case back to the
Secretary of Health and Human Services (HHS) to determine if a video monitor is
considered under the Medicare benefit “durable medical equipment” or as a
“prosthetic device.”
Consistent with this decision, the ITEM Coalition argues
that all vision aids with one or more lens, other than traditional eyeglasses,
should be considered for a Benefit Category Determination (BCD). We recommend that the agency consider not just
the common features between eyeglasses and other devices with lenses, but the
differentiating features as well that may lend themselves to coverage under the
program for specific populations with low vision needs. Some of these devices may use a power source
or a video screen to augment vision. These
are features that Congress was clearly not addressing in the statutory language
regarding eyeglasses when this language was included in the statute years ago. After such an individualized evaluation, if
it is determined that the device falls under a Medicare benefit category,
coverage criteria should be established by CMS.
For example, a video monitor used to aid extremely low
vision clearly meets Medicare’s four-pronged definition of durable medical
equipment (DME) in that it can withstand repeated use, is primarily and
customarily used to serve a medical purpose, generally is not useful to an
individual in the absence of an illness or injury and is appropriate for use in
the home. Therefore, Medicare should
develop a set of coverage standards for video monitors allowing appropriate individuals
with low vision access to this medically necessary technology. CMS should assess other technologies through
a similar process for purposes of Medicare coverage.
Conclusion:
The ITEM Coalition strongly recommends that CMS reconsider
its proposal to preemptively disqualify all low vision aids which utilize a
lens from Medicare coverage. Many of
these types of devices could assist individuals in completing activities of
daily living, thereby improving their health and independence. This proposed coverage exclusion will prevent
access to currently available vision aids for people with vision impairments as
well as decrease the development of new and innovative vision technology for
people with disabilities. We encourage CMS
to evaluate the medical/functional purpose of each assistive device and
technology at issue and establish individualized coverage decisions.
Additionally, the ITEM Coalition would be remiss if we did
not relate this proposal to the general pattern being displayed by CMS when it
comes to coverage of assistive technology and the interpretation of the Medicare
statute and regulations. While we
recognize the need for budgetary restraint on the part of the agency, we believe
that that agency does not adequately weigh the real-life value of assistive
technology for people with disabilities against the cost of covering such
technology for appropriate beneficiaries. For many people with disabilities, assistive
technology is often an essential factor in improving or maintaining one’s
health status, maintaining independence, living safely, returning to work or
school, and participating in community activities.
Members of the ITEM Coalition have been vocal in their opposition
to Medicare’s restrictive interpretation of the “in the home” language under
the definition of DME. Members have also
expressed serious concern with the recent iBOT Mobility System proposed
coverage decision which essentially denies coverage of this device. Now, CMS is proposing an expansive exclusion
of all vision technology which contains a lens of any kind because of statutory
language that narrowly excludes Medicare coverage of “eyeglasses.”
The ITEM Coalition urges Medicare to seriously consider the
impact of its restrictive interpretations of the statute and regulations on the
basic health and independence needs of people with disabilities. The fluidity and, often, ambiguity of the
Medicare statute allows CMS important opportunities to provide beneficiaries
with life-changing and innovative assistive devices. We request that Medicare embrace these
opportunities for the benefit of people with disabilities.
Thank you for this opportunity to comment.
Sincerely,
The ITEM Coalition Steering Committee
Mark Richert
American Foundation for the Blind
Lee Page
Paralyzed Veterans of America
Peter Thomas
CCD Health Task Force
Alain Perry
United Spinal Association
Zi-Xiang Shen
Medicare Rights Center
Attachments: List of
ITEM Coalition Members
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