November 7, 2006

Leslie V. Norwalk, Esq.
Acting Administrator
Centers for Medicare and Medicaid Services
200 Independence Ave, SW, Room 310-G
Washington, D.C. 20201

RE: Meeting Request Regarding "Low Vision Aid Exclusion" in Proposed Competitive Acquisitions for DMEPOS Regulation

Dear Acting Administrator Norwalk:

The undersigned organizations are writing to express our continued concern with a specific provision in the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Acquisition Proposed Rule issued May 1, 2006 referred to as the "Low Vision Aid Exclusion," and to request a meeting with you to discuss this potentially harmful provision for individuals with vision impairments.

To the surprise of many organizations, the DMEPOS Competitive Acquisition Proposed Rule contain a provision entitled "Low Vision Aid Exclusion" which 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. We believe this extremely restrictive reading of the "eyeglass" exclusion would result in the denial of vital assistive devices for seniors and other Medicare beneficiaries who may have disabilities, particularly those with vision loss, who need to use such devices to live healthy, safe and independent lives.

Impact of the Proposed Exclusion

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. 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 lenses 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 and other important materials.

In short, these devices allow individuals with low vision to live independently and safely and perform activities of daily living.

While the immediate impact of this unreasonably narrow interpretation of the eyeglass exclusion would be a decrease in access to current devices, the proposal will have an even more detrimental impact in the long-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 loss.

We believe that this preemptive coverage denial is particularly harmful because it serves as a tremendous disincentive to innovators and researchers to develop new and progressive vision technology. Medicare coverage policies often drive the coverage policies of private health plans, which are influential when it comes to investments in research and development. If Medicare establishes this preemptive coverage exclusion for low vision aids, we will undoubtedly see a decrease in innovation in this area.


We recognize that the Centers for Medicare and Medicaid Services (CMS) has the authority to reasonably interpret the Medicare statute, however, we believe that this categorical low vision aids exclusion is unreasonable. When Congress included the eyeglasses exclusion in the Medicare statute, there was clearly no congressional intent to prohibit coverage for any future low tech or high tech devices that would be available simply because such devices might make use of a lens. We believe that Congress' use of the term "eyeglasses" was simply intended to apply to traditional eyeglasses that fit on one's nose and around one's ears.

Therefore, we recommend that all vision aids with one or more lens, other than traditional eyeglasses, should be considered by CMS for a Benefit Category Determination (BCD) and evaluated on the medical/functional purpose of each assistive device, on a case-by-case basis. 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 clearly did not intend to address in the statutory language regarding eyeglasses when this provision was included 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.


We strongly recommend 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. 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.

Several of the organizations below met with Dr. McClellan on July 26, 2006 to discuss this and several mobility device issues. At that time, Dr. McClellan was interested in learning more about the "low vision aids" issue and stated the he would examine this proposal further. Now that the final DMEPOS competitive bidding acquisition rule is soon to be released, we would like to meet with you to discuss this issue further--prior to the release of the final rule. A representative of the American Foundation for the Blind (AFB) will be contacting you shortly on our behalf to schedule this meeting. In the alternative, we would welcome hearing from you to schedule this important discussion at the earliest possible opportunity. Please contact:

Mark Richert
Director, Public Policy
American Foundation for the Blind
(202) 408-8175

Thank you for your consideration and we look forward to meeting with you.


Alexander Graham Bell Association for the Deaf and Hard of Hearing
American Academy of Physical Medicine and Rehabilitation
American Association of Diabetes Educators
American Association of People with Disabilities
American Council of the Blind
American Congress of Community Supports and Employment Services (ACCSES) and Disability Service Providers of American (DSPA) Alliance
American Foundation for the Blind
American Medical Rehabilitation Providers Association
American Occupational Therapy Association
Amputee Coalition of America
Assistive Technology Industry Association
Association for Education and Rehabilitation of the Blind and Visually Impaired
Association of Assistive Technology Act Programs
Better Vision Institute
Blinded Veterans Association
Council of Citizens with Low Vision International
Hearing Loss Association of America
Helen Keller National Center
Medicare Rights Center
National Association for Home Care & Hospice
National Coalition on Deaf-Blindness
National Council on Independent Living
National Disability Rights Network
National Stroke Association
Rehabilitation Engineering and Assistive Technology Society of North America
The Arc of the United States
Topeka Independent Living Resource Center
United Cerebral Palsy
Vision Council of America