These comments are submitted on behalf of the Steering Committee of a national, consumer-led coalition known as the “ITEM” Coalition, which is an acronym for Independence Through Enhancement of Medicare and Medicaid. The ITEM Coalition was formed in 2003, and its over 70 member organizations include a diverse set of disability organizations, aging organizations, other consumer groups, labor organizations, voluntary health associations, and non-profit provider associations. The ITEM Coalition’s purpose is to raise awareness and build support for policies that will improve access to assistive devices, technologies and related services for people of all ages with disabilities and chronic conditions. From coverage for hearing aids to augmentative communication 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.

We wish to express our concerns over the implementation of “Power Wheelchairs and POVs – Policy Clarification and Medical Review Strategy” (the “Policy Clarification” or “Clarification”) issued in December, 2003 to address two points of the 10-point initiative released by CMS and the Office of the Inspector General (“OIG”) on September 9, 2003. The Steering Committee recognizes the importance of the federal government’s efforts to combat fraud in the purchase of mobility devices under Medicare’s durable medical equipment benefit, as scarce resources are needed to meet beneficiary need in this area.

However, we have serious concerns regarding the unintended consequences and potential harm to beneficiaries under the Policy Clarification, as well as the process of development, clarity, efficacy and scope of the Clarification. In short, this Policy Clarification raises more questions than it answers. The Steering Committee’s concerns and questions include the following:

Potential Harm to Beneficiaries under the Policy Clarification

Reinforces Restrictive “In the Home” Requirement. The Policy Clarification reinforces the policy that Medicare only covers mobility devices that are medically necessary in the patient’s home. The DMERCs have stated in writing that “[a]lthough a power wheelchair may be useful to allow the beneficiary to move extended distances, especially outside the home, Medicare statute and national policy do not currently provide coverage for those uses.” However, the DMERCs do not identify the source in the statutes for this proposition, which begs certain questions: (a) Where specifically does the Medicare statute state this “in the home” restriction? (b) What evidence of Congressional intent exists that supports this “national policy?”

Other pressing questions on the “in the home” requirement include:

• Is not a “national policy” that restricts a mobility device benefit to the confines of a person’s home, with no recognition or value placed on a person’s need to interact within their community, irrational on its face?

• Can CMS cite specific statutory language or congressional intent that the “in the home” restriction was meant to permit coverage of only those mobility devices that are considered medically necessary in the four walls of the home rather than mobility devices that are provided to beneficiaries outside of an institution such as a hospital or skilled nursing facility?

• Does CMS have any intention of reconciling the Ticket to Work law, which seeks to encourage SSDI/Medicare beneficiaries to return to work by extending Medicare coverage to them, with the policy that Medicare does not cover the very mobility devices that would allow certain beneficiaries to leave their homes and return to the workplace?

• The current Certificate of Medical Necessity (“CMN”) asks the treating physician to certify the following question: “Does the patient require and use a wheelchair to move around in their residence?” CMS thus correctly recognizes a person’s need for a mobility device without requiring that person to be completely immobilized by disability. How does CMS reconcile the Policy Clarification with the existing CMN?

• The Policy Clarification does not address the large and building body of clinical studies and other data that establish a correlation between long term manual wheelchair use and pain/weakness in the upper extremities, which often results in medical interventions for secondary conditions such as carpal tunnel syndrome, tendonitis, and rotator cuff injury. Why did CMS and the DMERCs not take evidence-based practice into consideration when determining the coverage policy for power wheelchairs? Would it not be cost-effective to do so?

• The need for the issuance of the Policy Clarification seems to ultimately stem from the inadequacy of the HCPCS coding system as it relates to power wheelchairs. The vast majority of power wheelchairs are billed under the HCPCS code K-0011, despite the fact that a wide variety of power wheelchairs are available on the market today. Different beneficiaries have different needs, yet CMS’ current system assumes one-size fits all. Why has CMS not adopted more specific billing codes and differential reimbursement for these codes in order to more effectively track Medicare’s purchases in this area to ensure that beneficiaries are getting what they need and the program is not being overcharged?

Failure to Seek Public Comment for Policy Changes

The ITEM Coalition is concerned about the process used by CMS and the DMERCs to develop the Policy Clarification, which was issued without notice or an opportunity for the public to comment:

• As described above, the Policy Clarification implements a new policy that limits access to wheelchairs to those who are considered nonambulatory or bed and chair confined. With such a stark difference between the longstanding standard and the more restrictive interpretation, can CMS really claim that this is a mere “clarification” of existing policy, rather than a substantive change in coverage policy? Doesn’t this change in policy rise to the level of requiring public notice and comment so that experts in the field as well as beneficiaries could make their viewpoint known before the policy took effect?

• The Policy Clarification uses the concept of the patient being able to “bear weight” in order to transfer from a bed to a chair or wheelchair, stating that if a patient “can bear weight to transfer from a bed to a chair or a wheelchair, the patient is considered nonambulatory.” Many people never bear weight when transferring from a bed to a chair or a wheelchair (e.g., they use devices like a sliding board to transfer or an attendant uses a hoyer lift to transfer the person from bed to chair). But these same persons require a wheelchair to be mobile. What authority exists in the statute, regulations, or carrier manual to support the use of the concept of a patient being able to “bear weight” as part of the coverage criteria?

Lack of Clarity

The Policy Clarification fails to define many terms that could be interpreted to severely restrict access to wheelchairs even when beneficiaries are otherwise eligible for the wheelchairs. As described above, the Clarification states that “[i]f a patient can bear weight to transfer from a bed to a chair or a wheelchair, the patient is considered nonambulatory.” It also states that that power wheelchairs are only covered if the patient is nonambulatory and the “patient is unable to self-propel a manual wheelchair within their home.” However, these provisions in the Clarification raise more questions than they resolve:

• The Policy Clarification fails to establish objective criteria to allow a physician to determine if a patient is “nonambulatory.” How many steps may a person take before he or she is considered “ambulatory,” and therefore, not eligible for wheeled mobility? One step? Two steps? Five? Ten?

• What if the person in need of wheeled mobility has a condition with waxing and waning symptoms such as Multiple Sclerosis or other neurological or musculoskeletal conditions? If a person can walk five steps on Monday, but cannot even bear weight in a standing position on Thursday, will a wheelchair be denied as not medically necessary?

• Will CMS and the DMERCs give any consideration to the expected course of progression of a person’s condition during the prospective 5-year time period? If not, will CMS and the DMERCs be willing to cover and reimburse a new power wheelchair when a manual wheelchair is no longer adequate, despite the fact that the manual chair is well within the 5-year useful life of the device? What financial impact will this have on the program? Will CMS and the DMERCs force such persons to rent a manual device so as not to have to pay for two devices within a relatively short period of time?

• The term “self-propel” is not defined in the policy. Will CMS and the DMERCs consider the level of fatigue that might occur in patients with cardiovascular, pulmonary, or neurological conditions? What time of the day will this determination be made? If a person can generally self-propel himself or herself throughout the home in the morning but is unable to do so later in the day because of fatigue, will the person be denied a power wheelchair?

Lack of Efficacy and Excessive Scope of Policy Clarification

The ITEM Coalition has several concerns regarding the efficacy and breadth of the Policy Clarification, which risks significant harm to beneficiaries, as outlined above, in the name of stopping fraud. These concerns include the following issues and questions:

• CMS has failed to explain how the specific provisions in the Policy Clarification will help prevent fraud. If an unscrupulous person is truly preying on Medicare beneficiaries to exploit the program through blatantly fraudulent means, how does CMS specifically envision the Policy Clarification identifying and eliminating this type of activity?

• The Policy Clarification was issued to respond to a large increase of Medicare expenditures for power wheelchairs and POVs. Why then, did CMS and the DMERCs issue a policy that restricts access to manual wheelchairs as well?

• The Policy Clarification was designed to reduce fraud and abuse in the Medicare power wheelchair benefit. Has CMS conducted an analysis to determine what portion of the increases in expenditures were truly the result of fraudulent activity and what portion were attributable to other factors, such as greater awareness of the Medicare mobility benefit, greater acceptance of wheeled mobility by the general public, greater expectations of life after disability due to civil rights laws and changing attitudes toward disability, greater use of mobility devices by beneficiaries with particular medical conditions? In short, has CMS examined what portion of the increased expenditures were justified?

• In 1990, multiple Medicare carriers were consolidated into the four DMERCs and the SADMERC was also created with, among other things, the express purpose of monitoring and analyzing trends in claims submissions in order to track instances of overutilization and potential fraudulent activity. What explains the delay in identification of spikes in claims in certain areas of the country (e.g., Houston, Texas)? Why is CMS’s reaction, i.e., the Policy Clarification, so broad in scope so as to be perceived by the disability community as a punishment for the failing of the system?

Thank you for your consideration of our concerns. On January 23, 2004, members of the ITEM Coalition Steering Committee sent a letter to Secretary Tommy Thompson urging that the Policy Clarification be rescinded and a new proposed policy be developed, issued, and made available for public comment. In addition, the letter requested a meeting with the Secretary to further discuss the Coalition’s concerns with the Policy Clarification. To date, no meeting has been scheduled, and the Steering Committee renews its request for a meeting with Secretary Thompson.

For more information on the ITEM Coalition, please go to www.ITEMCoalition.org.

Sincerely,

Lee Page Paralyzed Veterans of America ITEM Coalition Steering Committee Member		Henry Claypool Advancing Independence: Modernizing Medicare and Medicaid ITEM Coalition Steering Committee Member
Paul W. Schroeder American Foundation for the Blind ITEM Coalition Steering Committee Member		Peter W. Thomas Consortium for Citizens with Disabilities Health Task Force ITEM Coalition Steering Committee Member

ITEM Coalition Writes to HHS About Medicare Clarification on Power Mobility (3/12/04)

ITEM Coalition Commends Senator Grassley's Letter to CMS on Power Mobility Policy Clarification

Letter from Senator Grassley to CMS on Power Mobility Policy Clarification (PDF Version)

ITEM Coalition Writes to HHS About Medicare Clarification on Power Mobility (1/23/04)