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					                                                              Clinician Task Force Co-coordinators

                                                              Barbara Crane, PhD, PT, ATP
                                                              Assistant Professor
                                                              University of Hartford
                                                              180 Middletown Avenue
                                                              Wethersfield, CT 06109
                                                              Barb.crane@cox.net
                                                              (860) 529-4936

                                                              Laura Cohen, PhD, PT, ATP
                                                              Clinical Research Scientist
                                                              2020 Peachtree Rd NW
                                                              Shepherd Center
                                                              Atlanta, GA, 30309
                                                              Lauracohen2004@yahoo.com
                                                              (404) 350-3082


March 6, 2005

Elizabeth Truong
Shamiram Feinglass, MD, MPH
Lead Analysts, NCA Tracking Sheet for Mobility Assistance Devices
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Baltimore MD 21244-1850

RE: Comments on Draft Decision Memo for Mobility Assistance Equipment (CAG-00274N)

Dear Ms. Truong and Dr. Feinglass,

The Clinician Task Force (CTF) sincerely desires to support CMS in their move toward
functional-based criteria for coverage. To this end, we are submitting detailed recommendations
for language changes to Appendix-A, Clinical Criteria for MAE Coverage. In response to your
request for necessary documentation, the CTF submits a separate document outlining our
recommendations. In addition, we must reassert our concerns for issues such as the "In-the-
Home" restriction and the need for specifying the involvement of a skilled and knowledgeable
clinician. The CTF has shared a number of concerns re these issues. Not the least of which is
the negative impact, if unresolved, the issues will have on the development of a functional-based
criteria coverage policy. Within this document, we offer our perspective of how these issues will
undermine CMS's efforts to successfully create and implement functional-based coverage
criteria. We ask that CMS seriously consider our concerns in how these issues will affect this
specific purpose of this NCD.



Contents:       Comments on draft decision memo
                Appendices
                CTF Member List




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I. The Clinician Task Force commends CMS for proposing to delete the “bed or chair
confined” criterion currently used to determine if a wheelchair is reasonable and
necessary.

The Clinician Task Force agrees with CMS in its proposal to eliminate the ―bed or chair
confined‖ criterion and move to a functional-based clinical criteria and assessment.

II. The NCD-Draft Memo fails to recognize as a problem or appropriately address the “in
the home” restriction. CMS states “An NCD would not be the appropriate mechanism to
change this rule,” but fails to offer any information as to what the appropriate mechanism
would be. This restrictive interpretation of this benefit severely impairs the ability to draft
a coherent policy based on functional criteria and current clinical practice.

CMS has failed to address this critical issue, other than to state the following, in reference to
public comments:

               “Some commenters asked CMS to extend the criteria to include
               activities conducted outside of the home environment. Medicare
               law lists certain items of durable medical equipment (DME) used
               in a patient‟s home for which Medicare payment may be made,
               including wheelchairs. The regulations, 42 C.F.R. § 414.202,
               further define DME as equipment 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.
               An NCD would not be the appropriate mechanism to change that
               rule.”

   A. The NCD-Draft Memo response is inadequate and misleading. The following three
   points illustrate the limitations of CMS response in this area.

       1. Public Response to In-the-Home restriction:
       A review of the public comments posted in response to the IWWG report as of January
       28, 2005 revealed that 83% of the 158 respondents made statements against this
       restriction, with 1% (two respondents) in favor of the current policy. Respondents urging
       CMS to address this issue and create an NCD process that will allow beneficiaries access
       to environments outside the boundaries of their dwelling included:
           Healthcare or related professionals.
           Professional organizations or groups.
           Advocacy, service and diagnostic organizations.
           Clinical and medical centers.
           Wheelchair users, their proxies, and concerned individuals.
           Industry.
           State or federal programs or affiliates administering state or federal programs.


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 (Refer to Appendix-III: Table of Respondents - Public Comments for Mobility
 Assistance Devices (CAG-00274N) for respondent details.)

 In addition to the public comments, CMS has received formal reports, position
 statements, and letters critical of this restriction, typically including substantive
 arguments urging CMS and the Federal Government to modernize Medicare coverage
 policy by eliminating the restrictive in-the-home interpretation (Refer to Appendix-II:
 Alphabetical Listing of Organizations – Formal Reports, Position Statements, and Letters
 Submitted for a list of the 38 organizations included). In fact even the IWWG reported
 that, ―Some panel members noted that extending the coverage criteria to explicitly
 include mobility related tasks performed outside of the home (for example, shopping for
 food) would facilitate greater functional independence.‖ Unfortunately, CMS issued
 instructions to the IWWG to work within the agency‘s coverage interpretation of ―used in
 the patient‘s home‖. In doing this, CMS interfered with the IWWG‘s role and process.
 The IWWG members, although mentioning spirited debate amongst their members,
 accepted this restriction, which restricted the applicability of all their recommendations.

 By sustaining the outmoded restrictive policy, CMS contradicts policies already in effect
 in other branches of the Federal government, well-recognized professional organizations
 and documents on international standards defining disability.

     Resources:

           The Code of Federal Regulations, Title 20—Employees' Benefits, CHAPTER
            III—Social Security Administration, Appendix 1 to Subpart P of Part 404— in
            Section 1.00B2b(2) of the Listing of impairments, describes that effective
            ambulation extends beyond the confines of the home (SSA, 2003).

                    (2) The ability to walk independently about one's home
                    without the use of assistive devices does not, in and of
                    itself, constitute effective ambulation.

           Mobility needs include participation in activities within the full range of life
            areas as identified in the World Health Organization‘s International
            Classification of Functioning, Disability and Health (WHO, 2001). This
            essential need is expressed throughout the document and easily visible within
            the structure of the document itself. The WHO International Classification of
            Function describes Activities and Participation in nine chapters:
                    1) Learning and Applying Knowledge
                    2) General Tasks and Demands
                    3) Communications
                    4) Mobility
                    5) Self-care
                    6) Domestic Life
                    7) Interpersonal Interactions and Relationships
                    8) Major Life Areas

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                    9) Community, Social and Civic Life

            Section 4: Mobility describes moving around in different locations, outside
            the home and in other buildings.

           In 2001, a letter was submitted by the Assistive Technology Law Center to the
            New Freedom Initiative Group, Department of Health and Human Services,
            RE: Barriers to Community Integration and Participation by Individuals with
            Disabilities.
                o This letter responded to the DHHS Secretary‘s invitation by
                   ―addressing a Medicare policy-interpretation that is among the most
                   significant barriers to individuals with disabilities achieving [those]
                   stated goals‖.
                o Organizations participating in the coalition: American Association of
                   Home Care, American Association of People with Disabilities,
                   American Occupational Therapy Association, American Physical
                   Therapy Association, Consortium For Citizens with Disabilities, THE
                   MED Group, National Association of Protection & Advocacy
                   Systems, RESNA, Sunrise Medical, VGM.
                o This report includes clear evidence of the clinical necessity of mobility
                   outside of the home and requested, ―that the Department immediately
                   undertake to replace the ‗used in the patient‘s home‘ interpretation‖.

 2. Restrictive Interpretation of the regulation:
 The cited regulation, “42 C.F.R. § 414.202 . . . 4) is appropriate for use in the home”
 does not state that the appropriateness is for use only in the home. However, CMS‘
 current restrictive interpretation does apply this limitation. A notable difference exists
 between changing a regulation and changing an interpretation. The current strict
 interpretation is arbitrary and ultimately discriminatory against persons needing wheeled
 mobility to function at their highest possible level.

 The Clinician Task Force joins the numerous organizations and public commenters to,
 once again, formally call for CMS‘ long overdue attention to this issue. We ask that CMS
 address the issue with more substance than simply indicating what is not the perceived
 best mechanism.

 The Clinician Task Force shares the following view with 37 other organizations that have
 formally addressed this issue (Appendix-II): The in the home interpretation is in conflict
 with a series of federal statutes aimed at preventing discrimination against persons with
 disabilities, and that there is no evidence Congress intended that durable medical
 equipment would not be covered if it were also used outside of the home (AOTA, 2005;
 AMA, 2004; Medicare Rights Center, 2004; AAPM&R, 2003; Assistive Technology
 Law Center, 2001; Consortium for Citizens with Disabilities, 2001), nor that the
 specifications of the equipment have to be limited to in-home use only. The phrase ―used
 in the patient‘s home‖ was intended to define DME devices (and related services) that
 were provided outside an institution. It is reasonable to interpret that Congress fully

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       intended the restriction not as a structural limitation, within the beneficiary‘s dwelling,
       but to distinguish ―home‖ from a hospital or skilled nursing facility where other sources
       of coverage are employed. This is indicated by what follows immediately after the "used
       in the patient's home" phrase in 42 U.S.C. § 1395x(n). It expressly says that individuals
       living in 1395x(e)(1) facilities – hospitals, or 1395i-3(a) facilities -- skilled nursing
       facilities -- are excluded. But over time, the in-home criterion was used to limit coverage
       of DME to that which was only medically necessary within the four walls of the
       beneficiary‘s home.

       3. What is the Appropriate Mechanism to Address this Issue?
       CMS has received abundant requests, formal appeals, and public comments, as outlined
       above. CMS‘ reply, with no indication as to the appropriate mechanism to change the
       interpretations, would appear non-responsive to the many concerned petitioners.

In summary, CMS should publicly recognize the problems associated with this restrictive
interpretation and if CMS believes that the NCD process is not an appropriate mechanism to
address its own interpretation of the law, then CMS should formally advise those concerned as to
what steps CMS will take to change this interpretation.


   B. Clinical Issues: The current, highly restrictive CMS interpretation of “in the home”
   precludes a clinician’s ability to follow fundamental principles of basic healthcare
   provision.
      1.The Clinician Task Force is concerned that clinicians will be unable to ethically
      practice under this restrictive interpretation for the following reasons:
           A concern for the ultimate heath and safety of the individuals we serve
           The pursuit of realistic and meaningfully functional outcomes of MAE
              intervention
           That all recommendations for MAE are based on sound, thorough clinical
              principles and practice
           Recognition of and response to the long-term impact of mobility on the
              individual‘s physical and mental health

       2. The in the home restriction leads to inappropriate equipment for a beneficiary‘s true
          environmental requirements, placing the beneficiary at risk for morbidity or injury
           Equipment specified for in-home use would in many cases be different than
              equipment used both in and outside the home during typical daily activities.
           By following the in-home criteria for reimbursement, equipment provided has
              limited capability to truly meet the multi-environment mobility needs of the
              beneficiary
           Beneficiaries become confined to their homes due to equipment limitations - the
              beneficiary cannot effectively use the equipment in environments outside the
              home
           Safety issues arise when a beneficiary uses MAE outside the home that was
              appropriate for in-the-home environment only (as required by CMS)


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          A beneficiary‘s long-term health is compromised when restricted to the home or
           when using equipment in environments outside the home, not considered in the
           clinical criteria.
          MAE may repeatedly break down, require a higher frequency of maintenance, and
           require premature replacement when it is prescribed for in-home use only, while
           used by the beneficiary in multiple environments outside the home. This not only
           increases equipment maintenance costs, it causes undue hardship on the user,
           contending with frequent breakdowns and unavailability of equipment while
           being repaired.

   3. The in the home restriction diminishes CMS‘s ability to develop a functional and
   usable Clinical Criteria for determination
   Despite The Clinician Task Force‘s strong support for CMS‘s proposal to move toward
   function-based clinical criteria for MAE determination and coverage, we see the current
   in-home-only interpretation as innately disabling to this process:
        It hinders CMS‘s ability to successfully develop a realistic functional criteria-
          based assessment
        It inhibits a clinician‘s ability to follow and implement the clinical criteria within
          fundamental standards of practice

C. Clinician Task Force RECOMMENDATIONS:

1. Eliminate the ―used in the patient‘s home‖ interpretation of this benefit. In its place
   should be a standard of functional need for wheelchairs and other mobility devices that is
   based on an individual‘s ability to meet the mobility needs arising during the course of
   his or her daily activities, in typically encountered environments.
2. CMS should initiate the appropriate steps to eliminate this restricted interpretation
   immediately.




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III. The suggestions for “Guidelines for Appropriate Provision of Wheelchairs,” as
reported in item number 7 (expert opinion) of the draft memo and reproduced in Appendix
A include several inconsistencies and troubling omissions. In addition, the materials
presented are unclear as to how they apply to individuals who are dependent on others for
all activities and functions. These limitations seriously impede standard clinical practice in
provision of mobility assistance equipment. As a result of the identified problematic areas,
The Clinician Task Force submits the following proposed revisions to the section labeled
“Appendix A” in the draft decision memorandum.


                                         APPENDIX A
                              Clinical Criteria for MAE Coverage

The beneficiary, the beneficiary‘s family or other caretaker, or a clinician will usually initiate the
discussion and consideration of wheelchair use. Sequential consideration of the questions below
provides clinical guidance for the prescription of equipment of appropriate type and complexity
to restore the beneficiary‘s ability to move around and perform functional activities. These
questions correspond to the numbered decision points on the accompanying flow chart. All
wheeled mobility devices (manual, POV, and powered wheelchairs) require the additional
consideration of appropriate seating interfaces including seat systems that facilitate position
change. When documented historical and examination evidence exists, clinicians can use this
documentation to determine if ambulation equipment, manual wheelchair, and scooter trials are
needed during the course of an evaluation.

   1. Is the beneficiary able to functionally ambulate? Functional ambulation means:
            a. The ability to walk consistently, safely and sufficiently to carry out all of the
                beneficiary‘s typical daily functions and activities. (Inability to functionally
                ambulate may be caused by one or more medical conditions causing pain or
                impairing strength, endurance, coordination, balance, speed of execution,
                sensation or joint range of motion sufficiently to prohibit functional ambulation.)
            b. The determination of functional ambulation status requires an evaluation of
                whether a beneficiary is consistently able to safely balance and walk at a
                reasonable rate of speed, without companion assistance, the distances necessary to
                complete all typical daily activities. The beneficiary must also demonstrate the
                endurance to do these activities. The beneficiary is considered to be ―unable to
                functionally ambulate‖ if he/she lacks functional ambulation in a setting which
                the beneficiary would be expected to routinely encounter.

   2. Can the functional ambulation deficit be sufficiently resolved by the prescription of a cane
       or walker?
           a. If an equipment trial is indicated, the cane or walker should be appropriately fitted
                to the beneficiary for this determination.
           b. Assess the beneficiary‘s ability and willingness to safely and effectively use a cane
                or walker to accomplish all typical daily functions and activities. Safety
                considerations include personal risk to the beneficiary as well as risk to others.

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       c. A history of unsafe behavior or falls should be considered.

3. Does the beneficiary have sufficient function in his or her extremities to self propel a
    manual wheelchair adequately to perform all typical daily activities?
       a. If an equipment trial is indicated, the manual wheelchair should be optimally
           configured (seating options and configuration of rear wheel position, wheelbase,
           device weight and other appropriate accessories) for this determination.
       b. Limitations of strength, endurance, range of motion, coordination and absence or
           deformity of one or more extremities are relevant.
       c. Temporary or permanent, and static or progressive nature of the functional mobility
           impairment is relevant.
       d. A beneficiary with sufficient extremity function may qualify for a manual
           wheelchair. The appropriate type of manual wheelchair, i.e. light weight, power
           assisted, etc. should be determined based on the beneficiary‘s physical
           characteristics, environmental needs and anticipated intensity of use.
       e. The beneficiary's typical environments should provide adequate access,
           maneuvering space and surfaces for the operation of a manual wheelchair.
       f. Assess the beneficiary‘s ability to safely and efficiently use a manual wheelchair to
           accomplish typical daily functions and activities.
       g. Safety considerations include personal risk of injury or compromise in health status
           for the beneficiary as well as risk to others. This includes careful consideration of
           the potential for secondary injuries to the shoulders or other upper extremity joints
           resulting from long term use of a manual mobility system by an individual with a
           compromised musculoskeletal or neurological system.
       h. A history of unsafe behavior should be considered.
       i. All seating and positioning needs must be considered including, but not limited to
           specialized postural support, tilt or recline systems and additional positioning
           equipment necessary for pressure management and independent or dependent
           changes in body position.

4. Does the beneficiary have sufficient strength and postural stability to operate a power-
    operated vehicle (POV/scooter)?
       a. A POV is a 3 or 4-wheeled device with tiller steering and limited seat modification
           capabilities. The beneficiary must be able to maintain stability and position for
           adequate operation.
       b. The beneficiary's typical environments should provide adequate access,
           maneuvering space and terrain for the operation of a POV.
       c. Assess the beneficiary‘s ability to safely use a POV/scooter to accomplish typical
           daily functions and activities. Safety considerations include personal risk to the
           beneficiary as well as risk to others.
       d. Consideration should be given to a predictable rate of change in physical/ cognitive
           functioning due to a progressive condition.
       e. A history of unsafe behavior should be considered.
       f. All seating and positioning needs must be considered including, but not limited to
           specialized postural support, tilt or recline systems and additional positioning



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           equipment necessary for pressure management and independent or dependent
           changes in body position.

5. Will the beneficiary‘s mobility limitations be properly addressed through the application
    of a powered wheelchair?
        a. These devices are usually controlled by a joystick or alternative input device, and
            can accommodate a variety of seating needs.
        b. The beneficiary's typical environments should provide adequate access,
            maneuvering space and terrain for the operation of a power wheelchair.
        c. Assess the beneficiary‘s ability to safely use a power wheelchair to accomplish
            typical daily functions and activities. Safety considerations include personal risk
            to the beneficiary as well as risk to others.
        d. Consideration should be given to a predictable rate of change in physical/ cognitive
            functioning due to a progressive condition.
        e. A history of unsafe behavior should be considered.
        f. All seating and positioning needs must be considered including, but not limited to
        specialized postural support, tilt or recline systems and additional positioning
        equipment necessary for pressure management and independent or dependent changes
        in body position.

6. Is the beneficiary unable to independently and safely operate any type of mobility
    assistance device, such as canes, walkers, manual wheelchairs, POV‘s/scooters or
    powered wheelchairs due to other conditions that limit the beneficiary‘s ability to
    perform typical daily functions and activities?
        a. Some examples are significant impairment of physical function, cognition or
            judgment and/or vision.
        b. If the beneficiary is unable to independently operate any type of mobility
            assistance device due to these other limitations, a dependent mobility device
            should be considered.
        c. All seating and positioning needs must be considered including, but not limited to
            specialized postural support, tilt or recline systems and additional positioning
            equipment necessary for pressure management and independent or dependent
            changes in body position.




 Coalition to Modernize Medicare Coverage Policy for Mobility Products (CMMCMP)
                            www.cliniciantaskforce.org
                            Clinical Criteria Algorithm for Wheelchair Prescribing
Request initiated for mobility
  device for beneficiary



 1. "Is beneficiary able to             Yes
                                                                                                                              Not R & N
 functionally ambulate?"

            No

                                                                                                                 Canes
        2. Able to use            Yes                  Safe and functional          Yes                        or walkers
        canes/walkers?                                using cane/ walker?                                    No additional
                                                                                                             documentation
            No                                                        No



                                                Safe and                                                              MWC future and
                                 Yes                                  Yes    Environment supports     Yes             anticipated need,
     3. MWC Self-propel?                  functional to perform
                                                                                 manual chair?
                                            typical activities?                                              safety, function and configuration
                                                                                                                   must be documented
                                                                              No
            No
                                                        No



                                 Yes                Safe and                                          Yes        POV future and anticipated need,
            4. POV?                           functional to perform
                                                                       Yes      Environment
                                                                                                                       safety and function
                                                                               supports POV?
                                                typical activities?                                                   must be documented

            No
                                                         No                    No


                                                    Safe and                                                     PWC future and anticipated need,
                                 Yes                                   Yes                             Yes
      5. PWC appropriate?                     functional to perform            Environment supports            safety and function and configuration
                                                typical activities?                   PWC?                              must be documented

            No                                                                        No

                                                                                            Dependent manual wheelchair base future
   6. Unable to independently    Yes
        use any device
                                                                                              and anticipated need, safety, function
                                                                                               and positioning system as indicated




                 Coalition to Modernize Medicare Coverage Policy for Mobility Products (CMMCMP)
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IV. Additional comments re: CMS Draft Decision Memo

A. Two fundamental principles are overlooked within the proposed Draft-NCD:
              1) Mobility is a well-established activity of daily living and recognized as a
                    necessary functional activity
              2) The primary function of a wheelchair is to compensate for a mobility
                    deficit.
   By not including mobility as an ADL, CMS creates an unnecessary challenge to then
   justify how a mobility/ADL-dependent user would qualify for equipment fundamentally
   specified for the very purpose of assisting in mobility (i.e. Mobility Assistance
   Equipment)

   1. Mobility is a fundamental Activity of Daily Living (ADL).
   The American Occupational Therapy Association Occupational Therapy Practice
   Framework: Domain and Process provides a comprehensive list of ADLs, which includes
   functional mobility, defined as follows (AOTA, 2002):
          “Moving from one position or place to another [during performance of
          everyday activities], such as in-bed mobility, wheelchair mobility,
          transfers (wheelchair, bed, car, tub, toilet, tub/shower, chair, floor).
          Performing functional ambulation and transporting objects.”

   Mobility, with or without assistance is recognized as a functional activity by the World
   Health Organization (WHO, 2001).

   During the recent development of an outcome measurement tool (The Functioning Everyday
   with a Wheelchair [FEW]) at the University of Pittsburgh, a systematic review of the English
   language scientific literature from 1994 through July 2004 yielded 20 studies that utilized or
   described the development of performance-based observable outcome measurement tools
   specifically to measure functional capacity and performance in wheelchair users. Of the
   reviewed studies, indoor mobility was the most frequently cited and included in 17 of the 20
   studies. This was followed by items related to operating the wheelchair (15 studies), and the
   tasks of getting around outdoors. It has been cited throughout the scientific literature related
   to wheelchair mobility that ―mobility‖ whether it be indoors, outdoors, or mobility related to
   a person‘s ability to operate an MAE is an important task that needs to be included and
   measured in any functional outcome measurement tool.

   The Clinician Task Force supports the fact that mobility, (moving from place to place and
   adjusting one‘s own position or posture in one place) is, in and of itself, a necessary activity
   of daily living and an internationally accepted component of treatment and intervention
   throughout the fields of Rehabilitation and Health Sciences.

   2. The primary function of a wheelchair is to compensate for a mobility or functional
   ambulation deficit.
   Miller-Keane Encyclopedia & Dictionary of Medicine, Nursing, & Allied Health defines a
   wheelchair as (O‘Toole, 1992):



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           “a means of locomotion for non-ambulatory individuals, consisting of a
           seat on a platform with wheels, which provides comfortable, safe sitting,
           and a steering mechanism. The disabled person should be evaluated by a
           physiatrist, physical therapist, or occupational therapist with the
           assistance of an equipment specialist in order to choose the right type of
           wheelchair.”

   Given that the primary, functional purpose for the use of a wheelchair is mobility assistance,
   then the primary indicator for the need of a wheelchair should be the degree in which an
   individual is unable to functionally ambulate.

Clinician Task Force RECOMMENDATIONS:
In summary, the Draft NCD fails to establish functional ambulation limitation as the primary
requirement for provision of mobility devices. In the Draft NCD, CMS has instead focused on
the need for mobility devices to allow the performance of ill defined ―mobility related activities
of daily living.‖ This is unacceptable based on long-standing function-based practice standards.
The Clinician Task Force believes this will lead to confusion and misinterpretation. Below are
two recommendations to remedy this serious limitation.

1. Integrate Mobility as a recognized and defined ADL within the NCD.

2. Establish, that impairment in Functional Mobility is the basic criterion for the reasonable
and necessary coverage of MAE.


B. The Draft NCD uses non-standard terminology (Mobility Related Activities of Daily
Living - MRADLs) while failing to provide a clear definition of the new language.
MRADL is not a recognized term in AOTA, APTA, AMA, or WHO-ICF literature. The Draft
NCD provides a very limited list of activities of daily living and CMS only offers this list in
explanation of this new term.
               “activities of daily living, such as: toileting, feeding, dressing,
               grooming, and bathing”
The Clinician Task Force does not believe this is an adequate representation of activities of daily
living.


C. The Draft NCD fails to include basic Instrumental Activities of Daily Living (IADLs).
The American Occupational Therapy Association (AOTA, 2002) defines instrumental activities
of daily living (IADL) with a comprehensive listing, in the Occupational Therapy Practice
Framework. It includes Health Management and Maintenance—developing, managing, and
maintaining routines for health and wellness promotion such as physical fitness, nutrition,
decreasing health risk behaviors, and medication routines, and Safety Procedures and
Emergency Responses—knowing and performing preventive procedures to maintain a safe
environment as well as recognizing sudden, unexpected hazardous situations and initiating
emergency action such as exiting one’s home to reduce the threat to health and safety.



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Limited mobility is known to prevent individuals from completing their instrumental activities of
daily living. Reliable and valid instruments to measure function have been published that
recognize the need to consider IADLs in assessing functional outcomes. These include:
         Chong, Dennis Khin-Heung (1995). Measurement of Instrumental Activities
             of Daily Living in Stroke. Stroke. 26:1119-1122.
         Stessman, J., Hammerman-Rozenberg R., Maaravi, Y., Azoulai, D. Cohen,
             A. (2005). Strategies to enhance longevity and independent function: The
             Jerusalem Longitudinal Study. Mech Ageing Dev. Feb 126(2): 327-331.
         Instrumental activities of daily living scale [IADL] (1969). Lawton MP;
             Brody EM. IN: Burns A; Lawlor B & Craig S. (1999). Assessment scales in
             old age psychiatry. London : Martin Dunitz. Pg. 128-129.
         OASIS (the Outcome and Assessment Information Set), Centers for Medicare
             and Medicaid Services (CMS).

D. The Draft-NCD fails to include Standards of Practice, Practice Frameworks, and
Practice Guidelines from recognized professional associations or societies, that should be
used in guiding the development of this NCD. This information would also be useful in
determining who should perform the assessments and what constitutes adequate
documentation for the provision of MAE to a specific beneficiary.

RECOMMENDATION: The Clinician Task Force encourages CMS to utilize current,
applicable, and readily available, professionally-produced material as guidelines (examples
given below) to develop sound, widely accepted, and unambiguous content for the NCD.

In the Draft-NCD, Section-VI, subsection B, 6. Professional Society Position Statements, CMS
states:
              “A search for published professional society position statements
              on the appropriate prescription of mobility assistive equipment,
              including canes, walkers, wheelchairs and scooters, was
              conducted. No professional society position statements were
              identified.”

Based on the collective professional and clinical education, training, and experience among the
Clinician Task Force members, we believe it would be unreasonable to expect to find
Board/Assembly- passed position statements that contain clinical-based protocol for the
prescription of MAE. However, many documents can easily be found, published by pertinent
professional associations, which address principles, practice, and guidelines relevant to the
information sought by CMS. Numerous references have been made throughout this Clinician
Task Force document, and are listed in Appendix-I. In addition to those cited above, the
American Medical Association addresses specific protocol and practice expectations in the
assessment and provision of equipment in their publication, Guidelines for the Use of Assistive
Technology: Evaluation Referral Prescription, (AMA, 1996). A sampling of applicable content
follows:
        "Physicians need to be aware of other disciplines and consultants who can
        provide more in-depth assessment and training and assist with prescription of
        assistive technology. Physicians treating persons with disabilities should

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       understand that an interdisciplinary team approach is often necessary to deal
       with the multifaceted problems facing these patients. Primary physicians should
       make sure that knowledgeable consultants, providers, and technology suppliers
       are readily available to help them meet their patients‟ needs. Before a device is
       prescribed, a thorough assessment of the patient's needs, skills and preferences
       along with a review of the available devices must be undertaken to match patient
       and device properly." (Page 13)

Included under, ―Obtaining Funding for Assistive Technology‖:

       “An „appropriate‟ prescription is one that takes into consideration the
       comprehensive assessment process (see pages 6-12) including motivation and
       availability of training, the potential patient functional outcome and the
       cost/benefit of available products.” (Page 37)

Included under, ―Patient Examination and Evaluation‖ are the listings of both ―ADLs and
IADLs” (p. 7), and the “Environment,” includes, “Home, School, Work, and Community,” (p.
8), all of which are to be considered in the “Functional Screening/Assessment” for assistive
technology, including, for “seating and mobility systems” and specific considerations for
“wheelchair mobility in the home and community” (pp. 9 & 39).

American Occupational Therapy Association (AOTA):
In the official AOTA written response to CMS, ―Re: NCA for Mobility Assistance Devices
(CAG-00274N)/ IWWG Recommendations,” dated 1/14/05, AOTA addresses numerous
assessment issues and recommendations, based on AOTA practice guidelines and standards. The
following is a representative selection of those statements:

Under: “I. Clinical Evaluation”

       “The NCA does not provide sufficient guidance regarding the clinical
       evaluation.”

       “It also fails to clearly state that when qualified practitioners perform mobility
       assessments, the assessments are covered by the Medicare program. In the past,
       failure to identify types of qualified clinicians has created significant barriers to
       appropriate clinical evaluations.”

       “AOTA suggests that the type and amount of documentation necessary to
       demonstrate medical necessity for a powered wheelchair, including relevant
       assessments, should be informed by clinical expert opinion and clearly stated in
       DMERC”

Under: “II. Functional Criteria”

       “. . . the mobility related activities of daily living are not well defined in [the]
       IWWG document. AOTA‟s Occupational Therapy Practice Framework: Domain

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       and Process provides a comprehensive list of ADLs, which includes functional
       mobility . . .”

       “In addition, several instrumental activities of daily living (IADLs) are also
       critical to wheeled mobility use. The IADLs include: Care of others (including
       selecting and supervising caregivers,) care of pets, child rearing, communication
       device use, community mobility, financial management, health
       management/maintenance (wellness, fitness, medication etc.) home establishment
       and management, meal preparation and cleanup, safety procedures and
       emergency responses and shopping (grocery and other.)

       American Occupational Therapy Association. 2002. Occupational Therapy
       Practice Framework: Domain and Process. American Journal of Occupational
       Therapy, 56, 609-639.

       “The above-mentioned ADLs and IADLs are absent from the functional criteria,
       yet they are critical aspects of mobility. AOTA strongly urges CMS to include
       AOTA‟s ADL and IADL definitions as part of any national policy definition of
       mobility related activities of daily living.”

The American Physical Therapy Association (APTA):
In the official APTA written comments to CMS, electronically submitted in response to the
IWWG recommendations, the APTA addresses numerous assessment issues and
recommendations, based on APTA practice guidelines and standards (APTA, 2003). The
following is a representative selection of those statements:
        “The Guide to Physical Therapist Practice (p. 442) provides Test[s] and
        Measures regarding gait and locomotion during functional activities with and
        without the use of assistive and adaptive devices. The goals addressed in the
        Guide include the individual having the ability to gain access to home
        environments, the ability to safely perform self-care and home management, in
        addition to work (job or school), community, and leisure activities. The use of a
        manual or power wheelchair to move within a room or from room to room is an
        appropriate intervention that a physical therapist assists patients in achieving as
        part of normal clinical practice.

       A thorough evaluation of the beneficiary‟s home, community, and work
       environment is an essential element in the appropriate prescription of a mobility
       device. The “bed or chair confined” standard currently in use is unnecessarily
       restrictive and does not take into account the beneficiary‟s role in the home,
       community or workplace. CMS should bear in mind that this policy will not only
       provide coverage for the over 65 Medicare beneficiary, but also the disabled
       population currently receiving Medicare benefits. APTA therefore believes that
       the new CMS policy must take into account each individuals‟ life roles and
       responsibilities and through an appropriate policy, strive to maximize functional
       independence for all beneficiaries affected by this policy.”



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E. The Draft-NCD fails to recognize the increased risk of injury it places on its
beneficiaries due to 1) use of equipment outside the home, and 2) not including the need for
a skilled and knowledgeable clinician to perform a functional-based assessment for
coverage.

A common example of increased injury risk would be the increased use of a beneficiary‘s upper
limbs when using a manual wheelchair. This can occur due to a recent injury or illness onset
when an individual is receiving their first assessment for MAE (e.g., spinal cord injury, traumatic
brain injury, post polio syndrome, multiple sclerosis, etc.). Another common problem could
occur when a beneficiary uses equipment, outside the home, which was covered, by Medicare,
for in-home-use only. Numerous risk factors would exist in such cases. One risk could be due to
an individual‘s ability to safely/effectively use a manual wheelchair inside his or her home, but is
lacking the upper body function to safely use the wheelchair outside of the home. A recent
work provided through the Consortium for Spinal Cord Medicine (2005), (Preservation of Upper
Limb Function Following Spinal Cord Injury: Clinical Practice Guidelines for Health-Care
Professionals) reports:

       “For individuals with spinal cord injury (SCI), paralysis of the lower limbs
       necessitates reliance on the upper limbs for mobility. This greater reliance on the
       arms can lead to pain and injury, which can impact not only mobility, but the
       ability to complete activities of daily living as well. The high prevalence of upper
       limb pain and injury in SCI is well documented as are the negative consequences
       on quality of life”

The purpose of the above work “is to provide health-care professionals with concise,
practical information that will help them prevent and treat upper limb pain and injury in
their patients.”

In this commonly occurring situation, two factors could significantly reduce the risk of
these common injuries:
    1) The presence of a skilled and knowledgeable clinician that: a) performs the MAE
         assessment and recognizes the individual‘s mobility needs in all typical functional
         activities and environments, b) is able to recommend the appropriate equipment,
         and, c) follow through with other possible needs for intervention.
    2) A National Coverage Determination that will a) require that the skilled and
         knowledgeable clinician perform the assessment, and b) the coverage for the
         MAE assures that the equipment can be used in all environments that the
         individual performs his or her typical functional activities.

While CMS may allow a beneficiary to use equipment outside the home that was provided for in-
the-home-use-only, as indicated in the statement below; a clinician would be practicing well
below acceptable standards and licensure requirements if he or she placed an individual at such a
risk – using equipment outside the home that is specified as in-home-use-only.




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       “ . . . the “in the home” restriction means that in order to be covered under
       Medicare, durable medical equipment (DME), such as a wheelchair, a
       beneficiary must have a medical need to use the equipment in the home. This
       requirement excludes DME from coverage if there is only a medical need to use
       the equipment outside the home. However, if DME is medically necessary in the
       home and the beneficiary also uses it outside the home, the equipment would still
       be covered.” (CMS, 2005)

The Clinician Task Force respectfully submits the above recommendations, supported by
research and analysis of existing data, to provide expert clinical guidance to CMS as the agency
finalizes drafting of a new National Coverage Determination for Mobility Assistance Equipment
(MAE).




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                                  Appendix-I: References

AAPM&R – American Academy of Physical Medicine and Rehabilitation. (2003). Access to
    assistive technologies: Improving health and well-being for people with disabilities.
    Chicago: AAPM&R.

AMA - American Medical Association. (2004). AMA resolution 123. Retrieved February 22,
     2005, from http://www.ama-assn.org/ama1/pub/upload/mm/465/a04rford.doc.
             “The Board voted that our AMA . . . 3) Support the efforts of the
             AAPM&R, American Academy of Neurology (AAN), and the 70
             other organizations in the ITEM (Independence Through
             Enhancement of Medicare and Medicaid) coalition to change the
             “in the home” coverage restrictions for wheelchairs. The “in the
             home” language appears to be in conflict with a series of federal
             statutes aimed at preventing discrimination against persons with
             disabilities (Rehabilitation Act of 1973, Americans with
             Disabilities Act of 1990) and the US Supreme Court decision in
             Olmstead v. L.C. ex rel. Zimring.”

AMA - American Medical Association. (1996). Guidelines for the use of assistive technology:
Evaluation, referral, prescription, Second Edition. Chicago: AMA Press. (ISBN 0-899-70-694-
0)

AOTA - American Occupational Therapy Association. (2005). [Letter to CMS Re: NCA for
     Mobility Assistance Devices (CAG-00274N) IWWG Recommendations], January 15,
     2005.

AOTA - American Occupational Therapy Association. (2002). Occupational therapy practice
     framework: Domain and Process. American Journal of Occupational Therapy, 56, 609-
     639.
APTA - American Physical Therapy Association. (2003). Guide to physical therapy practice:
     Second edition, (Revised June 2003. Originally published in the January 2001 issue of
     Physical Therapy [Guide to physical therapist practice. 2nd Ed. Phys Ther: 2001;81:9-
     744]). Alexandria, VA: APTA.

Assistive Technology Law Center. (2001). [Letter to New Freedom Initiative Group,
        Department of Health and Human Services, RE: Barriers to Community Integration and
        Participation by Individuals with Disabilities], August 24, 2001.

CMS – Centers for Medicare and Medicaid Services. (2005). [Letter to Peter Thomas, ITEM
      Coalition from Herb Kuhn, Director, CMS], February 17, 2005.

Consortium for Citizens with Disabilities. (2001). [Letter to Secretary Tommy G. Thompson,
      Department of Health and Human Services RE: New Freedom Initiative For Persons
      with Disabilities], August 22, 2001.



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Consortium for Spinal Cord Medicine. (2005). Preservation of upper limb function following
      spinal cord injury: Clinical practice guidelines for health-care professionals. (In press).
      Washington, DC: Paralyzed Veterans of America.

Medicare Rights Center. (2004). Forcing isolation: Medicare‟s “In the Home” coverage
      standard for wheelchairs. New York, NY: Medicare Rights Center

O‘Toole, M. (Ed.). (1992). Miller-Keane Encyclopedia & dictionary of medicine, nursing, &
      allied health. Philadelphia: W. B. Saunders Company

WHO - World Health Organization. (2001). International classification of functioning, disability
     and health. Geneva, Switzerland: WHO

SSA - Social Security Administration. (2003). Disability evaluation under social security.
       Washington, DC: SSA.




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               Appendix-II: Alphabetical Listing of Organizations:
            Formal Reports, Position Statements, and Letters Submitted

1.  Adapted Physical Activity Council
2.  American Academy of Neurology
3.  American Academy of Physical Medicine and Rehabilitation
4.  American Association of Home Care
5.  American Association for Mental Retardation
6.  American Association of People with Disabilities
7.  American Association of University Affiliated Programs for Persons with Developmental
    Disabilities
8. American Disabled for Attendant Programs Today (ADAPT)
9. AMA – American Medical Association
10. American Occupational Therapy Association
11. American Medical Rehabilitation Providers Association
12. American Network of Community Options and Resources
13. American Physical Therapy Association
14. American Speech-Language-Hearing Association
15. Brian Injury Association
16. Consortium For Citizens with Disabilities
17. Center on Disability and Health
18. Easter Seals
19. ITEM Coalition - Independence Through Enhancement of Medicare and Medicaid
20. THE MEDGroup
21. Medicare Rights Center
22. National Association for the Advancement of Orthotics and Prosthetics
23. National Association of Developmental Disabilities Councils
24. National Association of Protection & Advocacy Systems
25. National Association of Rehabilitation Agencies
26. National Council on Independent Living
27. National Multiple Sclerosis Society
28. National Spinal Cord Injury Association
29. Paralyzed Veterans of America
30. Persons with Developmental Disabilities
31. Research Institute for Independent Living
32. RESNA (Rehabilitation Engineering and Assistive Technology Society of North America
33. Self-Help for Hard of Hearing People
34. Sunrise Medical
35. UCP (United Cerebral Palsy)
36. United Spinal Association
37. The VGM Group
38. World Institute on Disability




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                        Appendix-III: Table of Respondents:
             Public Comments for Mobility Assistance Devices (CAG-00274N)


Comments Submitted By:                                Total     Agreed   Stated        ITH Not
                                                      Entries   With     Against      Included
                                                                Plan     ITH

Healthcare or Related Professionals                   34                 25           9

Professional Orgs & Groups
AAPM&R                                                2                  2
Rehabilitation Engineering and Assistive Technology   1                  1
Society (RESNA)
American Occupational Therapy Association             1                  1
American Physical Therapy Association                 1                  1
American Association of Spinal Cord Injury Nurses     1                  1
American Association of Spinal Cord Injury            1                  1
Psychologists and Social Workers
National Registry of Rehabilitation Technology        1                  1
Suppliers (NRRTS)

Advocacy, Service & Diagnostic Orgs
Clinician Task Force                                  1                  1
Mosaic                                                11                 11
United Spinal Association                             1                  1
American Association of People with Disabilities      1                  1
(AAPD)
United Cerebral Palsy of Greater Suffolk, Inc.        2                  2
Brain Injury Association of Wyoming                   1                  1
National Council on Independent Living                1                  1
The Arc and United Cerebral Palsy                     1                  1
Assistive Technology Law Center                       1                  1
Medicare Rights Center                                1                  1
ITEM Coalition                                        1                  1
National Assistive Technology Advocacy Project        1                  1
Access Living                                         1                  1
Cape Organization for Rights of the Disabled (CORD)   1                  1
Advocacy Center Louisiana                             1                  1

Clinical Centers
Rehabilitation Institute of Chicago                   1                  1
Shepherd Center                                       1                  1
Susquehanna Health System Gibson Rehab Center         1                               1




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Appendix-III: Table of Respondents – Pg 2
Comments Submitted By:                                     Total      Agreed       Stated      ITH Not
                                                           Entries    With         Against    Included
                                                                      Plan         ITH
Wheelchair User/Proxy or Concerned Individual              45                      38         7

Industry
NobleMotion, Inc.                                          1                       1
Equip-To-Care                                              1          1
Bach's Home Health Care Supply                             1                                  1
Medstar Surgical, Inc.                                     1                       1
Maryland National Capital Homecare Association             1                       1
PA Association of Medical Suppliers                        1                       1
Rehab Dimensions of WV LLC                                 1                                  1
Amigo Mobility International, Inc                          1                                  1
National Coalition for Assistive and Rehab Technology      1                       1
Pride Mobility Products Corporation                        1                       1
The SCOOTER Store                                          1          1            1
Assistive Technology Group                                 1                       1
DEKA Research and Development Corporation                  1                       1
Convaid Products, Inc.                                     1                       1
Hoveround Corporation                                      1                                  1

Beneficiary Comments                                       14                      14

State or Federal Programs or Administering
Affiliates
Region A DMERC Advisory Council Rehab                      1                       1
Missouri Assistive Technology Council                      1                       1
Senior & Disabled Services, Lane COG                       1                                  1
NYS Office of Advocate for Persons with Disabilities       1                       1

Other
New Mobility magazine                                      1                       1

                                                  Totals        158            2        131         27

Table from: Landsman, Z. Public comments for mobility assistance devices (CAG-00274N),
January, 28 2005. United Spinal Association.




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CTF Member List:                            Elizabeth Cole, MSPT
                                            Director of Education, Sunrise Medical
Co- Coordinators                            Longmont, CO
                                            Elizabeth.cole@sunmed.com
Laura Cohen PhD, PT, ATP                    RESNA, Friend of NRRTS
Clinical Research Scientist
Crawford Research Institute                 Kimberly A. Davis, MSPT, ATP
Shepherd Center                             NH-ATEC
Atlanta, Georgia                            Laconia, New Hampshire
Lauracohen2004@yahoo.com                    Kad820@verizon.net
RESNA Member                                RESNA Member NPUAP Member

Barbara Crane, PhD, PT, ATP                 Gerry Dickerson, ATS, CRTS
Assistant Professor, Physical Therapy       Director of Rehabilitation Technology
University of Hartford                      MedStar, Inc.
Hartford, CT                                College Point, NY
barb.crane@cox.net                          gdcrts@aol.com
RESNA Member, APTA Member                   RESNA Member, NRRTS Member, NCART

Task Force Members                          Carmen DiGiovine, PhD
                                            Assistive Technology Unit, UIC
Michael Babinec, OTR/L, ABDA, ATP           Chicago, IL
The Invacare Corp.                          cpdigiov@uic.edu
Elyria, Ohio
mbabinec@invacare.com                       Linda-Jeanne Elsaesser PT, ATP
RESNA Member, AOTA Member                   Consultant
                                            Elsaesser Consulting, Inc.
Adrienne F Bergen PT, ATP/S                 Saylorsburg, PA 18353
Consultant                                  elsaesser@enter.net
Delray Beach, FL                            RESNA Member
adriennebergen@aol.com
RESNA Member, Friend of NRRTS               Jan Furumasu PT ATP
                                            Physical Therapy Instructor
Kendra Betz, PT                             Rancho Los Amigos National Rehabilitation
VA Puget Sound Health Care System           Center
Washington                                  Downey CA
kendra.betz@med.va.gov                      jfurumasu@ladhs.org
APTA Member                                 RESNA Member

Mike Boninger, MD                           David Kreutz, PT, ATP
University of Pittsburgh                    Shepherd Center
Pittsburgh, PA                              Atlanta, GA
boninger@pitt.edu                           David_Kreutz@shepherd.org
                                            APTA Member, RESNA Member
Susan Christie, PT, ATP
Supervisor, Assistive Technology Center     Ziggi Landsman
Bryn Mawr Rehab Hospital                    Director of Assistive Technology
Malvern, PA                                 United Spinal Association
christies@MLHS.org                          New York, NY
                                            zlandsman@unitedspinal.org
Chris Chovan, MOT, OTR/L, ATP
Director of Clinical Services
Rehab Mobility Specialists, Inc.
Belle Vernon, PA
cchovan@verizon.net
  Coalition to Modernize Medicare Coverage Policy for Mobility Products (CMMCMP)
                             www.cliniciantaskforce.org
Barbara Levy, PT, ATP                           Jessica Pedersen MBA, OTR/L, ATP
Supervisor Seating and Mobility Clinic          Administrative Dir Specialized Therapy Services
Care Partners/Thoms Rehabilitation Hospital     Rehabilitation Institute of Chicago
Asheville, NC                                   Chicago, IL
BLevy@CarePartners.org                          jpedersen@ric.org
APTA Member, APTA Liaison, RESNA                AOTA Member, RESNA Member
Member, Friend of NRRTS                         Tina Roesler MSPT
                                                Director of Training and Education
Dan Lipka, M. Ed., OTR/L, ATS                   The ROHO Group
President, NRRTS                                Belleville, IL
Miller‘s Assistive Technologies                 Tinar@therohogroup.com
Akron, OH                                       RESNA Member, APTA Member
ddl@millers.com
RESNA Member, NRRTS Member, AOTA                Mark R. Schmeler, MS, OTR/L, ATP
Member, NCART Member                            Director, Center for Assistive Technology
                                                University of Pittsburgh Medical Center
Eva K. Ma OTR, ATP, ABDA                        Pittsburgh, PA
Consultant                                      schmelermr@upmc.edu
Portland, OR                                    AOTA Member, RESNA Member
EvaMa@aol.com
AOTA member, NDTA, RESNA member,                Mary Shea, MA,OTR, ATP
Friend of NRRTS                                 Kessler Institute for Rehabilitation
                                                West Orange, New Jersey
Simon Margolis, CO, ATS, ATP                    mshea@kessler-rehab.com
VP for Clinical and Professional Development    AOTA Member, RESNA Member
National Seating and Mobility, Inc
Plymouth, MN                                    Jill Sparacio, OTR/L, ATP, ABDA
smargolis@nsm-seating.com                       Sparacio Consulting Svcs & Misericordia Homes
RESNA Member, NRRTS Member, NCART               Downers Grove, IL
Member                                          Otspar@aol.com
                                                AOTA Member
Chris Maurer, PT, ATP
Shepherd Center                                 Pam Stockman, OTR/L
Atlanta, GA                                     University of Washington Medical Center
Chris_Maurer@shepherd.org                       stockman@u.washington.edu
APTA Member
                                                David Wysocki, MS, OTR/L, ATP
Jean Minkel, PT                                 Therapeutic Consultation Services
Minkel Consulting                               Hillsborough, NC
New York                                        davidwot@earthlink.net
jminkel@aol.com                                 AOTA Member, RESNA Member
APTA Member, RESNA Liaison

Jill Monger PT, MHS, ATP
Assistant Professor, MUSC Seating Clinic Dir.
Medical University of South Carolina
Mt. Pleasant, SC
carterjm@musc.edu
APTA Member, RESNA Member




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