Mobility Assistive Equipment

Pride Mobility Products Corporation submits the following comments in response to the proposed change in National Coverage Determination (NCD) for mobility assistance equipment (MAE) issued on February 5, 2005. Pride Mobility is the world leader in the design development and manufacture of mobility products - power wheelchairs, scooters and lift chairs for people with disabilities and mobility impairments.

Pride Mobility appreciates the opportunity to provide comments on the NCD for MAE and we look forward to the establishment of a new national coverage policy based on a clear functional standard of the beneficiaries abilities to accomplish mobility related activities of daily living (MRADL's). We fully support CMS' decision to remove the bed or chair confined coverage standard which has led to a misinterpretation and overly restrictive coverage policy.

While Pride Mobility is supportive of the proposed change in the NCD for MAE, we believe the following issues must be addressed prior to issuing the Final National Coverage Decision.

Documentation Requirements:

• Clear and consistent standard Pride Mobility believes that first and foremost the new coverage policy must include clear documentation requirements in order for it to be appropriately implemented. Documentation is the foundation for determining medical necessity for coverage, and claims processors, suppliers and beneficiaries have all experienced the problems that result from a vague policy. It is clear that physician chart notes, which are currently being requested, do not provide the information required to clearly substantiate medical need under the coverage policy that has been proposed. This lack of information in the chart notes should not preclude an individual from qualifying for a power wheelchair. The new policy must define with clarity what documentation will be accepted as the definitive determinate of medical necessity and it must be consistently applied throughout the country. We support expanding the CMN so that it is the official standard of documentation under the new coverage policy, and believe that any additional medical information supporting the CMN should be accepted.
• Specify the Role of the Supplier Pride urges CMS to specify the role and responsibilities of the supplier in the final documentation requirements. The final documentation requirements should acknowledge the following supplier responsibilities:
• The supplier can be responsible for conducting the home/environmental assessment of safety and appropriateness of MAE use in the beneficiary's typical environment.
• The supplier is responsible for completing a technology assessment and for making recommendations as to medically necessary MAE.
• CMS should issue clear guidelines as to what data elements must be collected pertaining to the home and technology assessment and the format by which CMS will request it from the supplier.

The American Academy of Physical Medicine and Rehabilitation, representing almost 8,000 physicians who specialize in the practice of PM&R, submits the following comments on the proposed decision memorandum and revised NCD for Mobility Assistance Equipment (MAE) as requested by CMS in the Draft Decision Memo for Mobility Assistance Equipment (CAG-00274N).

The AAPM&R commends CMS’ for its efforts to reform the Mobility Assistance Equipment coverage criteria. However, the AAPM&R continues to have concerns about the “in the home” requirement. We concur with the Clinician Task Force’s comment that “The NCD-Draft Memo fails to recognize as a problem or appropriately address the “in the home” restriction.” CMS asserts that “An NCD would not be the appropriate mechanism to change this rule,” but then fails to offer any information on the content of an appropriate mechanism to achieve this. Such a restrictive interpretation severely compromises the drafting of a sound policy predicated on functional criteria as well as current clinical practice.

As the physician group uniquely dedicated to improving function and advocating for the medical rehabilitation needs of individuals with disabilities, the AAPM&R believes there is an inherent lack of medical justification or logic in the “in the home” rule. Medical decision- making does not generally rest on an “in the home/out of home” pillar. There exists tacit acceptance within the rehabilitation community that wheeled and power mobility devices are generally designed to travel beyond the confines of the home and are widely recognized as having great utility out-of-doors. Improved mobility access allows people greater independence and productivity, results in less of a burden for families and caretakers, and can decrease the use of medications for pain and depression, etc.

Regarding what constitutes adequate evaluation and documentation, the AAPM&R believes that as clinicians, we frequently can determine whether an individual has any potential to effectively use a cane, manual wheelchair, or scooter, without requiring an actual trial of the device. The AAPM&R is concerned that the CMS criteria prescribed for manual wheelchair configuration will needlessly lead to denials of power wheelchairs on the basis that the clinician did not actually fit the person to a manual wheelchair and see that he or she could not propel the wheelchair. When documented historical and clinical examination evidence exists, qualified clinicians can use this documentation to determine if ambulation, manual wheelchair, or scooter trials are needed during the course of an evaluation.

Also, regarding the evaluation and documentation recommendations for MAE, the AAPM&R believes that the physician should document the need for a wheelchair including an assessment of previous treatments, a medical history, and a clinical examination. This should help to satisfy CMS’s concern related to eliminating fraud and would avoid situations where physicians may unintentionally sign multiple prescriptions for patients.

Again, the AAPM&R urges CMS to explicitly endorse wheeled mobility policies with the attendant controls.

Sincerely,

Bruce M. Gans, MD
President,
American Academy of Physical Medicine and Rehabilitation

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FINAL RAMP COMMENTS
The Restore Access to Mobility Partnership (RAMP) appreciates the opportunity to provide comments on the Centers for Medicare and Medicaid Services’ (CMS) Draft Decision Memorandum (“Draft Decision Memo”) and National Coverage Determination (“Draft NCD”) for Mobility Assistance Equipment (MAE), issued February 3, 2005. RAMP, a coalition representing power wheelchair providers and manufacturers, is committed to ensuring that Medicare beneficiaries with medical need have access to appropriate mobility products.

RAMP applauds CMS’ efforts in developing the Draft Decision Memorandum and Draft NCD, which would accomplish the following objectives:

• Shift the focus from “bed or chair” confined standard to a more clinically based functional assessment approach;
• Recognize that medical necessity may arise from the inability to engage in one or more activities of daily living (ADLs) without MAE;
• Recognize that the patient’s treating clinician, the patient or the patient’s family may initiate a conversation about appropriate MAE; and
• Attempt to provide a concrete process that clinicians and providers can rely on for establishing medical necessity for MAE.

RAMP has identified several critical issues related to MAE that should be resolved prior to issuance of the final National Coverage Decision. In addition, RAMP shares CMS’ recognition that documentation is critical to ensuring appropriate access to MAE, and we are pleased to provide the following guidance on the issue. Below, we discuss our concerns and comments on these important issues:

I. Recommended Changes to the Draft NCD

A. Mobility for Mobility Sake Should Be Considered an Activity of Daily Living

At the outset, we applaud CMS’ proposed substitution of the current “bed or chair confined” standard with a standard based on a series of more clinically based functional criteria. While this is a significant step forward towards a clinically based set of criteria to determine coverage, there are a number of important additional modifications to both the Draft Decision Memo and the Draft NCD. To that end, RAMP recommends that the national coverage policy or NCD explicitly recognize the medical necessity of mobility for mobility sake. Specifically, mobility (the activity of being able to get from one place to another) should be specified as a primary activity of daily living.

The need to associate mobility with ADLs creates significant limitations in the draft coverage policy. For example, a beneficiary with a high-level spinal cord injury by definition cannot perform any ADLs; however, this factor should not prevent coverage of MAE to the beneficiary.

In this instance, the draft NCD (which presumably would be the basis for the national coverage policy) is more restrictive than the Draft Decision Memo. Mobility for mobility sake was discussed in the Draft Decision Memo as one criterion for providing coverage, but it was omitted from the Draft Clinical Criteria for MAE coverage. Therefore, the draft NCD criteria do not fully reflect what appears to be CMS’ intent of the national coverage policy, as CMS explains in the draft Decision Memo.

There is ample clinical documentation that would support an explicit statement that coverage of MAE is available for individuals who need the mobility device simply to move. For example, the World Health Organization International Classification of Function describes Activities and Participation with mobility-related activities of daily living defined in Chapter 4. Mobility "is about moving by changing body position or location or by transferring from one place to another..." and contains 4 sections:

1. Changing and Maintaining Body Position
2. Carrying, Moving and Handling Objects
3. Walking and Moving
4. Moving Around Using Transportation.

Section 3: Walking and Moving contains the descriptor d465, "Moving around using equipment, moving the whole body from place to place, on any surface or space, by using specific devices designed to facilitate moving or create other ways of moving around, such as ... moving down the street in a wheelchair or a walker."

Further, the American Occupational Therapy Association (2002) defines activities of daily living as including Functional Mobility, "moving from one position or place to another [during performance of everyday activities], such as in-bed mobility, wheelchair mobility, transfers..." in Occupational therapy practice framework: Domain and process. American Journal of Occupational Therapy, 56, 609-639.

Finally, The Clinician Task Force recommended in earlier comments to CMS that “Clinical criteria for prescribing a wheeled mobility device should recognize that safely and efficiently moving from place to place is a mobility-related activity of daily living. The inability to move around within or outside of the home in and of itself is considered to be a disability that would qualify a beneficiary for a mobility device.”

The above is also consistent with the statements of Dr. Louis Jacques at the February 24, 2005 CMS Open Door session on this issue. He made it clear that it was not CMS’ intent to exclude such beneficiaries and therefore, to remove subjectivity or interpretation, we ask that his statements be written into the NCD.

RAMP therefore recommends that CMS amend the draft Clinical Criteria for MAE coverage to include the activity of mobility as a functional need or ADL that would qualify a beneficiary for Medicare Coverage of MAE.

B. The Draft Clinical Criteria for MAE Coverage Should Be Expanded to Include Broader Definitions of Qualifying ADLs
A discrepancy exists between the descriptions of qualifying ADLs found in the draft Decision Memo and the Draft NCD Clinical Criteria for MAE Coverage in Appendix A. Specifically, the list of ADLs included in the Draft Clinical Criteria for MAE Coverage appears to be the exclusive list of ADLs contained in the Appendix. In contrast, in the Draft Decision Memorandum, the phrase “such as” is used with the identified ADLs, implying that other ADLs may qualify a beneficiary for MAE.

The draft Clinical Criteria for MAE Coverage should include additional ADLs, such as mobility for mobility sake. In addition, to ensure a uniform coverage policy, the description of the ADLs included in the draft Clinical Criteria for MAE Coverage should be revised to eliminate the inference that it is an exclusive list of ADLs. Finally, the identified ADLs are extremely limited, confined to a few “in the home” activities and RAMP recommends more broadly defining the qualifying ADLs.

C. The Draft NCD Clinical Criteria for MAE Coverage Unreasonably Limits Coverage to Beneficiaries Who Will Functionally Improve

The draft NCD Clinical Criteria for MAE Coverage focus on whether the MAE can reasonably be expected to materially improve the beneficiary’s ability to perform mobility-related ADLs. In assuming that MAE must improve – rather than maintain or prevent further deterioration of – a beneficiary’s ability to perform ADLs, the standard unfairly limits coverage of MAE to beneficiaries whose conditions can improve. RAMP strongly recommends that CMS revise the policy to recognize coverage for MAE that enables beneficiaries to maintain a level of functioning and/or prevent further deterioration.

D. CMS Should Adopt The Clinician Task Force’s Definition of Functional Ambulation

CMS proposes a definition of “functional ambulation” that would lead to significant ambiguity and differences of interpretation. To facilitate consistency throughout the industry and prevent unnecessary coverage delays due to misinterpretations, RAMP recommends that CMS adopt the standard provided by the Clinician Task Force in its report:

Functional ambulation means: The ability of a patient to consistently walk, with or without the aid of appropriate assistive devices (such as prostheses, orthoses, canes or walkers), safely and sufficiently to carry out typical mobility-related activities of daily living or instrumental activities of daily living. 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.

The determination of functional ambulation status requires an evaluation of whether a patient is consistently able to safely balance and walk at a reasonable rate of speed, without companion assistance, the distances necessary to complete the patient's typical activities of daily living. The patient must also demonstrate the endurance to do these activities. The patient is considered to be “unable to functionally ambulate” if he/she lacks functional ambulation in a setting which the patient would be expected to routinely encounter.

E. CMS Should Not Restrict Coverage to Individuals Who Need MAE “In the Home”

CMS’ “In the Home” limitation on coverage has no basis in clinical practice or evaluation. CMS’ current policy and the draft NCD recommendations contradict policies already in effect in other branches of the Federal government, well-recognized professional organizations and documents on International standards defining disability. For example, this coverage limitation is counter to the goals of the New Freedom Initiative, the American with Disabilities Act, the Ticket to Work Program and the Supreme Court’s Olmstead Decision.

From a clinical practice perspective, the current strict interpretation is in direct conflict with contemporary medical and clinical practice, and discriminates against persons needing wheeled mobility to complete the mobility related tasks of daily living that extend beyond the four walls of the home. RAMP strongly objects to this artificial restriction on coverage of MAE and recommends that CMS eliminate this artificial coverage restriction.

F. Treatment Non-Compliance Should Not Be a Determinant of Medical Necessity

Non-compliance with a course of treatment should not be a determinant of medical necessity for MAE. Medical necessity for MAE exists independent of a beneficiary’s behavior with respect to health treatment. The beneficiary’s willingness to use the MAE should be the only additional consideration prior to providing coverage. RAMP strongly urges CMS to clarify that medical necessity is established at the outset of treatment, not by a retrospective review of whether the beneficiary actually used the MAE.

G. CMS Should Establish Guidelines Regarding Environmental Assessments

RAMP recognizes that an environmental assessment will be an important part of determining the medical necessity of a particular device, but a number of issues should be clarified in the final NCD.

First, RAMP urges CMS to clarify who should conduct the environmental assessment. RAMP believes that either the clinician involved in the beneficiary’s care or a qualified supplier, either in advance of delivery or at time of delivery of the MAE, should be able to perform the environmental assessment.

Second, RAMP urges CMS to clarify when the environmental assessment should be performed. CMS’ draft algorithm sequence is not sufficient because the environmental assessment must be specific to the type of equipment being provided. For example, a beneficiary may have the ability to maneuver a power operated vehicle (POV) but architectural restrictions in the home may not make it usable. In such a case, the patient should be able to obtain a power wheelchair if it would be appropriate for use in the beneficiary’s home. RAMP recommends that CMS modify the algorithm in such a way that questions regarding safety and environmental appropriateness are asked after identification of the medically appropriate MAE.

Third, RAMP urges CMS to clarify in writing that power wheelchairs frequently do not fit through standard bathroom doors, and such a finding from the environmental assessment should not result in automatic disqualification for coverage of that device. For beneficiaries with mobility deficiencies, toileting and bathing are often done in other parts of the home for this reason.

H. Caregiver Availability Should Not Be a Factor in Determining Medical Necessity

RAMP objects strongly to caregiver availability as a factor in determining medical necessity for MAE. Medical necessity does not change because of the presence or absence of a spouse or other caregiver. The availability of a caregiver is not a requirement for coverage for other Medicare benefits. RAMP urges CMS to make caregiver availability an environmental consideration, rather than a factor in determining medical necessity. Again, this was addressed by Dr. Louis Jacques at the CMS Open Door Meeting on February 24, 2005. His statements were clear that the beneficiary’s need for MAE should be evaluated independent of a caregiver. So this provision is not left up to interpretation, we request that CMS clarify in the final NCD that the beneficiary’s medical need will be evaluated independent of a caregiver.

I. Canes, Crutches and Walkers Should Not Be Included in the Scope of This NCD

RAMP recommends that CMS exclude canes, crutches and walkers from the scope of this NCD, as the inclusion of these low-cost items would involve unjustifiably high documentation burdens and administrative costs. Rather, these items should be used during the algorithmic decision making process requiring consideration of least costly alternatives. Such a process would ensure that canes, crutches and walker do not meet the beneficiary’s needs prior to determining medical necessity for MAE.

II. Recommendations Regarding Documentation Issues

RAMP believes that three fundamental principles should guide the development of a policy on MAE documentation:

• First, given the complexity of the algorithm determining medical necessity, CMS should acknowledge that physicians will not, as a matter of practice, document the beneficiary’s medical condition with the level of specificity envisioned in the NCD.

• Second, the documentation requirements must be tied directly to the coverage policy and clearly outline the required information, who is responsible for providing the information and how the information must be documented.

• Finally, the documentation requirements must specify what documentation will be accepted as a definitive determinant of medical necessity absent fraud.

  These fundamental principles inform our recommendations on documentation requirements below.

A. The CMN Should Fulfill the Basic Documentation Requirements, with Additional Documentation Requirements that Vary Based on Complexity of MAE Required by Beneficiary

RAMP recommends CMS base the new documentation paradigm on the concept of an expanded Certificate of Medical Necessity (CMN) plus a companion questionnaire, or physician letter or clinician evaluation, as appropriate. For example, one CMN should exist for all wheelchairs and scooters, with varying additional documentation requirements depending on MAE. More basic items such as manual rental chairs should have lower documentation thresholds than more complex MAE. Currently, a CMN is not required for canes and walkers, and RAMP does not believe it would be appropriate to establish CMN for such low-cost items.

For level 1 MAE, a completed CMN should be sufficient to document medical need. Level 1 items would be basic items such as manual rental wheelchairs. For level 2 MAE, a completed CMN and a completed questionnaire with standard questions should be sufficient to document medical need. Level 2 MAE would include more involved items such as a basic power wheelchair. For level 3 MAE, a completed CMN, a completed questionnaire with standard questions, and a letter from the prescribing physician or a PT/OT evaluation should be sufficient to justify the medical need.

The CMN itself should be expanded to reflect the additional data elements for coverage contained in the final NCD. RAMP believes that it is more important for the CMN to reflect the required data elements necessary to facilitate coverage and payment than it is to limit the CMN to a single page. As with the current CMN, the revised CMN should be approved by the Office of Management and Budget.

RAMP recognizes that the final coverage policy may result in substantive modifications to the CMN. Nonetheless, RAMP has developed a model CMN (see Attachment A) as a possible starting point for the agency to use. Clearly, this document would need to be revised to reflect final coverage policy. However, RAMP believes it has some useful features. First, the document attempts to show how the decision algorithm can be incorporated into the CMN. The questions on the CMN should follow the decision-making process in determining the medical need for a particular item of MAE.

Second, it offers a Section E, which could be optional, but provide a model for gathering the additional information a supplier would need to show medical necessity. RAMP believes that suppliers should be able to use their own forms instead of the proposed Section E so long as the necessary information is collected. Also, Section E (or a substitute) could be completed by another licensed clinician as long as the judgment is countersigned by the prescribing physician. The information in Section E would supplement the information provided in the CMN and provide the additional specificity to support the medical necessity of the MAE in question. RAMP urges CMS to provide specific guidance as to what information should be reflected in the companion questionnaire.

B. Any Licensed Clinician Should Be Able to Complete Additional Documentation

RAMP recommends that CMS permit licensed clinicians to complete the additional documentation, as long as they are countersigned by the prescribing physicians. Such licensed clinicians could include the treating physician, nurse, physician assistant, physical therapist or occupational therapist. The recommended policy reflects the standard clinical practice of physicians to the evaluation for MAE to other licensed clinicians with designated expertise and training to assess needs. As noted earlier, the level of the evaluation should vary by the complexity of the MAE.

C. Final Documentation Requirements Should Specify the Role of the Supplier

RAMP urges CMS to specify the role and responsibilities of the supplier in the final documentation requirements. For example, RAMP recommends that the requirements should acknowledge the following supplier responsibilities:

• The supplier can be responsible for conducting the home/environmental assessment of safety and appropriateness of MAE use in the beneficiary’s typical environment.

• The supplier is responsible for completing a technology assessment and for making recommendations as to medically necessary MAE.

• There should be clear guidelines set for the data elements, which must be collected pertaining to the home and technology assessment and the format in which CMS will request such information when it is asked of the supplier.

D. The Supplier Should Have the Option of Paying for the Evaluation

The supplier assumes financial and other responsibility for providing the appropriate MAE. As part of that responsibility, the supplier needs to obtain appropriate documentation that will substantiate medical need, in the event of a pre- or post-payment audit. Importantly, it is not the typical practice for referring physicians to routinely maintain adequate documentation in their medical records that provides the level of clinical information to substantiate the beneficiary’s need.

Instead, physicians routinely rely upon a physical therapist (PT) or occupational therapist (OT) to evaluate a beneficiary’s need. Those PT/OT evaluations are an important document with significant and detailed information to document medical need. There is no reason the supplier should not have the option of paying for those evaluations to ensure that appropriate documentation is readily available. PTs/OTs are state licensed professionals and are subject to professional ethics as well as federal and state fraud and abuse laws regarding the provision of false information.

F. The Documentation Requirements should be Subject to the “Four Corners” Test

Documentation should pass the “four corners” test for claims payment and review. In other words, CMS should not be allowed to look beyond the four corners of whatever documentation is required or suggested, absent suspicion of fraud. The final documentation requirements should be determinative and controlling. For example, a clinician-completed CMN (see Attachment A) should provide the medical review staff with ample information to determine whether the beneficiary has a medical need that meets the criteria.

G. Relevant Manual Language Should Be Revised

On January 21, 2005, CMS issued Transmittal 100 (CR 3644), a revision to the Program Integrity Manual, section 3.4.1.2, regarding additional documentation requests during pre- or post-payment medical review the DMERCs can rely upon in the event of a medical review or audit. This CMS clarification appropriately directed contractors to review and consider documentation completed by clinicians other than the prescribing physician such as PTs or OTs when determining medical necessity.

The significant deficiency with this instruction is the unfounded assumption that the prescribing physician’s progress notes will have supporting contemporaneous information. As a practical matter, that simply does not occur.

Instead, RAMP recommends that the limitation be that if there is information in the physician progress notes that contradicts information in a clinician’s evaluation, then the medical review staff should discount the information in the evaluation. Specifically, RAMP recommends the following changes to the relevant sentence in section 3.4.1.2 of the sixth paragraph (additional language is in bold, deleted language is struck through):

“In instances where documentation is contradicted not supported by contemporaneous information in the physician progress notes, physician progress notes shall be the determining factor……” RAMP appreciates the opportunity to comment on these important issues. For more information, please contact either Cara Bachenheimer, Vice President Government Relations, Invacare Corporation at 440-329-6226, or Robert Falk, Esq., Powell Goldstein, at 202-624-7318.

Sincerely,

Restore Access to Mobility Partnership

RAMP Members include: The American Association of Homecare; Invacare Corporation; The MED Group; Mobility Products Unlimited, LLC; Pride Mobility Products Corp.; The Scooter Store; and Sunrise Medical.

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March 7, 2005

To Whom It May Concern:

While we applauded CMS for acknowledging that their bed or chair confined wheelchair requirement is antiquated. We at Bay Home Medical are worried that some of our clients will still not get the necessary mobility assistive equipment to improve their quality of life. Bay Home Medical has always believed that a qualified physical or occupational therapist should be utilized along with our qualified rehab specialists to verify that a client is in need of a powered or assistive device.

One of the issues that has us concerned is that CMS is not viewing locomotion as an ADL and proposing in fact that a full time aid be incorporated into a patients need for a MAE. We have several clients that have full time aids however, are able to safely utilize a power wheelchair to access all areas of their home allowing them some freedoms that their weakened body will not allow. In this example their quality of life is affected. These clients are also in need of pressure relief that is not other wise obtainable.

Another issue I don’t see addressed is in regards to patients with MS and ALS that may have good mornings where they are able to walk to the bathroom and kitchen however, by mid day these patients can’t take a single step. How will these clients fit into CMS’s new standards?

The issue of in home ALD’s is very limiting to patients as, in this day we seldom see a physician that is able to make house calls. Beneficiaries are living longer needing to supplement their income by working into their retirement age. Denying these patients the right to a MAE for movement outside the home is denying them the right to make a living.

We hope that CMS will review our comments and make adjustments accordingly as we are certain that others share our views and concerns.

Sincerely, Bay Home Medical & Rehab

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I am a Physical Therapist, a member of the Clinician's Task Force and am currently employed by Sunrise Medical as the Director of Education. I have nearly 20 years of experience in the evaluation and recommendation of seating and mobility assistive technology for the disabled population. Regarding the NCD proposal for mobility assitive equipment, I would first like to commend CMS for eliminating the "bed or chair confined" standard and replacing it with functionally-based criteria. However, I do feel that there are a number of problems with the language of the proposal, some of which I would like to address below.

My first concern is the failure of the proposal to eliminate the "in-home" restriction placed on mobility assistive equipment. I concur with the many respondents in this comments section that this is a restrictive interpretation of the regulation and that it needs to be changed. It prevents beneficiaries from obtaining the most appropriate mobility equipment for optimal health and function, it prevents beneficiaries from leading a full and independent life and it significantly restricts CMS from drafting an appropriate coverage policy. The interpretation needs to be changed.

My other major concern is that with the current language of the NCD proposal there would be many beneficiaries who would not be covered for mobility devices. I have listed below just a a sampling of the beneficiaries I could describe. I purposefully did not give them specific medical histories, since they could have any one of a long list of disabilities/conditions, however, they are all composites of clients that I have worked with over the years. They all have different physical and cognitive issues, but they all have one thing in common. Because of their physical and/or cognitive limitations, they will never be able to independently perform MRADL's whether they have a mobility device or not. For all of these beneficiaries, provision of the wheelchair would not "materially improve the beneficiary’s ability to perform mobility-related activities of daily living in the home", such as "toileting, feeding, dressing, grooming, and bathing". Therefore, according to the language in the proposal they would not be covered for an MAE. I have included reasons why I feel they should be covered and the detrimental effects that could occur without the appropriate MAE.

Beneficiary A is unable to ambulate, propel a manual chair or operate a power chair and is unable to perform any MRADL's due to the extreme physical limitations of her disability (non- functional strength throughout, severe spasticity, and lack of functional motor control). Without a wheelchair, she would be at risk for all the detrimental physiological effects of bedrest unless her care-giver can somehow get her into some other type of chair. In either case, she will be confined to lying/sitting in one location without proper support or positioning and without adequate change of position for pressure relief. Effects could include skin breakdown, respiratory and/or cardiac issues, development of fixed deformities and overall medical deterioration. This beneficiary needs a dependent mobility device (i.e. tilt in space chair with appropriate seating) not to provide the ability to perform a MRADL, but for appropriate change in position and pressure relief, for optimal positioning to prevent deformity and simply to be moved from place to place within her environment.

Beneficiary B is unable to ambulate or propel a manual chair and is unable to perform any MRADL's due to physical limitations (paralyzed in both arms and legs). He is, however, able to safely and functionally drive a power chair by sipping and puffing into a straw and can also operate a power tilt system on the chair using the same sip and puff mechanism. Again the provision of a wheelchair for this client is not to provide the ability to perform a MRADL, but to allow this client to independently mobilize from place to place within his environment - mobility for mobility's sake vs being stuck in one location for hours at a time. The power tilt system on the chair also provides him the ability to independently change position for pressure relief and the seating components provide optimal positioning to prevent deformity.

Beneficiary C, like Beneficiary B is unable to ambulate or propel a manual chair, and is unable to perform any MRADL's due to physical limitations (limited strength, spasticity and very poor motor control in both arms and legs). He is also unable to speak, although he is fully cognitive. He is, however, able to safely and functionally drive a power chair and operate the chair's power tilt/recline system using several mechanical switches. In addition, he is able to use the same switches to operate a communication device that is integrated into the electronics of his wheelchair (he is unable to operate the communication device on its own). As with Beneficiary B, a power chair would not materially improve his ability to perform MRADL's, but would provide him with independent mobility and pressure relief plus appropriate positioning to prevent deformity. In addition, the power chair would also give him the ability to communicate with those around him.

Beneficiary D is unable to ambulate due to very poor balance. Significant strength deficits in her arms prevent her from independently performing any MRADL's . However, she is able to propel a lightweight, appropriately configured manual wheelchair within her environment by propelling with her legs. As with the above beneficiaries, the provision of a chair is not going to enable her to perform any MRADL, however, it does provide her with the ability to move from place to place. In addition, the activity of propelling with her legs is beneficial to her cardiopulmonary system, helping to prevent swelling in her legs, skin breakdown on her buttocks and cardiac issues resulting from immobility. (Note - according to strict interpretation of the current language of the proposal, she would also not be eligible for a manual chair, because she does not have sufficient upper extremity strength to propel the chair).

Beneficiary E is unable to ambulate or propel a manual chair and is unable to perform any MRADL's due to extreme weakness in both arms and legs. She can, however, drive a power chair and operate a power tilt system using one finger on a very small "mini" joystick. She can also operate an environmental control unit that is integrated into the electronics of her power chair using the same mini joystick. This allows her to turn the lights, TV, and radio on and off and provides her a means to use a telephone. She has a care- giver for several hours in the morning, at noon and in the early evening. Again the provision of a wheelchair for this client is not to provide the ability to perform a MRADL, but to allow this client to independently mobilize from place to place within her environment, independently change position for pressure relief and independently maintain optimal position throughout the day. In addition, the system provides her with the ability to have some independent control over her environment when she is alone.

Beneficiary F is unable to ambulate due to overall strength and balance limitations. She does have the physical capabilities to propel a manual chair, to operate a power chair and to perform some MRADL's, but she is unable to do so because of extreme cognitive and behavioral limitations. Without a wheelchair, she would not have any means to move from one location to another within her environment, nor would she be provided appropriate support and positioning to prevent postural deformities (she does not have the cognitive awareness to sit in an optimal position). This beneficiary needs a dependent mobility device (i.e. manual chair with appropriate seating) not to provide the ability to perform a MRADL, but for optimal positioning to prevent deformity and to provide a means to be moved from place to place within her environment.

I could continue on and on with further examples. Again, all of these beneficiaries have different physical and cognitive issues, but they all have one thing in common - they will never be able to independently perform MRADL's whether they have a mobility device or not. Without a mobility device, however, many of them will be completely dependent on someone else to move them from place to place, to re-position them often enough to prevent skin breakdown and cardiopulmonary issues, and to try and make sure that they are sitting in the most appropriate posture to prevent deformity. Most care-givers are not physically capable of moving the client from place to place without a mobility device. In addition, since some/many of these clients do not have access to 24-hour care, they will spend many hours each day in the same spot, without a change in body position, some with no control over their environment and some unable to communicate.

During the recent Open Door Forum regarding the NCD proposal, I heard several times that the existence of a willing care-giver would "sway the decision in favor of the beneficiary", but what does that really mean? Also, in the decision draft memo, it states that "CMS concurs that the contributions of a caregiver may compensate to overcome the beneficiary’s limitations to operate a wheelchair. For example, the feeding or grooming of the beneficiary by a caregiver is acceptable as a compensation for the beneficiary’s inability to personally perform those activities". If this is true then why make the performance of a MRADL the basis for coverage? In any case, the actual language of the proposal is very unclear on this and lends itself to a wide variety of interpretations that could severely limit the availability of the appropriate mobility equipment to many beneficiaries.

It appears that the coverage policy needs to change in a number of ways. Either expand the list of "MRADL's" to include mobility itself, change in body position, maintaining optimal posture and position, communication, environmental control, etc or expand the coverage criteria to include things other than MRADL's such as:

MAE would allow the client to move/be moved from place to place in his/her environment either independently or dependently, OR;

MAE would provide a change in position throughout the day for pressure relief, prevention of skin breakdown and increased sitting tolerance OR;

MAE would provide appropriate positioning through seating components to prevent fixed postural deformities and the ensuing detrimental physiological effects OR;

MAE would materially improve the beneficiary’s ability to perform instrumental activities of daily living

Again, I do applaud CMS for proposing functionally-based criteria and I do not believe that CMS intends to deny access to MAE for the most vulnerable of Medicare beneficiaries. However, the current draft has the potential of causing that unintended consequence.

Sincerely,

Elizabeth Cole
Director of Education
Sunrise Medical

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The Rehabilitation Engineering and Assistive Technology Society of North America (RESNA), on behalf of our membership, submits the following comments on the draft decision memorandum for mobility assistive equipment per CMS’s National Coverage Determination issued on February 3, 2005.

RESNA is an interdisciplinary association of people with a common interest in technology and disability. Its 1,100 members represent dozens of professional disciplines including physical therapists, occupational therapists, speech- language pathologists, rehabilitation and assistive technology suppliers, rehabilitation engineers, researchers, orthotists, prosthetists, special educators and consumers of rehabilitation and assistive technology (individuals with disabilities and their family representatives).

RESNA is an ANSI accredited standards organization with experience in developing standards through its Technical Standards Board and creating a professional credentialing program for assistive technology practitioners (ATP), assistive technology suppliers (ATS) and rehabilitation engineering technologists (RET) through its Professional Standards Board (PSB).

RESNA once again thanks you for the opportunity to comment on your draft memorandum. We are pleased to see that CMS is proposing to delete the “bed or chair confined” restriction. This action should clear up a lot of the confusion around what this phrase actually means. However, we are disappointed that the memorandum did not address the “in the home” restriction. This issue is still a big concern for our members. As stated in previously submitted comments, continued interpretation to allow provision of assisted mobility only within the four walls of a home is entirely restrictive, discriminatory, and seems to contradict provisions the federal government has already adopted and put in place such as the Americans with Disabilities Act; the Rehabilitation Act of 1973, as amended; the Ticket to Work and Work Incentives and Improvement Act; and the New Freedom Initiative.

Some individuals are required to perform “Activities of Daily Mobility” outside the four walls of a home in order to carry out “Instrumental Activities of Daily Living”. Denying individuals with disabilities appropriate mobility assistance to access the outside world could result in denying them the support needed to continue living in their homes. This negative action could lead to more people being placed in facilities and would not be cost effective for CMS.

We are pleased that CMS is proposing to move toward a functionally-based standard of coverage for mobility devices as RESNA had previously recommended. However, with the “in the home restriction” still in place, we feel that clinicians will not be able to adequately do their jobs.

Additionally, the “in the home” restriction limits clinicians from fully performing their jobs in an ethical and professional manner. Therefore, we recommend that this restriction be rescinded.

In addition, RESNA feels that mobility should be added to the list of mobility-related activities of daily living. Mobility is an activity of daily living and is recognized as a necessary functional activity. Not including mobility as an activity of daily living will potentially add confusion and ambiguity on this issue and again, put clinicians in a awkward position of trying to provide services with “one hand tied behind their backs.”

Again, thank you for the opportunity to comment on the proposed draft memorandum. We appreciate your efforts to seek input on this very complex issue. We eagerly await a final decision and eventual implementation. In the meantime, if we can be of assistance, please do not hesitate to call upon us. As previously mentioned, RESNA is an interdisciplinary association with clinical and scientific experts among our membership who are willing to assist in any way. Over 20 members of the Coalition Task Force (CTF) are members of RESNA. The CTF has drafted its own comments and recommendations with supporting documentation which RESNA supports.

Respectfully Submitted,

Rory Cooper, Ph.D.
RESNA President

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I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the-home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the-home” restriction.

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The National Registry of Rehabilitation Technology Suppliers (NRRTS) has already submitted written comments regarding the Interagency Wheelchair Work Group recommendations for coverage of manual and power wheelchairs. Given that the IWWG report is very similar to the proposed National coverage Determination on Mobility Assistive Equipment (MAE), NRRTS comments remain similar to or original comments on the IWWG report

The National Registry of Rehabilitation Technology Suppliers agrees with the following elements of the NCD proposal:

1. The National Registry of Rehabilitation Technology Suppliers is in support of the NCD’s proposal for a new functionally based criteria for power and manual wheelchairs and for its recommendation to replace the “bed or chair confined” language that is in the current policy.

2. The National Registry of Rehabilitation Technology Suppliers also believes that a clinical evaluation process conducted by a qualified professional is critical to appropriate mobility equipment prescription . NRRTS believes that an essential component should include a qualified rehabilitation technology supplier.

3. The National Registry of Rehabilitation Technology Suppliers enthusiastically supports the IWWG opinion that diagnostic criteria alone should not determine the need for a mobility device, however in reviewing the proposed NCD, this concept could not be located. We wish to express our concern that when final language regarding the specific eligibility criteria are made, that the beneficiary’s diagnosis is NOT a primary or even secondary criteria. NRRTS believes that the functional ambulation abilities of the beneficiary are the first and foremost criteria that must be used for determining eligibility for an MAE.

The National Registry of Rehabilitation Technology Suppliers provides the following comments and recommendations regarding apparent problems with the NCD proposal:

Failure to address the needs of all non- ambulatory beneficiaries, especially those with severe cognitive or physical impairments:

• Perhaps the most fundamental problem with the MAE-NCD proposal is the failure to address the mobility needs of all beneficiaries, especially those who are unable to ambulate and are also dependent on others for performing “mobility related activity of daily living” (MRADL’s). The MAE-NCD inappropriately focused on the use of mobility devices as a means to achieve MRADL’s exclusively, and has failed to recognize that mobility is a basic and essential requirement for all individuals who would otherwise be immobile.

• The MAE-NCD appears to continue to use very narrow and potentially discriminatory language that would most likely exclude coverage of any and all forms of mobility devices for beneficiaries who are now eligible for attendant operated manual wheelchairs. There are many severely disabled beneficiaries who, in spite of the inability to feed, bathe, toilet or dress themselves, are still able to work (in either competitive or sheltered employment settings), go to school or live independently in a community setting due to rehabilitation technologies like specialized manual and powered wheelchairs. Without an appropriate manual or powered wheelchair, these individuals would most likely be institutionalized at a significantly greater cost than the cost of these enabling technologies. This is a grievous concern of the National Registry of Rehabilitation Technology Suppliers, as it would confine these individuals to their beds. NRRTS is in support of the language put forth by the Clinicians Task force (AKA the CMMCP) regarding individuals who are unable to perform ADL’s independently.

Failure to adequately address CMS’s restrictive interpretation of “in the home” use of manual and powered mobility equipment.

• The MAE-NCD continues to side step the “in the home” restriction for mobility assistive equipment, but this issue must be addressed. CMS has indicated that this NCD is not the place to address this issue and suggests that this is a statutory issue. There remains significant debate as to whether this is or is not within CMS’s power to address, but the general belief of most consumer and professional groups is that it is within CMS prevue. It is obvious to the National Registry of Rehabilitation Technology Suppliers that any functionally based coverage criteria must be devised without this restriction in place. In fact, current policy for manual wheelchairs is already vague and somewhat contradictory on this issue. For example, manual wheelchairs classified as high strength ultralights (K005) are rarely covered unless there is adequate and detailed justification for the highly active and independent use of this equipment both inside and outside the home. Factors such as community access for things like grocery shopping, banking, managing personal finances, child care and the like are the reason that these kinds of manual mobility equipment, with their multiple individual adjustment features (rear axle position, variable seat and back heights and angles etc) are designed and approved for funding. The inherently wide range of adjustability of this equipment to meet the most active and independent of beneficiaries needs is directly contradictory to use primarily and or exclusively within the home.

• Coverage criteria that only addresses the use of mobility equipment within in the home is also contradictory to many other federal mandates. Most noted examples include Section 504 of the Rehabilitation act of 1978, The Education of All Children (PL84-142) and it’s subsequent IDEA provisions, the Americans with Disabilities Act (ADA), the Ticket to Work iniative, among others were all designed to get people with even the most severe disabilities out of their homes and into community based education and employment settings. It is about time that CMS recognizes that individuals with disabilities have mobility needs which include participation in activities within the full range of life.

Failure to address the need for professional supplier standards for provider’s of manual and powered mobility equipment.

• It is the opinion of the National Registry of Rehabilitation Technology Suppliers that CMS should give more serious consideration the development of professional standards requirements for the individuals that provide of mobility equipment. NRRTS is the first organization in the country to establish a set of voluntary standards for providers who primarily provide more advanced types of manual and power wheelchairs. These voluntary standards have been in existence for over ten years and include four main components: continuing education, work experience, clinical peer review and adherence to a code of ethics and standards of practice. More information about these standards may be found at www.nrrts.org. It is important that disabled beneficiaries obtain mobility equipment, especially more complex and advanced systems, from qualified suppliers who operate in a professional and ethical manner. Too often, beneficiaries are provided with equipment that does not meet their needs, is improperly fitted or is not useful at all. This kind of practice can be prevented by requiring specific individual supplier standards in addition to the mandates for accreditation of the companies which employ these individuals (as required in the provisions of the Medicare Modernization act of 2004).

• The Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) has been instrumental in developing a volunteer credentialing program, and NRRTS has been a long time supporter of these efforts. RESNA has a basic level credentialing examination for suppliers (Assistive Technology Supplier, or ATS) and for practitioners (Assistive Technology Practitioner or ATP) which would also be relevant for CMS to consider in terms of developing supplier and clinician standards. Additional information about these credentials are available at www.resna.org.

• It is the opinion of the National Registry of Rehabilitation Technology Suppliers that either the standards established by NRRTS or the credential developed by RESNA be included in a national coverage policy for more advanced forms of mobility equipment. It is further recommended that the proposed SADMERC power wheelchair HCPCS currently under review that are categorized as “Rehab” be subject to some form of mandatory supplier standard like that of NRRTS or RESNA.

Summary:

The National Registry of Rehabilitation Technology Suppliers would like to recognize the valuable and commendable efforts made by CMS in the development of the Mobility Assistive Equipment National Coverage Determination. The MAE-NCD proposal contains many positive recommendations that if adopted, would lead to more appropriate provision of mobility equipment to people who need it most and at the same time would potentially reduce some of the instances of fraud and abuse involving these products.

Unfortunately MAE-NCD continues to leave many unanswered questions, and has even raised some very serious concerns with regard to individuals with severe cognitive and physical impairments. The NCD fails to define key terms, and most importantly, it made no effort to address one of the most important issues that people with disabilities have, the “in home use” restriction.

The National Registry of Rehabilitation Technology Suppliers feels that there is much work to do when it comes to the development of a comprehensive and fair national coverage policy on mobility equipment, and is prepared to offer additional input to CMS in whatever capacity is necessary.

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The American Association of People with Disabilities (AAPD) would like to submit comments on the National Coverage Determination for Mobility Assistance Equipment.

AAPD is the largest national cross-disability membership organization with over 100,000 members, working to promote the political and economic empowerment of all people with disabilities in the United States. AAPD works to promote bi-partisan legislation and policy that will further the ability of people with disabilities to live independently, pursue meaningful careers, make choices and enjoy integration into the mainstream of American society. AAPD works to protect programs that empower children and adults with disabilities and realign programs and policies that erect barriers to full participation.

AAPD is a member of the ITEM Coalition which also submitted remarks to CMS on several aspects of, and omissions in, the draft National Coverage Determination (NCD) on Mobility Assistance Equipment (MAE) as released on February 3, 2005 by the Centers for Medicare and Medicaid Services (CMS).

AAPD would like to take this opportunity to underscore the following points made by the ITEM Coalition:

AAPD would like to stress its disappointment with the apparent failure of CMS to consider the approximately 6 million Medicare beneficiaries with mobility impairments below the age of 65 in this draft NCD. The mobility device needs and functional activity demands of this population are often starkly different from elderly beneficiaries and this should be explicitly reflected in the final NCD.

Regarding Medicare’s “in the home” rule, by refusing to address the restrictions posed by this rule, the draft NCD fails to recognize the need for beneficiaries with mobility impairments to access their community. This rule is an antiquated restriction, reminiscent of a time when people with disabilities were not expected to leave the home and participate in society. It is an artificial barrier that stands in the way of appropriate wheelchair coverage policy and has far more to do with limiting utilization than it does with any conceivable clinical justification.

The “in the home” rule runs counter to numerous government policies and initiatives such as the Administration’s New Freedom Initiative and the Ticket to Work and Work Incentives and Improvement Act (TWIIA). In fact, the New Freedom Initiative listed Medicare’s “in the home” restriction on mobility devices as a policy in need of review by the Department of Health and Human Services; the TWIIA extends Medicare coverage for SSDI recipients who agree to go back into the workforce but the “in the home” restriction denies them access to mobility devices that are appropriate for use outside the home in the work and community environments.

Furthermore, the “in the home” restriction forces clinicians to perform arbitrarily confined assessments that often lead to the prescription of insufficient and potentially harmful wheelchairs. We encourage CMS to modify the “in the home” restriction either through this NCD process or in a separate regulatory process.

Requiring that a mobility device assist a beneficiary in completing a “mobility related activity of daily living (MRADL),” the draft NCD fails to take into account the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. This standard, if applied as written, would not allow the prescription of wheelchairs to individuals who are unable to complete MRADLs but could improve their capacity for mobility by using a mobility device. Therefore, we encourage CMS to incorporate mobility into the agency’s definition of mobility related activities of daily living.

In conclusion, the existing draft NCD fails to address the real-life, reasonable and necessary, medical and functional needs of Medicare beneficiaries, in part, due to CMS’s restrictive interpretation of the “in the home” criterion. The draft NCD asserts that the NCD process is not the proper vehicle to modify the “in the home” requirement, but it does not suggest the proper process to make such a critical change in CMS policy interpretation. It is for this reason that AAPD reiterates the ITEM Coalition’s recommendation that CMS, in conjunction with the publication of the final NCD, publish either a proposed rule or interim final rule that modifies the “in the home” requirements so that Medicare beneficiaries are not inappropriately denied access to the mobility devices they need to be functional and independent.

Thank you for the opportunity to comment. We hope serious consideration is given to our concerns.

Yours truly,

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Thank you for the opportunity to comment on the draft Decision Memo for Mobility Assistance Equipment. The American Physical Therapy Association (APTA) is a professional organization representing the interests of 66,000 physical therapists, physical therapist assistants, and students of physical therapy. Physical therapists are frequently the clinical experts involved when an individual is being evaluated for a mobility assistance device and APTA therefore has a strong interest in the new National Coverage Determination for mobility assistance equipment.

“In the Home” Language Must be Changed
The Draft Decision Memo for Mobility Assistance Equipment (MAE) goes a long way toward addressing deficiencies within the old policy. For example, we commend CMS for moving forward with functionally based clinical criteria as the basis for prescription of a mobility device and the development of appropriate codes for these devices. While there are many improvements in the policy, an area that continues to be problematic is the “in the home” restriction.
The APTA joins the many organizations and individuals who are requesting that this language be amended. The APTA recognizes that the “in the home” language is found within the definition of durable medical equipment in the Code of Federal Regulations, and as such, would require a regulatory change. APTA therefore strongly urges CMS to promulgate draft regulations to expand the definition of where mobility assistance equipment can be used. The definition should make allowance for use of these devices outside of the home for normal and necessary life activities.

During the evaluation process, consideration of a Medicare beneficiary’s roles, responsibilities and goals must be considered. The evaluation must include consideration of activities outside of the home for the health and safety of the beneficiary. Equipment needs for beneficiaries who are active outside the home will differ greatly from those who require equipment for in home use only. Moreover, the demands on a piece of equipment to be used outside of the home are different than those for a piece of equipment used solely within the home. A manual wheelchair designed for inside use only, for example, will be prone to breakdown due to greater wear and tear, if used outside of the home. Equipment breakdown not only endangers the beneficiary, but also causes more frequent and costly repairs. A beneficiary who takes this same manual wheelchair outside of the home to fulfill life responsibilities could sustain a complicating overuse injury to the upper body and subsequently require a power wheelchair. In this scenario, Medicare would be paying for two pieces of equipment instead of one.

Several peer-reviewed articles suggest that mobility and quality of life are closely correlated. For example, “Outcomes of Assistive Technology Use on Quality of Life” published in Disability Rehabilitation (1996, Sep 18(9):439- 48) is a review of the literature on assistive devices and their impact on quality of life. This literature review states the importance of matching the person with the appropriate technology, considering the device user’s environment, and also concludes that consumer involvement in the selection of equipment and increased availability are desirable goals.

There is pervasive use of the term “in the home” throughout the draft policy. If CMS does not initiate the rulemaking process to amend the “in the home” language, and align the policy accordingly, the potential promise of the draft policy cannot be realized. Many beneficiaries will suffer needlessly, whether they are under the age of 65 and have a disability, or 65 or older and require mobility assistance. Every Medicare beneficiary should be able to achieve maximum function and not be held back by the restrictive and out of date “in the home” definition. The APTA believes that people with disabilities, no matter what their age, should no longer be prisoners in their own homes as a condition of eligibility for a mobility device.

Mobility Itself is an Activity of Daily Living
It has been widely accepted that mobility itself is a key component of daily living and in maintenance of overall health. Indeed, there is a growing body of knowledge which demonstrates an inverse dose response relationship between physical activity and many of the chronic diseases faced by Americans. These include hypertension, heart disease, diabetes, and obesity. (Quantitative Research in Exercise and Sport (1993, 64:365-376). APTA was disappointed that the draft policy failed to include mobility itself as an activity of daily living (ADL) or a mobility related activity of daily living (MRADL) for the purpose of assessing a beneficiary’s need for a mobility assistance device. The use of a manual or power wheelchairto move within a room or from room to room is an appropriate intervention that a physical therapist assists patients in achieving as a part of normal clinical practice. The Guide to Physical Therapist Practice, Second Edition (page 442-443) provides Procedural Interventions 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. For some beneficiaries with severe functional impairments, gaining full access to home environments is a reasonable goal and would represent an improvement in function. A physical therapist cannot assist all patients in achieving their functional potential without the recognition that mobility itself is an activity of daily living.

Skin Integrity Considerations
The draft policy fails to address mobility devices or customized seating that would help preserve the integrity of the skin. Physical therapists are frequently involved in evaluating the skin integrity of patients. Based on this evaluation, physical therapists make recommendations related to positioning, appropriate assistive devices and accessories to prevent breakdown of the skin. Anticipated goals and expected outcomes from therapeutic interventions that relate to skin integrity include “Performance of and independence in activities of daily living (ADL) and instrumental activities of daily living (IADL) with or without devices.” (The Guide to Physical Therapy Practice, Second Edition, page 604). Tilt-in-space wheelchairs, for example, are mobility devices that assist with the preservation of skin integrity. For individuals with a functional impairment so severe as to require a mobility device, special care must be taken to ensure that the development of pressure ulcers is minimized. A pressure ulcer can become a serious medical condition that can be difficult to treat and therefore quite costly to the Medicare program. The final policy must adequately reflect the need for reasonable accommodations to preserve the integrity of the skin.

Conclusion
There are many improvements in the draft coverage policy for mobility assistance devices and we appreciate the work that has gone into the development of the policy. The APTA is very pleased to see that the “bed or chair confined” criteria was replaced with functionally based criteria as the basis for evaluation of those who require mobility assistance devices. We are also pleased to see that the contributions of caregivers in a beneficiary’s life are acknowledged and will not prevent the prescription of the appropriate mobility assistance device when it can improve the beneficiary’s functional status.

The many improvements in the new policy cannot be realized, however, without elimination of the “in the home” restriction. The “in the home” restriction is at the very minimum outdated. At its worst, it is discriminatory to those with functional impairments. Further, it fails to recognize that beneficiaries today are living longer and more active lives due to advancements in the field of medicine. Those over the age of 65 increasingly remain in the workforce for several years. The Social Security system has recently raised the age to begin receiving full retirement benefits from 65 to 67 in recognition of this reality. The “in the home” restriction also fails to recognize the under 65 disabled Medicare beneficiary who must go outside of the home to fulfill life responsibilities such as getting an education and going to work.

The APTA would also like to see an expansion of mobility related activities of daily living to include mobility itself. Physical therapists assist their patients with the goals of moving their bodies in space, and moving from one room to another as part of normal clinical practice. The ability to perform these functions increases quality of life and reduces the likelihood of certain comorbidities, such as depression and skin breakdown.

The APTA would also like to see skin integrity issues addressed in the new policy. Having the ability to change one’s position or seated posture, proper seating, and the use of appropriate accessories are essential in minimizing the development of pressure ulcers. This should be a goal for all individuals for whom mobility devices are prescribed.

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On behalf of The ALS Association, we are writing to comment on the proposed CMS National Coverage Determination (NCD) for Mobility Assistance Equipment (MAE). The ALS Association is the only national not-for-profit voluntary health organization dedicated solely to finding the cause and cure for ALS and improving living with the disease.

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with an average survival from the time of diagnosis of two to five years. The cause of ALS is unknown and there is no effective disease-modifying treatment to slow, halt or reverse the disease. The hallmark symptom of ALS is muscle weakness that spreads through all voluntary muscles of the body and leads to total body paralysis over time. The disease can begin in the lower limbs, the upper limbs or the bulbar region. ALS will eventually cause inability to move any voluntary muscle. Muscle paralysis causes significant problems with all activities of daily living including mobility, speaking, swallowing, eating, dressing, toileting and bathing.

The ALS Association appreciates CMS’ efforts to improve the Medicare coverage criteria for mobility assistive equipment and we are pleased that the Agency appears committed to addressing the access problems caused by the existing “bed or chair confined” standard. However, we believe that people with ALS should be presumed to require the need of mobility assistance devices without having to meet CMS’ eligibility requirement because people with ALS will always require mobility assistance equipment at some point in their disease. For many people, the disease progresses so rapidly that the evaluation CMS is suggesting would unduly delay needed equipment. Nevertheless, if CMS chooses to move forward with the proposed changes in the coverage criteria for mobility assistive equipment, we are concerned that it may create barriers that prevent patients with ALS from accessing the most appropriate device for their specific medical condition and the related functional deficits. These concerns include:

On behalf of The SCOOTER Store ("TSS"), a nationwide supplier of power mobility equipment headquartered in New Braunfels, Texas, we appreciate the opportunity to submit comments in response to the proposed National Coverage Determination ("NCD") and coverage criteria change issued by the Centers for Medicare and Medicaid Services ("CMS") entitled, “NCA Tracking Sheet for Mobility Assistance Devices (CAG-00274N).”

Since 1991, The SCOOTER Store has worked with more than 90,000 different physicians and has provided power mobility products to more than 200,000 disabled seniors. We make over 10,000 in-home visits to serve America’s disabled seniors every month. As the leading supplier of power mobility equipment, we have a strong commitment to ethical and legal business practices, and are accredited by the Accreditation Commission for Health Care, Inc. ("ACHC"). We look forward to working with the agency and physician, beneficiary, and supplier communities to develop coverage criteria and documentation standards that are fair and consistent.

I. Executive Summary

Over the past 10 years, power mobility equipment has been invaluable to disabled senior citizens and disabled Americans, because it provides the freedom and independence necessary to carry out activities of daily living, while leading to significant cost savings for the taxpayer and the federal government.

We applaud the proposed replacement of the current “bed or chair confined” standard with a functional ambulation standard, as was suggested by the recent Interagency Wheelchair Working Group ("IWWG") report. While this is a significant step forward, TSS has identified several issues that should be addressed before the issuance of the final NCD. Toward this end, we have developed a set of recommendations that should provide the basis for minor changes to the NCD.

TSS recommends that CMS issue immediate guidance consistent with the NCD, to its carriers, stating that the functional ambulation standard applies to claims retrospectively and prospectively. After providing immediate guidance to carriers, CMS should formally implement the NCD through the already begun public process. Finally, CMS must implement and enforce a policy directing its carriers, physicians, and supplier partners to use the Certificate of Medical Necessity ("CMN") as the document establishing medical necessity.

II. The Importance of the Power Mobility Benefit

A. The benefits of power mobility.

TSS believes that CMS must recognize and defend the fact that power mobility offers Medicare beneficiaries the opportunity to improve and lengthen their lives, and offers American taxpayers substantial cost savings.

With power mobility equipment, America’s disabled seniors have the ability to carry out the various activities of daily living ("ADL") such as cooking, toileting, or simply moving from room to room. Prior to the mid 1990’s, mobility devices were too large and bulky to maneuver effectively in most senior’s homes. Many seniors were left with little choice but to rely upon caregivers or enter institutional settings. Beginning in 1994, power wheelchair manufacturers significantly modified features that led to more Medicare beneficiaries being able to utilize the technology.

In addition to the immeasurable benefits that power equipment affords to qualified Medicare beneficiaries, the use of power mobility equipment in the home has resulted in a large cost savings to the Medicare program and the American taxpayer. For example, a recent mobility outcomes study performed by RRC, Inc., reviewed Medicare’s Standard Analytical Files for 1994-2001. This study concluded that beneficiaries who utilize power mobility save the Medicare program in excess of $11,000 over a three-year period when compared to similarly diagnosed and situated beneficiaries without power mobility. Savings can be attributed to reductions in costs associated with inpatient hospitalization (primarily due to less frequent falls), home health visits, and skilled nursing facility expenses. Further, the RRC study concludes that beneficiaries who receive power mobility products experience a lower death rate compared to those who had their power mobility claims denied.

In making judgments about the scope of coverage, CMS should consider the substantial costs savings associated with the use of power mobility equipment. Consideration of these cost benefits is consistent with recent guidance from Congress, which stated, "[T]he medically necessary application of this [power wheelchair] benefit can save Medicare money through avoiding expensive institutional care or hospitalization resulting from falls by the growing elderly population and beneficiaries with disabilities under age 65.”

B. "Over-utilization" of mobility products is an exaggerated problem.

Utilization of power mobility equipment has definitely increased since the 1990’s. However, the fact is that more people are utilizing power mobility equipment because new technology means that more people can use power mobility equipment. Physicians throughout the country recognize the importance of this equipment for their patients, and Medicare only pays for this equipment after a treating physician certifies medical need.

Much of the perception of what has been characterized as "over-utilization" of the power mobility benefit has resulted from the large number of claims that CMS paid in 2002 and 2003 as a result criminal actions, such as the fraud that occurred in Harris County, Texas. To the extent that any current utilization of the power mobility benefit has resulted from fraud, TSS is committed to preventing such fraud in the future. TSS has been an active and open partner with the government, as well as open about all of our business practices. In keeping with that approach we have notified investigative agencies on several occasions about fraud in the medical equipment industry.

Both fraud and overreaction to fraud are unacceptable and jeopardize the ability of the Medicare program to serve qualified beneficiaries. Despite efforts to assist anti-fraud efforts from entities such as TSS, CMS has made no tangible attempt to collaborate with physicians or suppliers to determine where utilization spikes may be related to fraud. Instead, CMS has attempted to measure the efficacy of anti-fraud efforts by reductions in the number of beneficiaries who are provided with power mobility equipment. Thus, despite improvements in technology allowing more seniors to use equipment that may extend their lives, enhance their freedom and independence, and save taxpayers and the Medicare program large sums of money, CMS considers the refusal to pay for such equipment a success.

We must make sure that we do not allow misguided denial of coverage to become a standard for government success. Unless CMS’s efforts to design new coverage criteria, documentation standards, and coding requirements are carefully targeted at fraud, rather than broadly designed based upon overall utilization numbers, they will do little to address the root causes of fraud, and they will make it more difficult for qualified beneficiaries to receive vital medical equipment.

III. Comments on the NCD Proposal

A. CMS should give immediate guidance to the DMERC claim processors.

CMS should immediately inform the DMERCs that, for the purposes of power mobility coverage criteria, if someone is not functionally ambulatory according to the IWWG definition, then they are considered to be bed or chair confined per the current NCD and therefore meet this portion of the power wheelchair coverage criteria.

CMS has chosen to implement the lengthy process of changing their NCD, and we support this permanent change. However, this process, even when expedited, can be lengthy as it involves extensive public input. We are greatly concerned with the void in guidance created by CMS’s retraction of the December 2003 “clarification” related to the power mobility benefit. When the December 2003 clarification was rescinded, CMS promised to clarify coverage by the end of 2004. CMS brought together the IWWG to communicate what was meant by “bed or chair confined’ and determine who was covered for a power mobility device. Currently, and since March 31, 2004, there has been no explanation from CMS to its beneficiaries, suppliers, or physicians, as to the definition of “bed or chair confined,” and as a result, legitimate claims are being inappropriately denied because CMS refuses to share the guidance given to their contractors with the supplier and physician communities.

CMS should immediately provide guidance to its carriers stating that those carriers should follow the functional ambulation standard explained by the IWWG. This can be implemented as a clarification and should incorporate the IWWG language, which reads:

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 the beneficiary’s mobility-related activities of daily living ("ADL"). A mobility device should be provided with a reasonable expectation that the mobility device will sufficiently remedy the mobility deficit and bring about a material improvement in the ability of the beneficiary to complete one or more mobility-related activities of daily living. Such improvements seek to restore functional mobility through the device-assisted augmentation of physical attributes such as strength, endurance, balance, coordination, speed of execution, or joint range of motion.

We ask that the IWWG Recommendation be communicated, as the December 2003 “Clarification” was, to the physician, supplier, and beneficiary communities immediately. Application of the functional ambulation standard should be retrospective and prospective in effect. Clarifying existing coverage is consistent with the recent Congressional directive stating that CMS should “use its resources to develop a coverage policy firmly based on a functional standard of non-ambulatory.”

B. TSS supports the functional ambulation standard.

We strongly agree with the conclusions reached by Dr. Sean Tunis, Dr. Louis Jacques, the IWWG, and the group preparing the NCD, to the extent that all those parties agree that functional ambulation is the proper standard of medical necessity for mobility equipment. In as much as the IWWG position, and the NCD, clarify the meaning of current language and require the DMERC’s to apply a fair and consistent functional standard, we believe the work of the IWWG and the results of the NCD will benefit Medicare beneficiaries and are consistent with the way physicians prescribe power mobility today.

We believe the proposed functional ambulation standard for medical necessity of mobility equipment is reflective of the intent of the national policy since CMS changed its CMN questions in 1996. As such, we support the following actions and principles set forth in the NCD:

• The policy of removing of the misinterpreted “bed or chair confined” language in the National Policy;
• The principle that power mobility equipment is medically necessary if the patient needs such a device to accomplish at least one or more activity of daily living;
• The principle that the patient, caregiver, treating clinician, or patient’s family may initiate a conversation about the mobility assistive equipment ("MAE");
• The principle that the beneficiary should be able to safely use the equipment in their normal environment and diagnostic criteria alone are not adequate in determining the need for a mobility device; and
• The principle that suppliers and clinicians should make a reasonable attempt to evaluate the beneficiary’s home environment. However, we believe this should be a responsibility of the supplier, and clinician, if needed, and more clarification is needed regarding the standards and documentation requirements associated with an evaluation.

C. Inadequacies in the NCD.

Although TSS is generally supportive in the NCD in relation to the functional ambulation standard, we believe that effective implementation of the NCD requires the following actions:

• CMS should explicitly state that there is no exclusion of coverage for beneficiaries who simply need mobility products to move from room to room, and who may not be able to perform activities of daily living on their own;
• CMS should adopt the recommendations of the following groups who have submitted comments regarding the elimination of the restrictive “in-home” rule: The Independence Through Enhancement of Medicare and Medicaid ("ITEM") Coalition, the Clinician Task Force, AA Homecare, the American Occupational Therapy Association ("AOTA"), the National Registry of Rehabilitation Technology Suppliers ("NRRTS"), and many other organizations. At a minimum, it would be irrational not to at least allow a beneficiary use of the equipment for the purposes of ingress and egress to and from their home in cases of emergency or need;
• Each step of the algorithm should ask if the product is suitable for use and can be safely operated in the patient’s normal home environment;
• CMS should explicitly state that medical necessity should be based upon the condition of the beneficiary independent of their caregiver. The presence of a spouse or occasional caregiver should not preclude access to mobility equipment;
• Any requirements regarding evaluations of the environment or patient must be clearly defined, required with every claim, and go through formal notice and comment procedures. While we do not disagree with the recommendation regarding evaluations, we do believe the policy, before being published, must address how this assessment will take place, who should perform such assessment, and who will pay for the assessment. If the assessment is to be documented, then a separate process through the Office of Management and Budget ("OMB") should be completed in accordance with the Paperwork Reduction Act ("PRA").

IV. Documentation Standards and the Role of the CMN

A. The central role of the CMN.

The CMN was created by Congress, carefully crafted and put into use by CMS, and upheld in federal court as the document which must be submitted to show an item is reasonable and necessary. The CMN serves a vital role in providing clear medical conclusions, streamlined paperwork requirements, and clarity in Medicare coverage, and this role should not be undercut by any new documentation standards.

The CMN was created by Congress for the specific purpose of encapsulating all the information necessary to evaluate medical necessity. This is made clear in the statutory definition of a CMN, which states that a CMN is a “form or other document containing information required by the carrier to be submitted to show that an item is reasonable and necessary for the diagnosis or treatment of illness or injury to improve the functioning of a malformed body member.” The importance of this Congressional definition cannot be overstated because, as CMS officials have recently noted themselves, CMS cannot act in contravention of the statutory language governing the Medicare program.

The centrality of the CMN has been reaffirmed by CMS several times. When the agency sought approval from OMB for the CMN, CMS declared that “the DMERC medical directors have determined the specific information needed to make a medical necessity determination. This information requires the application of medical judgment that can only be provided by a physician or other clinician who is familiar with the condition of the beneficiary.” Furthermore, in its original 1996 submission to OMB, CMS (HCFA at the time) stated that, “Certificates of Medical Necessity provide a mechanism for suppliers of Durable Medical Equipment…to demonstrate that the item being provided meets the criteria for Medicare coverage.” In March of 2004, CMS Administrator, Dr. Mark McClellan, stated to the United States Senate that the CMN is the appropriate document to show a beneficiary's need for equipment, explaining that:

As a condition of coverage, CMS does require that the beneficiary's need for a wheelchair or power wheelchair is supportable. In fact, all claims for power wheelchairs must include a CMN which "certifies the need for the device and that it is reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body part."

The fact that the CMN was created to serve as the primary documentation related to medical necessity has also been recognized by the courts. On June 28, 2004, the United States District Court for the Eastern District of California verified the significance of the OMB-approved CMN in the case of Maximum Comfort v. Thompson. The Court stated that:

Given that Congress designated the vehicle by which suppliers are to provide information requested by the Secretary to determine medical necessity, and that it took precautionary measures to prevent supplier misconduct, it seems implausible that Congress would allow suppliers to obtain and keep private medical records, second guess physicians' professional conclusions by making medical necessity judgments themselves, and then inform beneficiaries prior to furnishing an item of the likelihood of Medicare denial of payment….

The CMN is, and should remain, the document of record within the Medicare program for the determination of medical necessity. The content of the CMN has been carefully crafted in conjunction with the physician community, including the American Medical Association and all four DMERC Medical Directors. As such, CMS should make sure that the CMN is given its proper role as the tool for answering the question of medical necessity.

B. The proper role of the CMN is being undermined.

Despite the fact that the CMN was painstakingly created to serve as the definitive document establishing medical necessity, CMS and the DMERCs are unfairly penalizing companies in the form of automatically denied claims and overwhelming document demands. In their routine requests for volumes of information in addition to the CMN, and reviews of patient records without consideration of the medical conclusions memorialized on the CMN, DMERCs have acted far beyond the bounds of the law, and are second-guessing the judgments made by treating physicians.

Under the law, a supplier cannot be required to collect and submit unapproved records and then be held accountable for the content of such unapproved records. Acting pursuant to this law, on August 5, 2004, CMS proposed a rule that would amend current law to require physician documentation of medical need for durable medical equipment, prosthetics, orthodics and/or supplies ("DMEPOS") in patients' medical records. CMS acknowledged in the proposed rule that the physician documentation of medical need for DMEPOS constitutes a "collection of information" (recordkeeping requirement for physicians) and is subject to approval from the OMB pursuant to the Paperwork Reduction Act (“PRA”).

The CMS proposed rule (and submission to OMB for approval) represents an admission by CMS that physicians, as a matter of policy, are not currently required to document the need for DMEPOS, including power wheelchairs, in their medical records. This also represents an admission that such requirement must be formally approved through the PRA process. Thus, the agency's PRA submission demonstrates a policy requiring documentation of medical need in records outside of the CMN did not previously exist, as this collection of information had not been approved by the Office of Management and Budget ("OMB").

Despite the fact that the documentation requirements for physicians have not been finalized, and that no rule exists authorizing blanket demands for documentation in addition to the CMN, carriers around the country have routinely required paperwork be submitted by suppliers in addition to the CMN. This additional paperwork is being used to determine medical necessity, and the fact that physicians have certified their conclusions as to such a need is being ignored by reviewers. This process is both illegal under the PRA, and an improper tool process for reaching sound judgments about medical necessity.

C. Alternatives to the CMN are poor tools for determining medical necessity.

While recent developments regarding the functional ambulation standard are encouraging, a major responsibility remains: the development of clear, unambiguous, standard definition and description of the evidence of medical necessity, or documentation. We are gravely concerned that CMS feels that progress notes and the judgment of the DMERCs' medical review staff, who have no personal contact with the beneficiary, are a tool for determining coverage that can supplant the CMN and the clinical judgment of the beneficiary’s treating physician.

The fact is that chart notes are highly subjective, differ from patient to patient, and are not always fully explanatory of a physician's conclusions. As a result, the most efficient and precise way to make sure that a physician's diagnosis and prescription are consistent and documented is to use a consistent and clear form for doctors to certify their conclusions; and that form is the CMN.

The fact that progress notes are an inadequate substitute for the conclusions expressed on a CMN has been noted by many experts in the field. For example:

• In the CMS Open Door Session held on this topic on February 24, 2005, Dr. Louis Jacques explained that, “Certainly when I was in practice, which was up until 18 months ago, for example, if someone came in and they needed a school physical and they had a school physical form, all I did was simply make a copy of that form and incorporate it into their record. I didn’t feel the need to either redictate or rewrite the entire contents of something, because that clearly seemed to be sort of a waste of time and effort. I think there’s a reasonable way to look at what things has a physician essentially incorporated into the record, either by physically including it in a chart or by otherwise referring to it, without necessarily regurgitating or reiterating sort of every bit of it. I guess I would just sort of leave my comment there.”;
• The Physicians for America’s Mobility Impaired, in their comments on the NCD documentation standards, stated that "Chart notes typically are written by physicians for their own use regarding that particular patient visit; they are not an analysis of a patient’s overall condition. It is our experience that all physicians chart differently, and…Physicians’ notes are not written to substantiate Medicare or insurance claims, and the use of them for that purpose is inherently inappropriate…We recommend resolving that through a single, understandable document such as the Certificate of Medical Necessity.”
• In his statement in the February 24, 2005, CMS Open Door Meeting, Dr. Donald Vliegenthart, who is a board-certified orthopedic surgeon, specializing 12 years in spine surgery, Program Advisory and Oversight Committee Member, and is certified by the Rehabilitation Engineering and Assistive Technology Society of North America ("RESNA") as an assistive technology practitioner stated, “Progress notes can be very random at times. They’re burdensome.”

Currently, CMS regional contractors are improperly requiring suppliers to obtain and submit physician progress notes on a routine basis. In addition to the fact that such requirements are inconsistent with governing law, these requirements are also improperly substituting the subjective judgments made by the DMERC medical staff about another physician's notes for the conclusions of the physician who actually recorded those notes. Using this process to justify an extrapolation payment, or complex medial review status, is unjust and illegal.

If CMS hopes to make sound judgments about medical necessity, and comply with the PRA and the statutory language governing the Medicare program, the agency must discontinue the policy of routinely demanding documentation in addition to the CMN, and the agency should not turn to documents such as progress notes as a tool for determining medical necessity.

D. Recommendations on auditing and documentation.

Our recommendation is that CMS revise the CMN to be consistent with the provisions in the NCD and take the following actions:

• Incorporate the “functional ambulation” standard into the CMN and develop specific guidance on how to utilize the CMN in light of the NCD's algorithm;
• Consider expanding the CMN to multiple pages in order to collect all information that claims reviewers will need to make a medical necessity determination; and
• Implement a consistent policy stating that if there is no indication of fraud or deceit, a properly completed CMN should be treated by DMERCs as sufficient evidence of medical necessity.

In the cases where additional documentation is legally requested, documents that can be requested must be clearly defined and capable of objective evaluation, and these documents should be used in support of the CMN rather than being used and judged in lieu of the CMN. Additional information, in order to be most useful, could request that physicians clarify their diagnoses and conclusions about medical necessity. This could be in the form of a letter from the physician, or a questionnaire created to capture certain date elements answered and signed by the physician.

V. Conclusion

While TSS is generally supportive of recent efforts to implement a functional ambulation standard, it should be made immediately clear to CMS carriers that a determination of medical necessity should be based upon a functional ambulation standard.

With respect to documentation, we strongly believe that the CMN is the tool to determine medical necessity. The use of burdensome documentation requests and automatic denials as a tool to drive down utilization numbers should not continue. Furthermore, alternatives to the CMN, such as progress notes, are not consistent with applicable law or with sound medical practice, and as a result, the most efficient and precise way to make sure that a physician's diagnosis and prescription are consistent and documented is to strengthen the role of the CMN in determinations regarding medical necessity.

TSS has had a productive dialogue with the government in the past, and we are committed to finding ways to improve the Medicare process in order to better serve beneficiaries and American taxpayers. We look forward to continuing our open dialogue with CMS in the effort to provide clarity and consistency to this important benefit in the immediate future. CMS should continue to work with, and not against, industry leaders towards the goal of delivering mobility solutions to qualified Medicare beneficiaries.

Again, we thank you for the opportunity to submit comments on this issue of great importance to seniors and the disabled.

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Introduction:

These comments are being submitted on behalf of a national, consumer-led coalition known as the “ITEM” Coalition, an acronym for Independence Through Enhancement of Medicare and Medicaid. The ITEM Coalition was formed in 2003, and its 74 member organizations include a diverse set of disability groups, 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 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.

These comments will address several aspects of, and omissions in, the draft National Coverage Determination (NCD) on Mobility Assistance Equipment (MAE) as released on February 3, 2005 by the Centers for Medicare and Medicaid Services (CMS). We have two primary topics on which we would like to comment including the “in the patient’s home” restriction and the standard to be used to replace the “bed or chair confined” language of the existing program guidance. We also have a number of additional comments that we hope you take into consideration when finalizing this NCD.

At the outset, however, we would like to stress our disappointment with the apparent failure of CMS to consider the approximately 6 million Medicare beneficiaries with mobility impairments below the age of 65 in this draft NCD. Virtually every article cited in the draft NCD involves the elderly. In fact, the draft NCD explicitly acknowledges that it focused on the elderly population by stating in Section II, Background, “Impaired mobility, combined with difficulty in performing mobility-related activities of daily living…places the elderly at risk for a multitude of physiological and psychological consequences that can negatively affect health, well-being, and quality of life.” In addition, Section VIII, CMS Analysis, states “The literature reviewed is…of large sample size (109 – over 40,000) and includes Medicare aged beneficiaries, making the results generalizable to the Medicare population.” The mobility device needs and functional activity demands of this population are often starkly different from elderly beneficiaries and this should be explicitly reflected in the final NCD.

I. The “In The Home” Restriction

A. The Negative Impact of the Restriction:

The ITEM Coalition is extremely disappointed that the agency has decided not to modify the “in the home” restriction through this NCD process. The “in the home” requirement, as interpreted by CMS over the years, essentially confines beneficiaries in need of mobility devices to the four walls of their homes by preventing clinicians from prescribing mobility devices that are appropriate for use outside of the home. This rule is an antiquated restriction, reminiscent of a time when people with disabilities were not expected to leave the home and participate in society. It is an artificial barrier that stands in the way of appropriate wheelchair coverage policy and has far more to do with limiting utilization than it does with any conceivable clinical justification.

By confining the medical necessity inquiry to inside the home only, the draft NCD fails to provide adequate access to a substantial number of individuals who are unable to participate in daily life activities that routinely occur outside the home and in the community. A person’s need for an appropriate wheelchair is not confined to the four walls of their home. An individual with Multiple Sclerosis who is disabled might be able to walk about inside their home but still require a mobility device to move safely about their community. Consideration of an individual’s need to access his or her physician’s office, pharmacy, grocery store, place of worship, or return to work should be incorporated into Medicare’s coverage determination process as these constitute a set of reasonable and necessary medical and functional needs. These needs are just as apparent in the senior Medicare population as they are in the 6 million Medicare beneficiaries under the age of 65.

CMS has stated in the draft NCD that the NCD process is not the “appropriate mechanism to change the [in the home] rule.” However, the NCD fails to state what is the appropriate mechanism to address the “in the home’ restriction. On several occasions the ITEM Coalition has requested that CMS inform the public about the appropriate process through which the “in the home” restriction might be modified, most recently, in an October 2004 letter sent to CMS’ Director of Medicare Management as well as in our comments dated January 14, 2005 to CMS on the Interagency Wheelchair Work Group’s (IWWG) recommendations.

In a letter to the ITEM Coalition dated February 17, 2005, CMS stated that the agency “is comfortable with its interpretation” of the in the home rule. This statement was made in the face of nearly unanimous support by virtually all who commented on the IWWG’s findings that the “in the home” rule was in need of modification and was inconsistent with CMS’ move toward a function-based set of criteria to assess mobility device coverage. The ITEM Coalition, therefore, respectfully requests that CMS’ reconsider its current interpretation of the “in the home” restriction for the following reasons.

B. Reasons for CMS to Modify the “In the Home” Restriction:

1. The “in the home” restriction was not originally intended to confine beneficiaries to the four walls of their homes but rather to differentiate between the durable medical equipment (DME) that was meant for use in an institution and reimbursed under Medicare Part A, and DME that was intended to be used outside of a hospital or skilled nursing facility and separately reimbursed under Medicare Part B. In the Medicare statute, the term “home” is not specified as a geographic location. If the “in the home” restriction were to be applied consistently with the intent of the original Medicare law, mobility devices would be provided to beneficiaries with a medical need as they live in their homes and communities, not simply to those with medical needs exclusively inside their homes.

2. CMS’ current interpretation of the “in the home” restriction runs counter to numerous Government policies and initiatives aimed at increasing community integration and independence of people with disabilities.

• Fifteen years ago, the Americans with Disabilities Act (ADA) prohibited discrimination based on disability in employment, public services, public accommodations and in other areas. Mobility device accessibility became the norm and expectations about living at home and functioning in the community heightened dramatically. Yet, the in the home restriction locks in place the medical/functional expectations of disability as it existed forty years ago.
• The Bush Administration’s New Freedom Initiative, unveiled just weeks after President Bush initially took office, aims to help Americans with disabilities by increasing access to assistive technologies, increasing the ability of Americans with disabilities to integrate into the workforce, and promoting increased access into daily community life. In fact, the New Freedom Initiative listed Medicare’s “in the home” restriction on mobility devices as a policy in need of review by the Department of Health and Human Services. The perpetuation of the “in the home” restriction makes the goal of community integration virtually impossible for Medicare beneficiaries with mobility impairments.
• The Ticket to Work and Work Incentives and Improvement Act (TWIIA) (Public Law 106-170) aims to give Americans with disabilities the ability to choose their own support services and maintain their health benefits when they attempt to leave the disability rolls and return to the workforce. However, in part because of disincentives in federal law, less than one percent of those receiving disability benefits fully reenter the workforce. The “in the home” restriction and the TWIIA law send mixed messages to people with disabilities. The TWIIA extends Medicare coverage for SSDI recipients who agree to go back into the workforce but the “in the home” restriction denies them access to mobility devices that are appropriate for use outside the home in the work and community environments.
• In June 1999, the U.S. Supreme Court ruling in Olmsted v. L.C. found that the ADA requires the most integrated community-based settings for individuals with disabilities whenever possible. The Court found that “unjustified isolation is properly regarded as discrimination based on disability.” If the “in the home” restriction does not violate the letter of the law, it seems apparent that the “in the home” restriction violates that spirit of the Olmstead decision by unnecessarily isolating Medicare beneficiaries with mobility disabilities in their homes.

3. The “in the home” restriction also lends itself to increased health and safety risks for people with disabilities and limits the ability of clinicians to prescribe the safest and most cost effective mobility devices for beneficiaries. A beneficiary’s health, both physical and mental, is wholly intertwined with the ability to be as functionally independent as possible. Any benefit that arbitrarily limits the patient’s functional potential, therefore, unnecessarily places that beneficiary at risk. The wheelchair-related clinical literature suggests that being confined to one’s home can lead to a number of secondary psychological conditions associated with isolation. Additionally, the outside use of mobility devices deemed sufficient for use indoors has the potential to lead to various physical comorbidities and potential injuries.

For example, it is known that certain patient populations, such as individuals with quadriplegia, degenerative neurological conditions, and poliomyelitis, are at increased risk of experiencing upper limb pain and injury secondary to long term manual wheelchair use. Enforcement of the current interpretation of the “in the home” restriction has the potential to deny lightweight manual technology or a power mobility device to someone who is capable of operating a manual wheelchair in their home but who needs a more functional device for outside and community use. Forcing such a beneficiary to “make do” with their “in home” wheelchair in community environments places them at imminent risk of secondary injury to their upper extremities. The costs of medically treating these secondary conditions are, of course, very high, but Medicare will cover these expenses with little question.

II. Deletion of the “Bed or Chair Confined” Standard:

The ITEM Coalition applauds CMS for proposing the deletion of the “bed or chair confined” criterion that is currently used to determine if a mobility device is reasonable and necessary. Additionally, we are pleased to see that CMS is proposing a shift to a functionally-based standard of coverage for mobility devices as the ITEM Coalition believes an assessment of a beneficiary’s functional capacity is a more appropriate means of determining medical need for a wheelchair. Functional criteria will better enable clinicians to prescribe the most appropriate and effective mobility device for each beneficiary and may have the added benefit of reducing the risk of injury secondary to the prescription of inappropriate and ineffective mobility devices.

However, functionally-based criteria will ultimately prove to be of little value if CMS continues to administer the Medicare mobility device benefit under its current interpretation of the “in the home” requirement. Significant differences exist between functional limitations inside the home and functional limitations outside of the home. When clinicians are held to assessments of functionality based on activities that are only performed within the beneficiary’s home, they are forced to assess the patient’s needs with “one hand tied behind their back.” This results in the prescription of insufficient and often ineffective mobility devices that fail to meet the real-life needs of Medicare beneficiaries.

III. Functional Ambulation: Activities of Daily Living:

A. Purpose of Mobility Assistance Equipment

By definition, “mobility assistance equipment” or “MAE” is equipment used to aid in mobility. The draft NCD uses the term “functional ambulation” as a measure by which clinicians can assess the need for MAE on behalf of a beneficiary. However, the term “functional ambulation” is defined as “the ability to walk, with or without the aid of appropriate assistive devices (such as prostheses, orthoses, canes or walkers), safely and sufficiently to carry out mobility-related activities of daily living (MRADLs).” The ITEM Coalition finds this definition of “functional ambulation” to go beyond the primary purpose of MAE, which is to supplement mobility in the presence of a mobility deficit, not to aid in the completion of an MRADL.

In fact, as cited in the draft NCD, the items of mobility assistive equipment that are repeatedly referenced in the document (i.e. wheelchairs and power wheelchairs) are specifically categorized in the FDA Code of Federal Regulations (CFR) as follows:

21CFR § 890.3860 Mechanical wheelchair.
(a) Identification: A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. [Emphasis added].
(b) Classification: Class I (general controls).

21CFR § 890.3890 Powered wheelchair.
(a) Identification: A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. [Emphasis added].
(b) Classification: Class II (performance standards).

The ITEM Coalition understands that FDA categorizations and definitions do not apply to CMS but these definitions clearly enforce the primary purpose of MAE which is, of course, mobility.

The ITEM Coalition, therefore, strongly objects to the omission in the draft NCD of “mobility” itself as a mobility-related activity of daily living for purposes of assessing the need for a mobility assistive device. At the Open Door Forum held on February 24, 2005 to discuss this draft NCD, CMS officials stated that the MRADL concept was adopted to focus the coverage determination process on “purposeful” mobility. But we believe that for a person who spends his or her life without the ability to ambulate, all mobility is purposeful and the ability to improve mobility, whether or not it improves the ability to perform some other task, should be considered in the MAE coverage determination process. The ITEM Coalition believes this omission is a major failing of the draft NCD and is concerned that this omission will lead to denials for beneficiaries with a legitimate need for wheelchairs and other mobility devices.

B. The List of MRADLs is Highly Restrictive

In addition to the glaring omission of mobility itself in the list of MRADLs in the draft NCD, the five ADLs selected by CMS to represent the universe of functional abilities relevant for a Medicare beneficiary to perform are highly restrictive and expose a mismatch between what CMS will consider and the day-to-day needs of Medicare beneficiaries. Of the 700 research articles mentioned in the draft NCD and the 11 actually cited, not one of them defined the term “mobility related activities of daily living” to mean “toileting, feeding, dressing, grooming and bathing.” All of these ADLs are very basic and are performed exclusively in the home setting. There simply is no evidence in the literature or in clinical practice that supports such a limited number and range of ADL functions.

For example, a beneficiary with an upper spinal cord injury may never have the ability to cook for herself or bath herself independently even with the use of a mobility device. However, with the appropriate mobility device, the beneficiary may be able to move herself from the bedroom to the computer room where she might be able to read an online newspaper or participate in online classes. She may be able to travel to the kitchen to answer the telephone, move to the bookcase to read a book, move to the front door to pick up the mail, travel to the living room to watch television or move to a patio to visit with a friend. None of these improvements in function are currently recognized by the draft NCD and every one of them is an example of the basic functional needs of most beneficiaries with mobility impairments.

C. The Role of the Caregiver in the Assessment Process

The draft NCD establishes a standard for MAE coverage that focuses on the ability to perform MRADLs. But for beneficiaries who may not have the ability to independently perform these ADLs, the NCD states in Section VIII that “the contributions of a caregiver may compensate to overcome the beneficiary’s limitations to operate a wheelchair.” Additionally, during the Special Open Door Forum held on February 24, 2005, CMS officials stated that a caregiver can be considered during the assessment process if it benefits the patient. Yet the role of the caretaker in the assessment process continues to be very unclear.

The ITEM Coalition is concerned that the NCD creates a rule that in certain situations must be completely waived in order to make sense. Yet the standard that applies when the general rule is waived has not been clearly articulated. The ITEM Coalition, therefore, is concerned that this coverage paradigm cannot be consistently applied and will result in significant confusion in the wheelchair prescription process.

To be sure, the ITEM Coalition agrees with the notion that a caregiver’s role in assisting the beneficiary should not operate against the beneficiary in the assessment of need for a mobility device. For example, a beneficiary whose caregiver assists them in bathing should not be denied a wheelchair because the purpose of the mobility – bathing – is not completed independently. However, this exception essentially creates two separate coverage policies; one for those who have caregivers and one for those who do not. Those who have caregivers are actually being assessed appropriately on basic improvement in mobility as any MRADL that is completed with the assistance of a caregiver is considered the result of “purposeful mobility.” However, those beneficiaries who do not employ caregivers’ services are being assessed inappropriately on the completion of MRADLs.

The ITEM Coalition simply disagrees that an improvement in the ability to brush one’s teeth or comb one’s hair, independently or with assistance, should in any way determine whether a mobility device is medically necessary for a beneficiary with a mobility impairment. An improvement in functional mobility itself should be considered an independent criterion that qualifies a Medicare beneficiary for coverage of an appropriate mobility device, considering the totality of the circumstances and functional needs of the individual in both the home and community.

IV. Other Concerns with the Draft NCD

A. Safety Concerns Associated with Wheelchair Prescription

The ITEM Coalition is concerned that the draft NCD does not allow for sufficient consideration of secondary conditions associated with extended manual wheelchair use during the assessment process. Instead, the NCD vaguely requires that a beneficiary “demonstrate the capability and the willingness to operate the device safely.” The draft NCD states that “safety considerations include personal risk to the beneficiary as well as risk to others” and “a history of unsafe behavior in other venues may be considered.” In addition, the algorithmic process outlined in Appendix A of the draft NCD only permits the beneficiary to access a “scooter” or power wheelchair if they are not able to safely use a manual wheelchair. Unfortunately, the draft NCD does not make it clear whether the clinician can explicitly consider the risk of secondary injury to the beneficiary when assessing the safety of a beneficiary to operate a particular mobility device.

Numerous studies have demonstrated that individuals with long term mobility impairments often experience co-morbidities as a result of protracted manual wheelchair use. Clinical studies have shown that prolonged manual wheelchair use is a major factor in the high incidence of secondary injuries to the upper limbs among wheelchair users, resulting in shoulder, elbow, and/or wrist pain. Additionally, it has been demonstrated that certain patient populations, such as tetraplegics and quadriplegics, individuals with degenerative neurological conditions, and individuals with poliomyelitis, are at an increased risk of experiencing upper limb pain due to manual wheelchair use. Unlike most injuries, injuries to the upper limbs among manual wheelchair users are both relatively predictable and avoidable. The injuries are predictable because incidence of upper limb pain has been directly correlated with the time of use of the wheelchair.

The ITEM Coalition recommends that the final NCD and the accompanying algorithmic process explicitly recognize as a “safety” issue the need for clinicians to assess the risk of secondary injuries due to extended manual wheelchair use. We believe inclusion of this concept in the final NCD will not only prevent beneficiaries from experiencing additional injuries and secondary conditions, but will alsosave the Medicare program from covering the often extensive costs of reparative surgeries and rehabilitation care for these types of secondary conditions.

B. Technical Assessments and Research Disclosure:

The ITEM Coalition recognizes the degree of public participation that the new NCD process allows. However, we are concerned that in this case, the process has not been as transparent as possible. In our comments submitted to CMS on January 14, 2005, the ITEM Coalition requested disclosure of the Technical Assessment used to develop the NCD for mobility assistance equipment. However, as of today, we have not been able to access that assessment. With over 700 clinical articles reviewed during this NCD process and only eleven articles cited in the draft NCD—the vast majority of which only involved elderly populations—the ITEM Coalition is concerned that relevant lines of analysis andbodies of evidence may have been omitted in the development of this NCD.

The ITEM Coalition again requests disclosure of the Technical Assessment as we feel it is important for the public to review and assess the same documents CMS used in the development of this draft NCD. Without those documents, it is extremely difficult for commenters to understand and analyze the basis on which this NCD was created.

V. Conclusion:

The ITEM Coalition appreciates this opportunity to comment on the draft NCD for MAE and encourages CMS to seriously consider not only these comments but the numerous comments submitted by other consumer groups, clinician groups and providers as it drafts the final NCD. In our January 14, 2005 comments on the report of the Interagency Wheelchair Working Group, we expressed our concern about CMS’ delay in addressing this issue. While we continue to be interested in an efficient resolution to this unsettled area, we are far more interested in CMS finalizing an appropriate NCD than we are in having it completed quickly. The speed with which the draft NCD was published after reception of the January comments and the cursory treatment that the extensive public comments received in the draft NCD raises concerns that CMS is not adequately considering the views of the public during this process. We strongly believe that CMS must address a number of areas that it has, thus far, failed to address if this NCD is going to adequately clarify Medicare mobility device coverage policy.

The existing draft NCD simply fails to address the real-life, reasonable and necessary, medical and functional needs of Medicare beneficiaries, in part, due to CMS’ restrictive interpretation of the “in the home” criterion. And no NCD that fails to accomplish this should be published as a final coverage policy of CMS. The draft NCD asserts that the NCD process is not the propervehicle to modify the “in the home” requirement, but it does not suggest what the proper process is in order to make such a critical change in CMS policy interpretation.

It is for this reason that the ITEM Coalition strongly suggests that CMS, in conjunction with publication of the final NCD, publish either a proposed rule or interim final rule that modifies the “in the home” requirement so that Medicare beneficiaries are not inappropriately denied access to the mobility devices they need to be functional and independent.

By failing to include mobility itself as an MRADL and limiting consideration to only those activities of daily living that occur within the four walls or the home, CMS has reinforced its current interpretation of the “in the home” restriction. In the face of nearly unanimous and persistent public opposition to the current interpretation of the “in the home” rule, the ITEM Coalition finds CMS’ refusal to even address the “in the home” concerns of the public highly frustrating and insufficient. Until CMS addresses this glaring shortcoming in mobility device coverage, the ITEM Coalition believes that mobility device coverage will continue to generate controversy and remain mired in uncertainty and discord.

The ITEM Coalition stands ready to work with CMS and others in good faith to seek resolution of this vexing problem. Thank you for the opportunity to comment on this draft NCD for coverage of mobility assistance equipment.

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On behalf of the Power Mobility Coalition (PMC), a nationwide association of manufacturers and suppliers of motorized scooters and power wheelchairs, we submit these comments in response to the proposed change in National Coverage Determination (NCD) for mobility assistance equipment (MAE) recently announced by the Centers for Medicare and Medicaid Services (CMS). In their draft decision memo, CMS indicated that they were abandoning the often misinterpreted and overly restrictive “bed or chair- confined” criteria for a functional ambulation standard that would consider a beneficiary’s ability to ambulate safely around the home to accomplish mobility-related activities of daily living (MRADLs). The functional ambulation standard was recommended by CMS’ Interagency Wheelchair Working Group (IWWG), a group of federally- employed physicians, therapists, research and policy experts who reached this recommendation after examining peer-reviewed scientific data, expert opinion and public comments.

While the PMC supports this shift away from the restrictive “bed or chair-confined” language to a functionally based standard, we maintain that the Congressionally defined, physician-certified Certificate of Medical Necessity (CMN) had already established a functionally based criteria when determining eligibility under the “bed or chair-confined” NCD. In fact, the CMN requires the treating physician to determine whether his/her patient needs the wheelchair to “move around in their residence.” Congress has also weighed in, calling for a functional ambulation standard in the report language that accompanies the 2005 Appropriations Act (P.L. 108-792). Codifying the functional ambulation criteria as the NCD will ensure that the NCD is aligned with the CMN and Congressional intent as to which Medicare beneficiaries qualify for the power wheelchair benefit.

While overall supportive of the proposed change in NCD, the PMC still has several concerns with the draft decision memo which we hope CMS will address prior to final implementation. These concerns are as follows:

• Recommendations to the Draft NCD
  • Mobility for Mobility’s Sake Should be Included as a Qualifying MRADL

At CMS’ recent Special Open Door on the proposed NCD changes, clinicians, beneficiaries, suppliers, and manufacturers alike called for mobility – the act of being able to get from one place to another – to be considered a MRADL. Some severely disabled beneficiaries will not be able to perform any ADLs specified under the draft NCD, yet it would be unjust to exclude such individuals from having access to life and health enhancing MAE devices.

• Qualifying ADLs Should Not Be Limited to “In the Home”

The “in-home” restriction severely impedes on the health and independence of people with disabilities, as it essentially confines people to the four walls of their homes and does not take into account the need for beneficiaries to access their physician’s office, pharmacy, grocery store, bank or place of worship, which are all activities of daily living. Any new guidelines must reflect the functional assessment of a beneficiary’s needs both inside AND outside of the home (as indicated in IWWG recommendations). By failing to remove this restriction, needy beneficiaries will continue to be denied access to necessary mobility products and services. As a result, the PMC strongly urges CMS to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of any “in-home” restriction.

In addition, Medicare beneficiaries who leave the home on a frequent basis or for a lengthy duration are in jeopardy of losing their homebound status, and therefore, access to Medicare home health services (both skilled and custodial). Medicare beneficiaries should not be penalized and voluntarily “incarcerated” in their homes in order to retain their homebound status if they have the opportunity, through access to power mobility, to regain their independence and freedom. Both anecdotal and empirical evidence proves that Medicare beneficiaries with power mobility products and services lead more active, engaged, and as a result, healthier lives. As such, beneficiaries with a skilled nursing need should not be denied their rightful home health benefits if they are able to leave the home as the result of power mobility technology. Moreover, the “in-home restriction” policy is contrary to the letter and the spirit of Bush Administration goals like the New Freedom Initiative and Welfare to Work programs.

• MAEs Should Not Be Required to Demonstrate Functional Improvement

The clinical criteria for MAE coverage asks if access to MAE “will be reasonably expected to materially improve the beneficiary’s ability to perform” MRADLs. Such a requirement will restrict access to MAE to those beneficiaries with chronic, long-term conditions - such a diabetes or MS – whose conditions are static and may not improve despite any type of treatment. While MAEs should be perceived as maintaining or preventing further deterioration of a beneficiary’s illness, requiring materially improvement of a patient’s condition is unrealistic.

• The Role of a Caregiver Should Not Be Determinative of MAE Eligibility

The presence of a caregiver should have no bearing on a beneficiary’s medical necessity for a MAE. While a caregiver can be instrumental in helping a person with limited or compromised disability perform MRADLs and remain independent, a beneficiary’s medical diagnosis and condition does not change because a caregiver is present. At best, the role of a caregiver should be considered among the environmental factors when determining MAE eligibility. Even in this context, the age and capability of the caregiver should be considered to ensure a proper assessment of the role the caregiver can play in the ability of the beneficiary to conduct their MRADLs.

• Documentation Requirements Should be Clear and Consistent

Any comprehensive change to the NCD must include a clear documentation requirement that provides clarity and consistency to beneficiaries, physicians, and suppliers participating in the Medicare program.

• CMN Should Certify Medical Necessity for MAE

The PMC recommends that any documentation requirement be incorporated into a revised CMN that includes the eligibility criteria and algorithmic process that will be set out in the final NCD. The CMN was defined by Congress, developed by CMS, and approved by the Office of Management and Budget to establish medical need and thus to determine eligibility for the power mobility benefit. The treating physician completes the CMN and is in the best position to assess patient need and certify that the beneficiary meets the functional ambulation standard. The physician’s standing is further strengthened by a provision in the Medicare Modernization Act (MMA) (P.L. 108-173) requiring a face-to-face examination by a health care provider prior to submission of a power mobility claim.

At a minimum, suppliers should be able to submit the physician signed and completed CMN to the Medicare program with the clear and unequivocal expectation that, if not fraudulent, such documentation establishes medical necessity.

• Suppliers Should be Allowed to Conduct the In-Home/Environmental Assessment of the Beneficiary

Power mobility suppliers help thousands of Medicare beneficiaries with compromised or limited mobility gain their freedom and independence. PMC members take seriously their commitment to the Medicare program and, consistent with current supplier standards, ensure that their beneficiaries understand how to operate the equipment safely and appropriately. Permitting only health care professionals and clinicians to fit and furnish motorized wheelchairs would severely limit access to this benefit and could hinder the ability of experienced suppliers from offering these life enhancing products and services to needy beneficiaries.

The MMA contains a provision requiring power mobility suppliers to become accredited if they are to participate in Medicare competitive bidding. Accreditation bodies can require that proper protocols are in place to ensure that suppliers have the training to make home and environmental assessments, as well as ensuring that the beneficiary is properly fitted and can safely operate the power chair.

• CMS Must Immediately Issue Guidance for Present and Pending Claims

Under the most optimistic of timelines, CMS will not be in a position to issue a new NCD for several months and, even then, the NCD will only apply to claims going forward from the issuance of the new NCD. Since coverage was thrown into a state of uncertainty in December 2003, CMS contractors have restrictively and inconsistently applied various standards of coverage across the country. As a result, significant number of claims have been and are being inappropriately denied and suppliers are experiencing cash flow issues and, in some instances, declaring bankruptcy.

In December 2003, CMS issued a policy “clarification” stating that any individual who can “walk either without any assistance or with the assistance of an ambulatory aid” would be denied coverage for power mobility equipment. Further, the “clarification” indicated that CMS would no longer rely on the CMN for determining Medicare eligibility, characterizing the document as a “mere screening tool.” While CMS has since retracted this “clarification,” this restrictive interpretation of the “bed or chair-confined” standard is still being applied by some contractors.

To put stability back in the claims approval process, the PMC recommends that CMS immediately instruct its contractors to rely on the treating physician and the existing CMN to make determinations as to eligibility for power wheelchairs for all claims processed between December 2003 and the effective date of the new NCD. This will instill a measure of consistency and fairness into the claims approval process until such time as the NCD and revised CMN can be implemented.

We appreciate your time and consideration of these issues and look forward to working with CMS and the power mobility community to address these concerns.

Sincerely,

Eric W. Sokol
PMC Director

Stephen M. Azia
PMC Counsel

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Are all of these products currently well accepted in the market as specified?
Some of the specifications seem to be a compilation of specifications for products that do not currently exist or may be at the extremes of the specification limits of a product.

The documents need more definitions and consistent use of terminology.
It would help if some key phrases were defined and carefully used in this document. Using “ISO 7176-26 Vocabulary” and definitions from ANSI/RESNA 7176 would be helpful. Below are samples of some words or phrases that need defined or omitted.
Chair(s)
Power chair
Power wheelchairs
Power base
Captain’s chairs
Seat
Seating
Seating system

page 8
31. [Captains Chair] Please expand this definition to say something more than “automotive-style seat with rigid frame”. Is an adjustable back angle required? If yes, how much adjustments are needed and must it be a “no tools” adjustment.

Too much testing for some products and to little for others.
I think there are problems with the number of test drum cycles and drops indicated in the testing portion. The weight of the patient or the intended use should not excuse a manufacturer from meeting the minimum standard of 200,000 cycles on the drum and 6,666 drops. At the other extreme, I think running a drum test to 800,000 cycles and 26,000 drops is a waste of lab time. If a manufacturer tests at the maximum rider weight, there should be no reason to run tests until 800,000 cycles 26,000 drops or a failure occurs. If there is no functional reason or increased reimbursement level for power chairs that last longer in structural fatigue testing there is not much incentive to put the extra costs into building stronger products. It is our understanding that the initial acceptance will be based on meeting the minimums and time is being allowed to run additional tests. What is the point if you have already accepted the products.

Pediatrics
I believe that this category should be given another name if it is not intended to be used for “the care and treatment of infants and children” as defined in dictionaries.The 50th percentile male adult weighs 172 lb. compared with the 165 lb. weight requirement for what is being called pediatrics. If children and adults this heavy are covered in this category, wider or deeper seats than currently indicated must be allowed to support that much weight regardless of what the grouping is named.

Minimum obstacle climb
The test standards for obstacle climbing require disclosure of the results with several setups and techniques such as some beginning with the wheels parked against the obstacle before attempting to climb and some allowing for a .5 m run up so that you are moving when you attempt to climb. What one(s) are you asking for. (See ANSI/RESNA 7176-10).

Dynamic stability rating
The test standards for dynamic stability require disclosure of the results with several setups and techniques including stopping on a ramp while going full speed foreword and stopping on a ramp while going full speed in reverse. What one(s) are you asking for. (See ANSI/RESNA 7176-2)

I. Pediatric Power Wheelchairs K0680, K0681
The 22” max. width is too narrow to be stable and safe for many people in the pediatric weight range you have established. The extra material costs to manufacture products at 23” or 24”wide is only pennies higher than the cost to build 22” wide products. Please do not force people to compromise the safety of a child or small adult for a few pennies. Let a review of the pre-purchase site surveys play a role in what width of products are selected. Many injuries can be avoided if the equipment providers are given the choice to place someone on a slightly wider power wheelchair.

I believe the largest single component is often the frame with attached motors. It will weigh more than 30 lb.. Even if you remove the 30 lb. single component limitation, the overall weight on most if not all power chairs currently in the market exceeds 80 lb.. These are the type of specifications that normally produce one the two types of designs:
a) A very sophisticated and usually expensive design.
b) An unsafe, low quality, low cost, design resembling a toy that is prone to premature failure.

III. Pediatric Power Wheelchairs K0684
I discussed the 10” wide and 10” deep seat requirement with a pediatric specialist. Her comment was that it is unusually small for someone on a power product. She did not want that specification to dictate the choices available to her. She felt that 12” or 14” is more appropriate for most pediatric seating on power products.

IV Pediatric Power Wheelchairs K0685
Same 10” wide and 10” deep seating size concerns as K684

V Pediatric High Activity Use K0687
Same 10” wide and 10” deep seat size concerns as K684

I asked if she would place a child on a power chair that accommodates ventilators, travels at least 6 MPH, climbs 3” min. obstacles, and is rated for 9+ degree inclines. Her answer was some like “Oh my gosh no”. We think that this category creates questions about health and safety for the patients.

V Pediatric High Activity Use K0688
Same concerns about required performance combined with ventilators as K0687

VI Pediatric High Activity Use K0689
Same 10” wide and 10” deep seat size concerns as K684Same concerns about required performance combined with ventilators as K0687

VII ? Pediatric Specialized Use-Multiple Power Options
NOTE: I think that Pediatric Specialized Use-Multiple Power Options was mis-marked and should be VII instead of VI as published.

Same 10” wide and 10” deep seat size concerns as K684

VIII Power Operated Vehicles
Seating size required is too small
Wheel base too narrow for safety.

IX Adult Power Operated Vehicles
K0692 POV
Seating sizes required is too small
Wheel base too narrow for safety.
Wheel base too short for safety and accommodation of adults.
300# people should never be placed on a POV this small.

E1230 POV
Seating sizes required is too small
Wheel base too short for most 300 lb. people to be reasonably comfortable and in a proper seating posture. Some manufacturers spec. sheets show models that might be have the structural strength, power and stability to meet this spec. however most 300# people do not fit on something this small.

X Power Operated Vehicle-Heavy Duty
The length of ≤ 46” works OK for 3 wheeled POVs with some 450 lb. patients. The riders feet can remain low and stretched out on either side of the single front wheel. Some 450 lb. patients will be safer on a 4 wheeled version of a POV. The length on a 4 wheeled POV needs to be longer to accommodate the steering linkage, and the fact that when you stretch out your legs, your feet are elevated to rest on a platform above the two front wheels. If the POV is not longer than 46”, the patients abdomen will be pressed upon by their thighs. If you try to solve this problem by moving the seat back, the scooter is likely to have rear stability problems resulting in injuries.
Please consider changing the length to ≤ 50” to properly place 450 lb. riders on a 4 wheeled version of a 450 lb. rated POV.

XII Power Operated Vehicle-Recreational
I have concerns about the existence of this category for the following reasons:
How can a recreational vehicle possibly be in compliance with the “in home” restrictions? I am not against people with special needs enjoying recreation, however I strongly believe that the reason for financial assistance to purchase the equipment must be based on the more fundamental needs for daily living provided for in the other categories. Recreation can and should be a secondary benefit for having the equipment.
This category has omitted the requirement for the POV to be a medical device and has listed very few specifications. This will create a dumping ground for people to request funding on equipment they may not need for daily living at a time when funding is scarce and must be carefully dispersed those in society with the greatest needs.

XIII. Adult Power Wheelchairs, K0696 & K0697
An adult power wheelchair should be wider than 22” if it is to safely handle 300 lb. riders. The weight limitations of the power chair components seems to be too light to build a durable and reliable power chair. I do not believe that any manufacturers are currently building a version of this product meeting all the requirements listed and they should not. I believe it would result in a product that is unreliable and unsafe.

XIV. Adult Power Wheelchairs, K0698 & K0699
An adult power wheelchair should be wider than 22” if it is to safely handle 300 lb. riders. The weight limitations of the power chair components seems to be too light to build a durable and reliable power chair.

XVIII. High Activity Usepage 47 K0718 What is the upper weight limit of this build. (see K0717)

Jerry Traylor
Engineering Manager
Leisure-Lift

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COMMENTS ON POV CODES K0692 & E1230

I am a member of RESNA and on the standards committee for power wheelchairs and scooters. I have worked on scooter POVs since 1984 and have several patents. I believe the POV codes are very important and need to be expanded. If the POV Medicare medical requirements are equal and not more stringent than the Power Wheelchair, you will see a dramatic increase in the proportion of POVs to Power Wheelchairs used. I base this on V.A. data of similar demographics. In one year the V.A. reported purchase of 6,860 POVs or 64% and Power Wheelchair purchases of 3,848 or 36%.

Because the majority of Medicare recipients will be using POVs, I believe the “standard use” 300 lb. capacity POV category is inadequate to fulfill the requirements of the bulk of POV users and the bulk of all Medicare recipients of Power Wheelchairs and POV units which will be in this category. With 20 years experience building POVs and14 different models of POVs not one of the 14 POVs I build will meet the specification in K0692. Only one of 14 will meet the requirement of E1230. Pride Mobility builds 18 different models. In studying Pride POV specifications, I believe no unit meets the E1230 42” X 300 lb. X 9+ degree requirement. I believe only one model can possibly meet the E0692 40” X 300 lb. X 6+ degree requirement. Invacare makes several units, not one will meet the K0692 or E1230 specifications.

There are several problems with the proposed K0692 standard. The minimum standard 200,00 Double Drum and 6,666 drop tests should not be reduced. Any reduction of this minimum International standard will allow such poor quality product to be approved that Medicare will be forced to replace units at a much higher frequency rate and significantly increase Medicare’s cost. Real world scooter use is far worse than the double drum test. Driving a scooter full speed off a 9” curb results in a 7 fold increase in Kinetic energy force. A 100 pound scooter with a 300 lb. rider multiplied by 7 results in a 2,800 pound impact loading on the 3 or 4 wheels. While this may seem excessive I know from experience this has happened regularly.

Tipping is a major cause of serious injury and death on scooters. In 2004 manufacturers reported 73 incidences of death, serious injury or malfunction to the FDA. Of these 73 incidents about 25 or 1/3 of the incidents were tipping deaths or injuries. Not included in the count were incidents like death from an imported scooter’s wheel coming off resulting in a fall and an imported scooter’s wheel hub broke resulting in a fall, serious injuries and hospitalization. These falls are product defect/malfunction incidents not primarily stability issues. See: Scooter Safety Buyers Guide (Document #1) for additional tipping information. At 22” wide and only 40” long, this code is unstable, unsafe and very impractical for many large people. Imagine a 6”5” , 300 lb. person or worse a 300 lb. double amputee on the 40” POV on a hill in San Francisco. The 6 degree incline is too low even with the full speed roll back test. I do not make a 40” scooter because there are 15 degree home ramps, sidewalks, driveways and streets everywhere that people ride on constantly.

Even in “flatter than a pancake Kansas” there is a 15 degree street and sidewalk within a mile of my work. I am enclosing a 10 year old dealer safety video. The first half of the tape (4 minutes) will illustrate my point.

You are allowing 26” width +10% on wheelchairs. The standard scooter is 24”, why not allow 24” for scooters. This will reduce side tip incidents by as much as half. Standard scooters are < 46” in length. Allowing a 46” length will greatly reduce scooter tipping deaths.

Backward tipping results in a much higher death rate as people can not easily protect their heads in a backward tip. There are several problems with the E1230. As I stated, I believe only one model I make, no unit Pride makes and no Invacare made unit meets this standard. I believe the equal to or less than 42” length is too small for many if not most users. I am enclosing two pictures each of a 6”4”, 240 lb. person and a 6 ft., 290 lb. person to illustrate how impractical this length is for many large users. Obviously we do not recommend this unit for these large people. My shortest 4 wheeler is 47 inches as are most others in the industry. I do not believe any four wheeler POV and very few three wheel POVs can meet this standard.

Forcing the industry to redesign 90% of our POVs can be done. Forcing Americans to use POVs that we know will increase the risk of serious injury and death should not be allowed.

While we realize you may receive a number of comments based on units already available from multiple manufacturers, we would suggest that you contact an independent third party to examine our claims more thoroughly.

There is a gentleman named Dr. R. Lee Kirby who is a renowned expert in the field of wheelchair and POV stability. Dr. Kirby is a member of RESNA’s Standard Committee, the body whose standards you have opted to follow and would be of great value in assessing our comments as well as those of others,

Dr. Kirby may be contacted at:

Dr. R. Lee Kirby
Dalhousie University
Nova Scotia Rehab Center
1341 Summer Street
Halifax, NS B3H 4K4
Canada
PH: 902-473-1268
Two of Dr. Kirby’s many published research articles are “Mathematical Model of Lateral Wheelchair Stability” and “Dynamic Wheelchair Stability, Reliability of an Ordinal Scale”.

DuWayne E. Kramer, Jr.
President

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Despite the difficult and positive work by CMS with your proposal to eliminate the Bed or Chair Confined Criterion, including a move toward a functional-based coverage, all of these efforts will be undermined by:
- Maintaining the In-The-Home restrictive *interpretation.*
- Not designating the need for a skilled and knowledgeable clinician to perform the functional-based assessment
- Not recognizing and integrating “Mobility” as the sole functional ADL for which MAE is recommended

In-The-Home Restriction: As well articulated by so many of the commenters to date, it will either restrict the beneficiary to home confinement or expose the beneficiary to health/injury risks by using their in-home-only MAE, outside the home, in what would typically be very different environments with very different demands on the beneficiary and the equipment. This adds the burden of increased long-term equipment cost to Medicare and decreased function to the beneficiary. A “functional-based” coverage should consider an individual’s typical functional criteria, both in the home, and outside the individual’s dwelling. Whereas CMS is comfortable with allowing a beneficiary to use equipment ill-suited for environments outside the home, a clinician would be practicing well below modern healthcare standards and licensure requirements by allowing an individual to be placed at these risks.

Skilled & Knowledgeable Clinician: The content represented in Appendix-A would require the participation of a skilled/knowledgeable clinician (e.g., OT, PT, Physiatrist, etc.) who’s only goal is to provide the beneficiary with the appropriate assessment and appropriate equipment to meet the identified needs. The unbiased clinician should be paired with a skilled and knowledgeable RTS (Rehab Technology Supplier), who can then work with the clinician and beneficiary to help identify which equipment optimally meets the needs as identified in the assessment. Without specifying this in the NCD, it will likely spawn a myriad of various interpretations and opportunity for continued Medicare fraud and abuse.

Mobility *is* an ADL: Two fundamental principles are overlooked within the proposed Draft-NCD:
1) That Mobility is a well-established activity of daily living and recognized as a necessary functional activity; and,
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 [MAE])

CMS, Please:

1) Develop and report a clear plan to eliminate the restrictive In-The-Home interpretation.
2) Specify who is to perform the functional-based coverage assessment as described above.
3) Recognize and integrate the fact that Mobility Assistance Equipment’s primary functional purpose is to compensate for a mobility or functional ambulation deficit. (The field of Assistive Technology has a tremendous range of other assistive equipment designed for facilitating the other ADLs.)

Thank you, very much, for your efforts as well as your detailed consideration of public comment.

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I appreciate your interest in the public's comments. One concern that I have is the lack of mobility as a means of activities of daily living. For someone with a spinal cord injury, or muscular dystrophy, or a myriad of other diagnoses, who do not have the physical strength to perform any of the criteria you listed, they would be unable to qualify for a wheelchair. This would be a shame, since I know of many of these people who are a vital part of their community, family, and school environment. Surely, the intention is not to deprive any tax- paying, productive citizen of their means of mobility? Can this criteria be broadened or further defined to clarify this deletion? Thank you for your concern and interest. Sincerely, Lisa Peterson, PT

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My sincere thanks for your effort in developing the proposal.

I have no doubt that your intentions are honorable and much of the comment relative to imperitive changes are a result of that old bugaboo 'unintended consequences'.

The first issue is related to your connecting Mobility with improvement to an ADL. In reality mobility 'IN AND OF ITSELF' is an ADL without linkage to correction or improvement to any other condition or activity. If mobility is NOT defined as an ADL for any individual who cannot ambulate, you will force a significant population of immobile individuals to stay in bed for the balance of their lives!This would be a disaster for the individual their caregivers and financially for the payors!

Another aspect of the proposal is the process by which 'appropriate products' are provided. This has to include a face to face evaluation by qualified persons. Qualified persons include OT/PT who provide expertise on the clinical aspects of the evaluation and ATP, ATS and CRTS who provide expertise in the equipment, transport and environmental aspects of the evaluation. Both groups have completed formal education for their professions. Both groups have written Ethics commitments. Both groups have their Professional Licences on the line with each signed evaluation. Thank you, Hymie Pogir

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Comments on Behalf of NACDD On the Draft National Coverage Determination for Mobility Assistive Equipment, March 7, 2005

Introduction and Background

These comments are submitted on behalf of the National Association of Councils on Developmental Disabilities (NACDD). NACDD's mission is to provide support and assistance to its Member Councils (State Councils on Developmental Disabilities) in order to promote a consumer and family-centered system of services and supports for individuals with developmental disabilities. NACDD is a national, member-driven organization consisting of 55 State and Territorial Councils. Our organization was formed in 2002 to bring together two national organizations that previously supported State Developmental Disabilities Councils – the Consortium of Developmental Disabilities Councils and the National Association of Developmental Disabilities Councils. We support our Member Councils with implementing the Developmental Disabilities Assistance and Bill of Rights Act, P.L. 106-402 (DD Act).

The DD Act cites a Congressional finding that in 1999, there were between 3.2 and 4.5 million individuals with developmental disabilities living in the US. In the DD Act, Congress refers to a recent study indicating that individuals with developmental disabilities comprise between 1.2 and 1.65 percent of the US population. These figures likely have increased in the last six years. Congress also found in the DD Act that individuals with disabilities “often encounter discrimination in the provision of critical services” and that individuals with developmental disabilities are at greater risk than the general population of abuse [and] neglect.” Of utmost significance to these comments is a Congressional finding that “a substantial portion of individuals with developmental disabilities and their families do not have access to assistive technology…and remain un-served or underserved.”

NACDD is a member of the Washington, D.C.-based “ITEM” Coalition. ITEM is an acronym for Independence Through Enhancement of Medicare and Medicaid. The ITEM Coalition was formed in 2003, and its 74 member organizations include a diverse set of disability groups, aging organizations, other consumer groups, labor organizations, voluntary health associations, and non-profit provider associations. NACDD supports the comments submitted under separate cover by the ITEM Coalition.

The following comments will address aspects of the draft National Coverage Determination (NCD) on Mobility Assistive Equipment (MAE) as released on February 3, 2005 by the Centers for Medicare and Medicaid Services (CMS). Our comments primarily will focus on the “in the patient’s home” restriction and the omission of “mobility” itself in the list of Mobility-Related Activities of Daily Living. CMS Failure to Consider Medicare Beneficiaries Below Age 65

NACDD would like to express our disappointment with the apparent failure of CMS to consider the approximately 6 million Medicare beneficiaries with mobility impairments below the age of 65 in this draft NCD. Virtually every article cited in the draft NCD involves the elderly population. In fact, the draft NCD explicitly acknowledges that it focused on “the elderly” by stating the following in Section II, Background, “Impaired mobility, combined with difficulty in performing mobility-related activities of daily living…places the elderly at risk for a multitude of physiological and psychological consequences that can negatively affect health, well-being, and quality of life.” In addition, Section VIII, CMS Analysis, states “The literature reviewed is…of large sample size (109 – over 40,000) and includes Medicare aged beneficiaries, making the results generalizable to the Medicare population.”

As you know, a “developmental disability” is defined by Congress in the DD Act as: “a severe, chronic disability of an individual that is (i) attributable to a mental or physical impairment or combination of mental and physical impairments; (ii) manifested before the individual attains age 22.” Thus, CMS’s failure to evaluate properly the needs of this population is a major oversight. The mobility device needs and functional activity demands of individuals with developmental disabilities often differ starkly from those of beneficiaries who are elderly. This fact should be reflected explicitly in the final NCD. For example, individuals with developmental disabilities require appropriate mobility devices to seek and maintain employment outside the home.

“In The Home” Restriction

NACDD is disappointed that the Agency has decided not to modify the “in the home” restriction through this NCD process. The “in the home” requirement, as interpreted by CMS over the years, essentially confines beneficiaries in need of mobility devices to the four walls of their homes by preventing clinicians from prescribing mobility devices that are appropriate for use outside of the home. This rule is an antiquated restriction, reminiscent of a time when people with disabilities were not expected to leave the home and participate in society. It is an artificial barrier that stands in the way of appropriate wheelchair coverage policy and has far more to do with limiting utilization than it does with any conceivable clinical justification.

By confining the “medical necessity” inquiry to inside the home only, the draft NCD fails to provide adequate access to a substantial number of individuals who are unable to participate in daily life activities that routinely occur outside the home and in the community. A person’s need for an appropriate wheelchair is not confined to the four walls of their home. For example, an individual with a disability such as Cerebral Palsy might be able to walk about inside the home, but still require a mobility device to move safely about their community. Consideration of an individual’s need to access his or her physician’s office, pharmacy, grocery store, place of worship, or return to work should be incorporated into Medicare’s coverage determination process as these constitute a set of reasonable and necessary medical and functional needs.

Of great concern to NACDD is the fact that CMS has stated in the draft NCD that the NCD process is not the “appropriate mechanism to change the [in the home] rule.” However, the NCD fails to state what is the appropriate mechanism to address the ‘in the home’ restriction.

In a letter to the ITEM Coalition (of which NACDD is a member) dated February 17, 2005, CMS stated that the Agency “is comfortable with its interpretation” of the in the home rule. This statement was made in the face of nearly unanimous support by virtually all who commented on the IWWG’s findings that the “in the home” rule was in need of modification and was inconsistent with CMS’s move toward a function-based set of criteria to assess mobility device coverage. NACDD respectfully requests that CMS reconsider its current interpretation of the “in the home” restriction.

The “In-Home” Restriction Is Counter to Current US Policy

The current CMS interpretation of the “in the home” restriction runs counter to numerous US policies and initiatives aimed at increasing community integration and independence of people with disabilities. This archaic interpretation runs counter to major Federal legislation and policy as follows:

• Fifteen years ago, the Americans with Disabilities Act (ADA) prohibited discrimination based on disability in employment, public services, public accommodations and in other areas. Mobility device accessibility became the norm. Expectations about living at home and functioning in the community heightened dramatically. Yet, the in-the-home restriction locks in place the medical/functional expectations of disability as it existed forty years ago.
• The Bush Administration’s New Freedom Initiative, unveiled just weeks after President Bush initially took office, aims to help Americans with disabilities by increasing access to assistive technologies, increasing the ability of Americans with disabilities to integrate into the workforce, and promoting increased access into daily community life. In fact, the New Freedom Initiative listed Medicare’s “in the home” restriction on mobility devices as a policy in need of review by the Department of Health and Human Services. The perpetuation of the “in the home” restriction makes the goal of community integration virtually impossible for Medicare beneficiaries with mobility impairments.
• The Ticket to Work and Work Incentives and Improvement Act (TWIIA) (Public Law 106-170) aims to give Americans with disabilities the ability to choose their own support services and maintain their health benefits when they attempt to leave the disability rolls and return to the workforce. However, in part because of disincentives in Federal law, less than one percent of those receiving disability benefits fully reenter the workforce. The “in the home” restriction and the TWIIA law send mixed messages to people with disabilities. The TWIIA extends Medicare coverage for SSDI recipients who agree to go back into the workforce but the “in the home” restriction denies them access to mobility devices that are appropriate for use outside the home in the work and community environments.
• In June 1999, the U.S. Supreme Court ruling in Olmsted v. L.C. found that the ADA requires the most integrated community-based settings for individuals with disabilities whenever possible. The Court found that “unjustified isolation is properly regarded as discrimination based on disability.” If the “in the home” restriction does not violate the letter of the law, it seems apparent that the “in the home” restriction violates that spirit of the Olmstead decision by unnecessarily isolating Medicare beneficiaries with mobility disabilities in their homes. Perhaps of even greater importance is the fact that the “in the home” restriction also lends itself to increased health and safety risks for people with disabilities and limits the ability of clinicians to prescribe the safest and most cost effective mobility devices for beneficiaries. A beneficiary’s health, both physical and mental, is wholly intertwined with the ability to be as functionally independent as possible. Any benefit that arbitrarily limits the patient’s functional potential, therefore, unnecessarily places that beneficiary at risk.

The wheelchair-related clinical literature suggests that being confined to one’s home can lead to a number of secondary psychological conditions associated with isolation. Additionally, the outside use of mobility devices deemed sufficient for use indoors has the potential to lead to various physical co-morbidities and potential injuries. For example, it is known that certain patient populations, such as individuals with quadriplegia, degenerative neurological conditions, and poliomyelitis, are at increased risk of experiencing upper limb pain and injury secondary to long term manual wheelchair use. The costs of medically treating these secondary conditions, of course, are very high, but Medicare will cover these expenses with little question.

Functional Ambulation: Activities of Daily Living

By definition, “mobility assistance equipment” or “MAE” is equipment used to aid in mobility. The draft NCD uses the term “functional ambulation” as a measure by which clinicians can assess the need for MAE on behalf of a beneficiary. However, the term “functional ambulation” is defined as “the ability to walk, with or without the aid of appropriate assistive devices (such as prostheses, orthoses, canes or walkers), safely and sufficiently to carry out mobility-related activities of daily living (MRADLs).” NACDD finds this definition of “functional ambulation” to go beyond the primary purpose of MAE, which is to supplement mobility in the presence of a mobility deficit, not to aid in the completion of an MRADL.

In fact, as cited in the draft NCD, the items of mobility assistive equipment that are repeatedly referenced in the document (i.e. wheelchairs and power wheelchairs) are specifically categorized in the FDA Code of Federal Regulations (CFR) as follows:

21CFR § 890.3860 Mechanical wheelchair.(a) Identification: A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. [Emphasis added].(b) Classification: Class I (general controls).

21CFR § 890.3890 Powered wheelchair.(a) Identification: A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. [Emphasis added]. (b) Classification: Class II (performance standards).

NACDD understands that FDA categorizations and definitions technically do not apply to CMS, but these definitions clearly enforce the primary purpose of MAE which is, of course, mobility. NACDD strongly objects to the omission in the draft NCD of “mobility” itself as a mobility-related activity of daily living for purposes of assessing the need for a mobility assistive device. At the Open Door Forum held on February 24, 2005 to discuss this draft NCD, CMS officials stated that the MRADL concept was adopted to focus the coverage determination process on “purposeful” mobility.

But we believe that for a person who spends his or her life without the ability to ambulate, all mobility is purposeful and the ability to improve mobility, whether or not it improves the ability to perform some other task, should be considered in the MAE coverage determination process. NACDD believes this omission to be a major failing of the draft NCD. We are concerned that this omission will lead to denials for beneficiaries with a legitimate need for wheelchairs and other mobility devices.

In addition to the glaring omission of mobility itself in the list of MRADLs in the draft NCD, the five Activities of Daily Living (ADLs) selected by CMS to represent the universe of functional abilities relevant for a Medicare beneficiary to perform are highly restrictive and reveal a serious discrepancy between what CMS will consider and the day-to-day needs of Medicare beneficiaries. Of the 700 research articles mentioned in the draft NCD and the 11 actually cited, not one of them defined the term “mobility related activities of daily living” to mean “toileting, feeding, dressing, grooming and bathing.” All of these ADLs are very basic and are performed exclusively in the home setting. There simply is no evidence in the literature or in clinical practice that supports such a limited number and range of ADL functions.

For example, a beneficiary with an upper spinal cord injury may never have the ability to cook for herself or bathe herself independently, even with the use of a mobility device. However, with the appropriate mobility device, the beneficiary may be able to move herself from the bedroom to the computer room where she might be able to read an online newspaper or participate in online classes. She may be able to travel to the kitchen to answer the telephone, move to the bookcase to read a book, move to the front door to pick up the mail, travel to the living room to watch television or move to a patio to visit with a friend. None of these improvements in function are currently recognized by the draft NCD and every one of them is an example of the basic functional needs of most beneficiaries with mobility impairments.

On behalf of our 55 State and Territorial Councils and individuals with developmental disabilities, NACDD would like to thank CMS for the important work it has done and continues to do to improve the lives of persons with disabilities and their families. We appreciate the opportunity to comment on the draft NCD for Mobility Assistive Equipment. We believe strongly that the existing draft NCD simply fails to address the real-life, reasonable and necessary, medical and functional needs of all Medicare beneficiaries, in part, due to CMS’s restrictive interpretation of the “in the home” criterion. The Draft NCD asserts that the NCD process is not the proper vehicle to modify the “in the home” requirement, but it does not suggest what the proper process is in order to make such a critical change in CMS policy interpretation.

Further, by failing to include mobility itself as an MRADL and limiting consideration to only those activities of daily living that occur within the four walls or the home, CMS has re-enforced it current archaic interpretation of the “in the home” restriction. NACDD strongly suggests that CMS, in conjunction with publication of the final NCD, publish either a proposed rule or interim final rule that modifies the “in the home” requirement so that Medicare beneficiaries are not inappropriately denied access to the mobility devices they need to be functional and independent.

Should you have any questions about the comments we have submitted or should you require additional information, please do not hesitate to contact me.

Sincerely,

Anne P. Rohall
Director, Government Relations
(703) 739-4400, ext. 4
arohall@nacdd.org

Cc: Senator Dennis Byars, Chair, NACDD Public Policy Committee

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I am a Rehab Technology Supplier who has worked in the Seating & Mobility field for over 20 years. I wish to comment on the new coverage policy for wheelchairs.

First, Mobility is an activity of daily living. Being unable to move from one place to another should be the primary factor in getting a wheelchair.

Second, Coverage for mobility equipment should not be restricted to "in the home" use only. Going to a Physician's appointment, the grocery store, etc.. are all activities of daily living.

Third, CMS must provide clear guidance as to what will be involved in the environmental assessment, who will perform it, and how it will be documented. CMS must also involve all relevant players to produce a complete system that includes DMERC local medical policies, who does what, and how it will be documented. Additionally, CMS should establish clear documentation requirements that relate specifically to the coverage policy. Documentation should consist of an expanded CMN, and for higher level products, specific additional documentation. The requirements should be well defined and enable a supplier to secure the related paperwork and maintain it on file. Should the supplier have the specified documents properly completed, that should meet any post-payment review requests.

I encourage CMS to address these issues in a timely manner. Thank you for allowing my comments.

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Thank you for this opportunity to comment on the Draft Coverage Decision Memorandum on Mobility Assistive Equipment (MAE). The Illinois HomeCare Council (HCC) is a trade association representing approximately 200 home health providers and suppliers in Illinois. The comments presented below were developed by IHCC’s Regulatory and Reimbursement Committee.

Attention to the clinical criteria for selection of MAE is long overdue and IHCC applauds CMS’ decision to address this matter. IHCC also agrees that the existing billing codes for MAE are insufficient to address the increasing sophistication and variation in equipment available to help Medicare beneficiaries with mobility deficits. The new coding scheme also appears to allow for component parts of mobility systems to be covered, a distinct improvement in the system that will allow equipment to be tailored to meet individual beneficiary needs.

IHCC supports CMS’ efforts to accomplish the goals described in the paragraph above, but is concerned that various aspects of the proposed coverage decision memorandum may interfere with achievement of those goals, or cause other problems that will be more problematic than the issues providers and beneficiaries already face in securing needed MAE. Presented below are specific areas of concern.

1. While IHCC supports expanding the number of billing codes beyond the current number, our members believe that replacing five codes with 49 may result in a system that is too complicated for reasonable implementation. Is there any evidence that the required expertise exists in the real world settings in which these devices will be prescribed to use a billing coding system with 49 separate codes? IHCC is concerned that physicians writing these prescriptions and their support staff who prepare the billing will make multiple mistakes in billing because the system is too complex. Sometimes errors resulting from complexity are construed as Medicare fraud or abuse. IHCC believes that a set of billing codes numbering somewhere between the current five and the proposed 49 will be more appropriate for the current state of technology, and still usable by the people who have to use the codes.

2. IHCC is concerned that MAE for children have been lumped in with MAE for adults. Children’s needs are quite different from those of adults, and IHCC members believe children would be better served with a separate set of clinical criteria that recognize their developmental and other unique needs.

3. IHCC is also concerned that the draft decision memorandum would require a face-to-face meeting with a physician in order for MAE to be prescribed. First, the requirement presents a hardship for the most compromised Medicare patients, many of whom are served by home health providers. Adding another physician visit requirement for a homebound individual can be a real burden.

Second, the requirement for a face-to-face contact with a physician can have an unintended consequence of actually increasing Medicare fraud. The majority of primary care physicians serving the Medicare population are not experts in prescribing MAE, particularly when faced with having to bill correctly using so many codes. The increased complexity of the system, coupled with a face-to-face physician visit gives the unscrupulous supplier increased opportunities to market their services to overwhelmed physicians who want the best for their patients, but do not have the time to master this increasingly complex field. With scooter companies setting up shops in Wal-Marts across the nation, the opportunity for fraud simply increases.

4. Finally, IHCC is very concerned that CMS’ coverage criteria for these important devices is focused only on activities of daily living rather than on making it possible for Medicare beneficiaries to lead fuller lives both inside and outside the home. As providers of service to some of Medicare’s most vulnerable beneficiaries, home health providers know the benefits of increased mobility and reduced isolation on the quality of life of our patients, and on their ultimate use of health care resources.

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In accordance with the rights afforded for public comment in Section 731 of the Medicare Modernization Act (MMA), these comments are being submitted on behalf of Electric Mobility Corporation, one of the nation's leading providers of power mobility equipment. Electric Mobility Corporation has over 30 years of distinguished experience in the power mobility industry, and our Rascal brand of power mobility products is among the best recognized in the industry among clinicians and patients.

As Electric Mobility Corporation's Director of Insurance, where I hold responsibility for the management of our Medicare business nationally, I have carefully reviewed the February 3, 2005 Draft Decision Memorandum issued by the Centers for Medicare and Medicaid Services (CMS) titled "Coverage Decision Memorandum for Mobility Assistive Equipment (canes, walkers, manual wheelchairs, power wheelchairs, scooters)." Additionally, over the past two years, I have participated actively in CMS' open door fora on these issues, and have conducted abundant conversations with CMS officials, Durable Medical Equipment Regional Carrier (DMERC) officials, physicians and other clinicians, fellow medical equipment providers, and Medicare beneficiaries on this exact topic.

In response to the February 3, 2005 memorandum, I offer the following four comments on the Draft Decision Memorandum, which I ask that you take under advisement as you consider a final coverage decision:

1.) The proposal by CMS to abandon its highly restrictive "bed or chair" confined criteria is not just welcomed, but is, in fact, an essential reform. As nearly all clinicians, suppliers and beneficiaries can attest, this "bed or chair" confined criteria is highly restrictive and almost always confusing. Indeed, an abundant number of beneficiaries with various diagnoses that impair mobility may find themselves modestly ambulatory one day and bed or chair confined the next. In such cases, the ability of a beneficiary to ambulate periodically does not contraindicate the need for a power mobility product, since on other days these same beneficiaries would be unable to ambulate whatsoever without power mobility. Nor is such a scenario at all uncommon. A typical patient inflicted with an advanced neurological, orthopedic, or other diagnosis/diagnoses that impairs mobility very commonly will experience great variations in their mobility on a day-to- day basis. That they are unable to fully ambulate in the absence of power mobility on some days (which, left unaddressed, would commonly impair their health and welfare) should be the determinant for Medicare eligibility for payment for such technologies.

2.) As CMS appears to acknowledge in its February 3 memorandum, the ability to ambulate modestly with a cane, walker or manual wheelchair is essentially meaningless unless such ambulation is sufficient to allow a beneficiary to attend to all of their Activities of Daily Living (ADLs). Absent access to power mobility, many beneficiaries end up generally unable to care for themselves in their home and needlessly destined for institutional care settings. To the credit of President George W. Bush, this administration, through the Freedom Initiative and other policy steps, has made it a policy to enhance access to medical technology in an effort to afford the best opportunity for Americans with mobility and other medical impairments to remain in their home as long as reasonably possible. Power mobility has been shown consistently to serve such a laudable end. By enhancing beneficiaries' access to power mobility to those unable to tend to their ADLs, CMS should contribute constructively to permitting more beneficiaries to remain independent and in their home. This, in turn, should be helpful in containing overall health expenditures and also a welcomed initiative by many states, many of which fear a coming tidal wave of Medicaid expenditures on long-term care.

3.) As CMS looks to potentially depart from the "bed or chair" confined qualification criteria for power mobility and toward more of a "functional ambulation" definition, this latter definition should be defined in such a way as to recognize that functional ambulation means more than just ambulating within the home, since functioning includes performing at least some activities outside of the home. Activities such as grocery shopping, visits to medical professionals and other activities central to independent living are an essential part of functional ambulation. A beneficiary able to ambulate in the home with, say, a manual wheelchair, but unable to do so to tend to their shopping, medical and other needs requires access to power mobility to be able to maintain a legitimate functional ambulation and, ultimately, their independence. Should CMS broaden coverage criteria for power mobility inside the home, but not appropriately include some of the out-of-home activities inherent to independent living, such a step might still unnecessarily drive many beneficiaries into institutional care settings when, provided access to power mobility, these beneficiaries likely would otherwise be able to continue to function independently.

4.) However CMS ultimately ends defining its coverage criteria for power mobility, it must do so in a way that simultaneously simplifies the documentation requirements on suppliers. The Certificate of Medical Necessity (CMN) was initially established as a document that could easily be used by suppliers to assess, based on a treating physician's responses, whether a beneficiary did or did not qualify for a medical benefit. In power mobility, however, nearly every DMERC has discarded the CMN for the purpose of approving coverage (though, perplexingly, they do use it to deny such coverage) and instead has insisted on reviewing other documentation, up to and including patient progress notes. No supplier should be placed in the position of having to assess what are often complex, abbreviated or unrelated patient progress notes in determining whether or not a beneficiary qualifies for the power mobility benefit. The affirmation of a licensed physician in signing a CMN should be sufficient, and the CMN should be redesigned to include any and all questions that CMS considers important in determining, definitively, whether or not a beneficiary meets its new coverage criteria.

Should CMS conclude its current reform process by providing new coverage criteria guidelines that acknowledge the critical importance of beneficiaries to ambulate for important ADLs (both inside andoutside the home) and reinstate the CMN as the definitive and sole basis for assessing such eligibility, CMS will have performed a great service to this country and its beneficiaries by ensuring appropriate access to power mobility, encouraging independent living (consistent with President Bush's "Freedom Initiative") and reducing the bureaucratic, costly and needlessly complex assessment procedures currently inflicted on the country's suppliers of power mobility.

We thank the Congress and CMS for the opportunity to provide these comments on this very important issue that greatly impacts our nation and its Medicare beneficiaries.

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The controversy over CMS’s restrictive policy, often known as “In-the-Home,” has been revealed as central to the current debate over proper Medicare wheeled mobility device coverage. The latest Draft Decision Memo (“DDM”), dated February 3, 2005, only accentuated the dispute since the previous CMS document: the draft recommendations by the Interagency Wheelchair Working Group, posted on December 15, 2004 ("the IWWG Draft"). For the large volume of public comments generated by IWWG Draft were almost unanimously critical of CMS’s adherence to In-the-Home, on clinical, legal, and policy grounds. They included a statutory analysis by this commenter, and that of the Clinicians’ Task Force, which well described the negative role In-the-Home has played in “interfer[ing] with the IWWG role and process” and “render[ing] the IWWG powerless, ineffective and incapable of proposing appropriate and clinically relevant changes …” But CMS dismissed this outpouring of concern with a single, conclusory paragraph:

In light of the heightened importance of the In-the-Home policy and CMS’s plan to enshrine it in a formal NCD (national coverage determination), this comment attempts to hone in on only one task: to determine the actual meaning of the five statutory words CMS relies on — “used in the patient’s home” in the description of DME at 42 U.S.C. §1395x(n).

On the many other aspects of the issue, other commenters provided valuable insights during the January round responding to the IWWG Draft: actual clinical practice and standards, deficiencies, especially as against such clinical standards, in the CMS and IWWG proposals even apart from the restrictions imposed by In-the-Home, the effects of regulations and a variety of policy considerations such as the principle of community inclusion under the Rehabilitation Act and Americans with Disabilities Act, and the doubtful connection of coverage criteria to recent fraud problems. This commenter anticipates that such other comments, while already a part of this NCD-making, will be renewed, and generally concurs with them. The limited scope herein is intended only to be sure intensive attention is given to CMS’s statutory contention. The commenter urges that this all-important issue, and objections such as this one to CMS’s contention, receive more respectful consideration from CMS than the unexplained paragraph quoted above.

For years, the status quo for wheelchair coverage has been a confused combination of:

(1)the mere phrase “bed or chair confined” — a term that, so far as this commenter could determine, is not even recognized or defined by the clinical professions — that makes up the current NCD (national coverage determination), and

(2) the so-called “In-the-Home” rule, imposed only by a question on the required Certificate of Medical Necessity and not by a NCD or any other putative legal authority, but which establishes de facto coverage policy.[1]

This commenter joins many others in commending CMS for discarding “bed or chair confined.”

Yet In-the-Home persists, skewing all discussion of how to articulate functional mobility independence in a broad range of environments. It lives on notwithstanding that the clinical professions may accept such independence this as a proper goal of wheelchair application. CMS neither claims nor supports that it is not. CMS claims only that In-the-Home is imposed externally on the debate by law. So functional independence can only be discussed within that purportedly “legal” confines of In-the-Home, analogous to the literal confinement within the walls of the home, to which In-the-Home consigns many consumers in a midrange of mobility limitation. Accordingly, the “mobility-related activities of daily living” to which attention is given are everywhere restricted to “mobility-related activities of daily living in the home.”

To translate this situation into Medicare’s legal structure, treatments generally falling into one of the Part B benefit categories of 42 U.S.C. §1395x(s) — including durable medical equipment at §1395x(s)(6), glossed by the DME language now at §1395x(n) — are restricted for coverage by the general “reasonable and necessary” standard of 42 U.S.C. §1395y(a)(1)(A). Popularly, this is often called the “medical necessity” requirement.

The “reasonable and necessary” standard attains specificity by conforming to the practice standards and judgments of the relevant clinical communities and the treating clinician(s) for an individual. This principle derives from, among other things, its well-known expression by Congress in enacting Medicare (and Medicaid): “the physician is to be the key figure in determining the utilization of health services,” S. Rep. No. 404, 89th Cong., 1st Sess. (June 30, 1965), reprinted at 1965 U.S.C.C.A.N. 1943, 1986 — and by court decisions relying on that expression. E.g., Vista Hill Foundation, Inc. v. Heckler, 767 F.2d 556, 561 (9th Cir. 1985): “physicians, not administrative agencies, have responsibility for determining what constitutes necessary medical treatment.”

In turn, in applying a wheelchair to mobility limitations, clinical community standards reject In-the-Home, with its stringent restriction on human activities and their geographic locations as objects of concern. This is one of the points that this comment will simply leave beyond its scope, and leave to other commenters to demonstrate thoroughly, as many in the January, IWWG-draft round did, including those submitted or subscribed by clinical professional associations and academies. This comment will take such rejection of In-the-Home as a working assumption.

Accepting the last two premises together, it follows that In-the-Home is not supportable by 42 U.S.C. §1395y(a)(1)(A), i.e., as a matter of medical necessity — at least not “true” medical necessity. Without more, In-the-Home therefore violates the statutory entitlement to Medicare benefits.[2]

But, by answering the objectors as it does, CMS’s contention is effectively that for DME a special “medical necessity” rule is found in a provision other than §1395y(a)(1)(A). To restate the In-the-Home criterion more fully: As an individual-dependent condition of wheelchair coverage, the individual’s mobility limitations must be such that s/he needs a wheeled device to achieve mobility within the walls of his/her home. It shares formal characteristics of a medical necessity rule, as it depends on facts about the individual consumer, and those facts concern his/her clinical/functional condition. But it does not affect “true” medical necessity in the sense outlined above. Instead the contention is that, by arbitrary legal fiat, it overrides the usual significance of true medical necessity.

To this commenter’s knowledge, the IWWG Draft was the first express recitation of “used in the patient’s home” as the language that CMS claims creates this rule of “fiat medical necessity,” though this has long been assumed to be probable. The present DDM continues to identify those five words, while perhaps avoiding again the explicit declaration that those five words denote In-the-Home.[3] But in both versions the implication is clear enough; invoking the five words is held up as a complete refutation of all criticisms of In-the-Home.

The full clause involved, in the description of DME, originally at 42 U.S.C. §1395x(s)(6) and today at 42 U.S.C. §1395x(n), now reads:

Hereinafter, “Patient’s Home Clause” will refer to present and prior versions of this entire clause, i.e., including the parenthesized sub-clause concerning institutions used as a home. Hereinafter, Social Security Act numbering will be used rather than U.S. Code numbering; thus §1861 for 42 U.S.C. §1395x.

There is no known formal occasion on which CMS has made an argument for its contention that the Patient’s Home Clause denotes In-the-Home.[4] Nevertheless this comment addresses how such a contention, especially considering the historical evidence, is untenable.

Examination of just statutory language as it stands today weighs against the contention of CMS, and introduces the issues to be traced historically. The main alternative to that contention is that the sole meaning of the Patient’s Home Clause is this: Coverage of DME under Part B is available when, and only when, the beneficiary’s placement is in a “home.”[5] That is, for his/her equipment needs during institutional placements, by and large, a beneficiary is precluded from “direct” coverage that taps Part B funds and features the beneficiary’s own property interest — as rental or ownership — in a particular device, and must look only to what the institution provides as part of its services.

This distinction is set up, even looking just at the present-day statute, by its description of the Inpatient Hospital Services benefit, at §1861(b)(2)(emphasis added by ALL CAPS):

The corresponding language for SNF’s (the Extended Care Services benefit) is at §1861(h)(5). These “for use in the [institution]” clauses have the effect of drawing the border at which the institution may continue to provide access to a wheelchair, for example, insofar as such provision is fundable under Part A by inclusion in the institution’s costs. In short, the “hospital wheelchair” stays at the hospital door.

The Patient’s Home Clause, then, is simply the counterpart to these “for use” clauses, specifying that the benefit called “DME,” as such, picks up right where the institution’s obligation to provide needed devices left off. This transfer of coverage can be an actual, real-time one, for a beneficiary who is transitioning from an institution back to life in the community, or “home.” S/he leaves the particular device provided through §1861(b)(2) or §1861(h)(5) at the institution’s door and, in theory, switches to one covered through §1861(n).

Very exact timing, of course, would be required for that scenario to actually work. It is useful to note how CMS recognizes that problem and provides a limited remedy: a two-day pre-discharge period for delivery of Part B DME, for the purpose of conducting fitting and training needed to make the device effective upon the imminent beginning of extra-institutional use. In CMS recent manual re-codifications, see Medicare Claims Processing Manual, Ch. 20, §110.3 et seq. CMS there gives a description of the rules that form the predicate for this limited response, that confirms the above-noted allocations of institutional and extra-institutional equipment coverage:

1. A facility remains responsible for furnishing medically necessary items to a beneficiary for the full duration of a beneficiary’s stay. The DRG and PPS rates cover such items.
2. A facility may not delay furnishing a medically necessary item for the beneficiary’s use or treatment while the beneficiary is in the facility. A facility may not prematurely remove a medically necessary item from the beneficiary’s use or treatment on the basis that a supplier delivered a similar or identical item to the beneficiary for the purpose of fitting or training.
3. A facility may not, through a stratagem of relying upon a supplier to furnish such items, improperly shift its costs for furnishing medically necessary items to a beneficiary who is a resident in the facility to Medicare Part B.

Id. at §110.3.3.

In these expressions CMS highlights how the literal walls of certain institutions are also firm legal walls keeping Part A and B funds apart for equipment coverage. The latter are erected by the statute in the above-cited “use” clauses: in §§1861(b)(2) and (h)(5), together with its counterpart — the Patient’s Home Clause itself. The role of those clauses is to prevent any “seepage” of Part B funds inside the institutional wall (and correlatively, any escape of Part A funds to the outside). The concerns CMS states in this manual section reflect well the forms that such seepage would take. The institution might displace its obligations to the beneficiary (stressed in 1 and 2) by achieving direct “DME” supply and reimbursement, i.e., what 3 calls the “shift[ing of] costs … to Medicare Part B.” Since the costs of inpatients’ anticipated equipment needs are conceived of as having already been paid, by folding into the “DRG and PPS rates” referred to in 1, the result might be not just cost misallocation but a form of double payment.

The key point here, of course, is that this role for the set of three “use” clauses, which CMS has fully recognized, is their sole role and meaning.[6] The words of the Patient’s Home Clause cannot plausibly take on double duty.

Next, the In-the-Home restriction should be assessed as a competitor meaning of the Patient’s Home Clause. As mentioned earlier, this policy has the form of a “medical necessity” criteria, in that it conditions a grant of benefits to an individual beneficiary on his/her having specified medical/functional characteristics. Like most such criteria, it involves the concept of the patient needing the intervention, in order to achieve, or make more likely, some more desirable outcome.[7] (Impliedly, of course, such need must be caused by some condition cognizable as “medical.”) For wheelchairs specifically, the criterion could be accurately written as: “where needed for mobility within the patient’s home.” More generously to CMS’s contentions, to give the formulation some echo of the first five words of the actual Patient’s Home Clause, one could even allow: “where needed to be used in order to achieve mobility within the patient’s home.” Thus CMS’s proposal, allowing for the moment that those first five words be severed from the whole clause, and restricting attention to wheelchairs, rides on no less than the claim that “where needed to be used in order to achieve mobility within the patient’s home” could be substituted without change in meaning for “used in the patient's home.”

The claim is implausible on its face. The substitution injects the wholly new concept of need. Need is logically distinct from use. Simply, one could need a wheelchair without using one, and use one without needing it.

The problems with the claim are accentuated by a comparative approach: recalling the first proposal for the meaning of the Patient’s Home Clause, and setting up two scenarios for what Congress did, whose probabilities can be assessed:

Even for one who might regard Scenario One to be not completely free from difficulty, the difficulty is minimal compared with that for Scenario Two. It is a difference in phrasing versus an omission of the essential, substantive element of need.

The CMS contention has other problems, even before review of the historical origins of the Patient’s Home Clause. The contention requires that this substitute formulation of the whole clause would be synonymous:

But this loses the meaning on which there is general consensus, including CMS, that the Patient’s Home Clause does have: to effect the hospital/SNF exclusion. A defender might try to argue that it still does, in that a beneficiary during a SNF stay cannot currently use a wheelchair in a “home,” not for any reason of insufficient medical/functional condition but simply because the SNF is not a legal “home.” The problem is that making the initial phrase less cryptic for supporting the In-the-Home policy was achieved exactly by making it clearly a measure of facts about the individual, i.e., his/her functional mobility status, under a test that uses the fixed yardstick of his/her home. Thus if s/he satisfies that test, she still satisfies it without regard to her location of the moment.

Consider the case of a person who is in a SNF stay and who has a “home”; i.e., s/he is not using the SNF “as a home” but possesses a garden-variety, community one that s/he might return to, and serves as the basis for applying the foregoing mobility status test. Under the above re-formulation, so long as she satisfies such mobility test s/he is not disqualified during that stay from having a wheelchair supplied to her (and leaving it at the community home or bringing it to the SNF would be entirely up to him/her) and having it covered as §1861(n) DME. Again this flatly contradicts the actual Patient’s Home Clause, as generally understood to impose a hospital/SNF exclusion.

If doubt remains from review of today’s language alone about the meaning of the clause, historical evidence of its origins will weigh heavily against the CMS contention. The clause is original to the 1965 creation of Medicare and Medicaid (by Pub. L. 89-97, Title I) and its first appearance during the drafting process can be identified quite precisely.

As the long-standing debate over some form of public health insurance reached the new, 89th Congress in 1965, its main proponents took up the approach they been urging in past years, a fairly limited program centered on inpatient hospital costs of the elderly. These proponents consisted of officials from the Johnson Administration, headed by Wilbur Cohen, then an Assistant Secretary of Health, Education and Welfare, with Commissioner of Social Security Robert Ball who in turn headed a group of drafters, and some key Democratic legislators. The House version of their bill was H.R. 1 (sometimes termed the “King” or “King-Anderson” bill), introduced on January 4, 1965. It became the lead vehicle for Congress’s study for the next few months, in the House Ways and Means Committee, powerfully led by Chairman Wilbur Mills. Cohen, Ball and their drafting group were closely involved in the Committee’s work.[8]

Benefits provided by H.R. 1 did go beyond inpatient hospital services, but all were institution-based: some outpatient hospital services, “post-hospital extended care” (the terms “nursing home” or SNF did not appear in the initial bill) and home health services, conceived of as a counterpart to institutional service. It did not attempt coverage of physicians’ services or other outpatient medical services at all; there was nothing like the eventual provision for “DME.” However, the provisions mentioning “supplies, appliances, and equipment” appearing in the sub-listings for Inpatient Hospital and Extended Care, found in the present-day language as discussed above, were present in H.R. 1, including the “for use in the [institution]” qualification. H.R. 1, 89th Cong. 1st Sess., §102, internal §§1806(a)(2) and (d)(5).

While categorical opposition to any public program persisted, the opposition by two forces to Administration’s H.R. 1 took the form of alternatives. The American Medical Association (“AMA”), shifting tactics after its legendary categorical opposition, put forward a program featuring front-line administration by the States, with Federal financial assistance, and means-testing. These were features of the existing “Kerr-Mills” medical program, enacted in 1960 by Pub. L. 86-778, of which the AMA proposal, dubbed “Eldercare,” sought an expansion and strengthening. Its vehicle was H.R. 3737.

Congressional Republicans, headed by John Byrnes, urged that any program be “voluntary,” in that individuals could opt into or out of both its financing and benefits. The Administration approach was criticized as “compulsory,” financed by mandatory taxes on all, and no choice about eligibility (if not actual enrollment and use). The Republicans intended their proposal to be largely financed by premiums of its voluntary participants. Its main vehicle was H.R. 4351 or (the “Byrnes bill”), introduced on February 4, 1965.

Somewhat ironically, the proponents of both “Byrnes” and “Eldercare” also criticized H.R. 1 for the limits of its package of covered services. Both alternatives provided much more complete coverage of health care in general, inpatient and out patient. The service “menu” of the Byrnes bill is the one relevant to Medicare DME.

At §102(a)(3), the bill set out its menu of “surgical and medical services and supplies.” , It is easily recognizable as the precursor to the actual list of “medical and other health services,” still found today at §1861(s). Particularly, its sub-paragraph (G) provides for DME, in language that is easily recognizable as the precursor to, and still forming the core of, even today’s §1861(n):

Notably, there was no Patient’s Home Clause, in any version.

No amendments or motions to amend H.R. 4351 as such, such as might have included the first proposal to add some version of the Patient’s Home Clause, are recorded in the Congressional Record or otherwise. The DME language was unchanged, from the bill’s introduction on February 4, as above, and there it stood as of March 2, 1965. The same is true of H.R. 1, including its “appliances and equipment for use…” provisions.

On March 2, 1965, Chairman Wilbur Mills sparked the breakthrough for resolving the debate over the Administration’s approach and the Byrnes and Eldercare proposals, which had been regarded necessarily as competitors. Byrnes drew the attention of the Ways and Means hearing to his plan, noting its aspect of broader coverage. As Wilbur Cohen described the scene himself, he was the “primary Administration representative, seated in the center of a group of Departmental experts.” Reflections, at 6. Mills then “stunned” Cohen with the idea that the three proposals would not be competitors but components, working together in one overall plan. Marmor, at 64. In another account by Cohen:

Reflections, at 6.

Mills’s move was called a “tour de force,” a “coup,” and “ingenious.” Id., and Wilbur Cohen, Memorandum for the President, March 2, 1965 (hereinafter, “Memorandum for President”), first page of body.[9] In Mills’s view, speed in producing an actual plan was essential to its success. As Cohen explained:

Reflections, at 6.[10]

On the other hand, Cohen realized that producing such a combination plan was a “major undertaking” for his policy and drafting group, and he asked Mills for “a little more time.” “Mills said no, he wanted it the next day.” Id. So indeed, “we wrote up the new proposal, virtually overnight.” Id. See also, Memorandum for President, first page of body: “Mr. Mills turned to me and requested that we develop the details overnight of proposal that will put together in one bill features of all three of the major bills …”[11] The work began no earlier than the 3:00 p.m. recess of the Committee. Id.

The product of this unexpected and major drafting task, to be done in a single night, is reflected in Wilbur Cohen, Memorandum for Lawrence O’Brien, March 3, 1965 (hereinafter, “Memorandum for O’Brien”).[12] Per its cover page, it is “a memorandum outlining the provisions which Chairman Wilbur D. Mills has asked us to discuss in the executive session this morning.” The component that added the features of the Byrnes approach began to be called the “supplementary” plan. Its Attachment 2 stated the menu of “Benefits Covered Under [the] Supplementary Benefit Plan.”

It is plain that the drafters produced this menu by starting with the corresponding one in §102(a)(3) of the Byrnes bill, and made a handful of modifications. For the reader to see this him/herself, the full texts of the Byrnes and Cohen menus are set out in the endnote.[*]

Here, in this Cohen menu of March 3, 1965, a version of the Patient’s Home Clause made its first known appearance in the DME provision, as item number 7, reading:

Three weeks later, when the new combination plan became an actual bill (H.R. 6675, introduced by Mills on March 24), this language became the DME provision, at paragraph (4) of the menu of service categories called, as today, “medical and other health services,” in §1861(s) (within enacting section 102(a)). Only the punctuation was changed:

The provision underwent no further change, other than redesignation to paragraph (6), before ultimate enactment of H.R. 6675 as Pub. L. 89-97, on July 30, 1965. So the issue narrows that of the effect intended by the drafters of adding this clause, in the circumstances here described of the overnight drafting session of March 2 – 3, 1965.

The materials before the drafters, needing to be merged and harmonized, should be recalled. The tying in H.R. 1 of limited, institution-related benefits to “compulsory” financing and eligibility had to be preserved, as this was the essence of that approach. In Memorandum for O’Brien and elsewhere, that component was termed the “basic” plan (of course it would soon acquire the legal name of “Part A”), distinguishing it from the “supplementary” plan drawn from Byrnes and soon to be Part B.[13]

H.R. 4351 on the other hand was a comprehensive medical program, including hospital and nursing home services. The latter were included by the two paragraphs, that preceded paragraph (3) of §102(a) (the paragraph containing the larger “Byrnes menu” of service categories, recited in the endnote). These had to give way to the coverage already provided by the “basic” plan. (However, see items 2 and 3 in the “Cohen menu” set out in the endnote, whereby the supplementary plan would have covered a number of days per hospital stay, beyond those covered by H.R. 1. But this idea did not survive.) These had to be carved out of the nascent “Part B,” so it would “fit around” Part A without duplicate coverage. The result was to reduce “Part B” to the, loosely speaking, outpatient program which it remains known as today. This reduction was a major example of task of combination and harmonization demanded of the March 2, 1965 drafters: locating and building a wall between Parts A and B to eliminate duplication in coverage.

Regarding equipment, they had before them the two clauses in H.R. 1 noted above, each carrying the “for use in [the institution]” restriction. They faced a kind of service that is inherently capable of being accessed by persons in both institutional and non-institutional placements. Thus, when facing also the DME language in H.R. 4351, especially after the confirmatory expanding phrase “whether provided in or out of a hospital or nursing home” that preceded the whole §102(a)(3) menu, if simply inserted without change into the combined bill, it would have quite clearly authorized “Part B” coverage even for a hospital (or extended care facility) inpatient. That would duplicate the coverage under the equipment clauses of H.R. 1.

The drafters took several actions that can be taken as “repairs” to this duplication problem, because they have that effect. Most prominent are:

1st: The “in or out of” clause in the preliminary to Byrnes’s §102(a)(3) was deleted. It would not eventually appear in the March 24 formulations of H.R. 6675. But that deletion would have been necessary but not sufficient to negate the reach of the DME language into the undesired institutions. Plus, the critical task is to account for the language of the “Cohen menu” of March 3, where the Patient’s Home Clause first appeared. That menu was not in legislative form and lacked any analogous preliminary where the “in or out of” clause might have been continued or omitted. Thus, it was necessary that,

2nd: The Patient’s Home Clause was inserted. Any criticism of this response as a less than ideal expression of the non-duplication purpose must be tempered by remembering the extreme pressure on the drafters to articulate a combined program, dealing with all points and not just DME, that could be in just a narrative form for Mills’s Committee use, but did have to be done by morning. As seen, once put on paper in the “Cohen menu” in Memorandum for O’Brien, “used in the patient's home” continued without change into H.R. 6675, into Pub. L. 89-97, and down to this day.

The alternative theory for the insertion of the Patient’s Home Clause is that it reflects a Congressional decision to impose the In-the-Home policy, in the case of wheelchairs. Just as with the present-language discussion that began this section, this claim should be assessed by comparison.

There is not a shred of evidence for this theory. At the simplest level, it is commonplace that researchers scour available materials like committee reports, hearing transcripts and floor statements, and find no explicit discussion of the Patient’s Home Clause whatever. In assessing the significance of that silence, the starting point is that the clear precursor to the DME provision, H.R. 4351, §102(a)(3)(G), contains no such clause and so, by the assumption of this theory, imposed no such policy. It would have to have been a distinct choice to change policy made sometime during the 1965 deliberations.

Next, the nature and magnitude of that hypothetical change bears on whether the absence of explicit discussion is significant. The In-the-Home policy stakes out an extreme, hostile position in the debate over community inclusion of people with mobility limitations. The absence of any conspicuous discussion of the Patient’s Home Clause tends to show that it was not regarded as remarkable, in any proportion to the remarkable content of an In-the-Home policy.

Moreover, the Patient’s Home Clause was omitted from the DME entry in several summaries of the coming Part B benefit menu, written after the clause first appeared in Memorandum for O’Brien. See, Wilbur Cohen, Memorandum for the President, March 22, 1965,[14] H.R. Rep. No. 213, 89th Cong., 1st Sess. (March 29, 1965) at 36, Floor Statement of Wilbur Mills, reprinted at 1965 U.S.C.C.A.N. 2266, 2268 (April 7, 1965), and S. Rep. No. 404, 89th Cong., 1st Sess. (June 30, 1965) at 42, reprinted at 1965 U.S.C.C.A.N.1943, 1982. Others include the clause. This relative indifference by persons dealing with the DME language to whether the clause was included cuts strongly against the view that they regarded it as an essential element of a policy decision on DME. This pattern is much less consistent with (1) the clause going to the substance of the DME benefit, in the sense of what beneficiaries could get covered or the medical/functional conditions under which they could get it,[15] than with (2) its being a technical, conforming addition, in the sense that the possible availability of Part B DME to beneficiaries during “non-home” placement is a fairly fine point, whose intended remedy by the Patient’s Home Clause was inessential when summarizing.

It might be objected that viewing In-the-Home as extreme and hostile depends on heightened consciousness of the issue of community inclusion that only arose more recently than 1965. But this misconceives the issue: what matters in identifying intent in these circumstances is the likelihood of factual events. Here, that very low awareness in 1965 of a community inclusion debate cuts against the premise that the relevant drafters and policymakers took a position on it.[16]

Most importantly, this specific inquiry narrows, based on the clear evidence presented above, to the proposition that a small group of drafters, during the overnight session of March 2 – 3, 1965, took such a position. It would have to have been the case that they raised to themselves the sensitive issues implicated by In-the-Home, such as the proper “place” in society of people with limited mobility, and became informed enough about the issues to decide that a restriction was necessary to the existing Byrnes language in front of them.[17] A belief that this actually occurred is best attributed to result-based, wishful thinking, and not analysis that is, to borrow a recently popular phrase, “evidence-based.”

Congress’s actions during the 1967 amendments give additional reason to reject an In-the-Home theory. The Social Security Amendments of that year (Pub. L. 90-248, so dated although not signed by the President until January 2, 1968) were the first attention given to Medicare and some perceived flaws that had surfaced after little more than a year of operation. For this occasion, there is a readily available, explicit statement of the perceived problem, concerning so-called “ancillary services.”

It centered on the clause in the preliminary of §1861(s), “(unless they would otherwise constitute inpatient hospital services, extended care services, or home health services).” This had been major among the co-ordinating provisions, as discussed earlier, made necessary by the combination of Part A and Part B. It was the means by which the main set of Part B benefits, those listed in the §1861(s) menu, were made unavailable to, say, a hospital inpatient — defining the exclusion around the nature of the service rather than the setting. But apparently it was interpreted so that Part B was still unavailable to an inpatient even upon expiration of the Part A Hospital benefit, or other reason why s/he was not eligible, on the ground that the needed services still had the nature of Inpatient Hospital Services — an undesired “falling through the crack” between Parts A and B. As the Senate committee explained:

S. Rep. No. 744, 90th Cong., 1st Sess. (November 14, 1967), reprinted at 1967 U.S.C.C.A.N. 2834, 2919.

It is certain that DME was one of the ancillary services Congress had in mind, because amendment to the §1861(s)(6) DME language was one of a package of repairs of this problem, brought together in the eventual §144 of Pub. L. 90-248. The first repair was to delete altogether the “unless” parenthetical in the preliminary of §1861(s). Id. at §144(a). The repair in the DME language, §144(d), had the effect of restricting its scope, evidently addressing the other side of the “inequity” described by the Committee. It inserted the “other than” sub-clause to the Patient’s Home Clause, that creates the hospital/SNF exclusion. The result read, with the new language in ALL CAPS:

Whether the §144 amendments perfectly fixed the problems that concerned Congress, or any detailed understanding of their operational content, is beside the present point. The point here is only what the 1967 Congress made the Patient’s Home Clause to be as a matter of its subject-matter, whatever its content. That is, Congress used the clause as its tool for repairing an undesirable distribution of the DME benefit among persons who varied by placement, not by medical/functional condition. Thus it made the clause into one that regulates the DME benefit with respect to the individual’s placement, not with respect to his/her medical/functional condition.

Accordingly, even if the true significance of the 1965 Patient’s Home Clause is regarded as a question lost in time, from 1967 onward the Congressional intent behind has been unmistakable, at least at the level of its subject-matter, which is all that is needed to refute contentions for In-the-Home or any other medical/functional regulation.[18]

[NOTE 18: It would be irrelevant for someone who maintains that the 1965 edition of the clause was medical/functional to complain that the 1967 Congress got this “wrong.” As it had the power to do, Congress did not just comment on the clause but acted upon it. See, e.g., Brown v. General Services Administration, 425 U.S. 820, 828, 96 S. Ct. 1961, 1966, 48 L. Ed. 2d 402 (1976)(“For the relevant inquiry is not whether Congress correctly perceived the then state of the law, but rather what its perception of the state of the law was.”)]

From 1967 to today the Patient’s Home Clause has undergone only technical changes. Therefore it continues not to denote the In-the-Home policy.

Thank you for the opportunity to submit this comment.

The commenter is a 1985 graduate of Michigan Law School. He began working on problems in Medicare policy for wheeled mobility during his nine years at the protection and advocacy agency for Rhode Island. He now practices in Oklahoma City.

Surgical and medical services and supplies other than those specified in paragraphs (1) and (2), whether provided in or out of a hospital or nursing home, as follows:

(A) professional services of doctors (including surgery, consultations, and home, office, and hospital calls), or (subject to subsection (b)) of Christian Science practitioners;

(B) professional services of registered nurses, and services of licensed practical nurses and Christian Science nurses to the extent provided in subsection (c);

(C) diagnostic X-ray and laboratory tests, electrocardiograms, basal metabolism readings, electroencephalograms, and other tests that reveal need for treatment or are made because of definite symptoms of disease or injury;

(D) anesthetics, oxygen, blood and blood derivatives not donated or replaced, and intravenous injections and solutions, and the administration thereof;

(E) X-ray, radium, and radioactive isotope therapy, including materials and services of technicians;

(F) surgical dressings, splints, casts, and other devices used for reduction of fractures and dislocations;

(G) rental of durable medical equipment (including iron lungs, oxygen tents, hospital beds, and wheelchairs);

(H) professional ambulance service to the first hospital where treated, from that hospital to another hospital if necessary treatment is not available at the first hospital, and from the hospital to a nursing home or to the patient’s home (or from the nursing home to the patient’s home) if required by the patient’s condition;

(I) drugs and medicines which may be purchased only upon a doctor’s prescription;

(J) services of a qualified psychologist for a mental, psychoneurotic, or personality disorder in accordance with specific instructions as to type and duration by a doctor of medicine specializing in neurosurgery or psychiatry;

(K) services of a qualified physical therapist for administration of physical therapy in accordance with specific instructions as to type and duration by a doctor;

(L) prosthetic devices, other than dental, which replace all or part of an internal body organ, including replacement of such devices;

(M) leg, arm, back, and neck braces, and artificial legs, arms and eyes, including replacements if required because of a change in the patient’s physicial condition;

(N) hearing aids, and examinations therefore, if required to correct an impairment directly caused by an accident and obtained within 120 days thereof;

(O) eyeglasses and examinations therefore, if required to correct an impairment directly caused by accidental ocular injury or intraocular surgery and obtained within 1 year thereof (but not including spare eyeglasses); and

(P) dental work and oral surgery (including dental materials), subject to subsection (d).

1. Professional services of doctors including surgery, consultations, and at-home, office, and hospital visits.

2. Days of hospital care beyond 60 days and up to 100 days during a spell of illness.

3. Psychiatric hospital care of up to 60 days per spell of illness with a lifetime maximum of 180 days.

4. Diagnostic X-ray and laboratory tests, electrocardiograms, basal metabolism readings, electroencephalograms, and other diagnostic tests.

5. X-ray, radium, and radioactive isotope therapy, including materials and services of technicians.

6. Surgical dressings, splints, casts, and other devices used for reduction of fractures and dislocations, furnished to a patient outside of a hospital or extended care facilities.

7. Rental of durable medical equipment, including iron lungs, oxygen tents, hospital beds, and wheel chairs used in the patient’s home, including an institution used as his home.

8. Ambulance service to hospital, from hospital to hospital, and from hospital to extended care facility or patient’s home.

9. Drugs and biologicals available only upon a physician’s prescription.

10. Home health care for 100 visits per spell of illness in the case where the patient has not been hospitalized.

11. Extended care services for up to 120 days without a requirement that the patient have been transferred from a hospital, (with a $15 a day ceiling with a coinsurance of $5 per day) is applied and with a lifetime maximum of 360 days.

12. Prosthetic devices, other than dental, which replace all or part of an internal body organ, including replacement of such device.

13. Leg, arm, back, and neck braces, and artificial legs, arms and eyes, including replacements if required because of a change in the patient’s physicial condition.

14. Professional services of dentists in the case of dental surgery requiring hospitalization.]

[NOTE 1: The question is No. 1 on both DMERC 02.03A and 02.03B (May, 1997), for motorized and manual wheelchairs, respectively: “Does the patient require and use a wheelchair to move around in their residence?”]

[NOTE 2: 42 U.S.C. §1395k(a)(1), which incorporates the “medical and other health services” set forth in the menu at 42 U.S.C. §1395x(s).]

[NOTE 3: The analogous statement in the IWWG Draft read: “The IWWG recognizes that, by statute, Medicare restricts coverage to ‘wheelchairs… used in the patient’s home.’ 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.”

The DDM version is just the single paragraph quoted earlier, whose logic may be muddled by use of the term “Medicare law,” together with the puzzling next two sentences — discussed below — that cite a regulation and finish with the ambiguous term “that rule.”]

[NOTE 4: The DDM’s addition of a cite to the DME definition in 42 C.F.R. §414.202 is an odd makeweight. This definition deals with the scope of the DME service category, i.e., which device-types are included therein, or “covered,” as the term is commonly used. It is irrelevant to deciding cases of individual consumers, that is, the conditions regarding the individual case that are to be met for the individual to receive actual benefits to fund a generally “covered” device or service. So the definition, including the “appropriate for use in the home” element, has always functioned.

It appears that the language first appeared publicly in an NPRM (notice of proposed rulemaking) at 43 Fed. Reg. 58390 (December 14, 1978), leading to its promulgation, by 45 Fed. Reg. 44287 (July 1, 1980) at 42 C.F.R. § 405.514(b). By 57 Fed. Reg. 57675 (December 7, 1992)(interim final rule) the language was carried forward into the set of successor regulations (including 42 C.F.R. §414.202, with § 405.514 being simultaneously removed).

Both rulemakings solely concerned issues of the rental versus purchase of DME, and payment amounts. The definitional language was added almost as an aside, wholly tangential to this purpose. It received no commentary whatsoever by CMS (then called the Health Care Finance Administration or HCFA) and, according to the above CMS notices, no attention from public commenters. But the evident point of including the — apparently first — regulatory definition of DME was that it was desirable to sharpen the borders of the DME benefit, to which the new rental-purchase-amount provisions would apply. Again, therefore, the definition regulated the device-types that fall within the ambit of the term “DME” and hence the new rules, and had nothing to do with distinguishing among individuals for entitlement to Medicare benefits, as In-the-Home would do. So, for instance, wheelchairs as a device-type are undisputedly “appropriate for use in the home.”

Indeed CMS’s bare citation of §414.202 does not show how the “appropriate for use in the home” element even begins to support an individual-dependent rule like In-the-Home. Further, to the contrary, the “appropriate for use in the home” element is plausibly a reflection of the statutory “used in the patient’s home,” if given the meaning set out in the next section as simply clarifying that an institutionalized beneficiary is disqualified from “DME,” as such, under Act, §1861(n). The “appropriate for use in the home” element excludes equipment that is inherently, as a device-type, “institutional.” Thus when CMS wrote that element in 1978, ironically, it supported the latter, benign view about the meaning of the Patient’s Home Clause.

The DDM’s paragraph concludes with the term “that rule,” which it says cannot be changed in an NCD process. But in the context of the whole paragraph it is ambiguous whether “that rule” might be (A) In-the-Home simpliciter, (B) In-the-Home as the meaning of the Patient’s Home Clause, or (C) the “appropriate for use in the home” element in 42 C.F.R. §414.202. If it is Case (A), “that rule” can and must be changed at the point of an NCD, because it is unlawful. If Case (B), CMS would be right if it were right about the Patient’s Home Clause; but it is not. If Case (C), the regulation is irrelevant as just shown.]

[NOTE 5: “Home” here is the term of art resulting from the complications of the sub-clause of the Patient’s Home Clause. Under today’s language, the rules are apparently: (1) During placement in any institution not “used as the home,” the beneficiary’s placement is not in a “home”; (2) During placement in an institution that does or would constitute a hospital or skilled nursing facility (“SNF”) under the functional parts of Medicare definitions, these being the two statutory cross-references, even if the institution seems to be a “home” in an ordinary sense, the beneficiary’s placement is not in a “home.”

Further, it may be more accurate to say that this condition of coverage attaches not just to DME under Part B but to all DME “as §1861(n) DME,” noting the possibility of such DME, per §1861(m)(5), as part of the Part A Home Health Services benefit. While something like home placement is already a condition of that benefit, the express exclusion in §1861(n) of hospitals and SNF’s as qualifying places “used as [the] home,” is not repeated in the analogous clause in §1861(m) for Home Health. I.e., it seems that on the face of the statute, a “hospital resident” could have Home Health available, but not §1861(n) DME.

The term “placement” is used here, with misgivings about objectifying the persons, because neither “residence” nor “institutional status” is specific enough to accurately capture the complexity of that sub-clause. That is, some “homes” are “institutions” and some are not. And vice versa. A “placement” consists first of the type of physical site where the individual is currently staying the night, together with a specification of whether it is (1) a non-institution, or “home” in the garden-variety sense, (2) if an institution, where it falls along two dimensions: (A) used/not used as his/her home and (B) a hospital, SNF, or other.]

[NOTE 6: For example, in Warder v. Shalala, 149 F.3d 73 (1st Cir. 1998), DHHS evidently agreed with an exposition of the Patient’s Home Clause as meaning merely the hospital/SNF exclusion discussed above. The meaning of the Patient’s Home Clause was not in dispute in Warder. Rather the hospital/SNF exclusion for DME, denoted by the clause, was accepted by the plaintiff as well as DHHS. That meaning of the clause set up the dispute, which was whether “direct” coverage of a certain type of device could yet be available to hospital/SNF inpatients under a service category other than DME, i.e., under one of the other paragraphs of the §1861(s) menu. In that vein, plainly referring to the Patient’s Home Clause, the court said: “However, Part B reimburses devices classified as ‘durable medical equipment’ (‘DME’) only when provided at the patient's ‘home’ or other ‘institution used as [the patient's] home,’ and not in a hospital or skilled nursing facility …” Id. at 76.

This recognizes that the coverage exclusion hinges on whether the device is provided “at home,” versus provided in a hospital/SNF; not on the location, which might vary from moment to moment, of literal “use” of the device. While the court’s next sentence contains the phrase “used in a patient's home,” it is plainly just reciting verbatim from §1861(n), not intending to expound any different and additional meaning for the Patient’s Home Clause. Rather it regarded this second formulation, introduced by “in other words,” as synonymous with the first. Moreover, the reference to provid[ing] “at/in” the two contrasted sites is plainly shorthand for the placement status of the consumer, not the unimportant site of the delivery of the device. E.g., what matters is that a device was provided to a person while a SNF inpatient, not that it was put in his/her hands within the SNF building. Indeed, it is not a remote scenario that a beneficiary, who resides at “home” in the most garden-variety sense, and a wheelchair supplier arrange to meet within the four walls of a hospital — in the wheelchair clinic that evaluated her — for first delivery. Surely this does not take the wheelchair out of §1861(n).]

[NOTE 7: Despite the sound of it, there might be so-called “medical necessity” criteria that do not involve “need” in this sense, but still have the formal property suggested here of dependence on some kind of medical/functional characteristic. For example, a logically possible criterion might hinge entirely on diagnosis with no regard at all for outcome effects. This is likely favored by few people and at best rare in actual health funding practice.]

[NOTE 8: For this general background, good sources include the study by a leading historian of Medicare, Theodore C. Marmor, in his The Politics of Medicare 59 – 74 (Aldine Publishing 1973), David Blumenthal, “Medicare: The Beginnings,” in Blumenthal et al, eds. Renewing the Promise: Medicare and its Reform 4 – 19 (Oxford 1988), reports in March, 1965 Cong. Dig. 67, 74 – 77, and Wilbur Cohen, Reflections on the Enactment of Medicare and Medicaid, 1985 Health Care Financing Review (Annual Supplement) 3 (hereinafter, “Reflections”).]

[NOTE 9: This memorandum is part of a set of memoranda dated March 2 and 3, 1965 that include various covers to the body by Cohen, comprising Accession No. EXECUTIVE LE/IS1 WE6 IS1 FG11-1 FG165, White House Central Files, in the Lyndon B. Johnson Library, Austin, Texas.]

[NOTE 10: Blumenthal, at 12, adds the aspect that “one senses that Mills’s haste was intended as much to avoid bureaucratic and political entanglements in the executive branch as to keep the AMA and the Republicans on the defensive,” as there was some Democratic opposition to a “voluntary” approach such as Byrnes.]

[NOTE 11: The (Cohen) Memorandum for President has in turn two cover memoranda for the President, the second by Budget Bureau Director Kermit Gordon, dated March 3, which refers to “the memorandum from Wilbur Cohen” and relates, “[a]s a service to Wilbur Mills, Cohen and his colleagues worked out last night the details of a plan embodying the Mills approach. Cohen is discussing this plan with the House Ways and Means Committee today.”]

[NOTE 12: O’Brien was Special Assistant to the President for Congressional Relations. This Memorandum appears with the set of documents in the Lyndon B. Johnson Library described in note 9, with the separate Accession No. EXECUTIVE LE/IS1 IS1 FG165, White House Central Files. Its body and attachments variously bear dates of March 2, March 3, and none.]

[NOTE 13: The Eldercare approach of improving Kerr-Mills, of course, would result in Title XIX and Medicaid.]

[NOTE 14: Accession No. EXECUTIVE LE/IS1 7G165, White House Central Files, in the Lyndon B. Johnson Library. The body of this memorandum is dated March 19 and entitled “Summary of Major Provisions of ‘Social Security Amendments of 1965.’”]

[NOTE 15: In-the-Home, of course, would be an example of the latter. By contrast, none of the summaries, with or without the clause, were so “summary” that they omitted the illustrative list of “iron lungs,” etc., which does go to a substantive matter by ensuring that the listed device-types must be within the scope of the DME benefit.]

[NOTE 16: Moreover, to the participants in the momentous debates of 1965, frankly, the details of coverage within any one service category would not necessarily command close attention, as reflected in Cohen’s own description of most of the entries in the “Cohen menu” as “other, more minor benefits.” Memorandum for O’Brien, body at 3.]

[NOTE 17: In addition, they had to have chosen a most cryptic way to express such a marked restriction: “used in the patient’s home.” Its shortcomings were addressed earlier, in the analysis of only present-day language.]

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The National Multiple Sclerosis Society strongly urges CMS to reconsider the "in the home" restriction in the draft NCD. People with MS face a chronic disabling condition that is variable, unpredicatable and random in its presentation. There is often significant functional loss at the prime of life, and complex, clinical issues that require specialized medical care. However, in spite of what can be significant progression and dependency, technology and powered mobility can enable even the most disabled person with MS to continue to access the community and participate in its life as the disease permits. To dis-allow this opportunity is totally contradictory to the Olmstead/New Freedom philosophy of community integration and leads to increased isolation and withdrawal, as well as diminished well-being and quality of life.

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On behalf of the American Association for Homecare’s (AAHomecare’s) Rehabilitative and Assistive Technology Council (RATC), please accept the following comments regarding the draft decision memorandum (CAG-00274N) for mobility assistive equipment, released February 3, 2005. The American Association for Homecare (AAHomecare) is the only national association that represents every line of service within the homecare community. Our members include providers and suppliers of home health services, durable medical equipment services and supplies, infusion and respiratory care services and rehabilitative and assistive technologies, as well as manufacturers and state associations.
With more than 700 member companies at 3,000 locations nationwide, AAHomecare and its members are committed to advancing the value and practice of quality health care services at home. The RATC within AAHomecare is focused on the key issues affecting Rehab and Assistive Technology. Many Medicare beneficiaries receive Rehab products.

We commend CMS for initiating this dialogue, and we thank you for the opportunity to comment on these critical wheelchair policy changes. We hope that our comments will prove helpful as you complete the final National Coverage Decision for Mobility Assistive Equipment (MAE).

Comments on the Draft Decision Memo

Based upon the RATC review of the draft decision memo, we strongly support the following details:

I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the-home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines, as presented by the Clinician Task Force, that focus on a functional based clinical evaluation, performed by clinician therapists, and devoid of the “in-the-home” restriction.

Sincerely, Ziggi Landsman Director of Assistive Technology United Spinal Association

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Many persons with progressive neurological diseases (ie. MS, ALS, etc.) or those with adult CP do not have the ability to perform MRADLs but definitely NEED to be mobile to remain Healthy, functional and independent. PLEASE include mobility in the your definition of MRADLs. I work with many individuals who through the benefits of technology remain independently mobile and whose health would be significantly impaired if they could not be independently mobile, and remain contributing member of society. DO NOT do these individuals a severe disservice by cutting off their legs!! Thanks you.

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I am the third generation owner/manager of a 63 year old mobility business, Southern Illinois Surgical Appliance Co. I have 20 years experience in fitting and providing mobility products in southern Illinois.

I believe that mobility in and of itself is an activity of daily living. Being able to move from point A to point B should be a strong factor in getting a wheelchair.

The "in home" policy should be stricken. We as providers need clear, concise coverage guidelines and a clear concise CMN, so we can make good decisions. the Medicare policy is ambiguous and fuzzy leading to confusion.This wheelchair policy has been incredibly confusing the past few years, please take the time to get it right.

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March 4, 2005

On behalf of the Christopher Reeve Paralysis Foundation, I urge the Centers for Medicare and Medicaid Services (CMS) to remove the “in the home” restriction from the draft National Coverage Determination (NCD) on Mobility Assistance Equipment (MAE) as released on February 3, 2005 by the CMS.

By suggesting no changes to Medicare’s “in the home” restriction, the draft NCD fails to recognize the need for beneficiaries with mobility impairments to access their community. This standard runs counter to numerous government policies and initiatives such as the Administration’s New Freedom Initiative. Additionally, the “in the home” restriction forces clinicians to perform arbitrarily confined assessments that often lead to the prescription of insufficient and potentially harmful wheelchairs. We encourage CMS to modify the ‘in the home’ restriction either through this NCD process or in a separate regulatory process.

By requiring that a mobility device assist a beneficiary in completing a “mobility related activity of daily living,” the draft NCD fails to take into account the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. Additionally, this standard, if applied as written, would not allow the prescription of wheelchairs to individuals who are unable to complete MRADLs but could improve their capacity for mobility by using a mobility device. Therefore, we encourage CMS to incorporate mobility into the agency’s definition of mobility related activities of daily living.

Sincerely, Michael Manganiello, Senior Vice President, Government Relations Christopher Reeve Paralysis Foundation

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Dear CMS -

I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the-home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the-home” restriction.

Sincerely,Leslie VanHiel, MSPT

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Thank you for this opportunity to comment. While I appreciate your proposal to eliminate the "bed or chair confined" criteria for power wheelchairs and scooters,I am very disappointed with your continued refusal to address Medicare’s “in-the-home” restriction. You must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

As I said, I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the-home” restriction.

Sincerely,

Michael W. McNulty
Snellville, Georgia

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Dear CMS -

I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the- home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the- home” restriction.

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Dear CMS -

Please up-date to modern times and technology the language in the Medicare statute as the “in- the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access places outside their homes that normal people otherwise take for granted. Not to mention the inability of people with disabilities to attend important functions in their lives-such as weddings or funerals. Until you modify “in-the- home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives. Independent lives without barriers and with appropriate, necessary wheeled mobility among other things is what the Congress and President were trying to accomplish with The Americans with Disabilites Act!

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the- home” restriction.

Thank you for your time and consideration in these matters.

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To whom it may concern or interest,

First off I want to thank you for finally taking this matter seriously. Our company just completed an ALJ Hearing and it was disgusting! The appeal system is a joke. I never felt so betrayed in my life. The ALJ actually told me that my problem was "that I expected everything to make sense". We were appealing the denial of 32 out of 37 power wheelchairs after an audit. The stated reason for our series of appeal denials was that each patients file did not state or document that the patient could not walk. This in turn lead to a charge of having insufficient documentation and the denial of each and every chair as being Not Medically Necessary. A particular patients record even contained the statement from their physician that "patient can not walk". We were still denied payment. Appeals said it was only stated once and that was not enough. We need to have the required amount of documentation specified!!!! If you can't do this how do you expect and require us to do it. Our appeal is now into the Appeal Committe. I do not expect justice here either. Federal Court is next. When we retrieve each of the denied as overpayment chairs back from these patients who is the Wheeler Dealer here???

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I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the-home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the-home” restriction.

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I plead with you to reconsider the MRADLs requirement to grant a wheelchair benefit to your client's. Moving from place to place in and of itself is an essential activity of daily living. Are these client's to be confined to bed all day if they have no capability of eating, bathing, grooming, dressing, and toileting. By these guidelines, Christopher Reeve would not have been granted a wheelchair!!

I would also ask that changes be made to the "in the home" restriction. We are living in the 21st century. Persons with disabilities deserve and are very capable of becoming fully functioning contributory citizens of this country. This standard runs counter to the Administration's New Freedom Initiative, the American with Disabilities Act, the Ticket to Work Program and the Olmstead Decision.

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I submit the following comments as invited by CMS in the NCA Tracking Sheet for Mobility Assistive Equipment (CAG-00274N) on February 3, 2005. My name is Gerry Dickerson. I am a Certified Rehabilitation Technology Supplier in the greater New York City area. I have been providing assistive technology services, primarily in seating and mobility for almost thirty years. In those almost thirty years I have been, and continue to be, very fortunate to work with some very remarkable, very disabled people. These extraordinary people are known to many on the “outside” as Willowbrook Class Consumers, made famous by Geraldo Riveras expose’ on the Willowbrook Developmental Center in the 1970’s.

Classified with many diagnoses, the majority of those I work with present with Cerebral Palsy and some level of mental retardation, including profound mental retardation. Many people would have you believe that because of their classification of either mental retardation or profound mental retardation, these individuals are not capable of the simplest of tasks, let alone the control of a power wheelchair. Quite the opposite is true. Thanks to caring and skilled clinicians, advances in technology, technical expertise on my part and in spite of severe orthopedic deformity that most times leaves only the smallest movement available for control, access to independent powered mobility and powered seating options are achieved everyday.

There are thousands of examples of people I’ve just tried to describe to you. Some I’ve seen in the comments written by others. Many, many more examples exist. For some, their only independent function is their mobility. In reading the proposed NCD, these consumers will not meet the criteria and this enabling technology will no longer be available to them.

In speaking for those who are the least able to speak for themselves, please consider carefully this NCD, listen to the advice of the experts in the field, the people who work in this community everyday and don’t destroy the real independence of this most deserving group of consumers.

Additionally, the proposed NCD proposal fails to address the “in the home” restriction. Sustaining the current interpretation of the policy will unquestionably restrict access to individuals with functional mobility needs. The agency’s “multifaceted plan to ensure the appropriate prescription of wheelchairs to beneficiaries who need them” will undoubtedly go unrealized if the agency knowingly evades this opportunity to get a new NCD right. I urge CMS to abolish the “in the home” restriction in a new coverage policy. Failure to address this issue will dictate that I apply a standard that is inconsistent with contemporary or current standards of medical and clinical practice.

Furthermore, I urge CMS to clearly define Mobility Related Activities of Daily Living and recognize that being able to move from place to place or change one’s position in space, with or without assistance is a functional activity. Also, CMS is strongly urged to recognize Instrumental Activities of Daily Living (IADLs) as an essential component of Mobility Related Activities of Daily Living (MRADLs).

Similarly, the agency must address the mobility needs of individuals dependent on others for all mobility. These individuals have legitimate need for mobility devices and appear to have been exited out of the decision matrix resulting in blocked ccess to necessary and appropriate MAE.

CMS has implied that functional clinical criteria are needed yet the proposed NCD fails to:
1) require evaluation by a skilled knowledgeable clinician,
2) designate appropriate professionals qualified to perform MAE evaluations, and
3) specify documentation requirements with sufficient information to allow clinical determinations of appropriateness. Clearly, there has been ample public response concerning the negative impact of CMS’s interpretation of “in the home” on a new NCD. I strongly urge CMS to address these important and overlooked issues when finalizing the new National Coverage Determination for Mobility Assistive Devices.

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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

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.
(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
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.

As The Director of Senior Care and Rehabilitation I am concerned about the wording found in the recent release from CMS. I lead a team of occupational, physical and speech therapists in a retirement community that provides out-patient and in-patient services. Our job is to help maximize a person's mobility and therefore functional independence. We do not limit our patients functional mobility to ADL tasks as we feel there is much more to a quality of life than basic hygiene needs covered in your description of mobility needs. As a team of therapists our goal is to help seniors maintain a level of independence and health as long as possible. It has been proven that a comprehensive wellness program helps to extend the healthy senior years. This in return limits the expenses Medicare is responsible for. By limiting our resources, you will ultimately increase the medical expenses over time for any one person who does not receive the initial DME most appropriate. For example, a medicare approved wheelchair is a basic, heavy, one-size fits all chair. This is not appropriate for most individuals and they must pay the difference to receive a wheelchair that fits them best. A proper wheelchair for greater than 8 hours of use a day must provide appropriate positioning, possibly with a cusion, to prevent pressure ulcers, maximize lung capacity, be able to be propelled on an independent basis, and be an appropriate height for all functional ADL transfers. If one or several of these conditions is not met with the provided wheelchair other medical conditions can be exacerbated or new ones can arise. This again increases medical expenses in the long term that may otherwise have been prevented with proper DME.

I agree that guidelines need to be put into place to assure the people in need of adaptive equipment get the DME they require to live their lives to the fullest. First, I think a decision needs to be made as to who is a qualified clinician to make the decision as to what equipment a person requires to maximize functional independence to limit further medical expenses down the road. I strongley believe this should be an effort approached by both the treating physician and the treating therapist. A combined effort will provide the patient with the most appropriate equipment and help limit the expenses that otherwise can become uncontrolled. I believe a more detailed CMN is the best approach at this time.

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The Clinician Task Force (CTF) submits the following recommendations as to what constitutes adequate evaluation and documentation that the provision of a specific item of mobility assistive equipment to a specific beneficiary is reasonable and necessary as requested by CMS in the Draft Decision Memo for Mobility Assistance Equipment (CAG-00274N).

Evaluation and Documentation Needed to Justify Reasonableness and Necessity of a Specific Item of Mobility Assistance Equipment

To properly determine and justify reasonableness and necessity of a specific item of mobility assistive equipment (MAE), a face-to-face evaluation of the beneficiary by a skilled and knowledgeable clinician and a rehabilitation technology supplier is highly recommended. The skilled and knowledgeable clinician (e.g. a rehabilitation physician, physical therapist or occupational therapist) practicing within the scope of their professional practice and a qualified rehabilitation technology supplier should evaluate the patient’s physical and functional abilities and need and assess the patient’s environment. The clinical assessment process described below outlines the data related to the individual, the environment and the technology. Results in each area of evaluation should be documented, although the format of the documentation required may vary. There is no specific format recommended by the Clinician Task Force. Documentation needs will differ for different types of mobility assistive equipment (MAE), for example, a cane or a walker may simply require a prescription based on the fact that the beneficiary requires the device to safely ambulate, but a powered wheelchair with an alternative drive control system and extensive postural support system will require more documentation of the specific needs of the beneficiary and the equipment configuration recommended. The information required for documentation of MAE with increased complexity will not be available within the primary care physician’s progress notes.

For all aspects of the Wheeled Mobility Device Clinical Evaluation, the primary care clinician or clinical team will determine the required extent of data collection and the specific elements of each evaluation. For purposes of illustration, three levels of evaluation are described. The majority of Medicare beneficiaries and the majority of mobility assistive equipment items (i.e. canes, walkers, standard manual wheelchairs) will have only basic or intermediate level needs and will not require extensive evaluation or documentation. However, a face-to-face evaluation of the patient’s functional abilities and needs by a qualified medical professional is necessary to achieve the goals of preventing waste and abuse, even for patients with only basic mobility needs. Whenever the provision of rehabilitation technology (such as powered wheelchairs) is necessary, a qualified rehabilitation technology supplier must participate in the assessment process. Patients requiring more advanced powered mobility devices or extensive seating and positioning, will require the more extensive evaluation and assessment process described below. By assuring consistent procedures performed by competent and independent professionals, this more advanced evaluation process will aid in the goals of preventing waste and abuse of the Medicare system – particularly in the provision of powered mobility devices.

Patients with the most basic level of mobility needs for non-progressive medical conditions – e.g. those requiring basic manual mobility devices with limited degrees of adjustability and simple seating support, will only require a cursory review of the seven major evaluation components (medical history, physical abilities and needs, functional abilities and needs, seating and positioning needs, environment accessibility, currently used devices and environmental considerations). These patients typically have good sitting balance and do not have extensive neuromotor involvement. They do not have progressive medical conditions. They may be recovering from a temporary medical condition or recuperating from surgical intervention. Often this basic evaluation will be performed by only one medical professional – for example a primary care physician, or a physical or occupational therapist. This evaluation will result in the completion of an appropriate medical order or medical need determination form and need only determine that the patient is not able to functionally ambulate and requires a basic mobility device for temporary or dependent mobility. This very basic equipment (such as a cane, walker or temporary- use standard configuration manual wheelchair) will typically be provided by a durable medical equipment provider or through a pharmacy.

The next level of complexity, the intermediate level, will involve more in-depth review of the seven areas of evaluation (listed above). Examples of these patients include those with ambulation and mobility endurance limitations, typically from non-neurological and non- progressive medical diagnoses. They have intact or good sitting balance. These patients have simple or no seating and positioning needs but require a means of independent mobility to meet their typical daily functions. They may have arthritic conditions or cardiac and respiratory conditions that prevent functional ambulation and limit overall endurance. Patients in this category typically function in accommodated environments. This brief evaluation needs to determine the inability to functionally ambulate and whether the patient’s needs can be met with a manual wheelchair or not. If a manual wheelchair will not meet the typical daily mobility needs, then enough data need to be collected to determine if a scooter or light duty powered wheelchair is appropriate. The main components of the evaluation remain the same, but a less extensive team process will be needed. Often these evaluations will be provided by a primary care clinician – and may be provided in association with a durable medical equipment or rehabilitation technology supplier. The devices necessary for patients with intermediate level needs may be provided by DME providers or by rehabilitation technology suppliers.

The final level described incorporates patients with complex seating and mobility needs. This is a relatively small portion of the Medicare population and includes those with much more extensive seating and positioning needs. Patients in this category often have neurological disease involvement causing tetraplegia or tetraparesis. They also frequently have a progressive medical condition, such as multiple sclerosis, ALS, or muscular dystrophy. They are often unable to sit without external support or require support of both hands to maintain sitting balance. These patients will require a much more extensive evaluation process, as described below, and this process should be completed by a team of professionals including a rehabilitation technology supplier. Most will require advanced seating and positioning in addition to mobility assistance. They are also the most active individuals and function in non-accommodated environments on a frequent basis. The evaluation and assessment process described below is most applicable to this final level of patients. While the major areas of evaluation remain the same, the amount or complexity of data within each evaluation area is far greater for the complex level of patient. All possible components or factors to be evaluated are listed and described below.

History and interview
The history and interview process includes:

• referral information
• demographic data
• evaluation of typical daily mobility needs
• medical history
• surgical history
• equipment use history
• functional mobility needs and goals

Each of these areas is described in more detail below.

Referral Information
It is important to note who referred the patient for the wheelchair evaluation (e.g. physician, nurse, social worker, therapist, patient self referral, family member, equipment supplier), the reason for the referral (e.g. impaired functional ambulation), and any other therapy services the patient receives and the purpose of these services (e.g. out patient therapy services, home care services, respiratory services). It is also important to note if the patient uses any other assistive or adaptive devices or communication devices.

Demographic Data
Demographic data includes: patient’s height and weight, date of birth, insurance or third party payer information.

Evaluation of Typical Daily Mobility Needs
In order to make an appropriate technology recommendation, data must be collected regarding the patient’s mobility needs arising in the course of typical daily activities and any difficulties the patient has meeting these mobility needs. Data also is required regarding the patient’s living environment, transportation methods, and caregiver availability. Notes should indicate any recent or anticipated changes in work/home/school status.

Medical History
The medical history includes: primary and secondary diagnoses, onset dates of these conditions, nature of the medical conditions involved (progressive vs. static; acute vs. chronic), current medications used, allergies, precautions, spasticity management interventions, previous and/or future orthopedic or other surgeries, and history of skin breakdown and treatment intervention. It is also important to note any life support systems in use (e.g. ventilators, oxygen, suction) or the future potential need for this equipment. Notes will indicate whether the patient uses orthotic or prosthetic devices while in the wheeled mobility device.

The interview also includes identification and notation of the wheeled mobility technologies currently or previously used by the patient and the patient’s preferences and rationale for a future wheeled mobility device. These factors will be subject to comprehensive examination later in the evaluation and assessment process.

Physical assessment
A physical assessment is an essential component for clinical decision making to determine the seating and wheeled mobility prescription. This process allows a clinician to identify seating and mobility problems, assess potential, set goals, and determine the necessary equipment features required to attain those goals. This assessment includes sitting and standing balance, upper and lower extremity range of motion and strength, trunk and pelvic posture, and motor planning, motor control and muscular endurance.
If needed, additional elements may include trunk and neck range of motion and muscle strength, skin inspection, sensory testing, muscle tone assessment, testing for presence of primitive reflexes, righting and equilibrium reactions.

A sitting balance assessment is conducted with the patient seated on a mat to determine and document whether the patient is:

• able to weight shift
• able to sit “hands free”
• able to sit with the help of one or two hands, “hands dependent”
• unable to self-support even with use of two hands “externally supported”

More in-depth testing of seated posture and preferred seating body angles are important for a patient who requires significant postural support while using a wheeled mobility device (i.e. hands dependent sitters or those requiring external support to sit). Sitting posture and any abnormalities noted while using the current wheeled mobility device will be assessed and described (e.g. excessive kyphosis or lordosis, scoliosis, posterior or anterior pelvic tilt, pelvic obliquity, pelvic rotation, abnormal hip abduction/adduction or rotation). During this mat assessment, any postural abnormalities are assessed to determine if they are flexible in nature, fixed in nature, or a combination. Specific postural supports designed to either correct a flexible deformity or accommodate a fixed deformity are described at this time.

Joint range of motion, specific to seating and positioning, is necessary to match physical measurements to technology components. These measurements include true hip flexion capability, ability to extend the knees with the hips flexed, and ankle range of motion with the knees flexed. Other measures may be needed depending on the seated posture needs of the patient including trunk flexibility (amount of lordosis, kyphosis or scoliosis) and head control and positioning. During this assessment, body dimensions are needed to determine the size and configuration of the seating support system that will be interfaced with the wheeled mobility device.

A sensory assessment is performed if there are any neurological deficits or if a patient has peripheral vascular disease. This sensory evaluation can include an assessment of light touch, temperature and pain, sensation, and proprioception.

If the patient has any history of skin breakdown, current skin breakdown, or is at increased risk for skin breakdown, assessment of the patient’s skin integrity is essential. The location and staging of any current or healed pressure ulcers will be noted. Locations of any healed wounds or surgical scars and tissue or skeletal abnormalities creating at risk sites (i.e. bony prominences) should also be noted.

A pain assessment is indicated if the patient has any complaints related to pain. It is important to note the location of the pain, what causes the pain to worsen, what alleviates the pain. The effect of activities such as walking or wheelchair propulsion on the pain is also critical.

Specific measures that may be useful in the physical assessment include the Short Form of the McGill Pain Questionnaire (SF-MPQ), the Ashworth Score (tone assessment), ROM (goniometry), MMT (manual muscle test), Braden scale or Norton score (pressure ulcer risk assessment) and pressure mapping assessment (pressure assessment).

Functional assessment Important elements of a functional assessment include:

• cognitive skills assessment
• memory skills, problem solving abilities, judgment and safety issues, attention and concentration
• vision and hearing status
• functional ambulation ability
• fall history and risk
• frequency of falls, any known causes of falls, is the patient able to get up following a fall, has the patient suffered any injuries due to these falls – treatments to minimize fall risks
• endurance assessment
• how long a patient can stand, distance walked before needing to sit
• how far a patient can propel a manual wheelchair
• description of function on the “best” and “worst” days
• particularly important for medical conditions that cause fluctuations in weakness or endurance, such as multiple sclerosis
• bed mobility assessment
• transfer assessment
• transfers from bed to wheelchair, to commode chair, to car;
• type of transfer used, equipment needed and the level of outside assistance required
• ADL functional assessment
• moving from place to place and changing one’s position or posture
• bathing, dressing, grooming, feeding
• should note ADLs performed while seated in the wheelchair
• IADL functional assessment
• meal preparation, shopping, laundry, banking, household maintenance

Ambulation assessments would be performed without and then with the aid of assistive gait devices. If functional ambulation is not possible, even with an assistive gait device, then the mobility assessment continues using a manual wheelchair. If a patient is already using a wheelchair, then the number of hours of daily wheelchair use is noted. Skills that would be assessed include the ability to propel a manual wheelchair – the type of wheelchair used, the distance propelled, the efficiency or speed of propulsion, and the ability to manage environmental barriers (such as carpeting, door thresholds, ramps). If a patient is unable to meet the mobility needs arising in typical daily activities using a manual wheelchair, then an assessment for potential use of a power-operated vehicle (POV) will follow. If a POV will not adequately meet typical mobility needs, a powered wheelchair evaluation is required. This includes the ability to operate a standard joystick, the most effective type of alternative controls (if needed), management of doorways, obstacle avoidance skills, management of different ground surfaces, door thresholds, small rises, and overall safety using the device.

If a patient will be using a wheeled mobility device for most of his or her out of bed seating/positioning, then an assessment of his or her ability to perform independent weight shifts is essential in minimizing skin breakdown problems and determining the need for specialty seating equipment.

Specific tests that may be used during the functional assessment include:

• the Timed Get Up and Go Test (fall risk – a score of greater than 11 seconds indicates increased risk of falling),
• Tinetti Assessment Tool (fall risk –a score of less than 23 indicates a risk of falling),
• the Berg Balance Test (fall risk – a score of less than 20 indicates a patient is likely to be unable to ambulate), and
• the Borg Scale of Perceived Exertion (endurance).

Assessment of current equipment (only applicable for patients already using wheeled mobility devices)
A description of the device currently used by the patient is important. The critical factor to assess is the ability of the current device to meet the mobility needs of the patient arising in typical daily activities. However, other information impacts the technology recommendation as well such as, the status (i.e. rental, purchased, loaner equipment) and condition of the seating/positioning system and wheeled mobility device. In addition, information regarding the age of the equipment is obtained, or problems associated with the use of the device are described. The person responsible for caring for this equipment is identified and asked for input regarding necessary features of a new device. The positive and negative features of the current equipment are noted. The reason why the current device is no longer meeting the patient’s needs is determined (e.g. changes in the patient’s condition, age and wear and tear on the equipment, etc.) and any changes/modifications required specified. Mobility equipment that was tried in the past is noted and reasons for failures of these devices to meet the patient’s needs are identified.

In addition to the current wheeled mobility technology used, any other assistive devices used by the patient is described – including environmental control systems, life support systems, and communication or speech generating devices. Compatibility and interfacing requirements of this other equipment will need careful consideration in determining the features of a new device.

Environment and transportation survey
If a patient is determined to require a wheeled mobility device through this evaluation, then an environmental survey of the patient’s typical environment(s) is needed. When performing the environmental survey, it is preferable to assess mobility and function using the recommended equipment. If more than one device is under consideration, then an environmental survey using each type of alternative device is indicated in order to determine which best meets the goals of use.

Items to be reviewed include entrance/exit requirements (i.e. ramps, stairs, elevator), general layout of the environment, doorway widths including all doors used by the patient (i.e. bedroom, bathroom, living area), access to sink, commode, tub/shower and kitchen, floor coverings (carpet, rugs, etc.), threshold heights, bed height, other chairs used by the patient and seat height/configuration.

In addition to the physical layout of the environment, the roles and responsibilities of the patient are determined. In addition, any caregiver assistance available is noted (this includes identification of the caregiver, how many hours they are available, and any physical limitations of the caregiver).

The patient’s current roles and typical daily activities are noted including environments that he/she needs to access to perform these roles and activities (i.e. access to grocery store, work environment, and workstation access).

It is important to consider how the patient will transport the mobility device in the community. The following questions may help guide this assessment:

• Will the device be transported in a personal vehicle? (car or van)
• How will the device be loaded into the vehicle?
• Will the patient be a passenger or driver in this vehicle?
• What is the accessibility of the vehicle? (i.e. car vs. adapted van with a ramp or lift)
• Will the patient use public transit – fixed route or paratransit system?
• Will the patient ride while seated in the wheeled mobility device?
• What equipment restraint system will be needed?
• What other forms of travel will be used? (e.g. trains, cabs, etc.)

Treatment plan
For a patient with impaired ambulation or mobility, several different goals and treatment interventions may be applicable. Goals may include: evaluation of ambulation aids (e.g. canes, walkers), improvement of balance through therapeutic or medical intervention, improvement of ambulation through treatment intervention, or functional training related to mobility, transfers, ADL or IADL functions. These will all be goals related to specific therapeutic treatment interventions, usually determined by physical or occupational therapists under direction of a primary physician.

If traditional therapeutic intervention or the application of ambulation aids will not allow a patient to meet the mobility needs required by typical daily activities, then goals and interventions related to wheeled mobility device use will be required. The intervention will include functional assessment for a seating/positioning and wheeled mobility system, including recommendations for trial and training with a specifically chosen wheeled mobility device. These aspects of the service delivery process are described in more detail below.

Appendix

Roles and Responsibilities of Participants in the Wheeled Mobility Device Service Delivery Process

There are varied wheeled mobility device service delivery models utilized across the United States involving collaboration among professionals with a wide range of knowledge and experience including: medical professionals, clinical professionals (such as occupational and physical therapists), rehabilitation technology suppliers and DME suppliers. Consequently the party responsible for completing components of the service delivery process differs. The “team” referred to in the following discussion consists of, at a minimum, a single clinician and a supplier – either a DME supplier or an RTS. For more basic levels of evaluation, a simple team is all that is required. The more complex the needs of the patient, the higher number of team members involved.

It is critical that a skilled and knowledgeable clinician complete certain elements of the process. A DME supplier can complete some elements while other elements are more appropriate to be completed by a RTS. As described below, many of the elements of the service delivery process are shared responsibilities, handled as a team; other elements need to be assigned to a responsible party, completed and then shared among all team members.

History and interview
It is important to obtain all the required information. It is less important to designate who gathers specific information or even whether an employee of the medical facility or the supplier gathers it. What is critical is that the information is shared. Oftentimes, multiple team members gather ‘history and interview’ information allowing for comparison of findings and identification of inconsistencies.

Physical assessment
A skilled, knowledgeable clinician must complete the elements of the physical evaluation. However, measuring body dimensions is one step in the assessment where the patient is best served with a team approach. The eyes of both perspectives are valuable. In addition, the supplier carries the financial liability if the resulting equipment order is incorrect. Therefore, it is important for the supplier to participate during this process.

Functional assessment
A skilled, knowledgeable clinician should also complete the functional assessment. There is one exception to this as well. A team approach is recommended when evaluating the patient’s mobility skills using different types of equipment and the patient’s current technology if they currently use wheeled mobility. However, the clinician has the responsibility of documenting the results of this assessment.

Environment and transportation survey
The most qualified member of the professional team (supplier or clinician) will complete this survey. It should be agreed to, upfront, who will be responsible for completing the survey and the information gathered must be shared with the entire team. The resulting technology recommendation is only appropriate if it will function in the environment(s) that the patient will use it to perform all daily activities.

Treatment plan
This is the responsibility of the clinician(s) involved with the patient.

Goal Setting and preliminary device feature determination
In situations where seating and positioning goals and complex mobility needs are identified, a team approach, including a skilled and knowledgeable clinician and an RTS is recommended. It is the combined knowledge regarding the patient, the patient’s goals and the technology that will produce the best outcome.

Feature and product matching
The DME supplier or the RTS is responsible for matching the technology requirements identified through the assessment process with the available features of a specific technology solution. Through knowledge of the technology, catalog review and communication with manufacturers, the supplier will present a specific product(s) recommendation. A RTS will be required when modification of technology, highly configurable technology or when multiple technologies must be combined in order to meet the patient’s needs.

Fittings and delivery
If the clinician determines that the level of technology required to meet the functional needs of the patient will necessitate fittings or adjustments, a fitting involving the original assessment team will be recommended before the final delivery. This will allow the clinician to verify that the recommended technology meets the functional needs of the patient. If any additional needs or modifications are identified these issues can be addressed. If the recommended mobility device does not require custom fittings or adjustments, then equipment assembly and quality checks can proceed and the equipment delivered to the patient’s home by the supplier.

Training
It is the responsibility of the clinician to teach a patient how to use the technology to meet the identified functional goals. The clinician also will teach a patient how to safely perform activities such as transfers, obstacle climbing, traversing various terrains etc. The supplier however, is responsible for educating the patient, caregivers and family members on the proper care and maintenance of the device. In addition, the supplier demonstrates the proper use of the equipment such as how to engage a wheel lock, how to charge batteries etc.

Funding
In the Medicare model, funding occurs after the final delivery of the equipment. However, there are steps that occur throughout the service delivery process that are critical to the final submission of a claim. The clinician will develop the Letter of Medical Necessity (LMN) and, in many cases, complete section B of the Certificate of Medical Necessity (CMN). If denials occur, the clinician will often be involved in gathering additional documentation needed to demonstrate medical need. The supplier develops the cost statement for the technology solution, and completes section A and C of the CMN. There are many other funding steps completed by the supplier in attempts to determine medical coverage or explain limitations of coverage to the patient. The supplier is responsible for completing or assisting with the appeals process.

Determination of outcomes
Both the clinician and the supplier will determine whether the desired mobility outcomes and functional goals have been met. The clinician may want to ensure that the patient is satisfied with the device and the supplier. Additionally, the supplier will attempt to verify customer satisfaction regarding the supplier’s role in the service delivery process.

Follow up program
The clinician will establish recommended therapeutic follow up during the treatment- planning phase. The professional team will needto be involved if modifications, adjustments or fittings are required, that will change the original specifications recommended by the clinician. The supplier will conduct maintenance and service, as well as adjustments that will not modify the clinicians’ original recommendation.

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Dear CMS -

I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the- home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the- home” restriction.

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The restrictions of power wheelchair in home use are very descriminating to those who need a power wheelchair for their mobility whether it be indoors or outdoors. To restrict these people to in home use is cruel. Everyone deserves the right to go outside even if they do need a power wheelchair to go outside. To deny coverage for outdoor use is inconsiderate and prevents the pursuit of happiness for these individuals. This issue desperately needs to be addressed as soon as possible. Try to consider yourselves in this situation and hopefully you will realize how bad it would feel.

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To Whom it May Concern

By suggesting no changes to Medicare’s “in the home” restriction, the draft NCD fails to recognize the need for beneficiaries with mobility impairments to access their community. This standard runs counter to numerous government policies and initiatives such as the Administration’s New Freedom Initiative. Additionally, the “in the home” restriction forces clinicians to perform arbitrarily confined assessments that often lead to the prescription of insufficient and potentially harmful wheelchairs. We encourage CMS to modify the ‘in the home’ restriction either through this NCD process or in a separate regulatory process.

By requiring that a mobility device assist a beneficiary in completing a “mobility related activity of daily living,” the draft NCD fails to take into account the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. Additionally, this standard, if applied as written, would not allow the prescription of wheelchairs to individuals who are unable to complete MRADLs but could improve their capacity for mobility by using a mobility device. Therefore, we encourage CMS to incorporate mobility into the agency’s definition of mobility related activities of daily living

Sincerely M.Philips, MSOTR/L

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Dear CMS -

I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the- home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the- home” restriction.

Sincerely,

Janice Bird

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Dear CMS -

I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the- home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the- home” restriction.

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I strongly resent that persons that sre sitting in offices & being paid by us, the taxpayers, make decisions that affect the lives of people that are disabled.

CMS's ongoing refusal to consider the ramifacations of the "STAY-AT-HOME" severel;y restricts the ability of thousands of individuals that can and/or need to get out of their homes for various functions, such as going to the doctor, therapy, etc.

I implore you to remove the "bed or wheelchair" criteria in the medicare statute, and base it on clinical evaluation, if even that is needed.

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I serve as Rehab A Team Leader for the Region A DMERC Advisory Council. We respectfully submit the following for inclusion within the draft:

1. Identify Mobility as an ADL and if patient cannot walk independently and self-propel any level of manual wheelchair, that in itself qualifies for power mobility

2. Specify WHO may or MAY NOT conduct the Home Assessment within the NCD. We believe Rehab Suppliers employing CRTS (credentialled RTS by RESNA) are best qualified for this task due to the knowlege of equipment parameters.

3. Change/delete verbiage regarding what level of chairs will be compensated for Ventilators. Currently, the NCD states they will only be allowed on High Activity (which most likely will not be allowed due to their need on the outside) and Specialized Purpose Use - Multiple Power Option Wheelchairs.

4. We understand neither policy or pricidng is set by the IWWG Group, however, encourage prompt release of this information following March 7 so that Suppliers may review, digest and train on required changes.

5. Illustrate within the NCD clear documentation requirments for the CMN relating to the coverage policy that are well defined. Specify within the NCD examples of appropriate Medical Record information that would be required (other than just MD Progress Notes)

Thank you for your consideration.

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I would like to submit the following comments on the proposed decision memorandum and revised NCD for Mobility Assistance Equipment (MAE) as requested by CMS in the Draft Decision Memo for Mobility Assistance Equipment (CAG-00274N).

I would like to recognize the improvements of the draft NCD over current policy in a number of areas. Most importantly is the proposed policy change away from “bed and chair confined” criteria for coverage to a functional approach. Secondly, the recognition of those impairments which are changeable over time and that consideration of a mobility device needs to consider both current and anticipated future needs. Thirdly, the understanding that manual wheelchair propulsion is dramatically affected by the set-up configuration of the chair and that a chair should be properly configured to make an accurate assessment of the beneficiaries capabilities when using a manual wheelchair.

After listening to the Open Door session it became evident to me that the agency’s intent with regard to the availability of a caregiver and the interpretation of others outside of the agency are quite different. During a clinical assessment of a person’s mobility, a therapist is trying to determine the manner in which a person can independently move from one place to another. For persons with physical disabilities there is a common hierarchy used to assist the person who is unable to ambulate unassisted to still continue to move independently. This hierarchy is accurately represented in your Clinical Criteria Algorithm: use of ambulation aides, manual wheelchair, POV or a power wheelchair.

A person using an assisted ambulation device (cane, crutch, walker) is evaluated to determine if the person can safely and effiectly use the device and a determination is made whether or not the device restores functional ambulation.

If safe, effective functional ambulation is not achievable, then a wheeled mobility device is considered. Prior to being recommended a wheeled mobility device, these beneficiaries do experience restricted mobility, often resulting in a restriction to performing many common ADLS. However, once provided the appropriate mobility device, they are able to independently perform these routine daily activities. Many wheeled mobility device users still possess the necessary strength range and co-ordination of their head, trunk and upper extremities to perform these activities, without the assistance of a caregiver.

Persons who may lack the strength, range and/or co-ordination to independently perform the basic ADLs, without the assistance of a caregiver, are still evaluated to determine if there is a method available to provide independent mobility from place to place. For many, manual mobility is not an option, though a POV or power chair, especially with alternate controls, may be the device needed to restore independent mobility. While these people may need assistance of a caregiver to complete ADLs, they are able to move to and from one place to another, independently.

Only when a person has been fully assessed and it is determined that independent operation of any type of wheeled device is neither safe nor efficient, should the availability of a caregiver be considered in determining the type of mobility device. Dependent mobility devices rely on the caregiver for operation and are essential for persons who are unable to use a device independently.

If a person is able to demonstrates the ability to independently operate a device, then role of the caregiver is not essential for mobility. Thus I would like to suggest a change in the wording of each relevant section used in Appendix A to:

Assess the beneficiary’s ability and willingness to safely and effectively use a: cane or walker, manual chair, POV, Power chair to independently move from place to place to either perform or be assisted in performing activities of daily living. Safety considerations include personal risk to the beneficiary as well as risk to others.

This change in language would eliminate the need to assess the availability of a caregiver as part of the Clinical Criteria Algorithm for mobility devices. With the exception of the dependent mobility base, caregiver availability is not needed a critical clinical criteria for independent mobility, even if the person who may assistance in performing the activities once they have moved.

This suggested change of language also eliminates the need to refer to Mobility Related Activities of Daily Living (ADLs), a term used in the proposal which is causing great confusion outside of the agency. The critical criteria for the algorithm becomes the beneficiary’s “ability to independently move from place to place to perform or be assisted in performing activities of daily living”.

The final suggestion I would like to make is to delete the broad question of environmental support at the beginning of the process and rather insert a question of environmental support at each product level.

I would like to thank the agency for the tremendous amount of work that has gone into the whole mobility sector in trying to update policy to be more reflective of the functional needs of the beneficiaries. I encourage the agency to carefully review the comments at the Open Door, as well as submitted comments, to recognize that the agency’s intent to improve access is not being accurately interpreted outside of the agency. I hope these submitted comments and suggestion are helpful to more closely align the language of the policy with the intent of the agency.

If I could be of further assistance, I would be more than happy to be available to the agency. Please do not hesitate to contact me via phone or email.

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There is a pressing need to make consistent and to modify the DMERC Supplier Manual Coverage and Payment Rules that require polio survivors and all beneficiaries to be "bed or chair confined" and have "severe weakness of the upper extremities” to qualify for a power wheelchair. Recently, CMS has placed an even more stringent limitation on eligibility to stop power wheelchairs from being provided to those fraudulently receiving power operated vehicles that they use only outside the home. CMS recently promulgated a "clarification" that states a beneficiary cannot receive a power operated vehicle if they can take even one step. This "clarification" would not stop fraud and endangers the physical well being, ability to function and work and even the lives of beneficiaries, like those with Post-Polio Sequelae, who do need power wheelchairs. The "clarification" was rescinded. However, the DMERC Coverage and Payment Rules remain internally inconsistent and also not consistent with the Certificate of Medical Necessity (DMERC 02.03A):

• The rules state that a power wheelchair is covered when “The patient's condition is such that without the use of a wheelchair the patient would otherwise be bed or chair confined."Three paragraphs later the rules state “A patient who requires a power wheelchair usually is totally non ambulatory and has severe weakness of the upper extremities.” “Bed or chair confined” is not consistent with “usually…totally non ambulatory." It is also not clear if “usually” applies to both “totally non ambulatory” and “has severe muscle weakness.”
• However, the power operated vehicle Certificate of Medical Necessity does not ask about whether the patient is “bed or chair confined” but does require that “the patient have severe weakness of the upper extremities.” Does not the statement “A patient who requires a power wheelchair usually is totally non ambulatory allow patients who are not "totally non ambulatory" to receive a power wheelchair, making the new "clarification" a violation of the existing Coverage and Payment Rules? The DMERC Rules and Certificate of Medical Necessity need to be revised to allow power wheelchairs to those for whom they will provide mobility and prevent progression of conditions such as Post-Polio Sequelae. Patients should not have to wait until their arms are completely nonfunctional before they are eligible for a power wheelchair. The Rules need to state that:
• A power wheelchair is covered when “The patient's condition is such that without the use of a wheelchair the patient would otherwise be or become bed or chair confined.
• “A patient who requires a power wheelchair usually is totally non ambulatory and has weakness, pain or degeneration of the upper extremities that prevent propelling a manual wheelchair.” Also, the Certificate of Medical Necessity should be revised to ask if “the patient has weakness, pain or degeneration of the upper extremities that prevent propelling a manual wheelchair.” To prevent fraud, scooters should not be allowed by CMS and power wheelchairs should be provided only:
• When a patient is evaluated in their home or at a hospital by an occupational therapist or physical therapist or by a rehabilitation technology specialist employed by a DME provider experienced in power wheelchair evaluation.
• When the power wheelchair provider has a physical presence in the patient's state or in a contiguous state and has the equipment necessary and personnel with the technical expertise available to service the power wheelchair sold by them within 48 hours. Please put in place a policy that truly stops fraud and allows physicians and CMS to meet the needs of those who require power wheelchairs.

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I am very disappointed with CMS and your continuedrefusal to address Medicare's "in the home" restriction. It seems to follow the attitude of many that if you are disabled or old & disabled you are a disgrace and should not be seen in public. I am appalled that we do not have policy for the disabled set by those who are disabled. People who are not disabled cannot begin to understand what it is like to be ignored or hidden in the home by those who think the problemwill go away if it is swept under the carpet. We are human and wish to be with others just as youbut we can't because of the "in home restriction".The best and fairest way to solve the problem is to have the rules and restrictions made by those who are affected and who know what life is likewhen you are disabled. Please put people who knowthe need in positions to make decisions for thosein need.

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I am disappointed with CMS and its continued refusal to correct Medicare's "in-the-home" restriction. This restriction is terrible for the health and independence of people with disabilities and restricts people in need to their homes. It does not take into consideration the need for beneficiaries to have access to their communities, their doctor's office, grocery store, bank or place of worship.

While I support deleting of the "bed or chair confined" rule, I do not support tying medical necessity to a beneficiary's ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary's home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary's need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary's needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. Please consider these factors and act accordingly to help all of us with disabilities lives significant lives. We want to contribute to society rather than just draw from it and the only way we can do this is through contact with the "outside world" and not remain locked in our homes.

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Medicare needs to address the current in-home restriction which now impedes the population of citizens with mobility disabilities. This restriction makes citizens prisoners in their own homes. There is no restriction on citizens in the general population so why should those with mobility issues be refused access to their own communities. Please rid us of any more unnecessary restrictions as life is difficult enough for those living with this disability. Let us think in terms of equal access for all!!!!

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I have been a therapist in the A.T. field for eighteen years now. I would like you all to know that some people need a mobility device to get to their meals either down the hall, a few floors down or on the corner down the street. How do you define a home? It could be an apartment for handicapped or the eldery that offers meals once a day. It could also be a CBRF in which the person has a long way to the dining room for meals. There are many more scenarios, but I think you get the picture. If eating is not an ADL then we are all in for a long hard fight.

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Dear CMS -

I am very disappointed with CMS and your continued refusal to address Medicare's "in-the-home" restriction.  CMS must address this archaic and discriminatory language in the Medicare statute as the "in-the-home" restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes.  It does not take into account the need for beneficiaries to access their communities, their physician's office, pharmacy, grocery store, bank or place of worship.  Until you modify "in-the-home",  your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the "bed or chair confined" criterion.  However, I do not support tying medical necessity to a  beneficiary's ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary's home.  By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary's need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent.   CMS must recognize that mobility itself – moving from point A to point B  - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary's needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant.  Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes.  I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the "in-the-home" restriction.

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I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the- home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, harmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the- home” restriction.

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Dear CMS -

I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the-home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the-home” restriction and recognize that mobility itself must be considered a primary ADL.

Why solve half of the problem, when an equitable solution is within your grasp?

Sincerely,

Paul Tobin

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I am very disappointed with CMS and your continued refusal to address Medicare’s “in-the- home” restriction. CMS must address this archaic and discriminatory language in the Medicare statute as the “in-the-home” restriction severely impedes on the health and independence of people with disabilities and confines people to the four walls of their homes. It does not take into account the need for beneficiaries to access their communities, their physician’s office, pharmacy, grocery store, bank or place of worship. Until you modify “in-the-home”, your policy will continue to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

I support deleting of the “bed or chair confined” criterion. However, I do not support tying medical necessity to a beneficiary’s ability to perform MRADL, as long as MRADLs take place exclusively in the confines of the beneficiary’s home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary’s need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. CMS must recognize that mobility itself – moving from point A to point B - is an essential activity of daily living and incorporate mobility as an activity.

Unless your new coverage guidelines reflect the functional assessment of a beneficiary’s needs outside of the home, any new clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes. I strongly urge you to adopt coverage guidelines that focus on a functional based clinical evaluation devoid of the “in-the- home” restriction.

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Hello, I have been a Supplier working in the field of Durable Medical Equipment for 15 years. I am a Certified Assitive Technology Suppler (ATS) through the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) and Certified Rehabilitation Technology Supplier(CRTS) for the National Registry of Rehabilitation Technology Suppliers. I feel mobility is an activity of daily living and being unable to move from one place to another should be the primary factor in getting a wheelchair. I feel strongly that coverage of mobility equipment should not be limited or restricted to in-home use only. As for the enviromental assessment, clear guidance should be given to what will be involved, who will provide this service and how it should be documented. We need to establish clear documentation requirments that relate specifically to the coverage policy. Documentation should cosist of an expaned CMN and for high level products, specific additional documentation. The requirments should be clear and well defined and allow the supplier to maintain and secure the related paperwork in a file. Should the supplier have the specified documents properly completed, that should meet any postpayment review requests. There is a need to include all relevant players/areas to produce a complete system that includes DMERC local medical policies, who does what and how it will be documented. I look foreward to getting this issue resolved and I hope CMS will allow enough time to digest all the public comments and incorporate them into the finished policy. I thank you for your time.

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My name is Nanette Babyak. I have been a licensed nurse for the past 35 years and have worked in a variety of clinical office settings through out my work history. My experience includes but is not limited to working as a staff nurse in a Coronary and Trauma Intensive Care Unit at Swedish Hospital in Englewood, Colorado. I have had the opportunity to be the Evening Nurse Manager at Good Shepherd Home for Developmentally Disabled Adults. This facility was an 80 bed unit that cared for adults with physical and mental disabilities ranging from mild to profound. The organization also had 8 group homes at various sites within the community of Littleton, Colorado. My past history includes a total of 17 years of experience as a staff nurse for Family Practice Physicians and Internal Medicine/ Rheumatology Physicians. I was a member of The International Allied Medical Association when I lived in Jakarta, Indonesia, and have held Nursing Licensure in the states of Wisconsin, Colorado, and Texas. I am currently licensed in the state of Texas. Most recently I have co- authored A Continuing Education Activity for Nurses, Case Managers and other Healthcare Professionals. The subject of the article is Chronic Obstructive Pulmonary Disease (COPD) the causes, symptoms and treatment.

I would like to take this opportunity to comment on the traditional role of clinical notes that are entered into the Dr.’s office records. The traditional function of a clinical note is to document an acute or chronic complaint or symptom of a medical or psychiatric condition of a patient at the time of the office visit. When a physician enters a clinical comment into a file the primary intent is for his/her personal use as a point of reference and a history of past reasons for office visits. In this way he/she can have a running account of the patient’s historical and past medical or psychiatric needs for office visits. The clinical record is not intended to be used as a document to primarily support the need for Durable Medical Equipment. Traditional clinical notes consist of the patient’s subjective complaint at the time of the visit to the Dr. ‘s office. The clinical notes also may contain an objective examination of the patient. This assessment by the physician may vary according to the preferred physician format. Many physicians personalize their own format for a variety of reasons. Some physicians may be quite detailed in their writing and others may use a shortened format that meets their own personal needs which allows them to keep an accurate but brief record of the office visit. Some physicians prefer to hand write their observations and decisions while others prefer a formal and type written style. The physician’s examination procedures may include but are not limited to palpation, auscultation, and percussion along with a variety of medical laboratory tests and other tools of medicine that can be used as deemed by the physician’s art and knowledge. The tests and exam are generally addressing the acute complaint of the day. Physicians ordinarily address the “problem at hand” and do not routinely include in their clinical office exam a remark regarding need of Durable Medical Equipment such as a Power Wheel Chair. Indeed, it would be inappropriate to treat a patient for sinusitis and in the “Plan” section of the clinical note to remark about mobility needs for Durable Medical Equipment, (power wheel chairs.)

The notes may also contain an assessment of the medical/psychiatric problem. The assessment traditionally follows the examination of the patient. This section includes the physician’s “findings”. The final part of a traditional clinical note includes but may not be limited to a plan of treatment for the presenting complaint at that particular office visit.

There is no standard form for formatting clinical note presentation in a patient’ personal medical file. Very few physicians include great detail in their clinical notes regarding physical abilities or disabilities as they relate to ambulation or an ability to push a manual wheel chair. The condition of being “wheel chair bound” may be stated incidentally by an office nurse or medical assistant when trying to weigh a patient in the office setting. The nurse or M.A. may state, “unable to weigh, pt. is in a wheel chair.” The physician however may or may not allude to the fact that the patient is in a wheel chair. Specialists also are not accustomed to writing detailed notes regarding ambulation or mobility deficits unless it is directly related to an injury or disease for which the patient is being seen.

Therefore, I recommend that a letter of medical necessity should used by physicians as a document to support and convey information regarding the medical condition or conditions that would qualify a beneficiary for a Motorized Wheel Chair or Power operated Vehicle. The use of an LOMN would give an overall functional picture of the patient’s medical condition. It would indicate the diagnosis in a clear and concise manner. It would clearly implicate the upper and lower body condition that prevents the patient from independent ambulation as well as an inability to self propel a manual wheel chair. In conclusion, I believe that the intent of the clinical note is not now, nor has it ever been intended to be used to present historical evidence for need of durable Medical Equipment. An LOMN would paint a far greater and more precise picture that plainly shows the condition of the patient and conveys the intent of the physician to order the proper equipment as a medical treatment to restore independent mobility.

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CENTERS FOR MEDICARE AND MEDICAID SERVICES -THE DEVELOPMENT OF A NATIONAL COVERAGE DECISION GOVERNING THE APPROVAL OF “MOBILITY ASSISTIVE EQUIPMENT”

Comments Prepared By: James Kevin Roche PT
Therapy Consultation Services
2840 W. Pine Grove Road
Pennsylvania Furnace PA 16865-9796

Commissioned by: The Georgia Advocacy Office
March 1, 2005

Purpose
The Centers for Medicare and Medicaid Services (CMS) is requesting comments on the proposed deletion of the “bed or chair confined” criterion currently used to determine if a wheelchair is reasonable and necessary. CMS is also requesting public comments as to what constitutes adequate documentation to authorize the purchase of a specific item of mobility assistive equipment (MAE) for a specific beneficiary that is reasonable and necessary. The following addresses each of these requests.

Bed or Chair Confined CriteriaThe CMS proposal to delete the “bed or chair confined” criteria for eligibility for power wheelchair mobility is long overdue. It is, however, critical that the addition of functionally based performance criteria to make eligibility decisions for wheelchairs directly relate to activities of daily living (ADLs). An expansion of the variety of necessary ADLs is critical as the current list CMS uses in the draft decision that includes, “toileting, feeding, dressing, grooming, and bathing” is inadequate. For example, countless injuries and even deaths can result from the inability to complete tasks that require more balance, strength and endurance than many mobility-impaired individuals can perform.

It is necessary to add additional ADLs to the list, i.e., accessing community services, transportation, meal preparation, laundry activities, light housekeeping, environmental control, mobility, etc. Many high-rise apartments, designed with federal dollars for low-income individuals often house elderly and disabled individuals, have laundry facilities and other amenities at the end of long hallways, mailboxes on the first floor and congregate meals or group activities provided on the first floor of multi-story buildings. Meal preparation alone can easily compromise independence. An individual who appears independent in ambulation with a walker or crutches may be at risk for falls if the phases of meal preparation are not fully considered.

Sheer distance involved to accomplish tasks of daily living in these cases is prohibitive to many individuals with mobility impairments.Moving food from a refrigerator to a cooking surface, or a dining area, and back to the sink or dishwasher can be daunting. Incorrect assumptions are often made of individuals who require both hands to hold a walker or crutches when there may be no free hands to accomplish the above tasks.

If CMS is desirous of “placing a greater emphasis on health outcomes actually experienced by individuals, such as, quality of life”, then an expanded ADL definition must include the considerations for meal preparation, accessing laundry, mail and fatigue in traveling long distances to accomplish critical tasks of daily living. Full community living such as, attending religious services, keeping medical appointments, banking, shopping, etc., all require an expanded version of the ADL definition. Authorizing the purchase of needed equipment based on an expanded and functional ADL definition can contribute to a higher quality of life as well as improved safety in community verses institutional environments. An improved quality of life could contribute to cost savings as individuals acquire greater independence and mobility through the acquisition of appropriately identified MAE.

The studies cited in Appendix C of the CMS-NCD proposal demonstrate the use of appropriate assistive devices for mobility reduce the need for personal care or nursing care saving health care dollars. Further and greater cost savings are available by promoting the safe use of powered mobility to qualified individuals who in the past would have lived in institutional settings, but now can live in the community with the appropriate individualized supports.

Reasonable and Necessary Documentation of Needs
CMS is also requesting comments on what documentation is adequate to determine what is truly “reasonable and necessary” when matching individual needs to equipment. Presently, the regulations require physician signature on documentation created by licensed occupational and physical therapists. Individual therapy assessments (which include ADL, strength, balance, range of motion, and other clinical information) currently provide the standard information found in these evaluations.

Expanded environmental assessments must be mandatory and accompany all powered and wheeled mobility requests including scooters. These assessments would identify safety concerns for the individual and equipment and detail any safety concerns for the equipment for functioning in future environments. All requests for motorized wheelchairs requiring specialized seating or customized propulsion methods (sip-puff, head switch, etc.) should be assessed at accredited rehabilitation facilities by licensed therapists and seating specialists.

CMS must create peer review boards for appealed cases after first level denials. Six month and one-year follow-ups/evaluations for individuals receiving powered mobility equipment must be required to determine the effectiveness of MAE in maintaining functional independence.

CMS must create audit trigger mechanisms. Triggers would include repeat DME vendor usage, repeat clinical referral, and or random audits. This would require a defined paper trail, a defined process to measure pre and post ADL scores on MAE and defined reprisals for abuse of MAE funding requests for all parties involved.

CMS is poised to improve access to needed safe mobility for many disabled Americans. The expanded definition for functional ADL related criteria and oversight of this process are critical. The potential cost savings of expanded community alternatives greatly outweigh the cost of increased funding of MAE. More importantly, the expected improvement in the quality of life is priceless.

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To: Center for Medicare and Medicaid Services
From: United Spinal Association
Date: March 7, 2005
RE: Comments on Draft Decision Memorandum under the National Coverage Determination Process for Mobility Assistive Equipment (CAG-00274N)

United Spinal Association, a national disability rights organization dedicated to enhancing the quality of life for individuals with spinal cord injury or spinal cord disease by assuring quality health care, promoting research, and advocating for civil rights and independence, submits the following comments on the draft decision memorandum under the National Coverage Determination (NCD) process for mobility assistive equipment (CAG-00274N) released by the Center for Medicare and Medicaid Services (CMS) on February 3, 2005.

CMS Must Address "In-the-Home"

United Spinal Association continues to express our significant dismay with CMS as you continue to perpetuate the archaic and discriminatory "in-the-home" restriction. You neglect, yet again, to modify "in-the-home" under this draft NCD. The "in-the-home" policy continues to deny people with disabilities access to the appropriate and necessary wheeled mobility for living independent lives.

As you know, the "in-the-home" language was originally meant to define durable medical equipment as devices provided outside of an institution such as a hospital or skilled nursing facility and, therefore, warranted separate reimbursement under Medicare Part B. Instead, you choose to continue interpreting this language as restricting coverage of wheelchairs and other mobility devices that are only necessary for use in the patient's home.

United Spinal is encouraged by your intent to delete the "bed or chair confined" criterion currently used. However, this change will account for very little progress unless CMS also addresses the most biased and inequitable aspect of the Medicare wheelchair benefit: the "in-the-patient's-home" restriction. As we and countless others continue to assert, the "in-the home" restriction severely impedes on the health and independence of people with disabilities, as it confines them to the four walls of their homes and does not take into account the need for beneficiaries to access their communities, physician's office, pharmacy, grocery store, bank or place of worship. Your interpretation prevents individuals from receiving the appropriate technology necessary to live as integrated and productive members of American communities.

While moving to a functional based criteria is generally a laudable improvement, any functional assessment of a patient will be incomplete if that assessment is limited to the beneficiaries' functional abilities in their homes. This restriction will continue to inhibit community integration and limit the independence and freedom of people with disabilities. Unless your new coverage guidelines reflect the functional assessment of a beneficiary's needs outside of the home, any new functional clinical guidelines CMS may choose to adopt are irrelevant. Access will continue to be denied at the primary level, and people with disabilities will be prisoners in their homes.

In addition, the "in-the-home" restriction places clinicians, doctors and providers in extremely difficult moral and ethical situations. "In-the-home" affects a clinicians' ability to make sound clinical decisions often preventing them from prescribing the most appropriate device. These actions place beneficiaries at high risk for additional injuries that will lead to increased costs in Medicare.

- United Spinal Association recommends CMS modify the "in-the-home" restriction.

The Appropriate Mechanism?

CMS fails to acknowledge and appropriately address the "in-the-home" restriction in the draft NCD. You state that "an NCD would not be the appropriate mechanism to change this rule," but fail to offer any information as to what is the appropriate mechanism. This restrictive interpretation negatively impacts on the ability of CMS to draft a coherent and effective NCD based on functional criteria. In essence, as long as this NCD process ignores "in-the-home", it is nothing more than an exercise in futility.

While CMS has alluded to the need for legislation in order to address "in-the-home", United Spinal firmly believes that you have the authority to address this issue through the formal rule-making process. In fact, Thomas Hoyer, Director of the Office of Chronic Care and Insurance Policy, Bureau of Policy Development for the Health Care Financing Administration (CMS) echoed this belief in a January 3, 1995 letter stating that ""If we (CMS) determine that the requirement of home needs further clarification, we will issue regulations to achieve that purpose."

Furthermore, throughout this process you have never taken a position as to whether the "in-the-home" restriction hinders your ability to provide appropriate and necessary power wheelchairs and scooters giving people with disabilities their independence, freedom and ability for full community integration.

- United Spinal Association recommends CMS inform the public of how it intends to address this archaic and inequitable policy. We also seek clarification from CMS of it authority (or lack there of) to interpret "in-the-patient's-home" as used in the Medicare statute. Finally, we urge CMS to state its position as to whether believes this language impedes its ability to develop effective functional and clinical assessment guidelines and to provide appropriate mobility assistive devices.

Mobility itself is an Activity of Daily Living

United Spinal supports deleting the "bed or chair confined" criterion. However, we do not support tying medical necessity to a beneficiary's ability to complete mobility related activities of daily living (MRADL) as long as these MRADLs take place exclusively in the confines of the beneficiary's home.

CMS defines mobility-related activities of daily living (MRADL) as feeding, bathing, grooming, toileting and dressing. All MRADLs are activities confined to the home. By requiring that a mobility device assist a beneficiary in completing a MRADL, you fail to account for the beneficiary's need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent.

Mobility itself should be considered an activity of daily living. The ability to move from point A to point B is equally a functional improvement as completing the task of brushing your teeth, and it should be viewed as such. "Improvement in mobility" should be a sufficient criterion for coverage of a power wheelchair, as the purpose of a mobility device is to increase mobility. By requiring that a patient complete a specific MRADL, you fail to account for the needs of beneficiaries with conditions that might prevent them from completing an ADL such as a quadriplegic or an individual with cognitive impairments. In each of these cases, mobility is certainly an improvement and increase in function.

- United Spinal Association recommends CMS incorporate ambulation mobility into the agency's definition of mobility related activities of daily living as mobility itself is an increase in function.

Clarify Care Givers Role

United Spinal expresses concern over the beneficiary/care giver relationship as set forth in the draft NCD. This relationship could end up precluding beneficiaries, who are currently eligible for power wheelchairs and scooter, given your definition of ambulation, from qualifying.

- United Spinal Association requests CMS clarify your position on the role of care givers as they related to helping a beneficiary meet MRADLs.

Conclusion

CMS' continued refusal to address the "in-the-home" restriction in the draft NCD represents an enormous missed opportunity. Despite demands for greater independence and community integration from beneficiaries, advocates, clinicians, providers and even the Administration, by way of the New Freedom Initiative, Federal programs such as Ticket to Work and the U.S. Supreme Court Olmsted decision, you appear intent on maintaining a rule that keeps people with disabilities prisoners in their homes. It is counter productive and hypocritical to promote independent living and encourage return to work, but then determine that the appropriate technology necessary for carrying out these activities is unavailable due to the "in the home" restriction.

United Spinal asks that you please take the time to consider all comments submitted on this draft NCD. Evaluating public comment is a critical and integral part in preserving the transparency intended in the national coverage determination process. Thank you.

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"By suggesting no changes to Medicare's "in the home" restriction, the draft NCD fails to recognize the need for beneficiaries with mobility impairments to access their community. This standard runs counter to numerous government policies and initiatives such as the Administration's New Freedom Initiative. Additionally, the "in the home" restriction forces clinicians to perform arbitrarily confined assessments that often lead to the prescription of insufficient and potentially harmful wheelchairs. We encourage CMS to modify the 'in the home' restriction either through this NCD process or in a separate regulatory process.

By requiring that a mobility device assist a beneficiary in completing a "mobility related activity of daily living," the draft NCD fails to take into account the beneficiary's need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. Additionally, this standard, if applied as written, would not allow the prescription of wheelchairs to individuals who are unable to complete MRADLs but could improve their capacity for mobility by using a mobility device. Therefore, we encourage CMS to incorporate mobility into the agency's definition of mobility related activities of daily living."

The above comments are the official position taken by the ITEM coalition and I am in total support with their position. Individuals with phsyical challenges who depend upon wheelchairs for any level of mobility should not have the quality of their lives restricted by the unfair limitations within the proposed regulations. These changes are discriminatory and in violation of the equal protection provision of our Constitution. The restrictions violate fundamental rights of severely impaired individuals.

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While we appreciate some of the changes in this proposal that will improve the lives of people with mobility disabilities, we are extremely concerned about the negative impact on the lives of our clients that will result from the lack of acknowledgment of the importance of mobility for mobility's sake, i.e., having the freedom to get out and about "when the spirit moves you" as is possible for people without disabilities. The most current, and humane, model for treatment of a wide variety of disabilities calls for a community-based living standard. Guidelines that focus on what a client can do 'in the home,'and ignore whether he/she can get around outside it, unfairly restrict or eliminate a facet of life that is a major part of daily existence for temporarily able-bodied people (the rest of the world). This is 1930s thinking. Please take the steps to change your focus to a more acceptable perspective. Thanks for the opportunity to speak up.

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My name is Leslie Rigg. I am the current Chair of the DAC Rehab A Team and co-owner of a Rehab company, ATS Wheelchair and Medical. I am also a Certified Rehabilitation Technology Supplier. As the Rehab A Team chair, I would like to provide the following comments regarding the NCD for Mobility Assistive Equipment.

We appreciate the time and effort that CMS is devoting to the issues surrounding the medical necessity of Mobility Assistive Equipment. We see in this Draft Decision that many of our concerns were heard and have been addressed. Deleting the "bed or chair confined criterion" for the determination of medical need is a great beginning in allowing this benefit to reach more individuals with mobility limitations.

Linking coverage criteria to the ability to perform activities of daily living is an interesting consideration. MAE is not typically prescribed to allow an individual to brush their teeth or do the dishes. MAE is prescribed to allow mobility. This mobility often does allow individuals to participate more fully, faster and/or safer in these activities, however, we feel that the activity of mobility should be added to the list of daily living activities. The pure need to get from one place to another during the course of the day is an activity of daily living.

We appreciate that the proposed coverage acknowledges that MAE is reasonably necessary when the mobility limitation of the patient places them at a heightened risk of morbidity or mortality.

This proposed coverage criteria does provide for expanded coverage for individuals with mobility deficits. It does not specifically address mobility itself as an activity of daily living. Mobility must be included as an activity of daily living to allow individuals who may not be capable of independently completing MRADLs listed in the draft policy, even with the assistance of MAE, access to this benefit. If the MAE enhances the individuals ability to complete daily living activities with or without assistance, it should be considered medically necessary. Perhaps Item #3 in Appendix A may be attempting to address this concern, however, it is not clear as can be noted in a variety of comments.

We would also like to express our concern that the "in home" restriction remains. Normal daily activity includes short excursions out of the home including doctor's visits, grocery shopping, trips to the post office, etc. These activities of daily living contribute to greater self reliance, improved quality of life and enhanced psychological well being. As long as this restriction remains, many individuals will remain limited in their mobility.

Leslie Rigg, M.S., ATS, CRTS Certified Rehabilitation Technology Supplier

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The Shepherd Center, on behalf of our Board of Directors, Medical and Clinical Staff, and the individuals we serve, submit the following comments as invited by CMS in the NCA Tracking Sheet for Mobility Assistive Equipment (CAG- 00274N) on February 3, 2005. The attached document includes the names and contact information of 83 clinical staff and patients in support of the comments submitted here.

Shepherd Center understands and approves of efforts by CMS to revamp the mobility prescription policy to reduce waste and abuse of wheelchair prescriptions. We respect these efforts to identify requirements for mobility aids and appreciate the complexities of this task. Yet the proposed NCD does not go far enough. Individuals currently eligible for mobility assistive equipment (MAE) will not qualify for medically necessary and appropriate equipment as outlined in the published NCD proposal.

Shepherd Center is a catastrophic care hospital, serving individuals with many different diagnoses including spinal cord injury, acquired brain injury, multiple sclerosis, CVA, ALS, etc. A large number of our patients have severe functional impairments. Based on the proposed NCD many of the people we serve would be found ineligible for a wheeled mobility device. We have grave concerns about the potential impact of the proposed recommendations on the patients that we serve at Shepherd Center.

Our primary concerns with the NCD proposal and clinical criteria are outlined below:

• The proposed NCD proposal fails to address the “in the home” restriction. Sustaining the current interpretation of the policy will unquestionably restrict access to individuals with functional mobility needs. The agency’s “multifaceted plan to ensure the appropriate prescription of wheelchairs to beneficiaries who need them” will undoubtedly go unrealized if the agency knowingly evades this opportunity to get a new NCD right. We urge CMS to abolish the “in the home” restriction in a new coverage policy. Failure to address this issue will dictate that professionals apply a standard that is inconsistent with contemporary or current standards of medical and clinical practice.

• Furthermore, we urge CMS to clearly define Mobility Related Activities of Daily Living and recognize that being able to move from place to place or change one’s position in space, with or without assistance is a functional activity. Also, CMS is strongly urged to recognize Instrumental Activities of Daily Living (IADLs) as an essential component of Mobility Related Activities of Daily Living (MRADLs).

• Similarly, the agency must address the mobility needs of individuals dependent on others for all mobility. These individuals have legitimate need for mobility devices and appear to have been exited out of the decision matrix resulting in blocked access to necessary and appropriate MAE. A large population of individuals served at Shepherd Center fall into this category and will undoubtedly be denied access if this oversight is not corrected.

• We believe it is essential that qualified health care professionals (physical therapists, occupational therapists and physicians) be involved in the evaluation to determine a patient’s need for a wheelchair and ensure the provision of appropriate equipment The recommendation that a clinical evaluation be performed to ensure that a functional mobility need exists, the environment is accessible and that the appropriate device is matched with the patients’ needs should be outlined in the NCD policy.

Shepherd Center appreciates the efforts of CMS and the IWWG to update and modernize the National Coverage Determination process for wheeled mobility devices. This task is long overdue. We hope that the agency will give serious consideration to our comments on the NCD draft. Furthermore, Shepherd Center supports recommendations for a new coverage policy as outlined in the submission by the Clinician Task Force and desire that the agency give serious consideration to these suggestions during the finalization of a new coverage policy.

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I strongly support the adoption of the IWWG function-based guidelines for determination of medical necessity. However, the restriction to MRADLs of toileting,feeding, dressing, grooming and bathing ignores the needs of many beneficiaries to be able to safely travel from and to their home environemnts in order to receive routine or periodic medical and/or rehabilitaion services. This travel may be done independently or with the aid of a caregiver. In many cases, they will require the use of an MAE in order to access such essential services. Therefore, transport to medical services should be a recognized MRADL in the determination of medical necessity.

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Thank you for the opportunity to provide comment on the proposed decision memorandum pursuant to Section 731 of the Medicare Modernization Act related mobility assistive equipment (MAE). We are pleased that CMS proposes to delete the “bed or chair confined” criterion currently used to determine if a wheelchair is reasonable and necessary. CMS proposes that the evidence is adequate to determine that MAE is reasonable and necessary for beneficiaries who have a personal mobility deficit sufficient to impair their performance of mobility-related activities of daily living (MRADLs) such as toileting, feeding, dressing, grooming, and bathing.

Our concern is that the above mentioned examples of MRADLs are very limited and not representative of the tasks users of MAEs, or clinicians who recommend these devices, have identified as necessary. This is based on our years of clinical and research experience, research findings, and a recent systematic review of the scientific literature. Therefore we recommend the term MRADL be more clearly defined and inclusive of tasks that have been identified and documented in the literature.

Mobility (the ability to move oneself from point to point in the home and community) is in and of itself a necessary activity of daily living and an internationally accepted component of treatment and intervention throughout the field of Occupational Therapy and the field of Rehabilitation Science. To neglect this would be a significant departure from accepted standards of practice. The Functional Independence Measure (FIMTM) itself has a task area related to “locomotion”. This outcome measurement tool (although not sensitive to measuring function in people who use wheelchairs) has been accepted in other areas of the rehabilitation field including CMS.

We would like to take this opportunity to share with you recent findings of our research related to functional outcomes using a wheelchair. Early phases of this research are published however the final phases are nearing completion and will be submitted for publication to peer-reviewed journals. This work was supported by the National Institute on Disability & Rehabilitation Research, Rehabilitation Engineering & Research Center on Wheeled Mobility & Seating. We felt it was critical to share these findings at this pivotal point in time to consider when preparing the final NCD. We would be more than willing to share any of the previous publications related to this study, manuscripts, and reference lists.

The Functioning Everyday with a Wheelchair (FEW) is an outcome measurement tool that is currently in the final stages of systematic development at the University of Pittsburgh. The initial phases of FEW development determined based on the analysis of 1900 stated goals in medical records and statements by consumers of wheeled mobility and seating devices, that a measurement tool inclusive of consumer validated needs should measure how well a wheeled mobility and seating device addresses;

• stability, durability and dependability needs (e.g. contributes to ability to carry out daily routines as independently, safely and efficiently as possible.)
• comfort needs (e.g., heat/moisture, sitting tolerance, pain, stability)
• health needs (e.g., pressure sores, breathing, edema control, medical equipment)
• ability to operate the device (e.g., do what I want it to do when and where I want to do it)
• ability to reach and carry out tasks at different surface heights (e.g., table, counters, floors, shelves)
• ability to transfer from one surface to another surface (e.g., bed, toilet, chair)
• ability to carry out personal care tasks (e.g., dressing, bowel/bladder care, eating, hygiene)
• ability to get around indoors (e.g., home, work, mall, restaurants, ramps, obstacles)
• ability to get around outdoors (e.g., uneven surfaces, dirt, grass, gravel, ramps, obstacles)
• ability to use personal and public transportation (e.g., secure, stow, ride)

This list of tasks is not in rank order, however does include items that expand beyond CMS’s MRADLs such as toileting, feeding, dressing, grooming, and bathing to include ability to operate a MAE, ability to move around indoors, and ability to move around outdoors. Mobility in and of itself is an activity of daily living. We are also concerned that the MAE may not necessarily contribute to a person’s ability to perform certain ADLs such as toileting, feeding, dressing, grooming, and bathing other than allow them to get to the activity at which point they may remain dependent on others to assist due to severe weakness or paralysis. Examples of such cases are as follows;

• A person with C4-C5 tetraplegia dependent on on the use of a powered wheelchair for all mobility needs and also dependent on a caregiver for toileting, feeding, dressing, grooming, and bathing. With or without the MAE, this person is still dependent for these ADLs. The MAE does, however allow access to the location where the ADL takes place such as the kitchen, bedroom, or bathroom within the living environment. The MAE also allows this person to move themselves away or to locations under their own volition including the home and community where they can direct or interact with others to carry out daily routines. If alone, they could move away from danger or situations they choose not to be part of.
• A person with severe cognitive impairment is dependent for all ADLs including mobility and requires an attendant operated manual tilt-in-space wheelchair with a custom fabricated seating system. This wheelchair provides attendants the ability to move the person from place to place throughout the daily routine of a group home program including being transported to a day treatment program. The seating system accommodates postural needs/deformities of the body, and reduces the potential for further orthopedic complications as well as provides comfort and accommodation of deformity allowing the person to be up and out of bed for periods of time. The wheelchair does not however I,[rove this person’s ability to be able to improve their ability to perform ADLs such as toileting, feeding, dressing, grooming, and bathing.
• An elderly person with severe arthritis and cardiac condition has a very unsteady gait pattern placing them at risk for falls and injuries. They are independent with ADLs including toileting, feeding, dressing, grooming, and bathing with the appropriate accommodations including the ability to sit during activities, grab bars, and a tub transfer bench with a hand held shower. The MAE does nothing to materially contribute to their independence in these activities other than get them to the activity safely. In some instances the set-up of the wheelchair might assist such as a seat elevating device that could assist with reaching objects or making the sit to stand transfer process safer and more independent.

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 tasks were the most frequently cited and included in 17 of the 20 studies. This was followed by items related to operating the wheelchair (15 studies), outdoor mobility tasks (11 studies), reaching tasks (11 studies), transfer tasks (8 studies), personal care tasks (3 studies), stability, durability, and dependability measures (2 studies), health needs tasks (2 studies), transportation tasks (2 studies), and comfort related tasks (1 study). Again, 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.

One hundred and sixty unique observable subtasks were described across the 20 studies reviewed. Operate wheelchair had the largest number of distinct subtasks (44 subtasks). This was followed by outdoor mobility (36 subtasks), indoor mobility (26 subtasks), reach (22 subtasks), personal care (15 subtasks), transfers (9 subtasks), stability, durability and dependability (4 subtasks), transportation (2 subtasks), comfort (1 subtask), and health needs (1 subtask). When analyzing subtasks within each FEW item operate wheelchair had 22 subtasks related to maneuvering the wheelchair forwards, backwards, and making turns followed by 6 subtasks related to performing a wheelie in a manual wheelchair, and 5 subtasks related to wheelchair components such as armrest/footrest management, applying wheel locks, folding the wheelchair, and adjusting the speed control. Within the outdoor mobility item there were 12 subtasks related to curb negotiation; 11 subtasks related to negotiating ramps, inclines, and slopes; and 4 subtasks related to negotiating soft or uneven terrain. Within the indoor mobility item there were 12 subtasks related to negotiating the wheelchair to objects and places such as tables, bed, toilet, and sink; 8 subtasks related to negotiating doors and doorways; and 4 items related to elevator management. Again, this indicates a higher proportion of “mobility-specific” tasks as compared to CMS proposed MRADLs such as toileting, feeding, dressing, grooming, and bathing.

A capacity-based version of the FEW (FEW-C) has undergone systematic development showing good results in tests of reliability and validity. The FEW-C is being piloted on a sample of participants with a progressive condition or participants undergoing a significant change in lifestyle that warrants a new type seating and mobility device (e.g., loss of strength, new living environment, chronic shoulder pain). This includes people who are transitioning from a manual wheelchair to a scooter or power wheelchair. To date, 19 people have completed pre and post teats of the FEW-C. Although the sample size is still relatively small, we have noted statistically significant improvement in independence, safety, and quality related to tasks that measure a person’s ability to address their comfort needs (shift weight with tilt in space and recline), health needs (elevate legs above heart level), ability to operate the wheeled mobility device, indoor mobility, and outdoor mobility. We have not yet established statistical significance for improved task independence, safety, and quality related to reaching, transfers, or personal care. The lack of significance in the later tasks may be due to a small sample size, however our impression is that certain self-care, reaching, and transfer tasks are not always necessarily related to the wheeled mobility and seating device for people with severe limitations, however the properly prescribed and fitted device is more related to a person’s ability to operate it as well as get around indoors and outdoors.

Please consider these findings in the development of a new NCD related to MAEs. Please do not hesitate to contact us if we can provide further assistance or clarification. As stated previously, we would be willing to share any previous publications related to the development of the FEW instruments, current manuscripts, and references used in the systematic review.

Sincerely,

Mark R. Schmeler, M.S., OTR/L, ATP
Director, Center for Assistive Technology
University of Pittsburgh Medical Center
Instructor, Department of Rehabilitation Science & Technology
School of Health & Rehabilitation Sciences, University of Pittsburgh

Margo B. Holm, PhD, OTR/L, FAOTA, ABDA
Professor and Director of Post-Professional Education Occupational Therapy
Department School of Health and Rehabilitation Sciences, University of Pittsburgh

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How would you like to be trapped withing your own home simply because you have a disability? Individuals with disabilites deserve the freedom of outdoor mobility that we all have. By suggesting no changes to Medicare's "in the home" restriction, the draft NCD fails to recognize the need for beneficiaries with mobility impairments to access their community. This standard runs counter to numerous government policies and initiatives such as the Administration's New Freedom Initiative. Additionally, the "in the home" restriction forces clinicians to perform arbitrarily confined assessments that often lead to the prescription of insufficient and potentially harmful wheelchairs. I encourage CMS to modify the 'in the home' restriction either through this NCD process or in a separate regulatory process.

In addition, I believe that mobility in itself is a requirement for medical independence. By requiring that a mobility device assist a beneficiary in completing a "mobility related activity of daily living," the draft NCD fails to take into account the beneficiary's need to complete activities other than eating, bathing, grooming, dressing and toileting in order to be healthy, functional and independent. Additionally, this standard, if applied as written, would not allow the prescription of wheelchairs to individuals who are unable to complete MRADLs but could improve their capacity for mobility by using a mobility device. Therefore, we encourage CMS to incorporate mobility into the agency's definition of mobility related activities of daily living.

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Thursday, March 3, 2005

I am writing to express my concern about the limitations that are currently being discussed regarding the parameters of wheelchair usage. When dealing with people we need to remember that we are complex and as varied as snowflakes. As such it is important to understand that most Americans do not like limitations regarding where they go and how they spend their time. Indeed, this condition is reserved for those who commit crimes and must be removed from society. It is imperative that people have a plethora of choices regardless of whether they go about on two legs or use a tool called a wheelchair. No one should be limited to staying at home watching reruns of “I Love Lucy” because their wheelchair is not sturdy enough to take them out into the world to experience what many take for granted.

There are individuals who wish to visit friends, go shopping, hold down a job, or just enjoy a bit of fresh air. Are they to be denied the basic pleasures of life because of the challenges life has dealt them? This particular challenge could become ours or that of a loved one in the blink of an eye. This country has a long history of providing the pursuit of happiness to its citizens. It even passed a law to make more places accessible to those whose physical state is less than perfect.

Mobility is a basic right of Americans. It should not be limited to those with two good legs. Some say that money is an issue. If we can house, clothe, feed, and educate the people who come here to seek a brighter future, whether they come legally or ill-legally, then we cannot take this basic right away from a portion of our citizenry.

Please consider the issue of mobility when determining the most realistic choice for an individual who uses a wheelchair.

Thank you,

Beverly Christensen

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We appreciate the opportunity to present comments on the Draft National Coverage Decision Memorandum for Mobility Assistance Equipment (MAE). Mobility Products Unlimited is a Medicare Part B supplier that provides Medicare beneficiaries with medically necessary motorized wheelchairs and power operated vehicles (POVs). Based in South Daytona, Florida, Mobility Products Unlimited provides medically necessary Part B items to beneficiaries in numerous states throughout the country.

Mobility Products is also a part of the Restore Access to Mobility Partnership (“RAMP”) coalition. RAMP is submitting a separate set of comments which describes in greater detail all of our concerns and we support RAMP’s comments. The purpose of this letter is to highlight our particular concern over two areas, namely the documentation that will be required once the new NCD takes effect and second, the definition of functional ambulation.

DOCUMENTATION

First, we applaud the progress inherent in the proposed NCD and appreciate CMS’ request for industry guidance in the documentation arena. In order for the new NCD to be effective from the perspective of the agency, the supplier and the patient, the current problems associated with documenting medical necessity must be resolved. We believe that there should be a set of core principles that should guide CMS’ final requirements for suppliers in this area.

First, suppliers must know with certainty what documentation will be accepted as a definitive determinant of medical necessity (absent fraud) in order to design and implement internal processes for screening in/out prospective beneficiaries of the technology; and for determining the appropriate level of equipment to provide and bill for. We must be able to rely on clinician/physician integrity and judgment. There must, therefore, be a “four corners test” for any determinative document that is designed or accepted by CMS with regard to claims payment and review, absent fraud. By this we mean that the documentation for medical necessity must be accepted on the face of the document. A “new” NCD will not be new in any real sense unless the documentation required to support it is addressed clearly and definitively.

Second, while there has been some division of opinion between industry and the agency regarding the physician documentation practices with respect to current coverage criteria, we think now is the time for CMS to acknowledge that the level of detail required by the algorithm the NCD sets up would virtually never be present in the physician progress notes. Consequently, CMS and the DMERCs will have to look to other documentation to confirm medical need.

Third, we believe that the CMN should be the critical instrument for documenting medical necessity, but in order for the CMN to accomplish this function, it must change. The industry is willing to work with CMS to develop an expanded CMN that contains the elements contained in the NCD. It is critical that the CMN reflects the data needed to enable payment, and less critical that it be a single page. Although we recognize that obtaining OMB approval for a revised document is time consuming, we believe the investment is worthwhile to develop a document that is truly useful in the payment process.

Fourth, we recognize that the CMN alone will not answer all questions. We believe that a companion evaluation or assessment form that both amplifies the CMN and provides the appropriate level of specificity to corroborate the CMN is necessary. This could be signed by any appropriate clinician, countersigned by the ordering physician and may have varying degrees of complexity depending on the patient’s conditions. It is customary for physicians to consult with other clinicians regarding specific patient conditions. We contemplate that this would be a non-OMB approved document but would have significant industry consensus as to what it should contain, in addition to guidance from the DMERC medical directors. We believe that the level of documentation required should vary depending on the complexity of the assessment needed to demonstrate the medical necessity of the equipment.

Fifth, and finally, the revised CMN and the companion evaluation or assessment should be considered the determinative documents for medical necessity review. Once the physician has signed the CMN and countersigned a detailed evaluation, CMS should have sufficient confidence that the patient’s treating physician has exercised due medical judgment. If CMS has doubts about the validity of either of these two instruments, it has had the ability to resort to a fraud investigation if there is suspicion that the information provided is false.

We are concerned that the definition of functional ambulation contained in the draft NCD is too limited. Additionally, Appendix A is even more limited than the draft. We further believe that an appropriate model for guidance can be found in the Pennsylvania Medical Assistance program. In 2001, Pennsylvania issued a Medical Assistance bulletin clarifying the definition of when an individual lacks “functional ambulation.” The Pennsylvania Medical Assistance definition is a sound one, and dictates that to be functionally ambulatory, the beneficiary “must be able to walk the necessary distances safely, independently and in a reasonable period of time” in all settings that the beneficiary would be expected to routinely encounter. (Pennsylvania Office of Medical Assistance Programs, Medical Assistance Bulletin 01-01-02, 05-01-01, 17-01-01, 19-01-02, 49-01-02, 50-01-01, Clarification of Coverage for Motorized Wheelchairs and Other Motorized Durable Medical Equipment, issued February 16, 2001) (See attached bulletin.)

The key concepts contained in the Pennsylvania policy are that a patient is not considered to be functionally ambulatory if walking places her in danger, for instance of falls, if she needs help to ambulate or if the time frame involved to move from one place to another is so extreme as to prevent meaningful participation in activities of daily living. Similarly, if the patient’s medical condition occasionally allows her to walk, but most frequently she cannot, then again under the Pennsylvania definition, she would not be considered functionally ambulatory.

* * * * *

Mobility Products Unlimited would welcome the opportunity to work with CMS and the DMERCs to develop appropriate guidance in these areas.

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Dear folks,I am a PT who works at Bryn Mawr Rehab Hospital in Malvern, PA, and I run the Assistive Tech Center, including the Wheelchair Clinic. All of the clients we see have mobility impairments due to physical disabilities sometimes complicated by cognitive disabilities like traumatic brain injury and mental retardation.
1. I am concerned that the new guidelines referring to "mobility-related ADL's" would not allow some of the clients we see to qualify for a wheelchair. For example, someone like Christopher Reeve would not qualify under those guidelines because he was a vent-dependent person with quadripelgia who still couldn't brush his teeth or feed himself, even with the use of a wheelchair. Also, some of our patients with mental retardation still require assistance for ADL's once their wheelchair allows them to go to the kitchen, bathroom, etc.
2. I believe mobility is a goal in and of itself, not dependent on other ADL's. Evaluation for an appropriate mobility device should be a decision based on the least complicated device which will allow the person to be mobile, ie, cane or walker, then manual wheelchair, then power mobility of some sort.
3. I believe that CMS should reconsider the interpretation of "for use within the home". To me, this means that the device will actually work within the home, not that that the home is the only environment to consider. For example, a golf cart may act as a mobility device, but it is not suitable for use within the home, and shouldn't be a covered item. However, people have a need to travel outside the home for medical appointments, work, school, sheltered workshops, etc, and this restriction may serve to limit their access to real life
4. I feel that a skilled and knowledgeable clinicain should be a part of the evaluation for power mobility, although I worry that this may limit access to people in low-population density areas.

thank you

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I am pleased to see that CMS is recognizing that patient mobility is an essential part of life and CMS is voyaging in that direction to provide within reason what they can for patients to accomplish this.

As I stated during the forum last week we currently use an assessment form for doctors to complete when ordering a power wheelchair for any patient from us. It may not be a lengthy PT version but it does address what we believe to be some vital points not included on the current CMN. We also ask that the prescribing Physician is to have seen the patient within 30 days of the prescription. We have been doing this for over a year now and have had no complaints from any medical staff. We have patients and physicians we service in Phila and its five Counties as well as N.J.

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I submit the following comments as invited by CMS in the NCA Tracking Sheet for Mobility Assistive Equipment (CAG-00274N) on February 3, 2005. I am an occupational therapist with 12 years of experience providing care to individuals with mobility impairments in acute rehabilitation, outpatient and homecare settings, and skilled nursing facilities. I work with individuals with Medicare, Medicaid and multiple other third party payors. Many individuals are dually eligible for wheeled mobility devices through Medicare and Medicaid benefits and most payors follow CMS policy. I am very alarmed after reading the newly released NCD proposal for mobility assistance devices as clearly many individuals that I regularly work with will NO longer be eligible for mobility devices as outlined in the proposed policy.

The proposed NCD proposal fails to address the “in the home” restriction. Sustaining the current interpretation of the policy will unquestionably restrict access to individuals with functional mobility needs. The agency’s “multifaceted plan to ensure the appropriate prescription of wheelchairs to beneficiaries who need them” will undoubtedly go unrealized if the agency knowingly evades this opportunity to get a new NCD right. I urge CMS to abolish the “in the home” restriction in a new coverage policy. Failure to address this issue will dictate that I apply a standard that is inconsistent with contemporary or current standards of medical and clinical practice.

Furthermore, I urge CMS to clearly define Mobility Related Activities of Daily Living and recognize that being able to move from place to place or change one’s position in space, with or without assistance is a functional activity. Also, CMS is strongly urged to recognize Instrumental Activities of Daily Living (IADLs) as an essential component of Mobility Related Activities of Daily Living (MRADLs).

Similarly, the agency must address the mobility needs of individuals dependent on others for all mobility. These individuals have legitimate need for mobility devices and appear to have been exited out of the decision matrix resulting in blocked access to necessary and appropriate MAE.

CMS has implied that functional clinical criteria are needed yet the proposed NCD fails to: 1) require evaluation by a skilled knowledgeable clinician, 2) designate appropriate professionals qualified to perform MAE evaluations, and 3) specify documentation requirements with sufficient information to allow clinical determinations of appropriateness.

Clearly, there has been ample public response concerning the negative impact of CMS’s interpretation of “in the home” on a new NCD. I strongly urge CMS to address these important and overlooked issues when finalizing the new National Coverage Determination for Mobility Assistive Devices.

Sincerely,

Eileen Hartig OTR/LCarondelet Health Network Tucson, AZ

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I practice exclusively rehabilitation medicine and make house calls to understand and evaluate functional disabilities at the "grass roots level".

I would like policy that protects the tax payor and preserves the rights of disabled people.

Community reintegration has traditional been one of the many functional goals we work towards and goals that have been approved for funding in the general rehab care/funding system.

If a person struggles to walk around their apartment on crutches due to paraplegia, why should they not have the freedom to leave the house, go shopping, go the baseball game, visit relatives, go the doctor like anyone else. I do not think the US Government wants to discriminate against disabled people (a protected class) by saying "please stay at home".

Now, how do we do this fairly. I think for expensive items we need a medical process similar the military's system for determining the level of disability for the purpose of disability payments to the soldier: a medical-money value type of ratio.

After the reports are in on just exactly what the disability is and just exactly how the electric wheelchair is to be used, a panel should then vote on the the percentage that we taxpayers chip in and the percentage the recipent chips in.

This would eliminate a lot of the "oh, it's free let's get one", it would bring the price of the units down (I'm sorry - I think the power chairs are overpriced), and it would protect my paraplegic (with the exact same problem as FDR) from discrimination and from saying to her (she is 84) that you have to stay in your apartment and depend on others.

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My name is James C Bond RTS and I work for Alick's HME. I would like to comment on the power wheelchair changes.

First I would like to thank you for looking at this, it is long over due. I would ask that you make it very clear for dealers to know if the product will be covered. We can hound Doctors to give us more and more information so that we cover our self if you ask for more information. Give us a clear cut form that the DR. fills out and would show us a YES or NO and not a surprise down the road that we did not have enough information. We need the CMN to be more direct and detailed with the information you want. not just yes no questions but if you do a yes no question be detailed. Have a form that we can send in and have you tell us if you need more information BEFORE we send out the $5000.00 power wheelchair. I would also ask that you look at COPD and other issues like CHF. they can walk but not much and only because they have to. The strict policy on Scooters is not real. You would save allot of money in hip replacement, ER visits, medications for depression, cuts and other issues that are caused because they can walk and when the legs give out or they tire they fall. A $2000.00 scooter is cheaper that $5.50 a day over a year and less than$1.10 a day over your 5 year span. You pay for Viagra but not a scooter? Is the medical need more for that than a scooter? that cost more than $1.10 a day. Being safe and mobile is far more important than that. Look at doing preventive with power wheelchairs and POV. you don't make a customer wait till the hip is 100% out before you replace it, I get a walker when I am having issues with walking not when I cant walk at all. Why do we have to get to a point where life stops and we are looking at our 4 walls in a room before we have a CHANCE to get a power wheelchair. Then on top of that CMS tells me that I am to tell the Dr. that he may want the customer to have it but you feel that it is not a medical need. How can CMS tell a DOCTOR what is medically needed for a customer that you only know as a number?.

I understand that the system has been beat up and abused, I understand 100%. But the system has to be overhauled the right way this time and don't do to us dealers like you did on cushions and change codes, change $$, and hop skip and jump like a game that we have no rules on. You have a tuff job to do, don't try to do alone. Listen to NRRTS and other people that are in the face of the customer. Go after those adds that say FREE FREE NO COST JUST CALL. Stop the door to door salesman that is only paid if he sells that power wheelchair or scooter. WORK WITH US RTS, CRTS and other professionals that are trained in helping not selling. I do understand that you cant cover everything, but you need to look at the fact of what you pay in drugs and hip replacedments. Scooters and Power chairs will decrease that if you will let us.

And one final note. Dont cut the price so much that you force people to go over seas and buy it from them when you are paid by USA people WORKING not China.

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Thanks to CMS and to IWWG for the opportunity to provide input on this critical coverage subject. I have been providing assistive technology products and services for persons with disabilities for 15 years, both in their homes and at clinic facilities. The new criteria currently under consideration for coverage could be as devastating to this population and their caregivers as any natural disaster could ever be. Simply put, their needs are not being considered properly or realistically. We must not allow our disabled population to disappear again into the woodwork of their homes.

The 'in-home' restriction must be removed from the language of this coverage criteria; anyone who has dealt with a disability or the needs of a loved one knows that this is clearly an error in thinking - this restriction is akin to the anecdotal story of adding salt to Ivory Soap: after years of putting salt into the formula, someone finally asked why it was in there. After careful research, it was discovered that it did nothing for the formula - it only added cost. The analogy for the 'in-home' restriction is very close: it originally meant NOT IN THE HOSPITAL, but through the years it has been used to restrict access to needed equipment. This restriction is not only unnecessary; it is is counterproductive and not cost-effective.

Scenario: Patient needs a power wheelchair, to use both in the home and outside it for community activities. If he/she gets it, then this person will be relatively independent and can stay in the home. If he/she doesn't, because it is used primarily outside the home, then they most likely will lose the independent functions that they have, i.e. going to the mailbox, the grocery store just down the street, the drugstore, etc. After several months of this, the person cannot take care of themself and must move into a nursing home. How much more does this instance cost us all than the cost of a power wheelchair? Multiply this times the many, many folks who are in this situation, and we have a financial fiasco on our hands. If we cannot calculate this in human costs, then we should at least have the good sens to run the number in actual wasted or unwisely-applied dollars.

Notes: When he works AND PAYS TAXES, he employs two caregivers to assist him, WITH NO ADD'L COST to the government or other taxpayers.

Saving a total of $1,225,000 on ONE patient and providing him with resources to make a life for himself and jobs for two people: PRICELESS.

The other items that should be revisited for consideration are the links to 'mobility related activities of daily living' - this cannot be the overriding decision of a caring society, or we will put ourselves back in the days before ADA, when we warehoused our disabled population as prisoners in their own homes. Quality of life and the ability to be managed in the home setting with appropriate equipment are important considerations. Again, without equipment, there is always the more expensive option of nursing homes.

ICD-9 Codes are not appropriate for determining coverage; there are people with diagnoses and complications that do not address adequately their need for assistive technology. Conversely, there are people who have appropriate diagnoses for equipment who simply don't need it. A more appropriate means is the use of a documented evaluation of the patient's individual needs by credentialed and responsible providers.

Thanks again for the opportunity to provide comments on this very important subject; if we work together to find solutions that make sense, we will be able to provide those solutions for our clients AND prevent fraud/abuse of the government benefits that provide them.

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I am an occupational therapist at the Shepherd Center in Atlanta, GA, a catastrophic care hospital, specializing in spinal cord injuries, brain injuries (which often times coincides with spinal cord injury), and other neurological illnesses such as multiple sclerosis, post-polio syndrome, transverse myelitis and Guillain-Barré syndrome. 99% of my patients require the assistance of either a power or manual wheelchair in order to gain and maintain their independence in life, in order to be able to work and participate in society.

The proposed NCD proposal fails to address the “in the home” restriction. Sustaining the current interpretation of the policy will unquestionably restrict access to individuals with functional mobility needs. The agency’s “multifaceted plan to ensure the appropriate prescription of wheelchairs to beneficiaries who need them” will undoubtedly go unrealized if the agency knowingly evades this opportunity to get a new NCD right. I urge CMS to abolish the “in the home” restriction in a new coverage policy. Failure to address this issue will dictate that I apply a standard that is inconsistent with contemporary or current standards of medical and clinical practice.

Furthermore, I urge CMS to clearly define Mobility Related Activities of Daily Living and recognize that being able to move from place to place or change one’s position in space, with or without assistance is a functional activity. Also, CMS is strongly urged to recognize Instrumental Activities of Daily Living (IADLs) as an essential component of Mobility Related Activities of Daily Living (MRADLs).

Similarly, the agency must address the mobility needs of individuals dependent on others for all mobility. These individuals have legitimate need for mobility devices and appear to have been exited out of the decision matrix resulting in blocked access to necessary and appropriate MAE.

CMS has implied that functional clinical criteria are needed yet the proposed NCD fails to: 1) require evaluation by a skilled knowledgeable clinician, 2) designate appropriate professionals qualified to perform MAE evaluations, and 3) specify documentation requirements with sufficient information to allow clinical determinations of appropriateness. Clearly, there has been ample public response concerning the negative impact of CMS’s interpretation of “in the home” on a new NCD. I strongly urge CMS to address these important and overlooked issues when finalizing the new National Coverage Determination for Mobility Assistive Devices.

Sincerly,Ruth Ann DeFazio, OTR/L

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The current proposed guidelines for provision of mobility equipment (wheelchairs and customized seating systems)present a tremendous problem which will prove devastating if implemented.

The notion that beneficiaries who are unable to accomplish specific ADL's will not qualify for wheeled mobility is an outrage to an entire population of individuals.

This policy, if implemented, would have excluded Christopher Reeve from coverage for a wheelchair!

In my home area, local MediCAID policies have already changed in anticipation of this policy. The effects have been absolutely devastating, with clients now unable to leave the confines of their bedrooms.

It is crucial to change the wording of the policies to one which recognizes MOBILITY ITSELF as an essential activity of daily living.

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I submit the following comments as invited by CMS in the NCA Tracking Sheet for Mobility Assistive Equipment (CAG-00274N) on February 3, 2005.

My name is Michele Gunn and I work for Browning’s Health Care in Orlando, Florida. I have been helping clients with their rehab needs for thirteen years. I am an active NRRTS member and have been on the board of directors for the last three years. Our office here in Orlando does primarily high end rehab manual and powered mobility. Most of our clients have severe disabilities that do not just limit them from taking a couple of steps, but rather leaves them totally non ambulatory. We see a varied mix of different diagnoses, including S.C.I. (para and quads), C.P., C.V.A., M.D., M.S., A.L.S., and many more. There are three seating specialists here who have open or “active files” of up to fifty clients at any given time. As we pride ourselves on customer service, all clients once inactive have access to our service team, putting the number of our clients in the thousands. I would like to tell you a story about one facility where I call on clients. It is what we call a day center or work program. There are several clients there with C.P. who are independent with powered mobility. They leave their group homes and attend work at the program all day. Most of these clients are in wheelchairs that are six to seven years old and are soon to be needing replacement chairs. I am concerned that I may not be able to serve their needs if the new policy proceeds without considering the following.

The proposed NCD proposal fails to address the “in the home” restriction. Sustaining the current interpretation of the policy will unquestionably restrict access to individuals with functional mobility needs. The agency’s “multifaceted plan to ensure the appropriate prescription of wheelchairs to beneficiaries who need them” will undoubtedly go unrealized if the agency knowingly evades this opportunity to get a new NCD right. I urge CMS to abolish the “in the home” restriction in a new coverage policy. Failure to address this issue will dictate that I apply a standard that is inconsistent with contemporary or current standards of medical and clinical practice.

Furthermore, I urge CMS to clearly define Mobility Related Activities of Daily Living and recognize that being able to move from place to place or change one’s position in space, with or without assistance is a functional activity. Also, CMS is strongly urged to recognize Instrumental Activities of Daily Living (IADLs) as an essential component of Mobility Related Activities of Daily Living (MRADLs).

Similarly, the agency must address the mobility needs of individuals dependent on others for all mobility. These individuals have legitimate need for mobility devices and appear to have been exited out of the decision matrix resulting in blocked access to necessary and appropriate MAE.

CMS has implied that functional clinical criteria are needed yet the proposed NCD fails to: 1) require evaluation by a skilled knowledgeable clinician, 2) designate appropriate professionals qualified to perform MAE evaluations, and 3) specify documentation requirements with sufficient information to allow clinical determinations of appropriateness.

Clearly, there has been ample public response concerning the negative impact of CMS’s interpretation of “in the home” on a new NCD. I strongly urge CMS to address these important and overlooked issues when finalizing the new National Coverage Determination for Mobility Assistive Devices.

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I applaud the responsiveness of the IWWG to our comments, but think it is unfortunate that they are hamstrung by the CMS interpretation of the "in the home" rule. ADLs prepare people to be part of society and the ability to do them independently should not be the terminal goal. Regarding the current draft, I have a concern about Criteria # 7 that addresses upper extremity function sufficient to propel a manual wheelchair. Many people use their legs to propel a manual chair, either by "walking" forwards or pushing backwards with their legs. They need to be seated due to balance, strength or motor control problems. I fear that attention to only the upper extremities might result in a Medicare denial for a manual chair for someone who moves it with his or her legs.

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Re: Medicare’s “In the Home” Requirement for Mobility Assistive Equipment

We appreciate the opportunity to comment on the recent draft decision memorandum of the federal Interagency Wheelchair Work Group (IWWG), dated February 3, 2005. We commend the workgroup for its important work and the steps it is taking toward expanding and clarifying coverage as outlined in its Draft Decision Memorandum for Mobility Assistive Equipment (CAG-00274N), February 3, 2005.

Our major concern is that the draft, based on the IWWG’s reading of Medicare statutory coverage criteria, leaves Medicare beneficiaries who need mobility assisted equipment (MAE) confined to home. This is a significant limitation and barrier to mobility imposed through Medicare coverage. While recognizing this limitation, the IWWG takes the position that the national coverage determinations process is not the appropriate place to modify coverage criteria. It is our view that the current statutory language can be read more expansively, particularly in light of the agency’s proposed focus on a function-based determination of mobility limitations related to certain mobility-related activities of daily living.

In general, the IWWG’s proposed algorithmic process that sequentially considers mobility deficits and beneficiary needs in the prescribing of MAE is useful. It leaves the beneficiary, nonetheless, in the paradox of mobility in the home setting but not elsewhere. This, of course, ignores the reality that Medicare beneficiaries live, work, and interact in a variety of settings, including the home and the larger community. We fear that the likely application of the IWWG draft proposal will conflict with the broad public policy of promoting functional independence and community integration as envisioned by the Americans with Disability Act and the Assistive Technology Act, as well as federal proclamations and executive orders calling for broad community integration of all citizens.

We ask that you consider the following:

1. A regulatory clarification that persons who, after using your proposed sequential consideration of questions and guidance for MAE prescribing, are not penalized for using MAEs in the community and elsewhere;

2. A program guidance memorandum for DMERCs and others explaining the application of the regulatory clarification; and if necessary,

3. A congressional clarification, either in the statute or other direction to CMS to make clear that the “in the home” limitation does not applied to persons who otherwise meet the DME requirements for Mobility Assisted Devices.
It is our position that the “used in the patient’s home” requirement for durable medical equipment (DME), Section 1861(n) of the Social Security Act, 42 U.S.C. 1395x(n), should be eliminated as applied to mobility assisted equipment (MAE), including power operated vehicles used as wheelchairs.

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I am a physical therapist and have been involved in ecommending wheelchairs and other mobility devices to patients for almost 30 years. I have just finished reading most of the comments that have already been submitted regarding the criteria for provision of mobility devices. I won't reiterate everything that has been said. I do agree with the comments made by Barbara Crane which were submitted in January 2005. It sounds to me as if CMS did not fully utilize the expertise of the IWWG. The recommendations that Barbara makes are well thought out and reasonable. They would meet the needs of the Medicare recipients much more thouroughly than what is proposed in the LCD as it stands now. Of main concern to me, as with most of the other individuals that submitted comments are:
1. Doing away with the "in home" requirement in order to allow individuals to access a truly independent life, without having to depend on others for their "community" needs. Doing away with this requirement will also recognize the need for all human beings to have the ability to interact with each other through socialization.;
2) I am very concerned about how CMS is going to define "mobility related ADL's". For most of the clients that I have worked with over the years, the simple ability to turn from looking out the window to looking at the TV or to reposition themselves for pressure reduction independently is reason enough to have a power wheelchair. Human beings are designed to be mobile and restoration of this ability by any means is vital to a meaningful quality of life. Is it fair to keep young people with catastrophic injuries alive and then deny them any quality of life?;
3) As a therapist who has been involved in evaluating patients for mobility devices, I believe that more clearly defined criteria, such as those propsed by Ms Crane, would help the clinician in making recommendations that meet the guidelines. In the past, the term "functional ambulation" has been interpreted many different ways.

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I am concerned about this paragraph in the clinical criteria: A caregiver, for example a family member, may be compensatory, if consistently available in the beneficiary's home and willing and able to safely operate and transfer the beneficiary to and from the wheelchair and to transport the beneficiary using the wheelchair. This may be true if the caregiver is always there, but if the caregiver is not there all of the time you could have deadly problems. For instance, you might have a beneficiary who is unable to operate a manual wheelchair on thier own, but has a caregiver that comes to the home every day and pushes them wherever they need to go. This would work out fine until that caregiver goes home and the beneficiary has a house fire and dies because they can not get out of thier home. To avoid this happening I suggest that the paragraph be removed, or changed to: "A caregiver, may be compensatory, if they are available in the beneficiary's home 24 hours a day every day and willing and able to safely operate and transfer the beneficiary to and from the wheelchair and to transport the beneficiary using the wheelchair."

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