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Message to ________________

November 22, 2006

Subject:

Mark B. McClellan, MD, PhD
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1270-P
P.O. Box 8013, Baltimore, MD 21244-8013

RE: "Proposed Rule for Competitive Acquisition of Certain DMEPOS".
I am writing to provide my comments regarding the Proposed Rule for
Competitive Acquisition of Certain DMEPOS". I believe the proposed
changes will have negative long term effects on rehabilitative health
care for Medicare patients who are involved in a rehabilitation plan
and under the care of a occupational therapist, physical therapist or
speech therapist.

My Rehabilitation Credentials:
your experience and expertise ----------------

Key Point:
As an occupational therapist and a certified hand therapist, I urge
CMS to revise the proposed regulations and establish a process that
will enable rehabilitation therapists, i.e. occupational therapists,
physical therapists, and speech therapists to continue to furnish
orthotics, adaptive equipment for activities of daily living and home
exercise equipment. These items are critical to the care of our
patients and their ability to gain greater function enabling
independence in their home environment. This rule could significantly
impact the ability of therapists to furnish off-the shelf orthotics,
wheelchairs, ambulatory assistive devices, and other items to their
patients.
Although these products have been identified as products that require
minimal adjustment and therefore have been included in the DME bid
process, my __ years experience as a therapist suggest that choices
offered to a disabled seniors need criteria. These criteria are
generated through a thorough evaluation of the patient's physical
limitations and the goals of their therapy program.
I urge CMS to allow physicians and therapists who have authorization
to provide rehabilitation care to use all treatment procedures and
supplies, orthotics and equipment necessary to facilitate
independence in self care, ambulation, and promote safety in their
home and community.

Patient Access to Rehabilitative Supplies and Equipment:
Rehabilitation visits for the Medicare patient are generally
restricted to 6-12 visits. Within these visits, the therapist
evaluates the patient's need for orthotics, ambulatory aids, self-
care and ADL needs. A product that has been previously tested for its
effectiveness is tried with a patient in the clinic setting.
Sometimes, several over the counter orthotics need to be evaluated
due to secondary complications such as skin condition, allergies, and
peripheral neuropathies before a splint is chosen. Although there may
be only a few adjustments to make, there is a great deal of patient
education to know when to wear the splint, to identify pressure
spots, and to recognize symptoms of inflammation.
Many of these rehabilitative products and aids are needed at the time
of the initial evaluation. For example, a splint to support the wrist
fracture or a cane/walker to begin ambulation. These devices are made
available to the patient in the therapy setting to be taken home and
used. No devices are issued without a clinical evaluation by the
therapist and patient to determine efficacy for their specific
diagnosis and rehabilitation plan. DME providers would not be able to
determine which of many different products would benefit a specific
patient.
In addition, mandating that these over the counter devices be
provided outside of their rehabilitation provider will cause delays
in their rehabilitation progress. Having to go elsewhere is
burdensome to the patient and family member who must transport the
patient somewhere else for the device. If the device does not meet
the specifications that the physician and therapist feel are required
of the over the counter product, such as a splint, much time has been
wasted.
The idea of sending a away from the supervised rehabilitation
provider to a DME provider without medical credentials to evaluate
the need of a specific product will reduced the effectiveness of the
patient's rehabilitation plan.

Therapists Routinely Make Adjustments to Orthotics:
Splints that are currently being proposed in the regulation are
described as items that require "minimal self-adjustment." They
define items requiring more than minimum self-adjustment as
adjustments to items (e.g. bending, trimming, molding, or assembling)
that must be made by a certified orthotist.
Occupational and Physical Therapists perform adjustments to both pre-
fabricated splints and custom made splints as a routine part of their
practice. Occupational therapists and Certified Hand Therapists are
trained in splinting in college and many states offer certification
of occupational therapists as the clinician who evaluates and
provides patients with orthotics.
The patient's response to a pre-fabricated splint, one size that does
not fit all, may require inserts and management of the effects on
skin. In addition, the Medicare population and their families need
frequent and repetitive education to use the splints appropriately
and to be able to recognize warning signs of misuse.

The Importance of Specific Brands:
Therapists and physicians collaborate to assess the patients and
specify certain products that address the individual needs of
patients. As an experienced occupational therapist, I urge CMS to
revise the regulations to recognize the need for occupational
therapists and physical therapists to be able to specify brands to
prevent adverse medical outcomes. There is a difference in splints,
self-care and ADL equipment, ambulatory equipment, and exercise
equipment. The lease expensive could constitute an "adverse medical
outcome".

Summary:
I am proud to identify myself as an occupational therapist and a
certified hand therapist. I promote the practice of occupational
therapy that means the therapeutic use of purposeful and meaningful
goal-directed activities which engage the individual's body and mind
in meaningful, organized, and self-directed actions that maximize
independence, prevent or minimize disability, and maintain health. I
know how necessary it is to my Medicare's patient's successful
rehabilitation that their treating therapist be able to evaluate and
provide prefabricated splints, custom made splints, home exercise
items, ambulatory and sleeping aids, and activity of daily living
products. To limit and obstruct the rehabilitation process will
diminish the efficient use of therapy visits and be burdensome to our
patients with limited mobility and function.

I again request CMS to revise the proposed regulations and establish
a process that will enable occupational and physical therapists or
certified hand therapists to continue to furnish orthotics, self-care
and activity of daily living products, and home exercise equipment
that are critical to the care of our Medicare patients.
Thank you for your attention.

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