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					      UNITED STATES DEPARTMENT OF
                 HEALTH AND HUMAN SERVICES

                   SOCIAL SECURITY ADMINISTRATION
                   OFFICE OF HEARINGS AND APPEALS


In the Matter of Kimberly D.
SSN 004-20-8920C2
On Appeal from the Denial of
Medicare Part B Benefits              D. Lieb, A.L.J.

              APPELLANT'S MEMORANDUM OF LAW
         IN SUPPORT OF MEDICARE REIMBURSEMENT FOR
          AN AUGMENTATIVE COMMUNICATION DEVICE

      May 12, 2000

                               Respectfully submitted

                                         by

                               Lewis Golinker, Esq.
                        Suite 507, 202 East State Street
                             Ithaca, New York 14850
                     voice: 607-277-7286; fax 607-277-5239
                                 Attorney for Ms. D.
              REQUEST FOR FAVORABLE DECISION ON THE RECORD
       Ms. Kimberly Damon, a Medicare beneficiary, presents this Memorandum of Law to

support her request for a favorable decision on the record. However, if the Administrative

Law Judge is unable to grant this relief on the basis of the information thus far presented, Ms.

Damon will appear at the in-person hearing, to supplement the record with live testimony and

additional argument. That hearing is scheduled for May 23, 2000 at 1 p.m.




                                                2
       Preliminary Statement
       Kimberly Damon is 42 years old and resides in South Portland, Maine. She has cerebral

palsy, which causes quadriplegia and severe dysarthria, a motor speech impairment. Both of

these conditions are commonly associated with cerebral palsy.

       As a result of her quadriplegia, Ms. Damon is unable to use her hands to write.

       As a result of her severe dysarthria, her ability to speak, as reported by Mark Hammond,

her speech-language pathologist, is limited to a few utterances that are unintelligible even to

familiar listeners. For this reason, she uses an “augmentative communication device,” (also

known as AAC device or ACD), called a LightWriter.

       With the LightWriter, Ms. D. is able to lead a normal adult life. As her uncle explained

in a letter supporting Medicare reimbursement:
         [Her communication is enhanced to such a degree with her LightWriter that she
         can with relative ease and with increased efficiency converse with anyone she
         wishes. She can engage friends, relatives, strangers, associates and officials in
         concise, understandable conversation. She can ask questions, get directions or
         tell me over the telephone what is going on in her life while inquiring how my
         family is doing. She is able to communicate verbally as she should be able to, . .
         . , as she has not been able to before the acquisition of the LightWriter too. In
         short, she is freed from her non-verbal imprisonment.


Letter dated June 23, 1999 to Medicare Hearing Officer, from Dennis D., attached as Exhibit 1.

       The LightWriter is not Ms. D.‟s first AAC device, nor is this her first request for

Medicare reimbursement for an AAC device. From 1984 to 1996, she used another AAC

device, known as the VOIS 140. In September 1986, Medicare provided reimbursement for this

AAC device. However, after approximately a decade of continual use, the VOIS 140 ceased to

function. Ms. D. purchased the LightWriter after she learned the VOIS 140 was no longer being

manufactured or serviced.

       Augmentative communication devices are a long-recognized form of speech-language

pathology treatment for severe expressive communication disabilities, including dysarthria, and

AAC devices have a long history of use by individuals with cerebral palsy. The appropriateness
of AAC devices in the treatment of severe dysarthria has recently been confirmed by the



                                                3
American Medical Association, American Academy of Neurology, American Academy of

Physical Medicine and Rehabilitation, the American Speech-Language-Hearing Association, and

the United Cerebral Palsy Research and Education Foundation.

       Augmentative communication devices are covered by Medicare as durable medical

equipment and as prosthetic devices, and are covered by every other health-based funding or

benefits program, including Medicaid, commercial health insurance, CHAMPUS and the

Department of Veterans Affairs. As noted above, Medicare already has provided

reimbursement for one AAC device for Ms. D., in 1986. Medicare has provided reimbursement
for AAC devices since March 31, 1981, and every ALJ who has considered Medicare

reimbursement for AAC devices has approved the request. Among those favorable decisions is

an approval for a LightWriter, the same AAC device Ms. D. uses.

       Medicare Coverage Issues Manual § 60-9 is the reason that ALJ hearings are necessary

for AAC devices to be reimbursed by Medicare. C.I.M. § 60-9, which is binding on the

DMERC Region A, states that AAC devices are “convenience items” and directs reimbursement

to be denied. However, that guidance is not binding on administrative law judges:

operationally, Medicare ALJs are the first Medicare decision makers permitted to review AAC

device claims on their merits. And, as noted above, upon review of the merits, no ALJ ever has

denied an AAC device reimbursement request.

       No Medicare ALJ has ever applied this guidance because the Health Care Finance

Administration admits it has no known basis, and it is overwhelmingly contradicted by

professional medical literature, policy and practice, and by three decades of policy and practice

by other funding and benefits programs. On April 26, 2000, the Health Care Financing

Administration officially recognized the inappropriateness of this statement about AAC devices

and withdrew the “convenience item” guidance. HCFA now concludes that AAC devices meet

the Medicare definition of durable medical equipment.
       In sum, Ms. D. seeks Medicare reimbursement for the LightWriter, an AAC device that is

an essential link to the world. As she stated in her appeal letters from the repeated adverse


                                                4
DMERC decisions, the LightWriter “allows me to have a voice, be interactive with people and to

be as independent as I possibly can despite my severe disability.”      The functional

communication independence Ms. D. achieves with the LightWriter is recognized by Medicare

as a level of communication functioning that will be supported by Medicare under its

speech-language pathology benefit.

          There are no facts in dispute regarding her ability to use or benefit from the LightWriter:

with it, she can engage in normal, conversational communication as can any adult living in the

community. The LightWriter allows Ms. D. to meet all of the communication needs that arise in
her daily activities. By contrast, without it, she has no effective means of expressive

communication.

          Thus, with no facts in dispute, and no legal barriers to the issuance of a favorable

decision, Ms. D. requests that her reimbursement request for the LightWriter be approved on the

record.

                                     STATEMENT OF FACTS

          A.     Personal Facts
          Kimberly D. is an adult with cerebral palsy. This neuro-motor condition has caused two

associated severe impairments: quadriplegia and dysarthria, which combine to make it

impossible to obtain personal information directly. Due to severe dysarthria, Ms. D. is not able

to provide information verbally, and, due to her quadriplegia, she cannot use her hands to write.

However, because she has an augmentative communication device, i.e., the LightWriter, she is

able to respond to her attorney‟s questions and supply information necessary to complete this

Memorandum of Law. Thus, preparing this section of this memorandum of law is a paradigm

of the issues presented in this hearing: Ms. D. is an intelligent adult who is capable of providing

these facts as well as engaging in all other aspects of preparation for her appeal hearing, provided

that she has access to her AAC device.
          Ms. D. is 42 years old. She resides with her mother and an uncle in a private residence

located in South Portland, Maine.


                                                   5
       As noted above, Ms. D. has two very severe physical impairments associated with

cerebral palsy: quadriplegia and dysarthria. Quadriplegia affects Ms. D.‟s mobility as well as

use of her hands; dysarthria is a motor speech disorder which affects the intelligibility of her

speech.1

       However, Ms. D. has made every effort to keep either of these impairments from being

disabling. As reported by her uncle in a letter to the Carrier Hearing Officer:
        I have watched with amazement her growth and development. I have marveled
        at her tenacity and determination. She has constantly worked against odds to do
        the things that you and I take for granted. The barriers she faces daily in her
        struggle to be mobile and to communicate would discourage most people I know
        and would cause them to quit. Not Kim. She takes those everyday
        inconveniences in stride and moves forward.

Exhibit 1.


       To overcome the functional limitations imposed by her quadriplegia, Ms. D. uses a power

wheelchair for mobility, which she controls through the use of a helmet mounted pointer. She

uses this pointing device to operate her LightWriter as well. Her reliance on this head-pointer

led her to use Ms.Unicorn@prodigy.net as a former e-mail name.

       Ms. D. receives personal care attendant services for 5 hours per day to assist with

feeding, dressing, bathing, toileting, cleaning, bill-paying and errands. For more than a decade,

1
       Ms. D. experiences the most common functional losses associated with cerebral palsy:
impairments of mobility and of speech.

        The most common disabilities affecting the quality of life of persons with cerebral
        palsy are impaired mobility and difficulty with verbal communication (i.e.,:
        speech). Of these two, people in the disability community consistently rate poor
        ability with verbal communication as the more serious of the two. Not being able
        to communicate usually has disastrous effects in the home, the school, the
        workplace and the community. Also, it is of great importance in interacting with
        health care providers dealing with the many clinical issues relevant to disability. .
        ..
Letter dated February 24, 2000 to Hugh Hill, M.D., Acting Director, Coverage and Analysis
Group, Health Care Financing Administration, from Murray Goldstein, DO, MPH, Medical
Director and COO, United Cerebral Palsy Research and Educational Foundation, attached as
Exhibit 2.




                                                 6
Ms. D. has been responsible for interviewing and hiring these attendants. She also totally

independent in directing them in the performance of these tasks with the use of her AAC device

-- first the VOIS 140, and now the LightWriter.2

       Without an AAC device, Ms. D. would not be able to do accomplish these tasks. Her

attendant stated this directly. In a letter to the DMERC hearing officer, her attendant wrote:

“Since she purchased the LightWriter, my job has been much easier. I am no longer having to

try to understand Kim when she needs me to do something for her.”3

       Ms. D.‟s AAC device does more than just enable her to meet her personal care needs.
Her uncle reported:
       [H]er communication is enhanced to such a degree with her LightWriter that she
       can with relative ease and with increased efficiency converse with anyone she
       wishes. She can engage friends, relatives, strangers, associates and officials in
       concise, understandable conversation. She can ask questions, get directions, or
       tell me over the telephone what is going on in her life while inquiring how my
       family is doing. She is able to communicate verbally as she should be able to, ...
       as she has not been able to before the acquisition of the LightWriter tool. In
       short, she is freed from her non-verbal imprisonment.

Exhibit 1.


       Because she has access to the LightWriter, Ms. D. can self report about its importance to

her. She stated to the Carrier Hearing Officer:
      I have used my LightWriter constantly since purchasing it a year ago. It amazes
      me when I do something new with the LightWriter that I haven‟t been able to do.
      A couple of examples of things I have been able to do using the [AAC] device
      are: 1) while talking with a friend, I yelled “I need help” when she had an
      [epileptic] seizure in front of me. Someone came running! 2) A few months
      ago, I stopped a stranger and asked for directions as anyone else would have done
      with a voice. That instant, I thought, “Why is Medicare not able to see the




2
       See Letter dated August 6, 1998 to Region A DMERC from Deborah Cerullo, OTR/L,
Independent Living Specialist, Alpha One, attached as Exhibit 3.
3
       Letter dated May 31, 1999 to Medicare Hearings Department, from LeeRay Peterson,
attached as Exhibit 4.




                                                7
       LightWriter for what it really is? The LightWriter is my artificial voice, ... which
       I desperately need.4


       Ms. D.‟s successful use of the LightWriter also allows her to express her thoughts and

personality for the purposes of self-advocacy. This is an important role for AAC device users,

particularly because they are likely to participate in and must negotiate multiple services systems

in addition to those adults without disabilities will encounter.5   Ms. D.‟s skill in this role has

enabled her to impress a wide circle of others of the importance of her AAC device. One such

observer: Congressman Tom Allen. He wrote to the Carrier Hearing Officer:

       Ms. D. has cerebral palsy. She is wheelchair bound and unable to speak. Her

       only controlled motion is in her head and neck. Through a determined spirit and

       a wheelchair that she controls with a pointer attached to her head, she is able to

       navigate in the world. But it is no good to go out in the world, if you cannot

       communicate with your fellow human beings. Her LightWriter allows her to

       speak. In appealing her denial, Medicare gave her three choices: in person

       hearing, telephone hearing, or on the record hearing. Without a LightWriter, she

       would be able to have only an on the record hearing.6

       As Congressman Allen and these others have acknowledged, with the power wheelchair,

the LightWriter, and her head-pointer, Ms. D. is able to be an active adult, traveling throughout

the local community by accessible public transportation. Because she has independent mobility

as well as the ability to communicate, she is able to shop, go to restaurants, meet with friends,


4
       Letter dated October 25, 1999 to Medicare Fair Hearing, from Kimberly D., attached as
Exhibit 5.
5
     See D. Bryen, G. Slesaransky, & D. Brown, “Augmentative Communication and
Empowerment Supports: A Look at Outcomes,” 11 AAC 79 (1995).
6
        Letter dated June 16, 1999 to Medicare, Hearings Department, from the Hon. Tom Allen,
Member of Congress, attached as Exhibit 6. See also, Letter dated May 26, 1999 to Medicare
Hearings Dept. from L. Marie Guimont, attached as Exhibit 7 (a local bank employee describing
her interactions with Ms. D. both with and without the LightWriter).




                                                  8
participate in community activities and take advantage of the many opportunities that exist in any

community, and which individuals without disabilities take for granted. In 1990, Ms. D. was

the recipient of a state “independent living” award based on her ability to maintain her

independence, despite her impairments.

       In addition, Ms. D. also has the ability to be a far more equal member of her household.

Just as Ms. D. reported she was able to summon help for a friend in need, her attendant described

an important element of her family role is to be able to respond if her mother or uncle became ill.

She wrote:
      [And] another thing, if there ever was a reason for Kim or her mother needed
      emergency medical attention Kim would be able to tell them what she needed.
      Where as before she got the LightWriter it would have been almost impossible.

Exhibit 4.


Unfortunately, that circumstance arose just in the past few days. At the end of the first week of

May, Ms. D.‟s mother experienced chest pains that required emergency hospitalization. This

presented two challenges for Ms. D.. As she reported: “with my [LightWriter], I called my

attendant and was able to arrange coverage for the care my mother usually does when the

attendant isn‟t there.”7 In addition, Ms. D. was able to use her LightWriter to stay in contact

with her mother, by telephone, as well as alert other family members and friends of her

condition.8    Thus, Ms. D.‟s cerebral palsy imposes functional impairments that require her to

use adaptive devices for both mobility and speech. But with these devices, she is able to lead an

active, full life, as an adult in her family and in her community.

       B.      AAC Evaluation, Medicare Claim and Appeals




7
       E-mail message [1] dated May 6, 2000 to Lewis Golinker from Kimberly D., attached as
Exhibit 8.
8
       E-mail message [2] dated May 6, 2000 to Lewis Golinker from Kimberly D., attached as
Exhibit 9.




                                                 9
       Ms. D. acquired the LightWriter following an evaluation on January 20, 1998 by Mark

Hammond, M.S., C.C.C.-S.L.P., a speech-language pathologist located in Portland, Maine. Mr.

Hammond is an SLP experienced with the evaluation of the speech-language pathology

treatment needs of individuals with severe communication disorders, including the

recommendation of and services delivery for augmentative communication. His experience

includes having worked with Ms. D.‟s attorney in 1991-92 to convince the Maine Medicaid

program to cover and provide AAC devices.9

       Mr. Hammond‟s report is attached as Exhibit 11. It notes that Ms. D. has severe
dysarthria, the most common speech disability associated with cerebral palsy.10 Dysarthria is

caused by weakness, incoordination and/or paralysis of the nerves, muscles and other body

organs and structures used in speaking.11 It can range from mild speech production problems,

where only a few sounds may be slurred or indistinct (unintelligible), to a complete inability to

speak intelligibly or even make guttural sounds.12

       Ms. D.‟s dysarthria is at the more severe end of this range. Her speech has been

described by Mark Hammond, her speech-language pathologist as “limited to a few utterances

which are unintelligible to familiar listeners. Functional speech output is not available at this

time.” Exhibit 11, at page 1.

9
        See L. Golinker, “Freedom of Speech,” 4 Team Rehab Report 24 (1993)(attached as
Exhibit 10)(Describing efforts to persuade Maine Medicaid to cover and provide AAC devices;
the individuals presented as typical individuals who will need AAC devices were two adults with
cerebral palsy.)
10
      Research estimates that dysarthria arises in 31-88 %of individuals with cerebral palsy.
K. Yorkston, D. Beukelman & K. Bell, Clinical Management of Dysarthric Speakers (San Diego,
CA: College-Hill Press 1988).
11
       Darley, Aronson & Brown, Motor Speech Disorders (1975); see also Darley, Aronson &
Brown, "Differential Diagnostic Patterns of Dysarthria," 12 J.Speech and Hearing Research
246-269 (1969); Darley, Aronson & Brown, "Cluster of Deviant Speech Dimensions in the
Dysarthrias," 12 J.Speech and Hearing Research 462-496 (1969).
12
       Darley, Aronson & Brown, Motor Speech Disorders 2 (1975).




                                                10
        However, dysarthria does not compromise receptive communication abilities (the ability

to understand what is spoken or written).13 Ms. D. was described by Mr. Hammond as

“functioning at an adult level in her receptive language.” Id. In addition, Ms. D. has no

cognitive limitations. She has completed two and one half years of college. Mr. Hammond

also reported that she “presents as an individual functioning within normal limits for an adult

her age,” that her expressive language capability is“syntactically and grammatically correct,” and

there are “[n]o concerns regarding her expressive language capability.” Id.

        Mr. Hammond‟s report recommends use of an augmentative communication device as
treatment for Ms. D.‟s dysarthria. His report concludes:
       Kimberly D. is a woman who is in need of an extensive vocabulary and the ability
       to formulate novel messages. Therefore, the most appropriate devices to
       accomplish this purpose would be those devices that would allow text-to-speech
       output. Those devices allow the user to type in the messages and have them
       spoken. She would also benefit from a device which would allow her to
       preprogram many of the words that she wishes to say in order to accelerate her
       speech. The device should allow direct selection with her head stick and provide
       a female voice quality.

Id. at page 2.


        Mr. Hammond then identified a group of AAC devices that may meet Ms. D.‟s

communication needs. Of the four devices that were identified as equally effective alternatives,

the LightWriter is between $ 2000 to 3000 less expensive, and on July 6, 1998, the LightWriter

was prescribed for Ms. D.‟s use by her treating physician, David Scotton, M.D. Attached as

Exhibit 12.

        Ms. D. then purchased the LightWriter and submitted a Medicare reimbursement claim to

the DMERC, Region A on December 11, 1998. On December 17, 1998, six days later, the

claim was denied. It was followed by two reconsideration denials, issued on March 31, 1999

and April 26, 1999. Both are form letters which explain their rationale in full as follows: “This

is not covered. It‟s not a medical or durable item based on our rules.” Attached as Exhibit 13
13
        Id.




                                               11
and 14. These decisions were followed by a Carrier Hearing decision, issued September 23,

1999. In this decision, the denial offered the following rationale:
      Region A DMERC Supplier Manual, Section 12-43 and Coverage Issues Manual,
      § 60-9 specifically state that an Augmentative Communication Device or
      Communicator is a non-covered item. Both the Coverage Issues Manual and the
      DMERC Supplier Manual state the item is a convenience item and not primarily
      medical in nature.

Attached as Exhibit 15.   This decision was followed by a request for an ALJ hearing.

                                         ARGUMENT

                                                I

                  The Ability to Communicate is Vital: Speech-Language
                 Pathology Treatment Makes Communication Possible for
                 Persons with Severe Expressive Communication Disorders


       As Dr. Goldstein of the UCP Research and Educational Foundation noted, impaired

communication ability is generally recognized as among the most significant functional losses

associated with cerebral palsy.   This conclusion is not unique. In Fred C. v. Texas Health &

Human Serv. Comm’n, the district court observed that the loss of the ability to speak is the most

devastating aspect of any disability. The Court was reviewing the case of an adult who lost his

ability to speak following an accident, and its judgment was to order Texas Medicaid to provide

funding for an augmentative communication device.14R. Sienkiewicz-Mercer & S. Kaplan, I

Raise My Eyes to Say Yes (1989).


14
       988 F.Supp. 1032, 1034 (W.D.Tex. 1997), affirmed per curiam, 167 F.3d 537 (5th Cir.
1998)(Table)(Fred C.-II); Fred C. v. Texas Health & Human Services Commission, 924 F.Supp.
788, 789 (W.D.Tex. 1996), vacated and remanded on other grds, 117 F.3d 1416 (5th Cir.
1997)(Table)(Fred C.-I). See also E. Saideman, "Helping the Mute to Speak," 17 N.Y.U. J. Law
& Social Change 741 (1989/1990).

       The Court‟s observation about the impact of the loss of speech is based on statements by
Ruth Sienkiewicz-Mercer. Ms. Sienkiewicz-Mercer is an adult with cerebral palsy and severe
dysarthria, who was one of the first individuals provided access to an electronic AAC device.
That device was made available to her in 1971. Ms. Sienkiewicz-Mercer stated:




                                               12
       In addition, in both Fred C. and Hunter v. Chiles,15 the district courts added that the

ability to communicate is "vital,"16 based on the half-century long, generally accepted

recognition by speech-language pathologists, neuro-science researchers, and the public at large,

that the ability to speak and to use language for communication is the physical functional ability

that most clearly distinguishes human beings from all other species.17

       Other individuals who have been provided access to AAC devices describe their ability to

communicate as a way to retain their human-ness. Rich Creech, an adult with cerebral palsy,

has stated:
        [When a person who is unable to communicate is among other people] people
        [will be] talking behind, beside, around, over, under, through, and even for you.
        But never with you. You are ignored until you feel like a piece of furniture.




       Without a doubt, my inability to speak has been the single most devastating aspect
       of my handicap. If I were granted one wish and one wish only, I would not
       hesitate for an instant to request that be able to talk, if only for one day, or even
       one hour.


15
       944 F.Supp. 920 (S.D.Fl. 1996), the district court directed Florida Medicaid to cover and
provide augmentative communication devices to both children and adults.
16
       Fred C.-II, 988 F.Supp. at 1036; Hunter v. Chiles, 944 F.Supp. at 920; Fred C.-I, 924
F.Supp. at 792.
17
        Judicial notice can be taken of this fact, which has achieved cliche' status. Fed.R.Evid.
Rule 201, 803(18). The American Speech-Language-Hearing Association (ASHA) and the
United States Society for Augmentative and Alternative Communication (USSAAC) have both
asserted, as a matter of organizational policy, that "communication is the essence of human life."
ASHA, "Report: Augmentative & Alternative Communication," 33 Asha 9 (Suppl. 5) (1991);
USSAAC, By-laws, Article II, § 1. However it is phrased, this fact is generally accepted by
the scientific community, among the judiciary, and among the public at large. See Fred C.-II,
988 F.Supp. at 1034; Hunter v. Chiles 944 F.Supp. at 920; Fred C.-I., 924 F.Supp. at 789; see
also J.Light, "'Communication is the Essence of Human Life;' Reflections on Communicative
Competence," 13 AAC 61-70 (1997); D. Bickerton, Language and Human Behavior (1995);
S.Pinker, The Language Instinct (1994); M. Batshaw & Y. Perrett, Children with Handicaps: A
Medical Primer (2d Ed 1986); M. Fisher, Ed., Illustrated Medical & Health Encyclopedia (1956);
J. Wilford, "Ancestral Humans Could Speak, Anthropologists' Finding Suggests," N.Y. Times,
April 28, 1998, at A:1.




                                               13
C. Musselwhite & K. St. Louis, Communication Programming for Persons with Severe

Handicaps (2d. Ed. 1988).

        Jean Daemonic-Bauby, the former editor of the fashion magazine Elle, who lost his

ability to speak and developed locked-in-syndrome following a severe stroke, wrote with the aid

of a crude eye-gaze device:
        “On June 8, it will be six months since my new life began.” . . . Those were the
        first words of the first mailing of my monthly letter . . . [T]hat first bulletin caused
        a mild stir and repaired some of the damage caused by rumor. . . . The gossipers
        [in Paris had] left no doubt that henceforth I belonged on a vegetable stall and not
        to the human race. . . . [In response] I would have to rely on myself if I wanted to
        prove that my IQ was still higher than a turnip‟s.

J. Bauby, The Diving Bell and the Butterfly (1997).


        Beukelman and Mirenda, authors of the most well regarded treatise on augmentative

communication, wrote: “clearly, someone who has not „been there‟ cannot understand the

experience of having a severe communication disorder.” D. Beukelman & P. Mirenda,

Augmentative and Alternative Communication (2d. Ed. 1998). An earlier article explained why

this statement is true:
         For the normal adult who has spoken without difficulty since early childhood, the
         prospect of being unable to communicate through natural speech is
         incomprehensible. Efficient communication with colleagues, family, and friends
         is taken for granted.


D. Beukelman & K. Garrett, “Augmentative and Alternative Communication for Adults with

Acquired Severe Communication Disorders,” 4 AAC 104 (1988).

        If the fundamental importance of the ability to communicate effectively is not

self-evident, the life-threatening circumstances18 and outrageous injury19Affidavit of Judith

18
       See e.g. D. Wedemeyer, "His Life Is His Mind," N.Y. Times Magazine, at 22-25 (Aug.
18, 1996)(describing the question posed to Dr. James Hall, a renowned psychiatrist, who
experienced "locked in syndrome" following a severe stroke. Initially, Dr. Hall was only able to
communicate by blinking his eyes. Shortly after his stroke, he was asked whether, due to his
condition, he wanted medical treatment to continue. The question, however was asked
incorrectly: one blink for "yes," two for "no." An involuntary twitch, causing a second blink,
almost cost Dr. Hall his life. The questioner recognized his error and asked the question again,



                                                 14
Frumkin, Feb. 11, 1995, ¶ 80, submitted in Myers v. State of Mississippi, No. 3:94-CIV-185 LN

(S.D.Miss. June 23, 1995). experienced by people who lacked the ability to speak, and the

perceptions by others that they are non-sentient20Ms. Tavalaro, a New York City Medicaid

recipient who now uses an augmentative communication device, has become an accomplished

poet and published author. See In re: Julia Tavalaro, FH # 099304J (NYS Dept. of Social

Services May 7, 1987)(awarding augmentative communication device); D. Martin, "When

Paralysis is no Match for P-O-E-T-R-Y," N.Y. Times March 16, 1991); J. Tavalaro, Look Up for

Yes at 123 (1997)(memoir, written with augmentative communication device, describing
post-stroke experiences). or even non-human,21In re: Anonymous, Case No. 851-0-107314 Slip

Op. at 10 (Ohio Dept. of Human Services, Dec. 7, 1988). clearly demonstrate its value.


reversing the meaning of the responses. Dr. Hall, who now uses an augmentative
communication device, has returned to the practice of medicine.
19
        For example, the mother of a young adult Medicaid recipient in New York State reported
the preventable tragedy that befell her son:

       Andrew has a burn scar on his hand which occurred because he couldn‟t tell his
       attendants at school that they had pushed him up against a radiator and locked his
       wheels in a position where his hand was trapped to sear until the flesh melted off.


20
         Consider the example of Julia Tavalaro. In 1966, she suffered a severe stroke, and was
considered brain dead. For the next seven years she remained in the back ward of a public
institution where she had no input related to any aspect of her life. When she finally was seen
by a speech-language pathologist knowledgeable about augmentative communication
intervention and who treated her as an intelligent person able to communicate, she later wrote:

       I raise my eyes for yes, hardly able to believe that someone is asking permission
       before she does something to me.


21
       For example, an Ohio Medicaid recipient's treating doctor described in these shocking
terms his difficulties obtaining information from his patient:

       Current inability to communicate has greatly limited his access to medical care
       and indeed has reduced it to approximately veterinary proportions.




                                              15
       Ms. D., thankfully, has not experienced the harm that is all too common among

individuals with cerebral palsy and severe dysarthria. However, the pragmatic, day-to-day

impact of her communication impairment -- which would preclude Ms. D. from controlling any

aspect of her life -- are completely unnecessary.    Despite its severity, speech-language

pathology treatment, in the form of augmentative communication interventions, is readily

available to treat Ms. D.‟s dysarthria.

       Speech-language pathologists (SLPs) are health care professionals educated and trained

to evaluate, diagnose, treat and prevent speech, language and swallowing disabilities in children
and adults. Speech-language pathology treatment focuses on preventing the worsening of a

disorder or alleviating the adverse functional effects of a condition, rather than correcting the

root cause, such as ALS, cerebral palsy, traumatic brain injury, or stroke.22 [add reference to ALJ

decision]

       An issue of general concern in speech-language pathology is speech intelligibility.

Speech intelligibility can be defined simply as the ability of a listener to extract meaningful

information from speech, which allows for information transfer and exchange.23 It is the key to

communicative competence (effectiveness), and improvement in intelligibility is the primary

objective of most speech-language management.24

       For persons with dysarthria, speech intelligibility is progressively more impaired as the

condition increases in severity. Speech-language pathology treatment, however, can

substantially alleviate or ameliorate these effects, and the effectiveness and efficiency of

22
     ASHA, "Preferred Practice Patterns for the Professions of Speech-Language Pathology,"
ASHA Desk Reference (1997).
23
      R. Kent, "Speech Intelligibility," in D.Yoder and R. Kent, Decision Making in
Speech-Language Pathology, 39-40 (1988); K. Yorkston and D. Beukelman, "A Comparison of
Techniques for Measuring Intelligibility of Dysarthric Speakers," 11 J.Communication
Disorders 499 (1978).
24
        Beliveau, Hodge & Hagler, "Effects of Supplemental Linguistic Cues on the
Intelligibility of Severely Dysarthric Speakers," 11 AAC 197 (1995).




                                                16
communication in all speaking situations can be increased. The goal of such treatment is to

overcome or ameliorate the communication limitations that preclude or interfere with the

person's meaningful participation in daily activities.25 The appropriateness of this goal was

recently confirmed by the American Medical Association, American Academy of Neurology,

American Academy of Physical Medicine and Rehabilitation, and the American

Speech-Language-Hearing Association. The AMA stated:
      The AMA agrees with the American Academy of Neurology that these devices
      are medically necessary for severely speech-impaired patients to meet the
      communication needs arising in the course of their daily activities.26


       The scope of Medicare coverage of speech-language pathology treatment is consistent

with these general principles. Medicare guidelines state that coverage requires the

speech-language pathologist to identify "functional goals" that state the "level of communicative

independence the patient is expected to achieve outside the therapeutic environment."27
       The functional goals reflect the final level the patient is expected to achieve, are
       realistic, and have a positive effect on the quality of the patient's everyday
       functions.28


25
       D. Beukelman and P. Mirenda, Augmentative and Alternative Communication 104
(1992). Meaningful participation means effective and efficient communication of messages in
any form the person chooses. National Joint Committee for the Communicative Needs of
Persons with Severe Disabilities, "Guidelines for Meeting the Communication Needs of Persons
with Severe Disabilities," 34 Asha (Supp. 7) at 2-3 (1992).
26
        Letter dated March 21, 2000 to Hugh Hill, M.D., Health Care Financing Administration,
from E.Ratcliffe Anderson, M.D., American Medical Association; see also, Letter dated March
22, 2000, to Hugh Hill, M.D., from Francis Kittredge, Jr. M.D., American Academy of
Neurology; Letter dated March 23, 2000 to Hugh Hill, M.D., from Ronald Henrichs, American
Academy of Physical Medicine and Rehabilitation; Letter dated March 20, 2000 to Hugh Hill,
M.D., from Jeri Logemann, Ph.D., American Speech-Language-Hearing Association. These
letters were submitted to HCFA in support of the Formal Request for National Coverage
Decision for Augmentative and Alternative Communication Devices, and are attached as Exhibits
16, 17, 18, and 19.
27
      Medicare Hospital Manual, § 446(A)(3)(a). An identical provision is found in the
Medicare Intermediary Manual, HCFA Publ. 13, § 3905.3(A). attached as Exhibit 20.
28
       Id.




                                                17
The guidance provides four examples of communication goals designed to achieve "optimum

communication independence:"

       -- communicate basic physical needs and emotional status;

       -- communicate self-care needs;

       -- engage in social communicative interaction with immediate family or friends;

       -- carry out communicative interactions in the community.29

The discussion of functional goals concludes with the following explanation:
       A functional goal may reflect a small, but meaningful change which enables the
       patient to functional more independently in a reasonable amount of time. For
       some patients, it may be the ability to give a consistent "yes" or "no" response; for
       others, it may be the ability to demonstrate a competency in naming objects
       using auditory/verbal cues. Others may receptively and expressively use a basic
       spoken vocabulary and/or short phrases; and still others may regain
       conversational language skills.30


       Mr. Hammond recognized that the LightWriter will provide Ms. D. with the ability to

meet the highest level of communication functioning stated in the Medicare SLP services

guidance: carrying out communicative interactions in the community and engaging in

conversational communication. Ms. D.‟s actual use of this device for almost two years while

this reimbursement request has been pending confirms the appropriateness of this prediction. In

addition, in contrast to the “small change” in communication functioning permitted in the

Medicare SLP services guidelines, use of the LightWriter, as compared to the use of natural

speech, or to the letter-board she used between the date the VOIS 140 ceased to function and the

date the LightWriter was delivered, provides Ms. D. with an enormous increase in speech

production and intelligibility.

       Augmentative communication interventions, including devices such as the LightWriter

have been developed over the past 40 years to treat severe expressive communication disabilities


29
       Id.
30
       Id.




                                               18
and to prevent the adverse effects associated with an inability to speak or otherwise expressively

communicate.31 The American Speech-Language-Hearing Association defines augmentative

communication intervention as an area of clinical, research and educational practice that attempts

to compensate, either temporarily or permanently, for the impairment and disability patterns of

individuals with severe expressive communication and/or language comprehension disabilities.32

In Myers v. State of Mississippi, the district court correctly defined augmentative communication

devices as:
       electronic and non-electronic devices that allow individuals to overcome, to the
       maximum extent possible, communication limitations that interfere with their
       daily activities.33


          For almost two decades, augmentative communication intervention has been recognized

by ASHA as a type of speech-language pathology treatment methodology and that it is within the

scope of practice of speech-language pathologists.34 Augmentative communication has long




31
        Zangari, Lloyd & Vicker, "Augmentative and Alternative Communication: An Historic
Perspective," 10 AAC 27-59 (1994); G. Vanderheiden and D. Yoder, "Overview," in
S.Blackstone, Ph.D., Ed. Augmentative & Alternative Communication: An Introduction 10-13
(1986).
32
          ASHA, "Augmentative and Alternative Communication," 33 Asha (Suppl. 5) 9-12
(1991).
33
        No. 3:94-CIV-185 LN (S.D.Miss. June 23, 1995). This definition was itself taken from
the leading text related to augmentative communication, D. Beukelman & P. Mirenda,
Augmentative and Alternative Communication: Management of Severe Communication
Disorders in Children and Adults 104 (1992).
34
        ASHA, "Position Statement on Non-Speech Communication," 23 Asha 577-581 (August
1981). This position was recently renewed and updated and it remains ASHA's current and
official position. ASHA, "Augmentative and Alternative Communication," 33 Asha (Suppl. 5)
9-12 (1991); ASHA, "Scope of Practice: Speech-Language Pathology," 38 Asha (Suppl. 16)
16-20 (1996); see also ASHA, "Preferred Practice Patterns for the Professions of
Speech-Language Pathology," ASHA Desk Reference (1997)(providing guidance re:
augmentative communication assessment and treatment).




                                               19
been recognized as an appropriate means of treating the speech losses associated with cerebral

palsy.35

           Augmentative communication also is widely known as an appropriate treatment for

dysarthria and anarthria. Specifically, augmentation of the natural speech ability and

alternatives to natural speech are needed when dysarthria is or becomes so severe that the person

is unable to produce understandable speech to meet his or her communication needs. For

persons at this level of severity, treatment involves training in the use of augmentative

communication devices.36 Currently, the best practice for persons with severe dysarthria or
anarthria is augmentative communication treatment.

           For Ms. D., the use of augmentative communication is the least costly and the only

effective course of treatment for her dysarthria.37H. Shane, “Goals and Uses,” in S. Blackstone,

35
       E.g., L. LaFontaine & F.DeRuyter, “The Nonspeaking Cerebral Palsied: A Clinical and
Demographic Database Report,” 3 AAC 153 (1987); J. Angelo, “Comparison of Three
Computer Scanning Modes as an Interface Model for Persons with Cerebral Palsy,” 46
J.Occupational Therapy, 217 (1992); D. McNaughton & J. Tawney, “Comparison of Two
Spelling Instruction Techniques for Adults who use Augmentative and Alternative
Communication,” 9 AAC 72 (1993); D. Beukelman & P. Mirenda, Augmentative and Alternative
Communication 246-49 (d. Ed 1998).
36
        See Beukelman & Mirenda, Augmentative & Alternative Communication (1992);
LaPointe, "Neurogenic Disorders of Speech," in Shames & Wiig, Eds., Human Communication
Disorders 462-496 (1990); Kearns & Simmons, "Motor Speech Disorders: The Dysarthrias and
Apraxia of Speech," in Lass, McReynolds, Northern & Yoder, Eds., Handbook of
Speech-Language Pathology and Audiology 592-621 (1988); Yorkston, Beukelman & Bell,
Clinical Management of Dysarthric Speakers (1988); Rosenbek & LaPointe, "The Dysarthrias:
Description, Diagnosis & Treatment," in D.F.Johns, Ed., Clinical Management of Neurogenic
Communicative Disorders (d. Ed. 1985); J.C. Rosenbek, "Treating the Language Disorder," 5
Seminars in Speech & Language 359-84 (1984); R. Rubow, "A Clinical Guide to the
Technology of Treatment in Dysarthria," in J. Rosenbek, Ed., "Current Views of Dysarthria," 5
Seminars in Speech & Language (1984); Beukelman & Yorkston, "A Communication System
for the Severely Dysarthric Speaker with an Intact Language System," 42 J. Speech & Lang.
Disorders 265-270 (1977).
37
     The LightWriter allows Ms. D. to achieve one of the primary aims of augmentative
communication intervention:

           A principal aim of augmentative interventions is to provide individuals with the tools
           necessary to converse effectively. It is the ability to request goods and services, to



                                                  20
Ed., Augmentative Communication: An Introduction 29, 37 (Rockville, MD: American

Speech-Language-Hearing Association 1986).           The LightWriter is a compact, lightweight, easy

to learn and easy to use device that enables Ms. D. to meet the broadest, speech-restorative

treatment goals that are recognized by Medicare. The LightWriter enables Ms. D. to “say”

words, phrases, sentences, even entire messages -- whatever she wishes -- in the most intelligible

synthesized voice currently available.38   It also offers a unique feature: a “dual display,” i.e., a

small display is provided on the communication partner‟s side of the device that will provide a

written version of Ms. D.‟s message, in addition to the synthesized voice, which also increases
the intelligibility of her messages. In addition, as compared to other devices Mr. Hammond

recommended as equally effective alternatives, i.e., that have the same speech-restorative

potential, the LightWriter is much less expensive.




                      II
                       Augmentative Communication Devices Meet All
                            the Medicare Coverage Criteria for
                     Durable Medical Equipment and Prosthetic Devices


       The Medicare Part B program, governed by Title XVIII of the Social Security Act,

provides reimbursement to eligible recipients for "items and services which are reasonable and

necessary for the diagnosis and treatment of illness or injury, or to improve the functioning of a

malformed body member."39 Among the "items and services" provided by Medicare Part B are

       comment on current, past and future events, to specify preferences and emotions, or to
       simply “chat” that facilitates social and emotional involvement. . . .


38
       The LightWriter uses a speech synthesizer called DECTalk, which has been demonstrated
to provide the most intelligible synthesized speech available. Rupprecht, Beukelman & Vrtiska,
“Comparative Intelligibility of Five Synthesized Voices,” 11 AAC 244-247 (1995)(“DECTalk
has become the “standard” synthesized voice of the AAC field....”)
39
       42 U.S.C. § 1395(y)(a)(1)(A).




                                                21
durable medical equipment40 and prosthetic devices.41 Augmentative communication devices,

such as the LightWriter requested by Ms. D., satisfy all the criteria stated in the Medicare

definitions of both the durable medical equipment and prosthetic device benefit categories.42

       A.      Augmentative Communication Devices are Durable Medical Equipment
       An item of durable medical equipment (DME) under the Medicare program must have

four characteristics:
       (1)     can withstand repeated use;
       (2)     is primarily and customarily used to serve a medical purpose;
       (3)     generally is not useful in the absence of illness or injury; and
       (4)     is appropriate for use in the home.43


       Augmentative communication devices satisfy all of these criteria. Without question they

are able to withstand repeated use. The VOIS 140 which was approved by Medicare for Ms. D.

in 1986, see Exhibit 21, was used for a period of approximately 9 years. The LightWriter which



40
       42 U.S.C. §§ 1395(x)(n); 1395(x)(s)(6).
41
       42 U.S.C. § 1395x(s)(8).
42
         The definitions of durable medical equipment and prosthetic devices overlap sufficiently
to permit specific items to meet the criteria of both categories. In the Medicaid program, where
Congress also outlined broad categories of medical care as covered benefits, Beal v. Doe, 432
U.S. 438, 444 (1977), it is generally accepted that specific types of treatment can fall within
more than benefits category. Planned Parenthood Affiliates of Michigan v. Engler, 73 F.3d 634,
636 (6th Cir. 1996); Hope Med. Grp. for Women v. Edwards, 63 F.3d 418, 425 (5th Cir. 1995);
Little Rock Fam. Planning Serv. v. Dalton, 860 F.Supp. 609, 616 (E.D.Ark. 1994); affirmed 60
F.3d 497, 499 (8th Cir. 1995); Hern v. Beye, 57 F.3d 906, 910 (10th Cir. 1995). This finding
also has been expressly applied to augmentative communication devices under the Medicaid
program. In Fred C. v. Texas Health & Human Serv. Comm'n, 924 F.Supp. 788 (W.D.Tex.
1996); vacated and remanded on other gr'ds, 117 F.3d 1416 (5th Cir. 1997)(Table); on remand,
988 F.Supp. 1032 (W.D.Tex 1997) affirmed per curiam, 167 F.3d 537 (5th Cir. 1988)(Table), the
district court twice held that augmentative communication devices, such as the LightWriter,
satisfy the Medicaid standards applicable to both the durable medical equipment and prosthetic
device benefit categories. In addition, in Meyers v. Reagen, 776 F.2d. 241 (8th Cir. 1985), the
court concluded augmentative communication devices fit a third category of Medicaid benefits:
speech-language pathology services.
43
       42 C.F.R. § 402.202.




                                                22
has replaced that AAC device already has been in use for 2 years, and is expected to be of use to

Ms. D. for many years into the future.

       Augmentative communication devices are used solely to serve a medical purpose. The

Food and Drug Administration reached this conclusion about AAC devices in 1983. At that

time, the FDA created a classification of medical devices called “powered communication

systems,” which it defined as:
       An AC- or battery-powered device intended for medical purposes that is used to
       transmit or receive information. It is used by persons unable to use normal
       communication methods because of physical impairment. . . .
48 Fed. Reg. 53049 (November 23, 1983), codifying 21 C.F.R. § 890.3710(emphasis added).


       As discussed in Section I of this memorandum, augmentative communication devices are

a speech-language pathology treatment method for severe expressive communication disabilities,

such as dysarthria. They are recommended when the level of severity of these disabilities

precludes effective or efficient use of natural speech. Augmentative communication devices

serve the same medical purpose as speech language pathology, a covered Medicare benefit.          In

addition, the distributor of the LightWriter states:
       Zygo Industries' augmentative communication devices and other products,
       including the LightWriter, are designed to serve the needs of persons with severe
       speech and language disabilities, and have been and continue to be sold
       exclusively for use by persons with severe speech and language disabilities.
       These devices serve as a functional substitute for the organs and body structures
       required to produce intelligible speech which have been adversely affected by
       illness, injury or disease, including Cerebral Palsy.44


       The FDA classification of AAC devices provides yet another perspective on their medical

purpose. The FDA placed AAC devices in the same category of medical devices as power

wheelchairs. It recognized that both devices provide identical benefits: they permit an

individual to accomplish a specific functional intent, i.e., to move from place to place, or to


44
        Affidavit of Kim Wright, Medical Accounts Manager, Zygo Industries, submitted in In
re: Celia C., Dkt. No. 196-14-0195 (Social Security Admin. Office of Hearings & Appeals
December 2, 1998), attached as Exhibit 22, at ¶ 3.




                                                23
speak, by by-passing body parts that are necessary for the normal accomplishment of that intent,

but which are not working due to disability. For mobility, the brain generates an intent to move

from point A to point B; it then generates motor instructions for the muscles of the legs to

accomplish that intent; and it sends those instructions along the nerves to the muscles to

implement that intent. If, due to disability, those instructions cannot be carried out in the normal

fashion, the brain can by-pass the non-functioning body parts, and re-direct the instructions to the

arms and hands, which can propel a manual chair, or control a power wheelchair joystick. Thus,

by by- passing the non-functional body parts and with the aid of an item of durable medical
equipment, the original intent can be accomplished.

       The same by-pass exists for AAC devices. In a recent letter, Peggy Locke, the President

of the Communication Aid Manufacturers Association, described this process as follows:
        AAC devices allow their users to achieve [their communication] goals by
        providing a functional substitute for body organs and structures that are necessary
        for the production of speech but which are non-functioning or mal-functioning
        due to illness, injury, disease or condition. Another way to describe the purpose
        of AAC devices is as a functional by-pass of these non- or mal-functioning body
        structures, i.e., they allow the AAC device user to express a thought (message) as
        speech, by by-passing the nerves, muscles, and organs of speech which, due to
        impairment, make natural speech ineffective. The AAC device is the by-pass.
        Viewed in this way, AAC devices provide the same benefits and serve the same
        functional purposes as power wheelchairs. . . .45


       As Ms. Locke stated: the brain generates a thought; it is then linguistically encoded into

speech; motor instructions are generated for the speech organs; the nerves then carry those

instructions to the speech organs, but one or more of them are non-functional, due to disability.

To accomplish that original intent, the brain re-directs the instructions to the hands, which can

generate the message by use of an AAC device. As with the wheelchair, by by-passing the



45
       Letter dated October 23, 1999 to Lewis Golinker, from Peggy Locke, attached as Exhibit
24. This letter was submitted to HCFA as part of the Formal Request for National Coverage
Decision for Augmentative and Alternative Communication Devices, CAG-00055, filed
December 30, 1999, and decided, April 26, 2000.




                                                24
non-functional body parts and with the aid of an item of durable medical equipment -- the

LightWriter -- the original intent is accomplished.

         Ms. Wright‟s Affidavit and Ms. Locke‟s letter also address the third criterion of the DME

definition: that augmentative communication devices are not useful to or used by people whose

natural speech is sufficient to engage in functional communication. No person who is able to

speak using their natural voice will have any reason to consider an augmentative communication

device, whether the LightWriter or any other. The rate at which people can produce speech is

far faster and more flexible than the rate at which they can produce a message by any other
means.

         Finally, it is without question that augmentative communication devices in general and

the LightWriter in particular are appropriate for use in the home. These devices are designed to

be portable: they are intended to be used wherever the person has a need for communication.

         As to all of these factors, Ms. D.‟s request for Medicare reimbursement for a LightWriter

as DME does not raise questions of first impression. In six of the seven known Medicare AAC

administrative law judge (ALJ) hearing decisions, the ALJ approved the requested device under

the Medicare DME benefit.46 (In the other case, the ALJ approved the requested device under

the Medicare prosthetic device benefit.)47




46
       In re: Charles MacP, Dkt No. _____________ (Social Security Admin. Office of Hrgs
& Appeals March 27, 2000); In re: Donald S., Dkt No. 000-89-3072 (Social Security Admin.
Office of Hrgs & Appeals October 1, 1999); In re: Bernadine A., Dkt No. 000-86-0336 (Social
Security Admin. Office of Hrgs & Appeals April 27, 1999); In re: Celia C., Dkt. No.
196-14-0195 ( (Social Security Admin. Office of Hrgs & Appeals December 2, 1998); In re:
Richard A., Dkt No. 000-06-0110 (Social Security Admin. Office of Hrgs & Appeals March 24,
1997); In re: Blanche B., Dkt. No. 000-24-0399 (Social Security Admin. Office of Hrgs &
Appeals May 8, 1995), attached as Exhibit 23.
47
      In re: Emlyn J., Dkt. No. 360-09-1983 (Social Security Admin. Office of Hrgs &
Appeals August 18, 1993), attached as Exhibit 23.




                                                25
       In the earliest of these decisions, In re: Blanche B., the ALJ considered whether another

model of augmentative communication device, known as a Real VOIS, was durable medical

equipment. The ALJ‟s conclusion:
      There is no doubt whatsoever in my mind that the computer in this case meets the
      general definition of "durable medical equipment" set forth in the regulations.48


In In re: Donald S., one of the most recent, the ALJ relied on prior ALJ decisions, and reached

the same conclusion that AAC devices are DME. The ALJ in Donald S. also noted the

functional equivalence of AAC devices and wheelchairs:
       The Medicare [Carrier] Hearing Officer noted that the ACD [AAC device] did not
       primarily and customarily serve a medical purpose and she drew a distinction
       between items used to reduce or eliminate an illness or reduce or eliminate the
       effects of an illness. The opinion of the speech pathologist, the precedent of
       Administrative Law Judge decisions, and common sense leads to a different
       conclusion. With regard to common sense, many commonly recognized items
       that Medicare approves as durable medical equipment do not cure an illness but
       rather treats the effects of an illness. A wheelchair is an obvious example. It is
       the means to treat the effects of an illness and provides a substitute for the body
       part that is not functioning. . . .49


       And, in In re: Celia C., the ALJ approved a LightWriter under the Medicare DME

benefit. The ALJ concluded:
        The augmentative communication device at issue meets the definition of durable
        medical equipment. It is constructed and designed for repeated use and is used in
        the home. It is primarily and customarily used to serve the medical purpose of
        enabling its user to communicate when she could not do so due to a serious
        medical condition. It would not be useful for an individual without such serious
        medical condition.50




48
       In re: Blanche B., Dkt. No. 000-24-0399 Slip Op. at 6 (Social Security Admin. Office of
Hearings & Appeals May 8, 1995).
49
      In re: Donald S., Dkt. No. 000-89-3072 Slip Op. at 3-4 (Social Security Admin. Office of
Hrgs & Appeals October 1, 1999)
50
      In re: Celia C., Dkt. No. 196-14-0195 Slip Op. at 5 (Social Security Admin. Office of
Hrgs & Appeals December 2, 1998).




                                              26
       That augmentative communication devices meet these four criteria is further supported

by comparison to Medicaid coverage of augmentative communication devices under its durable

medical equipment benefit.51    Medicaid, governed by Title XIX of the Social Security Act,52

covers durable medical equipment,53 but neither the statute nor the federal Medicaid regulations

provide an operational definition of this term. Instead, each state participating in Medicaid has

the discretion to create its own definition. As a general matter, durable medical equipment is

the most common benefit category under which augmentative communication devices are

classified by state Medicaid programs.54 At least eight states have copied the Medicare DME
definition in whole or substantial part and also classify, cover and provide augmentative

communication devices within the durable medical equipment benefit.55      In addition, the Health

51
        Although Medicaid and Medicare are independent programs, comparisons between the
two are common and appropriate. For one, their statutory and regulatory terms, particularly for
durable medical equipment and prosthetic devices, are not materially different. Moreover, for
augmentative communication, reference to the Medicaid program is particularly appropriate,
because of it has a long history of coverage of augmentative communication devices. The
earliest Medicaid programs to cover augmentative communication devices did so in the
mid-to-late 1970's. See In re: Anthony M., No. 1360-79 (N.J. Office of Admin. Law July 17,
1979). In addition, Medicaid coverage is almost universal. See note 54 infra.
52
       42 U.S.C. § 1396 et. seq.
53
     42 U.S.C. § 1396d(a)(7); 42 C.F.R. § 440.70. Durable medical equipment is classified as
a mandatory component of the Medicaid home health care services benefit category.
54
       Every Medicaid program that has been asked to provide augmentative communication
devices have agreed to do so. To date, 46 of the 50 Medicaid programs have had such requests
presented to them. Of this total, half classify augmentative communication devices as DME.
The second most common benefit category is prosthetic devices. See L. Golinker, "Speaking
Up In Court," 8 Team Rehab Report 19, 20(Table 1) (Feb. 1997)(listing 45 states that to that date
had approved augmentative communication devices.) In the period since that article was
published, Alabama became the 46th state to cover and provide these devices, approving its first
request in July 1998. Brown v. James, CV-98-M-663-N (M.D.Ala. 1999)(Alabama also
classifies augmentative communication devices as durable medical equipment). This article is
attached as Exhibit 25.
55
       The states are Illinois, Ill. Dept. of Public Aid, Medical Assistance Provider Manual, §
II-M-3, M-201.2 (Dec. 1992); Indiana, 470 IAC 1-7, § 27(g), at p. A2-49 (Oct. 1, 1994); Iowa,
Iowa Dept. of Human Serv., Coverage & Limitations, Medical Equipment and Supply Dealer,
Chapt. E, page 2(b)(Jan 1, 1994), see also Iowa Medicaid Augmentative Communication Device



                                               27
Care Finance Administration, the federal agency that administers both Medicaid and Medicare,

also has recognized that augmentative communication devices can be classified as Medicaid

durable medical equipment.56

       Finally, as is explained in Section IV of this Memorandum, on April 26, 2000, the Health

Care Financing Administration formally announced its acknowledgment that AAC devices are

durable medical equipment under the Medicare Program.



B.     Augmentative Communication Devices Are Prosthetic Devices




Funding Criteria, Medical Equipment and Supply Dealer Manual, Chapt. E, p. 12, ¶ D (Oct. 1,
1988); New Jersey, N.J. Medicaid, Medical Equipment and Supplies Supplier Manual,
Sub-Chapt. I, § 1.2 (Nov. 1979); New York, 18 N.Y.Code of Rules and Regulations, §
505.5(a)(1); North Dakota, N.D. Dept. of Human Serv., Medical Assistance Program, DME
Supplies and Guidelines, ¶ 1., South Carolina, S.C. Medicaid Home Health Serv. Manual, at p.
2-1; and Wisconsin, Wisc. Admin. Code, HSS, § 101.03(50).
56
       See e.g., HCFA Regional Office VI, Medicaid Services Letter 95-31 (March 7,
1995)(augmentative communication devices can be classified as durable medical equipment,
prosthetic devices or an inherent component of a therapy service); HCFA Region VI, Medial
Services Letter 93-110 (Nov. 22, 1993)(citing same scope of coverage); HCFA Regional Office
III, Medicaid Letter No. 93-98 (Oct. 26, 1993)augmentative communication devices can be
classified for Medicaid coverage under the durable medical equipment, prosthetic devices or
speech-language pathology benefit categories (necessary supplies and equipment are included in
the definition of speech-language pathology benefits, 42 C.F.R. § 440.110)); HCFA Regional
Office III, Medicaid Letter 93-97 (1993)(same scope of services); HCFA Regional Office X,
State Agency Letter 93-25 (March 12, 1993)(augmentative communication devices can be
durable medical equipment or prosthetic devices).




                                             28
       The Medicare statute and regulations define prosthetic devices as devices "which replace

all or part of an internal body organ (including colostomy bags and supplies directly related to

colostomy care . . ."57 Other Medicare guidance clarifies this definition by noting that the focus

of the definition is functional replacement, not physical replacement. This guidance defines

prosthetic devices as devices "which replace all or part of the function of the permanently

inoperative or malfunctioning internal body organ."58         The broader "function-related"

definition may be seen as required because Medicare covers equipment like cardiac pacemakers

as prosthetic devices. Pacemakers do not replace all or part of the heart itself. Instead, they
provide electronic pulses which regulate and support heart function. Thus, to cover devices of

this kind, Medicare acknowledges that functional substitution or restoration, rather than actual

substitution of the body part itself, is a characteristic of prosthetic devices. This reasoning

applies equally to explain Medicare coverage of cochlear implants as prosthetic devices.

Cochlear implants do not replace the inner ear; rather, they substitute for and enhance its

function. See 5 CCH Medicare & Medicaid Guide, ¶ 27,210 at p. 29,283 (Oct. 1996)(current

coverage criteria).

       Augmentative communication devices, including the LightWriter, satisfy these criteria.

Without question, these devices provide a functional substitute for the severely mal-functioning

or permanently inoperative body organs and other body structures needed to produce speech.

       The proof of this assertion is simple and direct: when no impairment is present, the

proper functioning and coordination of the nerve pathways and muscles that control the larynx,

vocal folds or cords, tongue, teeth, and lips59 yield intelligible speech. For Ms. D., by contrast,
57
       42 U.S.C. § 1395x(s)(8); 42 C.F.R. §§ 410.36; 414.202.
58
       Medicare Carriers Manual, § 2130 (emphasis supplied.) Also compare 42 U.S.C. §
1395x(s)(9), which specifically identifies items that serve as physical replacements for body
organs and structures that are missing, e.g., artificial limbs and eyes.


59
       See G. Shames and E. Wiig, Human Communication Disorders 77 (3d Ed. 1990)(Figure
3.1: Human vocal organs).



                                                29
the functioning and coordination of these body organs and other body structures is substantially

impaired as a result of her cerebral palsy. The result is that she lacks intelligible speech, i.e. she

has severe dysarthria.

       There is no question that Medicare recognizes speech loss as a function sufficiently vital

to provide prosthetic devices. Medicare has express guidance identifying two types of devices

that provide functional substitutions for the larynx and thereby help their users produce speech

using their natural voice mechanisms. One is commonly known as an artificial larynx.60 The

other is commonly known as a tracheostomy speaking valve.61         In contrast to these devices,
augmentative communication devices, such as the LightWriter, also provide a functional

substitution for the speech function, but they are necessary in different circumstances: when

disease or disability makes it impossible for the person to use his/her natural voice to produce

functional speech.62In re: Blanche B., supra, slip op. at 5.

       More directly on point regarding coverage of augmentative communication devices is In

re: Emyln J.,63 In re: Emyln J. also is notable because, like the Blanche B. decision, the ALJ
60
       5 CCH Medicare & Medicaid Guide, National Coverage Decision 65-5, ¶ 27,201, at p.
29,277 (April 1993).
61
       5 CCH Medicare & Medicaid Guide, National Coverage Decision 65-16, ¶ 27,201, at p.
29,284 (October 1996).
62
       In In re: Blanche B., Judge Levin compared these two types of speech prostheses and
concluded, correctly, that the artificial larynx and tracheostomy speaking valve and an
augmentative communication device such as the LightWriter, are not comparable.

       The simple fact is that the item [a RealVois augmentative communication device]
       is not an "electronic speech aid" as described in that NCD [national coverage
       decision] --it is an entirely different type of electronic equipment that substitutes
       voice simulation [sic: synthesis] evoked by non-speech organs for ordinary or
       augmented speech generated in part by the customary vocal apparatus. I
       therefore do not conclude . . . that NCD precludes a finding that the item here at
       issue is not a covered "prosthetic device" within the meaning of § 410.36(b) of the
       regulations.


63
       In re: Emyln J., No. 360-09-1983 (Social Security Admin. Office of Hearings & Appeals
Aug. 18, 1993).



                                                 30
also concluded that the requested augmentative communication device is not a device

comparable to the artificial larynx. Thus, the ALJ in this case made no findings that the national

coverage decision related to the artificial larynx had any direct effect on the question of

augmentative communication device coverage. in which a Medicare Administrative Law Judge

expressly ruled that a computer-based augmentative communication device is covered as a

Medicare prosthetic device. The beneficiary in that case had a stroke, and had been provided

with a lap-top computer that functioned as an augmentative communication device (through the

addition of a speech-synthesizer and speakers, and augmentative communication software). At
the ALJ hearing, the beneficiary, through the computer, was able to state directly the effects of

and benefits derived from use of the device. These are identical to the intended effects the

LightWriter have for Ms. D.:
      He [the beneficiary] explained how the computer had opened up his life to
      express himself . . . "My computer has opened up my life again by allowing me to
      express my thoughts coherently to myself and others. Through the computer, my
      doctors and I estimate that 95 percent of my pre-stroke vocabulary had returned.
      Although the typing process is slow and laborious for me, the joy of expression
      and communication is unsurpassed. . . ."64


       In In re: Emyln J., the Medicare ALJ specifically concluded the requested device

satisfied the Medicare definition of prosthetic devices, concluding that the augmentative

communication device provides a functional substitute for the "functioning of his damaged
cerebral speech/communication center."
       The evidence clearly demonstrates that the claimant, now age 70, suffered a
       severe stroke rendering the right side of his body nonfunctional and significantly
       damaged the communication/transmission part of his brain to the extent that he is
       mute. His introduction to the computer and subsequent learning of the device
       has resurrected to a great measure his ability to communicate and become much
       more functional to the extent that he can maintain greater independent living. It
       has essentially replaced, as argued by counsel, the malfunctioning part of his body
       (brain) that caused significant communication limitations. . . . The Act does not
       preclude a computer from being a prosthetic device. In fact, due to the peculiar



64
       Id., slip op. at 3.




                                                31
       facts of this case as well as the unusual medical and related facts involved, it [the
       augmentative communication device] clearly satisfies the statutory definition of a
       prosthetic device as it replaces part of the function of an impaired body organ, Mr.
       J's brain.65


The ALJ continued, and addressed a factor previously mentioned here: that one of the effects of

the loss of speech function is the loss of connection to the world. The ALJ expressly noted that

for this beneficiary,
         [t]here is no question, given the evidence, that the computer has restored and
         improved his life. . . . Without this device, as the evidence points out, the
         claimant's life would continue to be severely restricted and his ability to enjoy the
         fruits of life would not be available.66


       In addition, at least 7 other Medicare decisions -- 4 additional A.L.J. decisions, one

decision issued by a Medicare HMO and two issued by DMERCs, have all approved

augmentative communication devices similar to the LightWriter as prosthetic devices.67

       As with DME, further support for the conclusion that augmentative communication

devices in general, and the LightWriter in particular, are prosthetic devices can be gleaned by

comparison to the Medicaid program. Medicaid defines prosthetic devices as devices which:
      (1)     artificially replace a missing portion of the body;
      (2)     prevent or correct physical deformity or malfunction; or
      (3)     support a weak or deformed portion of the body.68



65
       Id. at 4-5.
66
       Id. at 5.
67
        See In re: Charles MacP __________ (Social Security Admin. Office of Hrgs & Appeals
March 27, 2000); In re: Donald S., Dkt. No. 000-89-3072 (Social Security Admin. Office of
Hrgs & Appeals October 1, 1999); In re: Bernadine A., Dkt. No.000-86-0336 (Social Security
Admin. Office of Hrgs & Appeals April 27, 1999); In re: Richard A., Dkt. No. 000-06-0110
(Social Security Admin. Office of Hearings & Appeals March 24, 1997), attached as Appellant‟s
Exhibit 23; In re: Bertha K., Member No. 363324167-1 (Mcare Medicare HMO March 4,
1998)(approving a Link augmentative communication device as a prosthetic device); In re:
Ruth G., Claim No. 212-05-3650 (Region B DMERC Jan. 10, 1998)(same); In re: Jesse K.,
Claim No. 587-50-1488A (Region C DMERC April 24, 1998)
68
       42 C.F.R. § 440.120(c).




                                                 32
       Augmentative communication devices, such as the LightWriter, satisfy the second sub-¶

of this definition, which is not substantively different than the Medicare prosthetic device

definition. Both require prosthetic devices to address physical malfunction: for Medicare, the

devices "replace" lost function; for Medicaid, they "correct" lost function. Prosthetic devices is

the second most common benefit category under which state Medicaid programs classify

augmentative communication devices.69

       Medicaid programs throughout the country recognize that under the federal Medicaid

regulations, "prosthetic devices can be defined in functional terms,"70 and that augmentative
communication devices satisfy the prosthetic device definition because they correct a physical

malfunction of the body, namely a malfunction of the speech centers of the brain and vocal

muscles,71 and other body organs and structures involved in the production of speech, by

providing augmented or alternative speech.
       Clearly, an [augmentative communication device] is a replacement device to
       correct a physical malfunction of the body and therefore, qualifies as a prosthetic
       device as defined by 42 CFR § 440.120 . . . . As stated, an [augmentative
       communication device] satisfies the federal definition of Prosthetic Devices . . . .72

69
        See "Speaking Up In Court, supra, note 54, Exhibit 25. It identifies 12 states that as of
late 1996 classified augmentative communication devices as prosthetic devices. More recently,
the Colorado legislature enacted legislation that classifies augmentative communication devices
as prosthetic devices. Mapp v. Beuscher, No 98 CA 0287, Motion for Voluntary Dismissal, ¶¶
2-4 (Colo. Court of Appeal filed May 13, 1998).
70
        In re: Donald R., Dkt. No. 343-002967-2-01 Slip Op. at 5 (Ohio Dept. of Human Serv.
Jan. 13, 1989); see also Fred C-II, 988 F.Supp. at 1037; Fred C.-I, 924 F.Supp. at 792.
71
       In re: Sharon H., Appeal No. 13,919 (Vermont Human Services Board Jan. 8, 1996).
72
        In re: Anonymous, Dkt. No. 4110013, Slip Op. at 7 (Louisiana Dept. of Health &
Hospitals June 13, 1995). Accord, In re: Betty J., Dkt. No. 405310 Slip Op. at 6-7 (Louisiana
Dept. of Health & Hospitals Dec. 24, 1994); see also In re: Stephanie M., Appeal No.
93-98-7-4 Slip Op at 8 (Idaho Dept. of Health & Welfare April 29, 1993)("an [augmentative
communication device is] . . . an instrument for the mitigation of disease which is intended to
affect the function of the body . . . to mitigate the effects of the neuromuscular disorder by
assisting the function of the hand and tongue in communication."); In re: Nicholas R., Dkt. No.
92-SHCO-588 Slip Op. at 4 (Ohio Dept. of Human Services Jan. 5, 1992)("The rule speaks to
the correcting of physical deformity or 'malfunction.' There is no dispute that Appellant is
incapable of forming words due to physical malfunction."); In re: Donald R., Dkt. No.



                                                33
In addition, the Health Care Finance Administration has issued numerous policy letters which

acknowledge that augmentative communication devices can be classified within the prosthetic

device benefit.73

       In sum, augmentative communication devices such as the LightWriter satisfy the criteria

of both the Medicare durable medical equipment and prosthetic device benefits categories.

                                            III
                    Augmentative Communication Devices are Reasonable
                      and Necessary for Treatment of Illness or Injury


       The Medicare Act provides payment only for covered "items or services" that are

"reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the

functioning of a malformed body member."74 Medical necessity is described in other Medicare

guidance as follows:
       Equipment is necessary when it can be expected to make a meaningful
       contribution to the treatment of the patient's illness or injury or to the
       improvement of his malformed body member.75


Reasonableness is likewise further defined to be based on the following factors:

       (1) would the expense of the item to the program be clearly disproportionate to the

therapeutic benefits which could ordinarily be derived from use of the equipment?

343-002967-2-01 Slip Op. at 5 (Ohio Dept. of Human Services Jan. 13, 1989)("the Touch Talker
[another model of augmentative communication device] functions as a prosthesis and/or orthosis
. . . when the device is used to correct a physical malfunction. Although appellant's larynx may
be operational, the brain centers controlling speech are non-functional . . . ."); Lloyd, Fuller &
Arvidson (eds.), Augmentative and Alternative Communication: Handbook of Principles and
Practices 11, 523, 538 (1977)(defining augmentative communication devices as prosthetic
devices, i.e., artificial devices, often mechanical or electrical, used to replace a missing part or
assist a defective part of the body).
73
       See note 56, supra.
74
            42 U.S.C. § 1395y(a)(1).
75
       Medicare Carriers Manual, § 2100.2, reprinted in 1 CCH Medicare & Medicaid Guide, ¶
3144, at p. 1120 (1994).




                                                34
       (2) is the item substantially more costly than a medically appropriate and realistically

feasible alternative pattern of care?

       (3) does the item serve essentially the same purpose as equipment already available to the

beneficiary?76

       Augmentative communication devices, like Ms. D.‟s LightWriter, are entitled to

Medicare coverage and reimbursement because they squarely meet these standards.

       Augmentative communication devices are necessary, first, because they are generally

recognized by the professional medical community, and extensive published, professional
research literature as treatment for expressive communication disabilities, such as Ms. D.‟s

severe dysarthria.77 Such treatment is necessary because, as has been noted in this

memorandum, the ability to speak and communicate is "vital," and because these devices

represent the only form of treatment that will enable persons with such disabilities to regain

functional speech abilities. As to Ms. D., there is no question that her LightWriter -- like her

Medicare reimbursed VOIS 140 14 years ago -- will make a "meaningful contribution" to

treatment of her dysarthria.

       The degree of this contribution also makes clear that providing augmentative

communication devices is reasonable. For Ms. D., the expense of the LightWriter is

insignificant when compared to the therapeutic benefits it will provide, i.e., by the degree of

functional communication improvement that will be realized. As others have stated in the

Exhibits filed with this Memorandum, and as Ms. D. has stated herself, she is able to achieve full

conversational communication, the highest level of functional communication recognized by

Medicare criteria and the closest to normal functioning. With -- and only with -- the


76
       Id. ¶ 3144, at 1121.
77
       See Exhibits 16 - 20. See also, the Formal Request for National Coverage Decision for
Augmentative and Alternative Communication Devices, which offers a comprehensive review the
professional literature regarding AAC interventions. The Formal Request can be reviewed a the
web-site, www.augcominc.com.




                                                35
LightWriter, Ms. D.‟s functional communication has improved from completely unintelligible

even to familiar listeners, as reported by Mr. Hammond, her SLP, to as close to normal

communication as can be achieved with an AAC device. This represents the greatest possible

degree of improvement in her functional communication abilities.

       Moreover, as noted above, the emotional benefits to Ms. D. and her family to be able to

speak -- to each other, to other family members, to friends and to others -- are incalculable.

       The Medicare decisions previously mentioned herein provide further support. Each

prior decision approved funding for augmentative communication devices because these devices
were determined to have satisfied the reasonable and necessary standard. In each case, the

decision makers reported the functional gains made possible by these devices. As noted above,

these functional gains are the same as -- or less significant than -- those expected for Ms. D..

       A finding that augmentative communication devices as a class of devices are medically

necessary and reasonable is also supported by the policy and practices of every major

health-focused funding and benefits program -- including Medicare, as noted above -- which

cover and provide these devices.78 This list includes other federal health-benefits programs,

such as Medicaid programs,79 CHAMPUS80 and the Department of Veterans Affairs,81 as well

as private health-benefits programs, including hundreds of commercial health insurance



78
       As a general matter, disputes and appeals related to augmentative communication device
funding is the exception rather than the rule. Far more typical is that policy-based decisions
about coverage as well as individual fact-based decisions regarding funding are made without
controversy, and have supported both augmentative communication device coverage and
funding.
79
        See Affidavit of Phil Saines, Funding Coordinator of Assistive Technology, Inc., ¶ 2,
submitted in In re: Celia C., and attached as Exhibit 26; Affidavit of Yvette Walden, Supervisor
of the Funding Department, Dynavox Systems, Inc., ¶ 4, submitted in In re: Celia C., and
attached as Exhibit 27; see also fn 54, supra.
80
       Id.
81
       Id.




                                                36
providers and managed care organizations.82 All of these programs provide funding only for

treatments that are medically necessary, and all insist that only the least costly equally effective

alternative treatment be provided.

       In addition, all of the federal courts that have considered the medical necessity of

augmentative communication devices within the Medicaid program have concluded that they

met this standard. One case, Myers v. State of Mississippi,83 was an omnibus challenge to a

state policy that augmentative communication devices never were medically necessary. Upon

review of testimony outlining more than two decades of professional literature, policy and
practice regarding augmentative communication, however, the district court rejected the state's

position. The court concluded the view that augmentative communication devices are never

medically necessary was "manifestly wrong."84 Likewise, in Meyers v. Reagen,85 Fred C.,86 and

Hunter,87 the courts all concluded that augmentative communication devices were medically

necessary for specific individuals and directed that they be provided.

       In sum, there is abundant evidence about augmentative communication in general to

conclude that these devices satisfy the Medicare reasonable and necessary criteria. Likewise,

there are sufficient facts specifically regarding Ms. D.‟s LightWriter to support the same

conclusion: that it, too, satisfies the Medicare “reasonable and necessary” standard.


82
        See Exhibits 26 and 27; see also Myers v. State of Mississippi, 3:94-CV-185 LN Slip Op.
at 12 (S.D. Miss. June 23, 1995)(acknowledging fact that hundreds of insurers provide
augmentative communication devices).
83
       3:94-CV-185 LN (S.D.Miss. June 23, 1995).
84
       Id. Slip Op. at 13.
85
       776 F.2d 241 (8th Cir. 1985)
86
       924 F.Supp. 788 (W.D.Tex. 1996), vacated and remanded on other grounds 117 F.3d
1416 (5th Cir. 1997)(Table) on remand 988 F.Supp. 1032 (W.D.Tex. 1997), affirmed per
curiam, 167 F.3d 537 (5th Cir. 1998)(Table).
87
       944 F.Supp. 914 (S.D.Fl. 1996).




                                                37
                                            IV
                     There are No Coverage Limitations Or Program
                       Exclusions that Preclude Medicare Coverage
                  and Funding for Augmentative Communication Devices


       As noted by the ALJ in In re: Blanche B.:
       There are three sources of law to which an Administrative Law Judge must look
       in determining whether an item or service is covered under the Medicare Part B
       program: the statute (Social Security Act, Title XVIII); regulations officially
       promulgated pursuant thereto; and certain formally-published National Coverage
       Determinations (NCD's) issued by the Health Care Financing Administration
       (HCFA).


In re: Blanche B., No 000-24-0399, Slip Op. at 4-5. (Social Security Admin. Office of Hearings

& Appeals May 8, 1995), attached as Exhibit 23. Upon further review, the ALJ concluded there

is no binding authority that precludes a finding in favor of Medicare coverage and funding for

augmentative communication devices. This conclusion also was reached by each of the other

Medicare Administrative Law Judges who have reviewed augmentative communication device

claims, and approved them.88

       The Medicare Act and regulations describe the “certain ... National Coverage

Determinations” referenced above. National Coverage Determinations (NCD‟s) are “binding”

on ALJs when they are based on the Medicare “reasonable and necessary” provision, 42 U.S.C. §

1395y(a)(1).89
      HCFA makes NCDs either granting, limiting, or excluding Medicare coverage for
      a specific medial service, procedure or device. NCDs are made under section
      1862(a)(1) [42 U.S.C. § 1395y(a)(1)] of the Act or other applicable provisions of
      the Act. An NCD is binding on all Medicare carriers . . . . when published in
      HCFA program manuals or the Federal Register.

       Under section 1869(b)(3) of the Act [42 U.S.C. § 1395ff(b)(3)] only NCDs made
       under section 1862(a)(1) of the Act are subject to the conditions of paragraphs
       (b) through (d) of this section.


88
       See Exhibit 23.
89
       See 42 U.S.C. § 1395ff(b)(3)(A).




                                              38
       (b) Review by an ALJ. (1) An ALJ may not disregard, set aside or otherwise
       review an NCD.90


       Other Medicare guidance provides instructions regarding how to tell whether a National

Coverage Determination is based on § 1395y(a)(1) and is therefore binding.
      All [National Coverage] decisions that items, services, etc. are not covered are
      based on § 1862(a)(1) of the Social Security Act (the “not reasonable and
      necessary” exclusion) unless otherwise specifically noted. Where another
      statutory authority for denial is indicated that is the sole authority for the
      denial.91


       The highlighted passages in the preceding paragraphs were provided because they

establish that the National Coverage Decision related to AAC devices, found at Medicare

Coverage Issues Manual, § 60-9, is NOT binding on administrative law judges.

       The AAC device NCD states in full that AAC devices are “convenience items; not

primarily medical in nature (§ 1861(n)) of the Act.”

       Applying the rules set forth in the Medicare regulations and manuals, the AAC National

Coverage Determination is NOT binding on ALJs.         This guidance is not binding because it is

not based on 42 U.S.C. § 1395y(a)(1), but instead, it states it is based on § 1861(n) of the Act,

which is the definition of durable medical equipment.92    According to the regulations, only
                                                                                     93
National Coverage Determinations based on 42 U.S.C. § 1395y(a)(1) are binding.

       In addition, the AAC device National Coverage Determination deserves no deference.

In the period generally believed to be before the AAC Device NCD was written, Medicare had

90
       42 C.F.R. §§ 405.860(a)(1); (a)(2); (b)(emphasis supplied).
91
       Medicare Coverage Issues Manual, Forward, § A.
92
       42 U.S.C. § 1395x(n).
93
        42 C.F.R. § 405.860(b). In May 1997, HCFA issued revised administrative appeal
regulations applicable to Medicare claims which made clear the distinction between different
types of coverage determinations. See 62 Fed. Reg. 25,844 25,848 (May 12, 1997) attached as
Exhibit 28. The preamble to the regulations confirms the correctness of the ALJ‟s analysis and
conclusion in In re: Blanche B., that the augmentative communication device National Coverage
Determination is not binding.




                                                39
approved at least 2 AAC devices. The first, in March 1981, approved an AAC device as a

prosthetic device; then in September 1986, Medicare approved Ms. D.‟s first device, concluding

that her VOIS 140 was not a personal comfort item, but instead, was both an item of durable

medical equipment and a prosthetic device.94 Since 1993, notwithstanding the NCD, no

Medicare ALJ (the first Medicare decision maker with discretion not to follow the NCD) has

found it to be credible or persuasive.95

       Of greatest significance, according to the Health Care Financing Administration, there is

no known basis for this National Coverage Determination. No records exist to identify when it
was first written, the expertise of the person(s) who wrote it, or what was considered before it

was issued. There appears to be no administrative record whatsoever related to this National

Coverage Determination -- it merely exists.96 Moreover, HCFA has admitted that no search of

relevant professional literature was conducted before this national coverage determination was

issued, and no input was sought from HCFA medical officers.97       This National Coverage

Determination also has never been reviewed or updated.

       The AAC device NCD stands in stark contrast to the almost 30 years of speech-language

pathology professional literature, policy, and practice that contradicts its “convenience item”

conclusion, as well as the continued policy development of all other similar funding programs --

including Medicaid, which also is administered by HCFA -- which now offer almost universal

94
       The 1981 AAC device approval is attached as Exhibit 29 Ms. D.‟s 1986 AAC device
approval is attached as Exhibit 21.
95
       See Exhibit 23.
96
     See Letter dated July 8, 1998 to Ms. Elizabeth Carder, Esq., from Philip Brown, Director,
HCFA Division of Freedom of Information and Privacy, attached as Exhibit 30
97
        Grant Bagley, M.D., Former Director of the Coverage and Analysis Group, HCFA Office
of Clinical Standards and Quality, stated in response to questions posed about the development
of the guidance found in Coverage Issues Manual § 60-9 that no medical literature search ever
was conducted and no staff-prepared background paper exists for AAC devices. Response by
Grant Bagley, M.D., to Plaintiff‟s First Set of Interrogatories, filed in Rhode Island Disability
Law Center v. U.S. Department of Health & Human Services, No. 98-415T (D.R.I.)




                                               40
coverage and funding of AAC devices. These programs apply principles and vocabulary that

are identical or substantially similar to Medicare, and all conclude AAC devices are durable

medical equipment, prosthetic devices, and both reasonable and necessary.             In addition,

AAC such as the LightWriter have no characteristics in common with items that Medicare

identifies as convenience items within the durable medical equipment benefit category. These

items are described as "[e]quipment which basically serves comfort or convenience functions or

is primarily for the convenience of a person caring for the patient, such as elevators, stairway

elevators, and posture chairs."98 A brief review of some of the other types of equipment
designated as convenience items in the same list of National Coverage Determinations -- carafes,

overbed tables, raised toilet seats, telephone arms, and air conditioners, for instance -- makes all

the more clear that this designation is inappropriate for augmentative communication devices.99

       Augmentative communication devices, in contrast to these others, restore a vitally

important basic human functional ability lost due to illness or disease: expressive

communication. As noted previously in this memorandum, the ability to speak and to use

language is a defining characteristic of the human species -- none of these other devices

addresses functional issues of comparable significance.

       Yet another reason not to offer deference to the AAC Device National Coverage

Determination is that HCFA has re-reviewed it and determined that it should be withdrawn. In

June 1999, an aide to the HCFA administrator contacted Ms. D.‟s attorney and asked that he

submit a Formal Request for Medicare to re-review the AAC device “convenience item”

guidance. On December 30, 1999, a Formal Request for National Coverage Decision for

98
       1 CCH Medicare & Medicaid Guide, ¶ 3144.14, at p. 1128.
99
       Id., at ¶ 27,221 at 29,802-07. One of these devices is called a speech-teaching machine.
However, the type of device this refers to is unknown. It clearly is not an augmentative
communication device like the LightWriter. Ms. D., for example, has had more than 2 years of
college education. She does not seek and she does not need a "speech teaching device." Rather
she seeks a device that will let her produce speech. She has no need to be "taught" to speak; the
LightWriter will not do this; and based on her dysarthria, it would be a futile effort.




                                                41
Augmentative and Alternative Communication Devices, was filed by Ms. D.‟s attorney, on behalf

of 13 organizations representing every interest related to Medicare coverage of AAC devices.

That document can be reviewed at www.augcominc.com. Following its submission to HCFA,

the Formal Request was peer-reviewed by the American Medical Association, the American

Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation.

Each of these professional medical societies found the Formal Request to be a complete and

correct description of the professional literature about AAC interventions, and about the clinical

decision making process leading to AAC device recommendations and prescriptions. See
Exhibits 16 - 20.

       On April 26, 2000, HCFA announced its response to the Formal Request. It stated that it

will withdraw the “convenience item” guidance, and concluded that AAC devices constitute

durable medical equipment.
       The decision that AAC devices were "convenience items" and thus did not fit a
       benefit category had been made a number of years ago. In response to the
       requestors, CHPP has reversed this decision and has now decided that AAC
       devices are a Medicare benefit in the category of durable medical equipment
       (DME).100


       Thus, there is no binding national Medicare guidance that precludes a favorable decision

on Ms. D.‟s appeal, and even the Health Care Financing Administration now acknowledges that

its non-binding AAC guidance is incorrect and will be withdrawn.




100
       Coverage Policies, Review Issues, Augmentative and Alternative Communication
Devices,     (#CAG-00055), Decision Memorandum, April 26, 2000, attached as Exhibit 31. See
also Letter dated May 8, 2000 to Nancy Ann Min DeParle, Administrator, Health Care Financing
Administration, from the Representative Tom Allen, attached as Exhibit 32.




                                               42
                                                 V

                                         CONCLUSION
       Augmentative communication devices have the ability -- like other items of durable

medical equipment and prosthetic devices that Medicare covers and reimburses -- including

wheelchairs,101 artificial limbs,102 pacemakers,103 and cochlear implants104 -- to by-pass or

substitute for non-functioning body parts and to thereby restore functional abilities sufficient to

allow their users to participate fully in society. They accomplish these goals even though none

of these devices "cures" impairments. Rather, they eliminate impairments' limiting effects on
individual functioning and allow their users to participate in normal activities. See In re:

Donald S., Slip Op. at 3-4.

       In light of Ms. D.‟s quadriplegia and dysarthria, that the LightWriter permits "normal

activities" proves beyond question that it is not a convenience -- a conclusion long recognized by

Medicare ALJs and by every other health-benefits funding program in the United States, and

now officially recognized by Medicare itself. See Exhibit 32. Indeed, the functional abilities

the LightWriter will provide to Ms. D. would be far more accurately described as an

extraordinary event: one that might seem more like magic than medicine. As Ms. D.‟s uncle

101
         Medicare coverage for wheelchairs is authorized by 42 U.S.C. § 1395x(n). In the
Medicaid program, numerous states have equated the functional purposes served by wheelchairs
with those served by augmentative communication devices. For example, New Jersey and
Minnesota Medicaid, which have covered and provided augmentative communication devices
-- for both children and adults -- since 1979 and 1984, respectively, both recognize the
equivalent functional benefits and roles of communication devices and wheelchairs. See In re:
Anonymous-I (Minn. Dept. of Human Services April 30, 1984); In re: Anonymous-II (Minn.
Dept. of Human Services April 30, 1984); In re: John P., No. 7454-82 (NJ Office of Admin.
Law Dec. 8, 1982); In re: Kevin K., No. 2938-81 (NJ Office of Admin. Law Sept. 1, 1981); In
re: Anthony M., No. 1360-79 (NJ Office of Admin. Law July 17, 1979).
102
       See 42 U.S.C. § 1395x(s)(9).
103
       See 1 CCH Medicare & Medicaid Guide ¶ 3152 at p. 1152 (Jan. 1990).
104
       Cochlear implants are covered by Medicare pursuant to National Coverage Determination
65-14. 5 CCH Medicare & Medicaid Guide, ¶ 27,201, at p. 29,283 (Oct. 1996).




                                                43
xplained, cerebral palsy and dysarthria has “imprisoned” her in a body that does not function

across a wide spectrum of abilities and tasks that others take for granted.[cite]

       Access to augmentative communication, formerly through the VOIS 140, and now

through the LightWriter -- and nothing else -- has changed that. Its effect, in the words of the

claimant in as the claimant in In re: Emyln J. “opens up [her] life”105 and enables her to function

as an active, articulate, independent adult. These abilities are no less significant an occurrence

than if Ms. D. were to awaken from a coma.

       That the LightWriter enables Ms. D. to have a normal life, despite her communication
disability, is completely consistent with every relevant Medicare coverage and funding

criterion. Indeed, there is an unfortunate irony here: Ms. D. already demonstrated -- 14 years

ago -- that an AAC device she uses meets all the relevant Medicare standards for coverage and

necessity, and yet, she must go through a lengthy appeal process at this time. But no basis exists

for there to be a different outcome: there have been no material changes in her condition, the

device she uses is a replacement for one that lasted for 8 years and then ceased to function, and

there have been no relevant changes in law or regulation.

       In sum, this case is ready for summary determination on the record: there are no facts in

dispute, there are no legal impediments to providing Medicare reimbursement to Ms. D., and

there is no material difference between this appeal and any of the others in which reimbursement

for AAC devices was awarded. The devices sought in those cases include the same one as Ms.

D. uses: the LightWriter, and other devices that are indistinguishable in terms of both their

capabilities and benefits conveyed. The only possible barrier to a favorable decision here is the

AAC device national coverage decision, but this has been withdrawn and would not otherwise be

entitled to any deference.




105
       Exhibit 23, Slip op. at 3.




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         Thus, no basis exists for this appeal to reach any result other than the award of

reimbursement for the LightWriter Ms. D. uses.

Dated:          Ithaca, New York
                May 12, 2000



                                                       Respectfully submitted,



                                                       _______________________
                                                       Lewis Golinker
                                                       Attorney for Kimberly D.

                                                       Suite 507, 202 East State Street
                                                       Ithaca, New York 14850
                                                       607-277-7286 (voice)
                                                       607-277-5239 (fax)




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