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04A Celia C ALJ Memorandum of Law.doc - AACFundingHelp by chenmeixiu




In the Matter of Celia C.
                                             SSN 196-14-0195
On Appeal from the Denial of
Medicare Part B Benefits              H. Anyel, A.L.J.


      August 27, 1998

                               Respectfully submitted


                                Lewis Golinker, Esq.
                         Suite 507, 202 East State Street
                              Ithaca, New York 14850
                      voice: 607-277-7286; fax 607-277-5239
       Preliminary Statement

       Mrs. Celia C., a Medicare beneficiary, age 79, brings this hearing to seek approval and

funding for a "Lightwriter," a type of augmentative communication device. Mrs. C. seeks a

Lightwriter because it is the only form of treatment that will provide functional improvement for

her severe speech disability.

       Mrs. C. has Amyotrophic Lateral Sclerosis, commonly known as ALS or "Lou Gehrig's

Disease." ALS is a fatal, neurological disease that is marked by the progressive deterioration of

motor nerve cells. ALS causes weakness and atrophy of muscles, and corresponding loss of

function, including that of speech.

       In July 1997, Mrs. C. was evaluated by Ms. Jeri Weinstein, Chief of Speech-Language

Pathology Services, Beth Israel Medical Center, and was diagnosed as having anarthria, an

impairment characterized by the complete inability to speak. Anarthria represents the most

severe degree of speech disability caused by ALS.

       Despite its severity, speech-language pathology treatment exists for anarthria.

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

treatment for severe expressive communication disabilities, including anarthria. Augmentative

communication also is well recognized as a form of treatment for functional speech losses caused

by ALS. Most significantly, for persons with ALS recommended for augmentative

communication devices, they will represent the only form of treatment that will be effective for

achievement of functional, speech-language pathology goals.

       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.

       Mrs. C. is enrolled in a Medicare HMO, the HIP Health Plan of Florida. In July 1997,

based on Ms. Weinstein's recommendation and with the concurrence of her treating physician,

Mrs. C. requested that the HMO approve and provide funding for this device.

       In response, the HMO denied her claim initially and on appeal. The sole reason offered

was that augmentative communication devices are not covered as Medicare benefits. Upon

review, however, these decisions are incomplete: they address only whether augmentative

communication devices are covered under the Medicare durable medical equipment benefit,

omitting entirely consideration whether the Lightwriter is covered as a prosthetic device. Even
as to durable medical equipment, these decisions are based solely on guidance that is not

binding on Administrative Law Judges. Moreover, that guidance, according to the Health Care

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

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

other funding and benefits programs. Most significantly, this guidance has not been followed

by other Medicare Administrative Law Judges in identical circumstances.

       In sum, Mrs. C.'s appeal must be approved for four reasons: first, because the

augmentative communication device recommended and prescribed for her use meets all the

relevant criteria for two benefits categories covered by Medicare Part B; second, because the

Lightwriter represents the only form of treatment that will be effective for Mrs. C.'s

communication disability; third, because there are no Medicare limitations or exclusions

applicable to her request.

       Finally, Mrs. C.'s request for a Lightwriter must be approved, now, because time is

fleeting: she has a fatal, progressive impairment, one component of which -- her speech disability

-- is readily treatable. However, due to the nature of Mrs. C.'s enrollment in a Medicare HMO,

she does not yet have access to this treatment and unless and until a favorable decision on this

appeal is rendered, Mrs. C. will continue to be denied the benefits of this treatment.

                                   STATEMENT OF FACTS

         A.     Personal Facts
         Celia C.’s anarthria makes it impossible to obtain personal information directly.

Instead, the following personal information was obtained from her husband: preparing this

section of this memorandum of law is a paradigm of the issues presented by this hearing: Mrs. C.

is an intelligent person who is capable of providing these facts as well as engaging in all other

aspects of preparation for her appeal hearing, except she has no way of expressing her answers

to her attorney’s or her husband’s questions.

         From her husband, the following facts were learned: Celia C. is 79 years old. She was
born in 1919 in Warsaw, Poland, and emigrated to the United States in 1940, after the Nazi

invasion of her country, to escape persecution. At the time she entered the United States she

spoke no English. As a young adult, she worked in a millinery factory and ultimately became a

supervisor in a clothing manufacturing company in New York City. She retired from her

employment in 1980.

         Mrs. C. has been married to her husband Jack, for 55 years. She has two children, a son

and a daughter, and two grandchildren, ages 19 and 23. She also has 2 sisters and a brother still

living; her husband also has a sister who is still living. These siblings have created a wide

extended family with many nieces and nephews. Before the onset of her ALS, Mrs. C. enjoyed

frequent communication with these family members, including conversations with her children

on a weekly or more frequent basis.

         The C.s have lived in New York City throughout the marriage and also have a

cold-weather month residence in south Florida.

         In addition to ongoing contact with family members, the C.s maintained an active social

life. Mrs. C. was described by her husband as outgoing, with many friends. Social contacts

included frequent telephone conversations and in-person socializing.

         In general, both Mrs. C. and her husband were in good health, despite their advancing

          This description of the C.’s life-style and life-experiences began to change in 1995, when

Mrs. C. began to experience symptoms of Amyotrophic Lateral Sclerosis, more commonly

known as ALS or Lou Gehrig's Disease.

          B.      Impairments Related to Mrs. C.'s ALS
          ALS is a neuro-degenerative disease characterized by loss of upper and lower motor

neurons leading to progressive loss of motor function1 As the disease progresses, the ALS

patient loses the ability to move, speak, swallow and eventually to breathe.
        ALS steadily progresses in the majority of cases, and progression may be rapid in
        some patients. Muscle weakness may be mild at first but gradually, over time, it
        becomes more pronounced and spreads to other regions of the body. The patient
        eventually becomes paralyzed and death usually occurs as a result of respiratory
        insufficiency related to paralysis.2

ALS is a fatal disease, and once diagnosed, the average life span of a person with ALS is 2-5


          Loss of speech function is a well recognized secondary disability related to ALS.

Among the most common speech disabilities associated with ALS is a condition called

dysarthria.4 It is caused by the progressive weakness, incoordination and ultimate paralysis of

the nerves, muscles and other body organs and structures used in speaking.5 Dysarthria can

range from mild speech production problems, where only a few sounds may be slurred or

       H. Mitsumoto, M.D., "Diagnosis and Progression of ALS," in R. Miller, M.D., ed.,
Amyotrophic Lateral Sclerosis Standard of Care Consensus Conference, 48 J. NEUROLOGY S-2
(1997)(hereafter, "ALS Care Consensus Conference").
          Id. at S-6.
          Id. at S-2.
        R. Sufit, M.D., "Symptomatic Treatment of ALS," in ALS Care Consensus Conference,
supra, at S-15; THE MERCK MANUAL at 1438 (25th Ed. 1987).
       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).

indistinct (unintelligible), to a complete inability to speak intelligibly or even make guttural

sounds. The latter state, anarthria, which describes Mrs. C.'s condition, is characterized by

complete speechlessness, and represents the most severe stage of dysarthria.6 However, neither

dysarthria nor anarthria compromises receptive communication abilities (the ability to

understand what is spoken or written).7

       In addition to anarthria, Mrs. C.'s ALS has progressed to the point where she is no longer

able to chew and swallow food, or control the production of saliva. To ensure she receives

adequate nutrition, she has been given a percutaneous endoscopic gastronomy, or P.E.G., a
feeding tube directly into her stomach. She takes no food by mouth. She also is given

medication to control her drooling. Absent such measures, Mrs. C. is at risk of choking, and

possibly death, from her food or her own secretions.

       Despite these ALS-related functional losses, Mrs. C. is still ambulatory and is still

capable of leading an active lifestyle.

       However, Mrs. C.'s experiences with anarthria reinforce strongly the statement that loss

of the speech function is "not a loss of life, but a loss of access to life."8 For example, Mrs. C.

continues to prepare meals for her husband, but she goes shopping alone only rarely, and only

when she is reasonably certain she will not have to communicate with others. Otherwise, she is

always accompanied by her husband to shop or for any other community-based transactions.

Mrs. C.’s speech function is completely lost and her writing ability is not sufficient to

compensate for her loss of speech. As Ms. Weinstein noted in her evaluation report:

       Darley, Aronson & Brown, Motor Speech Disorders 2 (1975).
       Id. Mrs. C.'s residual receptive communication abilities are reported by Ms. Weinstein,
in Hearing Exhibit 2.
       This statement was made by another adult augmentative communication device user.
See Stuart, Vanderhoof & Beukelman, "Topic and Vocabulary Use Patterns of Elderly Women,"
9 AAC 95 (1993)(quoting D. Beukelman & K. Garrett, "Augmentative and Alternative
Communication for Adults with Acquired Severe Communication Disorders," 3 AAC 104

       She tries to communicate by writing, but gets frustrated with the slowness. The
       mechanics of her writing are also poorly intelligible which her husband explains
       is a pre-morbid deficit.9

As a general matter, Mrs. C.'s husband accompanies her whenever she leaves the house and is

responsible for all communication tasks.

       Other examples of "loss of access to life" include the inability to be left alone: although

Mrs. C. has a PERS, or personal emergency response system, which can be used to summon

assistance in an emergency, she has no means by which she can tell those responding to her

distress call what was the matter.   In addition, if anything happened to her husband, Mrs. C.

would be unable to explain what had happened; if Mr. C.’s health problem arose while they were

out in the community, Mrs. C. would not even be able to use the PERS to summon help.

       Mrs. C. also has suffered the loss of direct contact with other family members, most

notably her children and grand children. Before the onset of ALS, Mrs. C. had spoken to her

daughter in Massachusetts and grandchildren on a weekly or more frequent basis. Due to her

anarthria, however, these communications no longer are possible. Communication with other

family members also is precluded.

       Mrs. C.'s anarthria also has caused the elimination of both her and Mr. C.'s social lives.

Prior to the onset of ALS, both maintained an active social life.   Due to her inability to eat food

by mouth, going to restaurants is no longer possible. Due to her dysarthria and now anarthria,

however, both husband and wife have lost contact with friends and acquaintances.

       The cumulative effects of these functional losses and limitations are readily apparent.

Ms. Weinstein noted in her report:
      She appears to be an outgoing, warm woman, but cries easily and is
      understandably depressed by her total inability to communicate.10

       Hrg. Exhibit 2.

       Mr. C. also noted the effects his wife’s impairments had on him. In general, life has

become far less fulfilling as he has lost the conversational companionship of his wife of more

than 50 years. He too experiences the losses of contact with family and friends. In general, he

describes the quality of both their lives as significantly poorer as a result of Mrs. C.’s anarthria.

       Finally, the current level of Mrs. C.'s mobility, stamina, and other functional abilities,

with the exception of her speech and swallowing, must be seen as fleeting: although the timing

cannot be precisely predicted, ALS will cause the deterioration and ultimate loss of these

functional abilities. Thus, Mrs. C.'s ongoing in-ability to gain access to, and to derive benefit
from the Lightwriter is robbing her of personal, family, social and other opportunities for which

there can be no recovery "later."

       C.      AAC Evaluation, Medicare Claim and Appeals
       Mrs. C. was evaluated by Ms. Jeri Weinstein, M.S., C.C.C.-S.L.P., Chief of

Speech-Language Pathology, Beth Israel Medical Center, on July 16, 1997. Ms. Weinstein is a

speech-language pathologist experienced with evaluation of the speech-language pathology

treatment needs of persons with ALS and is experienced with assessment of the need for

augmentative communication.11

       Ms. Weinstein determined that Mrs. C. had anarthria. Thereafter, she outlined a

treatment plan. Its goals will be that Mrs. C. will regain her speech ability sufficient to carry out

communicative interactions in the community, and regain conversational language abilities

sufficient to allow her to communicate with her family, social acquaintances and health care

providers. To realize these goals, Ms. Weinstein further determined that the only appropriate

and available speech-language pathology treatment method or technique is augmentative


       The focus then shifted to identify the most appropriate and least costly augmentative

communication device appropriate for Mrs. C.'s use. After considering and ruling out other

       Ms. Weinstein's vita is attached as Appellant’s Exhibit 1.

devices that were too sophisticated (a laptop computer), and too heavy (a device called the Link),

Ms. Weinstein concluded the Lightwriter is the least costly, most appropriate augmentative

communication device for Mrs. C.. Mrs. C. was given the opportunity to try the Lightwriter and

demonstrated that she was able to use it and was interested in doing so.

       Ms. Weinstein recommended the Lightwriter, to which Mrs. C.’s treatment physician also

agreed.12        On July 17, 1997, a request was submitted to Mrs. C.'s Medicare HMO, HIP Health

Plan of Florida.13 Six days later, on July 23, 1997, the claim was denied. A form notice was

sent to Mrs. C.; the sole reason stated for the denial was that the requested device was "not a
covered HIP benefit." No further explanation was given as to why the Lightwriter was not

       On August 7, 1997, Ms. Weinstein, on Mrs. C.'s behalf, filed a request for

reconsideration.15      This letter noted that augmentative communication devices are commonly

classified as durable medical equipment by commercial health insurance providers and that the

Lightwriter should be considered within this covered Medicare benefit category. Ms. Weinstein

also described the Lightwriter as a prosthetic device. The reconsideration letter also stated the

importance of the device to Mrs. C.:
       Mrs. C. is virtually unable to verbally communicate medical information to her
       physicians without this prosthesis. As I stated in the original justification, this
       places her at great physical risk. Consequently, the device should also be viewed
       as a medically necessary item. ALS is a terrible disease. The inability to

12    12
                   Hrg. Exhibit 2.
        Hrg. Exhibit 2. It is important to note that Mrs. C. submitted a claim to her HMO for
approval of the Lightwriter in advance of receiving it. Unlike the fee-for-service Medicare
program in which claims are filed after the treatment is rendered or device acquired, Medicare
HMO's utilize a prior approval procedure. Thus, Mrs. C. has not yet been able to acquire or
derive the benefits from the Lightwriter.
       Hrg. Exhibit 3.
       Hrg. Exhibit 4.

       communicate, with intact mental and cognitive functions, is perhaps the most
       devastating aspect of the disease.16

       On September 18, 1997, the reconsideration request was denied. Once again, the sole

reason given for the adverse decision was that "this equipment is not a covered HIP benefit."17

       A further appeal was pursued with the Center for Health Dispute Resolution.18 On

November 10, 1997, the most recent adverse decision was issued. For the third time, the sole

reason stated for the denial was that an augmentative communication device is not a covered

benefit. For the first time, however, reference was made to Medicare guidance that purportedly

supports this decision. The letter refers to Medicare Coverage Issues Manual, § 60-9.19 The

letter states:
         There is no doubt that a communication device would be beneficial. However,
         the Health Plan cannot be held responsible for coverage of an item that is
         expressly excluded from Medicare coverage.20

       On January 27, 1998, Ms. Weinstein filed a request for an administrative law judge

hearing.21 The request seeks coverage of the Lightwriter as either an article of durable medical

equipment or a prosthetic device. It also states:
      For Mrs. C., this equipment is the only method that will allow for functional
      communication. Without it, she can not even express her medical needs.
      Unfortunately, she has already been struggling in this situation for many months.22

       Hrg. Exhibit 4.
       Hrg. Exhibit 6.
       Hrg. Exhibit 7.
       Hrg. Exhibit 8.
       Hrg. Exhibit 9.

       Most recently, on July 8, 1998, Ms. Weinstein arranged for the transfer of the hearing

from Florida because Mrs. C. and her husband had returned to their apartment in New York City.

       On August 5, 1998, a notice of hearing was issued. It notes that the issue is "whether or

not an augmentative communication device used by the claimant is covered by Medicare."24 As

noted above, at footnote 13, and in a letter from Mrs. C.'s attorney dated August 17, 1998, the

statement of the issue is incorrect in a most important respect: Mrs. C. does not yet have access

to or an ability to benefit from any augmentative communication device.25 Rather, as noted
elsewhere on the Notice of Hearing, this hearing arises in a "pre-service" context. Most

importantly, for more than a year, Mrs. C. has been denied, and as a consequence, has been

unable to use the device identified as the only form of treatment that will be of any benefit to her

speech disability.


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

       As Ms. Weinstein noted, the loss of the ability to speak -- to date -- is perhaps the most

devastating aspect of Mrs. C.'s ALS.    This conclusion is not unique. In Fred C. v. Texas

Health & Human Serv. Comm’n, the district court made an identical observation about the

impact of loss of speech function when it reviewed the case of an adult who lost his ability to

speak following an accident, and ordered Texas Medicaid to provide funding for an

       Appellant's Exhibit 1.
       Appellant's Exhibit 2.
       Appellant's Exhibit 3.

augmentative communication device.          In addition, in both Fred C. and Hunter v. Chiles,27

the district courts added that the ability to communicate is "vital,"28 and to speak and to use

language for communication is recognized as the physical functional ability that most clearly

distinguishes human beings from all other species.29

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

self-evident, the life-threatening circumstances30 and outrageous injury31Affidavit of Judith

26    26
         988 F.Supp. 1032, 1034 (W.D.Tex. 1997)(appeal pending)(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).
       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.
       Fred C.-II, 988 F.Supp. at 1036; Hunter v. Chiles, 944 F.Supp. at 920; Fred C.-I, 924
F.Supp. at 792.
        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); S.Pinker, The Language Instinct (1994); J. Wilford,
"Ancestral Humans Could Speak, Anthropologists' Finding Suggests," N.Y. Times, April 28,
1998, at A:1.
        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,
reversing the meaning of the responses. Dr. Hall, who now uses an augmentative
communication device, has returned to the practice of medicine.
        For example, the mother of a young adult Medicaid recipient in New York State reported
the preventable tragedy that befell her son:

 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-sentient32Ms. 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,33 clearly demonstrate its value.

        The loss of speech has caused comparable harm to Mrs. C.. As described herein, it has

 denied her "access to life:" the ability to interact with her husband and family, to take care of her

 personal needs and health care, to maintain her home and to maintain social contacts. For Mrs.

        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.

          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.

        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.

In re: Anonymous, Case No. 851-0-107314 Slip Op. at 10 (Ohio Dept. of Human Services, Dec. 7,

C., the loss of speech is profoundly isolating, precluding the very communication -- about home,

family, health and social matters -- that research recognizes is typical of older women.34

        However, the effects of Mrs. C.'s loss of speech are as disabling as they are unnecessary.

Despite its progressive nature and poor prognosis, some of the symptoms associated with ALS

can be treated, particularly the functional losses in regard to speech:35 speech-language

pathology treatment is readily available to treat Mrs. C.'s anarthria.

        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.36

        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.37 It is the key to

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

objective of most speech-language management.38

     Stuart, Vanderhoof & Beukelman, "Topic and Vocabulary Use Patterns of Elderly
Women," 9 AAC 95 (1993).
        R. Sufit, M.D., “Symptomatic Treatment of ALS,” in ALS Care Consensus Conference at
     ASHA, "Preferred Practice Patterns for the Professions of Speech-Language Pathology,"
ASHA Desk Reference (1997).
      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).
        Beliveau, Hodge & Hagler, "Effects of Supplemental Linguistic Cues on the
Intelligibility of Severely Dysarthric Speakers," 11 AAC 197 (1995).

       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

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.39

       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."40
       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

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.42

The discussion of functional goals concludes with the following explanation:

       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).
       Medicare Hospital Manual, § 446(A)(3)(a), attached as Appellant's Exhibit 2.

          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.43

          Ms. Weinstein developed a set of functional treatment goals for Mrs. C. that will permit

her to regain the broadest of these functional communication opportunities. Her proposed

speech-language pathology methodology is augmentative communication, specifically, use of the

Lightwriter augmentative communication device. Moreover, in contrast to the “small change”

in communication permitted in these guidelines, use of the Lightwriter will provide Mrs. C. with

an enormous potential 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

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

communicate.44 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.45

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

devices as:

        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
          ASHA, "Augmentative and Alternative Communication," 33 Asha (Suppl. 5) 9-12

         electronic and non-electronic devices that allow individuals to overcome, to the
         maximum extent possible, communication limitations that interfere with their
         daily activities.46

         For almost two decades, augmentative communication intervention has been recognized

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

scope of practice of speech-language pathologists.47 Augmentative communication also is

generally recognized as an appropriate means of treating the speech losses associated with

ALS.48     Indeed, the ALS Care Consensus Conference expressly cites the Lightwriter, the device

recommended for Mrs. C., as an example of an augmentative communication device that is

commonly used by persons with ALS.49

         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

        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).
        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).
         R. Sufit, M.D., "Symptomatic Treatment of ALS," in ALS Care Consensus Conference at

communication devices.50 Currently, the best practice for persons with severe dysarthria or

anarthria is augmentative communication treatment.

       For persons such as Mrs. C., the use of augmentative communication is the least costly

and the only effective course of treatment for her anarthria.51 For Mrs. C. specifically, the

Lightwriter is a compact, lightweight, easy to learn and easy to use device that will enable her to

meet the broad, speech-restorative treatment goals set by Ms. Weinstein. The Lightwriter will

enable Mrs. C. to “say” words, phrases, sentences, even entire messages -- whatever she wishes

-- in the most intelligible synthesized voice currently available.52 The Lightwriter has software
that will enable Mrs. C. to communicate effectively and efficiently despite her less than perfect

spelling skills. 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 Mrs. C.’s

message, in addition to the synthesized voice, which also will increase the intelligibility of her

messages. In sum, the Lightwriter is the least costly device that will accomplish a primary goal

of speech-language pathology treatment for persons with ALS:
        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 (2d 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).
       National Joint Committee on the Communicative Needs of Persons with Severe
Disabilities, "Guidelines for Meeting the Communication Needs of Persons with Severe
Disabilities," 34 Asha (Suppl. 7) 1-9 (1992).
       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....”)

        A person with Amyotrophic Lateral Sclerosis (ALS), for example, who becomes
        incapable of speaking and writing, can be provided with augmentative techniques that
        allow full access to expression of ideas, wants, and needs.53

In addition, Mrs. C.’s use of the Lightwriter will accomplish one of the primary aims of

augmentative communication intervention in general:
      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
      comment on current, past and future events, to specify preferences and emotions, or to
      simply “chat” that facilitates social and emotional involvement. . . .54

                          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."55 Among the "items and services" provided by Medicare Part B are

durable medical equipment56 and prosthetic devices.57 Augmentative communication devices,

such as the Lightwriter requested by Mrs. C. in this case, satisfy all the criteria stated in the

Medicare definitions of both the durable medical equipment and prosthetic device benefit


     H. Shane, Ph.D., “Goals and Uses,” in S. Blackstone, Ph.D., Ed., Augmentative
Communication: An Introduction 29, 40 (1986).
        Id. at p. 37.
        42 U.S.C. § 1395(y)(a)(1)(A).
        42 U.S.C. §§ 1395(x)(n); 1395(x)(s)(6).
        42 U.S.C. § 1395x(s)(8).
       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

        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.59

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

able to withstand repeated use. The Lightwriter with the scanning accessory requested for Mrs.

C. is expected to be of use to her for the rest of her life.

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

As discussed in this memorandum, augmentative communication devices are a speech-language

pathology treatment method for severe expressive communication disabilities, such as dysarthria

and anarthria. 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

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)(appeal pending), 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
        42 C.F.R. § 402.202.

medical purpose as speech language pathology. In addition, the distributor of the Lightwriter

          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 ALS.60

          This statement also addresses 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.

          In In re: Blanche B., ALJ Kenneth Levin considered whether another model of

augmentative communication device, known as a Real Vois, was durable medical equipment.

The Medicare beneficiary in that case also had ALS. Judge Levin'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.61

          That augmentative communication devices meet these four criteria is further supported

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

       Affidavit of Kim Wright, Medical Accounts Manager, Zygo Industries, Appellant's
Exhibit 3, at ¶ 3.
       In re: Blanche B., No. 000-24-0399 Slip Op. at 6 (Social Security Admin. Office of
Hearings & Appeals May 8, 1995), attached as Appellant's Exhibit 4.

medical equipment benefit.62 Medicaid, governed by Title XIX of the Social Security Act,63

covers durable medical equipment,64 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.65 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.66      In addition, the Health

        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 65, infra.
       42 U.S.C. § 1396 et. seq.
         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.
           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)(pending)(Alabama also
classifies augmentative communication devices as durable medical equipment). This article is
attached as Appellant's Exhibit 5.
       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
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, §

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.67

       The appropriateness of augmentative communication device coverage also can be

established by review of other items of durable medical equipment covered by Medicare. For

example, in In re: Irving M.68 a Medicare Administrative Law Judge concluded that a device to

aid a person with low vision, called a Telesensory high contrast black and white magnification

system, was an item of durable medical equipment. The beneficiary was losing his vision
function due to diabetes, macular degeneration and cataracts. He asserted this device was

necessary because his failing vision made it impossible for him to meet the vision demands of his

general medical regimen, which included testing and recording his blood glucose level four time

per day, measuring doses of other medications, and performing other writing related tasks, such

as check-writing, which are part of his routine daily tasks. In In re: Anonymous,69 a Medicare

Administrative Law Judge approved a similar device, called a Visualtek Read/Write System.

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).
          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).
       In re: Irving M., No. 000-44-0379 (Social Security Admin. Office of Hearings & Appeals
June 16, 1995), attached as Appellant's Exhibit 6.
       In re: Anonymous, No. 062-44-0658 (Social Security Admin. Office of Hearings &
Appeals Feb. 5, 1980), reprinted in CCH Medicare and Medicaid Guide, ¶ 30,387. Attached as
Appellant's Exhibit 7.

       The Lightwriter will serve the same general purposes as these low vision devices: both

address deteriorating functional abilities caused by disease or disability. Both enable their users

to participate effectively and efficiently in their health care -- one to communicate health

concerns, the other to implement a treatment program; both also enable their users to continue to

perform their routine daily activities -- one in regard to speech; the other in regard to reading.

And, as noted previously, Medicare speech-language pathology billing guidelines expressly state

that functional goals should be written to enable patients to achieve "optimum communication

independence," including "carry[ing] out communicative interactions in the community."70 In
this regard, i.e., the provision of an assistive device that enables its user to maintain important

functional abilities that are deteriorating due to disease or disability, the purpose of providing

augmentative communication devices is the same as that of a wheelchair or other mobility device

which is statutorily recognized as an item of Medicare durable medical equipment.71

         Medicare Hospital Manual, § 446(A)(3), attached as Appellant's Exhibit 2.
       42 U.S.C. § 1395(x)(n).

B.     Augmentative Communication Devices Are Prosthetic Devices
       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 . . ."72 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."73         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

(for a person with dysarthria), or for Mrs. C. (due to her anarthria), 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,

       42 U.S.C. § 1395x(s)(8); 42 C.F.R. §§ 410.36; 414.202.
       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.

vocal folds or cords, tongue, teeth, and lips74 yield intelligible speech. For Mrs. C., by contrast,

the functioning and coordination of these body organs and other body structures has been lost

due to ALS; the result is that no speech is possible.

       In this regard, there is no difference between Mrs. C.'s loss of function of these same

body structures and her need for a functional substitute (to ensure her access to nutrition) of the

P.E.G. Medicare expressly covers similar services (parenteral and enteral therapy) as prosthetic

devices.75     Moreover, that multiple interconnected and inter-related parts of the body are

involved in the production of speech is not material. Nor is it material that not every body
structure contributing to speech production be identified as impaired. There is nothing in the

Medicare definition of prosthetic devices -- and common sense belies the notion -- that for a

device to be a prosthetic device, it must be a substitute for the specific function of a single,

muscle, organ, nerve or other specific body structure. When multiple body parts must work

together to produce a vital function, such as speech, but cannot do so due to disease or disability,

a device that will provide a substitution for the ultimate body function -- speech -- squarely

satisfies the Medicare criteria for classification as a prosthetic device. Medicare guidance is in

complete accord: noted above is Medicare's coverage of parenteral and enteral nutrition therapy

as a prosthesis: such therapy is utilized when patients, due to chronic illness or trauma cannot be

sustained through oral feeding. This type of therapy replaces a host of organs utilized in

nutrition and the digestive process. See 5 CCH Medicare & Medicaid Guide, ¶ 27,201, at p.

9081 (National Coverage Decision 65-10). In addition, in many instances, only one organ

related to digestion may be dysfunctional.

       See G. Shames and E. Wiig, Human Communication Disorders 77 (3d Ed. 1990)(Figure
3.1: Human vocal organs). Attached as Appellant's Exhibit 8.
        See 1 CCH Medicare & Medicaid Guide, ¶ 3152.55, at p. 1162 (Feb. 1994); see also Fred
C-II, 988 F.Supp. at 1037; Fred C-I, 924 F.Supp. at 792(equating functional substitution role of
augmentative communication device and feeding tubes).

       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.76 The

other is commonly known as a tracheostomy speaking valve.77       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.78In re: Blanche B., supra, slip op. at 5.

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

re: Emyln J.,79 In re: Emyln J. also is notable because, like the Blanche B. decision discussed in

footnote 78, the ALJ in this case also concluded that the requested augmentative communication

       5 CCH Medicare & Medicaid Guide, National Coverage Decision 65-5, ¶ 27,201, at p.
29,277 (April 1993).
       5 CCH Medicare & Medicaid Guide, National Coverage Decision 65-16, ¶ 27,201, at p.
29,284 (October 1996).
       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

       In re: Emyln J., No. 360-09-1983 (Social Security Admin. Office of Hearings & Appeals
Aug. 18, 1993). Attached as Appellant's Exhibit 9.

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 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 will have for Mrs. C.:
        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. . . ."80

       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
       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

       Id., slip op. at 3.

       prosthetic device as it replaces part of the function of an impaired body organ, Mr.
       J's brain. 81

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 "access to life." The ALJ expressly noted that for this

       [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.82

       In addition, at least four other Medicare decisions -- one additional A.L.J. decision, one

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

communication devices similar to the Lightwriter as prosthetic devices.83

       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.84

       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

       Id. at 4-5.
       Id. at 5.
83     83
            See In re: Richard A., Dkt No. 000-06-0110 (Social Security Admin. Office of
Hearings & Appeals March 24, 1997), attached as Appellant’s Exhibit 10; 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)
       42 C.F.R. § 440.120(c).

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.85

       Medicaid programs throughout the country recognize that under the federal Medicaid

regulations, "prosthetic devices can be defined in functional terms,"86 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,87 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 . . . .88

        See "Speaking Up In Court, supra, note 65, Appellant's Exhibit 5. 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).
        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.
       In re: Sharon H., Appeal No. 13,919 (Vermont Human Services Board Jan. 8, 1996).
         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.
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

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.89

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

of both the Medicare durable medical equipment and prosthetic device benefits categories.90

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).
       See note 66, supra.
             The Administrative Law Judge in In re: Richard A., attached as Appellant’s Exhibit
10, reached this conclusion: that augmentative communication devices similar to the Lightwriter
met the Medicare criteria applicable to both durable medical equipment and prosthetic devices.

                    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."91 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.92

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?

       (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


       Augmentative communication devices, like the Lightwriter sought by Mrs. C., are

entitled to Medicare coverage and funding because they squarely meet these standards.
       Augmentative communication devices are necessary, first, because they are treatment for

severe expressive communication disabilities, such as dysarthria and anarthria. 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

91     91
             42 U.S.C. § 1395y(a)(1).
       Medicare Carriers Manual, § 2100.2, reprinted in 1 CCH Medicare & Medicaid Guide, ¶
3144, at p. 1120 (1994).
       Id. ¶ 3144, at 1121.

enable persons with such disabilities to regain functional speech abilities. As to Mrs. C., there is

no question that providing her with a Lightwriter will make a "meaningful contribution" to

treatment of her anarthria.

       The degree of this contribution also makes clear that providing augmentative

communication devices is reasonable. For Mrs. C., the expense of the Lightwriter will be

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

functional communication improvement that will be realized. Ms. Weinstein expects the degree

of improvement to be full conversational communication, the highest level of functional
communication recognized by Medicare criteria and the closest to normal functioning. With --

and only with -- the Lightwriter, Mrs. C.'s functional communication will improve from the

speechlessness that distinguishes anarthria, to the potential for full conversational

communication. This will represent the greatest possible degree of improvement in her

functional communication abilities.

       Moreover, as noted above, the emotional benefits to Mrs. C. and her husband by again

being able to speak -- to each other, to other family members, to friends and to others -- are

incalculable. It truly will return to her the "access to life" that she has lost due to her ALS.

       The Medicare decisions previously mentioned herein provide further support. Each

prior decision approved funding for augmentative communication devices and other similar

devices, such as low vision aids, 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 Mrs. C..

       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.94 This list includes other federal health-benefits programs,

such as Medicaid programs,95 CHAMPUS96 and the Department of Veterans Affairs,97 as well as

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

and managed care organizations.98 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,99 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."100 Likewise, in Meyers v. Reagen,101 Fred C.,102
       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
       See Affidavit of Phil Saines, Funding Coordinator of Assistive Technology, Inc., ¶ 2,
attached as Appellant's Exhibit 11; Affidavit of Yvette Walden, Supervisor of the Funding
Department, Dynavox Systems, Inc., ¶ 4, attached as Appellant's Exhibit 12; see also fn 65,
       See Appellant's Exhibits 11 and 12; 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).
       3:94-CV-185 LN (S.D.Miss. June 23, 1995).
       Id. Slip Op. at 13.

and Hunter,103 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 the Lightwriter sought by Mrs. C. to support the

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

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

       As noted by Judge Levin in In re: Blanche B.:104
       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

Upon review, Judge Levin concluded there is no binding authority that precludes a finding in

favor of Medicare coverage and funding for augmentative communication devices. This

       776 F.2d 241 (8th Cir. 1985)
       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)(appeal pending).
       944 F.Supp. 914 (S.D.Fl. 1996).
      In re: Blanche B., No 000-24-0399 (Social Security Admin. Office of Hearings &
Appeals May 8, 1995), attached as Appellant's Exhibit 4.
       Id., Slip Op. at 4-5.

conclusion also was reached by each of the other Medicare Administrative Law Judges who have

reviewed and approved augmentative communication device funding requests.106

        First, as explained in Section II of this memorandum, there is a match between the

statutory and regulatory factors required to affirmatively establish coverage: i.e., the

characteristics, uses and purposes served by augmentative communication devices and the

relevant statutory and regulatory definitions and coverage criteria applicable to two covered

benefits categories: durable medical equipment and prosthetic devices. Also, as explained in

Section III, there is a match between the role of augmentative communication as the only, and
also as a significantly effective form of treatment for severe communication disabilities such as

dysarthria and anarthria, and the statutory standards of medical necessity and reasonableness.

        Next, as those prior Medicare augmentative communication device decisions further

attest, none of the statutory exclusions from coverage and funding are properly applied to

augmentative communication devices.107

        Lastly, there are no binding regulatory provisions which preclude coverage and funding

of augmentative communication devices and there are no binding National Coverage

Determinations that require that result. In regard to the latter guidance, Judge Levin noted that

there is one National Coverage Determination related to augmentative communication devices,

within the durable medical equipment benefit.108 It states that funding requests should be denied

because augmentative communication devices are convenience items and are not medical in

nature.109   The record of this case reveals this National Coverage Determination served as the

sole basis for the prior adverse decisions on Mrs. C.'s claim.110
        See Appellant's Exhibits 9 and 10.
        42 U.S.C. § 1395y(a).
        In re: Blanche B. Slip Op. at 6-8, referring to National Coverage Determination 60-9.
       National Coverage Determination 60-9, reprinted in 5 CCH Medicare & Medicaid Guide,
¶ 27,221 at p. 29,802 (Oct. 1992).
        See Hearing Exhibit 8.

       However, this National Coverage Determination is not binding on Administrative Law

Judges. It is not binding because it is based on § 1861(n) of the Act, which is the definition of

durable medical equipment.111 Binding National Coverage Determinations, by contrast, are

those based on 42 U.S.C. § 1395y(a)(1).112

       The augmentative communication device National Coverage Determination is not only

not binding, it deserves no deference. 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.113 Moreover,

this National Coverage Determination does not appear to have been reviewed or updated.

       That failure stands in stark contrast to the almost 20 years of speech-language pathology

professional literature, policy, and practice that contradicts its 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 coverage and funding

of AAC devices. These programs apply principles and vocabulary that is identical or

substantially similar to Medicare, and all conclude augmentative communication devices are

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

addition, augmentative communication devices such as the Lightwriter have no characteristics in

       42 U.S.C. § 1395x(n).
       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 Appellant's
Exhibit 13. The preamble to the regulations confirms the correctness of Judge Levin's analysis
and conclusion that the augmentative communication device National Coverage Determination is
not binding.
     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 Appellant's Exhibit 14.

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."114 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.115
       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.

       Lastly on this point, in Detsel v. Sullivan,116 the Second Circuit struck down HCFA

guidance that was not materially different than the National Coverage Determination for

augmentative communication devices. In that case, HCFA had issued guidance in the mid-1960's

purporting to impose at-home limits on the location where Medicaid private duty nurses could

perform their services. No effort ever was made to update this guidance, even though by the

mid-1980's, the medical technology available as well as the standards of practice of nursing had

       1 CCH Medicare & Medicaid Guide, ¶ 3144.14, at p. 1128.
       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. Persons like Mrs. C., who use augmentative
communication devices, had speech for 75 years and then lost it due to ALS. 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 anarthria, it would be a futile effort.
       895 F.2d 58 (2d Cir. 1990)

changed considerably. These changes allowed nursing to become "setting independent" which

contrasted starkly with the HCFA "at home limit."      When a challenge was brought to the

limitation, HCFA could locate none of the original documents related to development of this

guidance, and upon review, the Second Circuit struck it down because it did not reflect current

nursing care standards, policy or practice.117

       For Mrs. C., it is neither necessary nor appropriate for an Administrative Law Judge to

"strike down" the National Coverage Determination -- rather, it will be sufficient for it to be

disregarded, as Judge Levin had done in In re: Blanche B., and as is supported by the
information presented here on behalf of Mrs. C..


       In the final analysis, there is no material difference between the Emyln J., Blanche B. and

Richard A. decisions, and the issues presented here. The devices and the benefits they are to

provide are not distinguishable, and all the applicable coverage and funding criteria are the same.

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

Mrs. C. seeks.

       As a general matter, augmentative communication devices have the ability -- like other

items of durable medical equipment and prosthetic devices that Medicare covers and provides --

such as wheelchairs,118 low vision aids,119 artificial limbs,120 pacemakers,121 and cochlear

118    118
            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.

implants122-- to overcome significant physical limitations and to restore functional abilities

sufficient to allow their users to participate fully in society. They can accomplish this 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.

        In light of Mrs. C.'s anarthria, that the Lightwriter will permit "normal activities" is

hardly proof that the device is merely a convenience -- as is clear from the approval of

augmentative communication devices in the three cases cited above. Indeed, the functional

abilities the Lightwriter will provide to Mrs. C. would be far more accurately described as an
extraordinary event: one that might seem more like magic than medicine. ALS and in

particular, anarthria, has reduced Mrs. C. to an empty shell of a person. She is unable to

effectively express her needs, thoughts, feelings, or wishes; unable to participate in a meaningful

way in conversation; unable to fully enjoy and share the companionship of her husband of 55

years, her family and friends, and unable to be independent and able to care for herself and her


        The Lightwriter -- and nothing else -- can change that. It will, in the words of the

claimant in as the claimant in In re: Emyln J. “open up [her] life again”123 and thereby enable her

to reclaim her person-hood, no less significant an occurrence than if she were to awaken from a

coma. Moreover, that the Lightwriter will restore Mrs. C.’s "access to life," is completely

consistent with every relevant Medicare coverage and funding criterion.

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).
119    119
           See Appellant's Exhibits 6 and 7.
              See 42 U.S.C. § 1395x(s)(9).
121     121
              See 1 CCH Medicare & Medicaid Guide ¶ 3152 at p. 1152 (Jan. 1990).
122     122
           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).
              Appellant’s Exhibit 9, Slip op. at 3.

         Therefore, based on the foregoing, Mrs. C.'s appeal should be upheld, and her Medicare

HMO be directed to provide her with the Lightwriter she seeks.

Dated:          Ithaca, New York
                August 26, 1998

                                                     Respectfully submitted,

                                                     Lewis Golinker
                                                     Attorney for Celia C.

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


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