UNITED STATES DEPARTMENT OF

HEALTH AND HUMAN SERVICES

SOCIAL SECURITY ADMINISTRATION

OFFICE OF HEARINGS AND APPEALS

In the Matter of Jeanine F

Case No. 99-179-00

SSN 124-36-6185

On Appeal from the Denial of

Medicare Part B Benefits	Martin K. Cahn, A.L.J.

APPELLANT'S MEMORANDUM OF LAW

IN SUPPORT OF MEDICARE REIMBURSEMENT FOR

AN AUGMENTATIVE COMMUNICATION DEVICE

August 2, 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 Mrs. F.

REQUEST FOR FAVORABLE DECISION ON THE RECORD

Ms. Jeanine Fiechter, 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, Mrs. Fiechter will appear at the in-person hearing, to supplement the record with live testimony and additional argument. That hearing is scheduled for August 8, 2000, at 1 p.m.

Preliminary Statement

Jeanine Fiechter, age 75, brings this hearing to seek Medicare approval and funding for a "LightWriter," a type of "augmentative communication device" (AAC device or ACD). Mrs. Fiechter seeks a LightWriter because it is the only form of treatment that will provide functional improvement for her severe speech disability.

Mrs. Fiechter has cortico-basal ganglia degeneration, a progressive neurological disorder that causes Parkinson's Disease-like symptoms. More specifically, in regard to Mrs. Fiechter's ability to speak, this condition causes "aphonia," which is the complete absence of voice, i.e., she is unable to produce intelligible speech. Medical evaluation has concluded that no treatment exists to restore her ability to speak. In addition, neither writing nor typing are effective alternative means of meeting Mrs. F.'s communication needs arising in her daily activities.

Based on her condition, Mrs. F.'s treating physician, a consulting otolaryngologist, and a speech-language pathologist recommended that AAC interventions be considered. Mrs. F. was subsequently evaluated by Charlotte Plotnick, M.S., CCC/SLP, a speech-language pathologist skilled in AAC assessment and services delivery. Ms. Plotnick recommended that Mrs. F. use an AAC device called a "LightWriter."

Mrs. F. has had a trial use period with a borrowed LightWriter and demonstrated the ability to understand and to use this AAC device effectively; however, because the device was available only for a trial use, she does not have continued access to it. Instead, she has borrowed a different type of AAC device, called a Link, which is not effective in meeting her needs.

Thus, at present, she remains without an effective tool to meet the communication needs arising in her daily activities. Yet with the LightWriter, Mrs. F. will be able to meet those needs, which include communication with her husband, Rene; a live-in care-giver; her 3 children and 3 grandchildren; physicians and other medical services providers; pharmacy suppliers; friends; fellow members of her church congregation; and individuals she encounters in the community.

Augmentative communication devices are a long-recognized form of speech-language pathology treatment for severe expressive communication disabilities, including aphonia.

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. Medicare has provided reimbursement for AAC devices since March 31, 1981, and every ALJ who ever has considered Medicare reimbursement for AAC devices has approved the request. Among those favorable decisions are two approvals for a LightWriter, the same AAC device as Mrs. F. seeks. The most recent of these decisions was issued one week ago, on July 28, 2000.

Mrs. F. is enrolled in a Medicare HMO, administered by Oxford Health Plans. Mrs. F. sought prior approval for the LightWriter, and pursued appeals through the HMO and the Center for Health Dispute Resolution. All 3 decisions denied Mrs. F.'s request. The sole basis for the denials was that AAC devices are not covered by Medicare. By contrast, no question exists as to the importance of an AAC device for Mrs. F.: the HMO admits that an AAC device will be helpful to allow her to communicate and it covers and provides AAC devices to individuals who have commercial insurance coverage with Oxford.

The basis for these adverse decisions is Medicare Coverage Issues Manual § 60-9. C.I.M. § 60-9, which is binding on the HMO and CHDR, states that AAC devices are "convenience items" and directs reimbursement to be denied. However, that guidance is not binding on administrative law judges: operationally, 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 (HCFA) 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 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, Mrs. F.'s appeal must be approved for four reasons: first, because the AAC device, the LightWriter, recommended and prescribed for her use meets all the criteria for coverage as an item of durable medical equipment, a conclusion shared by Medicare administrators; second, because the an AAC device such as the LightWriter represents the only form of treatment that will be effective for Mrs. F.'s communication disability; third, because there are no Medicare limitations or exclusions applicable to her request.

Finally, Mrs. F.'s request for a LightWriter must be approved, now, because time is fleeting: she has a progressive neurological impairment, one component of which -- her speech disability -- is readily treatable. However, due to Mrs. F.'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. F. will continue to be denied the benefits of this treatment.

There are no facts in dispute regarding Mrs. F.'s ability to use or benefit from the LightWriter. Nor are there any legal impediments to Medicare coverage and funding of AAC devices such as the LightWriter. Thus, with no facts in dispute, and no legal barriers to the issuance of a favorable decision, Mrs. F. requests that her reimbursement request for the LightWriter be approved on the record.

STATEMENT OF FACTS

A.	Personal Facts

Jeanine F. is an adult with cortico-basal ganglia degeneration. This neuro-motor condition causes symptoms similar to those of Parkinson's Disease, which include impairment to voluntary movements, such as walking, writing, and speaking.1 As a result, Mrs. F. uses a manual wheelchair for mobility. More specifically, Mrs. F.'s neurological condition has caused aphonia, a condition characterized by a complete loss of voice, i.e., the inability to produce intelligible speech.2 Mrs. F.'s speech production is so weak that it cannot be understood, even by familiar listeners, such as her husband and a full-time care-giver.3 Indeed, Mrs. F.'s condition makes it impossible to obtain personal information directly. Due to aphonia, Ms. F. is not able to provide information verbally, and, as a further consequence of her neurological condition, writing is not an effective alternative.4 Also, because she does not yet have access to an effective augmentative communication device, i.e., the LightWriter, she is not able to respond to her attorney's questions and supply information necessary to complete this Memorandum of Law.

The information provided herein is based on information stated on evaluation reports and information obtained from Mrs. F.'s son, Rene, Jr. Thus, preparing this section of this memorandum of law is a paradigm of the issues presented in this hearing: Mrs. F. 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 an AAC device.

Mrs. F. is 75 years old. She resides with her husband in a private residence located in Douglaston, New York. Mrs. F. has 3 children and three grand-children.

As stated above, Mrs. F. has cortico-basal ganglia degeneration. The symptoms of this condition were reported to have first been noticed in 1996.5 Since that time, Mrs. F. has continued to lose physical abilities. At present, to overcome the functional limitations imposed by this condition, Mrs. F. uses a manual wheelchair for mobility. In addition, Mrs. F. has a care- giver who provides assistance with such personal care activities as feeding, dressing, bathing, and toileting. Mrs. F. is reported to have difficulty with chewing and swallowing.6

With regard to communication, there has been progressive deterioration in Mrs. F.'s ability to speak intelligibly. She has been given speech-therapy, but compensatory strategies did not improve her ability to be understood.7 She also was evaluated by an otolaryngologist who observed abnormalities in her larynx function, for which, he concluded there is no "medical therapy" that will help to restore her ability to speak. 8

Mrs. F.'s communication impairment has been diagnosed as aphonia, which is defined by Medicare as the complete loss of voice function, and which has the practical, functional effect of a complete inability to produce intelligible sounds.9

Before the onset of Mrs. F.'s cortico-basal ganglia degeneration, she led an active life. She had been the business partner of her husband, working with customers and services providers, such as accountants and insurance representatives. She managed her household, with responsibilities for shopping, menu planning and preparation, and house-keeping. She is very religious, and was an active member of the Community Church in Douglaston. She participated in daily prayer with her husband, as well as discussion with him, and others, about religious issues. She has three children and three grandchildren, with whom she maintains a close, loving relationship. She and her husband, Rene, also had an active social life, filled with many friends and activities in the community.

B.	Communication Impairments Related to Mrs. F.'s Neurological Condition

This description of Mrs. F.'s life-style and life-experiences began to change in 1996, when she first began to experience the Parkinson's Disease-like symptoms of cortico-basal ganglia deterioration. Among the symptoms commonly associated with this type of neurological impairment are the following:

The most prominent and disabling physical sign . . . is muscle rigidity. . . . Voluntary movements are impeded by the muscle rigidity, which leads to slowness of movement and greater effort, causing fatigue. Even the abilities to speak and write are impaired by muscle rigidity. The voice volume becomes low and handwriting becomes much smaller than normal.10

Impairment of speech function, as noted above, is a well-recognized secondary disability associated with this type of neurological condition. Research reports that almost 9 out of 10 individuals with Parkinsonism exhibited laryngeal problems;11 and almost two thirds reported "weak voice," among the most common secondary effects.12

These are the same adverse effects that led Mrs. F. to seek medical examination of the nature of her communication impairment and possible treatments for it. She reported to Merrill Goodman, M.D., a consulting otolaryngologist that her:

speech has become weaker than it has been in the past and she is unable to produce sufficient speech for people to understand her.13

The larynx is the organ of speech that contains the vocal folds, more commonly known as the vocal cords. Their function is to alternately vibrate or not vibrate the column of air that is released from the lungs during exhalation, which in turn is shaped by the soft palate, teeth, tongue and lips into the consonant and vowel sounds of spoken language. Whether due to disease, injury or disability, when the vocal folds are impaired, speech becomes unintelligible.14

Following a laryngoscopy, Dr. Goodman reported that Mrs. F.'s speech disability was caused by impairments in the vocal folds. He wrote:

the vocal cords have restricted motion both for adduction making her speech weak and abduction and this makes her breathing slightly more difficult.15

For Mrs. F., the laryngeal impairment has reached a level of severity where she has a complete loss of voice, i.e., she is unable to produce functionally intelligible speech, even to familiar listeners, such as her husband and a care-giver.16 This affects her ability to get her daily needs met, as well as simply to enjoy the companionship of her husband of 50 years. Her practice of daily oral prayer with her husband has been precluded. Although Mr. F. has serious medical concerns, Mrs. F. is unable to inquire about them, or offer advice or comfort. She is unable to speak to her children about their lives, or share information about her own. She cannot read stories to her grandchildren, share information, ask about their lives, or answer their questions. In the community, she is unable to participate in her church, conduct the necessary transactions to maintain her household, or effectively communicate with the numerous health care professionals with whom she must have contact.

Mrs. F.'s experiences with her aphonia reinforce strongly the statement that the loss of speech function is "not a loss of life, but a loss of access to life."17 Mrs. F. has lost the daily personal, familial, and social contacts that defined and enriched her life. Although Mrs. F. can slowly and effortfully type out messages on a typewriter, this device is not portable, forcing the communication to occur only with someone in her home, and directly next to her. Communication by telephone, in the community, or even with someone in another room of her home is not possible.

The cumulative effects of these functional losses and limitations are readily apparent. As summarized by her speech-language pathologist:

Her communication needs in all aspects of her daily routine are not met. Mrs. F. is frustrated by her inability to communicate effectively.18

Finally, because of the progressive nature of Mrs. F.'s condition, her ongoing inability to gain access to and derive benefits from the LightWriter is robbing her of personal, family, social, and other opportunities for which there can be no recovery "later."

C.	AAC Evaluation, and Follow-Up

Mrs. F. has seen numerous medical professionals regarding the nature of her communication impairment and possible treatments for it. Initially, she was examined by Denise Killian, a speech-language pathologist. Ms. Killian stated that Mrs. F.'s communication impairment "significantly impairs her ability to functionally communicate in her environment."19 Ms. Killian described Mrs. F.'s efforts at communication as follows:

Mrs. F. primarily communicates her needs to her family by typing with her index finger on a conventional typewriter located in [her] home.20

She further described this communication method as insufficient to meet Mrs. F.'s communication needs, and that "communication interactions have become effortful and frustrating for Mrs. F. and her family."21 Ms. Killian also reported that Mrs. F. had been given speech therapy in an attempt to improve her ability to communicate orally, but this was not successful.22 Ms. Killian concluded that Mrs. F. should be evaluated for an AAC device, calling her "an excellent candidate" for use of such a communication aid.23

Mrs. F. was next evaluated by Merrill Goodman, M.D., an oto-laryngologist, upon referral by her treating physician, Robert Strauss, M.D. As noted above, Dr. Goodman conducted a laryngoscopic examination, and confirmed the existence of vocal fold impairment, i.e., an organic cause for Mrs. F.'s communication impairment. He, too, concluded that consideration of augmentative communication techniques was required, because there was "no medical therapy" that will improve her natural speech production ability.24

On October 15, 1999, Mrs. F.'s treating physician, Robert Strauss, M.D., wrote a prescription for an AAC device.25 This was followed by an examination by Charlotte Plotnick, M.S., C.C.C.-S.L.P., a speech-language pathologist associated with United Cerebral Palsy of Nassau County, New York. Ms. Plotnick has approximately 2 decades of experience with AAC assessment and services delivery. The purpose of her examination was to identify the specific type of AAC device that will be most appropriate to meet Mrs. F.'s communication needs and abilities.

Ms. Plotnick reviewed Mrs. F.'s examination and treatment history, including the inability of speech therapy to improve her intelligibility. She then conducted a comprehensive speech- language evaluation. The following information is taken from Ms. Plotnick's evaluation report, attached as Exhibit 1.

Ms. Plotnick reported that Mrs. F. is of normal intelligence: she is able to spell, create novel messages based on her desires and needs, to understand how a variety of AAC devices worked, and to report on her preferences for and objections to their various characteristics.

Ms. Plotnick described Mrs. F. as having a wide range of communication needs:

Mrs. F. needs to communicate with her family (children and grandchildren), friends, physicians, care givers and any other people (familiar and unfamiliar) with whom she will come into contact. She needs to be able to communicate with her husband who has a hearing problem. She needs to communicate to make her needs and wants known, to answer and ask questions, to communicate problems, medical status and to hold a conversation. She must make her physical and medial needs known easily and quickly. She must be able to communicate while seated in her wheelchair or in any other seat or in bed. She needs to communicate in all environments and to communicate via telephone.

Ms. Plotnick diagnosed Mrs. F. with aphonia, noting that Mrs. F. was not able to produce intelligible speech. She also observed and reported that alternative means of communication were not effective in meeting the communication needs, identified above: writing "is slow and effortful" and of "reduced legibility;" her use of the typewriter, "has not been effective as she is unable to take it from room to room or outside the home."

She is unable to communicate with people not directly in her environment. She is only able to request items that she is able to look at or point at. She is unable to communicate with her physicians and family. Her communication needs in all aspects of daily routine are not met. Mrs. F. is frustrated by her inability to communicate effectively.

To bridge the gap between Mrs. F.'s communicative needs and her expressive communicative abilities, Ms. Plotnick considered and allowed Mrs. F. to try a range of augmentative communication devices. Each of these devices has the capability of meeting Mrs. F.'s communication needs and were considered as appropriate alternatives. Ms. Plotnick ultimately concluded that the AAC device most appropriate for Mrs. F. is a LightWriter.

The LightWriter is a compact, lightweight, easy to learn and easy to use device that relies on spelling -- a skill Mrs. F. possesses -- to create words, phrases, sentences, even entire messages which the device "speaks" in a voice that is recognized as the most intelligible voice currently being used in augmentative communication devices.26 The LightWriter will enable Mrs. F. to meet all of the communication needs identified by Ms. Plotnick, which mirror the broadest, speech-restorative treatment goals that are recognized by Medicare. It also offers a unique feature: a "dual display," i.e., a small display is provided on the communication partner's (listener's) side of the device that will provide a written version of Mrs. F.'s message, in addition to the synthesized voice, which also increases the intelligibility of her messages. Another important feature is that the LightWriter will be useful to Mrs. F. even if her condition progresses and she loses the ability to use her hands to create messages. The LightWriter has an accessory that will permit "scanning," an alternative means to produce messages for individuals who do not have the ability to use"direct selection" (i.e. typing with the fingers) to produce messages. Lastly, as compared to the other devices Ms. Plotnick presented as equally effective alternatives, i.e., that have the same speech-restorative potential, the LightWriter is $ 2,000 to 3,000 less expensive.

Mrs. F. had the opportunity to try out the different devices, and agreed that the LightWriter was the one that was the most appropriate for her use. She then borrowed a LightWriter for a three month period, which she used to communicate at home. This period ended in April 2000. Since that time, Mrs. F. has had access to another AAC device, known as the Link, which has not offered an effective means of communication.

In June, 2000, Ms. Plotnick conducted a follow up evaluation of Mrs. F. after the trial period with the LightWriter, and after a period of time with the Link. The following is based on this evaluation report, attached as Exhibit 6.

Ms. Plotnick noted that Mrs. F. needed to slow down her rate of typing, and made some minor adjustments to the settings on the device being used for demonstration and evaluation, which improved Mrs. F.'s ability to use the device. Mrs. F. continues to show interest in the LightWriter as a communication tool, and when presented with another device to consider as an alternative, she again expressed preference for the LightWriter. Ms. Plotnick re-affirmed her recommendation that the LightWriter is the most appropriate AAC device for Mrs. F.'s communication abilities and needs.

However, Mrs. F. continues to lack access to this device, based on her enrollment as a Medicare HMO participant.

D.	Medicare Claim and Appeals

Mrs. F. is enrolled in a Medicare HMO administered by Oxford Health Plans. In the Fall, 1999, Mrs. F. submitted a request for approval of an augmentative communication evaluation, and thereafter for purchase of the LightWriter following its recommendation by Ms. Plotnick. These requests were denied, as were appeals on reconsideration and appeal to the Center for Health Dispute Resolution.27

As part of the claim and initial appeals process, Oxford acknowledged that the AAC device Mrs. F. seeks "will be helpful," but reported that it could not approve funding for the device because it was not covered by Medicare.28 Oxford's position regarding the value of AAC devices for people with severe communication impairments is consistent with its coverage and funding of AAC devices by individuals who hold commercial insurance policies with Oxford.29

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

In both Fred C. v. Texas Health & Human Services Commission,30 and Hunter v. Chiles,31 the district courts concluded that the ability to communicate is "vital,"32 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.33

In addition, in Fred C. 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.34 In Hunter, the issue was the same: was Florida Medicaid obligated to cover and provide AAC devices to adults? The conclusion, as in Fred C., was yes.35

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.

C. Musselwhite & K. St. Louis, Communication Programming for Persons with Severe Handicaps (2d. Ed. 1988).

Jean-Dominique 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-D. 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."36 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.37

If the fundamental importance of the ability to communicate effectively is not self-evident, the life-threatening circumstances38 and outrageous injury39 experienced by people who lacked the ability to speak, and the perceptions by others that they are non-sentient40 or even non-human,41 clearly demonstrate its value.

Mrs. F., thankfully, has not experienced the harm that is all too common among individuals with severe communication disabilities. However, the pragmatic, day-to-day impact of her aphonia, described above, are as severe as they are unnecessary. Despite its severity, speech- language pathology treatment, in the form of augmentative communication interventions, is readily available to treat Mrs. F.'s aphonia.

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, Parkinson's Disease, traumatic brain injury, or stroke.42 This role -- treatment of a condition's effects -- is well accepted by Medicare. As an ALJ has noted in an earlier AAC device decision:

The Medicare Hearing Officer . . . 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-language 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 threat 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 a body part that is not functioning. . . .43

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.44 It is the key to communicative competence (effectiveness), and improvement in intelligibility is the primary objective of most speech-language management.45

For persons with dysphonia, i.e., impairments of the voice, the most severe state of which is "aphonia," or the complete absence of voice, 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.46

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."47

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.48

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.49

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.50

Ms. Plotnick recognized that the LightWriter will provide Mrs. F. 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. Exhibit 1. In addition, in contrast to the "small change" in communication functioning permitted in the Medicare SLP services guidelines, use of the LightWriter will provide Mrs. F. 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 and to prevent the adverse effects associated with an inability to speak or otherwise expressively communicate.51 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.52 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.53

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.54

Augmentative communication also is recognized by the American Speech-Language- Hearing Association, and by Medicare staff as an appropriate treatment for aphonia. In late April, 2000, staff at the Health Care Financing Administration completed their review of the Formal Request for Augmentative and Alternative Communication Device National Coverage Determination, CAG 00055, filed December 30, 1999. That document had been prepared at the request of the Medicare administrator, made to Mrs. F.'s counsel, in June 1999. The purpose of the Formal Request was to provide information HCFA/Medicare staff needed to re-review the agency's existing coverage guidance for AAC devices. (This guidance is described further in § IV, below.)

The Formal Request discussed the professional literature and clinical decision making process related to AAC interventions, and described the characteristics of AAC devices. It reported that AAC devices were most commonly associated with three communication disabilities, which are dysarthria, apraxia and aphasia. (The full text of the Formal Request can be reviewed at the website for Augmentative Communication, Inc., www.augcominc.com.)

In response, HCFA staff stated that the Formal Request may have been too narrowly crafted, i.e., it focused too extensively on the most common conditions associated with AAC device need and AAC device use, but omitted a discussion of aphonia, for which AAC interventions also may be needed. HCFA staff wrote:

The original request was for a population that had loss of speech, characterized as dysarthria, apraxia or aphasia. We are concerned that this list is . . . also exclusive of populations that could benefit, and thus further specification and refinement are needed. For example, patients who are aphonic on a long term basis due to laryngeal disorders may be eligible for an AAC device, but are not discussed in the supporting material received.. . . .55

Exhibit 11 is the response to this and other HCFA staff comments to the Formal Request, and includes confirmation by the American Speech-Language-Hearing Association that AAC devices are appropriate treatment for individuals with aphonia.56 In addition, the professional literature recognizes that individuals who have communication impairments secondary to Parkinson's Disease, such as Mrs. F.'s aphonia, use devices like the LightWriter, which she seeks:

Typically, these individuals do not use multifunctional AAC devices, but rather use systems that require letter-by-letter typing with print or speech output. 57

For this reason, a proposed AAC device national coverage decision, which currently is undergoing final review by HCFA staff, was revised to include coverage of individuals with aphonia, in the following circumstances:

For individuals with a diagnosis of aphonia, the SLP must conclude the individual is not able to use natural communication, amplification devices or an artificial larynx (electronic speech aid) to meet daily communication needs.58

For Mrs. F., the medical and speech-language pathology reports contained at Exhibits 1, 2, 3, 4, and 6, provide all the specific facts necessary to satisfy these proposed criteria. Ms. Plotnick, Drs. Strauss and Merrill and Ms. Killian all concluded that for Mrs. F., use of augmentative communication is the least costly and the only effective course of treatment for her aphonia.59

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."60 Among the "items and services" provided by Medicare Part B are durable medical equipment61 and prosthetic devices.62 Augmentative communication devices, such as the LightWriter requested by Mrs. F., satisfy all the criteria stated in the Medicare definitions of both the durable medical equipment and prosthetic device benefit categories.63

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.64

Augmentative communication devices satisfy all of these criteria. Without question they are able to withstand repeated use. For example, the VOIS 140 AAC device, which was approved by Medicare for a beneficiary in 1986, was used for a period of approximately 10 years.65 When that device finally ceased to function, the beneficiary purchased a LightWriter, the same device as Mrs. F. seeks. That device already has been in use for 2 years, and reimbursement for it was approved by a Medicare Administrative Law Judge approximately one week ago.66 The LightWriter which Mrs. F. seeks is likewise expected to be benefit to her for a period of years, if not for the rest of her life.

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. . . .67

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 aphonia. 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.68

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 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. . . .69

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 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, Mrs. F.'s request for Medicare reimbursement for a LightWriter as DME does not raise questions of first impression. In seven of the eight known Medicare AAC administrative law judge (ALJ) hearing decisions, the ALJ approved the requested device under the Medicare DME benefit.70 (In the other case, the ALJ approved the requested device under the Medicare prosthetic device benefit.)71

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.72

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. . . .73

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.74

And, in In re: Kim D., the ALJ noted that Medicare had previously approved an AAC device for this beneficiary in 1986, which classified that device as an item of DME, and that the LightWriter being used as a replacement for that device also meets all the applicable criteria.75

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.76 Medicaid, governed by Title XIX of the Social Security Act,77 covers durable medical equipment,78 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.79 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.80 In addition, the Health 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.81

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, which provided yet further support for the favorable funding decision reached by the ALJ in In re: Kim D., Exhibit 13.

B.	Augmentative Communication Devices Are Prosthetic Devices82

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 . . ."83 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."84

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 lips85 yield intelligible speech. For Mrs. F., by contrast, the functioning and coordination of these body organs and other body structures is substantially impaired as a result of her cortico-basal ganglia degeneration. The result is that she lacks intelligible speech, i.e. she has aphonia.

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.86 The other is commonly known as a tracheostomy speaking valve.87 Like 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.88

More directly on point regarding coverage of augmentative communication devices is In re: Emyln J.,89 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 comparable to the intended effects the LightWriter is to provide to Mrs. F.:

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. . . ."90

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 prosthetic device as it replaces part of the function of an impaired body organ, Mr. J's brain.91

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.92

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.93

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.94

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.95

Medicaid programs throughout the country recognize that under the federal Medicaid regulations, "prosthetic devices can be defined in functional terms,"96 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,97 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 . . . .98

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.99

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."100 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.101

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 beneficiary?102

Augmentative communication devices, like the LightWriter being sought by Mrs. F., 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 Mrs. F.' aphonia.103 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. Ms. Plotnick, the evaluating speech-language pathologist, concluded that there is no question that the LightWriter Mrs. F. seeks -- like the LightWriters approved by A.L.J.s for two other Medicare beneficiaries -- will make a "meaningful contribution" to treatment of her aphonia.

The degree of the anticipated contribution also makes clear that providing augmentative communication devices is reasonable. For Mrs. F., 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.

With the LightWriter, but only with the LightWriter, Mrs. F. will be able to meet all the communication needs arising in her daily activities, including communication with her husband, care-giver, family, friends and others.

With, but only with the LightWriter, Mrs. F. will be able to achieve full conversational communication, the highest level of functional communication recognized by Medicare criteria and the closest to normal functioning.

With, but only with the LightWriter, Mrs. F.'s functional communication can and will improve from barely intelligible even to familiar listeners, as reported by Ms. Plotnick, her SLP, to as close to normal communication as can be achieved with an AAC device.

These gains represent the greatest possible degree of improvement in her functional communication abilities.

Moreover, as noted above, the emotional benefits to Mrs. F. 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 Mrs. F..

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.104 This list includes other federal health-benefits programs, such as Medicaid programs,105 CHAMPUS106 and the Department of Veterans Affairs,107 as well as private health-benefits programs, including Oxford hundreds of other commercial health insurance providers and managed care organizations.108 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,109 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."110 Likewise, in Meyers v. Reagen,111 Fred C.,112 and Hunter,113 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 Mrs. F. seeks to support the same conclusion: that it, too, satisfies the Medicare "reasonable and necessary" standard.

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).114

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.115

As explained by the ALJ in In re: Kim D., Exhibit 13 at p. 3, 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).116

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.

(b) Review by an ALJ. (1) An ALJ may not disregard, set aside or otherwise review an NCD.117

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.118

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.119 According to the regulations, only National Coverage Determinations based on 42 U.S.C. § 1395y(a)(1) are binding. 120

In addition, the AAC device National Coverage Determination deserves no deference even as non-binding guidance. In the period generally believed to be before the AAC Device NCD was written, Medicare had 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 another AAC device, concluding it was not a personal comfort item, but instead, was both an item of durable medical equipment and a prosthetic device.121 Since 1993, notwithstanding the NCD, no Medicare ALJ (the first Medicare decision maker with discretion not to follow the NCD) has found the NCD to be credible or persuasive.122

Of greatest significance, the AAC device National Coverage Determination deserves no deference because, according to the Health Care Financing Administration, there is no known basis for it. 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.123 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.124 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 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."125 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.126

Augmentative communication devices, in clear 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. As noted above, in June 1999, an aide to the HCFA administrator contacted Mrs. F.'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 Augmentative and Alternative Communication Devices, was filed by Mrs. F.'s attorney, on behalf of 13 organizations representing every interest related to Medicare coverage of AAC devices. 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 wrote to HCFA that the Formal Request is 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.

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).127

Thus, there is no binding national Medicare guidance that precludes a favorable decision on Mrs. F.'s appeal, and even the Health Care Financing Administration now acknowledges that its non-binding AAC guidance is incorrect and will be withdrawn.

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,128 artificial limbs,129 pacemakers,130 and cochlear implants131 -- 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 Mrs. F.'s aphonia, that the LightWriter will permit "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 25.

Access to augmentative communication, through the LightWriter -- and nothing else -- can change that. Its effect, in the words of the claimant in In re: Emyln J. will "open up [her] life"132 and will enable her to function -- despite her condition -- as an active, articulate wife, mother, and grandmother. These abilities are no less significant an occurrence than if Mrs. F. were to awaken from a coma.

That the LightWriter will enable Mrs. F. to have a normal life, despite her communication disability, is completely consistent with every relevant Medicare coverage and funding criterion.

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 Mrs. F., 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 two of those cases include the same one as Mrs. F. seeks: the LightWriter, and those AAC devices approved in the other cases 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.

Thus, no basis exists for this appeal to reach any result other than to direct Mrs. F.'s HMO to forthwith provide funding for the LightWriter Mrs. F. seeks.

Dated:	Ithaca, New York

August 2, 2000

Respectfully submitted,

_______________________

Lewis Golinker

Attorney for Jeanine F.

Exhibits List

1.	Letter dated February 16, 2000 to Ms. Caline Thomas from Charlotte Plotnick, United Cerebral Palsy Association of Nassau County, NY, with attached evaluation report

2.	Evaluation Report dated September 30, 1999 by Denise Killian, North Shore Center for Speech, Language and Swallowing Disorders.

3.	Letter dated September 29, 1999 to Robert Strauss, M.D., from Merrill Goodman, M.D.

4.	Prescription for AAC device dated October 15, 1999 by Robert Strauss, M.D.

5.	Descriptive booklet re: LightWriters.

6.	Follow up evaluation report by Charlotte Plotnick, dated June 7, 2000.

7.	Claim and appeal denial correspondence.

8.	Invoices from Arroyo & Associates re: payment by Oxford Health Plans for AAC devices

9.	In re: Donald S., Dkt. No. 000-89-3072 (Social Security Admin. Office of Hearings & Appeals Oct. 14, 1999).

10.	Medicare Intermediaries Manual, § 3905; Medicare Hospital Manual, § 446

11	Memorandum dated June 29, 2000 to Madeline Ulrich, M.D., Health Care Financing Administration, from Lewis Golinker

12.	Memorandum dated June 27, 2000 to Lewis Golinker, from Steven White, Ph.D., Director, Health Care Economics and Advocacy, American Speech-Language-Hearing Association.

13.	In re: Kimberly D., Dkt. No. 000-19-3751 (Social Security Admin. Office of Hearings & Appeals July 28, 2000).

14.	Affidavit of Kim Wright, Medical Accounts Manager, Zygo, Inc., submitted in In re: Celia C. Dkt. No. 196-14-0195 (Social Security Admin. Office of Hearings & Appeals Dec. 2, 1998)

15.	Letter dated October 23, 1999 to Lewis Golinker from Peggy Locke, President, Communication Aid Manufacturers Association.

16.	In re: Charles McP., Dkt. No. _____________ (Social Security Admin. Office of Hearings & Appeals March 27, 2000); In re: Bernadine A., Dkt. No. 000-86-0336 (Social Security Admin. Office of Hearings & Appeals April 27, 1999); In re: Celia C., Dkt. No. 196-14-0195 (Social Security Admin. Office of Hearings & Appeals Dec. 2, 1998); In re: Richard A., Dkt. No. 000-06-0110 (Social Security Admin. Office of Hearings & Appeals March 24, 1997); In re: Blanche B., Dkt. No. 000-24-0399 (Social Security Admin. Office of Hearings & Appeals May 3, 1995).

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

18.	L. Golinker, "Speaking Up In Court," 8 Team Rehab Report 19 (Feb. 1997).

19.	Affidavit of Phil Saines, Funding Coordinator, Assistive Technology, Inc., submitted in In re: Celia C. Dkt. No. 196-14-0195 (Social Security Admin. Office of Hearings & Appeals Dec. 2, 1998).

20.	Affidavit of Yvette Walden, Funding Coordinator, Dynavox Systems, Inc., submitted in In re: Celia C. Dkt. No. 196-14-0195 (Social Security Admin. Office of Hearings & Appeals Dec. 2, 1998).

21.	62 Fed. Reg. 25844 et seq. (May 12, 1997).

22.	Letter dated March 31, 1991, to Michael Williams, from Annabelle Broussard, Blue Shield of California approving Medicare funding for AAC device.

23.	Letter dated September 12, 1986 to Anna Hoffman, Phonic Ear Corp., from Margaret Carpenter, Medicare Hearing Officer, approving AAC device for Kimberly B., see Exhibit 13.

24.	Letter dated July 8, 1998 to Elizabeth Carder, Esq., from Phillip Brown, Director, HCFA Office of Freedom of Information and Privacy.

25.	Decision Memorandum re: Augmentative and Alternative Communication Devices, dated April 26, 2000 issued by Hugh Hill, M.D., Acting Director, HCFA Coverage and Analysis Group, announcing elimination of AAC device national non-coverage decision.