MARTIN GERRY: Still remember that time of the morning, and it is good
time to start, and I want to welcome you very much and thank you for
coming to what I know will be a very interesting and, I think, an
important session as we try to figure out how to improve the role that
we have governing the immune system disorders. Let me introduce, on my
right, Sue Roecker, the Associate Commissioner for the program, who will
be talking specifics of this meeting.

SUE ROECKER: Thanks Martin. Well, again, welcome, and we are delighted
to have you all here, and we really appreciate you taking the time. Many
of you have come from out of town; we do appreciate you traveling to
Philadelphia. We think this is a really good way to hear from members of
the public and members of various organizations, so we will really
appreciate your responses, and we hope it is a productive day. We do
have a facilitator and an agenda,

so we will get to that in just a little bit. But before we start into
the panels and in our interactive discussion, we wanted to give you a
sense of why we are here and a little about the structure of our policy
and rules and so forth. Some of you know those rules and structure as
well and even better than we do, and some of you don't. You are
immediately not involved on a day-to-day basis, so we think it a good
thing to give you a sense of how this policy discussion fits in with the
Social Security Disability program. We're here to talk about policy in a
specific area, but this is just one slice of the policy governing
disability claims adjudication and decisions about disability claims
that people have filed and that cover both what we call Title 2 which is
Social Security and Title 16, which is the Supplementary Security Income
programs. Although there are different criteria in terms of coverage or
income between the two programs, the rules about disability
adjudication, whether you are in fact eligible for disability because of
medical impairments, are exactly the same. There are other factors to
consider if you are filing for Title 2 or Title 16, but these kinds of
rules we are talking about today apply equally to both programs. A sense
of the program is a large program. I think most of you know that we
served in 2002 over 5 1/2 million disabled workers, who received
benefits, so that's a large number. We also had close to 5 million SSI
disabled and blind individuals receiving benefits, that a lot of people.
Some of those numbers overlap because some people get both benefits, but
again, we are talking about millions and millions of people who are
currently being served and currently getting a monthly check, in
addition to that, we get annual new claims files, applications for
benefits for folks. In 2002, a year ago, about 1.6 million workers filed
for disability for Title 2, and about 1.8 million people filed for SSI
blind or disabled benefits. Those are the kinds of claims that we would
be working each year, adjudication processing and applying rules about
what we are going to talk about today to those decisions. So, we affect
a lot of families and individuals, and we take our jobs very seriously.
One of the reasons that we are here today is that we always for many
many years ... these kind of listings what we call medical listings.
Bill is going to talk a little more about them. They are Federal
regulations, and we have to follow the process for accommodating Federal
regulations in order to make these enforceable and make them effective.
Normally, what we do is write and publish a rule called a Notice of
Proposed Rule Making (NPRF), and the usual length of time for commenting
on that time of notice is 60 days. We get public comments, we consider
them, and then we publish a final regulation. Of course, that has to
clear through not only internal clearance, in the Social Security
Administration, but also to the Office of Management and Budget, so that
process tends to take some months for each of those steps. What we have
done in each case in the immune system, and we are doing it also for
mental disorders, is not to just jump in and write a Notice for Proposed
Rule Making. We publish an advance Notice for Proposed Rule Making as a
call to the public to help us frame our proposed policy. We have not
written the proposed policy as yet. This was absolutely a ground-floor
opportunity for members of the public to give us some input and to tell
us what we should consider ... how we can shape those rules, and how we
should change those existing rules. So we did that for mental disorders,
and now we did this for the immune system. Very, very gratifying, these
responses. We get well over 200 commenters to the immune system's call
for comments. What we will do now, today, and again in February in San
Francisco is talk about those comments. We have very diverse comments
and so, believe it or not, not everybody says the same things or agrees
with each other. So now we have sorted through some, and there appears
to be some discrepancy or different point of view. In fact, as we
explore them we may not have any discrepancy, but we need to explore
that and get some clarification. And also get a little more definition
or more detail on some of them, so we can take some of those comments
back with us to the office and begin to write the proposed rules. We are
having this opportunity today and then again in February, and,
immediately after that, we will begin writing the Notice for Proposed
Rule Making; and, again, we are going to do this as quickly as we can,
but it does take months and months to go through the notice process and
the comments period and then resolve these comments and then issue a
final **\-\-\-\-\-\-\-\-\-\-\--**So you are not going to see the final
\-\-\-\-\-\-\-\-\-- any time in the spring or summer, but hopefully in
the not too distant future; but we will have the rule. So today we will
be talking about that, and we will follow the process after we get these
comments through the normal regulatory process. And of course,
everything is published in the Federal Register, so it's a matter of
public records and has the force of law. We also have to be in the
perimeter of the statute of the law itself, so we can do anything that
we want. We do have restrictions in terms of what the law allows and
asks us to do. The regulation we proliferate really further defines how
we are going to administer the program. The program has been legislated,
and we have to follow that legislation so that this has the force of
all, but it has to be consistent and within the perimeter of the law
that has been enacted. Before Bill talks more specifically about the
medical listing and how we use them and what they are, we want to
introduce some steps here. Part of what we hope would be happening today
is not just these open sessions, but I like to call them hallway
conversations. So if you have any questions or other thoughts as you
have a cup of coffee, during the break, or at lunch, please talk to the
policy staff that are here. I am going to introduce them so that you
know who they are so they cannot hide under the cloak of anonymity; so
you know who they are, and they know that you know them. They will be
expecting to be approached and to be engaged in some discussion or some
question during the day. Bill Anderson is up here with us. Bill is the
Director of the Office of Medical Policy. His office writes, monitors,
and otherwise has the care and the feeding of the medical listings. Bill
is the head honcho on that. To those at the table in the back in the
center, please stand when I call your name: Barry Igan. Barry is our
Executive Program Policy Officer. He works out of my office, and he is
one of the real experts in program policy and certainly has a hand in
the listing as well as other policy. Paul Scott is our lead for this
system. Peggy Tally is another Policy Analyst. Jane Dewed---I'm sure I'm
going in the right order---Judy Hicks, Dr. Monty Heddling; and also
another person that's helping us is Dr. Martin (?) Fountain. She works
in the Federal DDS, which is another component of SSA, so she is here
today also. The final person I want to introduce is Jerry (?) Boards. We
should call her General Boards. She is going to be our facilitator and
will keep us on track today. Jerry is from our Philadelphia regional
office here in SSA, and she is a very skillful facilitator. I think she
will help all of us get the most out of the meeting and use her time
most wisely. I want to say that it is an informal session, and we all
are taking notes so that we do not miss anything. This is not a formal
hearing in that sense, and we are trying to make sure that we get a good
record of all the conversations, all the discussion, all the
suggestions, but it is informal. We do have some speakers that generate
some discussion. Please, please participate if you have something to
say; please don't hesitate during the conversation. If you have
something else that occurs to you afterwards, we are still in the period
of time. Again, we are not going to have the meeting in San Francisco
until February. So we would love to hear from you after you get back,
and you think about something you heard today, and you have other
thoughts, please send them to us. The door is not closed after today;
this is not your only shot, so please consider sending any other
thoughts you have later on. So with that, I will turn it over to Bill to
talk about the listings.

BILL ANDERSON: Thank you and good morning. I am the Director of the
Office of Medical Policy. I have a staff of 12 professional policymakers
and 8 medical officers that work for me in trying to develop the
criteria in the listings. What I'm going to try to do today is to give
everybody a very brief overview of how the process works and how to use
the listings. Much of this it going to be a boring presentation for many
of you who have been in the process for a long time, but there may be
some people who have not been to Disability 101; so I'm going to try and
hit the high spots, and you are welcome to ask questions as I go along
if there is something that is not clear to you. The process of revising
the immune regulation. We are meeting here, and we invited people who
sent us specific comments when we published the advance Notice for
Proposal Rules Making or people we knew that were interested in the
immune system. For those of you that may not be aware, the immune system
actually started as a system about 10 years ago in 1993 and was
published primarily as a publication to cover the HIV criteria. We have
since added criteria to the immune system so that---we kind of separated
it as we tried to discuss it into the immune system that's HIV-specific
and then the immune system that is other immune deficiency disorder that
we cover. We published the advance Notice for Proposed Rule Making on
May the 9th as Sue told you. We got a lot of comments, and that was
gratifying because it helped a lot for us to develop criteria.

For the most part, as long as we have the listings, we will primarily
develop a Notice of Proposed Rule Making and publish it in the Federal
Register, and then the public will have 60 days to comment on it. We
will look at the comments and prepare a final regulation. One the
criticisms that we have had for years is that once we publish a Notice
of Proposed Rule Making, everybody was concerned because they saw very
little difference between the Notice of Proposed Rule Making and the
final, which meant that everybody had the idea that we at least looked
like we had our minds made up when we published the Notice of Proposed
Rule Making. That's not entirely true. We've gotten a lot of good
comments over the years, and we have tried to react to them. There are
only so many things you can do once you publish the Notice of Proposed
Rule Making. When Martin came to the SSA, actually even predating him a
little bit, there was concern that we should involve more people in our
listings process. Martin is the one that said OK, let's stop talking and
figure out a way to do it. What we did in the beginning was that we said
OK there are some body systems that are more controversial than others.
There are some where we want to make some fairly minor and
noncontroversial revision, and that's the way we try to separate. That's
why the two that are probably the most contentious are the mental
impairment and the immune system, because both of them affect some
people that are in most need of our assistance in the community. So
that's why we started these public sessions. As Sue told you, this
session is not the end but the beginning. Many of you, as you engage in
your hallway conversations, should be aware that once we have your name,
we will be following up with you over the next few months as we talk
about what we want to do with various criteria. This is also to help us
identify people who can help us because we really try to resolve a lot
of the problems as we publish new criteria. The listings our perimeter
is to set out in all rules 20 CRF Appendix 1, P in Part 4 for it is
called the Listing of Impairments. Most of you are more aware of the
Blue Book, which we publish. The Blue Book is published once a year; it
comes out and gives you all the background on all the listings. We have
a Web site with all the criteria of the Blue Book. When we publish a new
listing, it is changed immediately, rather than in the publication of
the Blue Book once a year. The listings are divided into two parts: Part
A and Part B. Part A is for adults, and Part B is for children. The way
our rules work is that an adult always has to use Part A of the criteria
for evaluating the impairment. Part B is written specifically and
primarily for children. The way we've done it is that we try to identify
items specific to children in Part B. However, for children, if a child
has an impairment that is not listed in Part B and is not specifically
mentioned, and there is a Part A listings that could in fact be used to
adjudicate that child's case, then we will start with Part B on the
child, and then we will go to Part A for the child.

The listings for the immune system disorders are found in 14.00 and
114.00 for the children. What we intend to do as we go through the day
is to use your prior comments, which we really appreciate, and we are
going to take notes of the conversation of today, and my staff will
write down all conversations that they have. And when we get back, we
will start looking at all the comments as we try to figure out what our
next step is in the process. The next step in the process will not be
writing the Notice of Proposed Rule Making. The next step is obviously
going to be dealing with everybody that we talk too, to try to figure
out what we want to put in those criteria. So that's what going to
happen in the next 4 to 6 months as we move forward. Obviously, any
participation that you have goes in affect. Once we do decide what we
want to do, we will publish a Notice of Proposed Rule Making and will
still have the 60-day comment period. That would not be a problem. For
the immune regulation, it is kind of redundant for many because there
are people in this room that dealt with us 10 years ago when we
developed the first immune regulation, and it was published as a final
rule on July 2, 1993. We actually published\-\-\-\-\-\-\-\-\-\--final
rules in November 2001 that had some impact on the immune criteria but
have not comprehensively reviewed any of these since 1993. Let me talk
about how the rules work. Sue told you about the statutory process.
Social Security Disability is based on a definition in the law. It is
based on the inability to work. Now, the trick that we have been trying
to accomplish for well over the last 40 years in terms of developing the
listings of impairments that are obviously the definition of disability
is to develop a functional disability. However, in trying to write
listings, we do try to stick to the parts of this statute that you talk
about. You have to have a medically determined impairment that is
documented by sign, symptoms, and laboratory findings; medical criteria
that result in an inability to work. Over the years, we have been more
or less successful in identifying medical criteria. Many of our listings
have a combination of medical criteria that we call functional criteria,
which is really the impact on the day-to-day basis of the impairment.
The biggest issue that everybody has in terms of dealing with medical
criteria versus functional criteria is that we have to balance the fact
that we want the medical listing to in fact be an administrative
shortcut to quickly identify people whom everyone would agree are
disabled, and that is a really, really tough thing to accomplish in some
criteria. In some of the body systems, it is easier to think that is in
others because you know that disability is a lot of perception and that
people can look at someone and say he or she is disabled.

The longer we are in business, the more we realize that disabilities are
not always evident. Identifying them is an issue for us. We consider
disability if you cannot do any of the work you have done in the past or
if you are unable to do any work existing in the national economy. That
is a\-\-\-\-\-\-\-\-\-\-\--definition in many ways but it is one that is
a fairly strict definition in terms of what the statute lays out, and we
have to deal with the statuary problem of it. The disability can be
physical and or mental and the fun part of our job is that the people
who come to see us don't have one impairment. Very rarely do we have
someone that comes in and say I have "X" disease; they always have a
multiplicity of things that are wrong with them and are looking to us to
help them. The other part of the definition of disability is what we
call the duration piece. In the original discussions of disability, one
of the things Congress wanted to avoid was having the Social Security
Disability program be a temporary disability program. Those of you who
have been around a long time like I have will remember when the original
definition was an indefinite determination, so that it was either going
to end in death or last a very long time. In 1967, we had a part that
was expected, or we expected, to last at least 12 months or result in
death. Those are one of the things we have to consider as we develop
criteria. We have to figure out how we can ensure that people that come
in and need help today---how we can look at them and decide, because
many, many of these people hit us very quickly after they have separated
from the workforce---and we have to figure out how we can look at them
and decide that they are impaired or either will last or could be
expected to last 12 months. For a child under the age of 18, we consider
them to be disabled if they have a physical or mental impairment or a
combination of impairment that causes \-\-\-\-\-\-\-\-\-\--and severe
functional limitation, that \-\-\-\-- that \-\-\-\-\-\--and severe
functional limitations has a specific meaning for us. It was always
picked at the level that is contemplated by the listing of impairments.
Those of you who have been dealing with the childhood program know that
we went through the first 1974--1994, the first 16 years of existence in
using a definition that was very controversial. A child had to meet
required listings in order to get paid, and in 1990, we had about
100,000 children on the roll. A lawsuit was filed call Zebley. In fact,
he said that the way the statute reads, we have to do more than meet or
equal, and the Supreme Court agreed. So between 1990, when the decision
came down, and in 1991, we published the first regulation, and we had to
put together an entire structure for children in like 18 months, like
what we been working on for adults for 40 years. It was quite a
challenge. We did a job that we thought was consistent with the
regulations, and most of you that follow the childhood program know that
the next few years were filled; from 100,000 children on the rolls to
almost 1 million on the rolls. Congress reacted and tightened up the
criteria, and when it did, it used what we call in terms of defining the
charter criteria and that is where the terminology that it is to mark
functional limitations. The child also has to meet the duration
requirement, which means it has to last for 12 months or result in
death. Sue told you that there are two different programs: the Social
Security Disability the Insurance Program and the Supplementary Social
Security Income Program. Obviously the SSD program as a Federal program
has been around for more than 40 years. The Federal Government took over
the State welfare program in 1974, and that's when SSI came along. SSI
is based upon income and resources. To become entitled to SSD, you have
to work enough to qualify for benefits; and obviously for SS
supplementary income program, you have to meet the income and resources
requirements. That is basically how the program is set up. Let me tell
you a little bit how the process works. This is where many, many, many
people get confused because we have a kind of strange hybrid in terms of
how we operate. The SSA operates the disability program, but we operate
in collaboration with what we call State Agencies. We have 54 State
Agencies that are responsible for administering the SS program. Those
State Agencies are 100 percent federally funded, but they have State
employees under control of the Governor of each State. Their requirement
is that they must follow the statute regulations and written guidelines
that the SSA puts out. It does involve a strange process for people that
come into file, because they come into one of our local Social Security
field offices, of which we have over 1,300 nationally and file a claim
for Social Security Disability. We take information, and our field
office employee then takes a look at it to see whether or not the
individuals meet the substantial requirements or whether or not they
will be eligible, regarding if they have worked long enough under SS
disability or appear to meet the income and resources. The field office
will also take all of the application information in terms of work
personnel ages, where they work and how long they work, and other
information. That package is then put together and shipped to a State
agency and then for the next 3 to 6 months the claimants who have gone
in to file in the Social Security field office is now dealing with a
State Agency who then sends them an introduction letter, but they are
responsible for developing and adjudicating the disability claims. The
primary way that it works is that those State Agencies have a core of
trained disability examiners who are responsible for developing and
adjudicating the claims. Each of the claims, when it gets ready to be
adjudicated, is reviewed and approved by both State Agency examiner and
a State Agency Medical Consultant. Obviously, we have some specific
guidelines on children's cases that involve a pediatrician or other
health care professional who is specialized in what the children need in
mental claim and mental denials. We have to make every reasonable effort
to make sure that a psychiatrist or physiologist is involved in the
adjudication.

How do they go about making their disability determinations? We have to
set up a process, which I am sure that is obvious, given the comments
that most of you have written that you understand. Let me run through it
real quickly. We use what we call a sequential process, a sequential
evaluation to evaluate disability. Obviously, the first step that we do
on any claim is to find out whether or not the individual is currently
working because it doesn't matter how severely impaired the individual
is---if they are working on an SGA level, they are not going to be
entitled to Social Security Disability or Supplementary Security Income
benefits. So that is step one. The next two steps are in the process of
what we'll call screening steps because they are used to quickly screen
people, either out of the program or into the program. They \[the
steps\] are administratively expedient for us. They allow us to take
people and try to categorize them such that even if we took them through
the process, they will not be disabled; or the second step, or the third
step, if we took them all the way through the process, they would be
found disabled. So the second step is what we call the severity step; we
look to see whether the individual has an impairment that limits his/her
ability to do basic work activities. Basic work activities include:
standing, walking, sitting, kneeling, speaking, hearing, and performing
mental things that are required. If the individual does not have an
impairment that limits his/her basic work activities, then we find them
not disabled, and that's the end of the process. The objective here is
not to screen people out that we don't want to deal with. It is to try
to identify people who have come to see us with minor impairments that
even if we took them through the process would not be found disabled.
It's a step that works well when applied appropriately. Applied
inappropriately, it probably results in not having a fair decision for
the claimant. We work very hard to make sure we apply the second steps
appropriately. The third step, the one that we are here to talk about
today, is whether or not the individual has a medical condition that
meets or equals what we call a listing requirement. Those are criteria
that we developed that are primarily medical in nature, and obviously we
add some functional criteria in many, many cases. If an individual has
an impairment that meets or equals the listings, we will stop the
inquiry there and pay benefits to the individual at that point. Once we
pass those two screening steps, the next two steps really require a full
look into everything that there is. The fourth step of the process---and
what happens between the third step and the fourth step is that we
decided that somebody does not meet the requirements of the
listings---we then have to decide what function limitations the
individual has. We call this residual function capacity, and we have
both a physical and a mental form for evaluating residual function
capacity. The next step is whether or not the individual can do work
they have done in the past, and we call it past relevant work and define
in our criteria. Essentially, it is any work that is done at a
substantial gainful activity work level within the last 15 years or a
15-year period that moves around a little bit and which they perform
long enough to become component in the job. If an individual can't do
any of the work that they have done in the past, obviously the last step
is can the individual do any work that is done in the national economy.
For a child, it's a little different; obviously, the first two steps are
the same. If a child is working at the SGA level, they will be denied.
The second step is obviously a severity step. If they do not have any
impairments that result in minimal residual functional limitations, they
will be found not to be disabled. Then, the last step for them is do
they meet or medically equal for children. We also add what we call
functional equivalence, which is defined in the functional criteria.
Real quickly, and I notice that the person that's keeping us on schedule
is looking at me. I could talk about this all day long; so let me cut it
real short with a couple more things. We have a four-step process in
terms of people filing. We have initial applications; if individuals are
found not to be disabled, they will get a notice explaining why we found
them not disabled. They get appeal rights and they can file an appeal.
The first appeal will be a reconsideration claim. The reconsideration
claim is done by the same State agency that did the initial claim or
another State agency. If they happened to move, it is done by a
different additional examiner, a doctor if it is the same State agency.
If they are found not disabled at the reconsideration step, they will
get another notice that will explain why and be given appeal rights and
the opportunity to appeal to an administrative law judge. The
administrative law judge holds the noble hearing process and issues a
noble determination. If the individual is not disabled at the ALJ level,
then, he/she has the right to request an appeal with the Appeals
Council. And that's the administrative process. That's the four steps of
the administrative process. The Appeals Council can either take review
or not take review. If they take review, then they will generally rehand
it to the ALJ. At the end of the administrative process, if the
individual is still not satisfied, he/she can file in the Federal
District Court for review. The Federal District Circuit Court and the
Supreme Court and we do have cases that go to the Supreme Court. Let me
stop right there because we need to move on to the first panel. If any
of you have questions about this process that I walked through quickly,
any of my staff or Berry or myself can help you. Call us, and we will
try to give you answers to any of your questions. Thanks Bill.

RICHARD ELION: Good morning everybody. I'm a little confused this
morning because I live in Washington, DC, but I was born in
Philadelphia. So in order to testify about the Social Security
Administration which I believe is based near Washington, I came from
Washington, DC, too, so it is a little confusing day for me. I have been
an HIV provider for 20 years. I have had the good fortune of practicing
with Howard for 8 or 9 years in New York City, so it's a kind of déjà vu
to be on the panel with him. In practicing HIV for so long, we have seen
a lot of changes from when the laws of disability were very appropriate
to what the paradigm of what HIV care was and what the epidemic was, and
fortunately the situation has in some ways got better and in some ways
not gotten better. What I hope to do is to address some of the ways it's
changed, and some of the change in the terrain has changed the way we
look at disability. I am speaking on behalf of the HIVMA, which is an
offshoot of the IDSA (Infectious Disease Society of America). This was a
group that was formed to take advantage of the people in the infectious
disease community who were interested, providers that were interested as
well, to create access for people like myself. I'm a family doctor,
board-certified back in '83, and I've been providing HIV treatment in a
kind of specialty format. Howard is going to speak on behalf of the
academy, which is another organization and two main positions and
provider organizations, and I will speak on family HIV. Even with
HIV/AIDS treatment advances, there are currently lots of people who
currently don't known that they are HIV positive. At least there are 25
percent of people that are HIV positive and don't know it. The estimate
is much higher---as much as 50 percent---and for many others, the
diagnosis comes late. In 2001, a bit shy of 40 percent of the people
with HIV progressed to AIDS within 1 year of diagnosis. So therefore,
the care varies. This might change to the earlier testing, and it's a
lot of work to get prevention, and perhaps oral tests will lead to
better results. Currently, there is still a huge preponderance of the
infected population that doesn't know that they are infected. The
treatment challenge has changed a lot. We have not only the fact that
access to care makes it difficult for people to understand when they are
affected, but we also have co-morbidities. One of the significant
co-morbidities is hepatitis C. At least 25 percent of the people with
HIV are infected with the hepatitis C; perhaps 50 percent to 90 percent
are injection drug users. These are high rates of psychiatric disorders,
so not only infections etiologies but also mental health etiologies.
Some of these may be infectious. Perhaps an etiology may present as a
central nervous system disorder; 20 percent to 50 percent of the
patients have psychiatric diagnoses. Howard is going to talk about the
role of depression, so I will leave these remarks to him. High rates of
substance abuse will share one-forth the AIDS diagnosis in 2002, which
was attributed to IDUs. I think the rate of substance abuse is probably
higher than that, which takes all the other kinds of substance abuse
that people can use in accordance with HIV. You get a feeling for
background that it is a very heterogeneous community. Not just
heterogeneous in terms of risk exposure, but heterogeneous in term
co-morbidities. So there are lots of things that affect HIV besides HIV
itself. In fact, these days, HIV infections past the early days are not
only due just to HIV-related causes. You can see that the area of the
yellow shading is all best related not to HIV in patients who are HIV
positive. To break that down, you can look at some of the increasing
incidence of diabetes in HIV infections. Some of these are probably
related to the medication. There are various ways that the mediations
predispose people to diabetes, be it the changes in insulin
insensitivity on the serious level to the secondary to the medication.
So the medication themselves are probably responsible as well as the
increase in longevity that we are seeing in the HIV-positive patients
and therefore some of the regular diseases that regular folks get. HIV
people are also at risk. This is also true for cancer. This is probably
again somewhat related to immune suppression, but also related to the
duration of time people are alive, and there are a variety of cancers
that are listed. Then you can see the difference between HIV-positive
patients in a VA study versus non-HIV-positive patients. So with cancer,
diabetics, there's certainly increased cohort risk of heart disease; we
are not going to talk about right now. A bunch of studies showed a
change in a short period of time. A subsequent study in Europe showed
increased coronary disease associated with years shows on heart, but not
specific to regimen and other study in the French study. A large French
study showed an increase of cardiovascular risk with protease
inhibitors. So there is a wide variety of co-morbidities, from hepatics
C to coronary diabetes to psychiatric disorders, that are occurring,
making life a little more complicated. This just shows you some of the
causes of death, and you can see an increase in risk of liver disease;
non-Hodgkin's lymphoma is decreasing in the infectious etiology, but
increasing specifically related to infections disease per se. Another
aspect besides the co-morbidity is the incidences of drug resistance as
we see more and more drug use and lack of compliance to a resistance
increase. This is true for patients already taking their medications as
well as patients who are newly infected. And there are cases where
patients get infected with a strain that is highly resistant, and that
strain persists despite the fact they have not been on medication that
predisposes them to a much more rockier road in terms of the treatment.

Not only are the co-morbidities a problem for our patients, but the
treatment themselves are a problem. There are a variety of patients for
whom, because of some of the aspects of losing fat in the face and body,
the quality of life is so declined that they wish to take medication. We
have come so far in terms of helping people with the advances, but we
have scarred them in a sense; and so there is a tradeoff with quality of
life of what happens when you take these medications versus the benefit
of longevity that you gain; this is obviously subjective. There are also
various morbidities related to these, (e.g., diabetes, heart diseases).
We talk about liver disease and pancreatitis. Let me give you a case
study to demonstrate some of the examples. I have studies that I want to
talk about. This is JG. I am sure that these names are not in any
relationship to anybody that I met or heard of, but if I am violating
any laws, please talk to me later about that. In any case, this is JG
who is diagnosed with PCP pneumonia, presenting diagnoses inductive with
the kind of situation that is related to this, and perhaps functional
capability would be what would be imperative. She is still underweight;
she has decreased energy; she has decreased ability to concentrate; she
is tolerating her medication moderately well but with persistent
diarrhea. The issue of compliance comes up with her, and is something
you will hear throughout my talk today. One of the key issues that
Howard is going to talk about is that 60 percent of the patients say
they fail the first-year regimen because of tolerability issues. It is
not because of potency; it is not because of resistance; its because of
tolerability. These medications are very different than other kinds of
medications. These are oral chemotherapies, and, because they are oral
chemotherapies the tolerability is fundamental to individuals taking it.
Not only it is fundamental, but the inability to take every dose is
fundamental to their taking it. In a regimen that's twice a day, meaning
14 doses a week, if they miss one dose, there is a 20 percent loss of
efficacy. That means if they are more than two to three hours late with
one dose, they have a 20 percent loss; these are very brittle regimens.
We as physicians and scientists do our best to make these regimens as
supple as we can; that's why they \[doses\] are not three times a day
anymore. But we are stuck with twice a day and perhaps going to once a
day. But still there is a lack of compliance, and if there is a side
effect, at least to that, that is going to increase the risk of this,
and increase the rate of resistance and affect the epidemic as a whole.
So in this particular patient with low weight, with low energy, with the
side effects of the medications, with the CD4 count above 200 but with a
functional disability that is somewhat determined based on the
investigator, is she still disabled? Currently, for Medicaid and
Medicare with HIV/AIDS, 22 percent of the patients are on Medicaid or
Medicare at the time of diagnosis, about 40 percent with HIV receive
care through Medicaid. In 2002, more than 200,000 people with HIV/AIDS
received care, and more than 50,000 people with AIDS are Medicare
beneficiaries. Between ADOT and Medicaid/Medicare, I think it's over 50
percent of all medications are paid for by the government. We won't be
talking about the recent drug law changes on Medicare today, but we will
be happy to take questions and answers, though it's not relevant to our
patients. But in any case, we see that this is an important sector for
treating HIV patients. Regarding the current disability criteria, to be
disabled, you must have a physical and mental condition that keeps you
from working and is expected to last at least a year or result in death.
This definition does not really reflect the reality of living with a
chronic disease such as HIV. \[For one\] To be expected to last a year
really depends on some degree of one's ability to take medications
appropriately and the ability of the medications to continue to work. If
there is resistance developing, it depends on those medications
responding in light of the resistant medications, point one. Point two
is can they tolerate the side effects of the new medication that is
going to be beneficial for the resistance? This is a very difficult call
for the provider to make in a very strict and scientific way. The
current flow that we see in disability due to AIDS qualifies patients
for Medicaid/Medicare after 2 years of having this condition. Medicaid
and Medicare for these patients, I have showed you the number of
patients on these policies, help them get access to life-saving
treatments. Health improvements for treatment may compromise the
disability status subsequently because the medicines have got better. So
now, without the continuous access to life saving treatment, how do we
guarantee that those patients are going to be able to continue to take
the meds? This is really part of the vicious circle we are in. Because
we make scientific advances, we help people to be better. Thank God we
have. So then, the question really is, how stable is their recovery? As
a physician, I try and gauge. If the patient is stable for 2 months, is
going to go back to work, perhaps not being able to maintain the
regimen, and not being able to maintain that stability, \[my\] saying
that he/she is going to be well in a year may not even be true, because
I can't guarantee they are going to tolerate their regimen; hence, I
cannot guarantee their health care will be stable. So we are in a kind
of "sticky wicket" here a little bit, because the medications have
improved things; they have affected our ability to prognosticate, and
because the medications have significant tolerability issues, if we
can't ensure that patients have access and continue to be able take
their medication in a reasonable way, we can't be sure they will be able
to maintain the biological benefits they received.

## CASE STUDY

Dee Dee is a mother of three kids with a CD4 of, I guess, I get stuck,
hung up on that number, of 211 today and a viral load of 1,400. She is
on her third regimen of HAART in 3 years. In other words, she's cycling
very quickly through the meds; a little quicker than we expect with most
patients, but not uncommon either. She takes her meds at different times
to avoid the side effects that would impair her ability to care for her
children. In other words, medications that are going to cause her
diarrhea, she doesn't take until the kids get off to school. If
something is going to make her nauseous and she's got that witching hour
from 6:30 A.M. to 8:30 A.M. when the kids have to get to school, she is
going to wait to take her medication until later. If she has medications
that she takes at night that's going to make her groggy in the morning,
and she gets past 8 or 9 o'clock, she might not take that medication
that night, because she cannot afford to be groggy in the morning. In
that sense, she is under a different kind of pressure, and we as
providers have to find ways of tailoring a regimen to her lifestyle.
It's not always so easy. Her immunologic status has fluctuated between
150 to 250 CD4 count. In other words, she goes back and forth between
the borderline that we call AIDS at the CD4 count 200. So the question
is, how will working affect her ability of working to maintain her
regimen, and her ability to be compliant with that? It's a difficult
call. I don't think there is anything in the SSA regulations that I saw
that really deals with the issue of compliance and HIV. And yet,
compliance, because it is responsible for at least 60 percent of
clinical failures, is fundamental to making HIV a treatable disease.

Symptoms of HIV disease and treatment of side effects are equally
disabling and often indistinguishable. So, one of HIV and AIDS comments
has been to add chronic pancreatitis to the listings, which is not a
huge (?) but will help a little bit. Within standalone listings, special
considerations are identified by the primary care provider. There's a
lot of data showing that people who are caring for HIV patients, the
people who should be caring for HIV patients, are people who have more
experience; and in order to do some of the disability determinations, we
need people who are more skilled in doing HIV, and that care that should
be given to them prior to their disability, and should be given by
people who are more experienced in HIV. This includes more examples and
repeated manifestations of patient experience (i.e., subjective
functional abnormities, such as fatigue, nausea, neuropathy, pains,
fevers, mental impairment). Because of some of the difficulties in
having providers maintain some of these standalone listings, a
significant number of patients are still diagnosed late, at least 40
percent. New manifestations of conditions identified in the standalone
listing would continue to emerge and should be looked at. These medical
examiners should be familiar with HIV disease, as I said, and disputes
should be settled by HIV-experienced providers. Research shows that
HIV-experienced providers are defined by relevant guidelines, and we can
talk about the different guidelines that are used by the two
organizations. To look at that helps patients have better treatment
outcomes. You can see here that it affects the baseline CD4. If you
accept physician experience on outcomes, MD knowledge would
significantly be associated with adherence and how patients were
approached. Physicians with less experience prescribe less medications
and have less \-\-- outcomes. It is very important that we find ways to
maximize the physician experience by giving them providers who are
sensitive to the scientific needs and psychological needs of HIV
disease. The final case study is of a patient who had a low CD4 count,
never had any OIs, who had difficulty concentrating for extended periods
of time. After being on HAART for a few years, the CD4 count goes up to
the 300 -- 400 range. They now find out \[that the patient\] is
co-infected with hepatitis C. If they start hepatitis C treatment, the
patient can get depression from treatment, and then cognition makes this
worse, could last for 6 months if they successfully treat the hepatitis
C. The patient is unable to work in the morning due to persistent side
effects of these meds. These patients, if they were to go back to work,
perhaps would have a disincentive to start their hepatitis C treatment.
Yet, their hepatitis C treatment is not part of their disability prior
to when they received their disability. This is another kind of
condition because their co-morbidities are associated with the treatment
for those co-morbidities. How do we sort out how to decide when a person
is able to go back to work, and when they should be starting the
treatment for some of their co-morbidities, and what impact they will
have? So \[here is\] our final recommendation for improving the link
between disability and health care. When \[a patient\] is denied
disability benefits due to improved health status, allow \[the patient\]
continued access to Medicaid and Medicare. There is a need for increased
flexibility to move on and off disability without disrupting your health
insurance, Medicaid/Medicare. We can understand that the functional
status for changes, I think, is one of the foundations of the
disabilities regulations, but the access to health care, if it is not
maintained. I will just go quickly toward functional status and go back
to disability. Provide some reemployment support to ensure that worker
tolerance does not result in a relapse that's very difficult in some of
the difficult sites, we try and do that with our patients, but that's
easier said then done, and support early treatment for HIV and to allow
access to Medicaid for people with HIV before they become disabled so we
don't swell the ranks of people with more immunological impairment who
are disabled. I believe that gets me in the time zone. We will take a
few questions and answers if you have things specific to my talk.

### QUESTIONS AND ANSWERS

Q.  **I know you talked about treatment and what that means in terms of
    patients staying either on or off disability. What is the compliance
    rate nationally or in your practice, so we will know basically what
    to think about that?**

```{=html}
<!-- -->
```
A.  The compliance rate nationally depends somewhat on the clinic, but I
    would say if you take a large number, probably 50 percent. Patients
    who are successfully controlled 1 year after starting all come
    across the board at about 60 percent. The reason for that
    predominantly is compliance-driven.

```{=html}
<!-- -->
```
Q.  **What does that do to the person that's taking it? I know you talk
    about the resistance and all of that. In terms of disability, would
    that in fact have to be taken into account when reviewing these
    patients in terms of compliance possibility for their disability?
    Let's just say that as a physician I know when it gets to over one
    pill a day. We are talking about patients who just don't take the
    medicines, not on a consistent basis; they might do it for 3 days,
    and after that the compliance rate drops significantly. For AIDS
    patients, we're talking about loads of pills to take once or twice a
    day. I'm just wondering, what does that do in terms of a person's
    compliance and whether they take them? And what do you think it
    means for a person who treats these patients in terms of how they
    feel? Because I get a lot of patients that are reviewed that have a
    lot of fatigue and malaise, and they just don't feel well. I am just
    wondering, what that does for the disability process?**

```{=html}
<!-- -->
```
A.  Two comments on that. Number one, it's the challenge of the
    physician to design a regimen for those patients that's going to
    have less pills. We have now got new regimens that really are
    simpler. You can create once-a-day regimens with four or five pills.
    There are various, twice-a-day regimens that might only include as
    many as six to seven pills a day. So the burden has improved, so you
    will hope to see some improvement. On the other hand, how that does
    affect disability? I think that to some degree compliance can be
    learned. Unfortunately, we try and teach that before they start the
    regimen; but, for all of us, experience is a very valuable teacher.
    When you fail your first regimen, you get a little more serious
    about the way you take your second regimen; and I see that all the
    time with my patients. We try and get that message abundantly across
    before we initiate therapy. We spend reams of time to help them
    realize that your first shot is your best shot. Despite all of that,
    \[with\] the second shot, a lot of time I see my patients learning
    to become more compliant patients.

```{=html}
<!-- -->
```
Q.  **Doctor, on your first case study, I want to make sure, I want to
    test this out, I want to make sure we're all on the same page, not
    talking about on the legal definition disability for Social
    Security, just talking about the definition on the disease. You have
    a person who is treated for 6 months, and the viral load is now
    undetectable, and the CD count is in the 300s. Do you now have to
    change the ICD code? Is that person, a worker, considered to have
    HIV/AIDS disease? Because the implication was if it would last less
    than 12 months, it couldn't be disability. Before, we didn't get to
    co-morbidities or functionality or any thing else in the sense that
    somebody who has chemo and undetectable cancer, and they are in
    recurrence. I have judges telling me, well, they no longer have
    cancer and the chemo's over so, it did not last a year. Could you
    address that?**

```{=html}
<!-- -->
```
A.  Two things. Number one, AIDS is a disease of an immuno-suppression.
    There are degrees of immuno-suppression that occur \[according to\]
    where you are in the immunolgoical continuum. We know that with the
    higher CD4 counts, there are selective losses of certain types of
    immunity that render those patients more prone to catching certain
    kinds of diseases. So to answer your question, the ICD9 code makes
    two distinctions: One is AIDS, and one is AIDS with symptoms. So
    when you are with your CD4 count, we now look at HIV positive and
    AIDS as very similar because it is a continuum of immunology
    suppression. Maybe I can take that for a second, because with
    cancer, the possibility of eradicating it is there, so that there
    are panels that have held that after certain number of years in
    remission, you do not have cancer anymore. With HIV, once you have
    gotten the AIDS diagnosis, the 042 designation, which is really HIV
    disease, once you have the AIDS diagnosis, you carry it whether your
    immune system is reconstituted or not, and that has not been revised
    at all; so once you got it, you got it. I think the analogy to
    cancer is very different because cancer in remission often doesn't
    require ongoing treatment. HIV requires ongoing treatment, so it's a
    very different model.

```{=html}
<!-- -->
```
Q.  **You mentioned in your slides that you were suggesting adding to
    the standalone conditions any condition diagnosed by a primary care
    provider. I wonder if you can elaborate on what conditions you are
    anticipating.**

```{=html}
<!-- -->
```
A.  My intention was twofold. First, when the primary care provider
    makes such a statement (a) that it be reviewed by an HIV provider. I
    think that is very important as a primary care provider. As a person
    trained as an HIV specialist, I understand the distinction in doing
    a lot of teaching. I see the distinction between the understanding
    of doctors who see a lot of HIV and those who don't. So regarding
    your first point about to the care, it is no longer primary care;
    the HIV treaters, credentialled folks, or experienced folks should
    be the people providing that care. In terms of what the conditions
    would be, I think it goes back to being a functional situation
    because the one that is most common is either cognitive impairment,
    fatigue, or some sort of pain or nausea-related thing that makes it
    harder for them to go back to work, and those are sort of softer,
    subjective diagnoses but very real to both the provider and the
    person making those evaluations.

```{=html}
<!-- -->
```
Q.  **NOT DISTINCT?**

```{=html}
<!-- -->
```
A.  So, in the decade since the SSA last examined the HIV listings,
    where are we? I would say we have moved through to a plane where HIV
    and AIDS was so often associated with a very quick death, and
    actually through the heyday of the invention of protease inhibitors,
    the sophisticated combination therapy known as HAART: Highly Active
    Anti Retroviral Therapy and into an age where multidrug resistance
    strains of virus exist, complicate treatment, complicate our clients
    conditions, where we have many people who maybe fortunate enough to
    live for years with treatments but have lives that are fraught with
    severe symptoms and debilitating side effects in a complicated way
    where even their doctors at times may see that these two things, the
    side effects and the symptoms overlap; sometimes it is very
    difficult to distinguish which is which, which is part of the
    disease, which is part the treatment. We have also moved into an age
    where we see emerging---in terms of people who work in a legal
    profession and work with the clients who are being treated by the
    doctors on the panel today, clients who are coming in with new
    manifestations of their disease; increased lymphomas, lipid
    disorders that can be quite critical to the treatment; liver damage
    that can be quite severe, which is also impacted by co-infection
    with hepatitis C---and moved into an area that was really unknown
    when we lacked the treatments that people are obviously gratefully
    to have. An area that is much more complicated now: We have
    thousands of people who are living with HIV who received their
    critical health care because they qualify for Social Security
    Administration benefits. And so looking as practitioners at the idea
    of revising these listings for the first time in 10 years is not
    your sound-bite scenario, it's a complicated challenge and has
    far-reaching consequences, not only for the individuals who are
    obviously receiving the benefits, who are applying for the benefits,
    who need them so they can access their health care. It also has
    far-reaching consequences for the public health in ways that reach
    out to people who are not yet diagnosed or not yet infected. And I
    think that public health consequences in that way, when you are
    dealing with a virus that responds to improper treatment by
    mutating, creates a public health situation and concern that's
    different from a lot of other conditions that the Social Security
    Administration deals with.

HAYLEY GORENBERG: I'm the AIDS Project Director for Lambda Legal Defense
and Education. We work nationally, originally on the rights of lesbian,
gay, bisexual and transgender people, and then in the 80s took on the
important issue of HIV/AIDS as we saw how it was devastating many
portions of the community that we traditionally served. And we were part
of a group of about 40 signatories to joint comments that were submitted
to the Social Security Administration this summer. That group was really
galvanized by the announcement of potential revisions, and the group
included legal experts from around the country, joined by
representatives from HIV MA and the American Academy of HIV Medicine to
really put together a network of what we thought needed to happen in
revisions. We conducted a series of national conference calls; we
exchanged a lot of e-mails; and we shared our drafts to develop the
comments we submitted. And we came up with pages and pages of
modification to the listings that we thought would better reflect what
our clients/patients were experiencing. We suggested details of how the
potential changed diagnostic techniques as they had evolved over the
years, and there were different things that were in the listings that
maybe aren't so commonly used now. There are different kinds of
observations, different ways that opportunistic infections, and other
symptoms are diagnosed. We came up with clauses on the experiences of
various symptoms that were affecting our clients, and a lot of
suggestions about how to recognize and understand side effects and the
extent to which they interfere with our clients' lives and ability to
work. We have specific suggestions, some of which I will mention
particularly about sources of proof and how proof is gathered and
assessed in the Social Security Cases. Our overall conclusion was that
the listings in the main remain valid even as the course of the disease
has changed to a great extent. How is this? The case given is that we
all know that there are powerful new drugs that we have developed since
the listings were revised in 1993. For one thing, opportunistic
infections that for many people led to quick death in the past are still
indicators of poor health as Dr. Elliott was mentioning. Where before
people might not survive as long now, there are treatments available if
one responds to them, but there are still indicators where people
presenting with them are of unstable health. And that is complicated by
all the social and socioeconomic factors that influence health and
clients who, for instance, come into the legal services office looking
for representation in a Social Security Disability Hearing. These are
often people who, if they were not in the health care system prior to
feeling bad and getting diagnosed, don't actually have the medical
records and the kind of documentation that would show the progression of
their health downward until they get that opportunistic infection. So
the opportunistic infection is still a signal of their poor health,
health instability and probative of that. Another factor that we find
overwhelmingly significant with our clients is the effect of the side
effects from their medication, even when they are engaged in health
care. I brought along with me today materials that were developed
through the stop AIDS project in San Francisco by a prevention group
trying to reach out to prevent the spread of HIV. And what they go to is
the issue that drugs, while they have lengthened lives for many people,
have also had a real impact on the quality of life and that many people
experience poor quality of life with the side effects. These materials
were developed by people with HIV who were concerned about complacency
that they sensed in their communities with the treatments that had
become available, that maybe folks were thinking that HIV was much more
manageable in life than it is. So, they developed these images of things
such as night sweats, uncontrollable diarrhea, wasting, and other side
effects because they wanted to explain what it was they were dealing
with, even as they lived and were grateful for their lives. And the tag
lines are: "Nothing is worth what I'm going through now, don't get me
wrong, I'm really glad to be alive, but HIV is no picnic." And that was
the message that they were trying to send out, and I think that's
actually a core of what we see in the clients that come to us for
representation before the Social Security Administration. The lens that
I take to look at HIV as the epidemic has progressed into the civil
rights lens, and it looks as if HIV is a civil rights problem. And the
reason that I say that is because as infection moves through
communities, it seems increasingly clear that it hits people how they
are marginalized in various ways, lack power over their lives, or
control their lives in various ways. Those issues of marginalization and
lack of control make them vulnerable to HIV. So when we look at people
who don't know their status, for instance, that statistic that we had
earlier of 25 percent at least of people who don't know their HIV
status, and that is the reason for this. These are often people who do
not have much access to health care; they may not have education about
HIV. We also see folks who are infected dealing with co-morbidities or
other factors, such as domestic violence, that can make them vulnerable
and unable to protect themselves in certain ways, sexual or otherwise.
There is homelessness, poverty, overwhelming amounts of multi-diagnoses,
HIV with mental illness. And mental illness can be a variety of mental
illnesses that we see in clients, depression and anxiety disorders being
quite common, but also bipolar disorders, schizophrenia, all these
things that make clients initially vulnerable to infection. Some of the
mental illnesses like depression and anxiety can be linked to the
diagnosis and the experience of the infection. They obviously affect
adherence in serious ways, since it is difficult to adhere when you have
this co-diagnosis of mental illness. And I'd also say from the point of
view of the legal representatives of folks who are seeking benefits that
there are additional barriers to actually securing the benefits because
people have trouble with the application, trouble marshalling evidence,
trouble making their appointments, trouble following an application to
various levels of denials if they are mentally ill. So one of our
specific recommendations was that there must be a mandate in these cases
to look for the expressions of mental illness, to look for the
documentation to examine clients, even if they don't initially in their
application present as one looking for benefits because of their mental
illness. Maybe they're talking about HIV primarily, but it is so
underdiagnosed, undertreated and undocumented that mental illness enters
into these cases in just a more serious way; and so folks were united in
wanting to stress that very seriously. I do want to say a few more words
about the issue of proof that I was mentioning. The most common cases
that the legal representatives get on appeal are not these cases of
opportunistic infections. The more clear diagnoses have often been, I'd
say, weeded out by the time we get to the levels of appeal. The most
common appeal cases are sort of a mix of symptoms and diagnoses
interacting in very difficult ways. These combinations can be difficult
to clearly present, and clients have to travel a very long road before
they can get there. We have suggested some revisions to Paragraph N in
this issue of repeated manifestations to try to add tweaks and
modifications to more clearly represent what we see in clients. We have
also suggested in the area of proof that---especially in the age of
managed care when people are seeing doctors unfortunately for less and
less time, we can all say that's pretty common---the information that
one could glean from other folks who are not physicians, but are very
associated with care, is critically important. So that the observances
of social workers, clinical social workers, nurse practitioners,
counselors, and family and friends also may be witnesses to the daily
lives of people with HIV with episodic expressions of their illness,
which can be very critical. And we would like to see more of the
systematic understanding and how important those observations can be. I
would like to close out my remarks by talking about some institutional
and system issues that concern us when we look at how the Social
Security Administration will assess our clients and patients. It seems
that HIV disease, as a disease that is so commonly expressed in
episodes, very changeable in some patients, is a real challenge to
assessment, and it is very common that we will have clients who have
good days and severely bad days, and they can be very close together. So
you can have somebody who manages a day or a few days and then has bouts
of just overwhelming fatigue, which is so common with HIV. It is not
because of the meds, or because of what the disease is doing to the body
systems. It is just an overall fatigue, so that the client that you were
talking to just a couple of days ago now is unable to get out off bed
for a few days; and then maybe on other days, better and out of bed but
having side effects from medications, so that they can't really be more
than a few yards away from a bathroom, and this all can be mixed
together in a way where if you could clearly get it into the record, you
can see that they really are incapable of sustained work. But it can be
a challenge to get into the record without adequate recognition of who
can present the proof and what actually is going on in the client's case
and understanding the importance of things like nausea, vomiting, and
fatigue taken seriously as expression of the disease and the treatment.
We completely agree with the idea of the importance of having
HIV-experienced physicians using some of these criteria that these two
medical associations have developed in assessing clients, not only in
their treatment and the presentation of proofs, but also within the
Social Security Administration's review and hearing processes. So what
we would like to see is that somebody who is claiming disability based
on his/her HIV wouldn't be denied without somebody who has expertise in
HIV treatment reviewing that potential denial. We think that with
co-infections, multi-diagnoses, and the overlapping diagnosis, the whole
of them is more threatening to health than some of the parts and that
the interaction of the diagnoses needs to be well understood, and that
it's the specialist in HIV who is going to be able to do that. I think
that people who work in legal services programs, who I hope would speak
a lot during the comment period, certainly feel that the SSA hasn't been
a program that has been able to easily accommodate people going on and
off benefits if they could work for a short period of time and then not.
And so we are concerned about persistent problems that we've seen over
the years, with notice to people about when they are eligible, when they
are not, payments, and resulting overpayments. And we attached access to
the services that they will or won't have depending on whether they are
on benefits or not. And those services most critical to health care,
again, I think are special in the HIV contacts because nobody wants to
see interrupted health care for anybody with a serious medical
condition. Again, if you interrupt health care with somebody with HIV,
you not only damage the health of that individual, but also run a
serious risk of helping to develop a resistant virus, and that's a
public health threat overall that goes beyond the individual. The
questions are rising---are there programs---if people came off Social
Security Associate Disability---are there other programs that can pick
up the slack? Unfortunately, what we see is that programs like the HIV
assistance programs are in crisis. There is rationing in that program
now in may States. States are developing waiting lists, and
\-\-\-\-\-\-\-\-\-\-\-\-\--worked recently with the program in Texas.
They are actually considering taking people who will initially come on
to HAART into these medication \[regimens\] through ADOT. And now there
is the potential with their revision on cutbacks that people who were
drawn into treatment through the program would be thrown out of
treatment because of severe cuts they had to put into place. So if there
is any question that we made error in revisions, it seems that
\-\-\-\-\-\-\-\-\-\-\-\-- on the side of keeping people in health care
and protecting public health. I think I speak on behalf of the whole
group of signatories that came together to develop our comments over the
past months by saying that we welcome the opportunity to be here and
look forward over the coming months in the continuing to work with the
Social Security Administration in developing the revision that would
come into play. So \[I\] appreciate being here. Thanks.

My name is George \-\-\-\--Chief Medical Consultant of Maryland
Disability Determination Services. Bill Anderson spoke earlier about the
Federal Safety Partnership, and I'm one of them folks that works for the
State agencies in evaluating disability claims. Just a couple of
comments: We talk about our policy and listings. Regarding the
application of listings---and I can assure you at least in Maryland, and
I venture a guess that in all the other DDSs in the country---we are
very aware of the difficulty in adjudicating these claims. In addition
to impairments which meet the listings, only face of the evidence
indicates diseases opportunistic infections, lymphomas, etc., they are
rarely very easy claims for us to do, and we keep at those as quickly as
possible. As you pointed, out with the very successfully
\-\-\-\-\-\-\-\-\-\-\-\-- anti retro-virus treatments, we are seeing
these less frequently, but we are seeing the other impairments. Sue
alerted you on both in her presentation this morning. We frequently not
only on AIDS claims, but also in other primary impairments, evaluate
multi-impairments, including individuals who have HIV disease, chronic
pancreatitis, and hepatitis C infections. We are familiar with how to
adjudicate claims with multiple impairments; we do take that into
consideration. The functionality Bill talks about, also, clarified in
the process of unification of SSR in 1996, is clearly involved in these
types of claims. The individual allegations, their impairments as they
alleged, the activities they are living are considered in each and every
claim as we move to the sequential evaluations past Step 3. The
assumption here is that we past Step 3. We do, however, add Step 3, used
as the equal concept with 1408N. This is a listing that I have always
considered to be the safety net for the individual. It was designed 10
years ago. I feel like that this was for those individuals that did not
meet a single listing, but now have multiple impairments they did not
quite measure up to that, and who have impaired ADL. So this gives us
also an opportunity to allow individuals at that level. Beyond that, we
consider symptoms and we also do consider the observations of
third-party social workers, nurse practitioners. Any individual whose
observations are included are also considered, and a waiver for
consistency with the medical evidence or records is provided by the
providers of the individual care. We also identify impairments that are
not \-\-- just because someone does not allege impairment during the
process, our documentation discovers this impairment; we do develop a
pattern. This is where the mental impairments frequently factor in when
individuals allege HIV or allege AIDS, and they are not found to be
necessarily disabled from the physical side of it. But we clearly pick
up if they are depressed either from the examinations that are part of
the medical evidence, or records are those are obtain consultative
examinations and we will pursue all of them. I started working with DDS
in 1982 and I came on board right as the AIDS epidemic was beginning to
appear in this country and we never saw older individuals with HIV they
were all young folks. Now we are seeing individuals who are in their 50s
and 60s even who are diagnosed with HIV. These people also have other
impairments that may or may not be related to HIV, as alluded to
diabetes \-\-\-\-\-\--coronary artery diseases, and arthritis and other
things are also taken into account as well. Alternatively, even
individuals who have not been found to meet or equal our listings can be
found to be disabled by finding that their activities that they were
living are so restricted that they would not be able to function in a
manner that is sustainable. You mentioned this earlier, about assisting
ability of individuals' activities; in order words, for a couple of
days, they are OK, and on the third day, they are as just wiped out. If
this is documented sufficiently in the evidence, we do take this into
account. If an individual is not able to sustain an 8-hour workday, 5
days a week for 50 weeks a year, rarely is the definition of being
disabled. So these individuals would be found to be disabled in Step 5
in the sequence of the evaluation process. This is a little background
as to how we used the listings and all the other evidence. It comes to
us at the level of the DDS.

I think if I could respond briefly to it. I think about some of the
comments you are making and why we're are talking about revising
listings rather than devising them from whole cloth. Because its true in
various places in Social Security Regulations and listings, but there
are aspects of what we are saying, that there is a piece that expresses,
or there is some good language there---that type of thing. Yet and
still, the cases that we are seeing, the cases that providers are having
to fight for an extended period of time and to develop something, do
serious work and to get the system to accept clients, are cases where
these virus factors bring \-\-\-\-\-\-- they seems to be things that we
have to fight for; they seem to be things that are not readily
accessible to the system as it is now. So we think that there do needs
to be modification to really understand how serious these factors are,
or modification to show how the administration does the work that it
does so that it is easier to put the clients in the benefits they need.
So after seven, it needs to be more explicit, after \-\-\-\-\-\-\--, it
needs to be more developed; there are new factors to add in. We're not
saying there is nothing good there to start with, but we are saying that
we consistently over time have these clients come into us, and the
system isn't working as it should, as we think you wanted it to for
these clients. And that's where we are trying to perfect it so you can
modify it.

Barry, I agree with everything you say. In fact, as the doctor was
talking, I was thinking he is describing the ideal world. If everybody
did what we said, we would not be having this meeting. So here is my
question. Some of the things we talk about, the reason some people have
such difficulty qualifying is that they are in the group that the doctor
described early as the more subjective people, the people that do not
have one thing that the listing said who have this. We don't care if you
are in treatment; we don't care about anything; we're in. We are talking
about the people who have collections of symptoms, symptoms with various
sorts, diarrhea or that sort of thing. As you guys were talking this
morning, my mind was racing with ideas of things we might be able to do
within our listings to improve that situation. But my question to you
is, are you suggesting that we do something to the listings proper? The
actual rules say that if you have what it said, you are in or the
introductory part. The part that said when you have a patient with HIV,
you ought to be thinking of if "BOOM, BOOM, BOOM," they are not in as
you are evaluating their case or both. Yes both. We'll take both. Thank
you.

Yes, actually we made suggestions to the listings proper, where we think
there are different things that need to be tweaked, added, or subtracted
in cases. So we have things that we should delete. We have things that
should be added; we have modifications. And when we talk about
diagnostic techniques that are sort of out of \-\-\-\-\-\-\-\-\-\-- and
are not used anymore to diagnose a particular infection that is still in
a proper listings level, and that people are talking about revision to
the introduction and procedures to make really clear what it is the
clients are most commonly experiencing and to guide decisionmakers
within Social Security as to what they should be pulling out and seeking
and what they are looking for more deeply. So it is a combination of the
two.

I'll say one thing, regarding the statement that the previous speaker
from my home State of Maryland said about being able to sustain a
40-hour work week, I don't think that our client understands that
concept. If anything, they can work 20, and they can work 40, and they
feel bad that they can work 40, and then they struggle with that. Why
can't I go back to work? There is a certain kind of allowance that we
place a burden sometimes on a limping person to walk normally, and I
think that if we are clearer ... and I think some of you the providers
are guilty. But if we know that there is a definition that said if you
can do ADL for 40 hours a week and do that for 50 weeks a year, you are
not able to go back to work, and that was stated clearly, that would
help everybody.

MALE VOICE: While we are getting everybody back in, perhaps \[I'd\] just
remind people to put your cell phones on stun for the presentations.
It's against the law in New York City for your cell phone to go off
during a theater performance. You can actually get a fine for it, which
I think is a great thing. We're just trying to hide your heads. I think
you want to move over towards that way. All set?

FEMALE VOICE: Yes. Okay, everybody. So, I'm going to turn the
presentation over to Howard.

HOWARD GROSSMAN: Thank you very much, and hopefully you will be able to
see us better. My name is Howard Grossman. I'm from New York City. Lots
of titles, but I'm an internist in private practice in Manhattan, with a
physician assistant and another doctor. We manage about 950 patients
with HIV as part of a general internal medicine practice. And I'm the
policy chair for the American Academy of HIV Medicine. From what you've
heard from a number of people, I think, what I'd like to talk about a
little bit more is that we've really changed the medical model of HIV. A
few years ago, certainly when the regulations were written, we were
trying to convince people that every primary care doctor should be able
to manage HIV because we were having problems getting doctors to see
people with HIV around the country, and so we were trying to push that
model. But in the last 8 years in what's probably the most rapid change,
I think, in medicine that I can ever remember, that whole model has
changed. And now, we really know that a person who sees more patients
does better and that practitioner's patients do better. So, we've come
up with this idea of an HIV specialty. The American Academy of HIV
Medicine is one of two specialty organizations that formed a couple of
years ago, and I thought I would take a minute just to explain what it
is we are trying to do. Here, you see our mission statement. We are an
independent organization of HIV specialists. This is not an American
Board of Internal Medicine-defined specialty. Most of us are more
general practitioners, internal medicine family practice, but we do a
lot of HIV work. We don't want to stop doing our other work in the
process. We are dedicated to promoting excellence in HIV care. We do
this through advocacy and education, and we support health care
providers as well as ensuring better access to care and better care for
people living with HIV and AIDS. Some of the ways that we have done this
with quality care in the Academy is to maintain a searchable national
listing of health care providers and credential specialists; and you can
go to our Web site, which is [www.aahivm.org](http://www.aahivm.org/),
and you'll find there a list of several thousand people who consider
themselves to be HIV specialists. It's been a great resource for me
because if I have a patient that moves from place to place, I can find a
doctor or nurse practitioner or PA who manages people in that area. We
are working to ensure the viability of practices in this madness that
has become health care in the U.S. \[we are\] trying to lower entry
barriers by making centralized educational materials available and
resources. We've put together a study guide that's about 700 pages,
which is available to anybody, which really covers everything you need
to know about HIV, including a whole book that's just things that have
occurred in the last year. We have a number of regional chapters, as you
can see here, about 1,500 members who represent the care of about
275,000 HIV patients. Our membership, if you look here, is mostly
infectious disease and internal medicine about evenly divided, although
we have a lot of other people in there. And we do have practitioner
diversity; we are, in fact, the only organization working in any disease
that I can think of that gives nurse practitioners and physician
assistants full voting membership and the equivalent membership. Nobody
else has done that. That's been very important to us.

We are credentialing specialists and independent of membership. It's
open to nonmembers, it's audited, it's psychometrically tested, it's
free, and happens every 2 years. In the first round, over a thousand
practitioners were credentialed. These are our credentialing
requirements: We require people to be licensed; they need to provide
ongoing care to at least 20 patients, and that number is an arbitrary
number, but was set so that we wouldn't exclude researchers and some of
the practitioners who have become more policymakers and aren't
necessarily following people all the time; 30 hours of a continuing
medical education; and taking our credentialing exam. If you look at our
credentialed providers and their practice size, and people say, oh, HIV
specialists, you're the people with all these big huge practices. In
fact, the majority of our people have between 50 and 150 patients, and
that's pretty common across the country. And again, you see infectious
diseases and internal medicine. Now, as Rick was describing, the
epidemic has clearly changed, and this is the standard CDC slide that is
only updated so far through 2001. What you can see here is that these
curves are getting flatter. If you look at the cases of AIDS, not only
is it getting flatter, but it's probably going up. We've seen a slowing
in the declines in death in cases of AIDS over the last couple of years.
This data is even a few years out of date. In fact, last year, we saw a
slight increase in HIV cases, and I think we also see reports that have
come out recently about the huge increases in the African American
community and the Latino community among young gay men, and among young
gay men in general. These are really frightening kinds of figures. What
we end up having is more people living with HIV because people aren't
dying; there are more people living with the consequences of both the
disease and our treatment. Now, I wanted to talk for a second---I was
trying to figure out what I could offer as a clinician here that was
maybe a little bit different, and one of the things that keeps coming
out of the Federal Government lately is this idea of medicalizing
disease. You know, we should get rid of all the "extraneous" stuff and
just talk about medical care. But the question here when you really talk
about medical care in HIV is that this is a relatively unique disease. I
think actually we should talk about all the immunologic diseases in this
way. They are relatively unique in the way that they lax and wane; that
they have a broad spectrum of manifestations; that they involve multiple
systems in the body; and that they really require a certain level of
specialty care that cuts across disciplines in medicine. One of the ways
that HIV is unique, as you've heard, is that we require 100 percent
adherence, politically correct term---adherence not compliance
\[laugh\]. We don't talk about doctors making patients bend and comply
anymore. We talk about people being able to adhere to their medication.
But Rick and I are both old---we were talking about being 50 now and
getting our AARP \[laughter\], you know. I tore mine up and sent it back
after the Medicare stuff.

RICK: I couldn't read mine without my glasses.

HOWARD GROSSMAN: But this is a disease and unlike any other. In
hypertension, if I've got 80 percent, 75 percent adherence to a patient
with their medication regimen, we're going to do fine. They're not going
to stroke, they're not going to get complications, but in HIV, its 100
percent or nothing. We need a tremendous amount of education; that's a
component of this. And, I said this a couple of years ago, its really
true that this is complex chemotherapy administered at home every day on
your own without supervision, and it needs to be looked at that way. You
need a stable environment for people to really be able to really adhere
to HIV treatment. And, again, we need the team approach; it's a
multisystem disease. Providing medications in an office visit is clearly
not enough in this disease. Although it might work in some of the other
things that I do with patients, it's not going to work in HIV. And here
you can see. This is a slide that everybody with HIV has seen a million
times. It's a little bit old; it's from a couple of years ago. It was
published in 2000, but what this slide did was look at adherence rates
and the percentage of patients who achieve undetectable viral loads. And
what you can see here in this first column that in order to get about 80
percent of patients to undetectable virus, which is what we need in the
end, you have to have over 95 percent adherence, and that's missing less
than one dose a month of medications. Now, one of the things that we've
found is that these people in here between say 80 percent -- 95 percent
adherence are actually the people who run the greatest risk of
developing resistant virus; and, as Halley said, there is a public
health interest here, because the more resistant virus you have out
there, the more it's getting transmitted, and the worse this epidemic is
going to become, and the less tools we're going to have to fight it. But
it's the people that are trying the hardest, the people who are getting
70 percent -- 95 percent adherence who are at the most risk of
developing resistance. People that don't take any of their medications,
are not going to get resistant virus. It's the people who try and don't
get there. Okay, so that's where we have our difficulties, and that,
again, is different than we see in any other disease.

Naïve patients---patients who have never taken medications---have lots
of choices. When Rick was talking about how we're doing once a day
therapy and less pills and everything else, that's really most true in
our naïve patients---the virgins we call them. But even there, if you
look at the HHS recommendations for treatment of HIV, you can see that
the two major drugs that they recommend for backbone treatment are
Susteeva, which can cause all kinds of central nervous system problems,
anxiety, and depression. I mean I've seen people totally suicidal, with
post-control problems and rash, disturbed sleep, a number of symptoms
like that. And Caleetra, which is a combination prodius inhibiter which
causes a lot of diarrhea, nausea, lipid, abnormalities, increased risk
of cardiac disease. So, even these newer, better supposedly drugs have a
tremendous amount of toxicity. But for the experienced patient, with
multiple drug resistance, we're talking about really complicated
regimens. And somebody asked the question: what does resistance have to
do as a disability? And what happens is the more resistant you become,
the much more complicated your treatment regimen is going to become and
the more side effects you're going to have and the more disabled you're
going to become. So, you know, this will be a typical patient who has
been on multiple treatment regimens, and you can see how many pills it
is every 12 hours. Fuseon T20, is the newest drug we have, and the most
expensive drug we've ever had. It takes about 30 minutes to mix it up;
you have to inject it under the skin. And these are side effects from
this kind of regimen: diarrhea, nausea, rash, dizziness, liver toxicity,
lipid abnormalities, painful nodules at the injection site. The T20
causes that, and almost everybody---people run out of places to inject
after a while. But look at this list; most of this stuff is very hard to
quantify. I'm not counting somebody's stools, so how often am I going to
know unless they tell me. They tell me they have 10 stools a day; okay,
that's what I write down. How do you quantify nausea? Dizziness is very
hard to quantify with a number. I think one of the things we've talked
about today with adherence that I think is really important is that it
isn't the patient's fault most of the time---some of the time. But there
are differences in the level of drugs that are absorbed in the blood;
there is a difference in metabolism among people. We are realizing with
things like prodius inhibiters---we're getting levels of drugs all over
the place---a tremendous amount of inter-patient variability. So, we're
quick to blame the patient, I think, but, in fact, the drugs that we
have are inadequate, and we really haven't accounted for differences
between patients. Rick referred to this: We're seeing a tremendously
huge level of resistant virus. This is a study that was done by Doug
Richman who is sort of the dean of resistant virus out in San Diego. He
basically said that about 78 percent of the people who were in treatment
from 1996 and still alive in 1999 had at least some resistant virus. It
really has become the most challenging problem that we deal with in
treating patients. You can see here from a number of different places.
This is the fold resistance over here, 2-1/2 fold, 10 fold; those are
significant amounts of resistance in HIV if a virus is 2-1/2 times less
sensitive, or 10-fold less sensitive. That will often make drugs not
work at all. And you can see that we are talking about large numbers of
patients.

Now the symptoms that we deal with, and we've heard it before, we call
them subjective. But the things we're dealing with most, the biggest
ones that we deal with in HIV, are fatigue and depression. In the
disability forms that I fill out, I don't really see any way to quantify
that in that process. There are issues specific to women, and that's not
something that I see recognized. Women in HIV tend to progress faster at
a lower viral load. So where men may have a viral load of 50,000 and not
be progressing very fast, a woman in the same situation will progress
faster. And I think we need to incorporate that data. Women on average
may experience more toxicity because they're smaller, and we don't dose
their medications as they do in oncology by weight. Most of our
medications are dosed the same dose for everybody, whether you're 200
pounds or 100. Yes.

QUESTION:

HOWARD GROSSMAN: Yes, I'm sorry. Women statistically will develop AIDS
at a lower viral load than men and at a higher T-cell count. They
respond to treatment the same way, but we don't know why this is
happening.

Now, one of the things that stands out to me from disability regulations
is that we really should reward people who try to work. I don't really
understand \[problem with microphone\]. Is this still
working?---requires a real sea change in the thinking, but it seems to
me that we are living in a time when we keep talking about people
assuming more personal responsibility and not burdening the system, and
yet we require people to be out of work before they can even apply for
disability. And it seems to me that we should be rewarding people who
try harder to stay at work. I see lots of people where their employers
make concessions for them having problems, or \[who\] try to stay at
work for extended periods of time. And they're really suffering, but
they also don't have the resources. We're dealing with a lot of younger
people and aging population like us, but younger people don't have the
resources to go out and work for a while before they apply. I think we
need to recognize that. I think we need to expand some of the
exceptions. There is an exception for patients who are doing arduous
work or \[who are\] unskilled, and they're sort of exempted from a lot.
But what about the factory worker who is able to only take scheduled
breaks, but has diarrhea from their medications. Aren't they disabled?
What about the professional who is now only able to do unskilled labor.
Are you going to take that person? I mean, I know we've talked about
people who have 15 years experience, and we look at the relevance of
their job, but what if they're only 30 years old, and they don't have
that kind of experience? They may not have that professional
achievement, and yet their whole life has been geared towards a certain
level of profession. Are you going to put them behind the cash register?
I think we really need to look at the kind of body disfigurements that
we've caused with HIV. If I've got somebody who has got a huge buffalo
hump on their back, which is rare, but happens, and can't sleep because
of it, or they're so disfigured facially that nobody will hire them, and
really get a room together sometimes of 400 people who've been on
prodius inhibiters for a long time. And take a look at what we've
medically done to people or physically done to people, it's scary; it's
very scary when you see it. That alone is a tremendous amount of
disability.

I think we need to improve back-to-work initiatives. This disease is
episodic and variable. Patients can do well for while and then start to
fail, or their drug regimens become much more complicated. I think we
need to have an expedited line for people who are going back onto
disability who were on disability previously. I think we need to bring
up the idea of partial disability and part-time work for people and help
with that. Again, fast-track return disability, and, as Rick said,
maintaining medical benefits when people go off disability. We need to
recognize pain syndromes. There are now clear data that there are tools
for looking at pain syndromes. There are pain specialists that are more
and more out their in the community, and they should be called on
because we deal with a lot of pain---neuropathy (?), night cramps,
disarthrious, joint problems. We see a lot of asseptive dechorosis,
people's hips are dissolving, whether that's because there's something
going on with aging or because of HIV or because of medications, all
those things are involved. I talked about some of the body dismorpheous;
and for women specifically, they can get very enlarged painful breasts
that really cause a lot of difficulties. There are a lot of central
nervous system considerations in HIV, including significant proportions
of people with multiple diagnosis and mental illnesses, as you've seen.
Mild dementia is common and very underdiagnosed. There are studies that
show that a large number of people with HIV who are basically physically
healthy and have high T cells have a certain amount of cognitive
impairment when you do neuropsychiatric testing; and so I think we need
to include that testing in evaluation of disability. The tests are out
there; they can be done; they're reproducible. We have a failure of a
lot of medications to penetrate the central nervous system, and I think
that's important because you may get different resistance patterns in
the body and in the brain, and that's going to cause a problem; and,
again, the central nervous \[system\] effects of the drugs that we use
are really important. Insomnia is a huge problem. Depression affects a
significant amount of the population. As Rick said, some studies say 50
percent; I think it's even more. Sometimes, I feel like I'm handing out
antidepressants like candy these days. Maybe that's the world, but I
don't know. But they can be worse than biotreatments that we
give---Susteeva, Valvorins is a prime example; but the hepatitis
treatments we do are really difficult. And these can certainly impact
adherence and efficacy.

Part of my message here, I think, is that it is important that we can
quantify things that we've always called subjective. The disability
forms I've seen seem to be geared to factory workers. Of course, we want
things to measure, but if I have somebody who is the Marketing Director
for a pharmaceutical company, how am I going to evaluate whether he can
push and pull levers, or how does that impact their job? I know that
it's something we think we can measure---but I'm not sure what the
relevance is. I think, again, we need more neuropsychiatric testing, and
we need to involve quality-of-life measurements. Quality of
life---people often think of \[it\] as soft, but, in fact,
quality-of-life measurements are reproducible, and they are predictive
of disease progression in HIV and other diseases where there's lots of
literature out there. These are the three scales of quality of life that
are out there for HIV specifically that have been used in literally
thousands of studies at this point. And the numbers you get with these
quality-of-life scales are predictive of disease progression and the
impact of these diseases. And you can quantify fatigue, you can quantify
the impacts of these things; and I think we need to start looking at
incorporating these into our disability determinations.

I'll stop there and take any questions. I appreciate your attention.

MALE VOICE:

HOWARD GROSSMAN: Can you please repeat the question?

MALE VOICE: Actually it's not really a question, it's a comment. I
represent the Lupus Foundation of America, and I'm struck by the
parallel here. Almost everything that you've said points at, basically,
the impact of the disease. The whole---theme or theory, people
hallucinate---tons and tons of drugs that are toxic. You have to have
100 percent compliance with their regimen, or their disease will simply
flare out of control.

Thank you very much. Fatigue, depression, a significant number of people
with lupus suffer from extreme fatigue---mostly women. The other point
here too, is about the inability to work. People with lupus take very
highly toxic drugs that have a significant impact on the body. It bloats
them up. Many of these people have very disfiguring scars and rashes and
lesions, particularly those with discoid lupus. And I agree with you 100
percent, who is going to hire them; and, as a result of that, they're
not going to be able to get meaningful employment. The drugs that they
are taking have significant, \[effect\] particularly since 90 percent of
the people are women. And in the final thing that you said that I very
much agree with is the dementia. There's such a thing that we call lupus
fog, in the sense that a lot of these people suffer from severe
cognitive impairment. It's not so much that they are mentally impaired
in the sense that they cannot concentrate, and that affects their
ability to hold and maintain employment. And the final thing is the
insomnia. You have these people who are really hyped up on prednisone,
and these folks cannot sleep. And as a result, the fatigue sort of
manifests itself in the sense that they get totally worn down. They
can't get up; they are very lethargic as a result of the fatigue, not
only by the disease that is causing it, but also by the medication
preventing them from getting the rest that is required. So, \[you're\]
right on everything that you've said.

HOWARD GROSSMAN: I think those are really important points. As I was
working on this the last couple of weeks, it kept occurring to me that
lupus and HIV were really two ends of the same spectrum.

MALE VOICE: As far as its manifestations go, I don't think that we \--

HOWARD GROSSMAN: \-- have the same public health implications, if people
don't take their medications. And finally, also primary care physicians
often miss these \--

MALE VOICE: \-- the latest treatment for people.

HOWARD GROSSMAN: Either I should take the microphone or you ---no. I'll
just take it off and yell.

HOWARD GROSSMAN: But primary care physicians just don't often recognize
this stuff. And as we go more towards a system where primary care
physicians are the gatekeepers of the medical system and the HMO
systems, we run the risk that people are going to miss the really subtle
things about these diseases.

MALE VOICE: You made the point that you don't count stools.

HOWARD GROSSMAN: I'm not there to do it.

MALE VOICE: I know, and no one is, except for the patient. Now, here is
the problem that we have. People are adjudicating claims of disability.
The difficulty that we have is twofold. One with the specialists, one
with the primary care physicians. The specialists tend, in my experience
as a lawyer, not to write over and over again in the treatment
notes---fatigue, nausea, diarrhea---because they expect it, and they
know it's there, and it's a given because of the regimen because of the
ARTs---and so it's just not in the treatment notes. And when folks are
asked to adjudicate these cases, the only people that are telling them
that they have chronic diarrhea, or they have nausea often or they have
fatigue 3 days a week are the patients or the patients' loved ones. It's
a problem. That is more of a problem with the specialists than with the
general practitioner. The general practitioners tend to write the
subscriptions because they see less of this, and it's more real to them.
It's not common place. The flip side of this is when depression gets
treated by the general practitioner or even by specialists, rather than
being referred out to psychiatrists or psychologists; there is less
credence given to that as a severe impairment in itself. And one of the
main reasons of adjudication here, as you alluded to, we have to go to
conditional equivalence. Ask your child with the disability or the
patient, because we have doctors. We have to get to equivalence because
we're supplying the parents, and it's a real problem. So we've got
problems coming from both directions. Perhaps we can address the medical
system issues, and the problem of things not being noted when there are
symptoms. I'll say just one more thing. There is a problem with
asymptomatic. The problem is that the asymptomatic people have symptoms,
they---

HOWARD GROSSMAN: They don't have them. There are AIDS-defining symptoms,
that doesn't mean they aren't HIV symptoms.

MALE VOICE: And it feeds into the problem that we have in adjudication.
Those symptoms are pushed aside and less reached.

HOWARD GROSSMAN: I think that's a very good point. We defined HIV in
1982 and 1983, not from a really necessary medical standpoint, but from
a social service standpoint. And again, in 1993, when we redefined what
constituted AIDS diagnosis, it was more of a legal decision than a
medical decision, and, you know, you did a cookbook. You have HIV and
you have these diseases, and everybody has recognized that there are
clearly very symptomatic people who have higher T cells for whatever
reason. So, I think that that's important.

As you were talking, I was thinking about \[that\] I did a couple of
weeks with a clinic in London with some friends. Just with looking at
what the British health care system is going through, in HIV for
example, HIV is all centralized care. All is done in hospital-based
programs. They have a lot lower numbers than we do. But if the HIV
doctor wants to prescribe a sleeping pill, he has to send the patient
back to the primary care doctor because the primary care doctor managed
to carve out that whole area that they will control---sleeping pills,
vitamins, antidepressants. They have to send them back to their primary
care doctor. Now, that primary doctor has trouble sending them onto
specialists as well. And that is something that I see sort of heading
this way with some of the managed care organizations. They're trying to
keep as much money in their own pockets as possible, let's face it. And
so they want primary care doctors to do more and more of the work. In my
practice, anybody who gets an antidepressant also gets an appointment
with a psychiatrist or a therapist because I think antidepressants are
short-term answers and not long-term answers; but that doesn't happen
all over. You're right.

And, as far as notes go, doctors don't learn to take good notes. There
is no question about it. I have been trying to convince my staff for
years to carry diagnoses forward. If a diagnosis is still active, even
if it's old, make sure that it's written down. Now that we're using
electronic medical records, that becomes much easier. But I think it
would really be good for these regulations to lay out very clearly that
we need to see this, this, and this. We should know right off the bat
that these are the things that are going to be looked for and that the
diagnosis is something that persists for a long period of time and is
documented. If you need me to make sure somebody is seeing a
psychiatrist, then let me know that, because I'm perfectly capable. I've
had training in diagnosing depression and with the antidepressants we
have these days, I can treat depression if it's mild. But if the first
antidepressant fails, you know, or the first series of anti-depressants
fail, then I'm not sure where to go. I want to see a
psychopharmacologist. And I think that needs to be clearly spelled out.

FEMALE VOICE: We have one more hand raised, and then we're---on that
side.

HOWARD GROSSMAN: You have a mike back there? I'll be happy to answer any
questions afterwards if people have them.

MALE VOICE: Actually, I wanted to pose a question both for you and for
Dr. Arian. There are really two questions. The first is about the
patients that you see---I think you mentioned 900 or something like that
on an ongoing basis. Assuming for the moment that you could decouple
access to health insurance benefits from cash benefits in the disability
program, roughly what percentage of those patients do you think could
work full time or part time, and would want to?

DR.\_\_\_\_\_\_\_\_\_\_: All commerce? I mean a lot of them are working
already.

MALE VOICE: Let's say of those who are not working and rely on
disability cash benefits at this point, but not working at a point
where---

HOWARD GROSSMAN?: If you could decouple all that---

DR. \_\_\_\_\_\_\_\_\_\_: Wait, wait, wait, wait, are you asking us
to---are you suggesting that we are maintaining people on disability to
keep their health insurance benefits?

MALE VOICE: I'm not suggesting it. I'm only asking the other version of
the question--- which would be that if access to health insurance were
separated and couldn't continue, and return to work were voluntary---to
have some kind of an essence of what percentage of the population would
chose to return to work full time or part time?

HOWARD GROSSMAN: It's hard. I mean there are so many considerations in
that. It's not just the decoupling of benefits, but it's if they tried,
how quickly could they get back in the system.

MALE VOICE: Well, at this point, I was just looking for people who would
want to do that as opposed to who---

HOWARD GROSSMAN: You know, I think there are a lot of people, if the
accommodations were made, that if they could do part time work, they
would try at least. I'm not sure how many people would actually be able
to do it, but I think a lot of people want to try. We're dealing with a
mostly fairly young population. They want some goal in their life. Lots
of them are finding other outlets if they can, but once it accommodates
them day by day, things change. That kind of thing. So, I think people
would try if there was more support, but I can't really give you a
number.

DR. \_\_\_\_\_\_\_\_\_\_: I'll answer it a little differently. Of the
patients of mine who are currently on disability, how many do I really
maintain so they can keep their health benefit? Very little, very few,
because they're disabled. So I feel very comfortable doing that either
way. Now, if they had a chance to go back to work, how many of them
would like to take the opportunity to go back to work if they didn't
stand to lose their health benefit? I'd say 50 percent to 70 percent,
because they would like to try to do that if they're not going to lose
the ability to pay for their medications. If you put yourself in their
shoes, they would have nothing to gain to risk their health benefit,
which is essentially---

MALE VOICE: No, I understand that. Well, what I'm thinking about is the
possibility of doing demonstrations in which we would decouple cash
benefits.

HOWARD GROSSMAN: Also, people feel so precarious with HIV. We're still
young in this treatment, and so if I have somebody who had pneumosysis
pneumonia or a couple of other AIDS diagnoses---I was just looking at
somebody the other day who in 1993 had seven T cells, and now has 560
and was sick, had pneumosys and a couple of other things, and now is
fine. But he's so worried that he's going to slide back.

MALE VOICE: So, let me ask the second question, which is sort of
related, and it's about Medicare and Medicaid. If your goal was to
design a health insurance benefits program that maximized treatment for
people in the population that you served, including treatment that would
assist them to maintain work, are there problems with Medicare---whether
we ought to find an alternate product to both Medicare and Medicaid. And
that's across the board. The real question I'm asking you is to what
extent do either of those or both of those---

HOWARD GROSSMAN: That's where the Early Treatment of HIV Act comes in,
because that's one of the things we're trying to push is that right now
you can get Medicaid if you have an AIDS diagnosis which also makes you
eligible for disability in many cases. We want to treat people early,
long before they have an AIDS diagnosis and that would be much more
cost-effective than the way we're doing it now. If you look at New York
and California, Medicaid has been a very successful plan, but certainly
if you look at Medicaid in many other States, it just hasn't. The same
benefits aren't offered, and now, of course, California may cut out lots
of those benefits as well. I still think that that's a good mechanism. I
think Medicare would be a good mechanism if we didn't have such a
convoluted system that was going to be introduced in 2006. Everybody's
laughing---I'm not going to go there. But I think clearly that is not
going to be the answer, the way that it's going to be set up. There are
Medicare formulas that are being developed; there were questions about,
for example, having one prodyus inhibitor on it, or one nucleus side.
These are classes of drugs that if you don't have access to everyone,
it's not going to work.

DR. \_\_\_\_\_\_\_\_\_\_: Just to add to it, Howard, I think that the
current way the system is set up specifically in regard to drug access,
health care access is a separate issue. But it's such a small dollar
amount than the drug line, so that the real issue here is about drugs.
There really needs to be a decoupling of that, because you're
encouraging people to be less productive and not giving them the
opportunity to be productive because of the risk that they would lose
the drug benefit. So there's a way---and I'm going to take Medicare out
of the picture, because until I see what those formulas will be in 2006,
I don't know how to judge that program. But if you take Medicaid -- I
think in terms of our ADAPT unit. One of the most successful things
we've done is to be able to take ADAPT funds and pay for health
insurance. The problem is that the person then gets the threefold above
poverty level; they get to lose. So they can do some work, but they
can't do too much. And that's been very successful about getting people
back in the workforce. And I think we want to encourage programs like
that. I think that where you're coming from, if I hear you right,
there's really a kind of an empathic way we can deal with the desire to
both have them be productive and maintain benefits.

MALE VOICE: Then we need, I think, a national standard, not leave it up
to individual States.

DR. \_\_\_\_\_\_\_\_\_: Right, that will be very important \-- because
these issues in regards to what I think about what the laws were for the
disability and how these State partnership -- we happen to work in
jurisdictions that are relatively user friendly, but you don't have to
go many miles south of where I live, and it doesn't get so
user-friendly.

FEMALE VOICE: In fairness to our main speaker, I really feel that we
need to---hopefully we'll have a few minutes for
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ before lunch. So I'm going to ask
everybody's indulgence for a minute and hear from Praveen Fernandez who
is a lawyer practitioner.

PRAVEEN FERNANDEZ: Actually, I'm going to keep this brief. The advantage
of going last is you can sort of---a lot of the important stuff has been
said already. I'm Public Policy Advocate with the Human Rights Campaign.
I'm speaking on behalf of the Human Rights Campaign today. It's the
Nation's largest LGBT civil rights organization, and for people who are
not familiar with the acronym that Lesbian, Gay, Bisexual and
Transgender. I'm speaking on behalf of an organization that doesn't do
direct service provision; either medical or legal, but really is a
political policy and advocacy organization. I'm speaking on behalf of
the organization, unless you vehemently disagree with my remarks, in
which case, you can lump them in with any of the more distinguished
panelists' \[remarks\] or attribute them to Thomas McCormick
\[laughter\], the missing panelist.

I'd like to start, since this is being recorded, to reference the July
8, 2003, letter that Haley had mentioned that was submitted by a variety
of different signatories who are concerned groups, including Lamda Legal
and the AIDS Alliance for Children Youth and Families. It's a really
good letter that I think sets out a lot of the microlevel policy
considerations. The considerations that I won't have time to go into
today, but actually going through each one of the listings and
mentioning what place where it could be strengthened and places where
the listings could be buttressed to encompass things like side effects
and competence, resistance issues. I'm going to start with some
overarching concerns and then go to some more specific comments. The
overarching concerns I have really have to do with the political, active
revising of disability listings in the face of a budgetary crisis. I
think that the tendency and perhaps temptation when revising listings,
particularly for an illness that's made a lot of therapeutic significant
advances, are to revise the listings in ways that might get some people
off the listing process to really reflect some of the progress that has
been made in this field. I think that one has to be very wary when that
goes on to look at this in a systemic way because, as some of the
panelists and questioners sort of brought up, disability is linked with
health care benefits, particularly with programs like Medicaid. You
can't look at that in a vacuum. If people are displaced outside of this
for meeting their health care or drug needs, you look at other systems
that would have to absorb the people who would no longer be getting
their Medicaid help through this. And you look at the ADAP, the Aids
Drug Assistance Programs that are currently in a bit of a crisis---there
are waiting lists in several States---and say will these individuals be
able to be absorbed in other places?

The second thing is administrative efficiency. I think that the
gentleman from Maryland had mentioned that a lot of individuals are
doing a thorough job of really taking into account resistance and the
constellation of issues that sort of would come up, I guess, in the N
level; sort of diagnoses that could also be considered together. And
that's great for individuals who are doing that, but I think if the
listings were strengthened, and in the discussions before, and not just
in the listings, but in the discussions.

I'm going to move on to the more specific comments, and one of the
things that I heard across the other speakers and that we will echo is
the issue of taking into account drug resistance and the potentially
disabling effects of the new treatments, the cocktails, the heart
treatments. One of the things I think needs to be spelled out more
clearly in the current listing and the discussion before is that
these---and there is a sentence that says this, but it could be more
further expanded---medication regimens can be independently disabling.
The side effects of these---and some individuals can be independently
disabling---are separate and apart from anything that's going on with
the disease progress. The other thing is in 1407(d)(8). I think that
there should be a sentence added to say that hard side effects must be
considered when assessing functional capacity, particularly for the N
level type constellation of conditions, none of which are severe enough
to appear in the A-L listings, but that when taken together should also
be considered with the side effects of the medication regimens that they
are taking. I echo the other panelists in saying that mental illness
needs to be considered in a deeper way in terms of the discussion and
how it plays in. I think that with mental illness and mental health, it
is complicated because of the fact that not only does it often play an
effect on the transmission of HIV because of the fact that individuals
with bipolar or other diagnoses might have different risk-taking
profiles, but then also it has an effect with the medicines, because if
you look at things like Sesteeva, etc., some of the side effects
actually talk about issues like depression and attention deficit, sort
of disorders that sort of have been seen in some patients. But then
finally, the actual disease has a sort of complex interaction with
mental health, whether it's being removed from work, whether it's being
diagnosed with the disease, whether it's just the process of going
through the assessment process for a disability or pulling away from the
workforce. There is obviously a complicated interaction with mental
illness and I think that that could be fleshed out a little bit.

The final comment I have really has to do with the advancing
complication and the nuance and the pace of scientific discoveries in
this field. I think that you've heard that from some of the people who
are sort of asking questions, but this field is advancing so very
quickly and in such complicated and nuanced ways that I think maybe a
greater discussion needs to be had in the regulations that assessments
and consult exams, review claimant claims, the claimant files need to be
done by specialists. And you've heard from two organizations that have
really pushed for codifying what that means, and I think as an
organization, \_\_\_\_\_ is flexible about what that would mean. But I
think you've had two groups sort of really chart out ways that you can
accredit this growing body of scientific evidence. And really
accrediting people in an informal or formal way to ensure that they are
really abreast of all the things that they would need to really perform
in a way that's up to date and precise. That is the American Academy of
HIV Medicine. Just in case anybody thought I was being cryptic. That's
it.

FEMALE VOICE: Thank you very much. Are there any questions for this
speaker?

FEMALE VOICE: My question actually goes both to what Praveen and Howard
Grossman just talked about in terms of the specialist issue. I think
that in terms of the diversity of practitioners who actually treat
people with HIV, it's incredibly important that Social Security become
more open to hearing from nurse practitioners and physician assistants
and other people who treat people because many times at the clinic
level---I work at Whitman Walker Clinic, which serves people in the
Washington, DC metropolitan area---that's who really is providing
specialty care to people; and Social Security has a real bias against
hearing from those people and using their evidence in the same way that
they would a medical doctor. So I just wanted to highlight what Praveen
was talking about, you know, listening to these people and specialists;
but also, I don't know, if we could have more comments on that as well.

HOWARD GROSSMAN: That's why we were so keen on doing something with
nurse practitioners and physician assistants, because I think---how do
you refer to people---mid-level providers, or physician extenders---all
these really ridiculous terms. In New York State, my PA can write for
narcotics prescribed. I mean, he's supposed to be working under my
supervision, but he knows more than my associate, who is just 2 years
out of residency. I think we definitely need to recognize that as an
expertise, and that's part of why we did our credential thing, so that
people would have something where they can say I took a test, I did a
certain amount of continuing education and, therefore, I should be
recognized as an expert.

DR. \_\_\_\_\_\_\_\_\_\_: And I would also make an appeal to---you know,
there are a lot of advocates in the room. One of the things that I was
talking with Haley about last night was that really medical people have
been excluded from, certainly from lots of HIV advocacy. I'm not sure
what's going on in the other advocacy communities, but doctors and
practitioners are the last people that anybody seems to want to hear
from. And I would encourage a change in that. There are lots of us who
are willing to sit and work on regulations and do all that stuff that
for some reason people think we wouldn't want to do.

FEMALE VOICE: Any other comments from any of you.

MR. BROWN: My name is Charlie Brown, and I work at the Prince Georges
County Health Department, which is in the suburb in Washington, DC.
Actually, I just wanted to make a couple of comments. I felt that what
the panel has said was really very good, and I do hope that all of the
folks from Social Security that are going to be thinking about how we go
about revising the regulations will take some of your comments to heart.
I did not hear anybody say, and at least the process of starting
disability begins with the potential recipient, is the complexity of the
system that they have to deal with, and all the changes in the
regulations won't affect people not having to appeal if they have the
stamina to get that far. When you look at the initial system that's
there---beginning with the local Social Security Office, which has to
coordinate with the medical providers, the forms that have to be filled
out, and then the way the State agency handles all of that---it's a very
complex process. That's why we keep talking about appeals, and it keeps
lots of lawyers employed both in the private sector and in the
government. That should tell us something right there, without trying to
sound like I'm an advocate; I'm not. I'm just pointing out what happens
when people with HIV begin the process, which, you know, they reach the
listings and the listings are applied to them. And, there may be some
systemic changes that could be made along with this when you think about
it. I mean, one of the comments that I particularly liked was the one
about well, if by working, do you mean 40 hours a week, 52 weeks a year?
Well, if that is what you mean, or if you have a lower barrier, if you
put that in plain English so that the physicians filling out the forms,
as well as the patients answering them understood what you're talking
about, then perhaps you might get the kind of answers that will help the
State agency work or the people that are doing the appeals work. Because
people that are getting sick try to look at the glass as half full, not
half empty. And they don't like you to say, well think about your bad
days when you fill this format. But that's what people have to do. And,
when physicians are doing it, they see some of the good days, the bad
days, but perhaps in their heart, the medical providers, say well they
can work a little bit, therefore I'll put that down. But it doesn't
translate very well when it gets to be adjudicated, because whatever the
line is that you're looking for is not real clear, and people don't know
what they are suppose to be addressing.

HOWARD GROSSMAN: That's an excellent point, and that's where the
quality-of-life measurement scales that are reproducible and
scientifically valid. They ask those kinds of questions. In the last
week, rate your energy level. So you get something over time rather than
trying to find a way to give a snapshot of it. And I think that's
important.

DR. \_\_\_\_\_\_\_\_\_\_: You know one other aspect here. HIV, unlike
other diseases, is still a disease of shame. It's just not the same to
have cancer or heart diseases as to have HIV. And so that shame plays
into how people rate their ability to go back to work. Well, maybe they
overestimate it because they don't want to be seen as weak. And I think
we need to codify that to take out that shame quality. It's a functional
evaluation; it's not about that. And that issue of shame is very, very
prevalent. So anything that we can do to limit that and minimize that,
we help the community a lot.

MR. BROWN: The other comment I would make---not to offend Dr.
Albright---but I discovered, at least in sort of my thinking, there are
actually 55 State agencies, since I'm from Maryland. There is the one he
works for, and the one that actually treats our clients. I don't mean
that rudely. It's just that on a practical level, adjudication is made
at the State agency which is the first place it goes. Clients aren't
very sophisticated; the people that are applying for disability aren't
like the people in this room. I suspect that the vast majority of you
have access to private disability insurance, yet we're making decisions
on a far more complex system than you have to deal with. When it gets to
the State agency, you can allege mental illness, you can allege HIV, you
can write a cover letter that says that this person is functionally
disabled because of the crossover between these two impairments; and
you'll still get a denial saying you don't have HIV, you don't have
mental illness, and no consideration is given. It sounds really nice to
say that we do all of this. At the local level, I don't see it happening
that much. I can't tell you why. I could guess that it's probably easier
to deny somebody in straight lines than all the work you would have to
do to get it approved, to get it out. I don't know. But I think that if
you look at clients that are going through the system, and I'm sure when
they get up to the appeal level, you'll see that has happened so much.
And I just think that there are a lot of things that could be done
internally, within Social Security, that could make things work better,
and just changing the regulations won't do it.

MALE VOICE: Just let me make one comment. I don't want to address
anything but one thing that you said. It is easier for disability
examiners to allow a claim than to deny one. So, for whatever that's
worth, I just want to disagree with you on any feeling that it is easier
to deny a claim than it is to allow; that's not true.

MS. COLLINS: My name is Susan Collins, and I'm with a medical consultant
at the Atlanta Regional Office level, Central Disability. I just have a
couple of comments. I'm going to speak concerning what Dr. Albright had
spoken about. Because a lot of issues have been brought up about
symptoms, issues of proof of evidence, whether we take into account
documentation from nurse practitioners or physical extenders. I've seen
cases at different levels. I've seen them from private practice when
forms were brought in and again at that level. Physicians don't know
what to fill out or what the agency is looking for in adjudicating the
claim. At the Regional Office level, what I'm seeing at the quality
assurance level, we're there to evaluate cases that are sent, a certain
percentage from the State level, so that we can determine whether the
decision has been made correctly or incorrectly. At that level, we do
have a specialist. We have the infectious disease specialist, we have
the orthopedics for even the other body specialists. So, you do have
individuals that do have some credentials to be able to evaluate these
claims, even though we're not able to see all of them, only those that
are sent through. So, I wanted to support---again, we have the process
unification rules that had been put in place for us to take into
consideration third-party contacts. So, it's not like that evidence is
not being looked at or evaluated.

The other point that I'm hearing a lot is that when the regulations were
initially put out, we were looking at opportunistic infections primarily
as evidence, then you're allowed for that. But what I'm hearing, and I
know from a medical perspective, is the need to take into account the
side effects, the functional disability that individuals are having from
the different medications that they're taking, even though they may be
living longer. And I think that that is an important consideration that
needs to be taken into account.

One more thing that I thought about with the documentation issue. I've
done medical expert reviews at the ALG level also, and when cases get to
that level, what you have---the judges that I have worked with are more
favorable for allowing the claims---you have more evidence that has been
submitted through the attorneys or through the claimant representatives,
so the judges at that level have more information to work with than you
may have at that initial level.

MALE VOICE: Can I just make a quick comment on that. I think that it's
really important that you have quality control there, and that's really
great. The one point that I would take with you is that an infectious
disease specialist is not an HIV specialist, and we cannot make that
point clearly enough. First of all, HIV is more than an infectious
disease. Yes, it's a virus, but then after that, you're dealing with an
immune disease and dealing with all kinds of multisystem disorders that
infectious disease people don't necessarily understand. That's why the
two organizations we have have been trying to find an HIV specialist,
and that's something separate. And lots of places will just pull in any
old IV specialist to review things, and I would encourage you not to do
that anymore.

MS COLLINS: Well, at the Atlanta Regional Office, I don't know about the
other Regional Offices, we do have individuals that specifically work in
the particular area of HIV. So, we have that advantage at our particular
region. It may not be at every region, but we have people that are
designated, that are actually out there in private practice, that area
seeing HIV patients.

MS. FISHER: I'm Ann Fisher. I'm with the AIDS Legal Counsel of Chicago.
We represent about 400 people each year in cases against the Social
Security Administration. And so obviously, this effort is very important
to our clients. I want to pick up on sort of the very direct question,
and it follows so closely on what you just said. And the question is,
what is different that's happening at hearing that we could make happen
at initial, especially now that we're talking about eliminating
reconsideration as a stage? We want to get that good information that
those administrative law judges have before the disability examiners at
the State agency. And, so I've been thinking about how we win cases at
the ALG. Frankly, the surest way we win cases at the ALG is diarrhea. I
mean talk about not counting the stools a day, we just do not. There's
nothing in the listings that currently reflect that. The listing itself
that includes the diarrhea requires IV hydration. It also comes in the
HIV wasting listing, but the truth is that diarrhea can be absolutely
convincingly incapacitating and is for many, many of our clients. And so
perhaps we can bring that up, change that earlier in the listing, start
developing some questionnaires that actually get to the impact. Many of
my clients have not been able to leave the house, or have left the house
and had accidents on public transportation. At the moment, we're not
getting that information generally except at the hearing level; and if
we got that sooner, I think the functional limitations caused by that
very, very common side effect would be right there. People have
mentioned mental impairments. I want to specifically mention mental
retardation. Many of our clients, especially those clients with the IDU
histories, we find that about a third of our clients have never even
gotten to high school, have dropped out at eighth grade, or before. Many
of those clients, when we go and get their school records, have a
history of special ed. If we get them out for a psychological
evaluation, they do have mental retardation or significant mental
impairment that is not now being picked up. Just another thing to look
at. And that's not something for which you would have a treatment
record. It's not something that requires treatment; it's something that
requires finding it and putting it together. Good days and bad
days---many people have mentioned that. That's something that an
activities-of-daily-living form does not reflect. This gentleman pointed
that with out activities of daily living, people tend to put a positive
spin on it; and then, if they put a negative spin on it they're, saying
well that's an exaggeration. Obviously, activities of monthly living
would be asking people to do a lot, but some way that we get to the
reality of good days and bad days. By the time you're going to have 3 or
4 bad days a month, you're not going to be able to sustain work in the
national economy. And so we need to figure out how to put that in the
regulations and quantify it. Combined impairments are obviously very
important.

Just two other comments in respect to a couple of other people. This
asymptomatic. Thank you, whoever brought that up. We get so many things
back from our RDDS saying your HIV is asymptomatic, and your depression
is not severe. Because a doctor has written HIV asymptomatic---now that
same doctor may have written fatigue, depression, diarrhea---but what
gets picked up is the asymptomatic. So perhaps something in the
introductory comments saying that asymptomatic is a term of art; that
doesn't mean you don't have symptoms relating your HIV. And then finally
in answer to that return to work question about how many people would
like to go back to work. Pretty close to 100 percent of my clients would
like to work if they could. There is no question that even---I've got a
client right now who has hemophilia whose been hospitalized with severe
bleeds four times in the last 2 months, which of course has not been
enough to get him Social Security benefits, and is scheduled for knee
replacement, and there is nothing that guy wants to do more than to go
back to work. Many of our clients would like to work; many of the new
work incentives do work for people with HIV; many of them don't, and so
I think that's a separate topic, but just sinse the question came up.

MALE VOICE: Okay, I'm going to follow up on that---

MALE VOICE: A quick comment on jargon, because I think that's something
also that people need to look at. Doctors are trained these days, as
always, to use a tremendous amount of jargon. One of things besides
asymptomatic is that in hospital charts it says no acute distress, NAD.
And I've had patients where their insurance says, we're not paying for
the hospital visit. And the same thing happens when they go for
disability as well. And it's something that people write automatically
if the person is not sitting there gasping for breathe and dying.
They're in no acute distress. It shouldn't be a trigger the way it has
been.

MS. FISHER: Can I actually bring up one thing in reference to making a
more surgic look at records that are not considered medical records per
se. You were saying that, for instance, mental health or other concerns
are described in special ed records, etc., for those things. I think
that's great. I also think that greater and more extensive discussions
need to happen between providers and their patients about mental health.
Sometimes, it's just not going to show up on the record, and that's not
just because their symptoms aren't there, but because there are definite
reporting biases against bringing up mental illnesses. And from the LGBT
population, in particular, when you're dealing with an identity that has
been pathologized and are our not so recent past treated as a mental
disorder, there is a real bias against bringing up mental health issues.
And so I think that these are underreported issues, and we have to
creatively---not only about what records, we look also at the creative
ways of bringing this up in medical discussions in ways that are
unthreatening, but definitely sometimes proactively started from the
provider.

DR. \_\_\_\_\_\_\_\_\_\_: I want to follow up on what Ann said,
particularly with the question Mr. Gary asked, and get more detail on
something. But first, Dr. Albright, I just want to say that I don't
practice in Maryland, so I can't tell you. But I will tell you that in
Pennsylvania, as an attorney and practicing here for over a decade, that
it is certainly easier for an examiner to deny a case than allow one.
And there's a reason for that. It's called the DQB. The DQB is not in
business to turn denials into allowances; it's in the opposite vein. And
those decisions have impacts on people's professional ratings in their
personnel files. So, I just wanted to say that at least in Pennsylvania,
that is not true from my experience, and that's a long experience.

FEMALE VOICE: Would you like to just put that acronym in?

DR. \_\_\_\_\_\_\_\_\_\_: Disability Quality Branch. It's quality
control. Now, Mr. Gary asked a very important question, and Dr. Elion
gave an answer of particularly 50 percent to 70 percent of his patients
would like to return to work. Ms. Fisher says her clients are more like
100 percent. I think that's right. Now, we're talking aspirational
there. One of things that doesn't happen between doctors in this legal
system is that you're not told what all the standards are. So, let me in
a nutshell tell you this. If you are on Social Security Disability and
you're on it, you have the ability to go back to work, and you have a
trial work period during which your cash benefits won't be removed; and
if you keep working, you maintain your Medicare. Leaving aside whether
the drug line is going to be accessible under the formula we have yet to
see, at least that's in place. For SSI people, it's a totally different
ball game. It's much more difficult; it's a much more chancy of
proposition. You don't have the same trial work allowances, even though
Medicaid, which usually in most States goes with SSI and does cover at
least some of the drugs. You don't have any guarantee that you're going
to be able to continue. So understand that distinction.

DR. \_\_\_\_\_\_\_\_\_\_: Yeah, but even the 18 months is in many
people's minds---you know a snap of the fingers and that still scares.
What happens after that?

DR. \_\_\_\_\_\_\_\_\_: You know that's the question I always get---what
about the future. But here's the final point I want to put on Mr. Gary's
question. Dr. Elion, if you understand what the standard for working is
you can't go back to work like you did in the past, that was part-time
and substantial, that the agency considers working to be basically 40
hours, 8 hours, 5 days. We're talking full-time work. And we're talking
not ADA-accommodated work; we're talking about the average
workplace---office, factory, you name it, in the United States. And with
those assumptions in mind, what percentage of your patients, would not
like to go back, but would be able to sustain work over an intermediate
term, let's say 2 years?

DR. ELION: It's a self-fulfilling prophecy. If they're already on
disability, I'd say less, I'd say zero. I think that they can't do that.
The problem is they'd like to go back to work, and chances are they
can't sustain the kind of activity they had at their prior job. So they
need to find some other way to work. That's a placement problem if
they're on disability from their employer. It's a different kind of
issue if it's Medicare disability. But it's a much lower percentage.

DR.\_\_\_\_\_\_\_\_\_\_: Well, I didn't sink the third assumption, which
was also Mr. Gary's. Assume we decoupled medication, medical insurance
completely? It's not the issue anymore. Even though it's speculation.

DR. \_\_\_\_\_\_\_\_\_: Same number, small percentage.

FEMALE VOICE: One more question over here.

DR. \_\_\_\_\_\_\_\_\_\_: One second. I'm going to need to leave a
little early. So, Dr Grossman is more than capable of answering almost
anything you could ask me. If there's anything you wanted from me, I
need to leave in a few minutes.

FEMALE VOICE: We're going to have another 5 minutes of questions---

FEMALE VOICE: You know, I keep coming back to the same question about
constitutional symptoms because that's the one that I think in the
adjudication process that doctors and examiners have the most trouble
with in term of determining what it means for disability. And I guess my
question is---is there any way to qualify or quantify what that means in
terms of disability. Because it's a real issue. We did a study in the
immune system, and it's not just specialists who don't document these
constitutional symptoms. Doctors don't document these constitutional
symptoms. So, how can you get at that issue, because it really is a
serious one for all of these immune system diseases because they really
are the ones that cause disability in my practice and other doctor's
practices; and we don't have the studies. So how do we get at qualifying
or quantifying that particular issue?

DR. \_\_\_\_\_\_\_\_\_\_: Well, you know, I think that those are
difficult issues. It's going to become worse because we're getting to a
medical system where this kind of care is more centralized in hospitals
and university-based, and we're getting private practitioners
disappearing in many places. There's almost no private practitioners,
for example, doing HIV care in Boston. Everybody is hospital-based. Now
you do that, then you don't have people who really understand how their
income is coupled to reimbursement. And so they don't think in terms of
putting down every diagnosis. They're not medical records people. And
their reimbursement is not based on them getting to know that. So they
really don't, and they just don't put things down. It's only going to
get worse rather than better. I think we need to use whatever scales we
can get and, again, I know I'm repeating myself, but those
quality-of-life scales---there are 10,000 studies that validate those
quality-of-life scales, and they do have fatigue scales. You can't put a
number on fatigue. The problem is that they've all been used in
research; we haven't used them in clinical practice. There are some of
us who are actually trying to do that---to validate them. I \[see\]
clinical practice as being predictive and being useful tools. If the
disability administration were to grab onto those scales, it would help
a lot to push this into clinical practice so that people actually start
using them day-to-day; and there are ways to do that. It gives you a
score that you could measure that's reproducible from test to test and
that has predictive value.

FEMALE VOICE: Do you have a question?

YOLANDA: My name is Yolanda. I'm with the AIDS Law Project of
Pennsylvania. I just came from a hearing this morning, and there were a
few things that happened that are germane to our discussion. One is that
my guy was infected at the age of 17, and he's now 20, which is a
problem in and of itself to try to establish the disability. But one
problem was that at every office visit, he was saying that he was
feeling great. But yet he testified to all these side effects from the
medication, and when the judge asked him about the discrepancy, his
response was that, indeed, the doctor just stopped writing it down, that
he just took it for granted and understood that he continued to
experience the nausea, the diarrhea, and the dizziness. The second thing
is that the vocational expert testified---not only that 3-4 days a month
out of work would render somebody or preclude them from work in the
national economy---she said one day per month for this guy who was
unskilled or semiskilled. And the other things we relied on were the
unscheduled bathroom breaks and the fact that the guy needs a nap
everyday. Well, between being off once a month either because you're
sick or you have doctor appointments or diagnostic tests, and you need
unscheduled bathroom breaks, and you need to take a nap, precludes you
from working. The other thing, is we relied on school records and his
work records. We had employers who sent us the records showing that he
had been terminated a few times because of his attendance problems. The
medical records were really good in that they documented. The doctor was
willing to write down that the guy was working here; the next time he
comes back, he's not working because it was too much for him. So, those
things are really important. And finally, my guy suffers from
depression; but he's not specifically in treatment for it. And you know
what, the best testimony is from the claimant who testified specifically
about the stigma. The basis for some HIV-related depression, the
inability to walk down the street, for feeling that everybody knows you
have HIV, or the feeling of being unsupported. And so that's really
important in terms of not just proving something under listing 12, but
exactly what it is the claimant is dealing with. Thanks.

DR. \_\_\_\_\_\_\_\_\_: You bring up a very important point about it's
more than just medical recordkeeping as well. And that's that when I
question a patient when they walk in and say how are you doing? They
say, oh, pretty good. Almost across the board. And it takes a very
definite questioning to bring out symptoms, and it takes, time and
that's something that lots of practitioners don't have anymore. So,
people's first reaction is, oh, we should be a good patient and say, I'm
doing fine. As you're walking out the door, they give you the 10 things
that are wrong with them, and you don't write it down because you're
already on the way out the door and on to the next patient.

FEMALE VOICE: I thank you all for your patience.

JOANNE HAGEMAN: Okay, thank you. And thank you, Paul, for monitoring the
heat---good job. Deputy Commissioner Gary, thank you for having us. This
is a wonderful opportunity. I tip my hat to the people ahead of me,
Virginia Ladd and the forces that have worked so hard for lupus
coordinating the advocacy and pulling us forward as far as we've come.
We have miles to go before we sleep, as they say. However, I'm not here
on an advocacy note today. I am here, and lucky to be here, because we
have done a 10-year watchdog industry watch. That's what I'm here to
talk to you about today. We will get to criteria, but my main issue
today is to give you a very broad overview from a very global
perspective. From there, you can take a very open look at some of the
core issues that the more experienced veterans here at this table can
zero in on. I think as a country and as a world with a mounting global
crisis of autoimmunity, lupus only being one, especially with roles of
14-22 million of us baby-boomers heading towards Social Security. We've
got a major problem, and we need to work together, and we're rolling up
our sleeves, and we've got to get to work. Researchers need to talk to
one another, the organizations need to talk to one another, the doctors
need to talk to the patients on the same level, and not on another
level. The number one problem with functioning is an inaccurate
diagnosis. And the number one reason why is the criteria is not true.
The criteria from 1971 is based on a nongeneralizable criteria that was
developed in a laboratory, and it's used for research purposes only.
It's on the presentation here. Folks, it's not available, you can't find
it. I'm only telling you this because we have had so many people call,
call, call, because they're presenting 8 to 10 of these criteria and not
getting diagnosed with lupus---partial diagnosis. This is not a partial
diagnosis. It sets up a cycle; it sets up a dangerous cycle; it sets up
a cycle not only of depression, but it sets up a cycle of panic. What
else do I have? What else can I get? And it weakens self-esteem, and it
weakens our bodies. We become immune to all sorts of things. I realize
I'm talking in very general terms here, but I really can't drive this
point home enough, because 10 years is too long that we've heard this
same thing. And for the last few years, especially with the new Medicare
changes, we're going from a heterogeneous into a homogeneous world here.
It works in the U.K., but it's not going to work here. We have doctors
who really want systemic care for their patients with lupus. I just came
out of a team trial, and I put them through the rigors. I said I want
this, this, this, and this; and you know what, they almost killed me,
because they couldn't talk to each other. So, I'm going to join Jerry
Lewis and try and get off all this medicine. Me and Jerry are going to
be in rehab. But when I'm done, I'll come back and talk to you some
more. Anyway, let me finish on this one, because it's very important. We
have five pages of listing suggestions that we can make to the rhetoric
or the writings of the Social Security Department. They can go to very
specific things, and they are very important. We'd love to rename the
word "fatigue" because it doesn't even touch it. It needs a category in
and of itself. It's a sunken ship. It's down at the bottom of the ocean
with a patient with lupus. You can't even rise to the occasion. I don't
even know how to describe it. We will send that on forward for your
attention and for your training. I think what's really important---I
know it's not within your power to do so, but I hope that we start a
ball rolling here about getting some criteria, real criteria, diagnostic
criteria that make a difference. The Fred Hutchinson Cancer Center,
since August of this year, has a definitive lupus test. One single test
that can actually, according to them, target the organ that lupus
affects. It's sitting hostage waiting for a partner to make money---just
need a patent. If we had money, we'd get behind it. I have no grants; I
have no money; I'm here on my own dime. So, if someone has it within
their power to do so, to save some lives, please somebody get behind
them and get this test out there. It needs to be marketed. They're ready
to go, they just need someone to back them up. That will save Medicaid,
Medicare, every insurance plan under the sun---seven diagnostic tests to
diagnose lupus. I will defer to my colleagues. They probably, since I'm
not feeling all that well, can tell me exactly which tests they are,
because my memory is not serving you at the moment.

A couple of things I wanted to touch on which we discussed at dinner
last evening was the way that Social Security looks at the defined limit
of total disability. As HIV touched on as well, that point where the
daily functions, HIV and lupus believe it or not, are very much the same
except on polar opposites. Our cells are flying that way and theirs are
the other way. On your tables are some symptoms lists set in
hospitalized patients any given day, at any time, at any whim. Training
a patient to identify triggers is difficult, because that's a whole
process in and of itself that someone acknowledging their disease,
accepting, embracing, and ready to make a change in their life,
empowering themselves, self-directing their care, and taking
responsibility. That's not always easy for a teenager. I have a
statement from an AOL chat host who was online with three 12- to
13-year-olds self-mutilating their wrists at the same time. Is that
where we want our kids seeking support for suicide in a chat room for
lupus? I don't think so. You can't expect their parents to get them in a
car and drive them to a hospital where they can't identify with someone.
You know teenagers, you probably got a few of them, all of you. The chat
rooms might be a place---we could certainly---hey, it could be a great
place for a teenager to let loose and talk. It has to be something that
we could certainly look into. There are great ideas out there. If we
work together, we could save some lives and save some kids. Our heart is
definitely with the teenagers who get misdiagnosed. There needs to be
screenings for these kids. They hit that puberty, the hormones, some
studies do say. Our dinner discussion last night included some of the
other things that we need to consider when we're looking at disability.
Our suggestion truly is if you're just flat out disabled, then that's as
much as Social Security can do. We need to know Oxford University, the
UK, everyone's off \[to\] all these big global conferences. I know
everyone's looking globally, all of you are, and we would be foolish not
to. We're all looking at what Social Security is doing around the world.
We're looking at socialized medicine. So let's look. Let's look at what
is working. Perhaps the powers that be have identified that. It would be
nice to know, maybe we'll find out in the end, but why don't we as a
country be the initiators and kick off some good fresh ideas? Sliding
scales for these type of things. Let's kick off some programs to kick
the economy back. What I've proposed to the Social Security Department
is something I wanted to also suggest at our dinner table last night.
We're not a lupus organization. We're not here to take money out of
anyone's pocket. We're here to come up with innovative approaches to
rebuild and recover. And that's all we're here for; on the backs of
lupus patients that want to get well, want to get back to work, want to
recover. We want to employ them. We want to get them ready to get off
Social Security because that's where we're going. We're taking a very
big look at this. The idea---it's global, I understand, but we have to
read the writing on the wall. The disability I know you're right off the
Tosch Conference, and it's a great momentum. Everyone's moving forward.
The disabled want jobs. That's great, where are they? We have to create
them. So let's create them. We need to get some programs going by
empowering those who are disabled to make their own way, but you have to
empower them first. You have to teach them and train them to get well
first before you hand them a ticket to work, because they're not ready.
Nobody's ready for that, especially not the lupus patient. They've been
beaten down to the quick. No one believes them because you can't see the
disease, and seeing is believing. You can ask any doctor. If you're not
presenting all those criteria, you're not going to get treated, you're
not going to get drugs for pain, and you're not getting a diagnosis. I
have copies of every file the doctors have. I have copies of every file
I've ever had and copies of every Social Security disability file. So
it's a report card, and I say it with blessings, and I say it, and I
give it to you because I've not been funded, and I'm saying this to you
because it's an honest approach with integrity to really make some
changes. And I say this from the bottom of my heart---that's what our
company is about. And we don't want to do anything else. So I defer to
my tablemates here that no more about how to address your specific
questions, but I can take questions about what lupus connections is all
about.

FEMALE VOICE: Thank you. Does anyone have any questions?

FEMALE VOICE: The Fred Hutchinson Cancer Center is in Seattle,
Washington. They need a sponsor. They are looking for someone to help
patent. The contact is Christian Woodward; telephone number
206-667-5095. This cleared from the FDA since August, and I can't tell
you how many lives have gone down the tubes since then. So, please, if
someone has the funding, can back this, get on it.

FEMALE VOICE: Any questions?

FEMALE VOICE: I left them speechless, I'm afraid.

VIRGINIA LADD: I'm very pleased to be here and I thank Paul and the
Deputy Commissioner, Gary Brooks, for inviting us to make a presentation
based on our testimony that was requested in the middle of the summer
regarding the listing. I'm going to go through this rather quickly. The
National Institutes of Health estimates that up to 22 million Americans
suffer from an autoimmune disease. And this number includes only those
diseases for which there are epidemiological studies. This was just
recently published by NIH. There are approximately 100 autoimmune
diseases. They affect about 50 million Americans when you consider the
ones that do not have epidemiological studies. They cost \$120 billion
annually; 250,000 new cases are diagnosed each year, and they are a
major cause of death in women. You can see by gender that about 75
percent of all autoimmune diseases occur in women. Here are some of the
25 most common autoimmune diseases. If you look down that, everybody
would probably recognize most of those diseases, but that's only 25 of
more than 100 autoimmune diseases.

The history of autoimmune diseases---many different disciplines are
involved, but no autoimmunologists; lack of focus on the underlying
etiology; only disease-specific research; very pro-cost talk among
different medical disciplines; and a lack of a coordinated approach at
NIH, resulting in much duplication, although NIH has now presented
Congress with a coordinated autoimmune research plan. However, it is not
yet funded. There is very little public awareness of autoimmunity as the
underlying cause of these diseases. That is very important because we
know they run in families, but families cannot offer out that
information; and it is a significant hindrance to getting a correct
diagnosis, which late and misdiagnosis leads to disability and death in
these diseases. Sometimes, I think we wouldn't even be talking about
disability and autoimmune diseases if we could just diagnosis them early
and intervene with current treatment. This is the listing. Listed
disorders, including impairment involving deficiency of one or more
components of the immune system; antibody-producing B cells and a number
of different types of cells associated with cell-mediated immunity,
including T-cell lymphocytes, micro\_\_\_\_\_\_ and monocytes and
components of the complement system. That's the listing for it.
Dysregulation of the immune system may result in the development of a
connective tissue disease. The reason I have that emphasized is because
it's not just connective tissue diseases, it can be hemological
diseases, it can be dermatological diseases, it can be endocrine
diseases. So the connective tissue disorders include several harnic
multisystem disorders that differ in their clinical manifestation cause
and outcome, and they generally evolve and persist for months and years.
They may result in loss of functionabilities and may require a long-term
repeated evaluation of management. I would just take out the word
connective tissue disorder and put autoimmune disorders. Systems
involved in autoimmune diseases---gastrointestinal, endocrine,
circulatory, cardiovascular, pulmonary, neurological, the eyes, ears,
skin, and kidneys. Serious and disabling autoimmune diseases that are
not listed in your listings---the Shets Disease, varocereal, high
inflammatory demiolating poloneuropathy, anti-foscal lipid Syndrome,
bolis panthogoid, panthogus, soriatic arthritis, biliary psorhosis,
cromes disease, autoimmune hepatitis. Some of these are listed in other
categories, but they're not under the immune system and they should be
because there hasn't been a paradigm shift in our knowledge about
autoimmune diseases in the last decade. Autoimmune diseases are now
known to have a common disease pathway. And I always like to use cancer
as an example here, because although there are over 100 forms of cancer,
in layman's terms, all cancers are caused by the immune system allowing
a mutant cell to proliferate. All autoimmune diseases are caused by the
immune system attacking the self. Also, we now know, which we did not
know just a short a time as 10 years ago, that they are genetically
linked. And, as I said, run in families. So, autoimmune diseases need to
be recognized as a category similar to cancer, rather than being listed
under the parts of the body affected by the disease.

Autoimmunity is a cause of disease. Although anatomically autoimmune
diseases are very diverse and can affect every organ in its system and
the body from the eyes, ears, heart, liver, skin, they are still all
caused by the same autoimmune response. There may be different triggers
for that autoimmune response, but it is still the same disease pathway.
The impact of the autoimmune diseases, to the brain, nervous
system---multiple psorosis, the lungs, autoimmune pulmonary fibrosis,
kidneys, lupus, juvenile diabetes, glanular antifridas,
gastrointestinal, chromes disease, Juliet sprew, joints, rheumatory
arthritis, oriatic arthritis, IMI\_\_\_, UVI, thyroid, graves disease,
hysterphobal, heart, cardiomyopathy, autoimmune miocarditis, skin,
pathic squarethermal, blood, hemoletic anemia, neutropenia, autoimmune
trombosiphenia, perniseous anemia. So you can see there is no part of
the body that cannot be attacked with an autoimmune disease. Many of you
will develop multiple autoimmune diseases. Here are some of the
disabling manifestations of autoimmune disease: Fatigue---fatigue is
probably the hallmark of the majority of autoimmune disease. I know it
was mentioned, but it's an overwhelming fatigue, and it's an important
marker actually. Some research has just shown that it is an important
marker for the development of autoimmune disease early on. Sometimes,
it's the very first symptom before even blood work shows positive; pain,
crippling, neurological manifestations, impaired overall functioning,
muscular weakness or atrophy. That's particularly true at CIDP and in
polymiasitis, impaired ambulatory ability. This happens in a number of
autoimmune diseases, although it is not always listed that way. Weight
loss, fever, anemia; these are symptoms that can occur with a majority
of these autoimmune diseases, which is why they should be listed
together. Systemic lupus---this disease is characterized clinically by
constitutional symptoms of science, such as fever, fatiguability in the
leg, weight loss, multisystem involvement and frequently anemia,
leucopenia, thrumbosypenia, and central nervous system involvement. In
the criteria for SSI, fatiguability is there. It's recognized as a
symptom. And that's the result of a patient organization, the Lupus
Foundation of American, several years ago fighting to get that in there,
because it was such a pronounced disabling factor in lupus. But it's a
pronounced disabling factor in multiple autoimmune diseases, but it's
not listed. Autoimmune hepatitis can have an extreme fatiguability of
pepicus, chromes disease, yet it's not in their listings. These symptoms
are very common to many autoimmune diseases, but only in, as I said,
lupus is fatiguability considered part of the criteria for disability
disease evaluation. I think what probably would be one of my strongest
comments is that fatiguability is a major factor in autoimmune disease.
Autoimmune diseases are chronic, so chronic autoimmune disease is the
cause of disability; it's the disease itself. So, you could have
after-effects of the disease but because the disease is chronic, the
disability can go on; and on and it's one of the reasons that you may
not have any alteration in the appearance of the person. But what's
going on systemically can make them very disabled.

To divert, just to step off this for one second. I just came back from
Los Angeles where we were producing a film, a documentary, on autoimmune
disease. We were interviewing patients with many different autoimmune
diseases from lupus, autoimmune hepatitis, scleroderma, panthelgis, and
alopiciariata. Alopiciariata is where you lose your hair, but that's
usually all that happens to you unless you have another accompanying
autoimmune disease. This is the person that looked the sickest. Her main
complaint in the interview was everybody always thinks I am sick. All I
have is loss of hair, not all. To her, that's an important thing. She
says but her calmest people will walk up to her and say I'm praying for
you, open the doors for her, because she looks like a cancer patient; so
they see her as sick. All of the other interviewees look like young
healthy people. They look like the picture of health. In fact, a
12-year-old girl with lupus, sealiactises, rheumatoid arthritis, type 1
diabetes, and vasculitis looked the healthiest of all of us. So, looks
are very deceiving in autoimmune disease. Autoimmune diseases have no
cure at this time and, therefore, last a lifetime. There may be many
periods of flasoramisia, but these periods can last from just days to
months and, only occasionally, years. Many patients have more than one
autoimmune disease, even as many as four or five, like the young girl I
just mentioned. It is actually very common when one lives with one
autoimmune disease to develop another autoimmune disease, thus adding to
the disability.

New treatments for several autoimmune diseases may impact on the
person's disability. TNF inhibiters have been like a miracle drug, and
also some of the other drugs on the market in the last 5 or 6 years for
multiple sclerosis. These new treatments really have been remarkable,
and they may allow a person to return to work. But they are not cures.
These treatments do not end the disability. They usually cause such
improvement that the patient could return to gainful employment or
full-time work. The majority of patients---and here are some of the
factors---now live a near normal lifespan with most of the autoimmune
diseases, chronic and \[those that\] last a lifetime. Growing numbers of
Americans with these chronic illnesses show one of the considerations
that we would like SSI to consider making a paradigm shift, to consider
partial disability as an option. This is particularly true, we believe,
since these diseases last a lifetime. They tend to affect, just as a
tendency, young people. So people are disabled for life. When you're 24
years old and you have MS, you want to be able to work; but you might,
and very likely, not be able to work full time. But why should you not
be as productive as you can be without the fear of losing your Medicare,
your Social Security, or insurance? It's something that needs, in our
opinion, to be considered.

Why would you consider partial disability? Well, in these diseases, a
person's endurance is low. Even when you're in a remission---what would
be considered a remission, you usually do not have full endurance of
your neighbor. Oftentimes, when you push yourself because you want to be
productive, that causes flare-ups. And many, many a person with an
autoimmune disease has been caught in the catch-22 of working and
pushing themselves, because now I feel good, and ended up back sick and
possibly damaged more to their kidneys, their heart, their lungs, or
their brain. Stress and overwork can cause flares-ups. Flare-ups may
cause additional damage, leading to even further disability. Pacing
activity level is crucial to controlling autoimmune diseases. Doctors
tell patients all the time, you must learn to pace yourself, but it's
very difficult to pace yourself when your employer expects you to work
45 hours. And when you mention that you can't---yes, they will make
adjustments, but it's still going to be a problem for you as far as
finding employment even. Many patients could work part time, long term.
Most would welcome the option of working part time. The patients that
I've spoken with over 25 years of being involved in working with people
with autoimmune disease actually would really welcome the idea of
working part time or working part time to what their disease will allow.
It would improve their sense of well-being. It would save SSA funds,
because they wouldn't mind giving up some of the funds to be able to
work and be productive without the fear of losing their Medicaid
coverage or having to go through the approval process again. It allows
patients to pace activity and control their illness. Thank you.

FEMALE VOICE: Any questions on this presentation?

FEMALE VOICE: I just wanted to make a statement One thing that I wanted
to reiterate that Virginia said was how autoimmune disease needs to be
recognized as a category, and we talked today about the immune system
disorders.

There were also a number of other areas that you were asking for
feedback with the deadline of July 2, 2003. So we also addressed all of
those different areas and, as Virginia showed with her slides of the
person and all the different body parts, many of those---like the
Sjogren's, you had that under there under Malconize, which is the major
target---diseases are actually systemic, affecting many body organs and
many systems. And oftentimes, this does not work under the current way
that the guidelines are under immune system disorders. So you can't
target it just as a body part because, like the Sjogren's, it can affect
every body part and every body system. At the moment, right now, for
example, a Sjogren's patient will try to fit the lupus guidelines; and
whereas there is great overlap; and there are a lot of similarities, it
doesn't exactly fit those guidelines. So we need a way to recognize all
of these autoimmune diseases that we're currently trying to address
under immune system disorders, but do affect multiple body organs and
systems.

MS. CHARLES: Hi. I just want to add to what Cathy said. I'm Linda
Charles from Sjogren's Syndrome Foundation. I've been a professional
registered nurse since 1983. I have primary biopsy-proven Sjogren's
Syndrome, and, as far as what you said about families, my sister was
diagnosed with Chromes at 11, with PBC primary bolier cerosis at 27. I
was Sjogren's' last year. I was diagnosed in 1999 after about 30 years
and maybe 25 ophthalmologists and millions of other doctors told me I
probably was most likely emotional, hormonal, and that I needed to seek
therapy. Well, thank goodness, I've been very lucky to find wonderful
physicians in Dr. Vivino and Dr. Pedolegson. But I also have to say that
I have been retired against my will medically by the Federal
Ggovernment. My retirement is based on the fact that over the past four
years, I've been increasingly unable to work. Although to all of you,
I'm sure, I look just like everybody else. And that's exactly what
everybody said as I walked down the halls, "Well, she doesn't look sick;
she's probably faking it; I can't believe they approved her disability."
Well, in 3 weeks, my disability was approved by the Office of Personnel
Management, and I'm sure all of you Federal employees who might be here
know anything about the layers of bureaucracy that lead to the OPM. That
was considered record time. And the reason that it was considered so
quickly wass because of the wonderful documentation that my physician
kept, and the fact that I, as a nurse, was very conscientious about
documenting every single sign and symptom of this disease and how it
affected my life from the morning when I tried to open my eyes until the
night when I tried to go to sleep. I've been working with Cathy and the
Sjogren's Syndrome Foundation, and I think it is critical for the Social
Security Administration to list Sjogren's Syndrome as a separate entity.
I just want you to know that also I have fought a successful fight with
the Veterans Administration because I am a Veteran of the Army Nurse
Corps, though I probably don't look that way either. The Veterans
Administration does not have Sjogren's Syndrome in its disease
compendium, so I was rated on lupus. And, again, that is another
overflow that goes from one section of the government to the other,
where there's no recognition. When you say you have lupus, people don't
understand. When I say I have Sjogren's, they say "what?" Those people
have never heard of this disease, and there is 4 million of us diagnosed
with it walking around in the United States. So, with my new years of
working as a nurse and being a patient and experiencing the misdiagnoses
and underdiagnoses over the past 30 years of my life or more, I plan to
help in any way possible to assist other patients out there who are
diagnosed or are suffering and to please help the Social Security to
streamline this process. The Office of Personnel Management was able to
get through my entire medical file in 3 weeks, through three separate
levels of a bureaucratic agency, and I haven't heard anything from the
Social Security Administration in 6 months. So, please, let's streamline
this; we can stop wasting the Social Security Administration's employees
time and effort and money. And, as a nurse, I volunteered to help the
Social Security Administration design a chart that could help make
defining what systemic manifestations are occurring in every Sjogren's
patient's body or any autoimmune patient's body workable on an
application so that the people that are doing the applications don't
have to search among these almost biblical proportions of the
Administration's listings. That's all I wanted to say. Thank you.

FEMALE VOICE: Any other questions?

FEMALE VOICE: Can I comment on that? I have Sjogren's too. But actually
we worked on a tool for that as well. What we did was actually do a
layover with a scale, because there is with function and pain and all
those subjective things that the medical examiners, even the doctors and
the researchers, do not have measurement tools that they can actually
use effectively. But it is subjective. If a client or patient is thrown
into a therapy type by observation, that also is subjective. Because
that's on a trusting relationship based on a day-to-day thing. And as we
know, and we're going to learn more today, symptoms change day to day.
Then you're running into your believability factor again. And then
you're running the risk of being misdiagnosed. And anyone that's been
there knows from one day you're sounding pretty good, the next day
you're bipolar.

FEMALE VOICE: And this is Frederick Vivino of the Sjogren's Syndrome
Foundation.

FREDERICK VIVINO: Can you hear me? Can you hear me in the back? Well,
thank you, Jerry. And I'd like to begin by thanking Commissioner Gary
and is colleagues for organizing this conference and, of course, for
inviting the Sjogren's Syndrome Foundation to be a participant. In my
presentation, what I'd like to do is briefly define the disease. I think
it's a good model for autoimmune disease and will help you better
understand a lot of the points that the other speakers have made or
alluded to this afternoon. I'd like to describe some of its major
clinical manifestations, complications, and how these cause impairment
in the workplace and inhibits somebody's ability to pursue gainful
employment. And, finally, at the end, I'd like to present a list of
specific recommendations that we have that we feel would help the Social
Security Administration better serve its patients, its clients, better
reduce costs, including the cost of the disability evaluation, and most
importantly, keep people at work, because that's my primary objective as
a physician; and I know that's something of interest to you all as well.
Sjogren's is a connective tissue disease. It's related to lupus, to
rheumatoid arthritis, and in this case, it's a chronic autoimmune
rheumatic disorder in which the body's own immune system attacks its
moisture-producing glands, what we call the etriken glands. You have
these glands all over in the body; in the mouth, they produce saliva;
and in the eyes, they produce tears. What happens is these glands become
invaded by lymphocytes, usually CD4-positive lymphocytes. Over time,
this leads to gradual destruction of the glands, and
symptoms---characteristic symptoms---like dryness of the eyes, dryness
of the mouth, and dryness of other body parts will evolve in this
patient group over a period of several months to several years. In some
instances, the inflammatory process will spread to other organs and
cause problems such as arthritis. That's why a rheumatologist such as me
ends up taking care of these patients and diseases of the internal
organs. Now, as a rheumatologist in practice for the last 15 years, and
as the medical director for a Sjogren's Syndrome center here in
Philadelphia at the University of Pennsylvania, it never ceases to amaze
me when some of my patients come in telling me that there are other care
providers that never even heard of Sjogren's Syndrome as a disease; but
that's actually quite typical for this situation. Not surprisingly, the
public has never heard of Sjogren's Syndrome as a disease, much less
able to pronounce the words Sjogren's Syndrome. And, again, not
surprisingly, there is very little information in the current Social
Security Administration regulations that directly apply to our patients.
Yes, some of our patients do get disability, but I can tell you this is
usually quite a arduous time-consuming process and in my experience,
people typically go through several tiers of the review process before
disability is sometimes awarded, or in other cases, sometimes denied.
This is not only long and difficult and costly for the patient, but it's
an incredible waste of Social Security Administration resources. Imagine
the task of a reviewer whose faced with the idea of trying to assess
disability in a patient for which you have no direct regs that apply to
the individual case. And, imagine the challenge for the patient and/or
her representatives trying to go through the remaining guidelines to
draw parallels between your disorder and disorders, which are listed in
the current regulations. Needless to say, we all greatly appreciate the
efforts of the Social Security Administration to take another look at
this problem and to try to devise some innovative solutions for it as
well.

Sjogren's is currently considered by most experts to actually be the
second most common autoimmune rheumatic disease with a prevalence second
only to that of rheumatoid arthritis. To put things into prospective,
that of the 22 million Americans affected by autoimmune disease, it is
commonly felt that as many as 3 or 4 million may be affected by
Sjogren's. That would make Sjogren's 10 to 15 times as common as
scleroderma or polymiacytis. That would make it more common than lupus
and about 5 times as common as multiple sclerosis. By numbers alone, it
certainly warrants further consideration by the SSA and the disability
regulations. As was mentioned, like most autoimmune diseases, about 90
percent of the patients are female. There is a high female-to-male ratio
in Sjogren's, just as in systemic lupus aratermatosis. So this, as do
other autoimmune diseases, really constitutes a major women's health
problem, but still unfortunately largely ignored by the medical
community. And as I'd like to present to you today, it's not---

DR. VIVINO: ---Sjogren, a Swedish ophthalmologist, when he first
described this disorder in 1933. However, what we've learned in the last
15 years is that, just like lupus, this is a systemic autoimmune
disorder that has the potential capability, with the possible exception
of the heart, of affecting virtually every organ in the body. It's not
only dry mouth; that's only the tip of the iceberg, because the entire
gastrointestinal track can be affected in people with Sjogren's. It can
affect the nervous system, both the central nervous system and the
peripheral nervous system. Like many other autoimmune disorders, it
affects the skin and can cause a vasculatic rash. It can affect the GYN
system, the lungs, and, as will come to talk about, the kidneys and
other internal organs. And, as was mentioned before, it's associated
with many other autoimmune diseases. So, when a patient has one
autoimmune disease, keep in mind that there are increased risks for
developing a second autoimmune disease. That's something that we, as
physicians, need to consider whenever our patients develop new health
problems. Now, in Sjogren's, there are three basic mechanisms by which
morbidity and impairment in the workplace can develop. Some of the
problems relate to the fact that the exatrin glands, the
moisture-producing glands, are being attacked and become dysfunctional.
Obviously, if you have dryness of the eyes or the mouth, I think the
impairments that you would develop are fairly obvious; if not, we'll
discuss them a little bit more later. But keep in mind, it can affect
other organs like the lungs. When you have involvement of the exatrin
glands and the lungs, the dryness can cause a chronic cough from zero
trachea, dryness of the windpipe, the upper airway. And, likewise, when
you have dryness in the lungs, you're susceptible to recurrent
infections. So, many of these people have an impaired ability to clear
bacteria and foreign debris from the respiratory track. So, they may
develop problems such as recurrent bronchitis, or recurrent pneumonia,
or when the sinuses are affected by dryness, by damage to the exatrin
glands that provide moisture for the sinuses, recurrent sinusitis. So
that's one mechanism by which morbidity can occur. A second mechanism is
the fact that in the early stages of the disease, the glands are invaded
by T cells, but these cells release various signals that recruit other
inflammatory cells to the site, including B cells, which create
autoantibodies; that's why it's an autoimmune disease. And over time, in
about 10 percent of patients, these B cells will degenerate and evolve
into malignant cells. Rather than producing a variety of autoantibodies,
they'll produce antibodies against a single clone and eventually evolve
into diseases like multiple myoloma or lymphoma, which obviously have
devastating complications. All of the autoimmune diseases are associated
in one way or another with cancer. The association between lymphoma and
autoimmune disease is strongest among the Sjogren's Syndrome population.
The third mechanism by which morbidity can occur in Sjogren's has to do
with non-exatrin disease. As was mentioned in lupus, the release of
various chemokines and cytokines in the blood, chemical mediators of
inflammation, cause systemic symptoms such as fever, fatigue, balays,
the blahs, and weight loss. Likewise, this whole process of inflammation
can spread to other tissues besides the exatrin glands. Again, pointing
to the lungs as an example, the spaces between the air spaces in the
lungs, what we call the innerstisium, can become inflamed. In the early
stages, this can cause a pneumonia-like picture with fever, cough, and
shortness of breath. As time goes on, if the physician fails to diagnose
and treat this, it can lead to scarring of the lungs, so-called
interstitial lung disease. Obviously, the more scarring you have, the
greater lung function you lose and the pulmonary function test will show
shrinking lung volumes, a decrease in the DLCO, the measure that we
follow to judge the air transfer into the lungs. And some of these
patients will go on to develop progressive shortness of breath and the
need for chronic oxygen therapy.

I hope you can appreciate from the wheel that comes to us from Europe,
that Sjogren's can really affect multiple organs just like many other
autoimmune disorders. As was mentioned, the disease course is
unpredictable. We don't always understand why, but, typically, most
patients will have a waxing and waning course with unpredictable flares.
I'd like to present to you some cases that exemplify how Sjogren's and
other autoimmune disorders impact on work productivity, and also make
the case that work environment can also impact on some of these
diseases. As was mentioned, many autoimmune disease patients walk around
for months or years before their condition is diagnosed, and, in
Sjogren's, I can tell you that's no exception. The mean duration, the
national average, between the time the symptoms begin and the time that
the diagnosis is finally made is on the order of six years. And, in our
population at PEN where we follow about 300 Sjogren's patients---I have
patients who have been diagnosed in some cases quickly, 4 or 5 months;
in other cases, the diagnosis has not been made until 14 years, or what
we perceive to be 14 years into the illness. In some cases, this is due
to lack of medical awareness. In other cases, people or practitioners
may trivialize symptoms, and still yet in other cases, people often look
a lot better than they feel. A lot of our female patients, I'm sorry to
say, are labeled as being depressed and written off as being a
hypochondriac before they can finally convince a practitioner that
there's a real significant problem.

So, how do you evaluate disability in this group? Remember the wheel,
remember the large number of organ systems involved. I would not want to
have the job of a disability evaluator in these cases because every
person is different, and you really have to take each individual on a
case-by-case basis. And you not only have to define which organs in the
disease are involved, but how seriously they're involved, whether
they're involved enough to impair gainful employment. And also compare
the patient's physical and mental profile to their job description. In
some cases, this impairs employment. In other cases, it is totally
irrelevant. About 90 percent of cases over the course of the disease
will develop severe dryness due to exatrin gland dysfunctions, most
characteristically in the eyes and mouth; but this can really, as you
see here, involve the whole body. So, consider a typical patient of
ours, a 50-year-old business executive who is a company manager, and her
job description requires travel, that she give professional
presentations, and that she interact with colleagues, both in a business
and a social situation. If she had dry eyes, she may have impairment of
her vision, because you need tears for normal vision; and when you lack
them, the surface of the eye, the cornea, becomes irregular and your
vision is altered. And, in the worse possible cases, when physicians
fail to treat these patients, or when the treatment fails, as it
sometimes does, many people will go on to develop corneal ulcers and
lose their vision. Not surprisingly, patients like this are often very
sensitive to light. Can you imagine what it would look like if you were
giving a presentation and every 15 to 30 minutes, you had to interrupt
it to put tears in your eyes? Not very professional, but it happens all
the time.

What about speaking? You need saliva; saliva is a vitally complex fluid
essential for oral health. You need saliva in order to speak. I wouldn't
be able to give this presentation if I had dry mouth because saliva is
needed to create sibalense between the tongue and other oral structures
so you can make certain sounds. Many of these people have difficulty
speaking. They have chronic hoarseness of the voice. That could
obviously impair their ability to speak. Imagine if a patient were a
schoolteacher. I have schoolteachers who can't speak. Imagine if the
Sjogren's patient were a telephone operator, how that would impair their
ability to function. As I mentioned before, many of them have a cough,
and, in some instances, the work environment only makes things worse.
This is a disease in which you want to try to keep yourself in as moist
and humid an environment as possible. So, if your company has
air-conditioning in the summer, as you would hope, or if your company
has heating in the winter, especially forced air heat, not surprisingly,
the humidity levels are going to be quite low, and it may be even more
difficult for you to do your work in the office than it would be outside
the office or in another environment. You need saliva to protect your
teeth. When you lack it, you can develop caries, and some of our
patients lose their teeth and have significant dental bills and a great
financial burden. Others have breakdown of the normal protective
barriers, the lining of the mouth, and develop chronic tongue and mouth
burning, either due to the dryness itself or due to yeast infections
that can complicate the dryness. That may make it very difficult for
them to eat acidic or spicy foods like pepper, tomato sauce, vinegar,
and, of course, very difficult to drink alcohol or wine. So that would
interfere with any type of business relationship in which social
interaction was required. About 20 percent of these patients go on to
develop systemic symptoms. By that, I mean involvement of the internal
organs, some of which can be life-threatening. A lot of these
patients---just like the lupus patient---develop vasculitis, what we
call palpable purpra, where the patient wakes up and sees raised red
purple spots on her lower extremities, let's say from the thigh all the
way to the ankle. In some cases, these may be painful. In some cases,
they may be itchy. They're certainly hard to get rid of, difficult to
treat. And not only do they cause discomfort and impairment from
discomfort, but it may affect the patient's choice of business attire in
a business situation. About 10 percent of Sjogren's patients develop
peripheral neuropathies, involvement of the nerve system, especially in
the leg where they lose sensation in their ankle and feet. This impairs
ability to stand and ability to walk and generally progresses up the
legs and then later, if untreated, will involve the arms and the rest of
the body as well. If the patient has joint or muscle pain, as is quite
common; muscular skeletal pain, including arthritis, Sjogren's can cause
a frank polyarthritis that mimics rheumatoid arthritis occurs, and the
small joints are affected. A person who had to use a computer or type
would be unable to do so, would be unable to write because of inability
to use her hands. If the large joints were affected, like the hips and
the knees, as can occur in Sjogren's, just as it can in rheumatoid
arthritis and lupus and related disorders, then she may have difficulty
walking; she may have difficulty transferring from a chair. Many people
with arthritis and vasculitis, unfortunately, tend to get inflammation
of the lungs or interstitial lung disease which, as I mentioned before,
can lead to scaring and, in the worse cases, lead to chronic shortness
of breath; and in some instances, the need for chronic oxygen therapy
just as is used in patients with emphysema.

The third patient group is the ones that we worry about the most, what
we call the lymphtho proliferative patients. These are the ones who look
sick; they're systemically ill, they have fevers, they're very, very
tired, and, in some cases, they have fatigue that's comparable to that
seen in the chronic fatigue syndrome. They may have swollen salivary
glands. In Sjogren's, the lymphocytes can invade the parodid glands in
the cheeks. So people develop glands and assume the so-called chipmunk
appearance, which can be quite disfiguring and just as difficult to
treat. They may also get swelling of the lymph nodes all over the body,
and many of these people will end up on immunosuppressive therapy on
hydroxy chloraquin, on prednazone, on azathyaprin, on psychlosporin, and
so on and so forth. Imagine if you had a 30-year-old nurse, and I did,
who was busy in the hospital trying to stay at work and move forward
with her career, but had frequent absences from the hospital because of
flares of fatigue and flares of fevers. She found the work and the long
hours required in nursing to be both mentally and physically challenging
and was unable obviously to do extra shifts when called upon by her
employer because of fatigue. In some instances, when the fatigue was
severe, it would even interfere with nursing duties, like lifting
patients, standing to dispense medications, and so on. And she was
continuously worried about how she looked, about how the swollen glands
affected her patients' and her employer's perceptions of her as a
professional. When she ended up on immunosuppressives, she was concerned
about side effects of therapy, because you can not only develop
morbidity from the disease, but you can develop morbidity from the
treatment and the complications of treatment, including chronic
infections. She was continuously concerned that she was going to catch
something from one of the patients she was trying to take care of. These
are typical problems in the Sjogren's population and in other autoimmune
disease patients. How do you measure this for disability? Well, that's a
very, very difficult question to answer; and right now, there is no good
way. The Sjogren's Syndrome Foundation, for its part, recently sponsored
an outcomes measures workshop to help physicians define the most
important measures to look at to track disease activity; but at the
present time, there is no universal agreement on what specifically we
should follow. Some things can be objectively measured, like dryness in
the eyes can be measured by putting little strips of filter paper in the
eyes, or putting dye on the outside of the eye to look for dry spots.
Other symptoms are much more difficult to assess in quantity, such as
fatigue and overall pain. At the present time, we only have two
prescription drugs FDA approved for Sjogren's. There are no new
medications in the pipeline. We're still in need for a cure. We're in
need for more research funding, because physicians still don't
understand what causes the disease. I think we are good at relieving
people's symptoms of dry eyes and dry mouth, but we have nothing to halt
the progression towards total gland destruction and dryness, which can
progress to the point where it's untreatable. At the present time, as
was mentioned, there is no concerted governmental focus on autoimmune
diseases. There's no long-term solution. There are no drugs in the
pipeline that would really help. The various groups are working now with
the NIH to try to coordinate the autoimmune disease plan to target the
areas of greatest importance and helping us understand the disease and
finding treatments. But right now, that has not been passed, and that's
a good 3 to 5 years or longer from becoming a reality. So, in summary,
these patients have significant morbidity and, in some cases, even
mortality. They're very difficult to diagnose, and they're very
difficult to treat; and it poses significant challenges to all of us.
What can be done to deal with this situation? Well, from the SSA's
standpoint and from the Sjogren's Syndrome Foundation's standpoint, one
factor that would help would simply be to list Sjogren's Syndrome,
because of its high prevalence, in the current disability regulations. I
think we can make a great case for doing that. And, for that reason,
last summer, the Foundation convened a whole panel of experts to suggest
revisions in the guidelines, not only for the immune system section of
the regs, but special senses, respiratory, digestive, chemic, endocrine,
and neurologic, because these diseases can affect multiple organs, and
disability is hard to evaluate, and a diagnosis is hard to make in some
circumstances unless all the organs are considered. We would consider
using a rating scale that determines disability based on the number of
organs affected as well as the severity of the organs affected. When you
have a disease that affects multiple parts of the body, to us, that
makes the most sense at rating disability. As the SSA has already done
in pediatrics and psychiatry, we would include more specialists, more
rheumatologists and immunologists in writing the new regs and in
considering some of these claims. And, finally, the SSA is in a unique
position, we feel, to co-partner with these groups, like the Sjogren's
Syndrome Foundation, the other autoimmune groups, the United States
Congress, corporate America, to try to devise some innovative work
programs to keep people at work. The idea of partial disability would
work quite well for the Sjogren's model, just as it would for other
autoimmune disease models. My impression is that most of the patients
would work at least a certain number of hours a week if given the
opportunity. So, if we had part-time work available with health
insurance and benefits, including prescription benefits and
over-the-counter medication benefits, that would be a great blessing to
our patients, and you would see a lot more people staying at work. If we
could modify the work environment or, alternatively, institute a program
of homework, where you're away from your work environment that dries you
out, that would be of tremendous benefit. If you had flexible work hours
that could accommodate you when you have fatigue as long as you could do
a certain number of hours per week, if you could do it on your own
schedule, you would be much likely to be a productive member of society
than you are if you get total disability. It really isn't all or nothing
with a lot of autoimmune disease patients. I think if we take another
look at how we view disability, we might be able to come up with some
constructive solutions to not only serve our clients better, but, more
importantly, to reduce costs and keep people at work. I thank you very
much for your attention, and I would be happy to answer any questions.

MALE VOICE: Real quickly. Dr. Vivino, what are the two front line
prescription medications you mentioned before and talk to us about some
of the side effects you see from using those chronically with your
patients?

DR. VIVINO: We have two medicines available that are FDA-approved for
Sjogren's---one is pilocarpene, and the trade name is saligen. The
second medication is savimaline, and the trade name is evozack. These
are both what we call secretagogs. They're medicines that were designed
to stimulate the moisture-producing glands to produce more moisture.
Although they are only FDA-approved right now for dry mouth, there is
some evidence from studies that we and others have done that they may
alleviate symptoms of dryness in other parts of the body as well. But
they don't do anything to alter the underlying progression of the
disease.

FEMALE VOICE: You have a question at the front table here?

MALE VOICE: How often do you see Sjogren's as a manifestation of a
quote, unquote overlap syndrome or an undifferentiated connective tissue
disease?

DR. VIVINO: That's a really excellent question. I was trying to avoid
opening that Pandora's box because we have a lay audience. But since you
brought it up, there are two kinds of Sjogren's. It's what we call
primary Sjogren's where usually a woman, previously healthy, develops
dryness and some of these other symptoms that I mentioned. She gets
evaluated and diagnosed with primary. Another type of Sjogren's is
called secondary Sjogren's where a patient has another preexisting
connective tissue disease already. Let's say she's had rheumatoid
arthritis for 10 years, and then later on, in her course goes on to
develop dryness of the eyes and the mouth. At that point, she'll usually
undergo further testing, and the physician will say, Mrs. Jones, you've
been diagnosed now with rheumatoid arthritis complicated by secondary
Sjogren's, because it's felt to be secondary to the original connective
tissue disease. To make matters more complicated, there are clearly
patients that we see who have manifestations of more than one connective
tissue disease; people who have certain manifestations of
Sjogren's---can you all hear me okay? ---Manifestations of lupus but
don't quite meet the diagnostic criteria for other diseases. I think one
of the other speakers alluded to the difficulty that we have when we try
to be rigid and apply rigid criteria to patients. That doesn't work in
clinical practice. I think we all realize that the criteria was
originally developed to define people for research studies, and they're
not always useful in practice. So, that's the third group. There is
still yet a fourth, group that you mentioned, of people with
undifferentiated connective tissue disease. These are people who you
know are sick. They may have Raynaud's phenomenon, where their hands
turn colors when they go out in the cold they may have skin rashes; they
may have arthritis; and they also have muscle weakness. And they have
features of more than one disease, but they don't meet the diagnostic
criteria for lupus; they don't meet the diagnostic criteria for
Sjogren's; they don't meet the diagnostic criteria for RA. Yet, we know
they're ill, so we use a wastebasket term called "undifferentiated
connective tissue disease," meaning that they have connective tissue
disease, but we can't quite fit them into a specific diagnostic category
at this time. Does this sound complicated to you? I mean, it's an
extremely complex and bewildering field.

MALE VOICE: Thank you. My guess would be that after hearing your
compelling presentations that Social Security might be inclined to, and
I hope, bundle a number of these responses under a test that looks at
cranicity and episodic flare-ups, much the way they do with HIV now. I
was wondering if you thought that that would be part of the correct way
to go. And I wanted to mention two problems that come up in this area.
One is the whole problem of if you do go that way, which I think is
probably a good first step, how do you get documentation of the length
of time that someone has a flare-up because our experience is frequently
that physicians aren't documenting the tail end of the flare-up, because
once they see it going in the right direction, they move on to the next
emergency. That's kind of the same thing that we see in HIV, and we see
it in a couple of other areas. The second observation I have is
that---and maybe you have some thought on this subject---with a lot of
these conditions, there is a propensity for various infections that
obviously afflict everybody else, but to a greater extent, like
sinusitis and like bronchitis and whatever. Our frustration a lot of
times in these cases, is trying to convince someone that this is more
than just a person getting a cold or sinusitis. It's the fact that they
get 10 of them in a year or that they last much longer than usual and
can be linked to something. Is there a way that we can get physicians to
opine about that, because frankly sometimes they're reluctant to do so?
They just shrug and say, "well, yeah, maybe it is, but I can't tell and
I treat it."

DR. VIVINO: I think the point that you made is extremely well taken. In
HIV patients, as you know, you can follow CD4 counts and viral tiders to
assess disease activity. Unfortunately, we don't have that available
right now in many of our autoimmune diseases. In Sjogren's, for example,
there really is no one parameter that we can follow to assess disease
activity. In lupus, some physicians like to follow complement levels
that tend to be low when the disease is active and return to normal when
it's less active. They follow anti-double stranded DNA tiders that can
be high when the disease is active and normalize when it's inactive. But
those only occur in a small subset of patients and don't universally
apply to every lupus patient. It would help greatly in our field in
practice if we had outcomes measures and specific diagnostic tests that
we could use to monitor disease activity. That would certainly help the
SSA better assess and reassess disability and the need for continued
support for disability over time, because some people do get better. I
always feel disappointed when my patients apply for disability, because
it's only the people that, in my view, have failed treatment that really
need disability. We have no magic test that we can use at this time to
monitor activity. This is where research comes in and where the
government, and hopefully the NIH with the autoimmune disease plan, will
step in and devise a concerted effort to address some of these issues
that are extremely important. These are all cutting-edge questions that
we need to answer as quickly as possible.

FEMALE VOICE: We're going to turn it over to Michelle Vogel.

MICHELLE VOGEL: Great. I want to thank the Social Security
Administration for inviting the Immune Deficiency Foundation and myself
to be here to participate in the policy conference. I first wanted to
ask one simple question. How many of you know what a primary immune
deficiency disease is? Can you raise your hand? Not many, okay, curious.
The World Health Organization recognizes over 100 primary immune
deficiency diseases affecting approximately 50,000 people in the United
States, but we think that number is low. But they are rare diseases;
they are the result of a genetic defect that involves the immune system
and its responses. Presently, the exact genetic defect for each of the
diseases is only known for a minority of the conditions. Primary immune
deficiency diseases are characterized by an increased susceptibility to
recurrent, poorly responsive, severe, and unusual infections. Affected
individuals have abnormalities of cells or proteins of the immune
system. The cells include B cells, cells producing antibodies, T cells,
cells that coordinate the immune system's responses and leucocytes,
white blood cells, or cells that fight infections. Some of the proteins
are immunoglobulins, also known as gamaglobulins, that complement
proteins and blocking agents such as C1, S trays inhibiter. The list up
here is the more common primary immune deficiency diseases. So, I'm not
going to go through all the list, but I would say the most common is
common variable immune deficiency. The most well known is severe
combined immune deficiency, SCIDS, which is also known as the bubble boy
syndrome, which many of you may have remembered the John Travolta movie.
Patients are diagnosed at different ages. Just like a lot of the other
diseases, it's hard to detect primary immune deficiency diseases.
There's only one test that can be done in newborn screening---that's for
SCIDS, but none of the States cover it; so it's not done at this point
unless a parent knows it's in the family and then they have it tested.
You can see that's it's all over the place, the age differences. The
usual average time it takes to diagnose from symptom onset is 9.2 years.
You can see, I mean, 17 percent of our patients are 20+ years. The
common permanent impairments due to delay in diagnosis are digestive
function, mobility, lung function, vision, hearing, and neurological.
Almost 70 percent of our patients use a therapy called IGIV or, as some
people here talk about it as IVIG; they're interchangeable. But it's
intravenous immunoglobulin, and, for the patients who don't use this
therapy, most of them are on antibiotic therapy or a combination of the
two, or they may be on interferon drugs. IGIV infusions---the majority
of the people are going to have the infusions at least once a week, once
every 4 weeks, or more frequently. The hours that it takes vary, but it
can take up to 5. I've heard 7-, 8-hour infusions. With children, it
tends to be a longer time because children can go down faster, and they
have to be monitored more closely for side effects. When a patient does
get infused, they tend to get infused during the workday, from 9 to 5.
Now, the places where patients get infused---preferably it's in the home
with a home health nurse; but some plans don't cover that, so they can
be infused in the hospitals or in some doctors' offices; and Medicare
has not covered home infusion up to the new bill. We were able to get a
provision included in there.

One of the big issues is---can patients feel IGIV wearing off? Yes. 68
percent do feel it. And when they do, it's like a peak and valley type
of thing. When the medicine starts wearing off, you're going to be more
susceptible to infections and, at that point, you're more fatigued, and
people are not going to be in the workplace or not in the schools. The
symptoms that tend to follow after the infusions are listed up there.
But I wanted to tell you, with the infusions, what's interesting,
there's eight different IGIV drugs on the market right now, and the
mistake is that many people think they're generic to each other, but
they're not. There's not one IGIV drug that works for one disease. It's
a trial and error to go through for each patient until you find the
right match that has the least side effects. Most patients go through
two or three medications before they find that. And I say the least side
effects, because there are side effects that are going to occur.

The top reasons that patients no longer use IGIV is lack of insurance
coverage. The insurance may drop them because of their cost; or they may
have coverage problems; or they can't afford it, too expensive; and
copayments just for Medicare alone. One of my patients was telling me
for one infusion, they were paying \$2,400 copay. Common acute
conditions patients experience, and this is even being on the IGIV
treatments, is pneumonia, bronchitis, repeated diarrhea, repeated eye
infections, urinary infections, candida, malabsorption sepsis. For the
employment status of our patients -- and this is coming from data that
we pulled. We have a data bank of about 18,000 patients, but we pulled
them last year; and out of that came about 16 percent that at this point
are considered disabled. Activity limitation varies from slight to
extreme limitation, but 68 percent are feeling some kind of limitation.
Source of health insurance---you can see that the largest health
insurance is coming from employer coverage. One interesting point is
that you see that there's 1 percent with no coverage. The reason why I
want to point that out to you is that if a patient doesn't have health
coverage and is not receiving the medication, they're not alive. And so,
2 years ago, the Immune Deficiency Foundation started a compassionate
care program with the help of industry, where industry donates some of
the IGIV drugs to us, and we are able to give that out to the doctors,
to the patients. And we're also able to help them pick up some of their
premiums and try to set them up into insurance policies. Sixty-four
percent of primary immune deficient patients have health insurance
problems, such as denial of coverage, exceeding lifetime caps, prior
authorization causing treatment delays, IGIV is not covered, States
prefer drugless informularies. This was an issue, again, with the
Medicare bill that came up on competitive bidding and only allowing the
cheapest brand. We were lucky that we got an exemption, and they
realized that the drugs are not generic to each other and that they will
allow all of the eight brands to be offered to Medicare patients. And
often policy cancellations. Before I go into this, I want to tell you a
story of a patient. But one of the things I wanted to mention too is one
of the reasons why there is such a long delay in diagnosing these
patients is because primary immune deficiency diseases aren't even
taught in the medical schools. They are considered rare diseases; they
may mention it in the immunology classes, but they're not in any of the
board exams, except for the immunologist board exams. So, we're working
to try to change that. We have CME courses set up on our Web sites, and
we have programs where we have visiting professors going out; and we're
working with the different specialists to get the board exams to put
these questions on these diseases to change the new doctors coming out
and the doctors that are out there, because they don't know what they're
looking for.

Now, Cheryl is a primary immune deficient patient who tried to obtain
disability benefits. She was sick all of her life and was on antibiotics
constantly for repeated infections. She was diagnosed as having common
variable immune deficiency disease at the age of 47. During the 10 years
prior to her diagnosis, she went to many specialists trying to find out
what was wrong with her. She had to have 10 sinus surgeries for severe
chronic infections, including the removal of her front sinuses before
she was finally diagnosed with a primary immune deficiency disease.
During her employment, she needed to take time off from work for doctor
appointments and IGIV infusions that she needed once every 4 weeks.
Prior to her infusions, she would often develop infections when the IGIV
was wearing off and had many side effects after the infusions that would
also cause her to be sick and not at work. And the other problems were
being around her coworkers, who brought in infections. I'm just going to
jump in one little issue that I wasn't going to even mention, but it's
in the news right now, the flu mist. Everybody is talking about the flu
mist with the shortage of the flu vaccine. Well, the flu mist is a live
virus that lives in the nose for up to 3 weeks. Especially in the
schools, if a child has the flu mist and sneezes, and there's an immune
deficient child next to them or in the area, that child is going to get
the flu, is going to be very ill and life-threatening. We worked hard to
make sure that Wal-Mart and other chains weren't using flu mist in the
beginning to explain how detrimental this would be to our population;
but now with the shortage, it's coming out. So, these are things that
our patients have to deal with. In 1997, after not being able to work,
she applied for disability benefits and she was denied and didn't
understand that she could appeal the decision. Cheryl tried to go back
to work, but because of her illness, she couldn't. Additionally, since
Cheryl wasn't diagnosed of her primary immune deficiency until later in
life, she also was diagnosed with autoimmune diseases, fibromayaldrin,
chronic fatigue syndrome. Because of not working, Cheryl eventually
became eligible for Medicaid and in 1998 hired a disability advocate to
reapply for her disability benefits. Once more, she was denied, but the
attorney appealed. After 2 1/2 years, she was granted a hearing. The
medical expert for the Social Security Administration at the hearing was
a rheumatologist, not an immunologist, who addressed Cheryl's secondary
conditions. When the attorney told the doctor that the condition they
were applying for disability benefits was common variable immune
deficiency, the physician admitted that he had limited knowledge on this
disease. The end result at the hearing was that Cheryl was approved for
the disability benefits for her secondary condition, not primary immune
deficiency disease. Cheryl was awarded \$900 a month in disability
benefits, which caused her to lose her Medicaid benefits because she was
only able to have an income of \$740 a month to be eligible for
Medicaid. Cheryl was eligible to purchase health insurance through her
State high-risk pool for the uninsured that cost \$1,400 per month.
Luckily, the Immune Deficiency Foundation was able to help Cheryl by
assisting her with the insurance premiums and supplying her with IGIV
through our compassionate care program. Two years after Cheryl was
awarded her disability benefits, she was eligible for Medicare, which
didn't cover many of her treatments like antibiotics. So, she needed to
purchase a medigap policy, which, again, the Immune Deficiency
Foundation came in to help with her premiums. And even though our
compassionate care program was supposed to be for a short period of
time, we are continuing to help her pay those premiums. Without that
compassionate care program, Cheryl probably wouldn't be alive today. The
significant factors in Cheryl's experience is delay in diagnosis of
primary immune deficiency diseases, the health-related problems in the
workplace, the length of process to obtain disability benefits, the need
to hire an attorney to be approved. Most of our patients do not get
approval the first time around and end up getting attorneys. The lack of
familiarity with the medical expertise on primary immune deficiency
diseases throughout the disability process and \[if you\] obtain
disability benefits, you'll lose Medicaid eligibility. Our
recommendations: to train the Social Security Administration
adjudicators to know what primary immune deficiency diseases are and use
a list of more common primary immune deficiency diseases to help
recognize the diseases. But know that there are other diseases that fall
under this category. And the Immune Deficiency Foundation would be more
than happy to work with the Social Security Administration to help
educate adjudicators. Consult with immunologists trained in primary
immune deficiency diseases throughout the disability process, especially
during the hearing process. Understand that primary immune deficiency
diseases are marked by recurrent, poorly responsive, severe, or unusual
infections. These infections are a result of the defects in the immune
system. The immune deficiency should be suspected in a person of any age
that has more than one pneumonia per decade of life, chronic sinusitis
requiring antibiotic therapy, chronic bronchitis without history of
smoking, increased number of ear infections after age two, and chronic
diarrhea lasting weeks to months, or recurrent bacteria infections.
Infections may occur as frequently as every 2 to 3 months. Affected
individuals may also have autoimmune diseases and cancer as a result of
their immune system abnormalities, and every infection must be
considered a serious infection for this population, since the immune
system is compromised. This is how you can contact me and thank you very
much.

MALE VOICE: ---advocate position to document the recurrence of ear
infections because there is no record. They can't afford the
antibiotics, but there's no documentation. So, that's one issue that I
sort of wanted to highlight in terms of looking at a potential glitch
with the listing that exists currently. How you fix it, I don't know.
I'm just pointing out the problem. The second one is the issue of can
some of these people return to work, and this is an interesting problem,
because very often people with impaired immune systems do much better
once they leave the workforce, not only because of the fact that they
are responding to therapy, but also because they're no longer in the
work setting. Their condition, like a lot of the disorders we talk
about, they do not respond well to distresses of the workplace. So, they
tend to show medical improvement when they stop working, not only
because of the therapy, but also because of the fact that they are no
longer in distress of the workplace. The other issue, which Michelle
alluded to, is that they are extremely susceptible to infections. Many
of them lead essentially housebound lives and so, again, when you take
them out of the workforce, they're not around coworkers and members of
the public, they're not contracting infections on such a regular basis.
Again, if you try to put them back into the work setting, you're going
to see them return to a disabling level. So, this is another area where
the listing doesn't quite capture some of the issues that the folks are
dealing with, because their problem is that they look a lot better once
you take them out of the workforce. When you try to put them back in
again, all of sudden, they look bad again. That's all I have. Thank you.

 

FEMALE VOICE: Are there any questions?

 

This gentleman is wonderful. He's helped us all out here. And he's not
with us; he's been wonderful. He loaded everybody's presentations. So I
wanted to go on and give him a hand.

 

ETHEL ZELENSKE: My name is Ethel Zelenske. I'm with the National
Organization of Social Security Claimants Representatives, known as
NOSSCR. We're a membership organization of about 3,500 attorneys and
other individuals who represent claimants in primarily disability
hearings before the Social Security Administration. Before I worked with
NOSSCR, I worked with Legal Services for many years representing
claimants in disability hearings. So, I have that experience first hand,
although I haven't for the last decade while I've been working on policy
issues in Washington. In addition, NOSSCR is a member of Consortium for
Citizens with Disabilities, which is an umbrella group in Washington,
DC, of the National Disability Organizations, and we are actively
involved in issues. We have a Social Security Taskforce, and we're
actively involved in issues before the Social Security Administration on
all issues. We submitted comments over the summer as a group. There was
a similar advance notice of proposed rulemaking for mental disorders,
and we submitted 28 pages of comments, which also gave me some ideas
about what to talk about today. What I wanted to focus on was functional
limitations in immune system disorders. I wasn't sure when I prepared
this presentation whether it was going to fit in with what everybody
else said all day, but it does. Basically, these disorders are hard
cases. They're the ones that involve a lot of subjective symptoms. And
they're chronic disorders, and they're often difficult to prove; and
it's why people often have to continually appeal and get to a hearing
before an administrative law judge, which also isn't the end-all and
be-all of being found disabled in these cases. I did go back and look at
comments that people had submitted and was taken by the firsthand
comments from people who are diagnosed with these disorders. It fits in
with the subjective nature of the symptoms and how difficult they are to
prove. And one person talked about how hard it was to get an adjudicator
to see the whole picture of their problems when they're being attacked
from the inside out. And somebody else said that one of the main
stresses for him was being believed that they were truly ill. In these
cases where the person isn't obviously disabled on the outside, it can
be very difficult to prove disability. It often turns on functional
limitations and how credible they are. And that's usually the bottom
line here. The current introduction to the immune system disorders,
which is Section 14.00, talks a lot about---these are statements that I
pulled out about the functional limitations and also sort of the nature
of the symptoms. You know, there are symptoms that evolve and persist
for months or years. They can result in a loss of functional abilities,
require long-term repeated evaluation, chronic adverse effects of
treatment. And the disorders may preclude a substantial gainful activity
because of serious loss of function. This is all just language that I
pulled out of the current introduction to the listings.

 

So, what is the introduction? The introduction precedes the actual
listing criteria for specific disorders. What the introduction does is
provide detailed guidance for all disability adjudicators, and it can
play an important role even in cases where the impairment doesn't meet
the listing. What I'd like to suggest today is that SSA include more of
its already stated policies in the introduction. Somebody was mentioning
to me at the break that it's important to have the policy statement in
one place for adjudicators. And actually having them in the listings is
the best place I think, to put them. This was the reason I wanted to
talk about this is that we recommended this approach with the mental
disorder listings, which already have a fair amount of guidance about
how you document functional limitations. But there are statements in a
lot of other places that we suggested SSA take those statements from the
other policy sources and put them into the listing so that they're all
there in the same place. Just in looking at the listings for immune
disorders and certainly from listening to all the speakers we've had
today, there are common problems that you start seeing that seem to cut
across all the disorders. Fatigue certainly seemed to be the huge one.
Joint pain and swelling, weakness, anxiety, depression, headaches and
many of these are subject to exacerbation by stress or exhaustion. These
disorders are difficult to diagnosis. There's no single test. You heard
Dr. Vivino say earlier it took somebody 14 years to be diagnosed. One of
the commenters for the advanced notice said that it took eight doctors
and 9 months to be diagnosed with the disorder. The symptoms mimic other
illnesses. Symptoms are vague or transient, and they are subjective, and
that means that credibility plays a large role.

 

So, where do you find guidance in other statements by Social Security? I
looked closely at Social Security rulings. And some of you may be
familiar with the Social Security rulings. These are official statements
of Social Security policy that are binding on all components of the
Social Security Administration. They're published in the Federal
Register, so they're official. They're different than regulations
because they're not subject to a notice and comment period. All of the
rulings are available, if you're interested, online at Social Security's
Web site, which is www. SSA.gov, which, by the way, is an excellent Web
site, and a lot of SSA's policy statements can be found there. What I
did in preparing for this session was to look closely at some specific
rulings that have come out over the last 3 or 4 years dealing with the
very specific disorders. These aren't immune system disorders, but they
have a lot of guidance in them that really cut across all kinds of
disorders, not just the specific ones that were in the ruling or immune
system disorders. The ones I looked at were chronic fatigue syndrome,
which came out in 1999. For those of you who aren't familiar, the first
number refers to the Social Security ruling number, and then at the end,
I just put the month and year that it was formally issued. In November
2002, there was a ruling on interstitial cystitis; in July 2003, there
was a ruling on post-polio sequela; and more recently in October, there
was a ruling on reflex sympathetic dystrophy syndrome. In looking at
these rulings, I tried to come up with some categories of statements
that could be used for the immune system and just tried to categorize
them. The categories were medical signs and symptoms, the transient
nature of symptoms---that's the ups and downs, the flares in remission,
situations when functional limitations must be considered, the
importance of treating source evidence, and use of third-party evidence,
pain, and credibility. What I'm going to do here is---what I did was
just pull out statements from the different rulings, and the initials
just refer to the specific ruling. So, RSDS is reflex sympathy dystrophy
syndrome; PPS is post-polio sequela; CFS is chronic fatigue syndrome;
and IC is interstitial cystitis. I just wanted to stick those in so that
nobody would think that I was making it up. The language is so
complicated, I couldn't possibly have made it up. This category, medical
signs and symptoms, just deals with sort of establishing the impairment.
And a lot of these statements will also appear in the regulations, but,
for purposes of this discussion, these are what were in the rulings. If
symptoms don't meet a particular listing, the findings are to be
compared to other listings to determine medical equivalence, and this
involves also considering symptoms alone or in combination to determine
if any other listing is met or equaled. Another important issue to
consider is that psychological symptoms should be evaluated under mental
disorders listings. When you look at the immune system disorders---and
this was true also for the disorders where the rulings were about
psychological symptoms can be a manifestation of the impairment itself,
or they may be a side effect of the medication---and so these all need
to be considered. The transient nature of symptoms---I mean this was a
very big issue today both in the morning and the afternoon in talking
about all the disorders, but it's also very true for the disorders
discussed in the rulings. There was some good language there. The RSDS
ruling talked about signs and symptoms that may remain stable over time,
improve, or worsen. It also said that transient findings are
characteristic of the impairment and do not affect the finding that it
exists. Conflicting evidence is not unusual due to the transitory nature
of objective findings and the complicated diagnostic process. Another
important point under this one is that conflicts should be clarified
first by obtaining evidence from treating and other medical sources.
And, again, this is important for the immune system disorders because
the symptoms come and go so much, and it is important. I'll get into
this in a minute, about getting information from the treating sources,
because you get the longitudinal history of the impairment. Another
points that's in the regulations is that the treating source should
always be recontacted first where there's a conflict in the evidence.
And, again, somebody this morning said that---I think it was the doctor
from the Maryland DDS---how things are supposed to work. And this is all
how things are supposed to work. It doesn't reflect reality, but it's
important to get the guidance there as something to point to for
adjudicators. One functional limitation must be considered. The MDI
stands for medically determinable impairment, and that's really just the
first step in the case; and it's just establishing the diagnosis and
that the impairment exists. And I understand from everybody I've
listened to today how difficult it can be just to get to that point with
immune system disorders. Assuming you get there and you've got the
diagnosis, then the issue becomes what limitations are there, and how
severe is that impairment. So once the MDI is established, the impact of
any symptoms, including fatigue, weakness, pain, intolerance to cold,
etc., must be considered to determine severity. And the adjudicator must
evaluate intensity, persistence, and the limiting effects of symptoms to
determine limitations on ability to do basic work activities. "Must"
isn't my word, that's what was in the ruling. So, that is a requirement
for the adjudicator to follow.

 

Importance of treating source opinions---this is obviously very
important for any disability claim. And, as I said earlier, it's
important in situations where---you need a good longitudinal history of
the case. Anybody who's represented a claimant at a hearing knows how
difficult it can be. You know, somebody goes in, and they have a good
day, and the adjudicator sees them on that one good day and may
disregard all of the medical evidence concerning that individual,
especially here with these disorders where you may look pretty good on
the outside but on the inside you don't. The treating source opinion is
really of utmost importance. The regulations, and if it's a policy,
state that treating physician opinions---that's what TPO stands
for---are entitled to deference, and they may be entitled to controlling
weight if they're clinically well supported by signs and findings and
that they're not inconsistent with other substantial evidence. If the
diagnosis is questionable, SSA is supposed to recontact the treating
source for clarification. Detailed longitudinal treatment records should
be obtained. These may be extremely helpful in establishing medical
findings and functional status. Also, any information from the medical
source contrasting the condition before and after onset is helpful.
Evidence from medical sources is often critical in deciding credibility.
I'm going to talk about credibility in a few minutes.

 

Information from third parties---I think somebody earlier was talking
about the issue about getting evidence from nurse practitioners. I think
that came up this morning in the HIV session. This was a point that we
pressed a lot at the meeting similar to this that we had on the mental
disorders listings. And it was a very interesting discussion, and I
think we made our point that nonphysicians have a lot of very important
information to provide about the severity and the day-to-day functioning
of impairments and can certainly help to establish a longitudinal
picture of the individual. This can include information from family,
clergy, employers, both medical professionals who are not physicians and
nonmedical professionals, and using a diary or journal. One of the
participants mentioned earlier that she's a nurse and that she kept a
journal; and this can be obviously very helpful in documenting the
day-to-day functioning for the individual. This information may be very
useful in deciding credibility and should be sought when there's a
discrepancy or question of credibility and a finding of disabled cannot
be made.

 

Pain---this is an issue that seemed to cut across most of the disorders
we were talking about today. The effects of chronic pain and the use of
pain medications must be carefully considered. SSA is to evaluate the
impact of pain and its treatment on an individual's physical and mental
functioning. Pain may affect the ability to maintain attention and
concentration, affect cognition, mood and behavior, and reduce motor
reaction times. And I also wanted to add that statement came from the
RSDS ruling, but the interstitial cystitis ruling had a good point. It
specifically stated that pelvic pain could affect the ability to sustain
and focus attention. These are factors that can interfere with an
individual's abilities to work activity over time or preclude sustained
work activity altogether.

 

Credibility is obviously a huge issue in these cases and is also one of
the more difficult ones to deal with in trying to get a favorable
determination in a disability claim. SSA actually has good rules about
it. The adjudicators often don't follow. The more it can be said how
credibility should be assessed, especially in these disorders where the
symptoms are so subjective, I think the more important and useful it
will be. I know it came up with many of these cases that people often go
in to see their doctors, especially with the chronic disorders, and
they're asked how are you doing today and they go, "I feel pretty good."
And it may be that they're just making nice. It also may mean maybe its
better than as bad as things were when there was a more severe flare-up.
You will sometimes see adjudicators take that statement and turn it
against the individual and take it completely out of context. In a court
case involving credibility, and it involved an individual diagnosed with
lupus, the court found that it's improper for an adjudicator to take
just that statement and to disregard all the medical evidence about the
claimant's functional limitations and severity of the disorder. A
statement like "I feel good," is not objective evidence about the claim
and can't be a basis for denying credibility without further analysis.
As a result, if additional information is needed to assess credibility,
the adjudicator must make every reasonable effort to obtain it. This
includes getting information from the treating physician and from third
parties. Whenever statements about pain are not substantiated by
objective findings, the adjudicator must make a finding on credibility
based on the entire record. I think that gets to the point I was just
making. It's improper to just take one statement out of context and then
to find somebody not disabled. And then if credibility is rejected, the
adjudicator must explain it. I just wanted to mention a couple of other
statements that came from the interstitial cystitis ruling about
symptoms leading to functional limitations, and I just didn't get it
onto a slide. For instance, it talked about urinary frequency, and this
could tie in also---there was talk this morning in the session on HIV
about diarrhea, and that it has a lot of functional ramifications,
including lack of sleep, fatigue, lack of mental clarity, limiting
somebody's social functioning in that they might be confining themselves
to their home because they're afraid to go out in public. It may also
affect the ability to---in this case, it was interstitial
cystitis---sustain function for a normal workday. That ruling
specifically talks about fatigue affecting the ability to sustain a
normal workday, which, as somebody earlier said, is an 8-hour workday, 5
days a week. That's the end.

 

FEMALE VOICE: Any questions on Ms. Zelenske's---

 

MALE VOICE: I have a couple of comments regarding the sequential
evaluation for all of these. Specifically, I'm interested in lupus, but
I think it's applicable to many other diseases. And probably all these
points I'm going to make, I've probably discussed individually with some
of you at one point or another, but I just want to summarize them for
the record, so to speak. Number one is I think when we get into the
sequential evaluation, the first step is the question, is somebody
working? In many of these cases, these people have to work because they
need the health care benefits, and they are holding on by a thread. I
think you've heard a lot of these folk say that they're very fearful of
not having any health care benefits, so they keep struggling. They use
up unused vacation time; they use up sick leave; they use up anything
that they can and, in some cases, even unpaid leave or sharing of sick
leave. Some companies allow you to buy sick leave from other people,
just so they can keep their health care benefits, so they can get the
medication and the treatment until they become eligible for disability
and then the Social Security. And here's the point I want to make about
that. There is sort of a disjoint in the sense that if you get so sick,
you have to quit; you can get COBRA for 18 months provided you can pay
for it, but you have to wait 24 months until you become eligible for
medical benefits with Social Security. So, you sort of have that 6-month
gap in there where you're kind of out in the cold. The second thing in
the sequential evaluation in the screening part---I think, we talk about
the functionality or the functionability---is the sustainability of that
functioning. In other words, some people can go up, and they could
probably lift weights and carry things and stand and sit and talk and so
forth, but could they do it 8 hours a day, 5 days a week, 52 weeks a
year, in order to maintain employment. I think that there has to be some
consideration given to sustainability of that functionability. The other
thing that I would like to comment on is in the introductory remarks. I
think there needs to be some stronger recognition of the disabling
effects of the treatments for some of these diseases. I know this is
true very much in lupus, and I'm sure in many other diseases where these
individuals, because there are no adequate therapies, are taking drugs
that have significant side effects associated with them. Not only
fatigue, which I'd like to refer to as extreme exhaustion, but also the
other disabling impact of severe weight gain, the impact on vision,
mental cognitive function. All of these medical side effects as a result
of the therapies that may not necessarily impair their physical function
of being able to perform a job, but that inhibit their ability to
perform professionally in their career. It is something that really
needs to be given some stronger recognition. The other thing too here is
in 14(b), the third paragraph, it talks about the longitudinal clinical
records of at least 3 months. I think there needs to be given some
recognition for a retrospective review of disease activity. We did a
study with our membership and found out that more than half of them
reported they went 4 years and visited three or more different doctors
before they received a diagnosis of lupus. In many of these cases, it's
not unusual for some of them to say that they have had the disease
activity for years, sometimes up to a decade, but that they were only
just diagnosed; but they are so sick that they cannot continue on. There
probably needs to be some recognition retrospectively of disease
activity, even though it may not necessarily have been diagnosed as that
particular disorder that they're applying for. I have two more comments,
then I'll relinquish the microphone.

 

Number one is in the section about lupus---and I think again this
applies to other diseases because I see this paragraph repeat itself
throughout there in 1401(b) ---it talks about having two or more
conditions of less severity. There's a sentence in there that goes
something like -- "with significant documented constitutional symptoms
and signs of severe fatigue, fever, malaise and weight loss." And the
keyword there is "and," because it is unusual for people to have all of
those constitutional signs and symptoms. They may have one or two or
weight loss. And in most cases, particularly with people on high doses
of cordico steroids, the idea of weight loss would be a blessing. So, I
really think that the operative word there needs to be "or." And,
finally, I think the other point that I really want to make here is that
there's no recognition for photosensitivity; and I discussed this with
Dr. Anderson, and I think he's going to deal with that. About a third of
the people with lupus are photosensitive. They cannot sustain themselves
under fluorescent lights for a very long period of time. We have one
patient who participates in our advocacy program who has to arrive at
nighttime, and we have to have a special car to take her back and forth
to Capitol Hill. The room that she has to go in, we have to make sure
that there are no open drapes or blinds because she is so photosensitive
that any kind of exposure to UV light would trigger a flare.

 

The final comment I want to make is I want to thank the Social Security
Administration for this kind of forum. So often---and this may be
considered the butter-up comment, but that's okay, I think it's deserved
---you hear an awful lot about uncaring bureaucrats in government, and
it makes great for political copy for fundraising for certain political
points of view. On my dealings on Capitol Hill and among the
Administration, I've met nothing but very caring and concerned
people---concerned about people and their disabilities. Thank you.

 

FEMALE VOICE: Here's a question; you first, then in the back.

 

MALE VOICE: I have a question for JOANNE HAGEMAN. I noticed in the
listings for the lupus \_\_\_\_\_, there are a lot of references off to
other sections. This might be hard for a caseworker to follow in their
routine everyday use and go off and look in those sections. It might be
easier to edit this like the HIV listings were done, to put it all in
one place without a lot of referrals. It would just be an easy thing to
do and might make it more useful in practice.

 

JOANNE HAGEMAN: Thank you for asking. Yes, I'd like to comment on that
because I did feel that the self-contained HIV that I've seen with the
LAMDA data was a really---did I pronounce that, yeah. That system seems
really logical for a caseworker that cannot reference that blue book,
the red book, whichever they're using at the moment if they continually
have to make reference. Not only are you looking into some human error,
you're definitely looking into computer error, and then you're looking
into handing that off to another person and, you know, then you're
looking into more interpretation. Certainly, a self-contained program is
something that lupus could fall into and if we had better criteria---you
know, I'd like to put my foot down and say geez, we really need better
diagnostic criteria, and that's all we want to comment on. But we have
the strength of doing---Peter's here, we have Virginia Ladd here, we
have some major history for lupus here and some strengths to draw on.
These people have made some incredible progress, so I'd like them to
comment as well on this because we're new here, and I don't want to be
the only voice for lupus up here. That's why we need to work together.
So, if I can do that, I certainly would like to.

 

FEMALE VOICE: You guys want to comment on that question?

 

MALE VOICE: I'll comment, and then Dwayne will comment. Of course, I
believe that we could be much more concise and not have people going
from one area of the regulations to the other, but I think that would
apply to many, many autoimmune diseases. So, I think a section on
autoimmune diseases where we look at, like I said before, the common
pathways of diseases. You hear the symptoms and the problems, especially
I like Dwayne's get rid of fatigue, because we can all say we're
fatigued. But the type of unrelenting exhaustion that people with
serious autoimmune diseases feel is true of multiple. Mobility problems,
it doesn't matter if it's lupus or if it's polymiocytis. There's
mobility problems. Chromes Disease has arthritis, but you don't find it
in the arthritis or the rheumatic autoimmune disease; you have to look
over at gastrointestinal, but they experience a lot of the same
crossover problems. So, I would like to see it condensed, the listing of
the regulations for autoimmune, because I think that that will take us
through the next, at least, 20 years of this century.

 

MALE VOICE: Hi, Bill Leech again. I just wanted to very quickly clarify
a point that an earlier person made about COBRA. There is a provision in
the COBRA law that states that if you are found disabled prior to the
expiration of the 18 months, you are entitled to an 11-month extension
of your COBRA eligibility, for a total of 29 months, which gets you
through the 5 months that you're waiting to become Social Security
eligible, plus the 24 for the Medicare card issues. Now, that's the good
news. The bad new is that in that initial 18 months, your COBRA premium
is capped at no more than 102 percent or 103 percent of normal. Again,
remember that this is a situation where you're stopping work, your
income has dropped to nothing, and your health insurance premiums have
suddenly doubled or tripled, going up to 102 percent or 103 percent
because the employer is no longer paying any share. And then, once you
get into that 11-month extension period, the cap is off. The premium can
go as high as it needs to go. Since we've been talking a lot about
access to health care today, I think it's important to look at the
global picture that very often people who are going through the
disability process are lacking medical documentation because they cannot
get access to health care because they cannot afford health care. And so
this is a significant issue, that a lot of people are falling through
the cracks because there is no provision for them to get their medical
documentation that will substantiate their credibility that will win
their claim.

 

FEMALE VOICE: Yes, I want to comment also. We work closely with access,
and we make sure that our patients continue to go onto COBRA; but again;
the payments are incredibly high. We have this compassionate care
program, but how far it can go to support the premiums to help the
patients to pay for the COBRA until they can get onto another program is
significant. So, it's a serious problem.

 

MALE VOICE: I wanted to issue a warning about---and maybe elicit some
comments---about the references to the other listings, because I'm not
sure that all the panelists are fully aware of the severity of the
listings that some of these references move over to. Perhaps Dr. Vivino
could comment a little bit on them. The respiratory listing that
cross-references is one where basically pulmonary capacity is less than
50 percent of normal, and I was wondering if that's really an
appropriate---and most of these other ones, I mean, you really don't
need a reference listing, because if you met them, you wouldn't need to
have lupus to begin with. I wonder whether with a lot of these reference
listings, we're not taking into account the degenerative and progressive
quality that these diseases have. And that really when you're tying them
to levels of deficiency that are free standing, what you're really doing
is only allowing benefits to be awarded when the damage has become so
severe that it's irreversible. And it doesn't take into account the
fatigue and the other factor and the pain and the other factors and the
risk of infection. It's actually dangerous. It's not just, "oh, they
don't know how to look at them." It's that by that time, the horse is
out of the barn.

 

MALE VOICE: Well, this is a very difficult question. I have to be honest
with you. I'm not an expert on disability. I try to keep my patients
from applying for disability, and this is something the attorneys
usually deal with when the patients get to that point. Personally
though, from the point of view of a physician, I would favor a system
that sort of gets away from the all or nothing approach and assigns
partial value for the number of systems or organs that are affected,
even if they're not organs that are in stage and in and of themselves
enough to explain total impairment. Because I believe it's sort of a
composite with the autoimmune disease in many cases, rather than a
single organ that's responsible for the patient's disability. I don't
know if that addresses your question or not.

 

MALE VOICE: Do you know any other systems that do that and try to
quantify that either you---you have that circular chart from Europe. Do
you know of any other systems where they try to evaluate the multiple
system involvement?

  MALE VOICE: Well, there are research collaborations underway to try to
determine the degree of organ damage in lupus and disease activity and
outcomes measures. And then we've tried to borrow from some of the work
that's already been done in lupus to apply similar principles in
Sjogren's syndrome. There are also activity and outcomes measures that
are available for rheumatoid arthritis. So, there is precedent for doing
that for some of our diseases, but not all of them. It depends on the
disease that you're interested in.

 

FEMALE VOICE: Can I comment? We're actually going to give you one of
those big global pictures again. We're actually really scratching our
heads on this as far as fitting a square peg theory. We really wanted a
new classification. You're talking about a multicellular, you know, an
aberrant multicellular problem, disease, disorder, whatever. We're
wondering how many more down the pike with the more difficult viruses
that are coming. And the more immunity problems that we're heading into,
our buildup of immunity, are we not on the cliff here? It's not just the
body systems. We're looking at the cells. So, should we not have a
cellular classification? That's my comment.

 

MALE VOICE: A couple of things have been touched on by other people's
comments and questions. The COBRA problem is even worse than the
gentleman pointed out because, at least in my experience, even if you've
got the money to pay the premium, if you are 30 minutes late with one
premium payment, you will not get any more coverage for 18 months, 29
months, or 1 month, it's over. There is absolutely no tolerance, no
grace period, nothing for these folks. So, certainly lots of people fall
between the cracks, even if they're trying to pay their premiums to keep
their coverage. It's a serious problem.

 

Rich's point about lupus, and it's not just lupus, these other ones as
well, the cross-references. This is really a question, and I'll address
it to Barry Iken, who knows better than anyone else here, perhaps, what
these really mean. There is confusion out in the field about what these
references mean. If they are like some of the other cross-reference
listings, then of course you have to wholly meet another listing for
chronic active hepatitis or sclerosis, or what have you. The way they're
written, it's not at all clear that that is what they mean. Since we
talk about ocular involvement described in the criteria in 2.00ff, which
I guess means following, since I don't find ff in the regulations.
Barry, could you address that before we go further?

 

BARRY IKEN: This is an issue we're wrestling with, too. First, let me
make some general observations about this subject.

 

BARRY IKEN: --- I wouldn't have put it the same way that Rich did. This
isn't necessarily a bad thing because in a sense it reminds our
adjudicators, that if you have a particular kind of disorder, you should
be alert to the fact that a person might have a listing---and any one of
a number of body systems. But it would definitely be better, in my view,
to come up with a way of addressing the issues within the same body
system up to a variety so that we don't end up with a book that's
twice---you only see the blue book. This is what our official book looks
like, and if you want to have one twice as big as that, that could be a
problem as well. Some of this might be fixed with computers eventually,
I suppose. I agree with you, Tom, that there's some unclarity about
certain listings. I think some of that's going away as we make our
listings more generic. It used to be that you would turn to a listing,
and it would be a particular diagnosis and people would say well, if I'm
using a reference listing, do I have to have that diagnosis or just the
severity criteria within the listing, which is what we really meant. We
can easily fix that problem, I think. I think we need to, if we keep
this system. Going to Rich's comment, it doesn't bother me at all that
we have some listings that a person, say with lupus turning to a listing
for a pulmonary disorder would automatically be found disabled if that
person had those findings. We have to go back to that sequential
evaluation. It's a way of saying to a person, "this is automatic, you're
in." Where I think we need your help the most, the thing that is most
problematic are the people who don't have that, who have this
combination of lesser impairments, which I have always felt that our
criteria for mood disorders listings. They tend to use the same
paragraph B that is trying in the best way we knew how back in 1993 to
say, well you don't have 50 percent of pulmonary function, or you have
some arthritis, but it's not so bad that it will prevent you from
walking really badly, or your eyes aren't that bad, but you have a lot
of things. How to define that better. It seems to me that there ought to
be some way to write a listing, a rule that we can apply to any given
person who comes through the door, to say we will accept that you're
disabled if you have this, that and the other thing. In addition to
that, I learned some things today that are related to this. I think that
we should be able to come up with a listing for people who get ill
frequently. This is actually something we tried to wrestle with in our
SSI childhood disorders listings, but it seems to me that there ought to
be some objective way of describing---even if we don't include
everybody---a fair number of people who the record shows they get sick a
lot. Similarly, this might be more difficult, but I think it's doable.
We ought to be able to come up with a rule for people who, when we see
them, when they present to us, aren't sick. But the reason is that
they're leading restrictive lifestyles so that they don't get sick, so
that they stay out of---so I think there are some opportunities there as
well. I'll stop.

 

MALE VOICE: Well, let me, if I could, just follow on this. The gentleman
from the Lupus Foundation pointed out another problem here, which is
requiring symptoms and signs of severe fatigue, fever, malaise, and
weight loss, requiring all four, even in the context of lupus, doesn't
make sense. It has been pointed out to me that fever is not a sign of
scleroderma. So when you turn to the scleroderma listing, you have the
exact same criteria. How could anybody ever meet the listing for
scleroderma unless they just happen to have fevers, which don't have
anything to do with scleroderma clinically?

 

MALE VOICE: Here's the answer. We get it. We need to fix that.

 

MALE VOICE: Okay, good, I'm glad to hear it.

 

FEMALE VOICE: Question here, too, and questions up here.

 

MALE VOICE: I just have one more thing.

 

FEMALE VOICE: Comments on Mr. Iken --

 

MALE VOICE: I just want to throw one more thing out, and I want to hand
the microphone over. There should be a Section 14.10 for fibromialta
period.

 

FEMALE VOICE: I just want to comment about listing of current frequent
infections that would be very welcomed for the primary immune deficiency
diseases, and also how would this help with the adjudicators. Because, I
mean, I know that most of our patients that are going through the system
are getting denied, and I think part of it is that people don't know
what primary immune deficiency diseases are. So, listing the diseases,
although I don't want to make it inclusive because the number of
diseases keeps on changing and increasing. Using them as examples may
make it easier for people to be able to have a checklist to know what
the diseases are and also know what the type of infections these
patients are having and how frequently they are having them.

 

MALE VOICE: These are the sorts of problems that we wrestle with as we
try to write these rules to be as inclusive as possible. We also have a
responsibility to the trust fund, what they call the public
\_\_\_\_\_\_\_. We're kind of stewards of the entire program, so when
we're writing these listings, we're trying to find ways that properly
include as many people who should be properly included. So as we come
back to you to ask you for assistance in coming up with these
provisions. Those are the kinds of problems you need to understand. You
just had a very insightful comment, I think. It's a very difficult thing
to do; it really is.

 

FEMALE VOICE: And I don't know if it would be possible to do some kind
of education program with the adjudicators to understand what primary
immune deficiency diseases are all about.

 

FEMALE VOICE: Yes?

 

FEMALE VOICE: Real quick, Mr. Iken. As far as the frequency on physician
visits or doctor visits, are you talking about documentation MER? Are
you talking about in file for disability?

 

MR. IKEN: I didn't' realize I was going to be so popular. Unfortunately,
basically, yes, although not necessarily always doctor visits, as Ethel
pointed out. Once you show that you have what we call a medically
determinable impairment, which doesn't even have to be a diagnosis. We
just have to have medical findings that show that there is something
wrong with you. We then start looking around for other information that
will help us figure out how bad your impairment is. But, for the most
part, we have a requirement in the law, not this book, but the law that
this book comes from, that we have to have some medical evidence to base
our decisions on. And the best evidence of day-to-day frequency of
severity is medical evidence. Not necessarily an absolute requirement,
but it's a very important one.

 

FEMALE VOICE: All right. Can I ask you one more thing? With a new lupus
test, with the target organ, you know, if indeed this is the case,
definitive, do you see that advancing your progress any?

 

MR. IKEN: That would help a lot, but it would only show us that you have
lupus, and then we would still have to be able to figure out how bad it
is and how it affects you.

 

FEMALE VOICE: So, sir, a scale, a rating scale, as the Sjogren's folks.

 

MR. IKEN: If it was reliable, we'd think we died and went to heaven. It
would be great.

 

FEMALE VOICE: We've gone over the constitutional symptoms before, which
is what everyone seems to be on, and I would suggest you don't take
those out until you find something that you can replace with it that is
equal in value, because how bad you are---these constitutional symptoms
are real important when they are in the chart, and they say that you are
actually having them frequently. But if they're not noted, that's where
the problem comes in. I don't think that they are a problem, I think
they need to be documented, not taken out. I wouldn't suggest taking
those out. I think they're very important because when patients come to
the office, that's what they present with. I have pain, I'm tired, I
can't get up, you know, not just the pain of the disease, but I just
don't function because I feel tired or I don't feel well. So, I would
suggest not taking those out until you find something that is
comparable, that you can document or qualify that's better. And I hear a
lot of people saying, take it out; I think that's a mistake.

 

FEMALE VOICE: We'll finish up with this comment.

 

MALE VOICE: Just on the severity---just a reminder of the quality of
life scales that Dr. Grossman mentioned in the HIV testimony this
morning. There has been a lot of research done on that, and apparently
they are quite consistent among the different tests.

 

FEMALE VOICE: I just want to say, I'm probably just adding comment to
everything that everybody said because I've been on both sides: (a) As a
Federal Government employee administering billions of dollars for
THICTHA for 68 regions, I know about the Federal Register and how
complex these things can get, but also then to be on the other side as a
patient and approaching the system where I have been through the
disability system for my job through the OPM, through the Veterans
Administration, which is an ongoing 5-year; let's educate the rock
system. They never heard of Sjogren's, and now I'm going through your
system or our system should I say, or something that should be our
system, which I just have to say I called Cathy and said I've never seen
a questionnaire like this in my life. It took me days to fill this out,
because it was (a) so repetitive and (b) so irrelevant to my disease.
Can I carry a grocery bag? Well, when I'm not in a flare-up and if it
doesn't weight a thousand pounds, yes, I can carry a grocery bag. So, I
had to answer every question on this the same way. If I am not in a
flare-up or I'm not having side effects, which I think should also be
included in the code that people should document when they have side
effects, and that should be part of the disability code. The side
effects of my medications, which Dr. Vivino will attest to, have been
very detrimental to my attendance at work. I've been through crinalin,
methatrexaid, quakersteroids, and now I'm on remacaid. So, let me say
that there have been days when the methatrexaid made me feel like six or
seven tractors had run me over, and I couldn't have gotten to work if my
life depended on it, and that was a side effect. It was not a direct
effect of Sjogren's. So, I believe an entire area should exist for side
effects of the treatment. One last comment, I have asked the
gentleman--- who I just have to say everybody \[in\] the Social Security
Office was very courteous, on time, didn't make me wait for my
appointments or anything---well, if I do get approved, how does this
work? Because I really didn't have any idea. And I found out to my
horror that I was almost one of those people that fell through the
cracks and could have probably been a street person if I were still
single, if I didn't have my Federal income from my job coming in,
because they said, well there's a 6-month waiting period. And I said
waiting for what? If you determine that I have this disability, why must
a patient wait 6-months. And he said, "Well that's just the way it is."
And I asked him, "Well let me ask you, what do you tell patients who
have zero income for that time?" And he said, "I can't give you an
answer ma'am." I called Washington and asked the same question, and they
gave me the same answer. So, I think a little bit of "let's get down to
some reality on a patient's level" needs to apply to when we change any
kind of Federal code. How people's lives are affected, are they going to
be living out on the street, can they pay for the medication, can they
eat---just the simple necessities of life. That's basically all I wanted
to comment on this.

 

FEMALE VOICE: Let's keep it to one or two more questions before---

 

MALE VOICE: Just one other comment. My understanding, and please correct
me if I'm wrong, is that the immune system regs are relatively young
among Social Security regulations, and they're out there; they're being
used, and they've done good for some people, just not as many as we'd
like. So, as a practitioner, my way of dealing with the solution in
hearing some of the problems that I've heard about the language; the
fevers in scleroderma, which you're right, are not a common
manifestation of the disease; the need to have fatigue; malaise; and so
on altogether in lupus could easily be addressed by convening a
consensus panel consisting of practitioners, various specialists in the
disease, disability attorneys, members of the Social Security
Administration, who obviously know more about all of these issues than
anyone else, and the patients. And I would think it would be not that
difficult to tackle one section with a committee and make some changes,
and then construct a list of diseases that by virtue of their prevalence
should be added to it and perhaps construct a model in one part of the
act as a test for the entire Social Security Disability Act to see if
that is successful---if it works, if it's cost effective for the Social
Security Administration and if its better for our patients, which is the
bottom line.

 

FEMALE VOICE: Yet another constructive idea; we've had many today. Any
other questions? I think we need to thank the panel. \[CLAPPING\] I
guess we'll give you guys a minute to step down here---

 

FEMALE VOICE: I guess there's no way to really thank the panelists
appropriately, the folks that traveled from Florida, Michigan, Boston
today, New York, of course, Washington. It's just so incredible that you
all would take your time and come this distance. We've had a 1-day
meeting, but for many of you this is really a 2- or even close to a 3
day venture. So we really want to recognize you---thank you for that. We
have listened, we've recorded, we have a lot to digest. There are some
suggestions that we know we can run with; there are some others that we
have to think about. When you hear a suggestion that makes so much sense
if you look at it from just a slice of the program; or a slice of the
policy might make sense. But when you put it in with everything else,
it's a little more complicated and has to be looked at in the whole,
too. So, we will be doing that. But there are certainly some things that
we know that, as we write the MPM, we're pretty confident we can easily
make some language changes, and some of the suggestions certainly are
imminently possible. So thank the panelists, thank all of you. Again, I
want to repeat, this is not the only opportunity you have to talk to us
or to give us ideas. We are also going to have another meeting, as we've
mentioned, in February. It's tentative dates are February 18 and 19,
that's a Wednesday and Thursday, in San Francisco. It isn't quite firm
yet; I don't think the hotel is firmed up yet, but we're working on it.
My understanding is that everybody who commented, even if you came here
today, will get a notice and an invitation to that meeting in
California. Now, that doesn't mean we expect everybody to come again in
California. There certainly are folks in the other part of the country
that would be coming to that meeting that wouldn't have come to an east
coast meeting. But, of course, if you want to come to California, you
will be invited and welcome to attend there also. So, anyway, look for
that. My understanding is that everybody will get an invitation to that.
You might want to alert your colleagues that live closer to San
Francisco about that meeting if, in fact, they don't get their own
invitation. We can certainly try to accommodate other folks that are
interested or that might be part of your network. Please do your
evaluations because, since we are going to do a meeting in February,
this will help us perhaps improve that meeting. Besides thanking
everybody I need to thank Jerry Borts, who is our facilitator and
certainly kept us on schedule and I think this added to being able to
have a very productive day.

 

Now, two quick things I want to talk about that aren't really related
directly to the listings, but to the process. A lot of what we've heard
today is, you know, people apply for benefits, and we don't always get
all the information, or they don't understand the questions, or
whatever; and so it's a year later before they get to a hearing before
an ALJ and certain things come out for the first time or we understand
certain things about their impairment or their situation for the first
time. There's been a longstanding issue. We recognize certainly that the
majority of folks shouldn't have to go to a hearing, shouldn't have to
spend a year or more pursuing their claim, if in fact, we could get the
information upfront and allow them appropriately at the initially level.
Part of what we're doing, and this will be happening over the next few
months, is moving away from what we call self-help. The disability
report, which is, I guess, one of those forms that you thought took days
to fill out, currently is mailed out when somebody makes an appointment
to file a disability claim. They get a packet in the mail and a bunch of
forms, and you spend the next 2 weeks before your appointment filling
them out. Some people are not really able to maneuver through those
forms themselves. Some people have help, and that's wonderful. But they
come to their interview, or they call into their interview, and then
mail their forms in if they don't come in person. What generally
happens, because of the way we've moved away from complete interviews
because of the self-help, is that the folks that do the interviews in
the field office, in the local office, take those partially completed or
completely completed forms and then just mail them to the State agency
that's going to make the disability determination. The quality of those
forms varies tremendously, because not everybody understands the
questions, or cannot articulate certain issues. Those forms are just
incredibly important to understanding what's wrong with the applicant,
who are the treating sources, what doctors, what hospitals have they
gone to, what medications they're taking. All of those are really
important for us to be able to quickly and accurately do a disability
determination. When we don't have an SSA employee going through those
questions, we do miss information upfront. We're moving away from that.
It's going to take a while over the next months to get to that point,
but starting in March, what we're going to be doing is sending out what
we call starter packets, starter kits. We have one for adult claims and
one for children's claims. These kits will be mailed to people who have
called in and made appointments for the interviews, and it will include
a worksheet, not the disability report form with all the questions; but
it will say to prepare for your interview, please have these kinds of
information and these kinds of documents available. And it has some area
for the person to make notes. But we're not going to ask the people to
actually fill out the form. And part of what we're doing is moving to an
electronic process, and we're coupling this change with the electronic
process so that all of the information taken at the interview by our
claims rep will be entered into a system, and that sets up an electronic
folder, an electronic claim. And over the next couple of years, we'll be
moving entirely to an electronic claims folder for disability. It will
take us that long to bring everybody up and to make the changeover. But
the intake piece is going to be electronic, and we've been working with
that for about a year. So, coupled with that, we're taking this
opportunity as we establish an electronic claim to have that
electronically, but also to move away from self help and have our claims
rep ask the question, try to articulate and explain what we're after,
and then enter that information into the system so that somebody who has
program knowledge can phrase the question in a way that hopefully the
applicant will understand, and we get a better answer. And not only do
we get a better answer, we get an answer to every question, because now
with self-help not all the questions are answered. So for those of you
who deal with claimants and deal with files, especially for those of you
who see files at the ALJ level, and you can go back to the original
3368. Hopefully, starting in the next few months, we'll have much better
completed 3368's as well as disability reports. And it's a very
conscious effort on our part to do complete, accurate intake. This costs
us resources, but this is something that we're going to do to the best
of our ability with resources. It's something that we recognize that if
we don't start out right, quite often it takes getting to a hearing
before we have that very important information about treatment sources.
Impairments---we don't even know all the impairments sometimes until we
get to our hearing. So, we're trying to rectify that. We know that it's
a basic issue that we need to try to address. So that's the starter
kits.

 

The other thing we're working on is you can file over the Internet. And
we do have a few people doing that, 500 or 600 a week. We haven't been
marketing that very much, but we will start marketing that over the next
few months, too, with the starter kits. But we find that there are
people that are very, very knowledgeable about our program and that help
claimants file, but they do not use our Internet forms because it's not
really conducive to the navigating. If you're very familiar with our
forms, you can do the paper forms quicker. We're looking at trying to
make that a little more attractive to third parties. We're working on
what we call third-party applications. When I say application, I don't
mean claims application, but functionality that would be more useful to
third parties who are familiar with the forms. Hopefully, that will also
help in terms of getting that information, getting it to us
electronically, and then we can use it; and it's much more efficient for
us. So those are two major things that we're looking at from an intake
standpoint. And, again, trying to get that information upfront so that
when we make the determinations, it is based on the information that we
really need. So, I think, those are both very positive things and
hopefully those of you who hold dear with our claimants will see some
improvement by next spring or next summer.

 

That's it, other than to thank you one more time. Martin, do you have
anything to say? And the evaluation forms, please just leave them on the
table. You can't leave unless you put an evaluation on the table; we
have guards at the doors. Thank you, thank you, thank you. We really
have appreciated this.