Public Meeting on Patient and Physician Concerns in Access to Intravenous 
Immunoglobulin (IVIG) 

 

 

 

 

 

 

Thursday, September 28, 2006 

 

 

 

 

 

Sheraton Crystal City Hotel 

Arlington, Virginia 

 


 

 P R O C E E D I N G S

10:00 a.m. 

 MS. CONNERY: Good morning, everyone. Its 
10:00 a.m., by some clocks, anyway. Wed like to have 
an on time start. My name is Jan Connery. Im with 
Eastern Research Group, also known as ERG, and we are 
a company that the Department of Health and Human 
Services has contracted with to conduct analyses and 
analysis of issues associated with access to 
intravenous immunoglobulin, or IVIG. 

 I will be your facilitator for this 
meeting, and Id like to welcome you all here today 
and thank you for taking the time to be here. Id 
like to note that were joined by well over probably 
50 folks in the room, and we also are joined by 50 -- 
over 50 folks who signed up to participate by phone, 
so Id like to welcome both those in the room and 
those on the phone. 

 I also want to check with Marcella -- we 


have an operator on the line because we have so many 
people connected -- to make sure that the technology 
is all working well. Can you hear me, on behalf of 
the folks on the phone; can you hear me well? 

 OPERATOR: Yes, Ms. Connery, we are able to 
hear you. 

 MS. CONNERY: Great. Thank you. The 
purpose of this meeting is to obtain public comment on 
issues associated with access to IVIG. This is the 
initial step in the analysis project that ERG will be 
conducting, and I am joined by two colleagues who I 
will introduce in a moment, and they will give you 
some background on this study and help you to 
understand how the meeting fits in the context of the 
study. 

 Before I do that, what Id like to do 
briefly is review the agenda. For folks in the room, 
you should have that in the packets that you picked up 
when you walked in, and its also similar to the 
agenda thats been posted on the meeting website in 


the past couple of days. For folks that are on the 
phone, you should have received an e-mail later in the 
day yesterday that contained the four items that are 
in the registration packets that we have here in the 
room. 

 The agenda is really very simple. After 
the background remarks from my colleagues, Im going 
to go over the process that well be using for the 
public comments, and then we will start that process, 
and we will be taking public comments up through our 
first break, which is at 11:30. For those of us on 
the East Coast, that will be our lunch break, and 
thats going to go for an hour and 15 minutes, and 
well start back in at 12:45. 

 At that point, well be joined by 
Congressman Tom Foley, a representative from Florida. 
Many of you probably know that hes also a member of 
the Ways and Means Committee and very interested in 
IVIG access issues, and so he will be here to say a 
few words, and that will be about 15 minutes. 


 Then, at 1:00 p.m., well start back in 
with the comment process and well go to 2:30 Eastern 
Time, then we will take our break. That will be 15 
minutes. Then well resume the comment process and 
keep going until we have worked through all the 
commentors that are on our list. 

 Ill note that we do have a very full day 
today. We have a lot of folks whove signed up to 
comment, so we do anticipate going until probably 4:00 
or even close to 5:00, or maybe until 5:00, but we 
will definitely get to everyone whos on the list. 

 I also want to note, especially for folks 
who are on the phone and maybe coming and going, that 
we will be taking our breaks on time, so starting at 
the time on the agenda and then coming back in to 
begin the comment process at the Eastern Time 
indicated on the agenda, just so you know that, so if 
you happen to be the commenter who is going to be -- 
is queued up to speak when the break ends, please be 
sure to be back here on time. 


 With that, I would like to introduce my 
colleagues to give you a little background. On my 
left is Dr. Aylin Sertkaya, and on her left is John 
Eyraud. Both are senior economists at ERG and both 
are co-directing the IVIG Issues Analysis Project. 

 DR. SERTKAYA: Well, thank you, Jan, and 
good morning. My name is Aylin Sertkaya and Im a 
senior economist at Eastern Research Group. Id like 
to start with giving you a quick background on our 
study. As you all know, IVIG is a valuable treatment 
for many seriously ill patients. However, the 
Department of Health and Human Services has been 
receiving reports of problems with access to IVIG from 
various patient groups and physicians. 

 In particular, these groups have been 
reporting increased difficulty in acquiring IVIG, 
changes in sites of service, fewer treatments, and 
problems related to switching among IVIG products. 

 So as a result of these reports, the 
Department of Health and Human Services Office of the 


Assistant Secretary of Planning and Evaluation has 
contracted with us to obtain an independent evaluation 
of the potential public health consequences of access, 
and also to gain a better understanding of the IVIG 
market dynamics. 

 So to meet these objectives, our study 
consists of three main components; first, an analysis 
of IVIG supply and distribution; second, an analysis 
of IVIG demand and utilization; and finally, an 
analysis of any IVIG access problems, including their 
nature, size, and scope. 

 Let me also quickly tell you as to how we 
are carrying out these analyses. Currently, were 
pooling and evaluating information from a variety of 
sources. These include published studies, research 
conducted and made available to us by patient groups, 
physicians, IVIG manufacturers, CMS and others, 
publicly and privately available databases, and also, 
interviews were conducting with IVIG manufacturers, 
distributors, group purchasing organizations, hospital 


and specialty pharmacies, infusion centers, 
physicians, and patient groups. 

 Now, as Jan indicated in her opening 
remarks, this meeting is designed to obtain public 
comment on access issues to be used in our analyses in 
conjunction with the other data and information being 
gathered. 

 I would like to conclude by emphasizing 
that we will carefully consider all the information 
you provide us here today and may follow up with some 
of you as needed to clarify any questions we may have 
during this process. Before I turn the microphone 
over to my colleague, John Eyraud, I would like to 
thank you all for being here today and sharing your 
experiences with us. 

 MR. EYRAUD: Thank you. Im John Eyraud. 
In case some of you are curious about ERG, we are a 
contractor to federal agencies and we have performed 
numerous economic and regulatory studies over the past 
22 years. One of our main practice areas is research 


on the pharmaceutical industry and unrelated medical 
and regulatory issues. 

 We have been working on the IVIG study in 
recent weeks and were still in the initial phases of 
our work. In this time, however, we have spoken with 
some of you in the audience. In todays session, we 
hope you will describe your personal or your 
organizations experience with the topics at hand. 

 It is helpful if you can provide any 
supporting studies or information, but that is not at 
all required today. We look forward to hearing your 
input. Thank you. 

 MS. CONNERY: Thank you, Aylin and John. 
What Id like to do now is go over how well be 
handling the comment process. In your registration 
packets or e-mail, to the folks on the phone, you 
should have the list of commenters, and this will be 
similar to the preliminary list that we sent out 
earlier. That is the order in which we will be taking 
the comments. 


 Its based on the order in which people 
signed up, and we will also be alternating between a 
commenter in the room and a commenter on the phone, 
just to have some variety. 

 What will happen with each comment is I 
will announce your name, and Im going to apologize in 
advance. Im surely going to mispronounce some names. 
But what wed like you to do when you begin your 
comment is to give us the correct pronunciation of 
your name and also, your affiliation for the record. 
For folks on the phone, please come to this floor 
mike. Thats important so that we can make sure that 
everyone is being heard. 

 There will be, as we said in some of the 
pre-meeting communications, a maximum of five minutes 
for each comment. I will be tracking the time and I 
also -- for folks in the room, I do have some visual 
time cues, just to sort of let you know where youre 
at. One minute, 15 seconds, and then time is up. For 
folks on the phone, Ill be giving you a very brief 


audio cue letting you know that its 15 seconds. 
Hopefully, youll have a clock in front of you so that 
you can monitor your own time. 

 We are going to need -- wherever you are 
when youre time is up, we are going to need to have 
you finish your sentence at that point and just end 
your comment. But there will be ways in which you can 
provide further comments that Ill mention in a 
moment. 

 Its important for us to be pretty strict 
about that for a couple of reasons. One is that we 
have a very full day. We have a lot of people who 
need to comment, and we want to be sure to get to all 
of you. Also, its a matter of fairness for everyone, 
in terms of everyone having the same time. So Id 
appreciate your cooperation in helping us follow those 
procedures. 

 At the end of the comment, it is possible 
now and then that Aylin and John may have a couple of 
-- one or two quick questions of clarification. These 


will be very simple. 

 For example, if there was something that 
someone said that they didnt understand and they want 
to make sure they had a clear understanding, they 
would ask to clarify their understanding, or if 
theres a point that they might like to get more 
information on, they might ask you if more information 
is available, and then follow up with you later. 

 We dont have the time for a lot of back 
and forth today, but based on what they hear, they can 
decide whether to follow up with more detailed 
questions later. So if there are any follow-up 
questions, theyll be really quite brief and very 
simple. 

 I do wish for all the commenters that I 
could have given you exact times when we would call on 
you to comment, but unfortunately, thats not possible 
for a number of reasons. There are many variables 
that are not in our control. 

 Some people may take less than their five 


minutes, and weve actually -- some people, when 
called upon, may not be there, and weve just heard 
this morning -- and Im grateful to three people who 
actually took the time to contact us and say I signed 
up but Im actually not going to be there. Im not 
going to be able to comment. Those are Commenters 
No. 9, 39, and 42. So we will be moving ahead at 
those points. 

 So for those reasons, we cant give you 
exact times. My personal best guess is that well be 
moving at a rate of about 12 to 15 commenters per hour 
that is scheduled for the public comments, so you can 
sort of do your own math. Especially for folks on the 
phone, if you want to come and go, thats fine. We 
recommend that you check back in periodically. 

 When I announce commenters, I will always 
say the number on the list so that you can quickly 
kind of learn where were at and gauge your time 
accordingly. 

 Now, if you have a written copy of your 


comments or documentation to support those comments, 
and youre here in the room, Id like to introduce a 
colleague, Linda Stein from ERG. One of her roles 
here will be to collect any of that documentation that 
you might have here in the room and make sure that it 
gets to the ERG project team. So just hand it in to 
her at any time. 

 If youre on the phone, one of the handouts 
in here is called Additional Information, and there 
is information in there about sending in additional 
comments and documentation, and so -- and written 
copies of your comments -- and so you can get those to 
us that way, either by e-mail or by regular mail. 

 For folks in the room, if you have a 
visual, maybe theres a graph or something that youd 
like Aylin and John to be looking at that supports 
your presentation and youd like them to be seeing it 
while youre making your comment, you can just hand 
that to me and Ill give that to them when youre 
called on. 


 If youre in the room and you have any 
logistical questions or needs, Id like to introduce 
another ERG colleague, Erin Corina. She is our 
conference manager, and shed be very happy to help 
you. See Erin with any of those questions. Ill also 
mention, for folks in the room, that the restrooms are 
located out the left and you keep going past the 
elevators and theyre tucked in over there. 

 For folks on the phone, you -- because we 
have potentially so many people on the phone at once, 
you will be on mute, except when youre called on to 
comment, and when you are, by the way, the operator, 
Marcella, will be -- itll take her just a couple of 
seconds to unmute your particular line, and then well 
hear your comment. 

 But we hope that weve anticipated and 
answered most of the questions that you may have 
through some of the pre-meeting communications and 
these comments right now, but in case theres anything 
more or any other questions you had about the process 


or logistics, your contact for that is Laurie 
Stamatatos. Many of you have already been in touch 
with her in registering for the meeting, but again, 
her contact information, if you dont have it in other 
forms, is listed on the Additional Information 
handout. 

 So if youre on the phone and you do have a 
question youd like to get the answer to, contact 
Laurie. Shell either be able to answer it directly 
or if need be, she can get in touch with us in the 
room and well get you that answer as quickly as 
possible. 

 Marcella, Id just like -- Marcella, our 
operator, is going to be letting us know if theres 
any audio problem. Is that right, Marcella? 

 OPERATOR: That is correct, maam. 

 MS. CONNERY: Okay. 

 OPERATOR: And if someone is having a 
problem hearing, they can send star-zero -- 

 MS. CONNERY: Okay. 


 OPERATOR: -- and let an operator know, and 
then we can contact your location. 

 MS. CONNERY: Okay, good, good. So on 
behalf of the people on the phone, we hope to 
maintain, and we have procedures to maintain, good 
audio feed the entire time, because thats obviously 
very important for the quality of this meeting. We 
want to make sure that everybody in the room can 
clearly hear those on the phone. As you can see, its 
plugged into the speaker system, so thats going well 
so far. And vice versa, everybody on the phone can 
hear folks who are speaking in the room, one of 
several reasons why wed ask you to use the 
microphone. 

 OPERATOR: Maam? 

 MS. CONNERY: Yes? 

 OPERATOR: Your line is starting to break up 
just a little bit. Have you walked away from the 
speakerphone a bit? 

 MS. CONNERY: No, I actually have a Lavalier 


mike, which is following me around. Is that better? 

OPERATOR: Yes, thank you. 

 MS. CONNERY: Okay. Yes, Im not -- there 
isnt a speakerphone. My mike is with me, so I just 
have to make sure that its very close to me, 
obviously. Okay. Okay. Now, a couple of notes about 
reports and so forth. First, I do want to mention 
that this entire meeting is being audiotaped for the 
record and from that, we will be producing 
transcripts, and those will be available to anyone who 
is interested. Also, Linda Stein, one of her roles 
here is to take notes and prepare a summary report of 
some of the main themes of the comments that were 
heard, and that will also be available. 

 If you are interested in obtaining a copy, 
you just need to contact Laurie Stamatatos, as 
detailed on here. Just let her know which, or maybe 
you want both of the documents. We expect that they 
will be available within the month and as soon as they 
are, we will send them out to anyone whos indicated 


they are interested. 

 Then the question Im sure many of you are 
wondering is when is that analysis report that ERGs 
working on going to be available. I did check with 
the Department of Health and Human Services about 
that, and it is anticipated to be available in early 
2007. Thats as precise as they can be about the time 
frame right now. Almost certainly, one of the 
channels of distribution will be their website, and I 
will get that web address for you and have it a little 
bit later. 

 So were almost to the point where were 
going to begin the process, and Id just like to 
remind everyone really, as is pretty obvious from the 
agenda, this is about comment, its about input, its 
about open listening. 

 We dont have time on the agenda, and its 
not a purpose of this meeting, to have any discussion 
or debate or any sort of decision-making. Rather, 
this is one of the many channels of input to this 


project. The ERG project team leaders will be 
listening carefully and following up as needed. 

 Id also like to note that if you dont 
feel youve been able to fit everything youd like to 
say in your five minutes of comments, or if you were 
listening to other people comment and think, Gee, 
theres more Id like to say now. I wish I could 
comment again, or if you didnt sign up at all and 
youre sitting there saying, Gee, I wish I had signed 
up, that you are welcome and encouraged to submit 
those thoughts in written form as written comments, 
which will be considered equally with the input from 
this meeting. 

 Again, the instructions for how to do that 
are on this handout, the Additional Information 
handout. Theyre also the same as the instructions 
for written comments that were available through the 
meeting website and other notices about the meeting, 
so were very much appreciative of that. 

 Let me just check and make sure everything 


is clear about the comment process. Folks in the 
room? Okay. I dont see any too-puzzled faces, so 
why dont we then begin with our first commenter? Our 
first commenter is Dr. Robert Dracker, and hes a 
commenter in the room. He is with us, coming to the 
phone right now. If you would give us your name and 
affiliation for the record. 

 DR. DRACKER: Its Dr. Dracker. 

 MS. CONNERY: Oh, Dracker? 

 DR. DRACKER: Thats right. 

 MS. CONNERY: Oh, started off 
mispronouncing. 

 DR. DRACKER: Im in private practice in the 
Syracuse, New York area, and my office is Infusacare 
Medical Services, which is a private office. It is 
not an infusion center, per se; its run as a 
practice. This is my fifth trip to the Washington 
area over the last few years to deal with this issue. 
Its probably my last trip, so I have every intention 
to be very open and direct about my comments. 


 I have the pleasure of taking care of 
patients that require IVIG, both pediatric and adult, 
and for primary immune deficiency, secondary immune 
deficiency, and also, for patients with autoimmune 
disorders, including neurologic disorders. 

 Ive often mentioned at these meetings that 
Ive had that the product gamma globulin is very 
different from other products. It is not a 
pharmaceutical, it is a blood derivative, and one that 
is not interchangeable with other products, as Im 
sure others will explain, but one that has to be given 
very careful consideration. 

 The problem Ive had and the reason I am 
here today is that first of all, Im here alone. The 
patients I cared for as a result of changes that were 
initiated through CMS are no longer cared for in my 
practice, so my patients have been (inaudible) my 
patients, and that has had very negative effects on my 
patients, both with regard to morbidity and mortality, 


which, to be very honest with you, though, is that 
were involved with this rationing process in health 
care which has occurred. 

 Both CMS and the manufacturers and now 
insurance companies are directly responsible for the 
negative effects on my patients. And so to any of 
them here, to consider the changes that have occurred 
that have had a negative effect is something that they 
are not responsible for, they are directly wrong about 
that, because it has significantly effected my 
patients. 

 So my patients are not here with me today. 
The last time they accompanied me was at the advisory 
committee, when there was a unanimous agreement to 
state that this should be considered a medical 
emergency, which was basically ignored. So Im very 
hopeful that with your involvement, you can help us in 
this fight as things continue to get worse and worse. 

 I really dont have much more to say. This 


is extremely frustrating for me. Ive taken, on 
numerous days, on behalf of my patients -- even those 
that I no longer take care of -- and its very 
difficult to be in a position when I always have full 
accountability and no excuses, and it seems that 
bureaucracy -- again, both private, from the 
industrys side, and also from government, has an 
incredible number of excuses, but theyre not the 
person that has to see the patient who can no longer 
walk and is hospitalized because of infection, or has 
to go to the wake or the funeral of that individual. 

 So thank you for giving me a chance to speak 
first. 

 MS. CONNERY: Thank you very much, Dr. 
Dracker. Marcella, how was the audio on that? 

 OPERATOR: There is a little bit of breaking 
up. I think it had to do with the style of 
microphone, perhaps? 

 MS. CONNERY: Okay. I think we can make a 


slight adjustment, and I think what thats going to be 
is youre going to have to point this mike in a -- for 
people commenting, just come very close and point it 
up or down, depending on your height. Okay. 

 The next commenter, and this is probably 
going to be someone on the phone, is Rosemary I-S-T-R-
E. 

 MS. ISTRE: Im here. 

 MS. CONNERY: Oh, Rosemarys here. Okay. 

 OPERATOR: Im sorry. Now, she definitely is 
on the phone? 

 MS. CONNERY: No, sorry, shes in the room 
with us. 

 OPERATOR: Thank you. 

 MS. ISTRE: Okay. Hows this for audio? 

 MS. CONNERY: Is that working, Marcella? Is 
that better? 

 MS. ISTRE: Can you hear me? 

 OPERATOR: Yes. Go ahead, maam. 


 MS. ISTRE: Okay. My name is Rosemary Istre. 
Im a member of The Myositis Association. I lead a 
support group for those with this autoimmune 
neuromuscular disease in Southeast Texas, which 
includes the Houston area. 

 Pam Way is dead. Robert Miller is dead. I 
am very grateful to be here today and I thank you for 
what you are doing, and I appreciate the data and the 
charts and the graphs and analysis of any significance 
that you can come up with, and your report will come 
out in 2007. But while Congress and the Health and 
Human Services Department continues to study this, 
people are dying, and my days are numbered. 

 I have this empty wheelchair here for you to 
look at today because in May of 2005, I wheeled Pam 
Way before the Health and Human Services Blood Safety 
Committee Meeting. She literally begged for her life, 
and I am going to try to put a face and humanness into 
your data and your charts and your graphs. 


 Pam Way was very, very ill. She had 
myositis and she also had overlapping autoimmune 
illness. When my doctor, a specialist and expert, 
found her, she was almost dead. She was in bed. She 
could not walk, she could not talk, and she had 
labored breathing. 

 She decided to try IVIG therapy, and it was 
like a miracle, but it took a while. Gradually, over 
the months and over a couple of years, Pam Way began 
to sit up, to talk, to feed herself, to get dressed, 
and finally, she could stand up. 

 In December of 2000 (phonetic), (inaudible) 
her chair, let go of her walker, and decorated the 
infusion center for Christmas. We cried and we 
cheered, because we had saved someone. 

 But by January of 2005, when the Medicare 
bill took effect, Pam Way was taken away from her 
doctor, the expert, and from the Infusion Clinic of 
Safety, and rerouted to a hospital, as were other 


autoimmune or immune deficiency or immune-compromised 
patients. 

 The hospital is not a good scenario, number one, 
for immune-compromised patients. They are at high 
risk for infections and infections are devastating to 
immunocompromised people. Pam is not unique. I am 
telling her story because this is echoing through all 
of America. 

 So Pam, in January, had trouble getting into 
the hospital because there wasnt a bed available. 
Then she had to wait for her regularly scheduled 
treatment. You see, Pam needed a certain brand of 
IVIG. There are several brands. But IVIG is a very 
individualized treatment. It is tailored to the 
patient, and Pam could not wait on her treatment until 
there was a bed available, until her brand was 
available. 

 The staff at the hospital was not set up to 
administer the treatment, so they kept calling the 


doctor at the Infusion Center saying, What do we do? 
How fast do we run this? Shes having this reaction. 
She ended up in ICU and almost lost her life 
immediately. 

 Then the next weeks and months came and she 
was still begging for treatment. So we did what we 
thought was right, as Americans, and we contacted our 
representatives in Congress, and we virtually talked 
to every senator and every representative more than 
once. 

 I had to call the media and stage a 
demonstration in front of my Congressmans office to 
obtain a meeting with him, and again, we begged for 
our lives, knowing that Medicare sets the standard and 
sets the directive and other insurance companies would 
follow suit. 

 Pam Way is dead, Robert Miller is dead, 
while everyone continues to study this problem. But 


Pam, with the last strength she had, had me wheel her 
in a wheelchair like this before the Health and Human 
Services Department in May of 2005. She was in a 
wheelchair, she couldnt walk, she could hardly talk, 
and we had oxygen for her to breathe, because of lack 
of continuity of treatment with a specific brand of 
IVIG in a doctors setting, the expert. 

 We left that meeting with the promise that 
something would be done that day to help us, and Pam 
had hope, and she looked at me and she said, I hope I 
matter. Well, she did not last while Congress and 
HHS continues to study this problem. She died and 
another person in my support group, Robert Miller, 
died. 

 There may be 50 people here speaking today. 
There may be 50 people in attendance. That doesnt 
begin to touch the number of patients out there who 
are affected and are too sick and who are too stressed 


to be here to fight for their lives. 

 If you need more data, I am one of those 
(phonetic). I have dermatomyositis. Blue Cross/Blue 
Shield has aligned with Medicare. My days are 
numbered. When I have a flare-up with my illness, I 
have nothing now to fall back on. Please explain that 
to my family. 

 Are we at the mercy -- one thing we learned, 
that Congress needs to be educated. Another thing we 
learned was that mistakes can be made in Washington. 
Someone myopic, with a stroke of a hand, can sign 
something into law that sentences us to death, and now 
that Congress knows that, I am surprised, amazed, 
angered, and frustrated that people do not step up to 
the plate to fix this. 

 Is the pro-life agenda for those that are in 
the womb, or people who are brain-dead? Well, we are 
not brain-dead. We are healthy, functioning 


individuals with our IVIG. Take it away from us, we 
are screaming out. We are not brain-dead. We want to 
live. Thank you for hearing me. 

 MS. CONNERY: Thank you very much for sharing 
that with us. Our next commenter is on the phone, and 
that is Mark Stein. 

 OPERATOR: Thank you, maam. One moment. 
Mr. Stein, your line is now open. You may make your 
comments. 

 MR. STEIN: Thank you. This is Mark Stein 
from Allergy Associates of the Palm Beaches in private 
practice. Im also the Chairman of the IVIG Committee 
for the Florida Allergy, Asthma, and Immunology 
Society. Im reporting on both my personal problems 
and the problems regarding the State of Florida. 

 First, Ill start by pointing out that 
(inaudible) apparently did a local review that if you 
do provide gamma globulin, it delays your 


reimbursement for four to eight (inaudible), making it 
impossible for physicians to do this in their office. 

 MS. CONNERY: Excuse me, Mr. Stein, is there 
any way you can get closer to the phone or speak a 
little more loud? 

 MR. STEIN: Is that better? 

 MS. CONNERY: Thats much better. Thank you. 

 MR. STEIN: Okay. Since the Medicare changes 
in reimbursement effective January of this year, weve 
had several hospitals in Florida discontinue 
outpatient gamma globulin infusion, one in our 
immediate area and one about an hours drive from us. 

 This has resulted in patients removing 
themselves from gamma globulin treatment because 
theyre unaware of any other access. Weve had five 
patients in the last month arrive at our office from a 
distance of about an hour and a half in Okeechobee, 
Florida, where the hospital -- this is Raulerson 


Hospital -- discontinued IV gamma globulin. 

 Some of these patients have been readmitted 
numerous times because of bronchiectasis associated 
with their primary immunodeficiency. These people are 
at constant risk of death when their products been 
withdrawn. 

 Were down to one hospital who reliably 
supplies gamma globulin to our Medicare patients in 
the area. Unfortunately, they only have one product 
available and thats a sucrose-containing product. 
Sucrose-containing products have a higher incidence of 
renal problems, and some of our patients with renal 
disease have had to either temporarily discontinue 
their product, run the risk of infection, until weve 
been able to arrange an alternative process, such as 
home subcutaneous gamma globulin. 

 We see numerous problems with our patients, 
first of all, not being accessible to office care, 


where theyre better managed. We see patients in the 
hospital who have severe reactions to the gamma 
globulin which then require hospitalization or 
discontinuation of product with wastage, because 
theres no physician immediately accessible to manage 
it. Theyre supposed to (phonetic) manage severe 
reactions over the phone. 

 Weve had reports in Florida, and Ive had 
one patient who came down to me from Vero Beach, 
Florida, where the hospital said Because of the 
shortage, you can only get your gamma globulin every 
three months, not monthly, as required. 

 Weve had other hospitals in the area who 
have said You will not get gamma globulin unless your 
immunoglobulin G-level drops below 400. Regardless of 
what level it takes for you to be sick, because of our 
limited supplies, thats going to be as much as we can 
give you. 


 We have issues relating to product 
selection. As youve heard, there are certain 
patients that only tolerate one product. We have one 
patient well hear from later today that had to drive 
about 50 miles and transfer to another physician to be 
able to get that product. 

 Weve had patients whose venous access have 
been ruined by hospital nurses who didnt have the 
expertise of our IV nurses we have in our practice, 
where the patient can be usually easily accessed. 

 The biggest problem with this location is 
even if there is a change in budgeting where the 
product price would go up to where we could afford to 
purchase it and give it to patients (inaudible) local 
review, we cant afford to wait out four to eight 
months worth of funding, waiting for reimbursement. 
Now, thats a local issue, but it is a major issue for 
people who provide services in their office. 


 We find that the efforts to provide a $60.00 
per infusion -- roughly $60.00 per infusion 
reimbursement, when adjusted for cost, is grossly 
inadequate, and the fact that the readjustments in 
pricing and what physicians are reimbursed for gamma 
globulin in six months time on a constant basis makes 
no sense, because we have almost an every six month 
increase in the cost. 

 MS. CONNERY: Mr. Stein, you have 15 seconds. 

 MR. STEIN: Okay. I think I covered the 
issues that I deem important for you, and hopefully, 
can provide additional information if needed. Thank 
you. 

 MS. CONNERY: Thank you very much. John and 
Aylin, if you do have -- just break in and let me know 
right away, okay? Otherwise, Im just going to keep 
going on. Our next commenter is in the room with us. 
Julie Birkofer. 


 MS. BIRKOFER: Good morning. My name is 
Julie Birkofer. Im the Executive Director in North 
America for the Plasma Protein Therapeutics 
Association, PPTA. This association represents the 
leading IVIG manufacturers in North America: Baxter 
BioScience, ZLB Behring, Grifols, Octapharma, and 
Talecris. 

 PPTA is pleased to be here this morning, and 
we appreciate the fact that the Department of Health 
and Human Services and ASPI is holding this important 
town hall meeting. We are all here today in this room 
out of concern that patient access to IVIG, especially 
for Medicare beneficiaries, has become increasingly 
difficult since the implementation of the MMA in 2005, 
in the physician office setting, the switch from AWP 
to ASP +6, and in 06, it was the impact in the 
hospital outpatient setting. 

 Again, this is not a coincidence that the 


first reports of patient access difficulties began 
after this seismic change in how Medicare reimburses 
IVIG. It is vital that Medicare reimbursement for 
physician-administrated IVIG in the appropriate 
setting is adequate to sustain beneficiary access to 
care. 

 As weve heard, IVIG is a unique therapy. 
It is recognized by the FDA as a sole source biologic. 
There are no generic equivalents, and these are not a 
one-size-fits-all treatment. PPTA has been working 
with the community for over 18 months on this issue. 
We recognize the importance of applying a market-based 
reimbursement methodology that reflects the true cost 
of the therapy to the provider, such as is in intended 
by the average sales price, ASP, methodology. 

 However, PPTA also is very sensitive to the 
concerns of consumers who have experienced 
difficulties accessing care with the shift to ASP 


reimbursement in 2005 in the physician office setting 
and in 2006 in the hospital outpatient setting. The 
primary goal of PPTA and its member companies is 
restoration of patient access to all brands of IVIG in 
the setting most appropriate for east individual 
Medicare beneficiary. 

 PPTA shares these concerns expressed by 
patients and providers regarding the failure of the 
present payment rates to reimburse adequately for IVIG 
under Medicare Part B and the hospital or outpatient 
setting. Reimbursement methodologies must recognize 
that plasma protein therapies, IVIG, they are vastly 
different from traditional pharmaceuticals. 

 Reimbursement methodologies apply -- 
unilaterally fail to consider the unique economic and 
clinical characteristics of IVIG. Acquisition of 
human plasma, the basic raw material for IVIG, 
represents a significant investment in resources 


before the first manufacturing step can ever take 
place. 

 In addition to the enormous up-front capital 
investigation required by PPTA member companies to 
bring a therapy to market, there is the seven to 12-
month time frame required to manufacture IVIG, the 
small and fragile patient populations served by this 
biological therapy, and the robust regulatory 
environment in which these companies operate. 

 PPTA believes that the current IVIG 
reimbursement formula of ASP +6 has proven to be 
inadequate and is driving complaints regarding IVIG 
availability and fully explains why patients are 
experiencing site of service dislocation and access to 
care. 

 Let me move to some of the issues with 
regard to supply. In 2006, more than 19 million grams 
of IVIG had been distributed by manufacturers in the 


first seven months of the year. Nonetheless, even 
with the record yearly increases in IVIG production 
and distribution, IVIG stakeholders advised PPTA that 
it is difficult for some patients and providers to 
obtain access to IVIG therapies. 

 PPTA has proposed a comprehensive solution. 
We have worked with legislators and policymakers. A 
permanent payment adjustment by CMS to make Medicare 
payments more reflective of the true cost for 
providers; separate payment for each brand of IVIG 
rather than grouping all IVIG therapies together; make 
permanent the pre-administration code; and recognize 
IVIG as a high-complexity infusion similar to a 
biological response modifier. 

 Thank you and we would also urge ASPI and 
ERG to ramp up the time frame in finalizing this 
study. I dont think this issue can wait until First 
Quarter 07. Thank you. 


 MS. CONNERY: Thank you very much. I note 
that there are written copies of your comments, so 
that for anything that you didnt get to, well have 
that. 

 MS. BIRKOFER: Okay. 

 MS. CONNERY: Thank you. 

 MS. BIRKOFER: Youre welcome. 

 MS. CONNERY: Our next commenter is Mary Jean 
Peterson. She is the fifth commenter, by the way, and 
we also -- I just saw the note that the tenth 
commenter is not going to be commenting, so well be 
moving ahead. Both the ninth and tenth now have told 
us they wont be here. 

 Mary Jean is on the phone. 

 OPERATOR: Ms. Connery, can you spell the 
last name, please? 

 MS. CONNERY: That is P-E-T-E-R-S-O-N. 

 OPERATOR: Thank you. Im looking. One 


moment. If Ms. Peterson is sitting with another 
party, please press star-zero at this time. One 
moment. Ms. Connery? 

 MS. CONNERY: Yes. 

 OPERATOR: We are having no response that Ms. 
Peterson has joined. 

 MS. CONNERY: Okay. Well, its possible, and 
I think we can anticipate that a few folks who signed 
up will not be here. If somebody misses their time 
and just has miscalculated and comes back in, well 
certainly try to accommodate them towards the end of 
the day, but we will, at this point, move on. 
Our next commenter, which would be Commenter No. 
6, who should be in the room with us, is Melissa 
Schweitzer. Melissa is here. 

 MS. SCHWEITZER: Good morning. You 
pronounced it correctly. 

 MS. CONNERY: Probably the only one so far. 


Could you point that just directly towards you so you 
-- 

 MS. SCHWEITZER: Yes. There -- is that good? 

 MS. CONNERY: Thank you. Thats good, 
thanks. 

 MS. SCHWEITZER: Id first like to thank 
ASPI and ERG for holding this important meeting and 
giving us the opportunity to provide comments on the 
concerns related to IVIG access. 

 Again, my name is Melissa Schweitzer. Im 
with the Washington Strategic Consulting Group, and 
Im also a patient with common variable 
immunodeficiency. As the previous patient advocate 
for the Immune Deficiency Foundation, I began talking 
with patients and physicians experiencing problems 
with IVIG access in January of 2005. 

 At that time, many patients on Medicare were 
being told that they could no longer continue their 


IVIG infusions in their physicians offices due to 
decreased reimbursement of IVIG by Medicare. Most of 
these patients transferred their care to local 
hospitals to receive their infusions. 

 However, as weve heard, this was not always 
a smooth transition, as it necessitated driving to 
centers many miles from patients homes, receiving 
care from inexperienced providers, and switching from 
the patients preferred brands of IVIG. All of these 
barriers to care created undue hardship on what was 
already a fragile patient population. 

 In August 2005, after working with scores of 
patients and physicians experiencing IVIG access 
problems, I resigned from IDF in part because of the 
overwhelming nature of this case work and the personal 
effect it had on me, as a patient with common 
variable, for which I receive IVIG on a monthly basis. 

 However, in April 2006, given the continued 


struggle, faced by patients who rely on IVIG as their 
live-saving therapy, I felt a strong calling to again 
work on this issue from the patient advocacy 
standpoint through my current employer, Washington 
Strategic Consulting. 

 While I have not personally experienced 
problems in IVIG access and continue to receive 
uninterrupted infusions, I live with the fear that if 
this crisis is not resolved immediately, all patients, 
regardless of health insurance provider, will 
experience problems in receiving their IVIG. 

 This fear is based on many reports from 
patients on private insurance who are also 
experiencing IVIG access problems related to 
reductions in reimbursement rates. 

 As part of the IVIG patient community, I 
know firsthand how vital IVIG therapy is to my well-
being. By replacing my antibodies and thus reducing 


the number of infections I experience, it has allowed 
me to lead a relatively normal and rewarding life. 
Because of IVIG, Ive enjoyed a successful career as a 
genetic counselor and patient advocate, working to 
help educate and support other individuals affected by 
rare genetic and chronic diseases. 

 Because of IVIG, I have had the immense 
fortune of becoming a wife to a wonderful and 
supportive husband and a mother to two beautiful 
children, after once wondering if I would ever have 
the opportunity of becoming a mother at all. 

 Because of IVIG, I feel that it is my 
personal and professional mission to help work toward 
a solution that will restore access to my fellow 
patients who are not here and cant do this 
(phonetic). Sorry. 

 MS. CONNERY: Its okay. 

 MS. SCHWEITZER: I always thought that if I 


had to be born with a rare and chronic condition, at 
least I was lucky to be born with one for which there 
is an effective therapy, and Im sure that this is 
what many of my fellow patients thought when they were 
finally diagnosed with their respective conditions, 
prescribed IVIG therapy, began their recovery, and 
started to live their lives again. 

 I can surmise that they did not envision the 
horrible day when they would be told that their IVIG 
product was not available, or that they could no 
longer receive it in their trusted physicians office, 
because the doctor could not afford to treat them. 

 What parent should have to imagine that his 
or her child can no longer receive the one therapy 
that has saved him from succumbing to life-threatening 
illnesses? What patient should have to imagine that 
she will again lose her ability to walk because of 
lack of access to this life-saving product? 


 As a step to help restore access to IVIG, a 
meeting was held on August 28th to discuss the 
problems faced by patients and providers. This was 
the first meeting of its kind, as it brought together 
several organizations that represent various patient 
communities that rely on IVIG as their life-saving 
therapy, professional medical societies representing 
the providers who treat these patients, as well as 
Congressional staffers from key committees, and ASPI, 
as well as the Advisory Committee on Blood Safety and 
Availability. 

 Regardless of disease state, the 
participants all expressed similar problems being 
experienced by patients. While we understand the 
importance of collecting data to determine all of the 
underlying causes of the IVIG access issues, we need 
to take action immediately in order to prevent more 
suffering and death. 

 On behalf of patients who rely on IVIG, I 
again thank you for holding this important meeting. 


 MS. CONNERY: Thank you very much for sharing 
your story and that information. I think were going 
to hear a lot of personal stories today, and thats 
part of what this meetings about. Its a very 
important part of the picture for the project team, so 
we really appreciate the folks who are doing that 
today. 

 Our next commenter, Commenter No. 7, is Mary 
Simon, and Mary should be with us by phone. 

 OPERATOR: Yes, she is. 

 MS. CONNERY: Okay, great. 

 OPERATOR: Ms. Simon, your line is now open. 
You may make your comments. 

 MS. SIMON: Oh, well, thank you very much. 
Hi, my name is Mary Simon, and Im a patient in 
Orlando, Florida, and Im also on an HMO Medicare 
replacement plan. In 1999, I was diagnosed with 
hypogammaglobulinanemia. 

 I was (inaudible) non-specific chronic 
infections and extreme fatigue for most of my life, 


but the cause wasnt diagnosed until I was 40 years 
old. It took the doctors over 20 years to find the 
cause of my chronic infections, and after I was 
diagnosed and a treatment plan was given, then the 
real problems started. I was denied IVIG treatment by 
one HMO and forced to switch companies. 

 The second HMO was willing to authorize the 
treatment, but after trying numerous brands of IVIG, 
it was discovered that I was allergic to all brands 
but one. The brand that I ended up needing was too 
expensive for the reimbursement rate by Medicare. I 
dont have a choice in what brand I can use, and its 
common practice for IVIG administration and for the 
providers to use the least expensive brand. 

 I had to start receiving my IVIG in a 
hospital because the hematologist couldnt afford to 
purchase it, and after switching to a different 
hospital because of my HMO plan changing, and that 
hospital saying they couldnt get the brand I needed, 
I was then switched to receiving my infusion at the 


hematologists office in their chemo center. 

 In 2002, I was told by the hematologists 
office that they could no longer administer my IVIG. 
I requested the reason, and this led to extreme grief 
on my part. I eventually learned that it was the 
reimbursement rate that was the cause. I never know 
from one month to the next where or if I will receive 
my infusions. I was being switched from receiving my 
treatments in the doctors office to the hospital and 
back again. 

 In 2004 and 5, there were a number of 
changes to the Medicare reimbursement rate again. 
This led to a number of financial hardships. There 
were (inaudible) bills for almost $5,000.00 
(inaudible) hematologists office. 

 It seems that when the new Medicare 
reimbursement rate changed in April of 2005, my HMO 
couldnt -- wouldnt reimburse the doctors office the 
cost of my IVIG. The hematologists office wasnt 
notified -- or wasnt aware of it before it happened, 


and I was getting my infusion at their office. 

 This resulted in a shortage of reimbursement 
of $9,000.00 that was passed on to me. With my only 
income as Social Security Disability, there is no way 
I could ever afford to pay it. I have been paying 
them $25.00 a month, but at that rate, it will take 
almost 30 years for me to pay it off. Also, there is 
no guarantee that this wont happen again. 

 To add insult to injury, now, it is getting 
harder and harder to even get the brand that I 
require. Ive been told there was a shortage of the 
product, and I never know from one month to the next 
if I can even get what I need. I was given the choice 
in June of this year to either forego my infusion, 
because they didnt have the total amount I needed, or 
take the decreased amount that they had on hand. 

 Not only is that physically and 
psychologically burdening, but a financial burden, as 
well. If and when the balance of my IVIG became 
available that month, it would require me to take an 


additional visit to the hospital and pay two co-
payments in one month. I dont have the money or the 
energy to do that. Also, it wouldve been an issue 
with my HMO. They dont want to pay for two infusions 
in one month. 

 As it turned out, the person who receives -- 
who was to receive the infusion which wouldve used up 
the hospitals supply never ended up getting it, and I 
got the IVIG (inaudible). Thats great for me, but 
what did the other person end up doing? 

 In addition to the financial hardships of my 
IVIG infusion, there is the infection factor. I 
unfortunately (phonetic) receive my infusions at a 
public site. The chance of my contracting any 
bacterial or viral infections is very much increased. 
I have to limit my exposure to the public to keep my 
infection rate lower. Having to go to the doctors 
office or hospital to get my infusions is very 
stressful because I never know what I could end up 
contracting. 


 My HMO does not allow home infusions or 
subcutaneous infusions. Its cheaper for them to pay 
a hospital for it because of their contract. When my 
treatments are delayed because of availability, I 
physically go downhill very fast. It could take 
months for my body to build its immunities back up. 

 I also will inevitably end up on 
antibiotics. Being on long-term antibiotics has 
pretty much destroyed my digestive system. Since I 
have an HMO Medicare replacement plan, Ill never get 
to see the bills that are sent to my HMO. 

 MS. CONNERY: Mary, were at 15 seconds left. 

 MS. SIMONS: The HMO did all the paperwork 
with Medicare. The bill was over $23,000.00 two years 
ago. That was the one-month treatment. If I did not 
have Medicare, Id never be able to afford the 
treatment, something I pray the powers that be 
understand how crucial it is for people with primary 
immune deficiencies to be allowed to receive IVIG that 
their bodies require, and (inaudible) infectious 


disease (phonetic) environment. (inaudible) Thank you 
for allowing me to voice my frustrations. 

 MS. CONNERY: Thank you very much for taking 
that time, Mary. I appreciate hearing from you. Our 
next commenter is Marcia Boyle, who is in the room. 
Im just going to remind us, she is -- Marcia is the 
eighth commenter. 

 Were skipping over Commenters 9 and 10 
because theyve they us the wont be here, so our next 
commenter is going to be Patty Mitzenmacher, who will 
be on the phone, Marcella, in case you want to queue 
her up while Marcia is talking. 

 MS. BOYLE: Okay. Hows that? 

 MS. CONNERY: Good. 

 MS. BOYLE: Okay? 

 MS. CONNERY: Great. 

 MS. BOYLE: Thank you very much. My name is 
Marcia Boyle. Im the President of the Immune 
Deficiency Foundation. I want to thank you for 
providing me with the opportunity to testify today on 


behalf of IDF, founded in 1980 as the national patient 
organization for primary immune deficiency diseases, 
or PI. 

 Through the years, we have advocated 
tirelessly for PI patients, one of whom is my son, 
whose life depends on access to IVIG. Today, Im 
speaking with the Primary Immune Deficiency Coalition 
comprised of IDF, the Jeffrey Modell Foundation, the 
American Academy of Allergy, Asthma, and Immunology, 
in association with the American College of Allergy, 
Asthma, and Immunology, and the Clinical Immunology 
Society. 

 Access to IVIG is critical to patients with 
PI. At least seven out of 10 PI patients have 
diagnoses for which IVIG is the only effective 
treatment. As a result of age or disability, about 
20% of these patients are on Medicare, or about 10,000 
PI patients nationwide, who are being treated with 
IVIG. 

 Since January 2005, IDF has testified many 


times and has provided quantitative and anecdotal 
information on the problems many of our patients have 
had with access to IVIG. In order to provide current 
information, IDF has undertaken three national surveys 
with the partnership of the (inaudible), a survey of 
patients with PI, a survey of physicians treating 
patients with PI, and a survey of hospital pharmacists 
dispensing IVIG. 

 Although all three surveys are now underway, 
today, Im providing preliminary findings from the 
patient survey. Three thousand patient surveys were 
mailed to a random sample of patients drawn from the 
foundations database, as well as a supplemental 
sample of 135 households we believe to include 
Medicare patients. 

 My report today is on preliminary findings 
from the first 763 completed surveys. From our 
preliminary findings, approximately 70% of the 
patients are currently being treated with IVIG. To 
date, we have 532 patients in the sample who are 


currently being treated and 206 of whom are Medicare. 
And of the 41 stopping treatment since the beginning 
of 2005, of those who stopped receiving treatments, 11 
cited inadequate insurance coverage or higher expenses 
and three mentioned the difficultly obtaining IVIG. 

 One of the impacts of Medicare reimbursement 
has forced patients from their usual site of service 
for infusions to other sites of service where payment 
rates are higher and/or Medicare patients were still 
accepted. 

 More than a third of Medicare patients 
reported that they are now being treated in a 
different site since December of 2004, compared to 
less than a quarter of non-Medicare patients. 38% of 
Medicare patients said that the change was due to 
insurance reimbursement reductions, compared to 9% of 
non-Medicare patients. 

 More than a quarter of Medicare patients who 
had changed site of infusion said it was because IVIG 
was no longer available at the previous site, compared 


to 6% of non-Medicare patients. 

 Patients were asked whether they had less or 
more trouble getting IVIG, or had there been no 
change. Almost three times as many Medicare patients, 
nearly one-third of Medicare patients, encountered 
more problems getting IVIG treatments compared to non-
Medicare patients. 

 Current users of IVIG were asked whether 
they had experienced problems related to IVIG since 
the beginning of 2005. Medicare and non-Medicare 
patients were about as likely to say that they had to 
switch to another brand of IVIG. Similarly, both 
groups are equally likely to say that they had to pay 
more for IVIG. 

 These findings suggest that a tight market 
has affected product availability, choice, and price 
over the past two years for IVIG users, regardless of 
type of insurance. However, Medicare patients were 
twice as likely as non-Medicare patients to report 
that their treatments had to be postponed since the 


beginning of 2005. Medicare patients were also twice 
as likely as non-Medicare to report that the time 
intervals between infusions had been increased at the 
beginning of 2005. 

 Most dramatically, Medicare patients were 
seven times as likely as non-Medicare patients to 
report that their dosage had been reduced since 2005. 
These differences between Medicare and non-Medicare 
users of IVIG are statistically significant. Since 
the main difference between the two populations is 
their type of insurance, the survey findings 
demonstrate a serious reimbursement impact on the 
treatment of Medicare patients needing IVIG. 

 Medicare patients were nearly three times as 
likely as non-Medicare patients to report having 
negative health effects as a result of problems of 
getting or paying for IVIG since the beginning of 
2005. Those on Medicare who experienced problems were 
more likely to suffer infections and bronchitis, and 
they were more likely to require increased use of 


antibiotics. 

 For one in nine Medicare patients reporting 
negative health effects, the health consequences were 
severe enough to require hospitalization. One of the 
dilemmas in the discussion of IVIG access has been 
whether there is an availability or reimbursement 
problem. The data suggests a substantial minority of 
patients is experiencing limited product choice and 
increased product cost, regardless of insurance 
status. 

 MS. CONNERY: Fifteen seconds. 

 MS. BOYLE: Okay. However, the more serious 
problems of postponed infusions, increased intervals 
between infusions, and reduced dosage, fall 
disproportionately on Medicare patients. The 
significant difference in these treatment experience 
meant (phonetic) Medicare status, along with higher 
rates of negative health outcomes, is clearly a 
reimbursement problem. 

 The health consequences of older and 


disabled patients on Medicare is a government problem 
and the government needs to tackle this issue 
immediately, as theres no alternative treatment for 
PI. Thank you. 

 MS. CONNERY: Thank you. 

 MR. EYRAUD: Jan? 

 MS. CONNERY: Yes? 

MR. EYRAUD: One thing. 

 MS. CONNERY: Go ahead, John. 

 MR. EYRAUD: Could you just say -- from the 
mike, please -- when will the survey be finalized? 

 MS. BOYLE: We will have it finalized by -- 
within a month, and I will be submitting 
electronically my testimony, as well as the graphs, 
and written testimony that includes more the 
statistics. 

 MR. EYRAUD: Thats the patient survey for 
the -- 

 MS. BOYLE: This is the patient survey. The 
other two surveys will be available later in the fall. 


 MR. EYRAUD: Okay. 

 MS. BOYLE: Okay? 

 MR. EYRAUD: Thank you. 

 MS. BOYLE: Thank you. 

 MS. CONNERY: Thank you very much. Marcia, 
did you have written copies that you want us to have 
of your comments? 

 MS. BOYLE: Yes. I (inaudible) 

 MS. CONNERY: Okay. Excellent. Thank you. 
The next commenter -- as I said, were skipping over 9 
and 10, so were going to Commenter No. 11, Patty 
Mitzenmacher, who we hope is on the phone with us. 

 OPERATOR: Thank you, maam. I do have 
Patricia Mitzenmacher. 

 MS. CONNERY: Oh, Patricia? Okay. 

 OPERATOR: Thank you. Maam, your line is 
open. 

 MS. MITZENMACHER: Hello? 

 MS. CONNERY: Hello. We can hear you. 

 MS. MITZENMACHER: Okay, great. Hi. 


 MS. CONNERY: Hi. 

 MS. MITZENMACHER: Patty Mitzenmacher, and I 
am a patient advocate for my child. I draw my 
experience from all sides of this issue. I have 
experience working on the providers side in the 
medical management, I have experience working with the 
clinical research with a pharmaceutical company. 

 The patient side, my father was a heart 
transplant patient and I have two brothers who are 
immune deficient, and Im a breast cancer survivor. 
And the (inaudible) because I have the opportunity to 
have (inaudible) over a number of issues that I got 
devious behaviors on the back side of the insurance 
companies. 

 Im mostly advocating for my son, who has 
complex medical issues, who is one of the patients 
getting IVIG on an off-label way, because he had 
severe Crohns Disease (inaudible) from his esophagus 
down to his rectum at the age of eight months. 
Through all of his medical care, it has produced 


systemic lesions (phonetic) in him, and he now has 
chronic immune deficiency disease. 

 We went back to Northwestern in Chicago for 
another -- to get another choice on how to treat him 
at this point, because he was failing fast, and IVIG 
was the only answer for him. We came back to 
California, where we live, and hes been on IVIG for 
two years. 

 My first battle with Clark (phonetic) being 
an off-label patient was with the insurance company, 
because Medicare sets that standard for what is 
indicated for IVIG and what isnt. So I did beat that 
battle, and his insurance company had to cover him, 
although in the last month, I just found out why they 
have abandoned his care, for getting his IVIG 
(inaudible) on -- at the (inaudible) that he gets it 
at. 

 Prior to this happening, in July of 05, I 
had made a phone call to the insurance company when I 
was questioning the reimbursements to the providers 


for the IVIG. I explained to the insurance company 
that (inaudible) because they werent being reimbursed 
for at least half of the drug, and I was told by the 
insurance company, as long as I had no patient 
liability, to get out of the middle of it, because it 
did not concern me. I explained that it did concern 
me because eventually, its going to come down to 
directly affecting my sons health or other peoples 
health, and I am concerned. 

 A few months after that, when I went to go 
get my sons IVIG, I was notified that he couldnt get 
the IVIG that he needed because he had so many severe 
allergic reactions from the other ones, but now, they 
needed to switch him to another one. Given the 
situation with the lupus, I wasnt willing to cough up 
his kidney -- or knowing that would kill his kidney 
(inaudible) and the (inaudible). 

 So gratefully, every time that we walked in 
the door, I breathed a sigh of relief that he could 
get (inaudible) doesnt have the reactions or severe 


migraines or all the side effects to -- does offer him 
quality of life. 

 As time went on, I watched the decline in 
payment from the insurance company and the delay at 
which those companies paid the providers. And I feel 
bad, and knowing, coming from the providers side, 
that a person cant keep their doors open if theyre 
taking a huge loss every time a patient walks in the 
door, and eventually, theyre going to have to say 
that theres a shortage-- when this occurred, there 
became a shortage of this type of IVIG that 
(inaudible). 

 And me being the research person that I am, 
I went and called the drug company directly and asked 
them if theres a shortage. They said no, there 
wasnt a shortage. 

 So I took it a step further, went to my 
local pharmacist who (inaudible) for me. He called 
around to find out if he could acquire IVIG. He found 
a place in Texas that he could get it, but then he was 


told that unless he was a wholesaler, he couldnt 
obtain IVIG. And then secondly, the facility would 
not let me bring in my IVIG, because of liability 
issues. 

 I then was approached by an insurance 
company in Culverton (phonetic) for -- (inaudible) the 
case manager on my son that wanted to come visit me in 
my house and bring all his medicine to the home. 
Given my sons severe history of anaphylactic 
reactions, not just IVIG, but an array of things, its 
not a safe environment for him to get his IVIG at 
home. 

 The name of the company and the case 
management which they stuck on me (phonetic) was 
called Paradigm Health. And when Paradigm Health 
called me and stated that they wanted to do this, I 
thought, You know, Im going to ask right up front. 
Are you a patient advocate or are you on the insurance 
side? The answer I got was that they were contacted 
by that insurance company. 


 MS. CONNERY: Patricia, were at 15 seconds 
left. 

 MS. MITZENMACHER: Okay. Anyway, it did go 
on, I talked to the local community hospital. They 
wont give him the IVIG. They said it costs too much. 
I have to talk to the CEO. And on and on, it kind of 
goes over what everybody else has said. 

 But the bottom line is Im wondering at this 
point, people have to become -- I dont understand why 
people have to become experts on all facets of 
medication, and that they have to become financial 
geniuses in order to pay for it. Thats a lot to 
expect of someone who needs to take care of a family 
member, or are concerned with serious medical issues. 
They shouldnt have to do that. 

 In a (inaudible) system, the reimbursement 
(inaudible) problem wont go away, not just from 
Medicare, but for all insurance companies, since 
Medicare sets the standard. 

 MS. CONNERY: Okay. Thank you very much, 


Patricia. 

 MS. MITZENMACHER: Okay. 

 MS. CONNERY: And I certainly encourage you, 
if there are more details youd like us to have, to 
send that into us. 

 MS. MITZENMACHER: I would very much. 

 MS. CONNERY: Okay, thank you. 

 MS. MITZENMACHER: Thank you. 

 MS. CONNERY: All right. Our next commenter, 
who should be in the room with us, is Susan Pappas? 

 MS. PAPPAS: Good morning. My name is Susan 
Pappas. Im a Certified Nurse Practitioner. Im the 
Director of Operations and Legislative Affairs for 
Critical Care Systems, a leading provider of 
speciality infusion therapies in home and other 
alternate site settings. 

 We prepared this statement today in 
conjunction with our national association, the 
National Home Infusion Association based in 
Alexandria, Virginia. Thank you for the opportunity 


to present these comments to you today. 

 CCS has 46 branch pharmacies, each of which 
is accredited by the Joint Commission on Accreditation 
of Healthcare Organizations. CCS has a long-standing 
speciality in-home IVIG treatment. Today, we have 560 
home IVIG patients on census nationwide. This census 
has increased more than 100 percent in recent years, 
but this growth has definitely not been in the 
Medicare population, despite clear medical necessity 
in many Medicare-eligible patients. 

 IVIG is a promising therapy for a wide rage 
of indications, and CCS supports expanded Medicare 
coverage of home IVIG by allowing Medicare 
beneficiaries greater access to these life-saving 
therapies. 

 We believe that from a clinical and cost 
perspective, home IVIG is the preferred treatment 
setting. Unfortunately, however, the passage of new 
Medicare Part B coverage for home IVIG in 2003 did not 
increase access to home IVIG under Medicare. In fact, 


weve seen no additional Medicare utilization of home 
IVIG since the passage of this provision. 

 The implementation of the new Medicare Part 
B home IVIG benefit coincided with significant 
reductions in Medicare reimbursement for IVIG 
administered in physician offices and outpatient 
clinics. Consequently, physicians in outpatient 
clinics are generally unwilling to serve these 
patients. In effect, there are now no outpatient 
treatment settings available for these patients. 

 There are three fundamental problems with 
current Medicare B coverage of home IVIG. Number one, 
the current Medicare allowable for IVIG product itself 
is below our acquisition cost, and our acquisition 
costs are increasing. Policymakers should understand 
that not all health care entities have access to the 
same pricing. 

 Under an average sales price plus 6% 
methodology, home care providers have difficulty 
covering their acquisition costs, not including 


inventory handling and other product management and 
dispensing costs. 

 While it could be conjectured that as the 
larger nationwide provider, CCS would have sufficient 
marketplace leverage to obtain more favorable IVIG 
pricing, this is simply not the case, possibly due to 
an ongoing IVIG product shortage. 

 Number two. While in a physicians office 
or outpatient clinic, Medicare reimburses for 
administration costs, supplies, and equipment, in 
addition to the IVIG product itself. 

 This reimbursement does not exist under 
Medicare Part B for IVIG administered in the home. 
For home IVIG, Medicare Part D does not cover the 
pharmacy, professional services, administration 
supplies, or equipment, or home nursing visits needed 
for safely and effectively administering IVIG. 

 By not covering these essential components 
of care, Medicare has left a significant proportion of 
the cost of home IVIG care uncovered. By contrast, 


private insurers and state Medicaid programs do cover 
these costs, and this is a cost-effective coverage 
decision, as home IVIG administration eliminates the 
need for administration in more costly treatment 
settings. 

 In other words, of the three outpatient 
settings we are discussing today -- physician, 
hospital outpatient, and home care -- there are 
clearly reimbursement issues plaguing all three, but 
it is clear that Part B coverage for home IVIG is the 
most lacking and shows the greatest variance for what 
is provided for privately insured or Medicaid 
patients. 

 CCS strongly supports the position of the 
National Home Infusion Association that these non-drug 
costs should not be covered under a drug spread 
between acquisition costs and Medicare reimbursement. 
Rather, these care costs should be explicitly covered, 
using the same per diem payment methodology used by 
private insurers that helps to ensure appropriate 


access to these therapies. 

 Number three. The benefit applies only to 
primary immune deficiency diagnosis. In our 
experience, PIDD patients represent only a small 
proportion of the patient population with a medical 
necessity for IVIG. If Medicare is to truly provide 
access to patients needing IVIG, Medicare must extend 
its approved diagnosis beyond PIDD and cover these 
diagnosis properly and fully, including all the 
necessary supplies, equipment, and nursing visits 
needed to administer these therapies safely. 

 Number four. Medicare D theoretically 
provides coverage for IVIG products for patients with 
a diagnosis other than PIDD, but unfortunately 
Medicare D is essentially a drug retail benefit, not a 
home infusion benefit. It provides little or no 
access to home IVIG because like Part B, it fails to 
cover these costs of pharmacy services, supplies, and 
equipment needed to administer these products. 

 Therefore, we strongly believe that Part D 


is not the solution to providing appropriate access to 
home IVIG for Medicare beneficiaries of any diagnosis. 
Thank you for allowing me to present these comments. 

 MS. CONNERY: Thank you. Thank you very 
much. Our next commenter is Commenter No. 13, is Fred 
Modell? Fred Modell. 

 OPERATOR: Ms. Connery, will that be from the 
room or the phone line-up? 

 MS. CONNERY: Im sorry, that is in the room. 

 OPERATOR: Thank you. 

 MS. CONNERY: But the next one will be on the 
phone. 

 MR. MODELL: Thank you. My name is Fred 
Modell, together with my wife, Vickie. Im co-founder 
and president of the Jeffrey Modell Foundation. Our 
organization was established in 1987 in memory of our 
son. Jeffrey passed away at the age of 15 as a result 
of a primary immunodeficiency disease. 

 These genetic defects affect more than a 
million Americans. The face chronic and recurring 


infections that significantly impact the quality of 
their lives. 

 Now, our familiarity with immunoglobulins go 
back to the early 1970s, when Jeffrey was first 
diagnosed. He had to endure extremely painful 
intramuscular shots of immunoglobulins. In the early 
1980s, he participated in the first clinical trials of 
intravenous immunoglobulins, and then eventually, he 
was put on a regular regimen of FDA-approved IVIG 
infusions every three weeks. 

 I can tell you firsthand how important it is 
to receive this treatment. IVIG gave our son 15 years 
of life, 15 years he surely would not have had without 
this therapy. 

 Over the past 20 years since we started the 
foundation, we have heard from thousands of patients 
going through some of the same problems that Vickie 
and I have faced, patients who require this critical 
therapy in order to survive. Without it, they are 
subject to frequent and serious infections and the 


most severe cases, absent some treatment, can be 
fatal, and quite simply, alternative treatments do not 
exist. 

 Now, all of us in this room today know that 
reimbursement for this therapy must be adequate in 
order for physicians to deliver the treatment. We 
also know that our good friends in government, they 
want to do the right thing, but they need data in 
order to make that happen. 

 Over the past several years, Vickie and I 
have offered testimony before the House Appropriations 
Subcommittee on Health, and our foundation has worked 
in close collaboration with the CDC. Government 
officials have made it very clear to us that we must 
provide data with supporting documentation and results 
that can be measured. 

 Our physician education and public awareness 
programs with the CDC were developed to identify 
undiagnosed patients, get them referred to experts at 
leading academic teaching hospitals, get them properly 


diagnosed, and then, appropriately treated. 

 We surveyed 86 Jeffrey Modell diagnostic and 
referral centers to measure the effectiveness of that 
program. The doctors provided us with baseline and 
subsequent data from their patient records, and heres 
what they reported: a 79% annual increase in the 
number of diagnosed patients, a 57% increase in the 
number of patient referrals, and a 54% increase in the 
number of patients receiving treatment. 

 Now, surely, we can all agree that these 
efforts by the foundation and the CDC and supported by 
Congress to identify patients and get them properly 
referred and diagnosed makes no sense if treatment is 
not accessible or if the physician cannot deliver the 
treatment because of reimbursement. 

 Now, there are some who might say does it 
really matter if we do identify, diagnose, and treat 
these patients, does it matter to our health care 
system, and might these programs negatively impact 
upon budget contractors at Medicare, Medicaid, into 


the third-party payers. 

 Is there a real difference that can be 
measured, the quality of life for diagnosed and 
undiagnosed patients. Well, we went back to our 
expert physicians at the diagnostic and referral 
centers and this time, 76 centers provided data from 
their patient records. They go a long way to 
answering those questions. 

 Weve compiled the information and now we 
want to share it with you for the first time. Heres 
what the physicians told us. Undiagnosed patients 
with primary (phonetic) immune deficiencies spend an 
average of 19 days in the hospital annually, compared 
to six days if diagnosed and treated. They suffer 
with an average of three pneumonias a year, compared 
to less than one if diagnosed and treated. They 
endure an average of 45 days a year with chronic 
infections, compared to 13 if diagnosed and treated. 
It goes on and on. Seventy-one visits to 
emergency rooms and doctors offices compared to only 


12 when diagnosed and treated. How can we wait? How 
can we wait? How can we stand by in anticipation of 
more reports, more data, more hearings, while patients 
endure a quality of life for which none of us would 
trade places. 

 There was no way we could help Jeffrey 20 
years ago, but we can help thousands of primary immune 
deficient patients who are relying on all of us, all 
of us in this room, to allow them to go on and have a 
fair chance at a quality of life. 

 Let us act on what we know. We have heard 
from expert physicians. Let us do what we can do. 
There are existing statutes that allow us to act. Let 
us assure our patients that they will receive the 
treatment they need to survive. We can do no less. 
We should do no less. We thank you for this 
opportunity. 

 MS. CONNERY: Thank you very much, Mr. 
Modell. Yes, question? Question? 

 DR. SERTKAYA: Yes, just a quick question. 


Are the two studies available? 

 MR. MODELL: Yes. I submitted written 
testimony, and then I have the raw data at the 
foundation offices. 

 DR. SERTKAYA: Okay. Thank you. 

 MS. CONNERY: Okay. Our next commentor is 
Dominick Spatafora, and hes on the phone. If you 
need the spelling of that, its S-P-A-T-A-F-O-R-A. 

 OPERATOR: One moment. You may make your 
comments. 

 MR. SPATAFORA: Thank you. Good morning. My 
name is Dominick Spatafora and Im the President of 
(inaudible). 

 MS. CONNERY: Excuse me, can you get a little 
closer to the phone or speak a little more loudly? 

 MR. SPATAFORA: Sure. Is this better? 

 MS. CONNERY: That is better, yes. 

 MR. SPATAFORA: Okay. A full-service public 
affairs firm based in San Francisco, with a strong 
presence in Arizona, Nevada, and New Mexico, as well. 


Also President of the newly created Neuropathy Action 
Foundation. 

 Most importantly, though, Im also an IVIG 
patient. I was diagnosed with immune-mediated motor 
neuropathy in September of 2003. I received my first 
IVIG infusion one month later, in October. IVIG was 
an absolute miracle drug for me, basically getting rid 
of all of my symptoms, other than my neuropathy. 

 I continued receiving this treatment every 
five to seven weeks until April 2005, when my 
neurologist called me and told me that there was a 
national shortage. I conducted significant research 
to find out to find out if, in fact, there was a 
national shortage, and I contacted a lot of groups 
that are on this call today -- at this meeting today; 
the Immune Deficiency Foundation, PPTA, several 
California hospitals and health systems, as well as 
elected officials at a state and federal level. 

 There was clearly no shortage. In fact, I 
talked to Mayo Clinic in Scottsdale, who had a very 


large supply of IVIG and offered some to me. 
Unfortunately, my insurance company would not cover it 
because it was out of state. 

 I did find out, however, Mayo Clinic 
purchased their IVIG from a San Francisco Bay area 
company called Acredo Therapeutics. This is a company 
about 15 minutes from my home. Acredo had a very 
large supply at the time, with no shortage. My health 
plan ended up purchasing 10,000 grams of IVIG from 
Acredo at the time. 

 I couldnt get 35 grams out of 10,000 grams 
that was shipped to my health plan because my name 
wasnt on it, and because my name wasnt on it, the 
IVIG was sent to the general population and therefore, 
it only went to people in (inaudible) situation. 

 I fought with my insurance company and the 
Department of Managed Heath Care for three months, 
until one Sunday morning, I woke up and I was 
paralyzed in my right hand. Ultimately, it just drove 
me crazy. I contacted the Governors office and the 


World Health Chairs of the Senate and the assembly in 
California, and I won my appeal, and I started 
receiving treatments again, and the use of my hand was 
fully restored. 

 There were two things, however, that 
troubled me about the letters I received from my 
health plan, which prompted me to start the Neuropathy 
Action Foundation this year. The first comment 
stated, Theres currently an acute nationwide 
shortage of IVIG due to marketing (phonetic), 
manufacturing (inaudible) shortages. IVIG is used to 
treat a variety of conditions. Some conditions do not 
have sufficient evidence of efficacy to justify 
continued use during this critical shortage period. 
Your condition falls into this category. 

 The second statement, from a letter I 
received from my insurance company, said Please 
understand that although the committee made a 
favorable exception to the terms and conditions of 
your benefit, we are not required to make the same or 


similar exceptions for you or any other member in the 
future. 

 Now, for the last year, I have been 
receiving my IVIG treatments every month since I won 
this appeal. However, the first four months of 2006, 
I was unable to get the brand of IVIG that works the 
best for me as an individual. I was receiving an 
alternate brand, which caused very severe side effects 
and did not work as well. It took me four months to 
win that battle, as well. 

 In conclusion, I am a young, high-energy, 
successful professional who happens to be very well-
connected, and I understand how to navigate the 
complex health care system, but what about others? 

 What about my 60-something year-old parents 
who are not as educated as myself or not as connected 
as myself? What about poor Medicaid recipients? What 
about the elderly, who can barely take their 
medications on a daily basis? 

 My opinion of the IVIG access issue shortage 


is -- are not the fault of the manufacturers or Part 
D, 100% the fault of health plans. Theres a term 
called evidence-based medicine which, if used 
correctly, is a very valuable tool for physicians. 
Evidence-based medicine is typically based on the 
evidence out there, the physicians personal knowledge 
and observation, and the individual patient needs at 
that time. 

 Health care decisions must be made between 
the doctor and the patient on an individual basis. 
This sacred relationship is in jeopardy because 
insurance companies have hijacked evidence-based 
medicine and have turned it into cost-based evidence-
based medicine. 

 This type of cookie-cutter medicine is 
dangerous and more expensive in the long term. 

 MS. CONNERY: Dominick, weve got 15 seconds 
left. 

 MR. SPATAFORA: Something has to be done so 
that people like myself can actually function and live 


better lives, as weve heard today. 

 MS. CONNERY: Okay. Thank you. Thank you 
very much. We are at about 11:30, which is the time 
for our first break, our lunch break. We -- Dominick 
was Commenter No. 14. Commenter No. 15 is Joseph 
Bailes. Is Joseph in the room? 

 DR. BAILES: Yes. 

 MS. CONNERY: Oh, good. Okay. So well take 
you after lunch, so I just wanted you to know that you 
will be our first commenter after lunch. However, 
before that, when we come back from lunch at 12:45 -- 
and we encourage you all to be here then -- 
Congressman Tom Foley will be here, and will be 
speaking, so well probably get to you around 1:00, 
Joseph. 

 For folks on the phone, youre -- you can 
stay on the line, but there wont be anything to hear. 
We probably recommend that you just dial back in close 
to 12:45. 

 (Off the record at 11:27 a.m.) 


 (On the record at 12:46 p.m.) 

 MS. CONNERY: Its just a little bit after 
12:45, so we would like to get started again. We were 
expecting to be joined by Congressman Tom Foley. Is 
he in the room? Sorry, Mark Foley. I guess hes not 
here with us yet, so we are going to proceed with 
commenters, and then if we do -- if he does come, we 
will adjust accordingly when that happens. 

 Now, I did have a message that one of our 
earlier commenters was confused about the time, and so 
wasnt there when we called her. Thats Mary Jean 
[sic] Peterson, and shes on the phone, so what Id 
like to do is put her back in the queue right now and 
have her be our next commenter. 

 OPERATOR: Thank you, maam. I will open her 
line. 

 MS. CONNERY: Okay. 

 OPERATOR: Ms. Peterson, your line is open, 
maam. You may begin your comments. 

 MS. PETERSON: (inaudible) 


 MS. CONNERY: Oh, Im sorry. We are having a 
very hard time hearing you. Is it possible to get 
closer to your phone, or -- 

 MS. PETERSON: Im right on my phone. 

 MS. CONNERY: Youre right on your phone? 
Okay. 

 OPERATOR: Or maybe increase her volume? 

 MS. CONNERY: Okay. Yes, just speak up as 
much as you can. That will be a help for us. Thank 
you. Go right ahead. 

 MS. PETERSON: My name is MerleJean Peterson 
and Im a primary immune deficiency patient, and my 
body does not fight bacterial infections. For this 
reason, I need IVIG treatment. January 2005, I had to 
change the site of treatment from doctors office to 
outpatient services at the hospital. 

 Because of Medicares low reimbursement for 
gamma and the cost of administering it, the hospital 
gave me all kinds of excuses why they could not give 
my treatment, and delayed me for hours. By December 


2005 to January 2006, my doctor was told verbally by 
the hospital not to send any more Medicare IVIG 
patients. February and March, I receive no treatment. 
Had three bouts of upper respiratory infections that 
shouldve required antibiotics. 

 For years, I had severe skin and other 
bacterial infections, and the IVIG treatment has kept 
me well and not having to be hospitalized for IV 
antibiotics that I dont tolerate well. 

 Without this treatment, I have had 
infections, body, joint pain, complete fatigue, and my 
scalp psoriasis is much worse. Because of the bad 
reaction to my home infusion in July, my doctor 
ordered blood work to check my kidney function and 
lowered the IV rate in August. The rate had been 
previously increased to lower the cost of giving it. 

 Medicare reimbursement programs (inaudible) 
adversely affected my care, and the actions of my 
secondary insurance company followed Medicare policy. 
We fully expect our secondary insurance company to 


follow Medicares refusal to pay for any -- for my 
treatment, as they usually do so. Its only a matter 
of time. 

 Ive been told by my home health care that 
if getting my home infusions that Medicare would 
refuse to pay, my secondary insurance would pay 100%. 
I recently found out they will only pay 20%, if 
Medicare pays for my home infusion, which they do not. 

 To save money, my nurse mixes my gamma at 
home. Medicare paid for my April and May 2006 
infusions, and that must be refunded because of their 
change in policy and that mine is a non-specific 
immune deficiency, which they have covered in the 
past. 

 My question is, why has Medicare cancelled 
their coverage for my illness? Is this tweaking of 
the rules the administration was talking about when it 
comes to Medicare? What do I do when a hospital has 
refused to give me my treatment because of Medicares 
reimbursement. Ive heard that Medicare says they do 


not receive any complaints about the IVIG treatment 
policy. 

 In February 2006, I received a letter from 
Medicare, after I tried to make an appointment. It 
was 12 pages of civil rights complaints after trying 
unsuccessfully to verbally lodge this complaint. So 
by sending letters to my local politicians and making 
phone calls to their offices, I received no letter or 
one telling me that to be sure, Medicare was following 
up on my complaint. 

 Politicians did not sign the letter to 
Medicare asking for an emergency to be declared to 
change their policy to give us our (inaudible). I did 
not fill out these papers -- these civil rights papers 
-- at this time, as I felt so -- I felt like what 
needed -- What can I do without getting a lawyer? 
Ive talked to getting the needle and many different 
agencies and I have different answers for them all. 

 I will try and make a special effort to get 
these civil rights papers filled out and send in a 


complaint to Medicare. I get very upset when I hear 
the illegal aliens need Medicare and Medicaid 
coverage, when mine has been denied and my life is at 
risk if I dont get my IVIG treatment. 

 I feel like a ball being tossed about with 
no answer to date. They keep playing with our health 
care coverage. Thank you for your attention. 

 MS. CONNERY: Thank you very much, MerleJean, 
and Im sorry for the difficulty youve been having. 
Our project team has been listening carefully as weve 
heard your comments. We thank you for taking the time 
to be with us. 

 For those who are in the queue to comment 
this afternoon, Ill just note that weve had a few 
more cancellations, Commenters No. 32, 34, 39, 42, and 
54 have all let us know that they wont be taking 
their time, so at those points, well be going forward 
to the next commentor. 

 I have heard that Congressman Mark Foley has 
been a little bit delayed by a need to vote on 


something, but he is expected probably in 10 or 15 
minutes, so what well do is keep going with the 
comments until he arrives, and then well pause to 
hear him speak to us. 

 If the next commenter is in the room -- and 
I realize were a little bit earlier than I had 
indicated previously, but well take him -- is Joseph 
Bailes. Okay, great. Thank you. 

 DR. BAILES: Thank you. Im Dr. Joseph 
Bailes, the Executive Vice President of the American 
Society of Clinical Oncology, or ASCO. Were the 
national organization which represents physicians who 
specialize in cancer. 

 IVIG is typically used by an oncologist, 
widely in a supportive care role for individuals with 
chronic lymphocytic leukemia who have low 
immunoglobulin levels. Also used to treat idiopathic 
thrombocytopenic purpura, when platelet counts need a 
rapid rise and in some bone marrow transplant 
situations. 


 In response to the notice of this meeting, 
ASCO conducted a survey of its members to identify 
access and health problems related to IVIG. Ive 
provided a copy of these comments to your staff. 
Sixty-eight practices that reported administering IVIG 
over the last six months responded and provided a 
significant amount of information that we believe you 
studied in probably some of the issues. 

 First, there continues to be a shortage of 
IVIG. Half of the survey respondents reported that in 
recent months, their practices had not been able to 
purchase the full quantity of IVIG that they desire to 
purchase. In addition, most practices reported there 
were significant delays in obtaining the IVIG. 

 Second, which youve heard previously, 
inadequate Medicare reimbursement for IVIG is a 
serious problem. There was a wide range of prices 
paid for IVIG by practices but those prices were 
generally substantially in excess of the Medicare 
claim and amount. The average price paid by our 


survey respondents in the last six months was about 
$40.00 per 500 milligrams for lyophilized IVIG, and 
about $50.00 for non-lyophilized IVIG. 

 The current Medicare allowable amounts are 
$25.00 for lyophilized IVIG and $30.00 for the non-
lyophilized version. Our survey also indicates that 
the add-on payment that Medicare made for IVIG 
acquisition has not been a solution for most 
practices. They have not viewed it as such. 

 Third, as a result of this, many practices 
are referring patients to hospitals for IVIG therapy. 
In fact, about half of the survey respondents stated 
that that is their current practice. Some of these 
referrals, as in the qualitative discussion by 
respondents, require patients to travel long 
distances. 

 Fourth, the respondents indicate that the 
shortage of IVIG has altered treatments. 42% of 
respondents said they give patients less than a full 
dose because of the amount available, and 31% said 


that they have decreased the number of doses given to 
IVIG patients. 

 Finally, in the qualitative or comment part 
of our survey, there were a number of adverse effects 
on patient health mentioned by the respondents: 
delayed treatment, in some situations, increased 
bleeding episodes, bruising, infections, 
hospitalizations. And also, the intermittent 
availability of IVIG, especially in relation to 
idiopathic thrombocytopenic purpura, has increased 
spleenectomies and transfusions in some practices. 

 Patients also sometimes have to be switched 
from one manufacturers IVIG to another, and side 
effects, including the allergic reactions that did not 
occur with the initial IVIG, can result and have 
resulted from a different version. 

 ASCO thanks HHS for its work and for the 
opportunity to present these comments, and we look 
forward to working with HHS to resolve the access and 
patient health problems caused by the inadequate 


reimbursement and product availability. Thank you. 

 MS. CONNERY: Thank you very much. Our next 
commenter, who would be someone on the phone, is 
Jackie Liles, L-I-L-E-S. 

 OPERATOR: Thank you, one moment. Maam, do 
you have the spelling of her first name? 

 MS. CONNERY: The first name, Ive just got, 
I think its Jackie, J-A-C-K-I-E. 

 OPERATOR: Thank you. Im currently not 
seeing her name on the screen. If on line with 
someone else, please press star-zero so an operator 
can open your line. Im receiving no response, Ms. 
Connery. 

 MS. CONNERY: Okay. Okay. No -- if she 
comes in later, we can take her comment later. 

 OPERATOR: Thank you. 

 MS. CONNERY: Our next commenter is -- would 
be in the room, and Ronald Hartmann, is he with us? 
Yes, okay, great. Thats Commenter No. 17. 

 MR. HARTMANN: Good afternoon. My name is 


Ron Hartmann and I am Vice President of Pharmacy 
MedAssets Supply Chain Systems. Were a health care 
purchasing organization. Were the third largest GPO 
in the country and have been fortunate to have been 
the fastest growing, as well, over the past four or 
five years. We currently represent over 1,400 
hospital members, as well as 23,000-plus non-acute 
providers across the country. 

 My comments today, Im representing just 
MedAssets. Im not representing the industry. May 
make some general comments about the industry, but I 
just wanted to be clear that Im basically just 
representing MedAssets here. 

 The group purchasing industry plays sort of 
a very important role in this entire equation. The 
group purchasing organizations are one of the groups 
that secure contracts with manufacturers on behalf of 
our members and have a significant role in determining 
allocation of product, where that product goes on a 
monthly basis, in terms of not only specific product, 


but quantity in product. 

 Talking also about albumin here, not just IV 
immunoglobulin. Theyre very much needed by our 
members, and the albumin is allocated here similarly 
to the way that the IVIG is allocated. In fact, in 
todays market, the albumin is more of a challenge for 
us than IVIG. IVIG certainly has some challenges in 
terms of securing an adequate supply, and the dynamics 
of the market have changed dramatically over the past 
couple of years. Even more recently, albumin has 
become an even greater challenge for us. 

 The manufacturers generally base their 
allocations, the amount of product that they set aside 
for a specific contract holder, specific, in our case, 
group purchasing organization, based on historical 
needs. As we have heard this morning from several of 
the presenters, patients have shifted from one 
location to another to receive those allocations. 

 Another factor in this, the one that more 
directly impacts us in our industry, is that health 


care providers can choose and do choose to move from 
one group purchasing organization to the next. The 
groups have acquired and secured allocations of 
product for their members based on that members 
historical purchases. 

 The current supply system in the current 
market does not support the movement of a member from 
one GPO, from one allocation, from one place where 
that supply has been secured, to another, causing 
certainly difficulties in the course of movement of 
hospitals and health systems, and in our case, 
inability to secure additional product to take care of 
them. 

 The point that we would certainly like to 
make and the challenge that we would like to make to 
the industry is to support a system whereby the 
product moves with the customer should the customer 
choose to change, in our case, their GPO affiliation. 
There certainly are going to be challenges in that, we 
understand that, some logistic issues, but we are 


certainly more than happy to sit down and work with 
the manufacturers and distributors to help facilitate. 

 But in addition to movement of product from 
a patient office to a hospital, its our hospitals 
that are receiving those patients and truly have a 
limited ability to acquire the product that they 
carry. 

 Thats further complicated by, in a larger 
sense, an entire health system moving from where their 
historical allocation was located to a different 
place, and in our case, from moving from another group 
purchasing organization to MedAssets. 

 What we would certainly like to help keep in 
mind is in our focus, certainly, were patient 
advocates, as well. The patient care needs to be the 
number-one priority and needs to override other issues 
that may influence positions that certain groups may 
take on this. 

 Id like to thank the HHS, as well as ERG, 
for the efforts here and the opportunity to address 


this and I certainly look forward to some continued 
dialogue. Thank you. 

 MS. CONNERY: Thank you. Thank you very 
much, Ron. Our next commenter will be in the room, 
and thats Edith Marshall. She is with us. Great. 

 MS. MARSHALL: Good afternoon. Im Edith 
Marshall and Im speaking today on behalf of the 
Public Hospital Pharmacy Coalition, known as the PHPC, 
an association of close to 400 disproportionate share, 
or DSH hospitals, that participate in the so-called 
340(b) drug discount program. 

 Under the 340(b) program, companies that 
manufacture drugs covered by Medicaid or Medicare Part 
B are obligated to afford significant discounts on the 
purchase of covered drugs to qualifying safety net 
providers, such as DSH hospitals and other qualified 
facilities. 340(b) prices are subject to a 
statutorily defined ceiling. 

 Charging a 340(b) covered entity a price for 
a drug that is above the 340(b) ceiling price violates 


formal written agreements manufacturers must execute 
with the Secretary of HHS, as well as the legislative 
mandate of Section 340(b) of the Public Health Service 
Act. 

 In other words, our member hospitals are 
where many people who need IVIG, but cant pay for it, 
go, and the 340(b) discounts are an important part of 
what enables these hospitals to provide that care. 

 340(b) hospitals and their patients, like 
many other health care providers and the individuals 
they serve, have been experiencing severe difficulties 
in obtaining adequate supplies of IVIG. Indeed, based 
on a survey of its members conducted by PHPC earlier 
this year, only about half of our member hospitals are 
able to obtain enough IVIG to fulfill the treatment 
needs of their patients. We dont know if theres a 
shortage. We dont know exactly what could be the 
cause of the problem, but we do know that there 
appears to be a crisis situation. 

 The 340(b) covered hospitals we represent, 


however, also face special problems with regard to 
IVIG access that are distinct from the generalized 
problems of product access and availability that we 
have been hearing about today. 

 Specifically, because our members serve 
large numbers of indigent and often uninsured patients 
who cant pay for their health care, or who can only 
pay for a small percentage of its costs, these 
hospitals rely heavily on the discounts they are 
entitled to receive under the 340(b) program to enable 
them to stretch their limited resources and provide 
pharmaceutical and other care to a vulnerable 
population. 

 Despite the legal obligation of drug 
manufacturers to offer IVIG for purchase by 340(b) 
covered entities at or below the discounted 340(b) 
price, manufacturers are only infrequently offering 
IVIG for purchase at the 340(b) price. Almost 80% of 
the hospitals in our survey sample, in fact, supported 
-- Im sorry, almost 80% of our hospitals reported 


being unable to obtain any amount of IVIG at the 
340(b) prices, to which theyre supposed to be 
entitled under the law, even though close to 70% of 
the same sample reported being able to obtain IVIG at 
higher prices through regular wholesale and 
distribution channels. 

 The result is that the 340(b) hospitals, 
which are under restrictions even from using GPOs to 
buy outpatient drugs because of their participation in 
340(b), are forced to pay prices for IVIG far in 
excess of what they can afford, and at what applicable 
laws intend them to pay. 

 Weve been told that representatives of the 
manufacturers, at least in the field, 
characteristically cite a shortage of IVIG as the 
reason 340(b) pricing is unavailable, but the data 
gathered in our recent member survey seems to belie 
that explanation. A shortage doesnt explain the 
frequency with which the product is indeed available, 
just not in a 340(b) price. 


 It appears that what is going on is 
something resembling a shell game. We have been 
assured by manufacturers that they do indeed offer 
IVIG at the 340(b) price as the law requires, but they 
also demand, unlike for other outpatient drugs, that 
IVIG has to be purchased -- this is usually what 
manufacturers insist -- they must be purchased 
directly from the manufacturer. 

 Then when a 340(b) hospital goes to the 
manufacturer and says, Okay, I want to buy some 
product under at 340(b) contract, theyre told, 
Sorry, but all of that product has already been 
allocated to other purchasers of a commercial 
contract, and we have to honor those contracts. So 
go and try to get the product elsewhere on the 
commercial market. 

 Then, when the 340(b) hospital goes to one 
of the speciality distributors or wholesalers, who are 
the entities that bought the product from the 
manufacturer, theyre told We cant give you a 340(b) 


price. Thats not our obligation; its the 
manufacturers obligation. And the manufacturers, 
although they will reimburse -- its called a charge 
back system -- they will reimburse wholesalers and 
distributors for the amount of the discount, 
generally, on a 340(b) product, they are not 
permitting any charge backs on IVIG. 

 So in other words, it really appears that, 
at least from the special perspective of the 340(b) 
hospital community, theres more going on here than a 
simple mismatch of supply and demand. Nobody, not 
manufacturers, not distributors of IVIG, seems to be 
willing to put in writing an explanation of what is 
really going on and why its becoming impossible to 
purchase IVIG under the 340(b) program. 

 But it just all doesnt make sense. It 
doesnt make sense why allocations are based on two 
thousand and -- Im sorry, 204 purchasing levels when 
clearly, the distribution of supply has changed. It 
doesnt make sense to say theres a shortage as the 


reason we cant get 340(b) prices if indeed, the 
product is out there to buy. 

 We applaud the governments efforts to look 
further into this entire situation and we are hopeful, 
for the sake of not only 340(b) providers and their 
patients, but all the providers and patients that 
desperately need adequate supplies of this product, 
that efforts that are being made here today will yield 
significant changes in the way IVIG is allocated, 
distributed, and priced within market. Thank you. 

 MS. CONNERY: Thank you very much. Our next 
commenter is Jean Sifingo, and she would be on the 
phone. The last name is spelled S-I-F-I-N-G-O. 

 OPERATOR: Okay. One moment, please. Im 
sorry, Im not showing that participant at this time. 

 MS. CONNERY: Okay. Well, again, if she does 
run in later, let me know. Well go then to the next 
commenter, which would be Commenter No. 20, also would 
be on the phone. Thats Tessa Gehardt, G-E-H-A-R-D-T. 

 OPERATOR: She has disconnected from the 


conference. 

 MS. CONNERY: Okay. Then well go to the 
next commenter who is also on the phone, Margie Pride, 
P-R-I-D-E. 

 OPERATOR: Okay. Im not showing Ms. Pride 
on the phone. 

 MS. CONNERY: Okay. Well, lets try somebody 
in the room. Our Commenter No. 22 is Mary Kruczynski. 
Marys with us. Okay. Glad youre here. 

 MS. KRUCZYNSKI: Thank you for the 
opportunity afforded me to witness to the experiences 
that I and others have experienced nationwide as a 
result to the pricing and availability of IVIG. I 
will go so far as to say the distributors are also 
having the same supply issues and sadly, demand is 
ever present. 

 I am also a member of Community Oncology 
Alliance, an organization aimed at preserving 
community cancer care, where 84% of cancer care 
therapies are delivered and among them, we treat a lot 


of patients with immune deficiencies. 

 I have experienced first hand the problems 
associated with securing and administering 
immunoglobulin, and I can see down the road a similar 
problem on the horizon with chemotherapy drugs and the 
associated drug therapies stemming from the 
reimbursement issues with MMA, and Im frightened. 

 As a practice administrator, the challenge 
of not only finding, but affording IVIG product, rises 
above pre-authorization (inaudible) administration of 
a product, which is something we all need to do now. 
So I thought Id give you the perspective of what 
happens in a physician office when a patient requires 
this drug. 

 The normal course of action in an oncology 
clinic is to seek approval from the patients 
insurance carrier to administer the drug for the 
specific patient diagnosis because, as you know, many 
times, this drug is given off-label. Some insurance 
companies pay for it, some do not. 


 Once that hurdle is achieved, we tackle the 
rate of reimbursement, but with IVIG, we actually have 
to reimburse our entire process. First, we have to 
call our distributor or speciality group to find out 
what product is even available; that is, Gammagard, 
Flebogamma, Gamunex, Octagam, etc., and what quantity 
will I be allocated that month? And then the next, 
the million-dollar question is how much is it going to 
cost me? 

 That number is then multiplied out by the 
number of grams required for that specific patient, 
which we then compare to the allowables from the 
carrier of that patient, be it Medicare or private 
pay, to determine if we are even going to make whole 
on the raw product. 

 Our decision to treat, as you can see, is a 
truncated one, and also a very time-consuming one, 
because once we have the answer as to what product and 
what quantity is available and whether or not we can 
afford it, we have to go back to the treating 


physician and explain to he or she what product we 
have, do we need to adjust the dose because of this 
product, can we even use this product for Mary Jo. 

 Oftentimes, this is not the first dose of 
IVIG that the patient has received, but due to 
proclaimed shortages of products which may be made for 
this life-saving treatment, regardless of the risk of 
reaction with this patient. This is a tough decision 
that we have to make. 

 Thereafter, we need to call the insurance 
company and review local or national coverage 
determinations in an attempt to get that final 
approval to treat now that we know that we have the 
drug. That doesnt always occur. If we get a 
positive, we proceed to our internal scheduler to find 
out when we can fit a five-hour infusion in in our 
very busy infusion suite. 

 This is a long infusion and it cannot be 
rushed and the patient needs to be monitored, and we 
use certified chemotherapy infusion nurses, and I 


dont have to tell you how in short supply they are, 
or perhaps I do have to tell you. They are in short 
supply and they demand a high salary and theyre worth 
every penny. 

 If we are unable to secure the IVIG or be 
made whole on the purchase of it, then we have to 
explain to the patient why he or she needs to go to 
the hospital for this treatment. This is usually 
followed by questions, anxiety, and oftentimes, tears. 
Of course, those patients have been shifted to me 
after the doctor gives them this news because Im 
supposed to pull a rabbit out of a hat and find this 
product, which I cannot. 

 If the patient is being outsourced, we have 
to call the hospital outpatient department. We have 
to schedule a date and time for the patient. We have 
to write physician orders, patient demographics, and 
pertinent medical records and fax all that over. That 
takes a lot of staff time. 

 Then we have to go back to the patient and 


communicate what weve done and invariably explain 
once again why they cannot receive this treatment that 
they used to receive in our office, oftentimes for 
years, and its not an easy task. 

 In todays technologically advanced society, 
its amazing that this is what we have to go through 
(inaudible) just telling you about it, and may I also 
mention that most times, we cannot treat the patient, 
and weve already expended hours of time in an effort 
to do that, with zero remuneration by Medicare or any 
other carrier, yet but we tried to administer their 
policies, essentially for free. 

 MS. CONNERY: You have 15 seconds. 

 MS. KRUCZYNSKI: Oh. We are contacted from 
time to time by home care companies offering to take 
our IVIG patients off the market -- off the market -- 
off our hands. A recent call (inaudible) revealed 
that they had no supply difficulty with IVIG and in 
our area, they were treating 17 patients an hour 
(phonetic). When I asked why we couldnt get the IVIG 


and they could, she said Because we have special 
arrangements. Were very large. 

 Well, as a member of a GPO, we thought we 
were very large also, and we wonder, could this be a 
planned relocation of place of service for this very 
expensive blood product? Are there separate 
contracting arrangements between manufacturers, 
insurers, home infusion companies, limiting the very 
position to prescribe their care? 

 Could the shortage then be contrived rather 
than actual? Are these entities profiting from these 
transactions? Human life is at stake here. I have 
just one last quote, if I could just squeeze it in. 

 MS. CONNERY: Go ahead. 

 MS. KRUCZYNSKI: In February 2006, 
Congressman Mark Foley, supported by Congresswoman 
Nancy Johnson and Nathan Deal, Chairman of Energy and 
Commerce, had a meeting, and they said We need to get 
to the bottom of this -- and I quote -- and find a 
fix to this problem before someone dies. 


 Regrettably, at the Ways and Means Hearing 
in July 06, someone did die. Weve missed our 
deadline. 

 MS. CONNERY: Thank you very much, Mary. 
Well, that quote provides an excellent segue, because 
we are joined now by Congressman Mark Foley, and were 
very grateful that you could take the time to be here. 
We are joined not only by the folks in the room, but 
several folks who are on the phone, as well, who will 
be able to hear very clearly, as long as you use the 
microphone. We can -- would you like to -- here, 
lets do this. That way you can -- 

 MR. FOLEY: Well, then I can do an Oprah. 
Hello, everybody. Lets take questions from the 
audience. No, this is obviously -- I am Mark Foley 
from the 16th Congressional District, which is in 
Florida. I represent the fifth largest Medicare 
population in America. This is a critical issue. I 
dont want to underestimate the impact this has had on 
constituents in my community and people that Ive met 


with throughout the entirety of both patients and 
patient advocates. 

 You know what the topic is, so I dont need 
to read that portion, but about two years ago, I 
started to hear from my local immunologists, other 
providers, and patients that doctors were not going to 
be able to continue providing IVIG in the office 
setting because the doctors claimed their Medicare 
reimbursements were too low. As a result, patients 
would have to seek treatment in a hospital outpatient 
setting, something that would be devastating for this 
patient group because of their susceptibility to 
catching other illnesses in those settings. 

 It was at that point that I, along with 
several of my colleagues, began taking a very close 
look at the problem. We began to meet with 
manufacturers, distributors, GPOs, providers, patient 
groups, to get their input on what they were 
experiencing in the marketplace. However, despite our 
best efforts, there was no consensus as to what was 


causing the problem. Soon after, I began to hear from 
hospitals that they would be cutting off services 
entirely, leaving countless patients without this 
life-saving therapy. 

 With a newly found sense of urgency, 
Congress turned to CMS, FDA, and HHS for their input 
and asked them to develop a solution to this crisis. 
However, we were quick to discover that no one in 
official Washington could tell us what the cause was 
and thus, could not offer a solution. 

 We then asked the U.S. Department of Health 
and Human Services Inspector General to do a study of 
the problem. Again, regrettably, that wont be done 
until next year, and people are dying without their 
remedy. 

 During an earlier hearing this year, 
Congressmen Jim McCreary, Nancy Johnson, Clay Shaw, 
and I asked Health and Human Service Secretary Leavitt 
to immediately look into the problem and provide 
Congress recommendations on how we can solve it. 


Thats why were here today. 

 After several years of looking at this 
problem, theres a general consensus on Capitol Hill 
that there are three factors causing the problem. 
First, reimbursement. 2003, Congress changed the way 
CMS paid for Part B drugs because the spread -- the 
difference between the amount of money CMS was paying 
and the actual cost of administering the drug was 
enormous in causing the Medicare program financing 
hardship. 

 As a result, we required payments to be made 
using the average sales price formula and not the 
widely used, but invented, average wholesale price 
formula. One of the biggest problems with ASP is that 
it requires CMS to use months-old data to determine 
pricing, not to mention that it doesnt take into 
account final acquisition costs. I think that by 
requiring CMS to require a one-quarter lag in data, it 
may help. 

 Second, is there a product shortage? While 


pricing the product may be a factor, the fact is that 
many hospitals are not able to get product at all. 
Part of the reason for this is because the treatment 
is a victim of its own success. Ive heard from 
countless doctors across the country that IVIG is a 
miracle drug. 

 Hospitals all across the country had very 
off-label uses, and the amount of non-PIDD patients 
receiving the drug are on the rise. This will be a 
very difficult issue to deal with, but we must triage 
our patients and give IVIG to those that need it most. 

 Third, and what has been colloquially called 
channel conflict, when the patient shift from 
physician setting to hospital settings occurred, we 
discovered in most cases, the product was not 
following the patient to the new setting. 

 This is extremely important because of the 
way contracts are entered into for the purchasing of 
this treatment. Amounts are based on the providers 
previous year usage. Therefore, if a hospital has 


contracted for a certain amount of grams, it is 
difficult for them to get more at contracted prices. 
We need to take a look at how these contracts are 
done and revisit whether federal law and other 
regulations need to be changed. 

 In conclusion -- which is always the 
happiest word for panelists to hear -- the fact that 
we need to find an answer and quickly. As of 
yesterday, according to the Florida Hospital 
Association, no hospital -- no hospital -- is offering 
IVIG any longer in their outpatient setting. We are 
going to see patients die, and this is simply 
unacceptable. 

 You here have been charged with finding an 
answer, and as someone who is responsible in 
overseeing Medicare, I am telling you we need an 
answer now. 

 In the meantime, I wanted to let you all 
know that Im continuing to work with Chairman Bill 
Thomas, Congressman McCreary, on several options, and 


we are hoping to have something soon. While I cant 
discuss what we have been talking about, I can tell 
you that we do not plan on moving a reimbursement-only 
bill, as some may want. No one is without some 
responsibility for what has happened here. Any 
responses that we take will reflect that fact. 

 Again, I want to thank you for allowing me 
to appear before you today, and thank you for your 
consideration of this very important population. 

 MS. CONNERY: Thank you. Is this anything 
that you would take a couple of questions on, if 
people have questions about your activities? Do you 
have time for -- yes? 

 MR. FOLEY: Yes. 

 MS. CONNERY: Okay. 

 MR. FOLEY: I may have to turn the mike -- 

 MS. CONNERY: Well, and Im going to have to 
-- 

 MR. FOLEY: (inaudible) 

 MS. CONNERY: Right, because we do have to 


get everything on the mike. And what well do is 
well alternate between a question in the room and a 
question on the phone, and maybe you could discuss the 
procedure for folks on the phone, if they have a 
question? Is it press star-one? Operator? 

 OPERATOR: Yes. 

 MS. CONNERY: Is it press star-one? 

 OPERATOR: Press star-one if youd like to 
ask a question. 

 MS. CONNERY: Okay. 

 PARTICIPANT: What vehicle would you use to 
move that solution that you and Chairman Thomas and 
the like are working through? How would you get that 
vehicle -- how would you get that through? Are you 
tacking that onto a bill, or -- 

 MR. FOLEY: Again, the first is to come up 
with a solution, and then find a vehicle that would be 
appropriate. It could be an omnibus (phonetic), it 
could be in special session. It certainly wont be 
before we adjourn Friday, but there will be some 


vehicle we can tack that to. 

 I know physicians are looking at 
reimbursement issues. There are a number of outside 
and outstanding issues that we have to tackle. If we 
come up with a solution, it would probably be melded 
into one of those vehicles. 

 PARTICIPANT: So it would be not before the 
end of the year? 

 MR. FOLEY: It could possibly be before the 
end of the year. I wouldnt want to give anybody that 
close assurance, because Im not telling you what 
were going to get done, unfortunately. 

 PARTICIPANT: Right. 

 MR. FOLEY: But we are going to be back here 
on November 13th for a week. Were going to be back 
here at least two weeks in December. There are a lot 
of outstanding issues, so things may move a little bit 
more quickly once the election seasons finished. 

 MS. CONNERY: Is it -- Marcella still with us 
as the operator on the phone, or somebody new? 


 OPERATOR: Yes, Im here. 

 MS. CONNERY: Oh, okay. Still Marcella. 

Do we have anyone on the phone who wanted to ask a 
question? 

 OPERATOR: By hitting star-one, we have no 
other parties in queue. 

 MS. CONNERY: Okay. We have a couple of 
others in the room, so well go to those. 

 MS. BIRKOFER: Thank you, Congressman Foley. 
Im Julie Birkofer with the Plasma Protein 
Therapeutics Association, representing the 
manufacturers of IVIG. 

 First, Id like to thank you and Bradley for 
your leadership on this issue, and let you know that 
the companies are committed to finding the solutions, 
and weve been working tirelessly with many in the 
community, and were talking about things 
substantiated by data by the Lewin Group, as well as 
external data from the Office of Inspector General, 
and any ASPI findings to support a payment adjustment. 


 Were also advocating for separating out the 
(inaudible) codes brand specific reimbursement, as 
well as maintaining the pre-administration code, and 
identifying IVIG as a complex infusion similar to a 
biological response modifier. 

 Were working with some of your colleagues 
in Congress and wed like to work with you, of course, 
sir, and we have some draft legislation Id like to 
give to (inaudible). I just want to thank you so much 
for your leadership, you and Congressman McCreary and 
Israel (phonetic). Weve been working with 
Congressman Pitts (phonetic). 

 The bottom line is were all working for the 
same end goal, to restore access for IVIG, so I just 
wanted to thank you, sir. 

 MR. FOLEY: Thank you. Ill take your 
compliment and (inaudible). Thats a lot to do, but 
we have it. 

 MS. CONNERY: Well, we have another question 
over here. 


 PARTICIPANT: Hi, Congressman. First of all, 
again, I ditto what Julie Birkofer said. Youve been 
an incredible advocate for our community and your 
remarks have been wonderful and I know what your 
constituencys going through, and I know that there 
are constituents from your district right now 
listening on the phone, so youve been great. 

 But youve also taken a leadership role in 
doing two letters to the Secretary requesting that he 
declare a public health emergency, which would get us 
out of this mess right now. Would you consider 
requesting a member-level meeting with your 
colleagues, McCreary and Israel (phonetic), with your 
-- with members of the community to sit down with the 
Secretary and discuss what could be done to get some 
relief? 

 MR. FOLEY: Yes. Bradley -- and you 
mentioned that to me when I entered. Theres no 
question we would like to facilitate a meeting and 
urge him. I know weve spoken to him repeatedly on 


it, sent him letters. We testified before the Ways 
and Means Committee. We brought that, as did Mr. 
McCreary and others, to his attention. 

 Im delighted to work with the 
Representative Israel (phonetic) on this issue, as 
well, and he and I will coordinate the formation of a 
letter seeing if we can (inaudible) a meeting. 

 PARTICIPANT: Thank you. 

 MS. CONNERY: Marcella, is anyone queued I[ 
by pressing star-one with a question on the phone? 

 OPERATOR: Yes, we have Tessa Gehardt. Your 
line is open. 

 MS. CONNERY: Okay. 

 MS. GEHARDT: Hi. My names Tessa Gehardt. 
Im a patient. 

 MR. FOLEY: Yes, maam? 

 MS. GEHARDT: Do you hear me? 

 MR. FOLEY: Yes, I can, please. 

 MS. GEHARDT: Okay. My question is, also 
with the insurance companies, there is a cutoff limit 


with lifetime capabilities and getting treatment. Is 
there any way that the Congress can deal with this 
issue where -- this is a lifetime treatment for me, 
and at the rate the cost of it is, it will cut me off 
at the age of 60. 

 I am 44 years old right now, and my 
insurance company, if I stay with the one I have, will 
cut me off around age 60, so what am I to do if I live 
beyond that and I still need treatment? 

 MR. FOLEY: Thats a very, very important 
question, and thats one of the concerns we have in a 
multitude of areas where they have caps on coverage, 
because you cant -- in fact, its actually a waste of 
money to continue to fund and provide it if youre not 
going to sustain it to the lifetime of the individual. 

 So we want to be very careful. I dont have 
an instant solution, but much like weve worked on 
issues of organ transplants, it was ironic that we do 
an organ transplant and not have Medicare reimburse 
for the anti-rejection drugs. It seems a very 


expensive and devastating procedure to put a person 
through when youre not going to provide the very 
relief that will sustain the organ living in the new 
body. 

 And so these are the same questions were 
going to be challenged with in the reimbursement caps 
that are in some insurance policies. So Ill ask 
Bradley to look into that further. 

 MS. CONNERY: Thank you. Well go the next 
commenter -- I mean, sorry, questioner in the room. 

 MS. BOYLE: Hi. Im Marcia Boyle from the 
Immune Deficiency Foundation. I just wanted to 
reiterate and thank you for your leadership. Many of 
our patients have been in touch with your office, and 
they know that youre a member of Congress who really 
cares. 

 Earlier today, I gave some preliminary data 
from a survey weve done of patients and the impact of 
Medicare reimbursement. Id like to be able to send 
that to the office and sit down with you and Bradley 


at a time of convenience, because we do have data now 
that is current stat that certainly shows whats 
happening disproportionately to Medicare patients. 

 So I know that one of the things you need is 
data at all times, so were happy to provide it and we 
just want to thank you from the bottom of our hearts. 

 MR. FOLEY: Well, theres no question, I 
mean, there are so many stress points on Medicare 
right now, and we mentioned reimbursements, hospital 
reimbursements, home health visits, and all kinds of 
things, physical therapy caps. We have got to do a 
major restructuring of how Medicare works. 

 It seems like the only answers we find in 
Washington cut reimbursement and hope it stops the 
hemorrhaging of money. But oftentimes, it leads to 
greater illnesses, which then exacerbate the expenses. 
Weve been trying to, and I know I worked 
with Senator Graham and Carl Levin and others on 
wellness models -- John Lewis -- trying to find ways 
to enhance Medicare as a wellness model, not just a 


sickness model. For it to be a wellness model, 
reimbursements have to provide this type of therapy so 
we can keep people healthy. 

 So this is going to be an inherent struggle, 
but unfortunately, the response we seem to get from 
the administration, or at least CMS and others, is 
just flatline physician fees, take a nick or a cut 
here, find ways to do things differently, and 
ultimately, its leading, in my view, to deterioration 
of human health, which then again exacerbates the 
system, puts them in either intensive care units or 
long-term care units well in advance of when they 
couldve or shouldve been admitted to these 
facilities. 

 So we will continue to work on it. Im 
hopeful. Both sides of the aisle -- and I think both 
sides are clearly interested, and this isnt a 
partisan issue -- both sides need to tackle this, and 
not simply just wish it away, because these things 
wont go away. 


 MS. CONNERY: Okay. Marcella, is there 
anyone else queued up on the phone by pressing star-
one to ask a question? 

 OPERATOR: Yes. Peggy Hassel, your line is 
open. 

 MS. HASSEL: First, I would like to thank 
you, Senator Foley, because you have helped both Ken 
Bennis and myself immensely many times. (Inaudible) 
please into your (inaudible) facility layer doctors 
fees, because if we moved our doctors, we will not be 
able to get treatment, no matter what you come up 
with, and then you have our doctors, as well as 
(inaudible) their practices. 

 MR. FOLEY: First, let me thank you for the 
promotion to Senator. That was so wonderful without 
even having to go through election. Best victory of 
my life. 

 There is no question that physicians have to 
be equitably treated. I think thats when this 
problem seems to have spiraled out of control, when we 


moved it from physician practice settings into 
hospitals, then changed reimbursements, then made it 
hard for hospitals, then changed the utilization of it 
for other reasons. 

 So its a cumulative effect, but I want, out 
of my heart, the doctors to be intimately involved in 
this issue, because they are the closest to the 
patient, they have to monitor and deal with the side 
effects and after effects, and you cant simply push 
them into a third party facility and hope somebody 
there is going to be able to give the continuity of 
care that your own physician has been able to do 
knowing your case management and the things that you 
had to experience. So I am all for trying to resolve 
that, including the physicians back in the system. 

 MS. BOYLE: Okay, thank you. 

 MS. CONNERY: Okay, thanks. Anyone else in 
the room have any questions? Theres one over there. 
Let me -- Ill walk your mike over. 

 MR. FOLEY: Then this will be the last 


question. 

 MS. CONNERY: The last question? Okay. 

 MR. FOLEY: I dont want to miss folks. Ill 
leave my -- thats all right. Yes? 

 MR. SCHLEIS: Hi. Tom Schleis, Octapharma. 
Do you feel you have the necessary information at this 
point to come up with a plan and implement it? 

 MR. FOLEY: Well, the information -- were 
not sure we have everything. People have been very 
good. I must say, the manufacturers have come in -- 
theres nobody that hasnt been willing to share data 
points, and I think thats encouraging. So theres 
nobody that -- were not casting a blame and saying 
theres one side holding supply out of the corner. We 
dont know why these things are occurring, but we have 
been very, very pleased that whether they be 
manufacturers, patient groups, hospitals, doctors, 
theyve all come forward, because theyre all under 
the same duress as each other. 

 So I -- so far, Bradley, do you have any 


thoughts on additional information? 

 BRADLEY: Yes, I mean, as far as specifics 
why this issue has arisen and how we can prevent it in 
the future, we dont have that pinpointed. Thats why 
these folks are here and thats what theyre charged 
with by ASPI. 

 We do, however, have a great deal of 
concern, if you look at the universe of whats out 
there, how the contracts are entered into, the chain 
of custody of that product, making sure its not being 
siphoned off into the gray market where there seems to 
be a ton of product right now at double, maybe 
sometimes triple, the prices. 

 But there -- I mean, while we cant 
necessarily say whatever were going to do is going to 
be a silver bullet, if there is anything done, it 
certainly can address some of these other concerns 
that weve been made aware of over the past two years. 

 MR. FOLEY: My lawyer probably just got the 
sound bite of the conference been siphoned off to a 


gray market. But that is, its true. Its one of 
the concerns that were facing. But thank you. 

 Let me thank everybody for attending and for 
your interest in this, and again, weve shared 
accolades with our colleagues who have been very, very 
vigorous in this issue, so its not me alone. There 
are a number of people on both sides of the aisle that 
are taking this very seriously and theyre trying to 
help. Thank you. 

 MS. CONNERY: Thank you, Congressman. 

 [Applause] 

 MS. CONNERY: Thank you very much, 
Congressman Foley. Okay. We will go back to taking 
the public comments. Our next commenter -- actually, 
our next three commenters are with us via the phone 
line, so lets hope theyre there. First is Christine 
Butler, who is Commenter No. 23. 

 OPERATOR: Ms. Butler, your line is open. 

 MS. BUTLER: Okay. What do I do now? 

 MS. CONNERY: We can hear you. 


 MS. BUTLER: Okay. This is Christine Butler 
from Montgomery, Alabama. I became a patient of Dr. 
Harry Burns in 1985. I was having pneumonia every 
other month and coughing up blood, and so I had 
(inaudible) and took antibiotics every other week 
without any improvement. Dr. Burns referred me to the 
University of Alabama Medical School in Birmingham to 
be evaluated. 

 I made many trips over several months and 
(inaudible). The doctors diagnosed me as having a 
compromised immune system. This concurred with Dr. 
Burns diagnosis. This doctor recommended taking 
gamma globulin with an IV every month under Dr. Burns 
supervision. I started the treatment in 1990. I was 
not making much progress with the monthly treatment of 
gamma, so then, I was increased to 35 grams every 
three weeks. 

 The instructions (phonetic) werent clear 
from (inaudible), but it takes five hours (inaudible) 
the medicine. Over these years, a few times, the 


gamma was not available, because the cancer center 
said (inaudible) and lets reschedule in the next few 
days. This happened at the early years of treatment 
and (inaudible) gamma. 

 As you well know, gamma is very expensive. 
It (inaudible) Medicare (inaudible) Blue Cross with 
Alabama (inaudible) all covers for me. Dr. Burns was 
taking the reduced cost (phonetic) of IVIG, and I 
appreciate that. 

 I know there are (inaudible) not have the 
benefit of Medicare and Blue Cross coverage. I could 
not financially afford these treatments without them. 
The reason that I will continue with doses of 
(inaudible) antibiotics, itll keep my lungs clear. 

 I believe that if I fail to get these 
treatments, my life will be in danger because this 
(inaudible) is very essential. With this treatment, I 
take very few antibiotics and my quality of life is 
much better. I have not been hospitalized for lung 
problems for many years. Dr. Burns has a great 


facility for these treatments. Hospitals could not 
furnish what he offers to his patients. Many 
qualified (inaudible) and and at least one of the 
oncologist/hematologist is always in the building. 
Thank you so much. 

 MS. CONNERY: Ms. Butler, thank you for 
taking the time to comment today. 

 MS. BUTLER: Thank you. 

 MS. CONNERY: Our next commentor is Commentor 
No. 24, also on the phone, Peggy Hassel, H-A-S-S-E-L. 

 OPERATOR: Ms. Hassel, your line is open. 

 MS. HASSEL: Yes, my name is Peggy Hassel and 
I work for the Sheriffs Department in Palm Beach 
County. I was sprayed with a chemical back in 89 
which triggered (phonetic) my immune system. I was 
diagnosed with common variable immune deficiency, 
neutropenia, and ITT. 

 I hope you are aware that all three of these 
illnesses combined with each other (inaudible) gamma 
globulin to survive. I was then taken to the 


University of Miami Hospital. I was (inaudible) 
because I had lost 40 pounds and I had infections and 
(inaudible) my body. 

 I tried various gamma globulin (inaudible) 
price and we wound up at that time getting the gamma 
(phonetic). I have been on that pump (phonetic) since 
1990. Just let me give you a few experiences of what 
happened when the rule (phonetic) changed for gamma 
for Medicare. I then had a lump in my breast. My 
doctor had scheduled me to get an IV of gamma with an 
IV antibiotics before the (inaudible). The day before 
this was to happen -- and at this time, I was getting 
that at the hospital. Up to this point, I was still 
(inaudible) for the procedure, per Medicares 
decision. 

 The day before, I was told I would not be 
able get my gamma, nor my IV antibiotics, in the 
morning when I was scheduled to have the breast biopsy 
the day after (inaudible). You cannot have 
(inaudible). I (inaudible) took place. After that, 


of course, I was without a home, (inaudible), because 
thats before we (inaudible) getting in the same 
facility. 

 We were put out of the hospital. We didnt 
know where to go. I needed another dose of gamma 
globulin before the procedure with the breast, and 
(inaudible) had not received it, but all that 
(inaudible). We wound up having to purchase it out of 
our own money (inaudible). At that point, we could 
show that because we had (inaudible) that we could get 
in the hospital (inaudible) medical? (inaudible) this 
week that I would no longer be able to get my gamma at 
the hospital. 

 My question to you is what does a patient do 
(inaudible). We have no (inaudible) and we are 
blessed to have Medicaid or (inaudible), but we need 
to have access to our regular treatment. And because 
these things happening, I have taken IV antibiotics 
and (inaudible), which is costing Medicare probably 
more money than if they had given me a dose of gamma 


globulin, and, of course, antibiotics (inaudible) 
orally. 

 The other problem that you have is the 
doctor is completely out of the loop. While youre in 
the doctors office, you had the ability to go to the 
doctor, and he saw -- he could see that you had an eye 
infection. He can tell that you had an infection 
wherever it was, and would immediately give us what we 
needed. This way, youre in a hospital. (Inaudible. 
You dont know what the (inaudible) level is when 
youre walking in. You dont know if youre going to 
get the product, and (inaudible). 

 (Inaudible) of course with (inaudible) and a 
quality of life and that we will live and be able to 
enjoy life, just like everyone else who is sitting in 
the room and on the telephone (inaudible) their life. 

 My other problem, too, is if Medicare does 
not come up and meet the needs at a cost where these 
companies can afford to provide, they will sell this 
product out of the country, and Americans are donating 


their blood for us to survive, whether they get paid a 
small amount or not. Once it leaves this country, 
patients like myself will die. 

 I want to thank, first of all, the IDF, 
Congressman Wexler (inaudible), especially Michelle 
(inaudible), those kinds of people who go out of their 
way to keep us alive, and help (inaudible) with 
improving our doctors. 

 I also want to thank my friend Ken Bennis, 
who we had lunch (inaudible). He had statements over 
phone calls (inaudible) and vice-versa. And these 
people do not have the support of a friend or someone 
who (inaudible). 

 We plead for our lives today. I know if you 
are not affected with this illness, you dont really 
understand this, but we do have a right to live, and 
pray in our hearts that you will listen and that you 
will think of the people who have died because we have 
not done anything yet. 

 MS. CONNERY: Peggy, were at about five 


minutes. 

 MS. HASSEL: Thank you. 

 MS. CONNERY: Okay. Thanks so much. Our 
next commenter, also joining by phone, is Betty 
Gordon. Betty is Commenter No. 25. 

 OPERATOR: One moment, please. Ms. Gordon, 
your line is open. You may make your comments. 

 MS. GORDON: Hello. My name is Betty Gordon. 
I live in Warwick, Rhode Island in the New England 
area. I am a patient with IG decrease deficiency 
(phonetic), and I receive IVIG infusions at Kent 
Hospital here in Warwick. Im happy today to give 
testimony on behalf of myself and (inaudible) Immune 
Disease Foundation. 

 I have two concerns: product 
choice/availability and (inaudible). Just a brief 
personal history. After 13 years of misdiagnoses of 
sinus, bronchitis, or six pneumonias (inaudible) the 
whole year, I was forced to retire at age 49 from 
(inaudible). 


 At 56, by the time (inaudible) after the 
unsuccessful sinus surgery, and I was finally 
correctly diagnosed with hypogammaglobulinanemia, IG 
decrease deficiency (phonetic). With this diagnose 
came a miracle, outside my medication that had slowly 
helped me regain my life. I had received 35 grams of 
Gamunex every three weeks (inaudible). If I had a 
problem (inaudible) product choice/availability. 

 I began my IGIV in February of 2004 with 
first, my (inaudible). And then that product, I 
believe, was discontinued and without forewarning, 
(inaudible). Within the next six months, again, with 
no forewarning, I found that I would be given 
Octapharma because the hospitals infusion unit did 
not have enough of the Gamunex. I refused the 
Octapharma and they found enough of the Gamunex by 
1:00 that same day. 

 (Inaudible) this year, I (inaudible) someone 
in the emergency room and after frantic phone calls to 
my doctor, my Immune Disease Foundation mentor, the 


hospital (inaudible), I agreed to have the antibiotic 
just that day. 

 (inaudible) as most you know who have this 
disease, the (inaudible) has given side effects, and 
it took my body two months to return to previous 
health levels. 

 At the next month, after preparing for the 
(inaudible) Hospitals administration in pharmacy, I 
was after Gamunex, but I (inaudible) pharmaceuticals. 
(Inaudible) having patients scheduled for this product 
and I heard -- one of the comments that Dominick and 
Tara say, that (inaudible) that IVIG is divided by 
locks and not by gates, and hes correct. 

 So mine was given to another patient and it 
has not happened since and hopefully, it wont happen 
again. 

 My other aim is reimbursement. Plus, 
location of the infusion seems to be an issue when it 
comes to this. So in 2004, I decided having IVIG in 
the hospital rather than in the doctors office, and 


heres the reason. My Blue Cross would only say 80% 
if I had IVIG in the doctors office, but it would pay 
100% if I had hospital outpatient treatment. 

 Second -- and I hope you can follow me 
through this catch-22 -- Medicare reimbursement has 
created a huge problem (inaudible) Medicare. Last 
fall, as soon as I was eligible for disability, I 
applied, was rejected twice, and was up for appeal at 
the (inaudible) level. 

 But in January of 2006, my hospital, the 
Kent Hospital in Warwick, began testing IDG level of 
all patients, both on Medicare and so as not to be 
accused of discrimination, both, like myself, on Blue 
Cross. The reason not enough reimbursement, the 
Medicare patient and the hospital has to find a way to 
(inaudible) specific (inaudible) average IDG levels. 
This has come off as an invalid and discriminatory 
test. Its like testing someone for low blood count 
after a blood transfusion. 

 Also, my insurance does pay fully for this 


treatment. I am not yet on Medicare. Plus, I have 
IDG-3 deficiency, which is a specific problem. The 
trial level was invalid to me, and so I should not be 
tested. But if I refuse testing, Kent Hospital will 
not treat me. 

 Go back to bullet Social Security and 
Medicare Part A. After e-mailing my (inaudible) State 
Senator, Senator Lee, and the (inaudible) Foundation, 
I wondered if I refused Medicare Part A, I will be 
denied Social Security Disability, which is what I 
need, as I retired on a small pension. 

 So heres the catch-22. If I get Social 
Security Disability, I cannot refuse Medicare Part A 
and keep my own Blue Cross. But if I take Medicare 
Part A, the hospital will not treat me. 

 So I notified my attorney with a number of 
the (inaudible), and heres what Im hoping, that 
sooner than five years, when I turn 65, this will all 
be resolved, because while I need it in a facility 
(inaudible) we need IVIG to stay alive. 


 Id also add that I e-mail an IVIG patient 
in California who is on Social Security Disability and 
Medicare and has had no problems with either access or 
reimbursement, so there must be in equality, and it 
must be regionally. 

 MS. CONNERY: Ms. Gordon, were at about five 
minutes. 

 MS. GORDON: Okay. My last comment, Medicare 
has to return to previous levels of reimbursement, 
again recognize plasma (phonetic) as a life-saving 
blood product, and access to IVIG must be the same all 
over the United States. Medicare reimbursement levels 
and all the (inaudible) levels should be the same all 
over the United States. 

 Lastly, I know without this product, I would 
become sick again and eventually, it will kill me. I 
ask that you recognize IVIG as a life-saving blood 
product. It gives me some type of normal, better 
health, so perhaps I can see my grandchildren grow up. 
I would never want to go back to where I was health-


wise a few years ago. Thank you very much for all 
youre doing for us. 

 MS. CONNERY: Thank you very much for your 
comment. Our next commenter is in the room, and that 
is Michael Rigas, and he is Commenter No. 26. 

 MR. RIGAS: Good afternoon. Thank you for 
allowing me to speak. I am a pharmacist. Im the 
Senior Vice President of Clinical Affairs for a 
company called Crescent Healthcare based in 
California. We are an alternate site infusion 
provider with about 3,000 patients on service every 
month in 36 states. About 500 of those are IVIG 
patients. 

 What Ive provided today is two different 
spreadsheets. Id like to talk about them just for a 
minute. Im not going to get into details. I think 
Susan Pappas said it nicely for our industry. Im 
going to concur with what she said, but I want to talk 
about our patients now. 

 As a practicing expert clinician in the 


subject, Im quite disturbed. What Ive given you, 
the first one is in color. It is a chart that shows 
the beginning of the year of 2003, going off to the 
right, 2006. 

 The different sites of care that some part 
of Medicare wouldnt pay for, whether it be A, B, C, 
or D, if you like that alphabet soup. Then I have 
whats happened with reimbursement. If the 
reimbursements in black, that means its at or above 
the level of acquisition of the drug. If its in red, 
its below the acquisition of the drug. 

 Now, at the bottom, I have what the average 
acquisition cost is to our company during those years, 
and I have below that what the gross profit would be; 
that is, whats left over after you pay for the drug. 
If you look on the bottom line, lower right-hand 
corner, you can see that were about a negative $1.00 
per gram gross profit. Obviously, that isnt going to 
help -- you cant make that up in volume. 

 If you look over to the right at the 


results, what that describes is what I think is 
happening with our group of patients that we like to 
call the IVIG gypsies. Those are the folks that Ive 
been working with for over five years who are on their 
fourth and fifth site of care right now since Ive 
been taking care of them. 

 They started off in 2003 with a doctors 
office. The reimbursement was sufficient. In 2004, 
that was lowered. They went to hospital outpatient in 
2005. That was lowered. They moved out of that and 
into the home care under Part D in 2006, doing them, 
and as a result of that, now many of them are 
receiving it back in the hospital because they 
couldnt afford the co-pay and the catastrophic piece 
of Part D, which even at 5%, can result in a 
$10,000.00 fee per patient per year, above the other 
$7,000.00 they pay for their part of the co-pay and 
the insurance itself. 

 I did think I was going to be educated as a 
clinician. I didnt know Id know so much about 


reimbursement at this point in my career. The next 
spreadsheet I have for you is the impact of Medicare 
changes from 2005 to 2006. Right now, we have a total 
of 111 Medicare patients on service, 10 of them Part 
B; 101 of them Part D. 

 As you can see in the graph, the number 
there is the percent of patients affected by what Ive 
listed. So switching IVIG product due to allocation, 
25%. Switching due to access issues at the particular 
facility, 50%. Changes in administration, location, 
100%. Every one of our patients has had to change the 
site of care since Ive taken over their care within 
the last five years. 

 Okay. 20%, patients needing to become 
hospital inpatients to receive care. 10%, patients 
needing to have us supply the drug to the hospital 
because they cant get enough, so every Friday night, 
thats when my phone starts to ring. Can I spare 200 
grams? Can I spare 500 grams? Can I spare 1,000 
grams? 


 This is for hospitals whose annual budget 
dwarfs ours by 10 times. (inaudible) IVIG because 
they dont have it and they dont know how to get it. 

 Patients receiving fewer treatments, 10%. 
15%, patients receiving lesser dosages. 35%, patients 
with worsened health status due to any of the above. 
Patients with payers who deny Part D coverage, saying 
that its Part B, for non-PID diagnosis, 20%. We also 
have to deal with them. 20% stopped therapy 
altogether. 

 So as far as our company goes, I would 
consider this a health care emergency. Of these 500 
IVIG patients (inaudible) our service, representing 
100 of them that were Medicare, are feeling quite 
affected and quite put out, as well as our company -- 
as you can see from the first page, anything to do 
with Medicare right now, the gross profit is below 
cost. So right now, unless they have a second 
(inaudible) or somebody else to pay the difference, 
theyll either have to pay cash or theyll have to 


find some other place to get it. 

 So I appreciate the fact that you have a 
large task to do, but I think this is clear evidence 
of a great travesty thats happening in these patients 
right now. Thank you. 

 MR. EYRAUD: Could I just ask, while youre 
up there, in this spreadsheet, is this an actual -- 
just so I know, make sure I know what Im looking at -
- is this an actual census, or your estimates of the 
percentages? 

 MR. RIGAS: This is actual as of yesterday. 

 MR. EYRAUD: Actual census of the patients 
involved. Okay, great. 

 MR. RIGAS: Thank you. 

 MR. EYRAUD: Yes, thank you. 

 MS. CONNERY: Thank you, Mr. Rigas. The next 
commenter is joining by phone, and her name is Rosa 
Luna, L-U-N-A. (inaudible) to take those. 

 OPERATOR: Ms. Luna? 

 MS. LUNA: Yes? 


 OPERATOR: Your line is open. You may make 
your comments. 

 MS. LUNA: Okay. Hi, my name is Rosa Luna, 
RN, and I work at Clinical Neuroscience, P.A., which 
is located in De Soto, Texas, and we service the 
Dallas/Fort Worth area. There are approximately 10 
neurologists in our group. 

 We see patients who drive in from up to two 
hours away to receive IVIG, and I do have one patient 
in particular who wanted to change location that would 
be closer to her home since she moved closer to Fort 
Worth, and she was told that the drug was not 
available in any clinic, any outpatient setting at 
all. So pretty much, she was locked into our clinic 
due to the allocation or the limit that you can 
receive. 

 Our IVIG patients we see at our clinic have 
CIDP, which is chronic inflammatory demyelinating 
polyneuropathy. We also see some Guillain-Barre 
patients, myasthenia gravis, polyneuropathy, and 


multiple sclerosis. Our clinic opened in about 2003 
and at that time, the amount of IVIG that we wanted to 
purchase was pretty much limitless and cost-effective. 

 We are currently are able to service about 
50 patients a month on a regular basis. We have been 
able to offset the cost of the administration of IVIG 
since the reimbursement changes of Medicare formed the 
reimbursement of the other insurance companies. 

 But now, this is getting much tighter in our 
clinic. Many other clinics have had to follow, and 
that is to shut down because of reimbursement. 

 I have a chart -- I dont know if yall have 
that in there, but I did e-mail a chart with the 
tolerance with the insurance companies that our clinic 
receives reimbursement from, which includes Medicare, 
which is also PacifiCare, the HMOs Medicare, Blue 
Cross and Blue Shield of Texas, of Illinois, Oklahoma, 
and Kentucky. Also, United Healthcare and Cigna and 
other insurance companies. 

 I will focus on Medicare, as I believe they 


are the driving force for all the other insurance 
companies. Many patients are diagnoses with 
(inaudible) diseases and pretty much have to go on 
Medicare after one to two years. Currently, we are 
reimbursed about $50.31 per gram from the powder IVIG, 
which is procedure coded J1566, and were reimbursed 
$64.20 per gram for the liquid IVIG, which is code 
J1567. 

 Were also reimbursed for a few other 
things. The infusion, for the first hour, we get 
$81.68, and then for each additional hour, we get 
$27.01. Thats also a code that was added -- its a G 
code -- and we get $69.00 for that. We get no 
reimbursement for any of the supplies that we use at 
our office. 

 It costs us anywhere from $60.00 to $100.00 
a day just to infuse one IVIG patient, depending on 
what kind of IV (inaudible) to use, and we have to pay 
our nurses anywhere from $25.00 to $50.00 an hour, 
and, I mean, that just doesnt -- the cost of what 


were having to (inaudible) just doesnt -- and what 
were getting reimbursed. And I feel that Medicare 
drives the market, and because of the Medicare 
reimbursement, I also believe that all the other 
insurance companies are following. 

 The reimbursement from one of the insurance 
companies is $44.34 a gram, and thats just way below 
what were having to pay for it. Like I said, pretty 
much all of the other insurance companies are 
following. 

 Our cost that were paying right now for our 
powder IVIG is $46.00 a gram, approximately, and our 
cost for the liquid is approximately $60.00 a gram, 
and all the other insurance companies follow the 
reimbursement practices of Medicare. Again, as stated 
before, our clinic will have to shut down, and we just 
cant sustain the cost of administering IVIG when the 
cost of the drug is more than the reimbursement we are 
receiving. 

 In the last quarter, if Im not mistaken, I 


believe Medicare was also reimbursing about $44.00 per 
gram. 

 MS. CONNERY: Ms. Luna, youve got about 15 
seconds. 

 MS. LUNA: And like Senator Foley said 
earlier, I do like what he said. He said we need to 
do human health and not let the insurance companies be 
the doctors for our patients. I have a couple of 
other things here. I recently had a patient with 
myasthenia gravis who had no benefits for his IVIG in 
the outpatient clinic, so he had to get his in the 
hospital. The patient was admitted -- 

 MS. CONNERY: Ms. Luna? Ms. Luna? 

 MS. LUNA: -- and he did receive IVIG at 
9:00 in the morning -- 

 MS. CONNERY: Ms. Luna? 

 MS. LUNA: -- and he had a second shift come 
in, and they gave him another dose of the IVIG, and 
that really shouldve been spread out into two days. 
Anyway, its just that the nurses there in the 


hospital have no experience with IVIG, and he did -- 

 MS. CONNERY: Ms. Luna, can you hear me? 

 MS. LUNA: -- get two days (inaudible) in 
one day. These kind of things were very common, 
because the hospital setting is just not the best 
place for IVIG. These kinds of mistakes can cause a 
patient to go into kidney failure. 

 The other issue is the allocations. Due to 
the limitation of purchasing IVIG, pretty much we 
cannot take any patients that are (phonetic) in great 
need of it. Its just not there. Also, because of 
the delay in getting the IVIG from the distributor, it 
has caused the patients to have to be cancelled -- 

 MS. CONNERY: Marcella, can you hear us? 

 MS. LUNA: -- for a couple of days, or even 
a week until we get the drug, and this can also 
compromise -- 

 MS. CONNERY: Marcella? 

 MS. LUNA: -- the disease process in the 
patient. Some patients are having to be changed to a 


different product, and this also increases the risk of 
an allergic reaction, so we try to keep the patient on 
the same product. Basically, our clinic -- 

 MS. CONNERY: Marcella, can you hear us? 

 MS. LUNA: Hello? 

 MS. CONNERY: Hi, Ms. Luna? 

 MS. LUNA: Yes? 

 MS. CONNERY: Im sorry, this is Jan Connery, 
the facilitator. We were having trouble reaching you, 
but youre well past the five minutes. Im afraid -- 
Im sorry to interrupt, but youll need to wrap it up. 

 MS. LUNA: Okay. Thats fine. Again, like I 
said, we just try to provide the best safe care for 
our clinic. And thats it. 

 MS. CONNERY: All right. 

 MS. LUNA: Thank you. 

 MS. CONNERY: Thank you so much. Thank you. 
A little technical difficulties there. Marcella? 

 OPERATOR: Yes, maam? 

 MS. CONNERY: You indicated there were some 


people queued up to comment. How many -- or 
questions. How many do you have? 

 OPERATOR: I have five. 

 MS. CONNERY: Five? Okay. I would note that 
Congressman Foley is no longer with us. That is the 
period where we were taking questions. He left the 
room several minutes ago, so -- 

 OPERATOR: All right. I understand that one 
of the questioners got disconnected after asking a 
first question and had a second question. 

 MS. CONNERY: Oh, well, yes, and 
unfortunately, I -- we had a limited time for 
questions, so I think not everyone who wanted to ask a 
question had that opportunity. We took as many as we 
could, so -- 

 OPERATOR: All right. Thank you. 

 MS. CONNERY: Okay. All right. Our next 
commenter is in the room with us, Jenny Peckenpaugh. 
Okay. We -- somebody is live right now, Marcella. 
Could you make sure everyones on mute except our room 


here? 

 OPERATOR: Yes, one moment. 

 MS. CONNERY: Thank you. 

 OPERATOR: All right, that line has been 
muted. 

 MS. CONNERY: Okay, excellent. Thank you. 
And we are going to have our next commenter, Jenny 
Peckenpaugh. 

 MS. PECKENPAUGH: As much fun as this has 
been, I should not be here today. I should be out 
living my life. But mine is a life made possible by 
replacement gamma globulin, and today, it is a life 
lived in fear. To understand that fear, you have to 
understand what I went through beginning in 1998 at 
the age of 23. 

 I was the healthy kid growing up, sick once 
per year. But that fall, I became ill with a sinus 
infection requiring multiple courses of antibiotics. 
I did not recover until January. The infections 
became more frequent, lasting for months at a time, 


and even when the doctor said they were gone, I still 
experienced terrible fatigue as if I were sick. 

 By 2002, the ENT was telling me All we can 
do is keep you comfortable. I felt something was 
terribly wrong. I had sinus infections, not cancer. 
In another year, I was diagnosed with common variable 
immune deficiency and put on IVIG. It took five and a 
half years of sickness and (inaudible) for that to 
happen. 

 The summer before I began getting sick, I 
worked 60 hours a week, seven days a week, at two 
jobs. By the time I began IVIG in February of 2004, I 
was rarely able to work my scheduled 12 hours a week. 
I could not get through the day without a nap. The 
antibiotics I was on made me so sick to my stomach. I 
could only work in the evening, after taking the 
antibiotic early in the day, allowing it the full time 
to absorb, and then, taking several Imodiums to stop 
the horrible diarrhea. 

 I did not have the energy to walk across 


campus to go to class, so I would park illegally and 
get tickets every day that I was healthy enough to 
attend. I suffered severe joint pain, like many CVID 
patients do, particularly in my right knee. I moved 
like a 70-year-old at the age of 25. My weight shot 
up. 

 Many nights, I could not sleep due to the 
pain. My life was on autopilot. I was so sick, it 
was as if I were gone. A zombie remained, trying to 
keep myself in school and marginally employed, because 
I felt that I would come back sometime and I would be 
upset if I had lost those things. 

 I registered for classes and dropped them 
when I became ill later in the semester, but I never 
knew that I was going to become ill. It was very 
unpredictable, except that it kept happening. While I 
was getting sicker, the University of Marylands 
academic policies tightened. I could no longer 
withdraw from entire semesters, so when I did become 
ill, I ended up with incompletes or poor grades. This 


has destroyed my prospects to attend law school, and I 
feel I would be a very good lawyer. 

 When I began IVIG in February of 2004, I 
thought I would be better right away, but today, I 
have not fully regained my health. Many patients have 
this experience, where it takes a year, two years, 
feeling perhaps worse than before they began IVIG, as 
their body uses the donated antibodies to fight 
infections it before ignored. 

 I know Im not going to be healthy like I 
was before CVID, but my doctor indicates that I would 
be able to work 40 hours a week and live a normal 
life, as long as I receive immunoglobulin replacement. 
But in January 2006, my pharmacist had trouble 
obtaining any Gamunex for me. I need 45 grams per 
month. 

 He could not get it from his wholesaler or 
another branch of his company. He spent hours 
phoning, eventually forced to borrow from colleagues 
in other companies. His company switched to a 


wholesaler that received a large amount of Gamunex 
sometime in February of this year. That was supposed 
to fix the problem. 

 I began to participate actively in Immune 
Deficiency Foundation forums online, discovering 
others were also having difficulty getting different 
brands of IVIG. Different states, different doctors, 
different locations of care, different brands of IVIG. 
I decided to get to the bottom of the situation. 

 My doctor told me there was a shortage and 
a priority allocation system, and hospitals were 
looking to (inaudible) doctors offices. When I 
talked to the manufacturer of the drug, the 
representative told me that was not true, but that in 
January of this year, because of increased demand for 
IVIG, they reallocated supply and cut some 
wholesalers amounts in order that everyone could get 
some. 

 Since switching wholesalers, my pharmacy 
still has had problems getting my Gamunex. This 


month, it was late. Patients are panicking. Ive 
heard rumors that people are unable to get IVIG 
because desperate people pay cash to use it for off-
label devious purposes. I dont like dealing with 
rumors. This is my life. I want facts. 

 But we dont know what percent of IVIG is 
being diverted because theres no tracking of where it 
goes by diagnosis. When I researched more, I found 
disturbing testimony about -- from the last shortage 
of IVIG. 

 Let me be clear. I believe there is a 
shortage. If I cant get my IVIG, my insurance paying 
a high price for it, and hospitals are putting 
patients on waiting lists, so every month, theyre 
unsure if theyre going to get their IVIG on time, 
logic is telling me there is some kind of shortage. 

 On August 14, 1998, Miriam ODay of IDF 
testified at a CDER stakeholders meeting. It was 
surprising to us and others the difficulty FDA had in 
determining distribution and supply in the 


marketplace. 

 In that same year, the Advisory Committee on 
Blood Safety and Availability recommended HHS explore 
methods to optimize and standardize allocation of 
available products in an equitable manner, including 
management of emergency supplies and programs that 
distribute products directly from manufacturers to 
registered consumers. I do not see that HHS has done 
that. 

 On August 23, 1999, a memo from Miriam ODay 
of IDF states: Prioritization protocols and 
distribution strategies have not been 100% 
successful. 

 MS. CONNERY: Jenny, youve got about 15 
seconds. 

 MS. PECKENPAUGH: The result for patients is 
the same as it is during a shortage, whether theres a 
shortage today or not: less dosage, switching brands, 
going too long between treatments. Patient health 
ultimately suffers. The system is broken. We cannot 


rely on manufacturers such as the manufacturer of 
(inaudible) and the manufacturer of Gamunex, to 
register patients in order that they can get it. 

 Every time Ive switched location of care or 
insurance companies, Ive had a delay and Ive become 
sick because of that. I am now afraid, even though I 
would save approximately $400.00 a month, to transfer 
insurances, because Im afraid I wont get my 
treatment. Thats a lot of money to pay just because 
we cant think of a better way to do things. 

 MS. CONNERY: Thank you very much for your 
comment, Jenny. Our next commenter is Joanne 
LaDouceur, and she is joining us by phone, and the 
spelling is L-A-D-O-U-C-E-U-R. 

 OPERATOR: Thank you. Im looking for her, 
maam. 

 MS. CONNERY: Okay. 

 OPERATOR: If Ms. LaDouceur is on line with 
another party, please press star-zero, we will open 
your line, if you are on line with another party. 


 MS. CONNERY: Im anticipating that perhaps 
she isnt on the line. Our next commenter after her 
would be Jonathan Katz, so well just wait a moment 
and see whether anyone joins on the phone. 

 OPERATOR: There is no response, maam. 

 MS. CONNERY: Okay. Very good. Well move 
on to Jonathan Katz, then, Commentor No. 30. 

 DR. KATZ: Hi. Im a physician in neurology 
from San Francisco, California. Im affiliated with 
(inaudible) Health Care Systems, where I run a large 
neuropathy clinic. I was previously an Associate 
Professor at Stanford. 

 I also am a member of the Guillain-Barre 
Foundation International, which is one of the largest 
patient support groups for individuals with immune 
responsive neuropathies. I also work with Crescent 
Healthcare. You heard Mike Rigas talk a few minutes 
ago. 

 Ive also authored the criteria for IVIG 
used in neuropathy in the State of California for 


Medicare. Im a published author on the use of IVIG 
in neuropathy in several peer review journals, and Im 
a member of the CID (phonetic) validation study group, 
which is a large group -- a group of 13 worldwide 
physicians that are trying to better understand the 
diagnosis and use of IVIG treatment in neuropathy. 

 OPERATOR: Excuse me, sir. This is the 
operator. If you could, speak up just a little bit, 
please. 

 DR. KATZ: Okay. Is that better? 

 OPERATOR: Yes, thank you. 

 DR. KATZ: Ill start off by agreeing with 
everybody here that through my experience in my 
clinic, there is a gigantic problem right now with 
access to IVIG. 

 The reasons for this have been elucidated by 
many speakers before me, including inadequate payments 
to MDs and infusion clinics, difficulty admitting 
patients to hospitals who dont find profit incentives 
and have a hard time admitting patients with chronic 


diseases, a lack of FDA approval for many of the 
treatments that we want to use neuropathy [sic] for. 
Its a good excuse to push back against therapy. 
Payment delays and payment risks. 

 Youve heard all about this as the days 
gone on. But I wanted to say that within the segment 
of our clinic, its a gigantic difficulty finding time 
for these patients, answering their phone calls, and 
explaining to them that even though they have weak 
limbs, weak arms, numbness, whatever, we cant treat 
them. Theres nothing we can do right now. And its 
a real issue. 

 I think its worth reflecting, though, for a 
second, how we got here in the first place. Weve 
heard a lot of advocacy so far today, but theres 
questions that Ive seen in my experience in the last 
four or five years of working in IVIG that need to be 
looked at carefully before a pendulum swings back in 
the other direction and we begin to ask the same 
questions all over again about the reimbursement. 


 For one, within the field of neurology and 
in the field of neuropathy, the high cost of IVIG is 
truly an issue for Medicare, and theres always going 
to be pushback. Theres reasons for it. One is weve 
seen issues regarding the fairness of physicians 
profiting from the idea of (inaudible) medicine, as 
opposed to hands-on therapies, like surgeries or 
whatnot. 

 In my experience, its hard to find support, 
even from physician groups, for this sort of treatment 
because the doctors who make money in hands-on care 
dont see it as fair for other doctors to be making 
money in infusion, and for that matter, for anybody 
else to. That needs to be considered. 

 Theres an issue of what I call diagnosis 
drift, and I think people have the tendency to 
underestimate the complexity of a diagnosis in the 
area of neuropathy. What I mean by the complexity is 
we dont really know, like you would expect with a 
case of cancer, who has peripheral neuropathy thats 


treatable. 

 Were taking a guess a lot of the time. 
Were relying on pattern recognitions. Were relying 
on people who have an extreme amount of expertise in 
this area to tell us whos going to respond to 
therapy. We also dont know things like what 
represents a therapeutic response? Is a little 
improvement in numbness a therapeutic response, or a 
slight improvement in weakness of a limb a therapeutic 
response, or do we need complete recovery? 

 What matters is a big question, and we dont 
have answers to these questions. What thatll ask 
(phonetic), to a degree, is for physicians who run 
infusion centers to create a conflict of interest 
where you can say anybodys responding to therapy and 
you could say anybody has an immune treatable 
neuropathy. When you have to infuse these patients 
once a month, its a burden to the patient, but for a 
clinic with the wrong approach, this could be seen as 
a conflict of interest. 


 Another thing thats happened thats caused 
some pushback in the recent years is growth. These 
diseases didnt really exist before 1995, I mean, 
immune treatable neuropathies, and the idea of 
treating with IVIG. 

 What happened was gradually, we became 
accustomed to patients actually responding to therapy. 
With that response to therapy, we became more and more 
interested in treating more patients, and we were more 
willing to treat patients who just might have the 
disease than just treat patients who have to have the 
disease. So with that, there was an actual tendency 
for the amount of patients who were (inaudible) to 
grow. 

 Then theres finally this issue of criteria. 
Whos going to draw up the criteria? Is it going to 
be people with an interest in these diseases, or is it 
going to be among doctors who may not have any 
interest in profiting from infusions? So who are we 
going to listen to is an important question. 


 So those are just some MD oriented issues 
that I could think of that explains to us how we got 
here in the first place that need to be dealt with as 
we go forward. Now, with that being said, I do think 
the pendulum from 1999, 2000, 2001, where there was 
big issues with the cost of these medicines, has now 
swung too far back in the other direction, and the 
reimbursement issue is enormous. 

 So a short-term approach to solving this is 
simply to fix the reimbursement issue, which will at 
least open up the door to these patients again. The 
long-term issues are very important to think about 
also, so we dont go back to square one. 

 We have to think about how payers are going 
to become involved, not just in paying for these 
treatments, but in helping physicians understand these 
disorders, getting us access to data, so over time, we 
can better understand which patients respond to 
therapy, and which of these clinical patterns are 
meaningful, and which patients should be treated. 


Thank you. 

 MS. CONNERY: Thank you very much, and if you 
did have more that you didnt get to, please let us -- 
hand that into us in writing. Just send it after the 
meeting. 

 Our next commenter is Elaine Hill, and 
Elaine is joining us by phone, I believe? 

OPERATOR: Checking. One moment. 

 MS. CONNERY: Shes Commentor No. 31. 

 OPERATOR: Elaine Hill, Ive opened your 
line. You may make your comments. 

 MS. HILL: Thank you. (inaudible) Elaine 
Hill, and Im a patient. 

 MS. CONNERY: Elaine, can you get a little 
closer to your phone, or speak just a little -- speak 
up a little bit for us? 

 MS. HILL: Well, Im trying, but ironically, 
right now, I have laryngitis from a throat infection. 

 MS. CONNERY: Oh. Okay, well, we can hear 
you. 


 MS. HILL: Im a patient diagnosed with 
common variable immune deficiency, and I wanted to 
comment, first of all, that Ms. Peckenpaughs life, 
physically (phonetic), that she indicated, sounds a 
lot like mine. I have been receiving gamma globulins 
for 10 years. My treatment has (inaudibly) surely as 
any patient sees, dialysis, (inaudible) hernia, or 
(inaudible) treatment. 

 I am a daughter, a mother, and grandmother. 
I was diagnosed when living in Miami and working as 
Assistant State Attorney; in other words, a 
prosecutor. With treatment, I was able to work as a 
prosecutor for an additional seven years. However, 
after I was diagnosed, it took four months to get 
approval through the insurance company before I could 
begin my treatment. 

 Before (inaudible) childhood, I had numerous 
upper respiratory infections, pneumonia, (inaudible), 
a tonsillectomy, two sinus surgeries, gallbladder 
surgery, diverticulitis, and finally, typhlitis, and 


that is an extremely rare bacterial infection. It was 
this rare infection that led to my diagnosis finally, 
at the age of 47. I held my job and worked through 
all of this, and I havent even mentioned the fatigue 
that goes along with the (inaudible) and the numerous 
infections. 

 Because I was sick so often, I missed a lot 
of work, and paid. The cost of the treatments and 
(inaudible). Yet I want to live. (Inaudible) to 
live. And even though I had never smoked, I had 
prominent lung disease with fibrosis, a paralyzed left 
diaphragm, a partially collapsed lung, and 
bronchiectasis. 

 I had gastrointestinal diseases, which 
include the (inaudible) diverticulitis, gastritis, and 
irritable bowel syndrome. (Inaudible) diagnosed for 
so long. Yes, I still want to live. (Inaudible) Im 
more susceptible to infection, and even with the 
treatment, I have been hospitalized with pneumonia at 
least once a year for the last five years. 


 Yet, I struggle and I want to live. Please 
keep treatment and product options available. Im now 
a diabetic also, so specific products are needed. I 
need to have that product (inaudible). I am on 
(inaudible) and Im dependent upon Medicare to help 
pay for my health care. 

 My life is literally in your hands. My 
children want their mother to live and be around, and 
my grandchildren love their grandma and they need me. 
My father loves me and he needs me. Please recognize 
that you hold all of this in your hands. I want to 
continue to live. 

 (Inaudible) If I offered you a million 
dollars to trade places with me -- give me your health 
and you take mine -- would you take that, or would it 
take $10 million or $1 billion or $10 billion? 

 And then ask yourselves, what would it take 
to give up your life entirely? These lives are worth 
it. We are productive in a large part, even when 
were disabled. We do (inaudible). My previous 


employer was there twice a month and worked as a 
prosecutor. I loved it. I loved when he worked, and 
I wish I could do it still. I cried so hard when I 
had to give that up. 

 In the mid-1990s, when I was -- or the last 
1990s, when I was just starting on IVIG, we had a 
shortage in Southern Florida at that time, and it was 
because so much was shipped out of the United States 
to (inaudible) other countries. We need to keep that 
here at home. 

 As indicated, these are American people 
giving their blood to treat Americans, and Americans 
need it. If we dont need it, fine. Lets give it to 
other people. But you have a very needy group 
(inaudible) that can stand several (inaudible) in all 
legislative areas. Please help (inaudible). 

 MS. CONNERY: Okay. Thank you very much, 
Elaine. It is just about 2:30 Eastern Time right now, 
and thats the time for a mid-afternoon break here, so 
we are going to take it. Thatll be a 15-minute 


break, so lets start up again right at 2:45. The 
next commenter that I have lined up is Patricia 
McHugh, who will be joining us by phone, so well go 
to her then. 

(Off the record at 2:24 p.m.) 

 (On the record at 2:45 p.m.) 

 MS. CONNERY: Marcella? 

 OPERATOR: Yes? 

 MS. CONNERY: The next commenter will be 
joining by phone, so you could get that line open as 
people take their seats. Its Patricia McHugh, M-C-H-
U-G-H. 

 OPERATOR: (inaudible) right now. 

 MS. CONNERY: Okay, thank you. 

 OPERATOR: Youre welcome. 

 MS. CONNERY: Well just take a moment as 
everyone is taking their seats, and our next commenter 
is ready to join us by phone. Folks who are in the 
halls, Im just going to close the doors over here. 
Im sure weve got everybodys attention now. Would 


you like to begin? 

 MS. MCHUGH: Certainly. Im Patricia 
McHugh, a Medicare patient requiring IVIG treatment 
for chronic inflammatory demyelinated polyneuropathy, 
an autoimmune disease which attacks the peripheral 
nervous system, causes numbness in the feet and legs, 
and difficulty walking, fatigue, muscle weakness, and 
balance problems. Left untreated, severe disability 
and permanent nerve damage can occur. 

 In the two-year period prior to my diagnosis 
in January 2004, I had gone from being able to lift a 
25-pound television set and carry it from one room to 
another to having difficulty lifting a jar of peanut 
butter. 

 Because of the severity of my symptoms, I 
was started on a monthly IVIG treatment within a week 
of diagnosis. These treatments were given at the 
neurologists office. A pattern emerged such that in 
January, the day of the treatment, I began to 
experience improvement in my condition. As I 


approached the next treatment, I began to feel 
worsening symptoms. 

 With each successive treatment, improvement 
was greater, the worsening less. By September 
(phonetic) 2004, after 11 treatments, while its not 
(inaudible) it was markedly improved, and while I 
couldnt lit a 25-pound TV, I could lift a bag of 
groceries. 

 Then, in January of 2005, I began to 
experience difficulty getting my treatments because of 
Medicare reimbursement issues. My January treatment 
was delayed two weeks and after my February treatment, 
my treatment was (inaudible). 

 Another provider could not locate it until 
late June, 2005. Again, my condition had worsened 
considerably. 

 (Inaudible) the local hospital, which gave 
me the IVIG as an outpatient. However, that hospital 
could not always get the IVIG, so I had to wait eight 
weeks for my next treatment and then another six weeks 


for a treatment that consisted of only half my 
required dose. My condition worsened. 

 In September 2005, (inaudible) and my 
current provider, the clinic that has just opened 20 
miles from my home, and I have been receiving my 
treatments on schedule and have made considerable 
process. 

 I cant adequately express the gratitude I 
feel that I can still receive my IVIG on a consistent 
basis, but because I am well aware that there are 
still availability and reimbursement issues, I carry a 
fear that at any moment, my current provider will 
decide they can no longer afford to treat Medicare 
patients. If they stop my treatments, there are no 
other (inaudible) available to me. 

 Ive learned that without consistent IVIG 
treatment, my future is bleak, because without 
consistent treatment, my condition (inaudible) 
treatments (inaudible), btu not stop, and I dont want 
to find out what happens if my treatments could stop 


permanently. 

 Ive also learned another emotion strikes me 
here, and thats that I find (inaudible) doesnt seem 
to care what happens to me or other IVIG patients. 
Heres one example. In the Spring of 2005, I 
repeatedly made calls to Medicares 1-800 number, 
trying to let somebody know the urgency of the 
situation. 

 Each time, the person taking my call told me 
to change my doctor or contact my Congressional 
representative. And further no, there was no person 
(inaudible) at Medicare I could speak to about the 
issue. 

 Then I read, in an article dated July 19, 
2005, that Herb Kuhn of Medicare was quoted saying 
Were not seeing prices that others have referred 
to. Imagine my frustration with the system and the 
wall that exists between it and patients (inaudible) 
and extremely vulnerable. There are certainly people 
who do care, my neurologist, my IVIG provider, and my 


Congressman (inaudible), but the system seems to be 
such that (inaudible) in a timely fashion (inaudible) 
required. 

 I realize the IVIG issues are very complex, 
and that there is no simple long-term solution, but 
for IVIG patients, the short-term solution must expand 
to allow us to receive IVIG and to receive it on the 
schedule prescribed by our physicians. This short-
term solution is needed quickly, because, as I found 
out, (inaudible) time is not time for IVIG patients 
who are not receiving their IVIG. 

 I thank you for your work and for 
(inaudible) this opportunity to say my piece. Thank 
you. 

 MS. CONNERY: Thank you very much, Patricia. 
We can hear you clearly here and we can hear how 
difficult its been for you. Thank you for sharing 
your experience with us. 

 The next commenter is also on the phone, and 
that is Steve Bailey, B-A-I-L-E-Y. 


 OPERATOR: One moment, please. Im sorry, 
Im not finding him. Let me check one more time. If 
Mr. Bailey is on line with another person, please 
press star-zero. At this time, I am not seeing his 
name. 

 MS. CONNERY: Okay. While we wait to see if 
anyone will press star-zero, the commenter who would 
be after him and may, in fact, be our next commenter, 
is in the room with us, we hope, Ann Walton. Ann is 
here, wearing a beautiful purple shirt. Okay. Well, 
were not hearing anything, Marcella, from -- 

 OPERATOR: Thats correct. 

 MS. CONNERY: Okay. Then lets move on to 
Ann, and Ann is Commenter No. 36. 

 MS. WALTON: Can you hear me? 

 MS. CONNERY: We can. Youll just need to 
stay as close as you can to the mike. 

 MS. WALTON: Okay. My name is Ann Walton, 
and I appreciate this opportunity to speak on behalf 
of the Immune Deficiency Foundation. I became 


completely disabled before my disease had been 
diagnosed, so Im eligible for Medicare benefits for 
IVIG. My treatment is covered by my husbands 
insurance at his job presently, until he retires, and 
after that, I will be at the mercy of Medicare. His 
retirement is looming. 

 I lost most of my adult life to this 
disease. Even though Ive always had health insurance 
and Ive always been under the care of a physician, I 
was bedfast and housebound for years at a time, so 
sick with infections on a daily basis that I could not 
even walk to my own mailbox. 

 IVIG treatment is so effective that in 16 
months of treatment, I am now completely recovered 
from total disability. I am now able to work a full-
time job. Until Im overtaken by old age, I will 
probably remain well, as long as my IVIG treatment is 
not interrupted or terminated. 

 Because I am able to exercise, I am now -- 
my incipient osteoporosis has reversed, and my bones 


have normal strength. I no longer suffer from angina 
from ischemic heart disease, that my cardiologist said 
had been caused by deposition of infected cells on my 
capillary walls. 

 So I am building a life for myself for the 
very first time, starting at age 59. Yet without a 
fully functional immune system of my own, I fall ill 
again with infections whenever my infusions are 
delayed, even by a few days. Without IVIG, Ill be 
back in bed. 

 I cannot support myself on part-time work at 
entry-level wages. I need to know now that IVIG will 
be available after I go on Medicare without 
interruptions for bureaucratic and administrative 
reasons. Legal protections for disabled workers will 
not apply to me until and unless I can demonstrate to 
an employer that I am able to successfully perform the 
job, including meeting attendance requirements for 
whatever probationary period my employer specifies. 

 I cannot give myself subcutaneous IG 


infusions at home because of my dosage and treatment 
intervals, so I need to receive infusions at night and 
on weekends, but I cant get them on Medicare. No 
IVIG infusion service providers in my area work on 
nights and weekends, except for the home infusion 
services, and they dont take Medicare patients. 

 So unless something happens to solve the 
access problems for IVIG on Medicare, my last chance 
to earn my own living will come to an abrupt halt as 
soon as Medicare rules my treatment. 

 As you have heard, Medicare doesnt pay for 
the nursing services necessary to make home infusions 
a reality for Medicare patients unless they are 
homebound by Medicares definition, even though this 
is the least costly type of IV infusion to receive, 
and the safest in terms of exposure to infection. 

 Since Im now able to work full-time, Im 
not homebound by any definition, but I will be when I 
cant get treatment as a Medicare beneficiary and 
then, I will be homebound, and then Ill be eligible 


for Medicare home health nursing. And then, I would 
recover again, as soon as I get back on IVIG 
treatment, but at that time, the untreated disease and 
consequent illness will have destroyed my 
employability again, and it will be too late for me to 
start over with a new career. 

 Having been sidelined my entire life from 
the working world, I am heartbroken that I am finally 
well, but I am still unable to count on living a full 
and complete life because of contradictions in 
government policies and rules. Medicare agrees IVIG 
is a covered service and medically necessary. 

 When taxpayers provide a treatment that 
restores disabled patients enough to work, Medicare 
should create conditions for the formerly disabled to 
return to employment and contribute to the cost of 
their care. Thank you for listening to my story. 

 MS. CONNERY: Thank you very much, Ann, for 
telling us your story. Our next commenter is Imogene 
Moore, and she, we hope, is on the phone, and thats 


spelled M-O-O-R-E. 

 OPERATOR: Thank you. Ms. Moore, your line 
is open. You may make your comment. 

 MS. MOORE: Thank you. My name is Imogene 
Moore. I live in Gibsonia, Pennsylvania. I am an 84-
year-old female and I have chronic inflammatory 
demyelinated polyperipheralneuropathy. It has slowly 
progressed above the knees. I need to use a walker or 
a cane when outside of our home. 

 The first diagnosis by Dr. Steven Semanski 
(phonetic) and Mayo Brothers (phonetic) was in 2001. 
I was fortunate to be in an area where my doctors made 
a quick diagnosis. My first infusion was done with 
one of the cheaper gamma globulins. The first day, it 
resulted in hives. Dr. Semanski (phonetic) switched 
to Gamunex, and these infusions have caused no 
problems physically. 

 There was such a dramatic change in my 
strength and overall improvement that I felt that the 
doctor had found the right answer. Gamunex put the 


(inaudible) on hold for three weeks and three days, 
and severe pain occurs less often. 

 Then, a human element entered the picture. 
Medicare informed me that they would not reimburse for 
the treatment, using the reason that my disease 
(phonetic) did not cure. That meant that my secondary 
insurance was not put in, either. My response to them 
was Medicare pays for diabetes, AIDS, and cancer, none 
of which have a cure, and (inaudible) numbers, we hurt 
also. 

 With a cost of over $1,500.00 every three to 
four weeks, I resigned myself to whatever nature 
handed out, because with an upper middle class 
retirement income and a declining stock market, I 
couldnt leave my husband with the eventual outcome. 
Medicare slowly relented, but during that time, the 
CIDP moved up from the ankles to the knees. 

 There are constant billing problems. 
Reimbursement is so low and the price so high, my 
doctor could no longer afford to have it done in his 


office. I was passed to a hospital medical unit as an 
inpatient. There have been three occasions when the 
pharmacy there had tried to switch to a cheaper form, 
to which I had allergic reactions. Fortunately, 
either the nurse or I have caught it. I do have a 
fear that it will be mislabeled at some time. 

 Once, I had to sit in the medical unit 
several hours while a messenger service brought the 
syrup (phonetic) from a warehouse elsewhere in 
Pittsburgh, and I had given her (inaudible) it would 
be needed. 

 There have been times when the product is 
not available in Pittsburgh at all, and the delays 
have been as long as two weeks. During those times, 
the CIDP has progressed farther up the legs, and I 
have less strength and I tend to (inaudible) from one 
side to the other when I walk. 

 Constant pain uses a lot of strength. To 
me, and to those around me, it seems unfair that I 
should have to live with the idea that perhaps the 


IVIG will not be available the next time. For me, as 
a patient, I feel that my doctors office had put 
together a great team for scheduling, financing, and 
administering these drugs, and that seems to be a 
better way to go. 

 Since the use of IVIG, I am much stronger 
and my husband and I are able to live independently. 
We prepare our food, do our laundry, and drive 
ourselves for errands, and enjoy our family. This is a 
big savings for United States citizens. 

 Thank you for listening. 

 MS. CONNERY: Thank you very much, Imogene. 
Our next commenter is also joining by phone. Her name 
is Adele Kirkpatrick, K-I-R-K-P-A-T-R-I-C-K, and she 
is Commenter No. 38. 

 OPERATOR: One moment. 

 MS. KIRKPATRICK: Hello? 

 OPERATOR: Ms. Kirkpatrick, your line is 
open. 

 MS. KIRKPATRICK: Thank you. Im speaking 


today on behalf of the primary immune deficiency 
community and at the invitation of IDF. I have common 
variable hypergammaglobulin anemia, which was 
diagnosed late in 1990, after having been ill for well 
over a year from infections that triggered severe 
asthma. 

 I was barely functional. Today, I lead a 
functional life only with IVs. IVs were started in 
March 1991, 15 years ago. I had IVs in Dr. 
(Inaudible) office or at home until January 31, 1999, 
when I turned 65. We generally used Gammagard SD, 40 
grams, five grams an hour for eight hours. Shorter 
time (inaudible) headaches for 24 hours, and other 
brands caused bad side effects and allergies. IVs are 
preceded with premeds of Tylenol, Benadryl, fenaden 
(phonetic), and solucortez (phonetic) to curb side 
effects. 

 My husbands blind, so I have to drive 
myself down to the location, then take premeds, whcih 
preclude driving until theyve worn off. In 97, I 


tried to get off of the IVs and skipped three IVs and 
caught an infection that -- complicated by asthma and 
lasted four months. 

 Under Medicare, since August 1999 through 
March 2005, I had IVs at my doctors office 
(inaudible) if something was available. I always had 
bad side effects with everything except Gammagard. 
IVs for Medicare patients in doctors offices stopped 
March the 31st. April 2005, local hospitals didnt 
use Gammagard, so I (inaudible) in Medical Center, 25 
miles from home via I-95 under construction. 

 The centers protocol was to infuse at 10 
grams an hour for four hours, no exceptions. The 
first IV was on April 27th. The nurse treated me very 
badly. Ill skip most of the details, though so she 
did tell me to put (inaudible) on my left arm myself 
and (inaudible) after blood was drawn, because I cant 
use adhesive tape or paper tape, and she placed a 
person with staph within three feet of my chair. 

 Premeds made it difficult to focus my eyes 


when en route home, so I had many near accidents. I 
returned two more times, but stopped due to the close 
accidents. 

 July and August 2005, I had no access to 
Gammagard. September 2005 through January 2006, I had 
it at Palm Beach Gardens Medical Center, 11 miles from 
home, when they used Gammagard SD as a backup. 

 After January the 31st, they only ordered 
(inaudible), to which Ive had severe reactions of 
confusion and headaches for three days. February and 
March 2006, no source for Gammagard. April 2006, 
Walgreens Home Care say they could provide it at home. 
April through July, home care with Gammagard liquid, 
and it was possible on the liquid to stop premeds, 
except for solucortez (phonetic). Infusion time was 
reduced to six hours, and no side effects at all. 

 August of 2006, Walgreens was told that I 
did not qualify for home care, as I was ambulatory. 
They provided interim home care in August. September, 
Walgreens provided Gammagard liquid to the doctors 


office where I received an IV. Walgreens submitted a 
bill for Gammagard to Medicare Part B and this was 
rejected. They were going to submit it to my Part D 
provider, Signature RX, which has Gammagard on its 
formulary. If this didnt work, I was to pay for the 
Gammagard myself. On October the 3rd, next week, I 
will receive another Gammagard IV in the doctors 
office, but it will be the SD, so I have to take 
premeds. Medicare hasnt paid for my 
Gammagard since April the 27th. Thus, after October 
the 3rd, Ill be personally liable for $24,000.00, 
assuming it costs $75.00 a gram, and I really cant 
afford it. 

 The consequences of missing the IVs or 
irregular -- when theyre irregular or missed 
(inaudible) three months, I catch infections going 
around, have difficulty getting well without strong 
antibiotics that dont contain penicillin. These 
illnesses last one to four months, depending upon the 
numbers of IVs missed. 


 I thank you for the opportunity to relate 
the problems Ive encountered in recent years, and I 
do think its a crime that Medicare pays an average of 
two and a half million dollars for terminally ill 
patients to spend their last two weeks of life in a 
hospital ICU, but cant pay for treatment that enables 
people to lead functional lives. And that two and a 
half million dollar quote is from the newspaper. 
Thank you very much. 

 MS. CONNERY: Thank you. Thank you, Ms. 
Kirkpatrick. Our next commenter is in the room with 
us. Its Natasha Pires. 

 MS. PIRES: Good afternoon. My name is 
Natasha Pires and I am here today to represent and 
speak on behalf of the Neuropathy Association. The 
Neuropathy Association is a public, charitable, 
nonprofit organization that was established in 1995 by 
people with neuropathy and their families and friends 
to help those who suffer from disorders that affect 
the peripheral nerves. 


 It is estimated that in the United States 
alone, neuropathy sufferers number upwards of 20 
million. Neuropathy challenges patients, not only 
with the pain they experience, but also, with the lack 
of appropriate treatments for its different 
variations. 

 However, except for one specific class of 
neuropathies, autoimmune neuropathy. IVIG products 
have made a significant difference. Controlled 
clinical trials have demonstrated that IVIG is an 
effective treatment for autoimmune neuropathy which, 
as a class, includes chronic inflammatory 
demyleinating polyneuropathy and Guillain-Barre 
Syndrome. 

 Autoimmune neuropathy is a debilitating 
condition that can leave people unable to work or care 
for themselves. To some patients, IVIG is the only 
effective treatment. Without it, the neuropathy 
progresses, leaving patients unable to walk, unable to 
function, and often paralyzed. 


 Alternative therapies like steroids and 
chemotherapeutics work for some patients, but not 
without severe side effects, side effects like 
diabetes, hypertension, osteoporosis, bone fractures, 
or life-threatening infections, to name a few. 

 The inadequacy of the current Medicare 
reimbursement rates have made it impossible for 
patients to obtain IVIG treatment outside of 
hospitals, which are not always able to provide 
treatments. This has resulted in our members 
suffering adverse health effects because of increased 
time intervals between infusions, switched brands of 
IVIG, and/or decreased dosage per infusion. 

 If access inadequacies continue, some of our 
patients may be confronted with returning to the 
alternative therapies at greater cost to their health 
and ultimately, to the health care system. 

 The reimbursements provided to health care 
providers of IVIG often do not cover the cost of 
acquiring this critical medication. In addition, when 


addressing the costs involved, one must also consider 
the hidden and unaccounted for costs. They include 
the administration, maintenance, and inventory and 
billing, to name a few. 

 Switching to a hospital setting for 
treatment has also been a (inaudible) Medicare. 
Hospital outpatient clinics add a substantial facility 
charge that is not added in the office setting, and 
sometimes, patients have to be admitted for treatment. 
This greatly increases the overall fee. One of our 
members recently brought in a hospital bill for 
$17,000.00 for treatment that would have cost no more 
than $4,000.00 in the office setting. 

 IVIG is a life-saving therapy with no better 
substitute. Patients who rely on IVIG need to have 
access to all types of IVIG and all care sites 
restored. This will reduce the burden in the 
hospitals, improve the quality of care systemwide, and 
decrease the potential for morbidity and mortality 
associated with delays in treatment with IVIG, or the 


lack of treatment altogether. 

 Inadequate reimbursements have resulted in 
shifting costs to hospitals and consequently, to the 
patients and taxpayers. 

 Thank you for allowing me to speak on behalf 
of the patients we represent, and to voice the 
Neuropathy Associations concerns about what we see as 
a looming crisis. 

 MS. CONNERY: Thank you, Natasha. Our next 
commenter is on the phone, and that is Iman Tanzey, T-
A-N-Z-E-Y. 

 OPERATOR: Maam, is the first letter T as in 
Thomas? 

 MS. CONNERY: T as in Thomas, yes. 

 OPERATOR: Thank you. 

 MS. CONNERY: He is Commenter No. 41. 

 OPERATOR: I do not believe he has joined. 

 MS. CONNERY: Okay. Do you want to ask if 
hes joined with another party? 

 OPERATOR: Certainly. Again, if Mr. Tanzey 


is on line with another participant, you can press 
star-zero and indicate what line youre on. We will 
be able to open the line for you. 

 MS. CONNERY: While were seeing if anything 
comes through that way, lets -- the next commenter 
after that, were going to skip over Commenter 42 
because he let us know that he wouldnt be commenting, 
and go to 43, which -- who also, we hope is on line, 
and her name is Susan Pentlin, P-E-N-T-L-I-N. 

 OPERATOR: Theres no response from Mr. 
Tanzey, but we do have Susan Pentlin on line. 

 MS. CONNERY: Okay. Lets go ahead, then. 

 OPERATOR: Ms. Pentlin, you may make your 
comments. 

 MS. PENTLIN: Thank you. Im registered with 
the Immune Deficiency Foundation as a patient with 
common variable immunodeficiency. Im an ameritus 
professor in Warrensburg, Missouri. I have my PhD 
from the University of Kansas and Im a patient in 
the University of Kansas Medical Center in Kansas 


City, Kansas. 

 As a child, I had unusual skin infections 
and in college, I began to have frequent sinus 
(phonetic) infections and bronchitis, which hung on 
for months. In 1976, my health worsened after I had a 
reaction to a wasp sting. In 1978, I found Dr. Daniel 
(inaudible), Director of Neurology, Arthritis, and 
Immunology at the Med Center (inaudible). He 
understood that I had primary immune deficiency, and 
in 1986, I began gamma globulin treatment. 

 Dr. (Inaudible) caring and (inaudible). He 
has given me excellent care for 28 years, and the 
nursing staff indicated that they were (inaudible) and 
have provided high-quality care. 

 IVIG has made a tremendous impact on my 
health. For the past 20 years, Ive gone to the Med 
Center every two or three weeks to get an infusion. 
It has been a lifesaver to me several times, once when 
I had a ruptured tubal ovarian abscess, another time, 
pneumonia, and another, osteomyelitis. Whatever 


infections I had began to improve almost immediately 
after an infusion. 

 Everything began to change in January 2006. 
Medicare patients getting IVIG were required to be 
admitted to the hospital. The brands they got there 
were different and several had reactions. It 
sometimes took up to nine hours instead of three to 
get treatment. I am not on Medicare and my private 
insurance policy approved my IVIG for 2006, so I 
thought I was okay. 

 I had always believed that at the medical 
center, my health was their concern, that they would 
care for me when I needed help. At the end of April, 
I learned that those assumptions were not wise ones. 
The internal medicine clinic cancelled my next 
infusion with no forewarning, and the individual 
patients received unsigned letters saying they would 
no longer provide IVIG therapy after May 1. You could 
make appointments at the cancer center or the 
hospital, where they are still scheduled (inaudible). 


 Dr. (Inaudible) did not know about the 
changes any sooner than I did. When patients called 
the cancer (inaudible). In fact, the center did not 
begin to process any necessary papers for my insurance 
until the day I was originally scheduled for my next 
treatment. I asked if I could get IVIG in the 
hospital, but that was no longer possible. 

 This was the first time in 20 years I had 
gone over one or two days late to get my infusion, 
except once, when there was a shortage in products a 
few years ago. That time, my infusion was delayed a 
week, and I ended up hospitalized with pneumonia. 

 I did not get an appointment in the cancer 
center for 10 days past the due date for my infusion. 
Im still trying to recover from colitis, skin 
infection, (inaudible) joint inflamation, which flared 
(inaudible), and only now, after four months, am I 
able -- am I almost back to where I was (inaudible). 

 When I contracted administrators at K.U. Med 
Center about the transfer to the cancer, they told me 


this was necessary because of Medicare reimbursements. 
They considered stopping treatments altogether, so I 
should be happy about being transferred to the cancer 
center. 

 Insurance companies that follow Medicare 
(inaudible) were not paying even the actual cost of 
gamma globulin, and my insurance company was no longer 
paying what they had to pay. A year ago, I 
(inaudible) they no longer give it, because of 
Medicare changes. I know the immune deficient 
patients in Kansas City (inaudible) diagnosed cannot 
find any (inaudible) gamma globulin. 

 Recently, this cancer center stopped giving 
gamma globulin to immune patients whose insurance 
requires them to purchase (inaudible) the hospital. 
The cancer center is not a good place for immune 
patients to be. 

 We are exposed to seriously ill patients. 
The nurses are not accustomed to the protocols from 
(inaudible) or we can make appointments (inaudible) 


physical. This is really hard for me in a cancer 
setting, because my sister died at age 38 from cancer. 

 Now, (inaudible) my cancer. When I go for 
treatment, everyone assumes I have cancer. Im 
concerned that theres a lack of quality control and 
consistency of care which affects most primary immune 
deficient patients at (inaudible). Dr. (Inaudible) 
comes to see me at the cancer center, but my charts 
are not usually available. Home health is an option, 
but I fear I would not be permitted to return to the 
medical care center for treatment should the 
reimbursement issue resolve or the home health care 
companies stop giving IVIG. 

 Im aware of the (inaudible), but I have a 
history of skin reactions and infections, and the rate 
of skin infections is over 30%. 

 MS. CONNERY: Ms. Pentlin, you have about 15 
seconds. 

 MS. PENTLIN: Okay. I was at the medical 
center yesterday. When I arrived, the cancer center 


told me theres a shortage of gamma globulin, and I 
could only get half my dose. The primary immune 
deficient population in the United States is estimated 
at about 50,000 people. 

 We are so (inaudible) number (inaudible) by 
their government for a situation. A democracys only 
as strong, because it takes time and resources, until 
we have those (inaudible). I believe that 
(inaudible). 

 MS. CONNERY: Thank you very much for your 
comment. Ill just note that we heard Commenter No. 
45 wont be joining us, and also, that we actually 
have an additional four people on the list. They were 
signed up after we went to press with the list, so 
there are actually 60 people here on my list, four 
more than you probably have on yours, and we will be 
getting to them today, as well. 

 Well move on to our next commenter, and she 
should be in the room with us. Melinda Haffron? 

 MS. HAFFRON: I want to thank all of you for 


the opportunity to come and talk with you now. I want 
to just point out that patients diagnosed with 
immunodeficiency diseases require the regular 
infusions. Its not a treatment thats supplemental 
or extra. It is required and it is for life. For 
life, both for long-term and for daily living. 

 I want to tell you that Ive been on both 
sides of this issue. Im the parent of a patient with 
immunodeficiency disease. Shes got chronic variable 
immunodeficiency. And I work for an immunologist who 
treats primary immunodeficiency and secondary 
immunodeficiency. 

 I want to talk about both sides, since Ive 
been on that aspect. As a patient, when you find -- 
well, as you see your child sicker and sicker and 
sicker and you go from specialist to specialist to 
specialist with no answer, and you just see them 
declining, we need to finally find that physician who 
goes, Have you been tested for immunodeficiency? 

 That had never come up before. Immediately, 


it was very obvious what it was. Began to receive 
treatment. It took -- in his practice, we are able to 
use all the different products. It took trial and 
error of about five different products before we found 
the one that worked for her, but the results were 
amazing. 

 She went from missing 40 days of school a 
year to being a normal child on the playground. Her 
life changed. But that, in itself, was not the 
biggest battle. The biggest battle that I want to 
talk about, for both myself and the physician I work 
for, is the reimbursement and the managed care. I 
work for a physician in Denver, Dr. Isaac Melmed 
(phonetic), and his primary focus is immunodeficiency, 
primary and secondary. I have seen the battles on his 
part and our part before managed care. 

 When you first get the diagnosis of needing 
IVIG because you have primary immunodeficiency, it 
takes months to go through the process. 

 When you finally are approved, you get the 


pre-auth, and then get the treatment, and then the 
doctors have to submit efficacy paperwork -- Oh, they 
lost this, they lost that, and then you realize that 
its taken the insurance company up to six months to 
cover one treatment when sometimes, patients that we 
work with can require bi-weekly, three-weekly -- or 
every three weeks, every month, and you have -- that 
physician has to cover and carry that cost while 
youre waiting for reimbursement. 

 With the Medicaid changes, the reduction in 
reimbursement level, were barely breaking even, and 
then these patients are not able to get the product 
that they need. 

 The other issue we have is sometimes like 
for my daughter during the beginning of the school 
year in the fall, she gets sick more often, she needs 
increased dosage. You increase the dosage, she 
carries through, we dont need hospitalization, we 
dont need IV antibiotics. But to get that covered, 
they -- I think its almost easier to go to a hospital 


to get that IV treatment because you then could get 
your IVIG. 

 One time, the switch between -- weve always 
had private insurance. We had to switch because of my 
husbands employment change. He had a new policy. We 
had to wait three months because of a preexisting 
condition. She missed four treatments before we could 
actually get her covered, which she ended up in the 
hospital for. 

 There needs to be some way to get these 
patients with these preexisting conditions that are 
life-threatening, even though when you see her, you 
would not recognize that she has anything wrong. But 
without these treatments, her life is at risk. 

 Then from the clinic perspective, Id like 
to talk briefly on that. Managed cares lack of 
knowledge on treating primary immunodeficiency is 
tremendous. They dont understand the replacement, 
the need, you need to change doses, the cost 
reimbursement, all of that. Product differences. 


Luckily, weve been able to keep that change and keep 
up with it a little bit, but our reimbursement levels 
were really, really struggling at this point. 

 The other thing is the extensive paperwork 
for every infusion that we have to do. We have to 
employ two people to deal with the paperwork, to get 
the coverage, and to make sure that we have the number 
of patients and the product that we need per month. 
And then when we have new patients, to get your 
allocation to start covering those is nearly 
impossible. Somebody -- its give and take all of the 
time. 

 And then the being compared as a physician, 
real quick, an immunologist who was trained in allergy 
versus immunodeficiency, I dont think they make that 
designation. These physicians are constantly being 
hassled and harassed about Youre high cost. They 
were told to lower IVIG usage. How can we do that? 
Thats the only way to treat these patients. 

 So I guess I want to thank you for being 


able to express the issues, the reimbursement issues, 
Medicaid, all of that. (Inaudible) Thank you. 

 MS. CONNERY: Thank you for those 
perspectives. Our next commenter is Robert Sugerman, 
S-U-G-E-R-M-A-N, and we hope hes on the phone. 

 OPERATOR: Maam, we have just heard from 
him, while the previous commenter was speaking, that 
he is unavailable to comment today. 

 MS. CONNERY: Okay, okay. Thank you. Then 
well move on to Commenter No. 47, and that is 
Jennifer Reed-Hack. According to my notes, you should 
be in the room with us? Could -- I dont see her in 
the rom, so would you mind checking on the phone and 
seeing if she may have phoned in? Its R-E-E-D, 
hyphen, H-A-C-K. 

 OPERATOR: Thank you, one moment. No, Im 
not seeing her. If -- 

 MS. CONNERY: Okay. 

 OPERATOR: If she is sitting with someone, 
she can press star-zero. 


 MS. CONNERY: All right. Then lets move on 
and see if the next commenter is on the phone. That 
is Sarah Lazarus, L-A-Z-A-R-U-S. 

 OPERATOR: Yes, we do have Ms. Lazarus. 

 MS. CONNERY: Okay. 

 OPERATOR: Ms. Lazarus, your line is open. 
You may make your comment. 

 MS. LAZARUS: Thank you. My name is Sarah 
Beth Lazarus. I am a patient. Im 63 years old. Im 
disabled (inaudible). I have not taken gamma globulin 
since January 2005 because of Medicare not paying the 
doctor the right amount. I mean, Dr. Sugerman that 
wasnt on the line a minute ago, he is one of the 
doctors where I go for my IV gamma. 

 My (inaudible) level has gotten a lot lower 
since I had to take it. I am an asthmatic and I have 
severe arthritis. The arthritis I have is 
inflammation of (inaudible) standards of living. 
Also, it deteriorated both of my knees, and they told 
me I need knee replacement, but because Im not taking 


gamma globulin, Im very scared of getting a major 
infection (inaudible). 

 In the early 80s, I started getting sinus 
infections, bronchitis, pneumonia, constantly. 
Towards the latter part of the 80s and the early 
90s, I had seven different sinus surgeries for 
infected sinuses (phonetic). In 92, I had my frontal 
sinuses removed. In fact, (inaudible). This was a 
very major surgery, but they told me it would be the 
answer to all my problems. 

 If I didnt have the frontal, the rest of my 
sinuses couldnt get infected and therefore, I 
wouldnt get sick (phonetic). Well, that was a good 
theory, but it didnt help me. Less than a month 
after surgery, two weeks without antibiotics, I had a 
sinus infection again. Within a few months of 
surgery, I was back on the IV antibiotics for two 
months at a time. 

 After this surgery, I spent the next two 
years at my ear, nose, and throat doctors office at 


least two to three times a day -- I mean, two to three 
times a week, having my sinuses cleaned out, and just 
(inaudible). 

 He was trying to convince me that these 
infections would get into my brain and kill me, so he 
decided to find a reason for my sickness. He sent me 
to other ear, nose, and throat doctors, and between 
all of them, they found out I was immune deficient. 
So then, I went to an immunologist in 94 and started 
taking gamma globulin (inaudible) every four weeks. 

 (Inaudible) immune deficient, I had so many 
sinus infections, it seemed like one long infection, 
never ending. I was on oral antibiotics 14 days -- 
Id be on oral antibiotics for 14 days, and then Id 
be off maybe seven or 10 days, and the infections 
would come back. Back on the oral antibiotics Id go. 

 Sometimes oral antibiotics would not work, 
and Id have to go to my doctors office for shots of 
antibiotics. Sometimes that wouldnt work, so Id go 
back on the IV antibiotics at home for up to three 


months at a time. I took (inaudible) for about six 
months before I could see a real improvement. I -- 
well, just gradually, I got better and better through 
the years. 

 I still got infections, but (inaudible) oral 
antibiotics for six weeks before I get an infection. 
(Inaudible). I know that doesnt sound like a long 
time, but compared to seven to 14 days and back on the 
oral antibiotics, that was (inaudible). My quality of 
life was better. 

 Another (inaudible) with gamma globulin, I 
have not had to take IV antibiotics at home since Ive 
been taking gamma globulin. When I was first 
diagnosed as immune deficient, I thought my life was 
pretty well over. And as sick as I had been, I really 
didnt want to live with no quality of life. But with 
gamma globulin treatment, my quality of life changed, 
and I thought I could manage my life with its help. 

 Since February, I think February was the 
first month in 2005 that I was not allowed to take 


gamma because of Medicares price reduction. 
(Inaudible) because I had my hope of getting better, 
and once I (inaudible), and getting better was really 
important. 

 Last years reduction in price per gram did 
not even cover the cost my doctor was paying for it, 
so therefore, he couldnt continue to give it to the 
Medicare patients. So in February of 2005, my quality 
of life was (inaudible) on a downward slope. Every 
day, week, month, Id get a little sicker. 
(Inaudible) taking gamma, gamma helps inflammation of 
the body. I didnt know (inaudible) 

 MS. CONNERY: Ms. Lazarus? 

 MS. LAZARUS: So that most of the time -- Im 
only 63 years old, but when I get up from a sitting or 
laying position, I walk like Im about 90, from the 
pain. I now take oral antibiotics every day and 
still get infections, and then I have to switch to a 
more powerful antibiotic for 21 days, and then I go 
back on my (inaudible) antibiotics. 


 MS. CONNERY: Ms. Lazarus, youve got about 
15 seconds. 

 MS. LAZARUS: All right. Since stopping 
gamma, I have increased my prednisone from five 
milligrams to 20 milligrams. My bones (inaudible) in 
the last couple of years. I need (inaudible) 
prednisone level back then, and without gamma, Im 
never going to get there. 

 I just want everybody to know that they 
include cancer, diabetes, other things that are not 
curable (inaudible). Thank you very much. 

 MS. CONNERY: Thank you for your comment. 
Our next commenter is Commenter No. 49, and thats 
Bruce Bunyan, and we -- yes, hes with us here in the 
room. 

 MR. BUNYAN: Thank you, Jan. Good afternoon, 
everyone. My names Bruce Bunyan. Im the Vice 
President of Corporate Communications and Public 
Policy for Talecris Biotherapeutics. We manufacture 
Gamunex, a product, as you have heard today, is 


critically important for many patients. 

 Talecris looks forward to being part of the 
review of this IVIG access process in more political 
outlets. Our approach to patient care is simple. We 
support giving each patient and his or her physician 
access to the IVIG brand thats effective for them in 
the setting best suited for his or her individual 
needs. 

 Were committed to working openly with ASPI, 
because your work will have such an important effect 
on access to IVIG therapies for thousands of Medicare 
beneficiaries, just like those that weve heard from 
here today. We are dedicated to ensuring access to 
this life-saving therapy. We continue to take reports 
of IG access issues very seriously. 

 Although some appear to be inclined to see 
the access issues as supply-driven and not 
reimbursement related, we do not believe that this is 
correct, particularly when we exam the evidence 
related to our product. Specifically, over the last 


five years, we have increased the amount of IVIG that 
we make available in the United States by over 75%. 

 Talecris has dedicated significant resources 
to meet the needs of the IVIG community. Finally, we 
have invested more than $250 million to build a highly 
efficient, state-of-the-art manufacturing facility in 
Clayton, North Carolina, the only facility of its size 
dedicated to IGIV production. 

 In addition to our dramatic efforts to 
increase production, we have established the Gamunex 
Emergency Supply Program for patients who might be 
facing a critical or urgent situation related to their 
IGIV therapy. This program provides Gamunex on a 
first-come, first-served basis to patients in 
emergency situations, and we have never come close to 
exhausting our emergency supply. 

 We have heard from a few patients today who 
have experienced access issues with our product. We 
encourage them to utilize this program or through 
their physician. 


 Further, our price increases have been quite 
limited, despite the increased production costs, 
significant investments in additional manufacturing 
capacity, and large investments in producing a new 
IGIV product. Since 2000, Talecris has not increased 
prices at a rate that keeps place with the rate of 
inflation. 

 Finally, we have sold Gamunex to both the VA 
and 340(b) programs at the required prices since 
inception of both of these programs without 
interruption. 

 The chronology of the IGIV access issue 
clearly shows our opinion, its fundamental (inaudible) 
to changes in Medicare reimbursement policy. Access 
issues were largely localized initially in physicians 
office settings, when those providers migrated to the 
ASP methodology in 2005 without separate J codes, and 
only spreading to the hospital outpatient setting in 
2006, when that setting switched to the ASP 
methodology. 


 We are also committed to preventing gray 
market activity from becoming a significant issue with 
respect to our product. Our reduction in the number 
of distributors and wholesalers, our work to increase 
substantially the proportion of encumbered product 
sales, and our audits of distributors and their sales, 
are ways of restricting our product being moved to 
this gray market. 

 We think CMS can meaningfully address the 
IGIV access issue in a manner that is entirely 
consistent with the average sales price methodology by 
(1) providing separate J codes to the quite distinct 
IGIV products used by Medicare patients and (2) 
providing more accurate administrative service fee 
reimbursements to providers. 

 IVIG products are treated differently than 
most drugs under the ASP methodology, although 
different IGIV products have different characteristics 
and according to the FDA, are not bioequivalent, they 
are lumped together under a single ASP. This should 


not be the case. IGIV products should have a separate 
J code like other single source products. 

 Attempts to improve the IGIV access problem 
that are temporary or that fail to address need for 
separate J codes and more accurate administration 
service fees, will actually create additional problems 
by discouraging the significant investigation 
necessary to maintain adequate supply of this life-
saving therapy. 

 To the extent that CMS wishes to explore 
certain coverage issues for particular indications, it 
should do so, as in the past, through its contractors 
and local coverage determinations. 

 Talecris thanks you again for this 
opportunity to provide input to a review of this 
patient and physician -- both patient and physician 
concerns and access to this therapy, and more 
importantly, look forward to working with you 
continually as we try to solve this access problem for 
patients. Thank you. 


 MS. CONNERY: Our next commenter, we hope 
will be with us by phone, and she is, and that is 
Martha [sic] Bond, B-O-N-D. She is Commenter No. 50. 
Marcella, do you have Marsha Bond -- 

 OPERATOR: Marsha, your line is open. Thank 
you. 

 MS. BOND: Hi, this is, its actually Marsha 
Bond. 

 MS. CONNERY: Okay. 

 MS. BOND: Im 39 years old and I have common 
variable immunodeficiency disease. Before I was 
diagnosed, I was medically disabled for about three 
years and bedridden for two years of that, and then 
they finally figured out what was going on. 

 Its taken me two years on IVIG therapy to 
get to this point to where Im very hopeful that Ill 
get to return to work in the spring, and thats all 
based on how I do this fall, as far as catching 
viruses and (inaudible) and how bad they are, but Im 
very hopeful that that will happen. 


 What Im talking about are various things. 
Basically, Im going to attest to all of the things 
that youve asked about, which is we no longer are 
able -- I havent been able to go to my doctors 
office -- its been -- February of 2005. We were 
received by every (inaudible) or hospital in Texas to 
even consider treatment, so for five months, we didnt 
get any treatment at all because we couldnt find 
someplace to have it done. 

 Then they were finally able to get an 
infusion clinic that was not a private hospital 
(inaudible) take it on, but every month, we have 
delays. We oftentimes have no idea what product were 
getting. Our delays can be anywhere from two weeks to 
two months, and like I said, every month, we get a 
different product. We can never get the same product 
hardly two times in a row. 

 I know what the -- I talked to the director 
of the infusion clinic, and she said basically its an 
allocation issue. They cannot get an allocation from 


the distributor or the manufacturer, because they 
dont have enough patients, and theyve been trying 
since 2005 to get an allocation, or if they get 
allocation, its not to cover enough of us. 

 So then its like, okay, what do you do? Do 
you get an allocation for two people and let 10 people 
go? I mean, its a real -- Im sure (inaudible) 
answer. Also, I know there are 15 patients out of the 
doctors office that I come from that are all on 
Medicare, and I have not noticed -- I have not 
experienced a (inaudible) reaction to the changing of 
the product, other than minor migraines and stuff like 
that, things that (inaudible). 

 But I do know that there were others who had 
severe reactions, so they had to actually stop their 
treatment because they had such severe reactions that 
it was just worse off. 

 I also know that the reimbursement problem 
is 99% of the problem. When I talked to the 
distributor -- the district -- excuse me, I cannot 


talk. When I talked to the manager of the infusion 
clinic, I asked her, Is it because you cant find my 
product, or you cant find product at our price? She 
always tells me she cannot find product at the price. 
You can buy lots of product, but its all way above 
the reimbursement level. 

 I do know that there are cases in our group, 
as well, that are receiving (inaudible) treatment -- 
about half of our patients, if they get treatment, 
(inaudible) two to three weeks (inaudible) every 
month, and I know that they are no longer getting that 
(inaudible) once a month or not at all. 

 I believe as far as my health consequences, 
and Ive already gone into that, I do know that there 
have been other people that have (inaudible) had not 
heard of any deaths at this point, but I do know that, 
like I said, we suffer every day. 

 And then when were a day late on getting 
this product, I feel it. I mean, everybody feels it. 
It -- I mean, and Im scared to death. I dont want 


to go back to being bedridden. And right now, with 
the way the situation is, I (inaudible) playing 
Russian roulette with my life (inaudible) because I 
dont know. Am I going to get my treatment this 
month? Is it going to be late? How late is it going 
to be? And this has a direct impact on obviously my 
future goal of wanting to go back to work. I dont 
want to be disabled. I want to work and take care of 
myself. 

 I just -- Im really frustrated, too, 
because Ive contacted my senators, my -- all the 
Congress, all the local media, national media. Ive 
written every talk show host that there is. Not one 
of them, did they want to give us any time of day, and 
I think thats how it is, because were too small. 
Theres only 50,000 people who have common variable 
immune deficiency. (Inaudible) write the law into 
that. 

 Whereas I know I heard that other lady say 
that neuropathy has a million patients. Theres a big 


difference in there of people using it for off-label 
versus label, and I can quickly, with (inaudible) 
treatment with the fact that they (inaudible). 

 If youre going to use it for off-label use, 
then you should have to pay this price. If youre 
going to use it for on-label use, then you should be 
able to pay this price, because it is widespread for 
us. Its not life-threatening for people with 
neuropathy; at least, Ive never heard of anyone with 
neuropathy that has actually died. 

 I just want to say thank you for listening 
to me and letting me (inaudible) and I would pray that 
you guys (inaudible). 

 MS. CONNERY: Thank you very much, Marsha. 
Our next commenter is, we hope, in the room with us, 
David Elkayam. 

 OPERATOR: David, your lines open. 

 DR. ELKAYAM: Okay. Can you hear me? 

 MS. CONNERY: Yes. Yes, we can. 

 DR. ELKAYAM: Im a physician in private 


practice in Bellingham, Washington. Im near the 
coast. Im an allergist and immunologist by training 
and (inaudible) I treat the folks, like the lady that 
we just heard from very eloquently described the 
dilemma and the problems that were having treating 
our patients with primary immunodeficiency. 

 My comments are directed specifically at 
those individuals who are often productive individuals 
in society. These are not people who are at the tail 
end of their lives. Theyre often very productive 
members of society. 

 My comments not only include the several 
patients that I have who have had Medicare coverage, 
but extend to all the patients that Ive had. In the 
years that Ive been in practice, I have treated 
approximately 35 patients with primary immune 
deficiency , and that goes back 18 years now. 

 I put into effect training that I received 
as a fellow in a certified allergy/immunology program 
in Denver, Colorado, which is very well-respected in 


this regard, so I feel that the treatment needs to be 
defined and supervised by somebody with adequate 
training. That may be something that you can look at. 
I also agree with the prior speaker that 
there needs to be a definition of who is the best 
candidate for receiving this therapy, primary immune 
deficiency patient versus off-label uses that have 
less treatment benefits for neuropathy and other 
neurologic conditions, and help to define the 
(inaudible) population. 

 I think (inaudible) outline the results that 
have occurred at the beginning of this year, which has 
been primarily in the record (inaudible) regarding 
IVIG (inaudible) last year. You may well be aware 
that in the other third-party insurance companies 
(inaudible) IVIG (inaudible). Theres been a very 
important consequence (inaudible) of that (inaudible) 
policy. 

 For example, theres one clinic that has had 
experience with IVIG now for about 18 years, and as 


recently as September of 2006 [sic], a year ago, I was 
treating 22 patients with (inaudible) various forms of 
primary immune deficiency (inaudible) versus IV 
(inaudible) globulin. 

 Since that time, I have (inaudible) direct 
care and supervision of IVIG therapy for 12 of these 
patients. I currently am treating (inaudible) and it 
is highly likely that I will be treating few to none 
of these patients by the end of the calendar year. 
The (inaudible) care of these patients does the 
(inaudible) end of last year that did not (inaudible) 
January. 

 This resulted in a very significant negative 
financial burden on (inaudible) and one that we can 
try very hard to contend with and one that we cannot 
simply sustain. The methodology of ASP +6% does not 
take into account that the indications (inaudible) 
IVIG product (inaudible) the reimbursement allowed, as 
the previous speaker just outlined. The problems that 
theyre having (inaudible) the problems that were 


having in Washington State. 

 The reimbursement has always been unfairly 
low with respect to the nursing services and the time 
commitment, and you may or may not be aware that the 
provision of IVIG is nearly a one to one nursing 
commitment for a period of three to five hours at a 
time. 

 As a practical consequence of what has 
happened during this past year, weve had to eliminate 
two full-time nursing positions from our clinic staff. 
These are not only lost wage-earners in our community, 
but their speciality expertise has been very hard to 
lose and will be very hard to replace if were ever 
able to (inaudible) IVIG (inaudible) the future. 

 In addition, the lack of more direct 
supervision of the care for these patients (inaudible) 
immunologist out of the loop. I did all the 
(inaudible) every three and four weeks for their 
infusions. Typically, this wouldve been what we 
consider a curbside consult and typically does not 


involve any additional billing. 

 Now, these patients are seen on a much more 
periodic basis. They have to be scheduled in. And I 
cant even (inaudible) pick up on the more subtle or 
early signs of their disease conditions, and this is 
not only with respect to infectious diseases. 

 For example, in the past year, Ive 
diagnosed a deep vein thrombosis, which is an 
immediate life-threatening condition in a patient who 
presented for IVIG, and fairly recently, I referred a 
patient who was found to have bacteremia directly to 
the hospital, because of appropriate (phonetic) signs 
and symptoms that she presented with in a routine 
office visit. 

 MS. CONNERY: Dr. Elkayam, you have about 15 
seconds. 

 DR. ELKAYAM: These types of events will 
(inaudible). In closing, we need the support of CMS 
of a permanent add-on payment to cover the gap between 
the cost of the drug and the reimbursement. We need 


creation of separate (inaudible) codes for each brand 
of IVIG (inaudible) separately. Finally, we need to 
pay physicians at a higher level (inaudible). Thank 
you. 

 MS. CONNERY: Thank you very much. I would 
like to check at this point if Joanne LaDouceur is on 
the phone lines with us. Thats spelled L-A-D-O-U-C-
E-U-R. She was someone who was scheduled to come in 
earlier and missed the time, and I think would like to 
-- I heard would like to do so, so I just want to see 
if shes -- 

 OPERATOR: Joanne, your line is open. 

 MS. LADOUCEUR: Yes, I am here. 

 MS. CONNERY: Okay, great. We can hear you. 

 MS. LAUDOUCEUR: Thank you for being so 
patient. Yes, Ill tell you a little bit about my 
story. Ive been on -- I was diagnosed four years 
ago, I believe it was, with CVID, and I have had 
numerous serious infections requiring hospitalization 
and home (inaudible). I think I had PICC lines like 


four or five times. 

 So I had been very sick, and so I was 
diagnosed and I started IVIG in an infusion clinic, 
and at that time, they had venoglobulin (phonetic), 
which is now off the market, and I had the first 
infusion, mild side effects. I mean, it was a lower 
dose. 

 The second infusion, I developed (inaudible) 
meningitis, and I was quite sick with that. And it 
was kind of scary, you know. You wonder, Well, 
should I have even started this? But they were 
certain that it seemed to be rate related, and so they 
said that the next infusion had to be at least six 
hours. 

 At the infusion clinic, it was very 
difficult for them to do an infusion that long, but 
they tried to, and I was developing a thrombocybitas 
(phonetic) with every infusion. So a couple months 
later, I switched to a different infusion clinic, and 
then I at least have a different brand. They dont 


have the same brand. You get whatever they happen to 
have that day. 

 So then I had more problems with severe side 
effects, body aches, severe headaches, and it was 
difficult to get them, again, to run the infusion over 
six hours. Thrombocybitas again. Then the doctor 
wrote orders that it had to be at least six hours, and 
they had to change the IV site midway through the 
infusion. Because of my numerous infections and my 
history, they would not do a port, so I was -- I had 
to -- through IV. 

 So the year went through and they changed 
brands a couple times. They tried to keep the same 
brand, but I continued with multiple side effects. 
Even though the infusion was every four weeks, after 
the infusion, I was sick for a week, and prior to the 
infusion, I was run down and not feeling well, so I 
was feeling crummy half the time, and the other half 
of the time, I seemed okay. 

 My infection rate went way down, so that was 


a good thing, but with my insurance, they refused to 
do it subcu (phonetic). However, a year later, the 
year after I was into this, my insurance changed and I 
was able to start subcu (phonetic). So I did that at 
home. The nurse helped me the first one or two times, 
and it seemed to go smoothly. However, I was infusing 
into one site, and that was a problem. Then we went 
to two sites and two pumps, and the big backpack 
instead of a little fanny pack. That seemed okay. 

 I still had some side effects, and when 
gamma globulin went off the market, I changed to 
Gammagard, and I did have fewer side effects with 
that, fewer headaches, because -- well, I take that 
back. I had headaches, severe headaches, for about 
six months, and they were always worried about getting 
meningitis again. Then, it was discovered that I had 
these problems whenever I changed lot numbers. So the 
company that I worked with, Accudo (phonetic), would 
kind of horde as much as they could of one lot number, 
put it aside for me, and if it lasted six months or a 


year, I would at least be able to stick with the same 
lot number. 

 At that time, during the course of this 
time, I should say, I started to lose weight. I went 
from, lets say, 140 pounds to 110, and finding 
infusion sites was difficult. We changed from a soft 
set (phonetic) to a silhouette, which is a very 
shallow needle that goes in, needle comes out, the 
catheter remains, so its very shallow. You can put 
it in just under the skin, and I was running my 
infusions 24 hours, but I seemed to get better. 

 I had fewer infections, no more infections 
that required hospitalizations, a couple of sinus 
infections a year. Still working with the same 
people. But some time in the middle here, it was 
discovered that my headaches were probably related to 
the IDA content, and then, we were able to get the 
Gammagard low IDA, which is what I still receive, and 
just about lets say four -- a couple months ago, 
three months ago, I found out that I could use 


something, a different kind of topical anesthetic 
(inaudible), which they usually use for (inaudible) 
patients, so I could use that. Its kind of icky 
(phonetic) to use. Its sticky. You have to put some 
kind of dressing on it and you keep applying it every 
couple of hours, and -- 

 MS. CONNERY: Joanne, youve got about 15 
seconds. 

 MS. LADOUCEUR: Okay. So I was able to cut 
down my infusion time, but then I had reactions to 
that. So Im back to the 24-hour infusions. I must 
have the low IDA, and subcu (phonetic), for me, is the 
best thing to do. I had a couple of hospitalizations 
this spring and they had a hard time getting it at the 
hospital, but I ended up getting IV, and they did it 
over six hours. 

 But thats the best thing for me, and I 
cannot change brands. If I had to, I would probably 
just resign myself and quit. And thank you very much 
for your time. 


 MS. CONNERY: Thank you for joining us, 
Joanne, with the comment. Our next commenter is also, 
we hope, joining us by phone, Commenter No. 52, and 
that is Ken Bennis, B-E-N-N-I-S. 

 OPERATOR: Thank you. 

 MR. BENNIS: Yes, Im here. 

 OPERATOR: Mr. Bennis, your line is open. 

 MR. BENNIS: Hi. I want to thank all of you 
for listening to me today. Im an injured (phonetic) 
firefighter from Fort Lauderdale. As Peggy Hassel 
said today earlier talking, her and I have both been 
tossed out of doctors offices and many hospitals. 
Weve had to pay for this gamma on our own. And 
sitting here listening to all these people speak 
today, it seems to be just one common thing. Medicare 
has cut back so much on paying for this, and this is a 
necessary drug for everybody. 

 I myself, they cut me back -- Im 170 pounds 
-- they cut me back to 15 grams a month. Im back 
walking with a cane, in pain constantly, and I just 


hooked up with the VA, and the VA doctors there said 
to me that Theyre not even giving you the proper 
amount that the product calls for, which with your 
weight, has to be 30 grams. 

 Again, being Medicare seems to be the bullet 
here thats hurting everybody. Theyve taken away the 
doctors care. Theyre putting doctors out of 
business by not paying enough. Theyre putting 
patients out of hospitals by not paying enough. 
Something has to change in Medicare. 

 These companies say theres no shortage. 
Every time I go to a hospital or doctors office, they 
say, Oh, theres a shortage of the product. Ive 
called Talecris. Ive called the other companies. 
There is no shortage of the product. They have it 
here in the United States. But the problem is 
Medicare wont pay, and theres too many middle people 
making a profit off of us. Something has to stop 
here, because this product is needed for all of us to 
live. Without it, oh, theres a lot of patients that 


are dying, and its not necessary. Thank you for all 
your time. 

 MS. CONNERY: Thank you very much. Our next 
commenter is, we hope, in the room with us. Mark 
Ballow? Okay, great. 

 DR. BALLOW: Good afternoon. I am Dr. Mark 
Ballow. Im Chief of the Allergy and Immunology 
Division at University of New York, at Buffalo School 
of Medicine, and also at Womens and Childrens 
Hospital. But today, Im representing the Primary 
Immune Deficiency Committee of the American Academy of 
Asthma, Allergy, and Immunology, which is the largest 
professional medical specialty organization in the 
United States, representing allergists and clinical 
immunologists. 

 We have over 6,000 members in the United 
States, plus 600 members in other countries. I am 
also a member, and with my comments today, I have the 
backing of other organizations of clinical 
immunologists, including the American College of 


Allergy, Asthma, and Immunology and the Clinical 
Immunology Society. 

 I myself, and the clinical immunologists of 
these professional organizations, are part of the 
Primary Immune Deficiency Coalition, along with our 
partners of patient support groups, the Immune 
Deficiency Foundation, and the Jeffrey Modell 
Foundation, whom I think weve heard earlier from, 
represent some of these views. Id like to cover four 
points, many of which youve heard already in detail. 

 One is that IVIG is life-threatening for 
patients with primary immunodeficiency disease. Two, 
IVIG is a complex biologic product. It should be a 
biologic response modifier, classified as such. 
Reimbursement issues, youve heard a lot about today, 
and I just cover a couple of points related to that. 

 Lastly, utilization, and we believe that 
long-term, well need to address appropriate 
utilization of IVIG. With regard to the first point, 
IVIG is the only therapy for patients with primary 


immunodeficiency disease. It is life-threatening. 
Can you imagine with a diabetic, telling them that 
they can only have their insulin two days a week? I 
mean, I think thats unacceptable. 

 Plus its also unacceptable to tell a 
patient with primary immunodeficiency disease that 
they have to deal with six weeks, seven weeks, eight 
weeks. They have to reduce their dose from 30 grams 
down to 10 grams. Its the same issue. 

 Although (inaudible) is purified IGG, there 
are differences in the purification process and 
antiviral steps that make each product somewhat unique 
with regard to tolerability. Again, youve heard this 
a lot today from the callers calling in today on the 
phone, in whcih they switched brands and clearly, they 
have difference in tolerability. There needs to be 
access to different IGIV products to ensure patient 
safety, and this is really critical. 

 Second, IGIV is a complex biological 
product. It should be classified as a biological 


response modifier. If you look at the package inserts 
of these products, it very clearly outlines that there 
are a number of adverse events associated with the 
administration of this product, and I refer you to 
these product inserts. I wont go over the data at 
this point. 

 Somehow, IGIV has been classified as a 
simple administrative agent, like saline or 
antibiotics. This is not the case. Vigilance needs 
to be maintained for detecting and managing these 
adverse events and I think weve heard many examples 
of that today, in different -- when patients have told 
their stories. 

 The risk of these adverse events are 
magnified by the decrease in availability of products 
and therefore, a limitation in the selection of 
products which may be more appropriate in some 
patients, with regard to tolerability and with regard 
to some of these adverse events. 

 Third, because IGIV is a complex biological 


product with adverse events, there are inherent 
increases in cost incurred in the infusion of this 
product, and again, weve heard a lot about this 
today. Nursing on a one to one or at most, one to 
two, the length of infusions of anywhere from three 
hours to eight hours, depending if there was a patient 
with autoimmune disease or a patient who had primary 
immune deficiency disease, and the list goes on and 
on. 

 There are up-front costs in acquisition, 
determining what the appropriate product is, and of 
course, costs associated with the administration. 
Weve heard -- again, a lot -- that reimbursement is 
just totally inadequate for the administration of this 
biological response modifier. 

 MS. CONNERY: Youve got just a few seconds 
left. 

 DR. BALLOW: Finally, the last point is that 
-- utilization. 70% of IVIG is for off-label, and 
even with that 70%, surely, there is a lot of true 


indications of IGIV outside of patients with primary 
immune deficiency disease, and I dont belittle that 
at all. 

 In fact, our committee, the Primary Immune 
Deficiency Committee, has published a utilization 
document where we have looked at evidence-based 
medicine to try to prioritize where IVIG is best 
utilized for patient care. Its also posted on our 
Internet (inaudible). 

 So as a community of physicians, clinical 
immunologists, together with our allied health 
providers, together with some of our lay 
organizations, we are certainly here to help 
governmental agencies address this issue of not only 
short-term issues of reimbursement and allocation of 
product (inaudible) pricing of product, but the long-
term utilization of IVIG in a cross-section of 
patients outside of patients with primary immune 
deficiency disease. Thank you. 

 MS. CONNERY: Thank you. Our next and last 


six commentors -- again, I have four more names that 
arent on the list in your packets because of late 
registration -- are all joining us by phone. So well 
go to our 55th commenter, who is Jason Slotnik, S-L-O-
T-N-I-K. 

 OPERATOR: Thank you, one moment. 

 MR. SLOTNIK: Im actually here in the room. 

 MS. CONNERY: Oh, hes here in the room. 
Okay. 

 MR. SLOTNIK: I could call in on my cell 
phone. 

 MS. CONNERY: Oh, no, its nice to see you. 

 MR. SLOTNIK: I just want to thank you. My 
name is Jason Slotnik, and Im Director for Medicare 
Reimbursement and Economic Policy at the Biotechnology 
Industry Organization, and I thank you very much for 
hosting this open-door forum today. I have some brief 
comments that focus on two particular aspects of this 
challenging situation. 

 The Biotechnology Industry Organization, 


like I just said, appreciates the opportunity to speak 
at this town hall meeting organized by the Department 
of Health and Human Services, the Office of the 
Assistant Secretary for Planning and Evaluation. 

 BIO is the largest trade organization to 
serve and represent the biotechnology industry in the 
United States and around the globe. We represent over 
1,100 biotechnology companies, academic institutions, 
biotechnology centers, and related organizations in 
the United States. 

 We represent an industry that is deeply 
devoted to discovering new therapies and ensuring 
patient access to them. We are pleased to see the 
continued focus on the need to ensure adequate access 
to IVIG. We appreciate the Departments willingness 
to support and maintain an ongoing dialogue on this 
issue, and are hopeful that these discussions will 
result in solutions that will increase reimbursement 
and restore access to all IVIG therapies. 

 As we have heard numerous times today, 


Medicare beneficiaries face serious and sometimes 
insurmountable barriers to IVIG access. These 
challenges have coincided with and are a direct result 
of the reimbursement revisions that occurred on 
January 1, 2005. 

 While BIO is fully support of efforts to 
ensure that the Medicare program does not overpay for 
drugs and biologics, appropriate reimbursement is 
critical to ensure patient access to treatment. 
Current reimbursement for IVIG and its administration 
is not adequate, unfortunately, to ensure access to 
all brands of IVIG. 

 In addition to the need for increased 
reimbursement for IVIG, unique codes should be 
established for each brand. Each brand should get 
their own code. IVIG is one of a very limited number 
of biological therapies with mixed (inaudible) codes. 
Both of the codes for IVIG contain products with 
differing characteristics and value. For example, 
some products contain less immunoglobulin-A, also 


known as IgA, which may prevent or lessen reactions 
for patients with IgA deficiencies, while others 
contain no sugars and are often prescribed for 
individuals with diabetes. 

 Despite the clinical reasons that one brand 
of IVIG may be preferred over another, reimbursement 
is based on the volume weighted average of all 
products in that code, rather than the average selling 
price of each product. The result is further under-
reimbursement for some therapies, creating a barrier 
to the therapy which may be best suited for that 
beneficiarys specific medical need. 

 We urge you to correct this problem by 
establishing separate codes for each brand of IVIG, 
while I was hopeful that the wide variety of comments 
provided today will demonstrate the need to restore 
beneficiary access to all IVIG therapies, through both 
increased reimbursement and brand-specific coding. 

 Thank you again for this opportunity to 
testify. See you later. 


 MS. CONNERY: Thank you. Well, I guess I 
need to qualify and say just according to my notes, 
the next five commentors are on the phone, but were 
happy to take the comment whether youre on the phone 
or here in person. 

 So well move on to our 56th commenter, Judy 
Woody, W-O-O-D-Y. I dont see anyone standing up in 
the room, so hopefully, she is with us on the phone. 

 OPERATOR: One moment, Im looking. And 
thats W-O-O-D-Y? 

 MS. CONNERY: Yes. 

 OPERATOR: Thank you. Im not finding Ms. 
Woody on line. If you have connected with someone 
else at their location, press star-zero. 

 MS. CONNERY: Okay. While were waiting to 
see if that works, could you check for our next 
commenter, Patrick Schmidt, S-C-H-M-I-D-T? 

 OPERATOR: Mr. Schmidt was online earlier. 
Hes no longer connected. 

 MS. CONNERY: Okay. All right. Lets check 


for Dolores Hanson, H-A-N-S-O-N. 

 OPERATOR: Thank you. I also am not finding 
her. 

 MS. CONNERY: All right. Well, we have two 
more folks who had indicated they would like to 
comment, so well check for them. The next is Eugene 
Richardson. 

 OPERATOR: Thank you. Yes, he is on line. 
Mr. Richardson, you may make your comments. 

 MR. RICHARDSON: All right, thank you. This 
is Lieutenant Colonel Eugene Richardson. Im retired 
from the U.S. Army with 27 years active service. I 
have had the experience of having been diagnosed with 
chronic inflammatory demyelinating neuropathy and 
peripheral autonomic neuropathy. 

 I have gone 34 years without diagnosis in a 
total nightmare until, in 1987, when I was forced to 
retire from a promising career and (inaudible) because 
things really had gotten -- were really out of hand. 
But I thought if I started a new career, which I did, 


and I worked for 14 years, but my condition, in a 
typical relapsing and remitting fashion, continued to 
get worse. 

 Basically, I hid from everybody so no one 
would know what I was going to until the 90s, when 
breathing became very difficult. I was put on 
steroids, but unfortunately, in two years, my eyesight 
was destroyed. I had surgery. Then later, after 
that, my back came apart from osteoporosis. I had 
major surgery. Again, having heart problems. 

 Then, in 2000, had to retire from this 
second great career, and went on Social Security 
Disability, literally beaten by this disease. I then 
was finally diagnosed with having a peripheral 
neuropathy, and then in 2004, was diagnosed with CIDP, 
and they gave me a trial of CIDT, and I got out of my 
wheelchair, I stopped spinning around the room like I 
had been all the time now, and I could breathe and 
talk at the same time, and pain was less, and I 
thought maybe I could live now. 


 I then was given this infusion at a doctors 
office when all of the sudden, they told me that 
Medicare was not reimbursing them, and besides, I was 
on a brand where the fluid volume was high, and I kept 
drowning in it, because they gave it to me too fast. 

 I then was sent to Holy Cross Hospital in 
Fort Lauderdale, where they changed me to Gammagard 
brand, and even though I had a lot of problems with 
that, and again, the problem with fluid, I then all of 
the sudden, in February of 05, was told that they no 
longer had the product, and no one seemed to know why. 

 My wife and I called all over the place in 
desperation, as I was getting sicker and sicker, and 
by the eighth of March, I was in the emergency room at 
Imperial Point Hospital. I couldnt breathe and talk. 
I was back in the wheelchair. I couldnt walk. I was 
now spinning and going around the rink 24/7. 

 I couldnt sleep. The pain and the electric 
shocks were beyond anyones imagination. Again, I was 
in a body of torture, almost wishing that I would just 


die. I then changed to the new brand of Gammagard -- 
no Gamunex -- at Imperial Point and the next day, they 
gave me this, and I got out of the wheelchair, and I 
could breathe now, and all my symptoms started going 
down. 

 I now am very anxious that that will stop, 
because Imperial Point says theyre losing $10.00 a 
gram, and that they will no longer give it to any new 
patients. I have called Holy Cross and other 
hospitals in the area and they no longer will offer it 
at all. 

 I know that those who are desperate with 
immune deficiency mean well when they talk about those 
of us with CIDP not dying, but people do die and I 
just hope this does not become some kind of game in 
which who is worse off, but rather to (inaudible) look 
at the issue, as the one doctor, I think, was 
suggesting they have done. 

 Anyway, I want to thank you very much for 
doing this, and I want to thank Congressman Clay Shaw 


and the Neuropathy Association, especially Dr. 
(inaudible) and the GBS Foundation International and 
the (inaudible) center, because if it wasnt for them, 
I dont think I would have made it this far. Thank 
you very much. 

 MS. CONNERY: Thank you very much, Mr. 
Richardson, for sharing your story with us. We wish 
you the best with the challenges that youre facing. 
Our last commenter on my list -- also, I believe, 
joining us by phone -- is Maryann Ostrowski, O-S-T-R-
O-W-S-K-I. 

 OPERATOR: One moment. Ms. Ostrowski was on 
line, but is no longer connected to the call. 

 MS. CONNERY: Okay. So I want to ask the 
folks who are on the phone if there was anyone who was 
scheduled to comment earlier who may have missed their 
time, but is on the line now, we could take them, and 
you could indicate that by pressing star-one. 
Marcella, is that correct; star-one? 

 OPERATOR: That is correct. 


 MS. CONNERY: Okay. Can you tell us if 
youre getting any signals? 

 OPERATOR: It will take a moment for them to 
queue up. 

 MS. CONNERY: Okay. Ill just check in the 
room if there is anyone we may have missed who was 
scheduled to go earlier. 

 OPERATOR: No -- oh, I have just two -- just 
a moment. 

 MS. CONNERY: All right. 

 OPERATOR: Mr. Reice? 

 MR. REICE: Its me. 

 OPERATOR: Go ahead, sir. You may make your 
comments. 

 MR. REICE: Thank you. I heard the Colonel, 
and this is a coincidence, because -- my name is Gerry 
Reice. Im a (inaudible) United States Army Reserve. 
Ive always learned that medical care is a right, not 
a privilege, and I learned that many years ago in the 
service. We have a right to this medical care. 


 I never thought I was a patient. My ego got 
in my way. For a number of -- seven years, eight 
years, Ive been taking gamma globulin, taking it and 
gaining benefits from it. Again, my ego got in my 
way. Never a patient. Always taking the gamma 
globulin because it was prescribed. 

 Now, a little while ago, we lost gamma 
globulin as a prescription through Medicare. The VA 
told me they would give it to me if I was close to 
death. My pain is in my hands. My sons help me. I 
think it is very cruel that our government is not 
funding this properly. 

 There is a responsibility somewhere up the 
ladder, and listening to this program as long as I 
have, I, as a layman, gained more knowledge than I 
have in many years because as I said, my ego got in my 
way, and I will call on Senators Clinton and Schumer 
(phonetic) and on Congressmen as long as my sons are 
able to carry me in their offices. 

 Thank you again for teaching someone 


something that his ego did not allow him to learn. 

 MS. CONNERY: Thank you for your comment. 
Marcella, did anyone else response? 

 OPERATOR: No, Ms. Connery. 

 MS. CONNERY: Okay. 

 OPERATOR: We have no one else in the queue. 

 MS. CONNERY: Okay. Well, that is all that I 
have on my list, so Id like to close out the comment 
period and just end with a few remarks. 

 OPERATOR: We do have one more, maam. 

 MS. CONNERY: Oh, okay. 

 OPERATOR: Thats just come up. 

 MS. CONNERY: All right. 

 OPERATOR: One moment. Donald Davies, your 
line is open. You may make your comments. 

 MR. DAVIES: Thank you. Ive had the 
opportunity to hear everybody from all different areas 
of the health care, and I really appreciate that. I 
am a value analyst for a pharmacy. Ive been doing 
this for 17 years, and Ive gone through the ups and 


downs for many product shortages throughout the United 
States. 

 I am seeing some significant issues for the 
past couple of years. I know usage is going up, but 
also, we need to take a look at the total output of 
the product coming from the manufacturers versus the 
demand. I know that American Red Cross went off the 
market. I know that Baxter shut down one of their 
plants that was producing their product. 

 I know that raw material collection sites 
across the United States have been reduced over the 
last five years. (Inaudible) where we used to get raw 
material and blood from Europe, its almost at a 
standstill because of the mad cow disease. 

 (Inaudible) all the (inaudible) that I 
havent heard today? Thats all I have to say. 

 MS. CONNERY: Okay. All right. Thank you, 
Mr. Davies. Marcella, any other participants? 

 OPERATOR: No, no. That was the last 
question in the queue. 


 MS. CONNERY: Okay. I think some of those 
latter folks were folks who were not signed up 
earlier, so if you want to make that same offer, if 
theres someone here in the room who didnt sign up to 
comment that youd like a few minutes right now, we do 
have a little time left, if anyone would like to do 
that. Okay. Go ahead. 

 MS. VOGEL: Thank you. My names Michelle 
Vogel and I work for Washington Strategic Consulting 
and work with a number of patient groups. I work for 
the Immune Deficiency Foundation and currently work 
with myositis and the Neuropathy Association, so Ive 
had, I like to say the privilege, but also, have 
experienced the hardship of all patients going through 
this, both as weve seen what people have stated on-
label and off-label. 

 The one statement Im going to make is a 
concern to me greatly. You should never see one 
patient put against another. This product is needed 
for many, many patients, and I know that theres a 


limited amount and its a scarce resource and its a 
miracle drug. Weve heard all of that today and were 
trying to decipher all of the problems. 

 We know for the primary immune deficiency, 
this is the only product that works and these patients 
need it. But also, for the myositis community, for 
the CIDP community, for ITP, for so many other 
diseases, this therapy, for many of those patients, is 
the only product that works and they need it. 

 So Id like to make sure that at no time do 
I see one patient being put against another, and I see 
all the patients working together and making sure that 
access is restored for all patients who need this 
product as a life-saving therapy. 

 I want to say thank you to ERG, to ASPI, and 
all of you. To put together a meeting like this, over 
the last years, weve all been working in the whole 
IVIG community to get the stories out for patients to 
be able to tell their stories, and physicians who 
havent been able to come to D.C., but to be able to 


call in today and tell these stories. 

 Its been tough listening to every single 
story, but for them to finally have a voice and to be 
heard, you dont know how much that means to those 
people, because they really feel that people now care. 
And so Im just hoping that all of us, continuing to 
work together, that we are going to get to a solution, 
and its going to happen hopefully quickly, because we 
are running out of time, as youve heard from a lot of 
the devastating comments that came forward. 

 But thank you. Thank you for opening it up. 

 MS. CONNERY: Thank you, Michelle. Anyone 
else in the room who had not commented today who would 
wish to do so? Marcella, do we have anyone on the 
phone? 

 OPERATOR: No, I do not. 

 MS. CONNERY: All right. Well, it looks 
like, then, we are at the end, so let me make just a 
few closing remarks. 

 As Michelle noted, weve heard a lot of 


personal stories today and its clear that some of 
them are very hard for people to tell, and even 
harder, as we can all imagine, for folks to live those 
stories. So our hearts go out to all the people weve 
heard from today that are struggling with those 
medical difficulties, and we wish you the very best 
with your health, and were very grateful for those 
stories, because that was the main purpose of this 
meeting, was to provide that opportunity, to get those 
stories, to get that input, as part of this project. 

 Im grateful, also, to everyone else who was 
speaking from other perspectives, for an organization. 
All that information is valuable. 

 Just a few reminders, that for those who 
spoke today, its possible some of you will be getting 
a follow-up call. We didnt have time for our project 
team to go into sort of detailed questioning, but Im 
sure for at least some, theres more information 
theyre going to want to get, and so some of you may 
be getting a follow-up call. 


 Also, as I mentioned earlier, there will be 
a transcript available of this meeting, and also a 
summary report that ERG is producing. We expect both 
of those to be available within the month, and we will 
be very happy to send them to anyone who is interested 
in getting them. On the handout marked Additional 
Information in the packets, or in the e-mail that we 
sent to people on the phone, there is information, 
basically telling you to contact Laurie Stamatatos at 
ERG. She will keep track of whos interested and will 
get those to you as soon as they are available. 

 Then, as I mentioned earlier, the analysis 
report that ERG will be producing will be available to 
the public in early 2007, and almost certainly, put up 
on a portion of the Department of Health and Human 
Services web site. I could not find the URL, but 
what I did talk to DHHS about was the idea that you 
all would receive a notification when thats 
available, so that you will know that it is available 
and know at that time how to get it. 


 We, of course, have the contact information 
of everyone who attended this information or indicated 
an interest, so we can work with DHHS to make sure 
that you get that notification. 

 Let me ask my colleagues here if you have 
any closing remarks that you would like to make. 
Could you draw that close to you, Aylin? 

 DR. SERTKAYA: Ill just be very brief. I 
just want to thank all of you for being here today and 
sharing your experiences with us. We luckily received 
quite a lot of information, which will be highly 
useful for our analysis. 

 Again, as Jan noted, I just want to 
encourage you to submit any additional comments, 
reports, studies, or other documentation you might 
have to us before October 15th and preferably earlier, 
if possible. 

 Again, I would like to conclude by reminding 
you that as we go through all this information, you 
might get a call or an e-mail from our project team to 


clarify any lingering questions we might have on your 
comments. Also again, thank you very much. 

 MS. CONNERY: Yes, and instructions for how 
to get us those written comments -- again, by October 
15th, please, to be considered in the project -- are 
on this handout. 

 So with that, Id like to thank everyone for 
being here and the project team will be getting to 
work (inaudible). 

 (Off the record at 4:25 p.m.)