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. It’s 
10:00 a.m., by some clocks, anyway. We’d like to have 
an on time start. My name is Jan Connery. I’m 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 I’d like to welcome you all here today 
and thank you for taking the time to be here. I’d 
like to note that we’re 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 I’d 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 I’d 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 it’s also similar to the 
agenda that’s 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, I’m going 
to go over the process that we’ll 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 
that’s going to go for an hour and 15 minutes, and 
we’ll start back in at 12:45. 

 At that point, we’ll be joined by 
Congressman Tom Foley, a representative from Florida. 
Many of you probably know that he’s 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., we’ll start back in 
with the comment process and we’ll go to 2:30 Eastern 
Time, then we will take our break. That will be 15 
minutes. Then we’ll resume the comment process and 
keep going until we have worked through all the 
commentors that are on our list. 

 I’ll note that we do have a very full day 
today. We have a lot of folks who’ve 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 who’s 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 I’m a 
senior economist at Eastern Research Group. I’d 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, we’re 
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 we’re 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. I’m 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 we’re still in the initial phases of 
our work. In this time, however, we have spoken with 
some of you in the audience. In today’s session, we 
hope you will describe your personal or your 
organization’s 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 I’d like to do now is go over how we’ll 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. 


 It’s 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 I’m going to apologize in 
advance. I’m surely going to mispronounce some names. 
But what we’d 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. That’s 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 you’re 
at. One minute, 15 seconds, and then time is up. For 
folks on the phone, I’ll be giving you a very brief 


audio cue letting you know that it’s 15 seconds. 
Hopefully, you’ll have a clock in front of you so that 
you can monitor your own time. 

 We are going to need -- wherever you are 
when you’re 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 I’ll mention in a 
moment. 

 It’s 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, it’s a matter of fairness for everyone, 
in terms of everyone having the same time. So I’d 
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 didn’t understand and they want 
to make sure they had a clear understanding, they 
would ask to clarify their understanding, or if 
there’s 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 don’t 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, they’ll 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, that’s 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 we’ve actually -- some people, when 
called upon, may not be there, and we’ve just heard 
this morning -- and I’m grateful to three people who 
actually took the time to contact us and say “I signed 
up but I’m actually not going to be there. I’m 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 can’t give you 
exact times. My personal best guess is that we’ll 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, that’s 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 we’re at and gauge your time 
accordingly. 

 Now, if you have a written copy of your 


comments or documentation to support those comments, 
and you’re here in the room, I’d 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 you’re 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 there’s a graph or something that you’d 
like Aylin and John to be looking at that supports 
your presentation and you’d like them to be seeing it 
while you’re making your comment, you can just hand 
that to me and I’ll give that to them when you’re 
called on. 


 If you’re in the room and you have any 
logistical questions or needs, I’d like to introduce 
another ERG colleague, Erin Corina. She is our 
conference manager, and she’d be very happy to help 
you. See Erin with any of those questions. I’ll also 
mention, for folks in the room, that the restrooms are 
located out the left and you keep going past the 
elevators and they’re 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 you’re called on to 
comment, and when you are, by the way, the operator, 
Marcella, will be -- it’ll take her just a couple of 
seconds to unmute your particular line, and then we’ll 
hear your comment. 

 But we hope that we’ve 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 there’s 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 don’t have it in other 
forms, is listed on the Additional Information 
handout. 

 So if you’re on the phone and you do have a 
question you’d like to get the answer to, contact 
Laurie. She’ll either be able to answer it directly 
or if need be, she can get in touch with us in the 
room and we’ll get you that answer as quickly as 
possible. 

 Marcella, I’d just like -- Marcella, our 
operator, is going to be letting us know if there’s 
any audio problem. Is that right, Marcella? 

 OPERATOR: That is correct, ma’am. 

 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 that’s 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, it’s 
plugged into the speaker system, so that’s 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 we’d ask you to use the 
microphone. 

 OPERATOR: Ma’am? 

 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, I’m not -- there 
isn’t a speakerphone. My mike is with me, so I just 
have to make sure that it’s 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 who’s indicated 


they are interested. 

 Then the question I’m sure many of you are 
wondering is when is that analysis report that ERG’s 
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. That’s 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 we’re almost to the point where we’re 
going to begin the process, and I’d just like to 
remind everyone really, as is pretty obvious from the 
agenda, this is about comment, it’s about input, it’s 
about open listening. 

 We don’t have time on the agenda, and it’s 
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. 

 I’d also like to note that if you don’t 
feel you’ve been able to fit everything you’d like to 
say in your five minutes of comments, or if you were 
listening to other people comment and think, “Gee, 
there’s more I’d like to say now. I wish I could 
comment again,” or if you didn’t sign up at all and 
you’re 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. They’re also the same as the instructions 
for written comments that were available through the 
meeting website and other notices about the meeting, 
so we’re 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 don’t see any too-puzzled faces, so 
why don’t we then begin with our first commenter? Our 
first commenter is Dr. Robert Dracker, and he’s 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: It’s Dr. Dracker. 

 MS. CONNERY: Oh, Dracker? 

 DR. DRACKER: That’s right. 

 MS. CONNERY: Oh, started off 
mispronouncing. 

 DR. DRACKER: I’m 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; it’s run as a 
practice. This is my fifth trip to the Washington 
area over the last few years to deal with this issue. 
It’s 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. 

 I’ve often mentioned at these meetings that 
I’ve 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 I’m 
sure others will explain, but one that has to be given 
very careful consideration. 

 The problem I’ve had and the reason I am 
here today is that first of all, I’m 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 
we’re 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 I’m very 
hopeful that with your involvement, you can help us in 
this fight as things continue to get worse and worse. 

 I really don’t have much more to say. This 


is extremely frustrating for me. I’ve taken, on 
numerous days, on behalf of my patients -- even those 
that I no longer take care of -- and it’s 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 
industry’s side, and also from government, has an 
incredible number of excuses, but they’re 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 that’s going to be 
is you’re 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: I’m here. 

 MS. CONNERY: Oh, Rosemary’s here. Okay. 

 OPERATOR: I’m sorry. Now, she definitely is 
on the phone? 

 MS. CONNERY: No, sorry, she’s in the room 
with us. 

 OPERATOR: Thank you. 

 MS. ISTRE: Okay. How’s this for audio? 

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

 MS. ISTRE: Can you hear me? 

 OPERATOR: Yes. Go ahead, ma’am. 


 MS. ISTRE: Okay. My name is Rosemary Istre. 
I’m 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 wasn’t 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? She’s 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 Congressman’s 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 couldn’t 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 doctor’s 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 doesn’t 
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, ma’am. 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. I’m also the Chairman of the IVIG Committee 
for the Florida Allergy, Asthma, and Immunology 
Society. I’m reporting on both my personal problems 
and the problems regarding the State of Florida. 

 First, I’ll 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: That’s much better. Thank you. 

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

 This has resulted in patients removing 
themselves from gamma globulin treatment because 
they’re unaware of any other access. We’ve 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 product’s been 
withdrawn. 

 We’re down to one hospital who reliably 
supplies gamma globulin to our Medicare patients in 
the area. Unfortunately, they only have one product 
available and that’s 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 we’ve 
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 they’re 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 
there’s no physician immediately accessible to manage 
it. They’re supposed to (phonetic) manage severe 
reactions over the phone. 

 We’ve had reports in Florida, and I’ve 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.” 

 We’ve 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, that’s going to be as much as we can 
give you.” 

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

 We’ve had patients whose venous access have 
been ruined by hospital nurses who didn’t 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 can’t afford to wait out four to eight 
months’ worth of funding, waiting for reimbursement. 
Now, that’s 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, I’m 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. I’m 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 we’ve 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 don’t 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 didn’t get to, we’ll have 
that. 

 MS. BIRKOFER: Okay. 

 MS. CONNERY: Thank you. 

 MS. BIRKOFER: You’re 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 we’ll be 
moving ahead. Both the ninth and tenth now have told 
us they won’t 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. I’m 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, it’s 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, we’ll 
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. That’s good, 
thanks. 

 MS. SCHWEITZER: I’d 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. I’m 
with the Washington Strategic Consulting Group, and 
I’m 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 we’ve 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, I’ve 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 can’t do this 
(phonetic). Sorry. 

 MS. CONNERY: It’s 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 I’m 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 physician’s 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 we’re going 
to hear a lot of personal stories today, and that’s 
part of what this meeting’s about. It’s 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 I’m a patient in 
Orlando, Florida, and I’m 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 wasn’t 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 
don’t have a choice in what brand I can use, and it’s 
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 couldn’t afford to 
purchase it, and after switching to a different 
hospital because of my HMO plan changing, and that 
hospital saying they couldn’t get the brand I needed, 
I was then switched to receiving my infusion at the 


hematologist’s office in their chemo center. 

 In 2002, I was told by the hematologist’s 
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 doctor’s 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) hematologist’s office. 

 It seems that when the new Medicare 
reimbursement rate changed in April of 2005, my HMO 
couldn’t -- wouldn’t reimburse the doctor’s office the 
cost of my IVIG. The hematologist’s office wasn’t 
notified -- or wasn’t 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 won’t happen again. 

 To add insult to injury, now, it is getting 
harder and harder to even get the brand that I 
require. I’ve 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 didn’t 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 don’t have the money or the 
energy to do that. Also, it would’ve been an issue 
with my HMO. They don’t want to pay for two infusions 
in one month. 

 As it turned out, the person who receives -- 
who was to receive the infusion which would’ve used up 
the hospital’s supply never ended up getting it, and I 
got the IVIG (inaudible). That’s 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 doctor’s 
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. It’s 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, I’ll never get 
to see the bills that are sent to my HMO. 

 MS. CONNERY: Mary, we’re 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, I’d 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. 
I’m just going to remind us, she is -- Marcia is the 
eighth commenter. 

 We’re skipping over Commenters 9 and 10 
because they’ve they us the won’t 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. How’s that? 

 MS. CONNERY: Good. 

 MS. BOYLE: Okay? 

 MS. CONNERY: Great. 

 MS. BOYLE: Thank you very much. My name is 
Marcia Boyle. I’m 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, I’m 
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, I’m providing preliminary findings from the 
patient survey. Three thousand patient surveys were 
mailed to a random sample of patients drawn from the 
foundation’s 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 there’s 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: That’s 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, we’re skipping over 9 
and 10, so we’re going to Commenter No. 11, Patty 
Mitzenmacher, who we hope is on the phone with us. 

 OPERATOR: Thank you, ma’am. I do have 
Patricia Mitzenmacher. 

 MS. CONNERY: Oh, Patricia? Okay. 

 OPERATOR: Thank you. Ma’am, 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 I’m 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. 

 I’m 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 Crohn’s 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 he’s 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 isn’t. 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 weren’t 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, it’s going to come down to 
directly affecting my son’s health or other people’s 
health, and I am concerned. 

 A few months after that, when I went to go 
get my son’s IVIG, I was notified that he couldn’t 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 wasn’t 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) doesn’t 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 can’t keep their doors open if they’re 
taking a huge loss every time a patient walks in the 
door, and eventually, they’re going to have to say 
that there’s 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 there’s a shortage. They said no, there 
wasn’t 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 couldn’t 
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 son’s severe history of anaphylactic 
reactions, not just IVIG, but an array of things, it’s 
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, I’m 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, we’re at 15 seconds 
left. 

 MS. MITZENMACHER: Okay. Anyway, it did go 
on, I talked to the local community hospital. They 
won’t 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 I’m wondering at this 
point, people have to become -- I don’t 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. That’s a lot to 
expect of someone who needs to take care of a family 
member, or are concerned with serious medical issues. 
They shouldn’t have to do that. 

 In a (inaudible) system, the reimbursement 
(inaudible) problem won’t 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 you’d 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. I’m a Certified Nurse Practitioner. I’m 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, 


we’ve 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 physician’s 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: I’m 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. I’m 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 here’s 
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. 

 We’ve compiled the information and now we 
want to share it with you for the first time. Here’s 
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 he’s on the phone. If you 
need the spelling of that, it’s 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 I’m 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, I’m 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 couldn’t get 35 grams out of 10,000 grams 
that was shipped to my health plan because my name 
wasn’t on it, and because my name wasn’t 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 Governor’s 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, “There’s 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. There’s 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 physician’s 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, we’ve got 15 seconds 
left. 

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


better lives, as we’ve 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 we’ll 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 we’ll probably get to you around 1:00, 
Joseph. 

 For folks on the phone, you’re -- you can 
stay on the line, but there won’t 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: It’s 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 he’s 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 
wasn’t there when we called her. That’s Mary Jean 
[sic] Peterson, and she’s on the phone, so what I’d 
like to do is put her back in the queue right now and 
have her be our next commenter. 

 OPERATOR: Thank you, ma’am. I will open her 
line. 

 MS. CONNERY: Okay. 

 OPERATOR: Ms. Peterson, your line is open, 
ma’am. You may begin your comments. 

 MS. PETERSON: (inaudible) 

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

 MS. PETERSON: I’m right on my phone. 

 MS. CONNERY: You’re 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 I’m 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 doctor’s office to 
outpatient services at the hospital. 

 Because of Medicare’s 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 
should’ve 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 don’t 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 Medicare’s refusal to pay for any -- for my 
treatment, as they usually do so. It’s only a matter 
of time. 

 I’ve 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 Medicare’s 
reimbursement. I’ve 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?” 
I’ve 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 don’t 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 I’m sorry for the difficulty you’ve been having. 
Our project team has been listening carefully as we’ve 
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, I’ll just note that we’ve had a few 
more cancellations, Commenters No. 32, 34, 39, 42, and 
54 have all let us know that they won’t be taking 
their time, so at those points, we’ll 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 we’ll do is keep going with the 
comments until he arrives, and then we’ll pause to 
hear him speak to us. 

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

 DR. BAILES: Thank you. I’m Dr. Joseph 
Bailes, the Executive Vice President of the American 
Society of Clinical Oncology, or ASCO. We’re 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. I’ve 
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 you’ve 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 manufacturer’s 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. Ma’am, do 
you have the spelling of her first name? 

 MS. CONNERY: The first name, I’ve just got, 
I think it’s Jackie, J-A-C-K-I-E. 

 OPERATOR: Thank you. I’m 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. I’m 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. That’s Commenter No. 17. 

 MR. HARTMANN: Good afternoon. My name is 


Ron Hartmann and I am Vice President of Pharmacy 
MedAssets Supply Chain Systems. We’re a health care 
purchasing organization. We’re 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, I’m representing just 
MedAssets. I’m not representing the industry. May 
make some general comments about the industry, but I 
just wanted to be clear that I’m 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. They’re very much needed by our 
members, and the albumin is allocated here similarly 
to the way that the IVIG is allocated. In fact, in 
today’s 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 member’s 
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, it’s our hospitals 
that are receiving those patients and truly have a 
limited ability to acquire the product that they 
carry. 

 That’s 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, we’re 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. 

 I’d 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 that’s Edith Marshall. She is with us. Great. 

 MS. MARSHALL: Good afternoon. I’m Edith 
Marshall and I’m 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 can’t 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 don’t know if there’s a 
shortage. We don’t 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 can’t 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 
-- I’m sorry, almost 80% of our hospitals reported 


being unable to obtain any amount of IVIG at the 
340(b) prices, to which they’re 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. 

 We’ve 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 doesn’t 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,” they’re 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, they’re told “We can’t give you a 340(b) 


price. That’s not our obligation; it’s the 
manufacturer’s obligation.” And the manufacturers, 
although they will reimburse -- it’s 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, there’s 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 it’s becoming impossible to 
purchase IVIG under the 340(b) program. 

 But it just all doesn’t make sense. It 
doesn’t make sense why allocations are based on two 
thousand and -- I’m sorry, 204 purchasing levels when 
clearly, the distribution of supply has changed. It 
doesn’t make sense to say there’s a shortage as the 


reason we can’t get 340(b) prices if indeed, the 
product is out there to buy. 

 We applaud the government’s 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. I’m 
sorry, I’m not showing that participant at this time. 

 MS. CONNERY: Okay. Well, again, if she does 
run in later, let me know. We’ll go then to the next 
commenter, which would be Commenter No. 20, also would 
be on the phone. That’s Tessa Gehardt, G-E-H-A-R-D-T. 

 OPERATOR: She has disconnected from the 


conference. 

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

 OPERATOR: Okay. I’m not showing Ms. Pride 
on the phone. 

 MS. CONNERY: Okay. Well, let’s try somebody 
in the room. Our Commenter No. 22 is Mary Kruczynski. 
Mary’s with us. Okay. Glad you’re 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 I’m 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 I’d 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 patient’s 
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 doesn’t 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 


don’t 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 they’re 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 I’m 
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 we’ve done and invariably explain 
once again why they cannot receive this treatment that 
they used to receive in our office, oftentimes for 
years, and it’s not an easy task. 

 In today’s technologically advanced society, 
it’s 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 we’ve 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 couldn’t get the IVIG 


and they could, she said “Because we have special 
arrangements. We’re 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. We’ve 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 we’re 
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, 
let’s do this. That way you can -- 

 MR. FOLEY: Well, then I can do an Oprah. 
Hello, everybody. Let’s 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 
don’t want to underestimate the impact this has had on 
constituents in my community and people that I’ve met 


with throughout the entirety of both patients and 
patient advocates. 

 You know what the topic is, so I don’t 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 won’t 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. 


That’s why we’re here today. 

 After several years of looking at this 
problem, there’s 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 doesn’t 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. I’ve 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 I’m continuing to work with Chairman Bill 
Thomas, Congressman McCreary, on several options, and 


we are hoping to have something soon. While I can’t 
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 I’m going to have to 
-- 

 MR. FOLEY: (inaudible) 

 MS. CONNERY: Right, because we do have to 


get everything on the mike. And what we’ll do is 
we’ll 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 you’d 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 won’t 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 wouldn’t want to give anybody that 
close assurance, because I’m not telling you what 
we’re going to get done, unfortunately. 

 PARTICIPANT: Right. 

 MR. FOLEY: But we are going to be back here 
on November 13th for a week. We’re 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 season’s finished. 

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


 OPERATOR: Yes, I’m 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 we’ll go to those. 

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

 First, I’d 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 we’ve been working tirelessly with many in the 
community, and we’re 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. 


 We’re 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. 

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

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

 MR. FOLEY: Thank you. I’ll take your 
compliment and (inaudible). That’s 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. You’ve been 
an incredible advocate for our community and your 
remarks have been wonderful and I know what your 
constituency’s going through, and I know that there 
are constituents from your district right now 
listening on the phone, so you’ve been great. 

 But you’ve 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. There’s no 
question we would like to facilitate a meeting and 
urge him. I know we’ve 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. 

 I’m 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 name’s Tessa Gehardt. 
I’m a patient. 

 MR. FOLEY: Yes, ma’am? 

 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: That’s a very, very important 
question, and that’s one of the concerns we have in a 
multitude of areas where they have caps on coverage, 
because you can’t -- in fact, it’s actually a waste of 
money to continue to fund and provide it if you’re not 
going to sustain it to the lifetime of the individual. 

 So we want to be very careful. I don’t have 
an instant solution, but much like we’ve 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 you’re not going to provide the very 
relief that will sustain the organ living in the new 
body. 

 And so these are the same questions we’re 
going to be challenged with in the reimbursement caps 
that are in some insurance policies. So I’ll ask 
Bradley to look into that further. 

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

 MS. BOYLE: Hi. I’m 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 you’re a member of Congress who really 
cares. 

 Earlier today, I gave some preliminary data 
from a survey we’ve done of patients and the impact of 
Medicare reimbursement. I’d 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 what’s 
happening disproportionately to Medicare patients. 

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

 MR. FOLEY: Well, there’s 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. 
We’ve 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, it’s 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 
could’ve or should’ve been admitted to these 
facilities. 

 So we will continue to work on it. I’m 
hopeful. Both sides of the aisle -- and I think both 
sides are clearly interested, and this isn’t a 
partisan issue -- both sides need to tackle this, and 
not simply just wish it away, because these things 
won’t 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 that’s 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 it’s 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 can’t 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? There’s one over there. 
Let me -- I’ll walk your mike over. 

 MR. FOLEY: Then this will be the last 


question. 

 MS. CONNERY: The last question? Okay. 

 MR. FOLEY: I don’t want to miss folks. I’ll 
leave my -- that’s 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 -- we’re 
not sure we have everything. People have been very 
good. I must say, the manufacturers have come in -- 
there’s nobody that hasn’t been willing to share data 
points, and I think that’s encouraging. So there’s 
nobody that -- we’re not casting a blame and saying 
there’s one side holding supply out of the corner. We 
don’t know why these things are occurring, but we have 
been very, very pleased that whether they be 
manufacturers, patient groups, hospitals, doctors, 
they’ve all come forward, because they’re 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 don’t have that pinpointed. That’s why 
these folks are here and that’s what they’re charged 
with by ASPI. 

 We do, however, have a great deal of 
concern, if you look at the universe of what’s out 
there, how the contracts are entered into, the chain 
of custody of that product, making sure it’s 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 can’t 
necessarily say whatever we’re 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 we’ve 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, it’s true. It’s one of 
the concerns that we’re facing. But thank you. 

 Let me thank everybody for attending and for 
your interest in this, and again, we’ve shared 
accolades with our colleagues who have been very, very 
vigorous in this issue, so it’s not me alone. There 
are a number of people on both sides of the aisle that 
are taking this very seriously and they’re 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 let’s hope they’re 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) weren’t 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 let’s 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, it’ll keep my lungs clear. 

 I believe that if I fail to get these 
treatments, my life will be in danger beca