TOWSON, Md. & NEW YORK--(BUSINESS WIRE)--May 16, 2005--Patient advocacy organizations are usuall...

1. Healthcare Crisis Hits Medicare Patients Needing Immune
Globulin; Medicare Modernization Act Has Unintended but
Devastating Repercussions for Seriously Ill Beneficiaries
TOWSON, Md. & NEW YORK--(BUSINESS WIRE)--May 16, 2005--Patient advocacy organizations are
usually joining using the healthcare market in order to alert your public as well as legislators to a
emerging healthcare crisis that's prone to cost lives if Congress and the Centers regarding Medicare
along with Medicaid services (CMS) do not necessarily act quickly.
The Immune Deficiency Groundwork as well as the Neuropathy Association, a pair of national
affected person advocacy groups, and FFF Enterprises Inc., the biopharmaceuticals distributor, have
joined forces to send an emergency alert for you to Medicare policy makers and the public which
new reimbursement rates regarding intravenous immune globulin (IVIG) are putting patients' lives
in danger and also growing healthcare expenses pertaining to taxpayers.
The January 1 congressionally mandated reduction in Medicare part B reimbursement rates as well
as the April one two-tier rates regarding liquid and lyophilized (powdered) IVIG proven 2 rates
regarding administering IVIG to patients, depending about exactly where they receive treatment:
inside the physician workplace and additionally at home, or even in hospital outpatient settings.
Your new reimbursement methodology significantly lowers the rate paid out in order to physician
offices and homecare companies pertaining to IVIG infusions - in a occasion when IVIG price is
rising and supplies regarding several IVIG items are tightening.
The mixture of reduced reimbursement, rising prices along with tightening provide has generated an
unsafe circumstance in which significantly ill, low-income patients along with main immune
deficiencies as well as neuropathies are generally struggling for you to maintain access to treatment
- as well as in a range of cases are usually not able to obtain care, causing their in order to
deteriorate. because private insurers typically adhere to Medicare's lead, the problem will likely
broaden to include private-pay patients who depend upon IVIG infusions.
Patients with Risk
"This can always be a healthcare crisis for patients whose well being - whose lives - depend upon
standard IVIG treatments," mentioned Michelle Vogel in the Immune Deficiency Foundation,
situated in Towson, Md. "We have got received over 300 calls through Medicare patients who are
generally in a new position to no longer obtain his or her IVIG remedies inside their physicians'
offices, infusion suites or perhaps homecare configurations (see attached testimonials). Many of
these patients had been referred in order to hospitals that will can not as well as is not necessarily
likely to provide his or her treatment, or which have waiting durations regarding as a lot as 6
months. Throughout six several weeks these patients might be dead - essentially because regarding
an inadequately informed choice for you to lower Medicare reimbursement rates!
"We are usually hoping which we could draw enough awareness of this crisis," Vogel continued,
"that CMS, together with congressional support, will just take immediate action along with conserve
these patients' lives."
Patients over the country tend to be calling and composing his or her representatives, attempting to
become able to seek help by making use of an individual schedule to obtain treatment. Marsha Bond,

2. who lives throughout Irving, Texas, is surely an immunodeficiency patient. she provides missed the
woman's monthly IVIG infusion, along with her physician has been struggling to persuade any of the
local hospitals for you to treat her.
"I'm now a couple weeks late with regard to my treatment," Bond said, "and I'm definitely viewing
and sensation your difference. I'm having a large quantity of symptoms ... I require the particular
IVIG treatments; I'll just continue increasingly ill without them. In one other hand, we're subjected
to lots of opportunistic germs inside a hospital, much more thus when compared with we'd
encounter within the community, and lots of hospitals aren't equipped to administer infusions using
the identical degree of expertise that people get within the doctor's office. So, by simply likely in to
the hospital to obtain our treatments, we're getting in a fantastic deal more risks at exactly the
actual same time that will we're trying to acquire better. Regarding course, I can't obtain handled in
practically any hospital right now, and I'm unsure what I'm planning to do. Yet I can't believe people
will sit by, knowing that people will die, prior to they will fix this problem. I pray which not actually a
single one does, nevertheless I don't know."
The new reimbursement price is indeed low, that will physicians can not continue to offer affected
person treatment with out putting their particular procedures in financial risk (see attached
testimonials). Across the particular country, physicians are now referring their patients to hospitals,
exactly where outpatient reimbursement is actually higher.
According for you to Dr. Mark Stein, an immunologist practicing inside Palm Beach County, Fla., the
particular reduction inside IVIG reimbursement prices with regard to physician offices just isn't
resulting in reduced Medicare costs. "I have 1 immunodeficiency patient whose IVIG cost regarding
$1,700 in my office," Stein said. "She just received any hospital bill pricing her IVIG at over $13,000!
Virtually Any suggestion in which Medicare reform is saving tax money can always be a fallacy."
Additionally, if main immune deficient patients do certainly not get their own IVIG, the actual
secondary infections they are heading to inevitably acquire lead to further healthcare costs, usually
such as pricey hospitalizations.
Providing infusions in the hospital setting furthermore
poses additional challenges. A number Of hospitals tend to
be refusing patients, reportedly credited in order to lack
of sufficient treatment facilities or even inadequate IVIG
supply. most hospitals simply purchase one type of IVIG
(whatever is most inexpensive when an order is placed),
resulting in patients receiving treatment with an alternate
product compared to be able to that suggested by simply
their physicians - as well as suffering the actual
consequent hazardous adverse effects. And, costly
hospital co-pays are usually causing a number of patients
in order to forego their IVIG remedies simply because
these people can not necessarily afford the larger
payments.
One Florida patient, who prefers to utilize just the girl 1st name, Christina, can be permanently
disabled and additionally on a really limited income. The Lady is now facing hospital co-pays as
higher as $649, so she's gone with out remedy since February, as well as the woman's well being

3. will carry on to decline.
"At this point," Christina said, "I'm not really going to the hospital for infusions simply because I can
not necessarily afford to. Basically won the actual lottery, I would, but I do not really want in order
to waste cash playing the actual lottery!"
The Supply in the Problem
The unexpected consequences with the Medicare Modernization Act and the part B price reduction
tend to be thanks to the distinctive nature involving a person's plasma goods industry plus a
insufficient policy makers' comprehension of item provide dynamics, according to Patrick M.
Schmidt, president and also CEO involving FFF Enterprises, the actual nation's largest distributor
regarding IVIG. He equates existing marketplace circumstances towards the start of an IVIG provide
tightening. "Rising demand coupled with a steady production output will be developing a tightened
supply market," Schmidt explained. "We are viewing escalating prices inside conjunction along with
tightening materials against any backdrop regarding reduced reimbursement that, together, are
generally creating this healthcare crisis. This kind of signifies that physician offices and also
homecare companies possess access only to items that tend to be significantly higher throughout
price than what Medicare now reimburses. The Actual math is actually simple: That will not equate.
and a person's toll is just as simple, nevertheless wholly unacceptable: We will begin to lose patients
if and we don't act swiftly.
"The Medicare Modernization Act created two-tier pricing for that identical therapy provided in
various care settings," Schmidt continued, "and this can easily be creating a severe impact on
patient care. Additionally, opportunistic distributors are using advantage of your tightening supply
simply by raising prices over your reimbursement price for any healthcare setting. This can easily be
diverting the actual once-responsibly priced provide coming from where it's necessary most."
Don Jacob, executive director of The Particular Neuropathy Association, estimates with regards to
5,000 neuropathy patients are usually handled together with IVIG. He believes the reimbursement
difficulty reflects any lack of understanding about the diseases that are treated together with IVIG
as well as the adjustments in which treatment will be delivered.
"Medicare's artificially created disparity inside reimbursement rates pertaining to IVIG, based on the
treatment setting, serves no purpose," Jacob declared. "Paying 1 kind of provider greater than yet
another will the disservice towards the patients. It victimizes people that are already victimized by
means of a disease. I understand of one man who, without his IVIG, can't get out associated with
bed. This specific is not just like getting mumps. This kind of disease determines if you may lift the
legs and also arms or even not. We understand that IVIG enables people, and then for you to deny
these his or her treatment or even allow it to be challenging to obtain, I just do not get it. I can not
suppose anyone who really is aware of something about this illness and in addition the necessity
pertaining to remedy would even contemplate doing what Medicare features done."
The Solutions
Dr. Daniel Suez is surely an immunologist, practicing in Irving, Texas. He has been treating primary
immune deficient patients for 28 years. He wants a solution towards the reimbursement difficulty
that is realistic and greatest serves his patients. "I consider the particular legislation needs to be
rewritten," Suez explained, "to ensure it is feasible for that reimbursement formula in order to
reflect reality: the actual vacillating cost with the IVIG, the expense of the specialized equipment
regarding administering it as well as the price with the specialized nursing along with physician

4. abilities needed."
Wanda Mench, a new Medicare recipient having a chronic immunodeficiency, continues for you to
be relying about charitable contributions to spend in the girl hospital co-pay consequently she can
carry on being treated. Regarding her, the perfect answer is is a a few making the actual patients'
lives the particular priority. "All we could do will be take it month to always be able to month, along
with try to get the legislation changed. We must impress individuals we could not vote for, and also
that's difficult to do. you feel just like your hands are tied. These People don't understand the
consequences involving the debts they are passing. Your system just does not necessarily function
properly right. Whenever you've any committee that's generating these decisions, it shouldn't issue
in which you live, regardless involving whether you're the Democrat or perhaps a Republican.
Exactly what ought to issue is the fact that people's lives have reached risk."
The Immune Deficiency foundation (IDF) delivers numerous options that might result in realistic
Medicare rates, which includes encouraging CMS in order to declare a public health crisis or
perhaps reimburse IVIG as becoming a blood product to ensure that IVIG pricing may revert for the
traditional Typical Wholesale price (AWP) methodology. Based on IDF's Michelle Vogel, "Patients
require use of almost all brand names of IVIG in all web sites associated with care, and
reimbursement ought to never dictate where as well as if your individual receives their own
lifesaving therapy."
Patient Marsha Bond believes the particular option would be self-advocacy, nevertheless as she gets
in order to be increasingly ill, the lady doubts her effectiveness. "I've questioned everyone I know to
end up being able to compose letters to their representatives, however consequently far, nothing has
come associated with that," Bond said. "I would get your self a letter back again coming from
Representative Kenny Marchant's office, saying they had contacted Medicare on my small behalf and
also which they would i want to realize when they hear something. but when it will take an excessive
amount of longer, I won't have any kind of power left to fight. I'm just hoping with all of us pushing
within this direction at once, which something excellent will fall out of the sky."
Note in order to Editors: For You To obtain a whole media kit (including physician and also
individual testimonies and also fact sheet), click on or perhaps cut along with paste in your browser:
http://fffenterprises.com/web_files/testimonials_fact_sheet.pdf. Download demands Adobe 7 or
perhaps visit www.fffenterprises.com for PDF download.
FFF Enterprises
Kit-Bacon Gressitt, 800-843-7477, ext. 1143
Cell: 760-522-1064
or
Immune Deficiency Foundation
Michelle B. Vogel, 800-296-4433, ext. 205
Cell: 202-329-8643