June 26, 2006 at 17:06 PM EDT
News Tip from IG Living Magazine and FFF Enterprises: U.S. IVIG Patients at Risk for Lack of Treatment

The following is an opinion editorial provided by IG Living Magazine and FFF Enterprises:

Includes: Background, subjects available for interviews and commentary, "She Begged for Her Life"

Background

U.S. Representatives Jim McCrery (R-LA), Mark Foley (R-FL) and Steve Israel (D-NY) have collected 55 colleagues' signatures on a letter to Health and Human Services Secretary Mike Leavitt, urging him to declare a public health emergency so patient access to intravenous immune globulin (IVIG) crisis can be resolved.

IVIG is manufactured from pooled human plasma. There are currently five manufacturers that sell six IVIG products licensed by the U.S. Food and Drug Administration (FDA). IVIG is used to treat primary immune deficiency diseases, neuropathies, myositis, bone marrow transplants, myasthenia gravis, idiopathic thrombocytopenic purpura and other serious immune system disorders.

The Medicare Modernization Act of 2003 resulted in a congressionally mandated reduction in Medicare Part B reimbursement rates for IVIG, effective January 1, 2005, and established two rates for administering IVIG to patients, depending on where they receive treatment: in the physician office and at home, or in hospital outpatient settings. Initially, the new reimbursement methodology significantly lowered the rate paid to physician offices and homecare companies for IVIG infusions, and then, in 2006, hospital outpatient rates were also lowered. Meanwhile, IVIG prices are rising and U.S. supplies of IVIG products are tight.

The Department of Health and Human Services (HHS) Advisory Committee on Blood Safety and Availability has twice recommended that HHS Secretary Mike Leavitt declare a public health emergency relative to IVIG or take other emergency steps that would give authority to the Center for Medicare and Medicaid Services (CMS) to make an emergency adjustment to the IVIG reimbursement methodology without requiring congressional approval.

Minutes of the Committee's meetings, including patient and healthcare provider testimony, are available at http://www.hhs.gov/bloodsafety/summaries.html.

You can read the Committee's recommendations to HHS and HHS's responses at http://www.hhs.gov/bloodsafety/resolutions.html.

The following House Members and Delegates have signed the letter to Sec. Leavitt:

 Rep. Jim McCrery                             R-LA
 Rep. Mark Foley                              R-FL
 Rep. Steve Israel                            D-NY
 Rep. Maurice Hinchey                         D-NY
 Rep. Phil English                            R-PA
 Rep. Bill Young                              R-FL
 Rep. Joseph Crowley                          D-NY
 Rep. Dennis Moore                            D-KS
 Rep. Ted Strickland                          D-OH
 Rep. Tammy Baldwin                           D-WI
 Rep. Carolyn McCarthy                        D-NY
 Rep. Bernard Sanders                         I-VT
 Rep. Adam Schiff                             D-CA
 Rep. Jim Ramstad                             R-MN
 Rep. Raul Grijalva                           D-AZ
 Rep. Gary Ackerman                           D-NY
 Rep. Charlie Rangel                          D-NY
 Rep. Michael McNulty                         D-NY
 Rep. Lee Terry                               R-NE
 Rep. Sherrod Brown                           D-OH
 Rep. John Tanner                             D-TN
 Rep. Dave Camp                               D-MI
 Rep. Rick Larsen                             D-WA
 Rep. Clay Shaw                               R-FL
 Rep. Brian Higgins                           D-NY
 Rep. Howard Berman                           D-CA
 Rep. James Oberstar                          D-MN
 Rep. Robert Wexler                           D-FL
 Rep. Don Sherwood                            R-PA
 Rep. Chris Shays                             R-CT
 Rep. Jo Ann Davis                            R-VA
 Rep. Michael Honda                           D-CA
 Rep. Gregory Meeks                           D-NY
 Rep. Rob Bishop                              R-UT
 Rep. Ellen Tauscher                          D-CA
 Rep. Dale Kildee                             D-MI
 Rep. Peter DeFazio                           D-OR
 Rep. John Boozman                            R-AR
 Rep. J.D. Hayworth                           R-AZ
 Rep. James Walsh                             R-NY
 Rep. Kevin Brady                             R-TX
 Rep. Barney Frank                            D-MA
 Rep. Jim Moran                               D-VA
 Rep. Sam Farr                                D-CA
 Rep. Shelley Moore Capito                    R-WV
 Rep. Carolyn Maloney                         D-NY
 Rep. Ron Paul                                R-TX
 Rep. Michael Fitzpatrick                     R-PA
 Rep. Frank Pallone                           D-NJ
 Rep. Dennis Kucinich                         D-OH
 Rep. Silvestre Reyes                         D-TX
 Rep. Gene Green                              D-TX
 Rep. John Conyers, Jr.                       D-MI
 Rep. Tim Bishop                              D-NY
 Rep. Eliot Engel                             D-NY
 Rep. Anna Eshoo                              D-CA
 Del. Donna Christenson                       D-VI
 Rep. Chris Smith                             R-NJ

Subjects available for interviews:

1. Rose Mary Istre, of Texas, is a friend of Pam Way, who is believed 
   to have died as a result of inadequate access to her IVIG 
   treatment.
   Home: 281-997-6600
   Rose Mary's cell: 281-381-4120
   Rose Mary's husband's cell: 409-682-0870
   Email: RoseMaryKay@sbcglobal.net

2. Dr. Mavis Fujii (two 'I's) is a neurologist who treated Pam Way.
   Cell: 832-721-3316
   Email: egretbayneurology@hotmail.com

3. Angelina Michalski, of Florida, believes the death of her husband, 
   Lawrence, is the result of their inability to obtain his IVIG 
   treatments (see 15 Oct 2005 AP story "Patients Complain About 
   Medicare Changes" By DEVLIN BARRETT).
   Home: 727-596-7586
   Email: flbolts@aol.com

4. Dr. Robert Hostoffer, an immunologist, has many patients treated 
   with immune globulin products, and he has lost at least one patient
   due to lack of continuity of care.
   Work: 216-381-3333
   Home: 440-460-0881
   Email: r.hostoffer@huges.net

5. Rep. Steve Israel (D-NY), one of three U.S. Representatives who 
   have taken the lead on advocating for a declaration of a public 
   health emergency. 
   Ryan Rudominer, Press Secretary: 202-225-3335, Cell: 202-593-2868, 
   ryan.rudominer@mail.house.gov

6. Michelle Vogel, Reimbursement consultant
   Cell: 202-329-8643
   MVogel@wscdc.com

The following commentary on this issue was released today to your opinion editor by IG Living Magazine and FFF Enterprises. Please feel free to use this for background.

She Begged for Her Life

By Kit-Bacon Gressitt

Rose Mary Istre, of Texas, says it's a national tragedy.

"We lost two members of our (patient) support group already, and we will lose more - it's just a matter of time. Because patients, when they miss an IVIG treatment, they don't usually die immediately, they don't crash and burn..." and she pauses, a little too long.

What Rose Mary can't say is: It takes them a while to die, but they die. She can't quite say the words, because she lost a friend. She lost a friend who needed intravenous immune globulin (IVIG) - a human plasma product - to stay alive, but her friend couldn't get it.

"Pam Way had a disease, CIDP (chronic inflammatory demyelinating polyneuropathy) overlapping with myositis, which caused tremendous fatigue and muscle weakness. When I first met her, she was not walking; she was near death. Then, with IVIG, she was improving; she was walking; she was on her way to becoming a healthy person again. But when the Medicare (Modernization) bill was enacted, she was rerouted from her doctor's office to the hospital; she was unable to get the treatments and the brand of IVIG she needed."

Then Rose Mary explains something that too many decision-makers just don't grasp:

"Patients with immune problems require very brand-specific IVIG, because each product is different. It's a very individual type of treatment."

In fact, patients treated with brands their bodies don't tolerate can suffer life-threatening anaphylactic reactions.

"And when you miss treatment," Rose Mary continued, "it takes its toll. Gradually, Pam went downhill to the point that she was again becoming nonfunctioning...

"Eventually, it took all the strength she had, so I pushed her in her wheelchair to speak before the Blood Safety Committee meeting, May of 2005. She literally begged for her life. The committee promised us they would take action immediately, and push for (declaration of) a national public health emergency. We represented thousands of patients across the country who were too sick to fight for themselves."

Although the committee tried to help them, the decision-makers still didn't understand that reimbursement is inadequate, that some products are scarce, that patients will die.

"The national emergency never came, Pam never got the continuity of treatment she needed, and she died. And we will have more deaths," Rose Mary says, "while Washington studies the problem."

Today, the data gathering continues, the public health emergency has yet to be declared, and patients are losing hope. Patients are losing their lives.

"I want to ask our government why these people are expendable - one of my senators even said that they were concerned that doctors might profit from this! Oh, it's OK for oil companies to make millions, but it's not OK for doctors to make a little money saving lives?

"Hurricanes happen; wars happen; we can't stop them. But this was a mistake in the Medicare bill that could easily be corrected."

Rose Mary is right: We don't have time to wait for studies or investigations or endless debates about whether the problem is short supply or excessively high pricing. Even with new reimbursement rate increases, effective July 1, only one immune globulin brand will become affordable and available to most patients.

But most patients need the brand that keeps them alive, not just the brand that's least expensive.

And still, patients are begging for their lives. Patients are dying. Patients are dead.

Rose Mary Istre says it's a national tragedy.

No, it's worse. It's a national abomination that this problem has persisted since January 2005.

In our great United States of America, how many dead patients does it take to make a public health emergency?

Kit-Bacon Gressitt is editor of IG Living, a bi-monthly magazine for, by and about healthcare consumers who rely on immune globulin therapies and their healthcare providers. She is also vice president of marketing and communications at FFF Enterprises, a human plasma products distributor and sponsor of IG Living. Gressitt can be reached at editor@igliving.com.

Info box:

If you are having a Medicare IVIG reimbursement problem, please call 800-633-4227 to report it. If you are having difficulty getting your immune globulin treatment, report your situation to the Department of Health and Human Service's Center for Biologics Evaluation and Research (CBER) at 800-835-4709 or email your story to CBERProductShortages@cber.fda.gov.

You can learn more at http://www.hhs.gov/bloodsafety/igiv.html, www.igliving.com, www.myositis.org, www.neuropathy.org, and www.primaryimmune.org.

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