IVIG and the committee on ways & means

Statement of Marcia Boyle, President, Immune Deficiency Foundation, Towson, Maryland

July 13, 2006

Chairwoman Johnson and Members of the Subcommittee, thank you for inviting me to testify on behalf of patients who need Intravenous Immunoglobulin replacement in order to stay alive. I would like to specially thank Congressman McCrery for his long-time support in helping to improve the lives of patients with primary immune deficiency diseases. Please know that although I represent the primary immune deficiency community, today I am speaking on behalf of all patients who require IVIG as their lifesaving therapy.

As president of the Immune Deficiency Foundation, I represent more than 50,000 patients across America who need IVIG as their only lifesaving therapy. My son is one of these patients. Like other PID patients, he was born without the ability to produce antibodies. He receives IVIG every three weeks to replace this essential component of his immune system. How good is the treatment? At 28 years old, with regular infusions of IVIG, he is married, has a demanding career, and is a healthy and productive member of society. Without this plasma-derived therapy, he would not be alive, or would be kept alive through antibiotics fighting infection after infection, and be severely disabled with a poor quality of life. IVIG prevents infections in the immune-compromised. There is no alternative therapy. The thought of his not having access to IVIG would be an unacceptable nightmare.

Unfortunately, many patients have been living this nightmare. Since January 2005, IDF has received thousands of calls, emails and letters from Medicare patients and physicians, who have not been able to receive their IVIG infusions at their physicians’ offices, outpatient infusion suites, home care settings and hospitals. About 20% of our patients are on Medicare. During 2005, many of the Medicare patients were shifted to hospitals where many were admitted for 23 hours and most were not receiving the most appropriate brand of IVIG, but rather, the brand the hospital had accessible. Patients who had not been successfully transferred to hospitals, especially those who did not have Medigap or secondary health insurance policies, were denied access to IVIG altogether. Here is a quote from a physician in New York the sums up the flavor of our calls in 2005: “I cancelled all of my Medicare patients. The price of IVIG has increased and I can no longer sustain the loss. I do not know what to do and I am in total despair.”

We received a call from a patient in Missouri, typical of many others, who said: “I am an 81 year old Medicare PID patient … I am sick all the time, and am not sure if I will be able to live long enough to get my next infusion. I had an infusion scheduled at the hospital. As I was leaving for the hospital, they called to cancel my appointment. They told me that they will not be able to infuse me. Can you help me?”

It does not make sense to move a primary immune deficient patient out of a closely monitored infusion suite, physician’s office, or home care environment — with nurses who are trained in the administration of IVIG — to a hospital where an immune-compromised patient can be exposed to an opportunistic infection. I cannot believe it was any policymaker’s intention to shift all patients to hospitals, which is, in fact, the most expensive site of care.

IDF and other groups spent a great deal of time communicating to Congress and CMS the devastating impact of Medicare Reimbursement reductions on our community. IDF conducted a national survey of Medicare patients, which provided quantitative data on the impact of the reimbursement changes. 39% of these patients had problems because of reimbursement, and 40% of these patients suffered negative health outcomes as a result of reimbursement.

We begged that the reimbursement rates for the hospitals not be reduced as dramatically as they had for the physician outpatient setting.

However, on January 1, 2006, hospitals were also switched from the AWP to the ASP formula. Even faster than expected, many outpatient hospital clinics eliminated IVIG infusions to patients because it was too costly to continue treating at the current reimbursement rates. CMS did implement a temporary preadministration fee for the physician’s office and hospital, but it was not enough to offset the reduction in reimbursement from the ASP formula and the reduced administration fees.

Patients in some states have been devastated. For example, the state of Nebraska has only one hospital treating on an outpatient basis with IVIG; the state of Florida has a handful of hospitals left, and in the state of Texas, most Medicare patients in Dallas, Houston and Irving cannot receive IVIG in a hospital. We have reports of patients not receiving IVIG since last November. Without IVIG they will eventually become disabled and die prematurely.

The impact of Medicare reimbursement does not stop with Medicare patients. During the past year, we have heard of more private insurance carriers reducing their reimbursement rates to those of Medicare — with even children being denied therapy! Our patient community has always dealt with an unusual burden of insurance problems because of the nature of their chronic illness and the cost of the expensive therapies….but the recent changes are unnecessarily devastating.

While the medical details are different, the medical outcome is the same as taking chemotherapy away from a cancer patient or insulin away from a from a diabetic. IVIG has been taken away from patients who will die without it. Are these patients not important to our society?

I am going to share a story of a patient who was personally affected by the changes to reimbursement after being denied access to IVIG. Her name is Pam Way. I met Pam at the Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting last May 2005. Pam had Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Myositis, disorders for which IVIG is recognized as medically indicated. When Pam was treated with IVIG, she was walking and fairly healthy. But when the Medicare Modernization bill was enacted, she was shifted from her doctor’s office to the hospital. At the hospital, she was unable to get thebrand of IVIG that she required. In addition, she could not receive her infusions on a regular basis.

Patients with immune problems require brand-specific IVIG, because each product is different. Patients treated with brands their bodies don’t tolerate can suffer life-threatening anaphylactic reactions. I once saw my son collapse after receiving a new product. Product choice for IVIG is critical for patients.

Congress understood this and exempted IVIG from the competitive acquisition program. Although it was Congress’ intent to ensure that patients have access to all brands of IVIG, the opposite has occurred, because the reimbursement rate for IVIG is too low.

Due to the changes in reimbursement, Pam stopped receiving her IVIG infusions on a regular basis and her health deteriorated to the point that she was becoming nonfunctioning. Eventually, it took all the strength she had, when she appeared in a wheelchair to speak before the Advisory Committee in May of 2005. She literally begged for her life. The Committee recommended that the Secretary declare a public health emergency. Pam was one of thousands of patients across the country that was too sick to fight for themselves, but she tried.

Although the Committee tried to help, Secretary Leavitt did not take action. Last year, a letter signed by 28 Members of Congress was sent to Secretary Leavitt requesting that he declare a public health emergency. Once again, nothing happened. A few weeks ago, 58 Members of Congress sent a letter to Secretary Leavitt requesting that he declare a public health emergency. I would like to thank Congressman McCrery and Foley for their leadership on this effort, as well as the Members of this Subcommittee who signed on to this letter, which include: Congressman Camp, Congressman Ramstad, Congressman English and Congressman Hayworth.

In the meantime, the public health emergency has not been declared, reimbursement remains inadequate and Pam never got the continuity of treatment she needed. Pam was only able to receive IVIG when she was admitted to the intensive care unit and it was too late. Pam died in April of this year. And we will have more deaths while the government continues to study the problems of the marketplace and supply.

When will someone say that the lives of these patients are important? We continue to share stories of patients suffering, but no one takes action to restore access to IVIG.

Even with the newest reimbursement rate increases effective July 1, only one immune globulin brand will become affordable and available to some patients.

It is a national disgrace that this problem has persisted since January 2005, and nothing has been done to help save these patients lives. The long-term effects to patients who were already on disability or elderly are immeasurable.

Chairwoman Johnson, how many more patients have to suffer, how many more patients have to die to acknowledge the public health emergency that has been allowed to continue since January 2005?

I implore of the Subcommittee today, to take emergency action to restore access to IVIG.

Once again, thank you for including the IVIG patient community in today’s hearing.

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