Patients Urge Implementation of FDA Advisory Committee Recommendation for Public Health Emergency; HHS Blood Safety and Availability Advisory Committee Stresses Need for Immediate Action to Protect Patients' Lives

Business Wire, June 2, 2005

TOWSON, Md. & WASHINGTON -- The Immune Deficiency Foundation, The Neuropathy Association and The Myositis Association have united to urge the U.S. Secretary of Health and Human Services Secretary Mike Leavitt to heed a recent recommendation to declare a public health emergency. The recommendation was approved unanimously on May 16 by the Health and Human Services (HHS) Advisory Committee on Blood Safety and Availability (BSAC) in response to the effects of a Jan. 1, 2005 reduction in Medicare Part B reimbursement rates for immune globulin (IVIG or IGIV). IVIG is a human plasma product used to treat people with primary immune deficiencies, neuropathic diseases and inflammatory myopathies.

The Committee's statement follows.

The Committee finds that:

1. Since our prior recommendations of January 2005, there is a worsening crisis in the availability of and access to IGIV products that is affecting and placing patients' lives at risk (e.g., patients with immunodeficiency).

2. Changes in reimbursement of IGIV products under MMA (Medicare Modernization Act) since January 2005 have resulted in shortfalls in the reimbursement of IGIV products and their administration.

3. Immediate interventions are needed to protect patients' lives and health.

We therefore urge the Secretary:

1. To declare a public health emergency so as to enable CMS (Centers for Medicare and Medicaid Services) to apply alternative mechanisms for determination of the reimbursement schedule for IGIV products, and

2. Otherwise to assist CMS to identify effective short- and long-term solutions to the problem of unavailability of and access to IGIV products in all settings.

The three patient groups are asking Sec. Leavitt to follow the BSAC recommendation immediately.

"We cannot allow patients to die," said Marcia Boyle, CEO and chair of the Immune Deficiency Foundation (IDF). "We have an FDA-approved lifesaving therapy that cannot be used in physicians' offices because the MMA reduced reimbursement to the point that the medication isn't affordable. We are counting on Sec. Leavitt to provide immediate relief to the patients before it's too late."

The reimbursement rate reduction fails to cover the cost of IVIG and its administration in physicians' offices, resulting in patients being referred for outpatient treatment at hospitals where reimbursement rates are higher, but costs are even greater and patient care often is not tailored to individual needs. Hospitals normally purchase limited types of immune globulin, buying whatever is the least expensive, but immune globulin is not a one-size-fits-all product: Each patient has different product tolerances. In a growing number of cases, hospitals are not accepting some patients, and others cannot afford the hospital co-pay, resulting in patients going without treatment, which puts their lives at risk.

"Forcing our members who need IVIG to travel long distances and be serviced in hospitals that are not prepared or capable of delivering the correct product and service is unfair," said Bob Goldberg, executive director of The Myositis Association. "It is not just a hardship, it is a public health emergency. We strongly encourage the return of reimbursement rates to where they were prior to January 1, 2005. Access to care with the correct product in a suitable location is not something that should be denied to those who need IVIG and have devastating chronic conditions such as myositis."

The Immune Deficiency Foundation has received hundreds of calls from patients whose health is threatened by the unexpected ramifications of the MMA.

"These people are afraid they are going to die," explained Michelle Vogel, IDF's vice president of government affairs. "We cannot stress enough the need to increase the reimbursement of IVIG immediately to ensure access to all brands of IVIG in all sites of care for our community before we do start losing patients."