New Bill Offers Medicare Reimbursement Fix for Intravenous Immune Globulin(IVIG) KD

New Bill Offers Medicare Reimbursement Fix for Intravenous Immune Globulin(IVIG) KD

New Bill Offers Medicare Reimbursement Fix for Intravenous Immune Globulin

--18 patient advocacy and health care professional groups join with Congressional sponsors Reps. Israel, Brady and Schwartz to announce new legislation; call for patient access to IVIG

Last update: 2:15 p.m. EDT April 22, 2009

WASHINGTON, April 22, 2009 /PRNewswire-USNewswire via COMTEX/ -- Members of Congress and patient advocacy groups announced today the introduction of new legislation - H.R. 2002, Medicare Patient IVIG Access Act of 2009 - meant to remedy inadequate Medicare reimbursements that currently restrict patient access to Intravenous Immune Globulin (IVIG), a life-saving and life-enhancing therapy for many primary immunodeficiency diseases; chronic lymphocytic leukemia; Kawasaki disease; autoimmune and neurological conditions such as chronic inflammatory demyelinating polyneuropathy, Guillain-Barre syndrome, idiopathic thrombocytopenic purpura, myasthenia gravis, myositis, multiple sclerosis, just to name a few.

Sponsored by Reps. Israel, Brady and Schwartz, this bill is similar to legislation introduced by Sens. Kerry and Alexander in March of this year. Passage of this legislation would benefit Americans nationwide for whom IVIG is a necessary therapy to help them live with their primary immunodeficiency disease, neurological, autoimmune or other rare chronic conditions and illnesses.

"For those suffering with immune-deficiency disorders, IVIG is a life-saving and life-sustaining treatment. But because of inadequate Medicare coverage, patients are suffering," said Rep. Steve Israel. "We must fix the insufficient coverage Medicare provides for IVIG treatment, which is why I'm sponsoring legislation to help get these patients the care they need."

"Access for those who rely on IVIG therapy to sustain a normal life is an issue that must be addressed, and we are doing so by introducing this bill," said Rep. Kevin Brady. "Through my work with patients and families living with conditions that rely on IVIG, the access issue has become very close to me personally and a cookie-cutter approach like Medicare can be dangerous to this unique treatment."

Eighteen patient advocacy groups and health care professional organizations, including the Immune Deficiency Foundation and the Alliance for Plasma Therapies, already have endorsed the bill via a joint letter of support, and IVIG patients and caretakers echoed that support while sharing their personal struggles in trying to access IVIG therapy during a briefing for stakeholders today. Special guests and patient advocates included Terri Cerda, who, together with her two young daughters, battles combined immunodeficiency disease and whose family will be featured on the May 10 episode of ABC's "Extreme Makeover: Home Edition," and Nebraska State Senator Abbie Cornett, who has common variable immunodeficiency disease. Other speakers included Jenny Gardner, a patient with common variable immunodeficiency; Lt. Col. Eugene B. Richardson, ret., who has progressive chronic polyneuropathy; and Craig Orfield, staff of Senator Enzi who has idiopathic thrombocytopenic purpura.

"Since 2005, patient access to IVIG has diminished, and Medicare beneficiaries throughout the country have experienced major health problems because of reimbursement reductions," said Marcia Boyle, founder and president of the Immune Deficiency Foundation. "We are grateful for the support of Representatives Israel, Brady and Schwartz and their sponsorship of this critical legislation that is designed to restore access to this vital therapy, and we are heartened by the overwhelming support from the patient advocacy community."

"Today is an unprecedented day to see so many different disease groups come together as a unified voice to strongly urge Congress to fix the unintended consequence of the Medicare Modernization Act which has caused Medicare beneficiaries to lose access to their lifesaving plasma therapy, IVIG, and has caused detrimental consequences to their health," said Michelle Vogel, executive director of the Alliance for Plasma Therapies. "We applaud Representatives Israel, Brady and Schwartz for championing this issue to restore patient access to this vital therapy in all sites of care."

About the Immune Deficiency Foundation

The Immune Deficiency Foundation is the national patient organization dedicated to improving the diagnosis, treatment and quality of life of persons with primary immunodeficiency diseases through advocacy, education, and research. To learn more about IDF, visit www.primaryimmune.org

About the Alliance for Plasma Therapies

The Alliance for Plasma Therapies is a national non-profit organization established to provide a unified, powerful voice of patient organizations, healthcare providers and industry leaders to educate about the diseases that rely on plasma derived therapies and advocate for fair access to plasma therapies for patients who benefit from their lifesaving effects. To learn more about the Alliance, visit www.plasmaalliance.org.

Patient Advocacy Organizations and Professional Societies Supporting the Medicare Patient IVIG Access Act of 2009

Immune Deficiency Foundation, Alliance for Plasma Therapies, American Academy of Asthma, Allergy and Immunology, American Autoimmune Related Diseases Association, American Partnership for Eosinophilic Disorders, A-T Children's Project, Clinical Immunology Society, Foundation for Peripheral Neuropathy, GBS/CIDP Foundation International, Infusion Nurses Society, International Pemphigus and Pemphigoid Foundation, Jeffrey Modell Foundation, The Myositis Association, National Patient Advocate Foundation, The Neuropathy Association, Neuropathy Action Foundation, Patient Services Inc., and Platelet Disorder Support Association.

SOURCE Immune Deficiency Foundation

http://www.primaryimmune.org

What is Kawasaki Disease

Kawasaki (KAH'wah-SAH'ke) disease is a children's illness. It's also known as Kawasaki syndrome or mucocutaneous (mu"ko-ku-TA'ne-us) lymph node syndrome. It and acute rheumatic (roo-MAT'ik) fever are the two leading causes of acquired heart disease in children in the United States.

Kawasaki disease is an acute, self-limited vasculitis of unknown etiology that occurs predominantly in infants and young children. First described in Japan in l967 by Tomisaku Kawasaki, the disease is now known to occur in both endemic and community-wide epidemic forms in the Americas, Europe, and Asia in children of all races.¹ Kawasaki disease is characterized by fever, bilateral nonexudative conjunctivitis, erythema of the lips and oral mucosa, changes in the extremities, rash, and cervical lymphadenopathy. Coronary artery aneurysms or ectasia develop in 15% to 25% of untreated children with the disease and may lead to myocardial infarction (MI), sudden death, or ischemic heart disease.^2,3 In the United States, Kawasaki disease has surpassed acute rheumatic fever as the leading cause of acquired heart disease in children.⁴ Treatment of Kawasaki disease in the acute phase is directed at reducing inflammation in the coronary artery wall and preventing coronary thrombosis, whereas long-term therapy in individuals who develop coronary aneurysms is aimed at preventing myocardial ischemia or infarction.

A new feature of these recommendations is an algorithm for the evaluation and treatment of patients in whom incomplete or atypical Kawasaki disease is suspected (refer to Criteria for Treatment of Kawasaki Disease later in this statement and Figure 1). We attempt to summarize the current state of knowledge of the management of patients with Kawasaki disease. The recommendations are evidence based and derived from published data wherever possible. The levels of evidence on which recommendations are based are classified as follows: level A (highest), multiple randomized clinical trials; level B (intermediate), limited number of randomized trials, nonrandomized studies, and observational registries; and level C (lowest), primarily expert consensus.

What Happens to those that get Kawasaki Disease (KD for short)

The symptoms of Kawasaki disease include...

• fever
• rash
• swollen hands and feet
• irritation and redness of the whites of the eyes
• swollen lymph glands in the neck
• irritation and inflammation of the mouth, lips and throat

Doctors don't know what causes Kawasaki disease, but it doesn't seem to be hereditary or contagious. Scientists who've studied it think the evidence strongly suggests it's caused by an infectious agent such as a virus. It's very rare for more than one child in a family to develop Kawasaki disease. Less than 2 percent of children have another attack of Kawasaki disease.

In as many as 15 to 25 percent of the children with Kawasaki disease, the heart is affected. The coronary arteries or the heart muscle itself can be damaged.

How does Kawasaki disease affect the heart?

The coronary arteries are most often affected. Part of a coronary wall can be weakened and balloon (bulge out) in an aneurysm. A blood clot can form in this weakened area and block the artery, sometimes leading to a heart attack. The aneurysm can also burst, but this rarely happens.

Other changes include inflammation of the heart muscle (myocarditis) or the sac surrounding the heart (pericarditis). Arrhythmias (abnormal heart rhythms) or abnormal functioning of some heart valves also can occur.

Usually all the heart problems go away in five or six weeks, and there's no lasting damage. Sometimes coronary artery damage persists, however.

An arrhythmia or damaged heart muscle can be detected using an electrocardiogram (EKG). An echocardiogram (or "echo") is used to look for possible damage to the heart or coronary arteries.

How is Kawasaki disease treated?

Even though the cause of Kawasaki disease is unknown, certain medicines are known to help. Aspirin is often used to reduce fever, rash, joint inflammation and pain, and to help prevent blood clots from forming. Another medicine, intravenous gamma globulin,(also know as IVIG) can decrease the risk of developing coronary artery abnormalities when given early in the illness.

Figure 1. Evaluation of suspected incomplete Kawasaki disease. (1) In the absence of gold standard for diagnosis, this algorithm cannot be evidence based but rather represents the informed opinion of the expert committee. Consultation with an expert should be sought anytime assistance is needed. (2) Infants 6 months old on day 7 of fever without other explanation should undergo laboratory testing and, if evidence of systemic inflammation is found, an echocardiogram, even if the infants have no clinical criteria. (3) Patient characteristics suggesting Kawasaki disease are listed in Table 1. Characteristics suggesting disease other than Kawasaki disease include exudative conjunctivitis, exudative pharyngitis, discrete intraoral lesions, bullous or vesicular rash, or generalized adenopathy. Consider alternative diagnoses (see Table 2). (4) Supplemental laboratory criteria include albumin 3.0 g/dL, anemia for age, elevation of alanine aminotransferase, platelets after 7 d 450 000/mm3, white blood cell count 15 000/mm3, and urine 10 white blood cells/high-power field. (5) Can treat before performing echocardiogram. (6) Echocardiogram is considered positive for purposes of this algorithm if any of 3 conditions are met: z score of LAD or RCA 2.5, coronary arteries meet Japanese Ministry of Health criteria for aneurysms, or 3 other suggestive features exist, including perivascular brightness, lack of tapering, decreased LV function, mitral regurgitation, pericardial effusion, or z scores in LAD or RCA of 2–2.5. (7) If the echocardiogram is positive, treatment should be given to children within 10 d of fever onset and those beyond day 10 with clinical and laboratory signs (CRP, ESR) of ongoing inflammation. (8) Typical peeling begins under nail bed of fingers and then toes.

Recommendations for initial evaluation, treatment in the acute phase, and long-term management of patients with Kawasaki disease are intended to assist physicians in understanding the range of acceptable approaches for caring for patients with Kawasaki disease. Where published data do not define well the best medical practices, our report provides practical interim recommendations. Ultimately, management decisions must be individualized to a patient’s specific circumstances.