Representative Christopher Cox (R-CA), Chairman of the House Policy Committee and Chairman of the Homeland Security Committee, today introduced the Medicare Patient Access to Drugs for Rare Diseases Act of 2003. The Act is co-sponsored by Representatives Norwood (R-GA), Issa (R-CA), Engel (D-NY), Boucher (D-VA), Berman (D-CA), Pomeroy (R-CA) and McDermott (D-WA).
The Medicare Patient Access to Drugs for Rare Diseases Act of 2003, H.R.2700, will ensure that Medicare beneficiaries have continued access to critical orphan drugs, in addition to providing pharmaceutical manufactures with renewed incentives to continue developing these life-saving medical treatments.
More the 25 million American from one of 6,000 rare diseases as catalogued by the National Institutes of Health Included among these 6,000 diseases are Huntington's disease, ALS (Lou Gehrig's disease), primary pulmonary hypertension, porphyria, muscular dystrophy, cystic fibrosis, tuberous sclerosis, and hemophilia. Twenty years ago, Congress passed the Orphan Drug Act of 1983 to stimulate the development of new treatments for persons with these rare diseases. Since then, more than 240 new "orphan drugs" have been approved by the Food and Drug Administration.
When Congress adopted the Medicare Hospital Outpatient Prospective Payment System in 1999, it placed orphan drugs in a category that provided sufficient reimbursement for these treatments to assure continuing access for rare disease patients. Unfortunately, in 2003 the Center for Medicare and Medicaid Services implemented new rules which only cover four orphan drugs. As a result, Medicare reimbursement for all other orphan drugs will be cut by as much as 35 percent, which will impose severe financial burdens on hospitals who want to continue to provide that latest treatment to people who suffer from these rare diseases.
"Our Bill clarifies Congressional intent under the 1999 lay to ensure that all orphan drugs will be covered," said Chairman Cox. "Without this bill, beneficiaries who suffer from rare diseases may be denied treatment because healthcare providers refuse to administer orphan drugs. Congress can not allow this to happen."
Friday, July 11, 2003: Contact: Kate Whitman: 202-225-5611
What is a Rare Disease or Disorder?
Rare diseases and disorders are those which affect small patient populations, defined as fewer than 200,000 individuals in the United States. Taken together 25,000,000 Americans suffer from one of 6,000 rare diseases or disorders.
Rheumatic disease represents more that 100 different diseases that are chronic and unpredictable. More than 40 million Americans, or one in six, have a rheumatic disease, including more than 285,000 children. Rheumatic disease as a group are the most frequently occurring chronic illness in the United States. It is a leading cause of work-related disability in people age 16-72 and is the leading cause of disability for Americans over 65.
You can make a difference!
Please contact your Senators and Representatives today and ask that NORD's proposal be included in the Medicare bills now being considered by the House and Senate. Ask them to protect access to drugs and biologics provided to Medicare beneficiaries in the hospital outpatient setting. Let them know that the current CMS rule is completely counter to Congressional intent going back twenty years when they passed the Orphan Drug Act to encourage development of "orphan" therapies for patients affected by rare diseases.
Remember that the rare disease community CAN impact public policy. Just look at what we were able to accomplish in just 15 short months with the passage of the Rare Disease Act. (P.L. 107-280) and the Rare Diseases Orphan Product Act (P.L. 107-281).
