THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release April 1, 1993
"Comprehensive Child Immunization Act of 1993"
FACT SHEET
The President today sent to the Congress the "Comprehensive Child Immunization Act of 1993". This bill is the first legislative proposal he has sent to the Congress for consideration and enactment. When enacted, the bill will assure that all children in the United States are protected against vaccine-preventable infectious diseases by their second birthday. This legislation inaugurates a new collaborative partnership among parents and guardians; health care providers; vaccine manufacturers; and Federal, State, and local governments to protect our children from the deadly onslaught of infectious diseases.
This legislation would:
Background
Immunizations represent one of the most cost-effective means of disease prevention. Although Federal support for childhood immunization has been in existence since 1962, the full potential of immunizations remains to be achieved.
Approximately 80 percent of vaccine doses should be received before the second birthday in order to protect children during their most vulnerable periods. Unfortunately, many children do not receive their basic immunizations by that time. In fact, in some inner city areas as few as 10 percent of 2-year olds have received a complete series. This low level of immunizations has been reflected in recent years in outbreaks of measles among unimmunized preschool children. The resurgence of measles in 1989 through 1991 afflicted over 55,000 people and cost the country $20 million in avoidable hospital costs alone.
In 1982, the recommended vaccine schedule cost $6.69 in the public sector and $23.29 in the private sector. By 1992, the total cost for fully immunizing a child was $122.28 in the public sector and $244.10 in the private sector.
Legislative Proposal
The problem posed by soaring vaccine costs is exacerbated by a deteriorated immunization infrastructure. This legislation continues the rebuilding of our capacity to deliver vaccines and educate parents started in my economic stimulus package. With this bill, our Nation's vaccine infrastructure will continue to be revitalized, including delivery, safety and research capacity, patient and vaccine tracking ability, and the community-based outreach and information campaign.
To remove the financial barriers to immunization that impede children from being vaccinated on time, and to facilitate development of a national tracking system, we must begin Federal purchase of all vaccines recommended for universal use in children.
Universal Vaccine Purchase and Provision
The bill would require that the Secretary consult with other Federal agencies for advice on the quantities of recommended childhood vaccine to be purchased. It would authorize the Secretary to consult with representatives of State governments, experts in vaccine delivery, health care providers, and other experts prior to commencing negotiations for the purchase of vaccine.
This proposal would direct the Secretary to negotiate a reasonable price with manufacturers participating in a procurement. The price would be based on data supplied to the Secretary by manufacturers regarding (1) costs related to research and development, production, distribution to States and health care providers, and marketing; (2) profit levels sufficient to encourage future investment in research and development; and (3) the ability to maintain adequate outbreak control. In addition, the bill would require that data provided to the Secretary be treated as a trade secret or confidential information for purposes of the Freedom of Information Act and would provide criminal sanctions for violations of this provision.
Under this legislation, the Secretary would provide (either directly or through the States) for the free distribution of vaccines to health care providers who serve children and are
located in a State that participates in the State registry grant program. In non-participating States, free vaccine will be distributed to Federal health care providers, community health centers, migrant health centers, health centers serving residents of public housing or the homeless, other federally qualified health centers, and health care providers serving Indians pursuant to the Indian Self-Determination Act or section 503 of the Indian Health Care Improvement Act.
Under the Act, health care providers could not charge patients for the cost of the vaccine, but may impose a fee for its administration unless such a fee would result in the denial of a vaccine to someone unable to pay.
Finally, the bill provides that the authority of the Secretary established under this legislation to purchase and provide vaccines shall cease to be in effect beginning on such date as may be specified in a Federal law providing for immunization services for all children as part of a broad-based reform of the national health care system.
State Immunization Registries
The bill provides for a collaborative Federal and State effort to track the immunization status of the Nation's children. It authorizes the Secretary to make grants to States to establish and operate State immunization registries containing specific information for each child in the State. Entering infant birth data into registries will enable the identification of children who need vaccinations and will help parents and providers assure that children are appropriately immunized.
Providers would be required to report to the State tracking registry (or to the Secretary if there is no State registry) information regarding each vaccine administered and their periodic estimates of the future vaccine needs. For each child, information will be gathered on immunization history, including types and lot numbers of vaccines received, health care provider identifiers, and adverse reactions associated with the immunizations. In addition, the State immunization registries will provide vital information on safety and efficacy of vaccines by linking administrative records with adverse reactions reporting and disease outbreak patterns.
The National Vaccine Compensation Program
A keystone to the Nation's vaccine immunization effort is the National Vaccine Injury Compensation Program. This proposal would amend the Internal Revenue Code to allow payments from the Trust Fund for compensable injuries from vaccines administered on or after October 1, 1992. It would authorize appropriations from the Trust Fund for years after fiscal year 1992 for administrative costs to carry out the National Vaccine Injury Compensation Program. In addition, it would provide for a permanent extension and reinstatement of the vaccine excise tax and repeal the Internal Revenue Code provision that authorizes the Secretary of the Treasury to terminate the vaccine excise tax.
Other provisions related to the National Vaccine Injury Compensation program state that any vaccine recommended for universal administration to children by the Secretary would be included on the Vaccine Injury Table. The bill would provide the Secretary authority, with respect to any vaccine so added, to modify the Table, but only in accordance with notice, hearing, and comment procedures, and other limitations. The chief special master would be allowed to suspend proceedings on petitions from retrospective claims for up to 30 months, rather than the 540 days (or 18 months) in current law.
Finally, vaccine information materials would be simplified by replacing the detailed list of items that must be addressed in the information materials with a requirement for a concise and understandable statement of the benefits and risks of the vaccine, and the availability of the National Vaccine Injury Compensation Program.
Funding
For the purpose of making State registry grants, the bill would authorize appropriations of $152 million for fiscal year 1995, $125 million for fiscal year 1996, and $35 million for each of the fiscal years 1997, 1998, and 1999. In addition, the bill would authorize appropriations of such sums as may be necessary for fiscal years 1993 and 1994 for start up costs associated with activities to implement the "Comprehensive Child Immunization Act of 1993."
Beginning in fiscal year 1995, the bill would authorize the Secretary to carry out the program of vaccine purchase and distribution from the Comprehensive Child Immunization Account in the United States Treasury. The sources of revenue that will be deposited into the Comprehensive Child Immunization Account for the vaccine purchase and distribution program will be identified in legislation for broad-based reform of the national health care system when it is submitted to the Congress by the President in May.
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