HF 2333 (LSB 5237YH (4) 90)

HOUSE FILE 2333

BY  SHIPLEY

A BILL FOR

An Act relating to the establishment and administration of a state vaccine adverse event reporting system and a state vaccine injury compensation program, and providing a standing appropriation.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  NEW SECTION.  135.194  Definitions.
   As used in this subchapter, unless the context otherwise requires:
   1.  “Federal vaccine adverse event reporting system” means the national vaccine safety surveillance program comonitered by the United states food and drug administration and the centers for disease control and prevention of the United States department of health and human services.
   2.  “National vaccine injury compensation program” means the national vaccine injury compensation program established pursuant to 42 U.S.C. §300aa-10 and administered by the division of compensation programs, health care systems bureau, health resources and services administration, United States department of health and human services.
   3.  “State vaccine adverse event reporting system” or “state system” means the state vaccine adverse event reporting system established in section 135.195.
   4.  “State vaccine injury compensation program” or “state program” means the state vaccine injury compensation program established in section 135.195.
   5.  “Vaccine” means any vaccine or immunization required pursuant to section 139A.8 for a person’s enrollment in any licensed child care center or elementary or secondary school in Iowa.
    Sec. 2.  NEW SECTION.  135.195  State vaccine adverse event reporting system —— state vaccine injury compensation program —— established.
   1.  The department shall establish a state vaccine adverse event reporting system and vaccine injury compensation program that replicates at the state level the federal vaccine adverse event reporting system and the national vaccine injury compensation program, including required reporting and compensation provisions.
   2.  a.  The state system and state program shall provide information to the public regarding the process for reporting potential vaccine injuries to both the federal reporting system and national compensation program, and the state system and state program.
   b.  The state system and the state program shall provide technical assistance and training to health care providers who administer vaccines to ensure the health care providers respond to and report all potential vaccine injury cases brought to the health care providers’ attention. The state system and state program shall work with health professional licensing boards and professional organizations to provide continuing education and vaccine safety and efficacy training for all health care providers based on information provided by the centers for disease control and prevention of the United States department of health and human services, the federal food and drug administration, the national vaccine injury compensation program, vaccine manufacturer package inserts, and current research.
   c.  The state system and state program shall annually provide a public forum on vaccine adverse events that includes participants who are vaccine injury victims. The public forum shall provide information on the requirements health care providers who administer vaccines must meet, including providing a copy of the vaccine information statement when a vaccine is administered pursuant to 42 U.S.C. §300aa-26, recording provision of the vaccine information statement and other required information in the patient’s medical record, and the process for making a vaccine adverse event report.
   d.  The department shall establish a vaccine injury board to advise the department in administering the state system and state program. The board shall be composed of health care providers, and at least one-half of the members of the board shall be vaccine injury victims or parents or legal guardians of vaccine injury victims who are minors.
   e.  The department shall provide an annual report to the governor and the general assembly regarding the number of vaccine adverse event reports made and the amount of compensation provided by the state.
   3.  The department shall adopt rules pursuant to chapter 17A to administer the state system and the state program.
    Sec. 3.  NEW SECTION.  135.196  State vaccine injury compensation program trust fund.
   1.  A state vaccine injury compensation program trust fund is created in the office of the treasurer of state. The trust fund shall consist of moneys appropriated under section 135.197 and deposited in the trust fund. Moneys in the trust fund shall be separate from the general fund of the state and shall not be considered part of the general fund of the state. Moneys in the trust fund are not subject to section 8.33 and shall not be transferred, used, obligated, appropriated, or otherwise encumbered, except as provided in this section. Notwithstanding section 12C.7, subsection 2, interest or earnings on moneys deposited in the trust fund shall be credited to the trust fund.
   2.  Moneys in the trust fund are appropriated to the department and shall be used only for compensation of vaccine injuries as provided under the state program.
    Sec. 4.  NEW SECTION.  135.197  Standing appropriation.
   There is appropriated annually from the general fund of the state for deposit in the state vaccine injury compensation program trust fund created in section 135.196 an amount sufficient to cover the costs of compensation of vaccine injuries as provided under the state program.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill requires the department of health and human services (HHS) to establish a state vaccine adverse event reporting system (state system) and a state vaccine injury compensation program (state program). The state system and state program are to replicate the federal vaccine adverse event reporting system (federal system) and the national vaccine injury compensation program (federal program), and the state system and the state program are to be applicable to any vaccine or immunization required pursuant to Code section 139A.8 (immunization of children) for a person’s enrollment in any licensed child care center or elementary or secondary school in Iowa.
   The bill requires the state system and state program to provide information to the public regarding the process for reporting potential vaccine injuries to both the federal system and federal program and the state system and state program. The state system and state program shall also provide technical assistance and training to health care providers who administer vaccines to ensure health care providers respond to and report all potential vaccine injury cases brought to the health care providers’ attention; and shall work with health professional licensing boards and professional organizations to provide continuing education and vaccine safety and efficacy training for all health care providers based on information provided by the centers for disease control and prevention of the United States department of health and human services, the federal food and drug administration, the national vaccine injury compensation program, vaccine manufacturer package inserts, and current research. The state system and state program are also required to annually provide a public forum on vaccine adverse events that includes participants who are vaccine injury victims. HHS shall establish a vaccine injury board to advise HHS in administering the state system and state program. The board shall be composed of health care providers, and at least one-half of the members of the board shall be vaccine injury victims or parents or legal guardians of victims who are minors. HHS shall provide an annual report to the governor and the general assembly regarding the number of vaccine adverse event reports made and the amount of compensation provided through the state system and the state program. HHS shall adopt administrative rules to administer the state system and the state program.
   The bill also establishes a state vaccine injury compensation program trust fund in the office of the treasurer of state. The trust fund consists of moneys appropriated annually from the general fund of the state for deposit in the state vaccine injury compensation program trust fund in an amount sufficient to cover the costs of compensation of vaccine injuries as provided under the state program. The moneys in the trust fund are appropriated to HHS to be used only for compensation of vaccine injuries as provided under the state program.