§247d–6e Covered countermeasure process

Summary

When the Secretary issues the emergency declaration under 247d–6d(b), the Treasury must set up the "Covered Countermeasure Process Fund" using emergency money designated under section 402 of H. Con. Res. 95 of the 109th Congress. That emergency designation lasts through October 1, 2006. After money is provided, the Secretary must pay eligible people who suffer serious injury or death that was directly caused by a covered countermeasure used under the declaration. Payments follow the same types and amounts as the laws that cover certain smallpox vaccine injuries (sections 239c, 239d, and 239e), except section 239e(a)(2)(B) does not apply. Reasonable medical care and lifetime lost‑work benefits for permanent total disability are not limited by section 239e. How eligibility, injuries, and amounts are decided will generally follow the rules in section 239a (except subsection (d)(2)), the regulations under that section, and any extra rules the Secretary makes. Except for the special presumptions described below, decisions must be based only on strong, reliable medical and scientific evidence. The Secretary must make a table, by regulation, listing injuries that will be presumed to be caused by the countermeasure and the time window when symptoms must first appear for the presumption to apply. Injuries may be put on that table only when strong, reliable medical and scientific evidence supports it. Section 239b mostly applies to that table, except the part in subsection (a)(2) about accidental vaccinia inoculation. No court may review the Secretary’s actions about the table. States and HHS must follow the declaration and CDC guidance when they plan to use a covered countermeasure and must tell people about contraindications, that participation is voluntary, and that compensation may be available. A person generally must use the Fund process before suing a covered person, unless funds were not provided or the Secretary fails to make a final decision within 240 days after a claim was filed. Filing deadlines for lawsuits pause while a Fund claim is pending. If the Secretary finds someone eligible, that person can either accept the Fund payment and give up the right to sue, or decline the payment and sue instead. Key terms: covered countermeasure = defined in 247d–6d; covered individual = someone in the group named in the declaration or who used the measure in good faith thinking they were; covered injury = serious physical injury or death; declaration = under 247d–6d(b); eligible individual = a covered individual found to have a covered injury.