42 U.S.C. § 247d–6e — Covered countermeasure process

(a) Establishment of Fund. Once the Secretary issues a declaration under section 247d–6d(b), the law creates an emergency fund in the Treasury called the "Covered Countermeasure Process Fund," meant to give eligible individuals timely, uniform, and adequate compensation for covered injuries directly caused by administering or using a covered countermeasure under that declaration. The Fund is made up of the amounts designated as emergency appropriations under section 402 of H. Con. Res. 95 of the 109th Congress; that emergency designation stayed in effect through October 1, 2006. (b) Payment of compensation. (1) In general. If the Secretary issues a declaration under section 247d–6d(b), the Secretary must, once money has been legally provided for the Fund under subsection (a), compensate an eligible individual for a covered injury the countermeasure directly caused. (2) Elements of compensation. Compensation follows the same elements and amounts set out in sections 239c, 239d, and 239e for people injured by certain smallpox countermeasures — except that section 239e(a)(2)(B) does not apply here. (3) Rule of construction. Section 239e's limits don't cap either reasonable and necessary medical benefits or lifetime total benefits for lost employment income due to permanent and total disability. (4) Determination of eligibility and compensation. Except as this section otherwise says, the procedures for deciding — and reviewing decisions about — whether someone is an eligible individual, whether that person suffered a covered injury, whether compensation is available, and how much, are the procedures in section 239a (other than part of subsection (d)(2)), the regulations issued under that section, and any additional or alternate regulations the Secretary issues for this program. Except for direct-causation decisions described in paragraph (5)(A), the Secretary can decide these questions only based on compelling, reliable, valid medical and scientific evidence. (5) Covered countermeasure injury table. (A) The Secretary must set up, by regulation, a table of covered injuries presumed to be directly caused by administering or using a covered countermeasure, along with the time window in which the first symptom must appear for the presumption to apply. The Secretary may only add an injury to the table if the Secretary determines, based on compelling, reliable, valid medical and scientific evidence, that the countermeasure directly caused it. (B) The rules in section 239b for amending that kind of table apply to this table too, except for the part of subsection (a)(2) of that section dealing with accidental vaccinia inoculation. (C) No U.S. or state court has authority to review, by mandamus or otherwise, any Secretary action under this paragraph. (6) Meanings of terms. In applying sections 239a through 239e for this program: the terms "vaccine" and "smallpox vaccine" mean a covered countermeasure; the terms "smallpox vaccine injury table" and "table established under section 239b" mean the table established under paragraph (4); and other terms used in those sections carry the meaning this section gives them. (c) Voluntary program. The Secretary must make sure that any state, local, or Department of Health and Human Services plan to administer or use a covered countermeasure matches any applicable declaration under section 247d–6d and any applicable CDC guidelines, and that potential participants are told about contraindications, the fact that the program is voluntary, and the benefits and compensation that may be available. (d) Exhaustion; exclusivity; election. (1) Exhaustion. Except as paragraph (5) allows, a covered individual can't sue a covered person (as defined in section 247d–6d(i)(2)) under section 247d–6d(d) until exhausting the remedies available under subsection (a) — unless money hasn't yet been legally provided for the Fund under subsection (a), or the Secretary hasn't made a final decision on a benefits or compensation request within 240 days after it was filed. In either of those two situations, the individual may pursue any remedy available under section 247d–6d(d) instead. (2) Tolling of statute of limitations. The filing deadline for a lawsuit under section 247d–6d(d) for an injury or death is paused while a compensation claim under subsection (a) is pending. (3) Rule of construction. This section doesn't change any requirement, under chapter 171 of title 28, to exhaust administrative remedies. (4) Exclusivity. The subsection (a) compensation remedy is the only civil remedy for any claim or lawsuit this section covers, except for a proceeding under section 247d–6d. (5) Election. If the Secretary decides under subsection (a) that a covered individual qualifies for compensation, that individual can choose to accept the compensation or instead bring a lawsuit under section 247d–6d(d) — but if the individual accepts the compensation, that individual can't also bring the lawsuit. (e) Definitions. (1) "Covered countermeasure" has the meaning given in section 247d–6d. (2) "Covered individual" means, for administering or using a covered countermeasure under a declaration, an individual who is in the population the declaration names and for whom the administration or use meets the declaration's other requirements, or who uses or receives the countermeasure in a good-faith belief that they fit that description. (3) "Covered injury" means serious physical injury or death. (4) "Declaration" means a declaration under section 247d–6d(b). (5) "Eligible individual" means an individual determined, under subsection (b), to be a covered individual who suffered a covered injury.