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Pub.L. 108-021 To prevent child abduction and the sexual exploitation of children, and for other purposes. <> ...


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[[Page 637]]

           SMALLPOX EMERGENCY PERSONNEL PROTECTION ACT OF 2003

[[Page 117 STAT. 638]]

Public Law 108-20
108th Congress

                                 An Act


 
To provide benefits and other compensation for certain individuals with 
injuries resulting from administration of smallpox countermeasures, and 
       for other purposes. <<NOTE: Apr. 30, 2003 -  [H.R. 1770]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress <<NOTE: Smallpox Emergency 
Personnel Protection Act of 2003.>> assembled,

SECTION 1. <<NOTE: 42 USC 201 note.>> SHORT TITLE.

    This Act may be cited as the ``Smallpox Emergency Personnel 
Protection Act of 2003''.

 SEC. 2. SMALLPOX EMERGENCY PERSONNEL PROTECTION.

    Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is 
amended by adding at the end the following part:

            ``Part C--Smallpox Emergency Personnel Protection

``SEC. 261. <<NOTE: 42 USC 239.>> GENERAL PROVISIONS.

    ``(a) Definitions.--For purposes of this part:
            ``(1) Covered countermeasure.--The term `covered 
        countermeasure' means a covered countermeasure as specified in a 
        Declaration made pursuant to section 224(p).
            ``(2) Covered individual.--The term `covered individual' 
        means an individual--
                    ``(A) who is a health care worker, law enforcement 
                officer, firefighter, security personnel, emergency 
                medical personnel, other public safety personnel, or 
                support personnel for such occupational specialities;
                    ``(B) who is or will be functioning in a role 
                identified in a State, local, or Department of Health 
                and Human Services smallpox emergency response plan (as 
                defined in paragraph (7)) approved by the Secretary;
                    ``(C) who has volunteered and been selected to be a 
                member of a smallpox emergency response plan described 
                in subparagraph (B) prior to the time at which the 
                Secretary publicly announces that an active case of 
                smallpox has been identified either within or outside of 
                the United States; and
                    ``(D) to whom a smallpox vaccine is administered 
                pursuant to such approved plan during the effective 
                period of the Declaration (including the portion of such 
                period before the enactment of this part).
            ``(3) Covered injury.--The term `covered injury' means an 
        injury, disability, illness, condition, or death (other than a 
        minor injury such as minor scarring or minor local reaction)

[[Page 117 STAT. 639]]

        determined, pursuant to the procedures established under section 
        262, to have been sustained by an individual as the direct 
        result of--
                    ``(A) administration to the individual of a covered 
                countermeasure during the effective period of the 
                Declaration; or
                    ``(B) accidental vaccinia inoculation of the 
                individual in circumstances in which--
                          ``(i) the vaccinia is contracted during the 
                      effective period of the Declaration or within 30 
                      days after the end of such period;
                          ``(ii) smallpox vaccine has not been 
                      administered to the individual; and
                          ``(iii) the individual has been in contact 
                      with an individual who is (or who was accidentally 
                      inoculated by) a covered individual.
            ``(4) Declaration.--The term `Declaration' means the 
        Declaration Regarding Administration of Smallpox Countermeasures 
        issued by the Secretary on January 24, 2003, and published in 
        the Federal Register on January 28, 2003.
            ``(5) Effective period of the declaration.--The term 
        `effective period of the Declaration' means the effective period 
        specified in the Declaration, unless extended by the Secretary.
            ``(6) Eligible individual.--The term `eligible individual' 
        means an individual who is (as determined in accordance with 
        section 262)--
                    ``(A) a covered individual who sustains a covered 
                injury in the manner described in paragraph (3)(A); or
                    ``(B) an individual who sustains a covered injury in 
                the manner described in paragraph (3)(B).
            ``(7) Smallpox emergency response plan.--The term `smallpox 
        emergency response plan' or `plan' means a response plan 
        detailing actions to be taken in preparation for a possible 
        smallpox-related emergency during the period prior to the 
        identification of an active case of smallpox either within or 
        outside the United States.

    ``(b) Voluntary Program.--
The <<NOTE: Procedures. Applicability.>> Secretary shall ensure that a 
State, local, or Department of Health and Human Services plan to 
vaccinate individuals that is approved by the Secretary establishes 
procedures to ensure, consistent with the Declaration and any applicable 
guidelines of the Centers for Disease Control and Prevention, that--
            ``(1) potential participants are educated with respect to 
        contraindications, the voluntary nature of the program, and the 
        availability of potential benefits and compensation under this 
        part;
            ``(2) there is voluntary screening provided to potential 
        participants that can identify health conditions relevant to 
        contraindications; and
            ``(3) there is appropriate post-inoculation medical 
        surveillance that includes an evaluation of adverse health 
        effects that may reasonably appear to be due to such vaccine and 
        prompt referral of, or the provision of appropriate information 
        to, any individual requiring health care as a result of such 
        adverse health event.

[[Page 117 STAT. 640]]

``SEC. 262. <<NOTE: 42 USC 239a.>> DETERMINATION OF ELIGIBILITY AND 
            BENEFITS.

    ``(a) In General.--The <<NOTE: Procedures.>> Secretary shall 
establish procedures for determining, as applicable with respect to an 
individual--
            ``(1) whether the individual is an eligible individual;
            ``(2) whether an eligible individual has sustained a covered 
        injury or injuries for which medical benefits or compensation 
        may be available under sections 264 and 265, and the amount of 
        such benefits or compensation; and
            ``(3) whether the covered injury or injuries of an eligible 
        individual caused the individual's death for purposes of 
        benefits under section 266.

    ``(b) Covered Individuals.--The Secretary may accept a 
certification, by a Federal, State, or local government entity or 
private health care entity participating in the administration of 
covered countermeasures under the Declaration, that an individual is a 
covered individual.
    ``(c) Criteria for Reimbursement.--
            ``(1) Injuries specified in injury table.--In any case where 
        an injury or other adverse effect specified in the injury table 
        established under section 263 as a known effect of a vaccine 
        manifests in an individual within the time period specified in 
        such table, such injury or other effect shall be presumed to 
        have resulted from administration of such vaccine.
            ``(2) Other determinations.--In making determinations other 
        than those described in paragraph (1) as to the causation or 
        severity of an injury, the Secretary shall employ a 
        preponderance of the evidence standard and take into 
        consideration all relevant medical and scientific evidence 
        presented for consideration, and may obtain and consider the 
        views of qualified medical experts.

    ``(d) Deadline for Filing Request.--The Secretary shall not consider 
any request for a benefit under this part with respect to an individual, 
unless--
            ``(1) in the case of a request based on the administration 
        of the vaccine to the individual, the individual files with the 
        Secretary an initial request for benefits or compensation under 
        this part not later than one year after the date of 
        administration of the vaccine; or
            ``(2) in the case of a request based on accidental vaccinia 
        inoculation, the individual files with the Secretary an initial 
        request for benefits or compensation under this part not later 
        than two years after the date of the first symptom or 
        manifestation of onset of the adverse effect.

    ``(e) Structured Settlements at Secretary's Option.--In any case in 
which there is a reasonable likelihood that compensation or payment 
under section 264, 265, or 266(b) will be required for a period in 
excess of one year from the date an individual is determined eligible 
for such compensation or payment, the Secretary shall have the 
discretion to make a lump-sum payment, purchase an annuity or medical 
insurance policy, or execute an appropriate structured settlement 
agreement, provided that such payment, annuity, policy, or agreement is 
actuarially determined to have a value equal to the present value of the 
projected total amount of benefits or compensation that the individual 
is eligible to receive under such section or sections.
    ``(f) Review of Determination.--

[[Page 117 STAT. 641]]

            ``(1) Secretary's review authority.--The Secretary may 
        review a determination under this section at any time on the 
        Secretary's own motion or on application, and may affirm, 
        vacate, or modify such determination in any manner the Secretary 
        deems appropriate. The Secretary shall develop a process by 
        which an individual may file a request for reconsideration of 
        any determination made by the Secretary under this section.
            ``(2) Judicial and administrative review.--No court of the 
        United States, or of any State, District, territory or 
        possession thereof, shall have subject matter jurisdiction to 
        review, whether by mandamus or otherwise, any action by the 
        Secretary under this section. No officer or employee of the 
        United States shall review any action by the Secretary under 
        this section (unless the President specifically directs 
        otherwise).

``SEC. 263. <<NOTE: 42 USC 239b.>> SMALLPOX VACCINE INJURY TABLE.

    ``(a) Smallpox Vaccine Injury Table.--
            ``(1) Establishment required.--
        The <<NOTE: Regulations.>> Secretary shall establish by interim 
        final regulation a table identifying adverse effects (including 
        injuries, disabilities, illnesses, conditions, and deaths) that 
        shall be presumed to result from the administration of (or 
        exposure to) a smallpox vaccine, and the time period in which 
        the first symptom or manifestation of onset of each such adverse 
        effect must manifest in order for such presumption to apply.
            ``(2) Amendments.--The Secretary may by regulation amend the 
        table established under paragraph (1). An amendment to the table 
        takes effect on the date of the promulgation of the final rule 
        that makes the amendment, and applies to all requests for 
        benefits or compensation under this part that are filed on or 
        after such date or are pending as of such date. In addition, the 
        amendment applies retroactively to an individual who was not 
        with respect to the injury involved an eligible individual under 
        the table as in effect before the amendment but who with respect 
        to such injury is an eligible individual under the table as 
        amended. With respect to a request for benefits or compensation 
        under this part by an individual who becomes an eligible 
        individual as described in the preceding sentence, the Secretary 
        may not provide such benefits or compensation unless the request 
        (or amendment to a request, as applicable) is filed before the 
        expiration of one year after the effective date of the amendment 
        to the table in the case of an individual to whom the vaccine 
        was administered and before the expiration of two years after 
        such effective date in the case of a request based on accidental 
        vaccinia inoculation.

``SEC. 264. <<NOTE: 42 USC 239c.>> MEDICAL BENEFITS.

    ``(a) In General.--Subject to the succeeding provisions of this 
section, the Secretary shall make payment or reimbursement for medical 
items and services as reasonable and necessary to treat a covered injury 
of an eligible individual, including the services, appliances, and 
supplies prescribed or recommended by a qualified physician, which the 
Secretary considers likely to cure, give relief, reduce the degree or 
the period of disability, or aid in lessening the amount of monthly 
compensation.
    ``(b) Benefits Secondary to Other Coverage.--Payment or 
reimbursement for services or benefits under subsection (a) shall

[[Page 117 STAT. 642]]

be secondary to any obligation of the United States or any third party 
(including any State or local governmental entity, private insurance 
carrier, or employer) under any other provision of law or contractual 
agreement, to pay for or provide such services or benefits.

``SEC. 265. <<NOTE: 42 USC 239d.>> COMPENSATION FOR LOST EMPLOYMENT 
            INCOME.

    ``(a) In General.--Subject to the succeeding provisions of this 
section, the Secretary shall provide compensation to an eligible 
individual for loss of employment income (based on such income at the 
time of injury) incurred as a result of a covered injury, at the rate 
specified in subsection (b).
    ``(b) Amount of Compensation.--
            ``(1) In general.--Compensation under subsection (a) shall 
        be at the rate of 66\2/3\ percent of the relevant pay period 
        (weekly, monthly, or otherwise), except as provided in paragraph 
        (2).
            ``(2) Augmented compensation for dependents.--If an eligible 
        individual has one or more dependents, the basic compensation 
        for loss of employment income as described in paragraph (1) 
        shall be augmented at the rate of 8\1/3\ percent.
            ``(3) Consideration of other programs.--
                    ``(A) In general.--The Secretary may consider the 
                provisions of sections 8114, 8115, and 8146a of title 5, 
                United States Code, and any implementing regulations, in 
                determining the amount of payment under subsection (a) 
                and the circumstances under which such payments are 
                reasonable and necessary.
                    ``(B) Minors.--With respect to an eligible 
                individual who is a minor, the Secretary may consider 
                the provisions of section 8113 of title 5, United States 
                Code, and any implementing regulations, in determining 
                the amount of payment under subsection (a) and the 
                circumstances under which such payments are reasonable 
                and necessary.
            ``(4) Treatment of self-employment income.--For purposes of 
        this section, the term `employment income' includes income from 
        self-employment.

    ``(c) Limitations.--
            ``(1) Benefits secondary to other coverage.--
                    ``(A) In general.--Any compensation under subsection 
                (a) shall be secondary to the obligation of the United 
                States or any third party (including any State or local 
                governmental entity, private insurance carrier, or 
                employer), under any other law or contractual agreement, 

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