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Pub.L. 108-021 To prevent child abduction and the sexual exploitation of children, and for other purposes. <> ...
SMALLPOX EMERGENCY PERSONNEL PROTECTION ACT OF 2003
[[Page 117 STAT. 638]]
Public Law 108-20
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
``(A) administration to the individual of a covered
countermeasure during the effective period of the
``(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
``(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
``(2) there is voluntary screening provided to potential
participants that can identify health conditions relevant to
``(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
``(a) In General.--The <<NOTE: Procedures.>> Secretary shall
establish procedures for determining, as applicable with respect to an
``(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
``(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,
``(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
``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
``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
``(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
``(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) 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
``(4) Treatment of self-employment income.--For purposes of
this section, the term `employment income' includes income from
``(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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108th Congressional Public Laws Records and Documents
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