108th CONGRESS
1st Session
H. R. 865
To protect the health and safety of individuals receiving smallpox
vaccinations and to provide compensation and assured access to care for individuals
injured by the vaccine, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
February 13, 2003
Mr. WAXMAN (for himself, Mr. BROWN of Ohio, Mrs. CAPPS, and Mr. MARKEY) introduced
the following bill; which was referred to the Committee on Energy and Commerce,
and in addition to the Committee on Education and the Workforce, for a period
to be subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee concerned
A BILL
To protect the health and safety of individuals receiving smallpox
vaccinations and to provide compensation and assured access to care for individuals
injured by the vaccine, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Smallpox Vaccine Compensation and Safety Act
of 2003'.
SEC. 2. SMALLPOX VACCINATIONS.
The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by adding
at the end the following:
`TITLE XXIX--ADDITIONAL VACCINE PROVISIONS
`SEC. 2901. COVERED COUNTERMEASURE.
`For purposes of this title, the terms `covered countermeasure' and `covered
countermeasure against smallpox' have the meanings given to those terms in
section 224(p)(7)(A).
`SEC. 2902. GRANTS TO ASSIST STATE AND LOCAL GOVERNMENTS IN MEETING THE
COSTS OF SMALLPOX INOCULATION PROGRAMS.
`(1) GRANTS- For the purposes described in paragraph (2), the Secretary
shall make an allotment each fiscal year for each State in an amount determined
in accordance with subsection (e). The Secretary shall make a grant to the
State of the allotment made for the State for the fiscal year if the State
submits to the Secretary an application at such time, in such manner, and
containing such information as the Secretary may require.
`(2) PURPOSES- A funding agreement for a grant under this section is that
the State involved will expend the grant only for the following purposes:
`(A) Providing for the administration of covered countermeasures against
smallpox.
`(B) Monitoring the health of individuals receiving covered countermeasures
against smallpox or individuals in close contact with individuals receiving
such countermeasures.
`(C) Providing for the conduct of epidemiological studies related to the
administration of covered countermeasures against smallpox.
`(b) SUPPLEMENT NOT SUPPLANT- A funding agreement for a grant under this section
is that the State involved will use the grant to supplement and not supplant
funds received from other sources for the purposes described in subsection
(a).
`(c) LOCAL INVOLVEMENT- A funding agreement for a grant under this section
is that the State involved will ensure that a suitable portion of the amount
received under the grant is expended at the local level.
`(1) IN GENERAL- A funding agreement for a grant under this section is that
the State involved will comply with the requirements of this subsection.
`(A) ESTABLISHMENT- Each State that receives a grant under this section
shall establish an education program to provide to each individual to
whom a covered countermeasure against smallpox is proposed to be administered
an explanation of--
`(i) the screening and medical surveillance and evaluation programs
available under paragraphs (3) and (4);
`(ii) the risks and benefits from administration of such countermeasure
for such individuals and those individuals with whom they have close
contact;
`(iii) the availability of the compensation program under section 224(q);
`(iv) the eligibility of the individual to receive health care as described
in this Act;
`(v) the right of the individual to refuse the administration of any
covered countermeasure against smallpox;
`(vi) the right of an individual who exercises the option described
in clause (v) to be protected from disciplinary action under section
2903; and
`(vii) the general functions and duties that such individual may be
expected to carry out if there is a smallpox outbreak.
`(B) EXPLANATIONS- Explanations provided under subparagraph (A)--
`(i) shall be made available in a form that is easily read and understood;
`(ii) shall be provided, as appropriate, in languages other than English;
`(iii) shall be made available to those individuals who reside with
individuals to whom such covered countermeasure is proposed to be administered
and, as appropriate, to patients treated by individuals who have received
a covered countermeasure; and
`(iv) shall be made available without charge or loss of wages or benefits
to an individual to whom a covered countermeasure against smallpox is
proposed to be administered and to the individuals described in clause
(iii).
`(A) IN GENERAL- Each State that receives a grant under this section shall,
for each individual to whom a covered countermeasure against smallpox
is proposed to be administered--
`(i) provide without charge counseling services that describe conditions
which may exacerbate the risks of receiving such countermeasure; and
`(ii) offer on a voluntary basis, screening and testing that can identify
health conditions that can reasonably be expected to significantly increase
risks to the health of such individual, including screening and testing
for human immunodeficiency virus, eczema or other significant chronic
skin irritation, pregnancy, and such other conditions as determined
appropriate by the Secretary.
`(B) RESULTS- The results or other information (including information
concerning an individual's refusal to be screened or tested) generated
or obtained from the screening and testing described in subparagraph (A)--
`(i) shall be deemed protected health information under the meaning
of the term in the regulations promulgated pursuant to the authority
of section 264(c) of the Health Insurance Portability and Accountability
Act of 1996;
`(ii) shall not be made available to an employer; and
`(iii) shall be provided without charge to the individual receiving
such screening and testing.
`(4) MEDICAL SURVEILLANCE AND EVALUATION PROGRAM- If the Secretary declares
vaccinia vaccine or any other measure to be a covered countermeasure under
section 224(p), each State that receives a grant under this section shall
ensure that an ongoing active medical surveillance and evaluation program
is provided to all individuals to whom such countermeasure is administered
and to the close contacts of such individuals. Such program shall--
`(A) be provided from the date that vaccinia vaccine or another covered
countermeasure is administered to a date that is not less than 60 days
from the date of administration;
`(B) include evaluation of any adverse health effect that may reasonably
appear to be due to vaccinia vaccine or another covered
countermeasure and shall provide prompt medical treatment or referral of
any individual requiring health care as a result of such adverse health effect;
and
`(C) be provided without charge to any individual to whom vaccinia vaccine
or another covered countermeasure is administered and to the close contacts
of such individuals.
`(5) NEEDLES- If the Secretary declares vaccinia vaccine to be a covered
countermeasure under section 224(p), each State that receives a grant under
this section shall ensure that for any administration of such vaccine, the
individual administering such vaccine shall use a sheathed bifurcated needle--
`(A) to the extent that such needle is approved under the Federal Food,
Drug, and Cosmetic Act; and
`(B) to the extent that such sheathed bifurcated needle is available in
such State.
`(1) AUTHORIZATION OF APPROPRIATIONS- For carrying out this section, there
are authorized to be appropriated $850,000,000 for fiscal year 2003 and
such sums as may be necessary for each subsequent fiscal year.
`(2) ALLOCATION- From the amounts appropriated and available for allotment
under this subsection for any fiscal year, the Secretary shall allot to
each State that submits an application in accordance with subsection (a)(1)
an amount that is the greater of--
`(A) the base amount as determined under paragraph (3); or
`(B) the minimum amount as determined under paragraph (4).
`(3) BASE AMOUNT- For each State receiving an award under this section,
the Secretary shall determine the base amount, which shall be equal to the
product of--
`(A) the amount appropriated under this subsection for the fiscal year,
less an amount equal to the sum of all minimum amounts determined for
the States under paragraph (4); and
`(B) the percentage constituted by the ratio of an amount equal to the
population of the State over an amount equal to the total population of
the States (as indicated by the most recent data collected by the Bureau
of the Census).
`(4) MINIMUM AMOUNT- For each State receiving an award under this subsection,
the minimum amount is--
`(A) in the case of each of the several States, the District of Columbia,
and the Commonwealth of Puerto Rico, an amount equal to the lesser of--
`(ii) if the amount appropriated under this subsection is less than
$667,000,000, an amount equal to 0.75 percent of the amount appropriated
under this subsection; or
`(B) in the case of each of American Samoa, Guam, the Commonwealth of
the Northern Mariana Islands, and the United States Virgin Islands, an
amount determined by the Secretary to be appropriate, except that such
amount may not exceed the amount determined under subparagraph (A).
`SEC. 2903. PROTECTION FROM DISCIPLINARY ACTION.
`(a) FINDING- The Congress finds that unlawful employment practices described
in subsection (b) are detrimental to the general public health and an interference
with the interstate control of infectious disease.
`(b) IN GENERAL- It shall be an unlawful employment practice for an employer--
`(1) to fail or refuse to hire or to discharge any individual, or otherwise
to discriminate against any individual with respect to the compensation,
terms, conditions, or privileges of employment of the individual, because
of a refusal or inability to receive the administration of a covered countermeasure
against smallpox or because of an adverse reaction or reactions to such
countermeasure; or
`(2) subject to subsection (c), to limit, segregate, or classify the employees
of the employer in any way that would deprive or tend to deprive any individual
of employment opportunities or otherwise adversely affect the status of
the individual as an employee, because of a refusal or inability to receive
a covered countermeasure against smallpox or because of an adverse reaction
or reactions to such countermeasure.
`(1) IN GENERAL- This section does not prohibit an employer from limiting,
segregating, or classifying for a period of 30 days or less an employee
to whom a covered countermeasure against smallpox has been administered
for the purpose of protecting the close contacts (including patients) of
such employee.
`(2) REGULAR WAGES AND BENEFITS REQUIRED- Nothing in paragraph (1) shall
be construed to permit an employer to reduce the wages or benefits of an
employee because a covered countermeasure against smallpox has been administered
to such employee.
`(d) DEFINITIONS OF EMPLOYEE AND EMPLOYER- The terms `employee' and `employer'
have the meanings given such terms in section 701 of the Civil Rights Act
of 1964 (42 U.S.C. 2000e), except that the terms `employee' and `employer'
shall also include the meanings given such terms in section 717 of the Civil
Rights Act of 1964 (42 U.S.C. 2000e-16).
`(e) FILING COMPLAINTS AND PROCEDURES-
`(A) IN GENERAL- Not later than 180 days after an alleged violation of
subsection (b) has occurred, the employee alleging such violation or another
individual at the employee's request, may file a complaint with the Secretary.
`(B) NOTICE- Not later than 15 days after receipt of a complaint described
in subparagraph (A), the Secretary shall notify the employer alleged in
the complaint to have committed a violation of subsection (b) of the filing
of such complaint.
`(2) FINDINGS AND PRELIMINARY ORDER-
`(A) IN GENERAL- Not later than 60 days after receiving a complaint described
in paragraph (1), the Secretary shall--
`(i) conduct an investigation of the matters alleged in the complaint;
`(ii) determine whether it is reasonable to believe that the complaint
has merit; and
`(iii) notify the complainant and the employer alleged to have committed
the violation of subsection (b) of the determination.
`(B) REASONABLE BELIEF THAT A VIOLATION HAS OCCURRED- If the Secretary
determines pursuant to subparagraph (A) that it is reasonable to believe
that a violation of subsection (b) has occurred, the Secretary shall include
with the notice under such subparagraph findings and a preliminary order
for the relief provided under paragraph (3).
`(i) IN GENERAL- Not later than 30 days after receipt of the notice
under subparagraph (A), the complainant and the employer alleged to
have committed the violation of subsection (b) may file objections to
the findings or the preliminary order and request a hearing on the record.
`(ii) REINSTATEMENT- The filing of objections under clause (i) does
not stay a reinstatement ordered in the preliminary order.
`(iii) FAILURE TO OBJECT- If a hearing is not requested pursuant to
the requirements of clause (i), the preliminary order is final and not
subject to judicial review.
`(D) HEARINGS AND FINAL ORDER-
`(i) HEARINGS- A hearing under this subsection shall be conducted expeditiously.
`(ii) FINAL ORDER- Not later that 120 days after the end of a hearing
under this subsection, the Secretary shall issue a final order.
`(iii) SETTLEMENT- At any time prior to the issuance of a final order,
any further action under this subsection may be ended by a settlement
agreement made by the complainant and the employer alleged to have committed
the violation of subsection (b), and approved by the Secretary.
`(A) IN GENERAL- If the Secretary determines on the basis of a complaint,
that an employer violated subsection (b) of this section, the Secretary
shall order such employer to provide relief including--
`(i) taking affirmative action to abate the violation;
`(ii) reinstating the complainant to the former position with the same
pay and terms and privileges of employment; and
`(iii) paying compensatory damages, including back pay.
`(B) COSTS INCURRED IN BRINGING A COMPLAINT- If the Secretary issues an
order under subparagraph (A), and the complainant so requests, the Secretary
may order that the employer who violated subsection (b) pay the costs
(including attorney's fees) reasonably incurred by the complainant in
bringing the complaint, as determined by the Secretary.
`(f) JUDICIAL REVIEW AND VENUE-
`(1) IN GENERAL- Not later than 60 days after an order has been issued under
subsection (e), a party adversely affected by such order may file a petition
for review in the United States circuit court for the circuit in which the
violation occurred or in which the party resided on the date of the violation.
`(2) REVIEW- A review conducted pursuant to this subsection shall be heard
and decided expeditiously.
`(3) REVIEW IN OTHER PROCEEDINGS- An order of the Secretary subject to review
under this subsection is not subject to judicial review in a criminal or
other civil proceeding.
`(g) CIVIL ACTIONS TO ENFORCE- If an employer fails to comply with an order
issued under subsection (e), the Secretary shall bring a civil action to enforce
such order in the United States district court for the district in which the
violation occurred.
`SEC. 2904. MEDICAL LEAVE FOR CERTAIN VACCINE RECIPIENTS.
`(a) IN GENERAL- In accordance with regulations promulgated by the Secretary,
an employee (as defined in section 3 of the Fair Labor Standards Act of 1938)
shall be entitled to a total of not more than 4 workdays of paid leave because
of a health condition that makes the employee unable to perform the functions
of the position of such employee that arose as a result of the employee having
received or come into close contact with an individual who received a covered
countermeasure against smallpox.
`(b) APPLICATION OF CERTAIN PROVISIONS- Leave shall be provided under subsection
(a) in accordance with the provisions of the Family and Medical Leave Act
of 1993 except that--
`(1) such leave shall be provided for a condition described in subsection
(a) regardless of whether such condition requires inpatient care or continuing
treatment;
`(2) such leave shall be fully paid; and
`(3) this section shall apply to all employers regardless of size.
`(c) REIMBURSEMENT FROM THE PROGRAM-
`(1) NON-FEDERAL EMPLOYEES- Any employer, other than a Federal agency, that
provides paid leave to an employee for the reasons described in subsection
(a) may seek reimbursement for such leave from the compensation program
under section 224(q).
`(2) FEDERAL EMPLOYEES- A Federal agency that provides leave under this
section shall treat such leave as paid administrative leave.
`SEC. 2905. RESPONSIBILITIES OF THE SECRETARY.
`(a) SUPPLIES OF VACCINIA IMMUNE GLOBULIN- If the Secretary declares vaccinia
vaccine to be a covered countermeasure under section 224(p), the Secretary
shall ensure that adequate supplies of vaccinia immune globulin are made available
to any individual to whom vaccinia vaccine is administered during the period
of such declaration.
`(b) UNIFORM SYSTEM OF REPORTING-
`(1) IN GENERAL- The Secretary shall establish a uniform system for reporting
adverse responses to any covered countermeasure against smallpox to the
Secretary.
`(2) REPORT TO CONGRESS- Not later than 1 year after the date of enactment
of this Act and every year in which covered countermeasures against smallpox
are administered, the Secretary shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report that describes for
the preceding year--
`(A) the number of individuals to whom a covered countermeasure against
smallpox was administered; and
`(B) the number and kind of adverse reactions caused by the administration
of a covered countermeasure against smallpox.
`SEC. 2906. PROVISION OF NEEDLES.
`The Director of the Centers for Disease Control and Prevention shall provide
needles to States that receive a grant under section 2902 for the purpose
of administering vaccinia vaccine in accordance with section 2902(d)(5).'.
SEC. 3. HEALTH CARE FOR HEALTH CARE WORKERS AND FIRST RESPONDERS SUFFERING
ADVERSE REACTIONS OR COMPLICATIONS FROM SMALLPOX VACCINE; CONTINUED INSURANCE
COVERAGE.
(a) PAYMENTS FOR PROVISION OF MEDICAL ASSISTANCE- Title XXIX of the Public
Health Service Act (as added by section 2) is amended by adding at the end
the following:
`SEC. 2907. HEALTH CARE FOR INDIVIDUALS SUFFERING ADVERSE REACTIONS OR COMPLICATIONS
FROM SMALLPOX VACCINE.
`(1) IN GENERAL- The Secretary shall pay to each State with an agreement
described in subsection (b) an amount equal to the costs incurred by that
State to provide medical assistance described in subsection (b)(1), subject
to paragraph (2).
`(2) LIMITATION ON PAYMENT- The Secretary shall not make any payment under
paragraph (1) for costs for medical assistance insofar as such costs may
reasonably be reimbursed from a third party under the terms of the agreement
described in subsection (b)(2). Any payment under this section to a State
with respect to medical assistance shall be conditioned on reimbursement
to the Secretary when notice or other information is received that payment
for such medical assistance has been or could be made by a third party under
subsection (b)(2).
`(b) AGREEMENT- An agreement described in this subsection is an agreement
between a State and the Secretary in which the State--
`(1) agrees to provide such medical assistance as may be medically necessary
to--
`(A) any health care worker or first responder who--
`(i) has suffered any adverse reaction or complication as a result of
a covered countermeasure against smallpox or exposure to vaccinia virus
or any other substance administered for the prevention or treatment
of smallpox; and
`(ii) has not received compensation under the National Smallpox Vaccine
Injury Compensation Program established under section 224; and
`(B) any individual who--
`(i) has suffered any adverse reaction or complication as a result of
contact with another person who received a covered countermeasure; and
`(ii) has not received compensation under the National Smallpox Vaccine
Injury Compensation Program established under section 224; and
`(2) agrees to take all reasonable measures to obtain reimbursement for
the costs of providing such assistance from any third party (including health
insurers and group health plans (as defined in section 2791)) with responsibility
for such costs.
`(c) STATE ENTITLEMENT- This section constitutes budget authority in advance
of appropriations Acts and represents the obligation of the Federal Government
to provide for the payment to States of amounts provided under this section.
`(d) RULE OF CONSTRUCTION-
`(1) INSURANCE COVERAGE- Nothing in this section shall be construed to invalidate
or otherwise abridge any provision of law or any contractual obligation
that otherwise obligates a health insurance issuer to provide reimbursement
or otherwise defray the cost to an individual of health care needed to treat
the health consequences of the administration of or exposure to a covered
countermeasure against smallpox or exposure to vaccinia virus.
`(2) HEALTH CARE FACILITIES- Nothing in this section shall be construed
to invalidate or otherwise abridge any provision of law or any contractual
obligation that otherwise obligates a health care facility to provide health
care or other health services to an individual that are needed to treat
the health consequences of the administration of a covered countermeasure
against smallpox or exposure to vaccinia virus.
`(3) EMPLOYERS- Nothing in this section shall be construed to invalidate
or otherwise abridge any provision of law or any contractual obligation
that otherwise obligates an employer to provide leave, wages, vacation time,
or any other benefit to an individual.
`(4) STATE OR LOCAL GOVERNMENTS- Nothing in this section shall be construed
to invalidate or otherwise abridge any provision of law or any contractual
obligation that otherwise obligates a State or local government to provide
health care, workers' compensation, or any other benefit to an individual.
`(e) AUTHORIZING UTILIZATION OF MEDICAID IN PROVIDING MEDICAL ASSISTANCE-
Nothing in this section shall be construed to prevent a State from utilizing
its medicaid program under title XIX of the Social Security Act in order to
provide medical assistance under this section. The Secretary shall waive such
provisions of such Act as are necessary to permit a State to so utilize such
program under this subsection.'.
(b) CONTINUED COVERAGE OF BENEFITS FOR SMALLPOX VACCINE SIDE EFFECTS-
(1) STATE MAINTAINED PLANS- Section 2907 of the Public Health Service Act
(as added by subsection (a)) is amended by adding at the end the following:
`(f) CONTINUED COVERAGE OF BENEFITS FOR SMALLPOX VACCINE SIDE EFFECTS-
`(1) IN GENERAL- In accordance with regulations which the Secretary shall
prescribe, each group health plan that is maintained by any State that receives
funds under this Act, by any political subdivision of such State, or by
any agency or instrumentality of such State or political subdivision, shall
provide coverage of benefits for side effects resulting from covered countermeasures
against smallpox at the level of such coverage it provided as of September
10, 2001.
`(2) ENFORCEMENT- For purposes of section 2207, the requirement of paragraph
(1) is deemed a requirement of title XXII.'.
(A) AMENDMENT TO TAX CODE-
(i) IN GENERAL- Paragraph (1) of section 4980B(f) of the Internal Revenue
Code of 1986 is amended by inserting before the period at the end the
following: `, and (C) only if the coverage of the side effects from
covered countermeasures against smallpox (as such term is defined in
section 224(p) of the Public Health Service Act) is not less than the
level of coverage provided by the plan as of September 10, 2001'.
(ii) CONFORMING AMENDMENTS- Section 4980B(f)(1) of such Code is amended--
(I) by inserting `(A)' before `only if' the first place it appears,
and
(II) by striking `and only if' and inserting `, (B) only if'.
(iii) EFFECTIVE DATE- The amendments made by this section shall apply
to covered countermeasures against smallpox taken after the date of
the enactment of this Act.
(B) AMENDMENT TO ERISA- Section 609 of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1169) is amended--
(i) by redesignating subsection (e) as subsection (f); and
(ii) by inserting after subsection (d) the following:
`(e) CONTINUED COVERAGE OF BENEFITS FOR SMALLPOX VACCINE SIDE EFFECTS- A group
health plan shall provide coverage of the side effects from covered countermeasures
against smallpox (as such term is defined in section 224(p) of the Public
Health Service Act) at the level of coverage provided by the plan as of September
10, 2001.'.
SEC. 4. NATIONAL SMALLPOX VACCINE INJURY COMPENSATION PROGRAM.
(a) ESTABLISHMENT- Section 224 of the Public Health Service Act (42 U.S.C.
233), as amended by section 304(c) of Public Law 107-296 (116 Stat. 2135),
is amended by adding at the end the following:
`(q) NATIONAL SMALLPOX VACCINE INJURY COMPENSATION PROGRAM-
`(1) ESTABLISHMENT- The Secretary shall establish the National Smallpox
Vaccine Injury Compensation Program (referred to in this subsection as the
`Smallpox Program') under which compensation may be paid for injury or death
related to the administration of any covered countermeasure against smallpox.
`(2) PROCEDURES AND STANDARDS- The Secretary shall by regulation establish
procedures and standards applicable to the Smallpox Program that follow
the procedures and standards applicable under the National Vaccine Injury
Compensation Program established under section 2110, except for the following:
`(A) A person may not file a civil action under subsection (p) unless
the person has first filed a petition for compensation under the Smallpox
Program under section 2111.
`(B) After filing a petition under section 2111, a person may elect to
instead bring a civil action under subsection (p) if the person would
be authorized under clause (i) or (ii) of section 2111(a)(2)(A) and under
section 2121 to elect to bring a civil action.
`(C) Notwithstanding section 2111(c)(1)(A), a person who did not receive
a covered countermeasure against smallpox or any other substance administered
for the prevention or treatment of smallpox (including vaccinia virus)
may receive compensation under the Smallpox Program if the person was
injured as a result of contact with another person who received such a
countermeasure or substance.
`(D) Section 2111(c)(1)(D) (requiring petitioner to demonstrate death,
residual effects for more than 6 months, or inpatient hospitalization
and surgical intervention) shall not apply.
`(E) Notwithstanding section 2115(a)(2), in the event of a death related
to the administration of vaccinia virus or other substance or medication
administered for the purpose of preventing or treating smallpox (including
any covered countermeasure against smallpox), compensation under the Smallpox
Program shall include an award for the estate of the deceased of $850,000,
in addition to any other compensation to which the petitioner is entitled
under this section.
`(3) VACCINE INJURY TABLE-
`(A) INCLUSION- For purposes of receiving compensation under the Smallpox
Program, the Vaccine Injury Table under section 2114 is deemed to include
the following table of injuries, disabilities, illnesses, conditions,
and deaths resulting from the administration of the smallpox vaccine,
and the time period in which the first symptom or manifestation of onset
or of significant aggravation of such injuries, disabilities, illnesses,
conditions, and deaths is to occur after administration of vaccinia virus
or other substance or medication administered for the purpose of preventing
or treating smallpox (including a covered countermeasure against smallpox):
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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`Adverse event: Time period for first symptom or manifestation of onset or of significant aggravation after administration of vaccinia virus or other substance or medication administered for the purpose of preventing or treating smallpox (including a covered countermeasure against smallpox):
A. Anaphylaxis or anaphylactic shock 0-4 hours
B. Eczema vaccinatum (including in a contact case) any
C. Accidental inoculation (including in a contact case) any
D. Progressive vaccinia any
E. Encephalopathy (or encephalitis) 0-21 days
F. Stevens-Johnson syndrome 3-21 days
G. Generalized vaccinia 0-60 days
H. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed Not applicable
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
`(B) RULE OF CONSTRUCTION- Section 13632 (a)(3) of Public Law 103-66 (107
Stat. 646) (making revisions by Secretary to the Vaccine Injury Table
effective on the effective date of a corresponding tax) shall not be construed
to apply to the revision to the Vaccine Injury Table made by this paragraph.
`(4) PROHIBITION- The Secretary may not provide any compensation under the
Smallpox Program for any minor scarring or minor local reaction.
`(5) APPLICATION- The Smallpox Program applies to any injury or death associated
with the administration of any covered countermeasure on or after November
25, 2002.
`(6) REIMBURSEMENT- Notwithstanding paragraph (4), the Secretary may reimburse
under this section an employer who seeks reimbursement pursuant to section
2904.
`(A) HIRING- In accordance with section 2112, the judges of the United
States Claims Court shall appoint a sufficient number of special masters
to address claims for compensation under this subsection.
`(B) BUDGET AUTHORITY- There are appropriated to carry out this paragraph
such sums as may be necessary for fiscal year 2003 and each fiscal year
thereafter. This subparagraph constitutes budget authority in advance
of appropriations and represents the obligation of the Federal Government.
`(8) COVERED COUNTERMEASURE- For purposes of this subsection, the terms
`covered countermeasure' and `covered countermeasure against smallpox' have
the meanings given to those terms in subsection (p)(7)(A).
`(9) FUNDING- Compensation made under the Smallpox Program shall be made
from the same source of funds as payments made under subsection (p).'.
(b) RELATION TO FEDERAL TORT CLAIMS ACT- Paragraph (3) of section 224(p) of
the Public Health Service Act (42 U.S.C. 233(p)) is amended to read as follows:
`(3) EXHAUSTION; EXCLUSIVITY-
`(A) NATIONAL SMALLPOX VACCINE INJURY COMPENSATION PROGRAM- A person may
not bring a claim under this subsection unless the person has first filed
a petition for compensation under the program established under subsection
(q) and made a proper election under sections 2111(a)(2)(A) and 2121.
`(B) EXCLUSIVITY- Except for filing a petition for compensation under
the program established under subsection (q), the remedy provided by subsection
(a) shall be exclusive of any other civil action or proceeding for any
claim or suit this subsection encompasses, during the effective period
of a declaration by the Secretary under paragraph (2)(A).'.
(c) PERSONS SUSCEPTIBLE TO VACCINE-RELATED INJURY- Subsection (b) of section
2114 of the Public Health Service Act (42 U.S.C. 300aa-14) is amended by adding
at the end the following:
`(5) A petitioner shall be considered to have suffered an injury related
to the administration of a covered countermeasure even if the petitioner
might not have suffered the injury absent an infection, disease, or other
condition that made him or her more susceptible to the injury.'.
SEC. 5. TECHNICAL MODIFICATION.
(a) CIRCUMSTANCES IN WHICH PRESUMPTION IN CASES OF ACCIDENTAL VACCINIA INOCULATION
APPLIES- Section 224(p)(2)(C)(ii)(II) of the Public Health Service Act (42
U.S.C. 233(p)(2)(C)(ii)(II)) is amended by striking `resides or has resided
with' and inserting `has had close contact with'.
(b) COVERED COUNTERMEASURE- Subparagraph (A) of section 224(p)(7) of the Public
Health Service Act (42 U.S.C. 233(p)(7)(A)) is amended to read as follows:
`(A) COVERED COUNTERMEASURE- The term `covered countermeasure', or `covered
countermeasure against smallpox', means a substance specified in a declaration
under paragraph (2) that is--
`(i) a substance used to prevent or treat smallpox (including vaccinia
or another vaccine); or
`(ii) a substance (including vaccinia immune globulin and cidofovir)
used to control or treat the adverse effects of vaccinia inoculation
or administration of any other countermeasure against smallpox.'.
(c) COVERED PERSON- Section 224(p)(7)(B)(ii) of the Public Health Service
Act (42 U.S.C. 233(p)(7)(B)(ii)) is amended to read as follows:
`(ii) a health care entity, a State, or a political subdivision of a
State under whose auspices such countermeasure was administered;'.
(d) EFFECTIVE DATE- This section shall take effect as of November 25, 2002
(the date of enactment of the Homeland Security Act of 2002 (Pub. L. 107-296;
116 Stat. 2135)).
END
