[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1413 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 1413

  To provide benefits for certain individuals with injuries resulting 
   from administration of a smallpox vaccine, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 25, 2003

   Mr. Burr (for himself, Mr. Tauzin, Mr. Bilirakis, Mr. Upton, Mr. 
  Norwood, Mr. Whitfield, and Mr. Pickering) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
 in addition to the Committees on Education and the Workforce and the 
 Judiciary, 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 provide benefits for certain individuals with injuries resulting 
   from administration of a smallpox 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 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. DEFINITIONS.

    ``For purposes of this part:
            ``(1) Vaccine.--The term `vaccine' or `smallpox vaccine' 
        means vaccinia (smallpox) vaccines, including the Dryvax 
        vaccine.
            ``(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 
                approved by the Secretary; and
                    ``(C) to whom a vaccine is administered pursuant to 
                such approved plan--
                            ``(i) during the effective period of the 
                        Declaration (including the portion of such 
                        period before the enactment of this part); and
                            ``(ii) not later than the latest of--
                                    ``(I) 180 days after the effective 
                                date of the initial interim final 
                                regulations implementing this part;
                                    ``(II) 120 days after becoming an 
                                individual in an occupation described 
                                in subparagraph (A); or
                                    ``(III) 120 days after becoming an 
                                individual identified as a member of a 
                                smallpox emergency response plan 
                                described in subparagraph (B).
            ``(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) 
        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 vaccine 
                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 resided with, or 
                        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.

``SEC. 262. DETERMINATION OF ELIGIBILITY AND BENEFITS.

    ``(a) In General.--The 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;
            ``(3) whether the covered injury or injuries of an eligible 
        individual constitute a compensable disability, or 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 provides 
        notice to the Secretary of an adverse effect of the vaccination 
        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 provides notice to the Secretary of 
        an adverse effect of such vaccination not later than two years 
        after the date of the first symptom or manifestation of onset 
        of the adverse effect.
    ``(e) Review of Determination.--
            ``(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.
            ``(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. SMALLPOX VACCINE INJURY TABLE.

    ``(a) Smallpox Vaccine Injury Table.--
            ``(1) Establishment required.--The 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 amend by regulation 
        the table established under paragraph (1). Amendments shall 
        apply retroactively to claims pending at the time of 
        promulgation of final amending regulations and to claims filed 
        subsequently. If the effect of such amendment is to permit an 
        individual who was not, before such amendment, eligible for 
        compensation under this part, such individual may file a 
        request for compensation or file an amended request for such 
        compensation not later than one year after the effective date 
        of such amendment in the case of an individual to whom the 
        vaccine was administered and two years in the case of a request 
        for compensation based on accidental vaccinia inoculation.

``SEC. 264. 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. The Secretary may consider the 
Federal Employees Compensation Act (5 U.S.C. 8103) and its implementing 
regulations in determining the amount of such payment and the 
circumstances under which such payments are reasonable and appropriate.
    ``(b) Benefits Secondary to Other Coverage.--Payment or 
reimbursement for services or benefits under subsection (a) shall 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. The 
Secretary shall have the discretion to establish mechanisms and 
procedures for providing the secondary benefits under this section.

``SEC. 265. 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 incurred as a result of a 
covered injury, at the rate specified in subsection (b).
    ``(b) Amount of Compensation.--
            ``(1) In general.--Compensation under this section shall be 
        at the rate of 66 2/3 percent of monthly employment income. The 
        Secretary may consider the Federal Employees Compensation Act 
        (5 U.S.C. 8114 and 8115) and its implementing regulations in 
        determining the amount of such payment and the circumstances 
        under which such payments are reasonable and appropriate.
            ``(2) 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.--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, to pay compensation for loss of employment income 
        and shall not be made to the extent that compensation for loss 
        of employment income has been made under such other obligations 
        in an amount that equals or exceeds the rate specified in 
        subsection (b)(1).
            ``(2) No benefits for death or permanent and total 
        disability.--No payment shall be made under this section in 
        compensation for loss of employment income subsequent to the 
        receipt by an eligible individual (or his survivor or 
        survivors) of benefits under section 266 for death or permanent 
        and total disability.
            ``(3) Limit on total benefits.--Total benefits paid to an 
        individual under this section shall not exceed $50,000.
            ``(4) Waiting period.--An eligible individual shall not be 
        provided compensation under this section for the first 5 work 
        days of disability.

``SEC. 266. PAYMENT FOR DEATH AND PERMANENT, TOTAL DISABILITY.

    ``(a) Benefit for Permanent and Total Disability.--The Secretary 
shall pay to an eligible individual who is determined to have a covered 
injury or injuries meeting the definition of disability in section 
216(i) of the Social Security Act (42 U.S.C. 416(i)) an amount 
determined under subsection (c), in the same manner as disability 
benefits are paid pursuant to the PSOB program in section 1201(b) of 
the OCCSSA with respect to an eligible public safety officer (except 
that payment shall be made to the parent or legal guardian, in the case 
of an eligible individual who is a minor or is subject to legal 
guardianship).
    ``(b) Death Benefit.--The Secretary shall pay, in the case of an 
eligible individual whose death is determined to have resulted from a 
covered injury or injuries, a death benefit in the amount determined 
under subsection (c) to the survivor or survivors in the same manner as 
death benefits are paid pursuant to PSOB program in section 1201 of the 
OCCSSA with respect to an eligible deceased (except that in the case of 
an eligible individual who is a minor with no living parent, the legal 
guardian shall be considered the survivor in the place of the parent).
    ``(c) Benefit Amount.--
            ``(1) In general.--The amount of the disability or death 
        benefit under subsection (a) or (b) in a fiscal year shall 
        equal the amount of the comparable benefit calculated under the 
        PSOB in such fiscal year, without regard to any reduction 
        attributable to a limitation on appropriations, but subject to 
        paragraph (2).
            ``(2) Reduction for payments for lost employment income.--
        The amount of the benefit as determined under paragraph (1) 
        shall be reduced by the total amount of any benefits paid under 
        section 265 with respect to lost employment income.
    ``(d) Benefit in Addition to Medical Benefits.--A benefit under 
this section shall be in addition to any amounts received by an 
eligible individual under section 264.
    ``(e) Limitations.--
            ``(1) Disability benefits.--Except as provided in paragraph 
        (3), no benefit is payable under subsection (a) with respect to 
        the disability of an eligible individual if--
                    ``(A) a disability benefit is paid or payable with 
                respect to such individual under the PSOB; or
                    ``(B) a death benefit is paid or payable with 
                respect to such individual under subsection (b) or the 
                PSOB.
            ``(2) Death benefits.--No benefit is payable under 
        subsection (b) with respect to the death of an eligible 
        individual if--
                    ``(A) a disability benefit is paid with respect to 
                such individual under subsection (a) or the PSOB; or
                    ``(B) a death benefit is paid or payable with 
                respect to such individual under the PSOB.
            ``(3) Exception in the case of a limitation on 
        appropriations for disability benefits under psob.--In the 
        event that disability benefits available to an eligible 
        individual under the PSOB program are reduced because of a 
        limitation on appropriations, and such reduction would affect 
        the amount that would be payable under paragraph (1) or (2) 
        without regard to this paragraph, benefits shall be available 
        under subsection (a) or (b) to the extent necessary to ensure 
        that such individual (or his survivor or survivors) receives a 
        total amount equal to the amount described in subsection (c).
    ``(f) References.--References in this section--
            ``(1) to the Public Safety Officers' Benefits Program or 
        PSOB are references to the program under part L, subpart 1 of 
        title I of the OCCSSA; and
            ``(2) to the OCCSSA are to the Omnibus Crime Control and 
        Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.).

``SEC. 267. ADMINISTRATION.

    ``(a) Administration by Agreement With Other Agency or Agencies.--
The Secretary may administer any or all of the provisions of this part 
through Memorandum of Agreement with the head of any appropriate 
Federal agency.
    ``(b) Regulations.--The head of the agency administering this part 
or provisions thereof (including any agency head administering such Act 
or provisions through a Memorandum of Agreement under subsection (a)) 
may promulgate such implementing regulations as may be found necessary 
and appropriate. Initial implementing regulations may be interim final 
regulations.

``SEC. 268. PARTICIPANT EDUCATION REGARDING SMALLPOX EMERGENCY RESPONSE 
              PLANS.

    In reviewing State, local, or Department of Health and Human 
Services smallpox emergency response plans described in section 261, 
the Secretary shall ensure that such plans are consistent with 
guidelines of the Centers for Disease Control and Prevention with 
respect to the education of individual participants (including 
information as to the voluntary nature of the program and the 
availability of potential benefits under this part), and the adequate 
screening of individuals for vaccine contraindications.

``SEC. 269. AUTHORIZATION OF APPROPRIATIONS.

    ``For the purpose of carrying out this part, there are authorized 
to be appropriated such sums as may be necessary for each of the fiscal 
years 2003 through 2007, to remain available until expended, including 
administrative costs and costs of provision and payment of benefits.

``SEC. 270. RELATIONSHIP TO OTHER LAWS.

    ``Except as explicitly provided herein, nothing in this part shall 
be construed to override or limit any rights an individual may have to 
seek compensation, benefits, or redress under any other provision of 
Federal or State law.''.

SEC. 3. AMENDMENTS TO PROVISION REGARDING TORT LIABILITY FOR 
              ADMINISTRATION OF SMALLPOX COUNTERMEASURES.

    (a) Amendment to Accidental Vaccinia Inoculation Provision.--
Section 224(p)(2)(C)(ii)(II) of such Act (42 U.S.C. 
233(p)(2)(C)(ii)(II)) is amended by striking ``resides or has resided 
with'' and inserting ``has resided with, or has had contact with,''.
    (b) Deeming Acts and Omissions to be Within Scope of Employment.--
Section 224(p)(2) of such Act (42 U.S.C. 233(p)(2)) is amended by 
adding at the end the following new subparagraph:
                    ``(D) Acts and omissions deemed to be within scope 
                of employment.--
                            ``(i) In general.--In the case of a claim 
                        arising out of alleged transmission of vaccinia 
                        from an individual described in clause (ii), 
                        acts or omissions by such individual shall be 
                        deemed to have been taken within the scope of 
                        such individual's office or employment for 
                        purposes of--
                                    ``(I) subsection (a); and
                                    ``(II) section 1346(b) and chapter 
                                171 of title 28, United States Code.
                            ``(ii) Individuals to whom deeming 
                        applies.--An individual is described by this 
                        clause if--
                                    ``(I) vaccinia vaccine was 
                                administered to such individual as 
                                provided by subparagraph (B); and
                                    ``(II) such individual was within a 
                                category of individuals covered by a 
                                declaration under subparagraph 
                                (A)(i).''.
    (c) Exhaustion; Exclusivity; Offset.--Section 224(p)(3) of such Act 
(42 U.S.C. 233(p)(3)) is amended to read as follows:
            ``(3) Exhaustion; exclusivity; offset.--
                    ``(A) Exhaustion.--
                            ``(i) In general.--A person may not bring a 
                        claim under this subsection unless such person 
                        has received a determination about remedies 
                        available under section 262.
                            ``(ii) Tolling of statute of limitations.--
                        The time limit for filing a claim under this 
                        subsection, or for filing an action based on 
                        such claim, shall be tolled during the pendency 
                        of a determination by the Secretary under 
                        section 262.
                            ``(iii) Construction.--This subsection 
                        shall not be construed as superseding or 
                        otherwise affecting the application of a 
                        requirement, under chapter 171 of title 28, 
                        United States Code, to exhaust administrative 
                        remedies.
                    ``(B) Exclusivity.--The remedy provided by 
                subsection (a) shall be exclusive of any other civil 
                action or proceeding for any claim or suit this 
                subsection encompasses, except for a proceeding under 
                part C of this title.
                    ``(C) Offset.--The value of all compensation and 
                benefits provided under part C of this title for an 
                incident or series of incidents shall be offset against 
                the amount of an award, compromise, or settlement of 
                money damages in a claim or suit under this subsection 
                based on the same incident or series of incidents.''.
    (d) Requirement to Cooperate With United States.--Section 224(p)(5) 
of such Act (42 U.S.C. 233(p)(5)) is amended in the caption by striking 
``Defendant'' and inserting ``Covered person''.
    (e) Amendment to Definition of Covered Countermeasure.--Section 
224(p)(7)(A)(i)(II) of such Act (42 U.S.C. 233(p)(7)(A)(i)(II)) is 
amended to read as follows:
                                    ``(II) used to control or treat the 
                                adverse effects of vaccinia inoculation 
                                or of administration of another covered 
                                countermeasure; and''.
    (f) Amendment to Definition of Covered Person.--Section 
224(p)(7)(B) of such Act (42 U.S.C. 233(p)(7)(B)) is amended--
            (1) by striking ``includes any person'' and inserting 
        ``means a person'';
            (2) in clause (ii)--
                    (A) by striking ``auspices'' and inserting 
                ``auspices--'';
                    (B) by redesignating ``such countermeasure'' and 
                all that follows as clause (I) and indenting 
                accordingly; and
                    (C) by adding at the end the following:
                                    ``(II) a determination was made as 
                                to whether, or under what 
                                circumstances, an individual should 
                                receive a covered countermeasure;
                                    ``(III) the immediate site of 
                                administration on the body of a covered 
                                countermeasure was monitored, managed, 
                                or cared for; or
                                    ``(IV) an evaluation was made of 
                                whether the administration of a 
                                countermeasure was effective;'';
            (3) in clause (iii) by striking ``or'';
            (4) by striking clause (iv) and inserting the following:
                            ``(iv) a State, a political subdivision of 
                        a State, or an agency or official of a State or 
                        of such a political subdivision, if such State, 
                        subdivision, agency, or official has 
                        established requirements, provided policy 
                        guidance, supplied technical or scientific 
                        advice or assistance, or otherwise supervised 
                        or administered a program with respect to 
                        administration of such countermeasures;
                            ``(v) in the case of a claim arising out of 
                        alleged transmission of vaccinia from an 
                        individual--
                                    ``(I) the individual who allegedly 
                                transmitted the vaccinia, if vaccinia 
                                vaccine was administered to such 
                                individual as provided by paragraph 
                                (2)(B) and such individual was within a 
                                category of individuals covered by a 
                                declaration under paragraph (2)(A)(i); 
                                or
                                    ``(II) an entity that employs an 
                                individual described by clause (I) or 
                                where such individual has privileges or 
                                is otherwise authorized to provide 
                                health care;
                            ``(vi) an official, agent, or employee of a 
                        person described in clause (i), (ii), (iii), or 
                        (iv);
                            ``(vii) a contractor of, or a volunteer 
                        working for, a person described in clause (i), 
                        (ii), or (iv), if the contractor or volunteer 
                        performs a function for which a person 
                        described in clause (i), (ii), or (iv) is a 
                        covered person; or
                            ``(viii) an individual who has privileges 
                        or is otherwise authorized to provide health 
                        care under the auspices of an entity described 
                        in clause (ii) or (v)(II).''.
    (g) Amendment to Definition of Qualified Person.--Section 
224(p)(7)(C) of such Act (42 U.S.C. 233(p)(7)(C)) is amended--
            (1) by designating ``is authorized to'' and all that 
        follows as clause (i) and indenting accordingly;
            (2) by striking ``individual who'' and inserting 
        ``individual who--''; and
            (3) by striking the period and inserting ``; or
                            ``(ii) is otherwise authorized by the 
                        Secretary to administer such countermeasure.''.
    (h) Definition of ``Arising Out of Administration of a Covered 
Countermeasure''.--Section 224(p)(7) of such Act (42 U.S.C. 233(p)(7)) 
is amended by adding at the end the following new subparagraph:
                    ``(D) Arising out of administration of a covered 
                countermeasure.--The term 'arising out of 
                administration of a covered countermeasure', when used 
                with respect to a claim or liability, includes a claim 
                or liability arising out of--
                            ``(i) determining whether, or under what 
                        conditions, an individual should receive a 
                        covered countermeasure;
                            ``(ii) obtaining informed consent of an 
                        individual to the administration of a covered 
                        countermeasure;
                            ``(iii) monitoring, management, or care of 
                        an immediate site of administration on the body 
                        of a covered countermeasure, or evaluation of 
                        whether the administration of the 
                        countermeasure has been effective; or
                            ``(iv) transmission of vaccinia virus by an 
                        individual to whom vaccinia vaccine was 
                        administered as provided by paragraph 
                        (2)(B).''.
    (i) Technical Correction.--Section 224(p)(2)(A)(ii) of such Act (42 
U.S.C. 233(p)(2)(A)(ii)) is amended by striking ``paragraph (8)(A)'' 
and inserting ``paragraph (7)(A)''.
    (j) Effective Date.--This section shall take effect as of November 
25, 2002.
                                 <all>