[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 719 Introduced in Senate (IS)]






108th CONGRESS
  1st Session
                                 S. 719

 To amend the Public Health Service Act to provide for the payment of 
 compensation for certain individuals with injuries resulting from the 
              administration of smallpox countermeasures.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 26, 2003

   Mr. Gregg introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to provide for the payment of 
 compensation for certain individuals with injuries resulting from the 
              administration of smallpox countermeasures.

    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. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    Part A of title II of the Public Health Service Act (42 U.S.C. 202 
et seq.) is amended by inserting after section 224 the following:

``SEC. 224A. PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL.

    ``(a) Definitions.--In this section:
            ``(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--
                            ``(i) a health care worker, law enforcement 
                        officer, firefighter, security personnel, 
                        emergency medical personnel, other public 
                        safety personnel, or support personnel for such 
                        occupational specialties who is identified in a 
                        State or local, or Department of Health and 
                        Human Services smallpox emergency response plan 
                        that is approved by the Secretary; or
                            ``(ii) an individual with respect to whom 
                        the Secretary determines and declares that it 
                        is advisable to administer the vaccine (not 
                        including any individual to whom the Secretary 
                        determines only that such vaccine should be 
                        made available); and
                    ``(B) to whom a smallpox vaccine is administered 
                during the period in which the Declaration is effective 
                (including the portion of such period before the date 
                of enactment of this section) and--
                            ``(i) with respect to an individual 
                        described in subparagraph (A)(i), ending on the 
                        later of--
                                    ``(I) the expiration of the 180-day 
                                period that begins on the effective 
                                date of the initial interim final 
                                regulations to implement this section; 
                                or
                                    ``(II) the expiration of the 180-
                                day period that begins on the date on 
                                which an individual becomes identified 
                                in the plan specified under 
                                subparagraph (A)(i); and
                            ``(ii) with respect to an individual 
                        described by subparagraph (A)(ii), ending on 
                        the earlier of--
                                    ``(I) the date on which the 
                                Secretary publicly announces that an 
                                active case of smallpox has been 
                                identified either within or outside the 
                                United States; or
                                    ``(II) the termination of the 
                                Declaration.
            ``(3) Covered injury.--The term `covered injury' includes--
                    ``(A) an injury, disability, illness, condition, or 
                death determined, pursuant to the procedures 
                established under subsection (c), to have been 
                sustained as the direct result of administration to an 
                individual of a covered countermeasure during the 
                effective period of the Declaration (other than a minor 
                injury such as minor scarring or minor local reaction); 
                and
                    ``(B) an injury, disability, illness, condition, or 
                death determined, pursuant to the procedures 
                established under subsection (c), to have been 
                sustained as the direct result of accidental vaccinia 
                inoculation through contact with and individual who is 
                (or who was accidentally inoculated by) an individual 
                in a category specified in article IV of the 
                Declaration to whom vaccinia vaccine has been 
                administered during the effective period of the 
                Declaration (other than a minor injury such as minor 
                scarring or minor local reaction).
            ``(4) Declaration.--The term `Declaration' means the 
        Declaration Regarding Administration of Smallpox 
        Countermeasures issued by the Secretary of Health and Human 
        Services on January 24, 2003, and published in the Federal 
        Register on January 28, 2003, including any subsequent 
        amendment.
            ``(5) Eligible individual.--The term `eligible individual' 
        means an individual who is (as determined in accordance with 
        section 3)--
                    ``(A) a covered individual who sustains a covered 
                injury as the direct result of administration of a 
                covered countermeasure; or
                    ``(B) any individual who contracts vaccinia during 
                the effective period of the Declaration or within 30 
                days after the end of such period--
                            ``(i) to whom vaccinia vaccine was not 
                        administered; and
                            ``(ii) who sustains a covered injury as the 
                        direct result of contracting vaccinia.
            ``(6) Secretary.--Except as provided otherwise, the term 
        `Secretary' means the Secretary of Health and Human Services.
            ``(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 Secretary shall--
            ``(1) ensure that a State, local, or Department of Health 
        and Human Services plan to vaccinate individuals that is 
        approved by the Secretary establishes administrative procedures 
        to ensure the education and screening of potential 
        participants, and that the decision by a covered individual to 
        participate is voluntary, consistent with the Declaration and 
        guidelines of the Centers for Disease Control and Prevention; 
        and
            ``(2) ensure that any State, local, or Department of Health 
        and Human Services plan to vaccinate individuals that is 
        approved by the Secretary is consistent with the Declaration.
    ``(c) Determination of Eligibility.--
            ``(1) In general.--The Secretary, in consultation with the 
        Attorney General and the Secretary of Labor, shall establish 
        administrative procedures for determining, as applicable with 
        respect to an individual--
                    ``(A) whether the individual is an eligible 
                individual;
                    ``(B) whether the individual has sustained a 
                covered injury or injuries for which medical benefits 
                and employment income-loss compensation may be 
                available under subsections (e) and (f), and the amount 
                of such benefits or compensation; and
                    ``(C) whether the covered injury or injuries of the 
                individual constitute a compensable disability, or 
                caused the individual's death, for purposes of benefits 
                under subsection (g).
            ``(2) 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 an individual in a category 
        specified in article IV of the Declaration to whom such a 
        countermeasure has been administered by the applicable deadline 
        specified in subsection (a)(2)(B), as establishing that the 
        individual is a covered individual.
            ``(3) Determination of causation.--
                    ``(A) Injuries specified in injury table.--In any 
                case where an injury or other adverse effect specified 
                in the injury table established under subsection (d) as 
                a known effect of a covered countermeasure manifests in 
                an individual within the time period specified in such 
                table, such injury or other effect shall be rebuttably 
                presumed to have resulted from administration of such 
                covered countermeasure.
                    ``(B) Other determinations.--In making 
                determinations other than those described in 
                subparagraph (A) as to the causation or severity of an 
                injury, the Secretary shall take into consideration all 
                relevant medical and scientific evidence presented for 
                consideration, and may obtain and consider the views of 
                qualified medical experts.
            ``(4) Deadline for filing claim.--The Secretary shall not 
        consider any claim for a benefit under this subsection with 
        respect to an individual unless an initial claim is filed under 
        this section, alleging a covered injury to such individual, not 
        later than--
                    ``(A) the date a covered countermeasure was 
                administered to the individual; or
                    ``(B) in the case of a claim based on contact 
                vaccination (as described in subsection (a)(5)(B)), the 
                date of the first symptom or manifestation of onset of 
                an adverse effect of such vaccination.
            ``(5) Review of determination.--
                    ``(A) Secretary's review authority.--The Secretary 
                may review a determination under this subsection at any 
                time on the Secretary's own motion or on application, 
                and may affirm, vacate, or modify such determination. 
                The Secretary shall develop a process by which a 
                claimant may file a request for reconsideration of any 
                determination made by the Secretary under this 
                subsection.
                    ``(B) 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 decision, determination, action, or 
                regulation by the Secretary under this subsection. No 
                officer or employee of the United States shall review 
                any action by the Secretary under this subsection 
                (unless the President specifically directs otherwise).
    ``(d) Countermeasure Injury Table.--
            ``(1) Smallpox countermeasure injury table.--The Secretary, 
        taking into consideration all relevant medical and scientific 
        evidence, shall establish by interim final regulation a table 
        identifying--
                    ``(A) adverse effects (including injuries, 
                disabilities, illnesses, conditions, and deaths) that 
                shall be presumed to result from the administration of 
                (or exposure to) a covered countermeasure; and
                    ``(B) the time periods 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). Such amendments 
        shall apply retroactively to claims filed or pending at the 
        time of the promulgation of final amending regulations and to 
        claims filed after such promulgation.
            ``(3) Effect of revised table.--If at any time the Smallpox 
        Countermeasure Injury Table established under paragraph (1) is 
        revised and the effect of such revision is to permit an 
        individual who was not, before such revision, eligible to seek 
        payment or compensation under this section, such person may 
        file a claim not later than 2 years after the effective date of 
        the revision, except that no payment or compensation may be 
        provided under this section with respect to a smallpox 
        countermeasure-related injury or death covered under the 
        revision of the table if such injury or death occurred more 
        than 2 years before the date of the revision of the table.
            ``(4) Prohibition.--The Secretary may not provide any 
        compensation under the program under this section for any minor 
        scarring or minor local reaction or for an eligible individual 
        who is not a covered individual if the eligible individual does 
        not sustain a physical injury.
    ``(e) Medical Benefits.--
            ``(1) In general.--Subject to paragraph (2), an eligible 
        individual shall be entitled to payment by the Secretary for 
        medical items and services as reasonable and necessary to treat 
        a covered injury. The Secretary may consider the provisions of 
        chapter 81 of title 5, United States Code, (and the 
        implementing regulations with respect to such chapter) and 
        section 2115 of this Act in determining the amount of such 
        payment and the circumstances under which such payments are 
        reasonable and necessary.
            ``(2) Limitations.--
                    ``(A) Benefits secondary to other coverage.--The 
                obligation of the Secretary to pay for any services or 
                benefits under paragraph (1) 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 
                provision of law or contractual agreement, to pay for 
                or provide such services or benefits.
                    ``(B) No benefits for medicare-eligible 
                individual.--No benefits shall be available to an 
                individual under this subsection with respect to any 
                period in which the individual is eligible for benefits 
                under title XVIII of the Social Security Act (42 U.S.C. 
                1395 et seq.).
    ``(f) Compensation for Lost Employment Income.--
            ``(1) In general.--Subject to paragraphs (2) and (3), an 
        eligible individual shall be entitled to payment of 
        compensation by the Secretary for loss of employment income 
        incurred as a result of a covered injury, at the rate specified 
        in paragraph (2).
            ``(2) Amount of compensation.--
                    ``(A) In general.--Compensation under this 
                subsection shall be at the rate of 66\2/3\ percent of 
                the relevant pay-period (e.g., weekly, monthly) pay, 
                except as provided in paragraph (B).
                    ``(B) Augmented compensation for dependents.--An 
                eligible individual with one or more dependents is 
                entitled to have the basic compensation for loss of 
                employment income as described in paragraph (A) 
                augmented at the rate of 8\1/3\ percent.
                    ``(C) Consideration of other programs.--The 
                Secretary may consider the provisions of sections 8114 
                and 8115 of title 5, United States Code (and any 
                implementing regulations), in determining the amount of 
                payment under this paragraph and the circumstances 
                under which such payments are reasonable and necessary.
                    ``(D) Treatment of self-employment income.--For 
                purposes of this subsection--
                            ``(i) the term `employment income' includes 
                        income from self-employment; and
                            ``(ii) for purposes of computation of pay 
                        and determination of wage-earning capacity 
                        under subparagraph (A), self-employment income 
                        shall be treated as wages.
            ``(3) Limitations.--
                    ``(A) Benefits secondary to other coverage.--The 
                obligation of the Secretary to pay compensation under 
                paragraph (1) 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.
                    ``(B) No benefits for death or permanent and total 
                disability.--No payment shall be made under this 
                subsection in compensation for loss of employment 
                income due to the death or permanent and total 
                disability of an eligible individual.
                    ``(C) Limit on total benefits.--Total benefits paid 
                to an individual under this subsection shall not exceed 
                $50,000.
                    ``(D) Waiting period.--An eligible individual is 
                not entitled to compensation under this subsection for 
                the first 5 work days of disability.
    ``(g) Payment for Death and Permanent, Total Disability.--
            ``(1) Benefit for permanent and total disability.--Subject 
        to the succeeding provisions of this subsection, an eligible 
        individual who is determined, in accordance with the procedures 
        established under subsection (c), 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)) shall be entitled 
        to have payment made by the Secretary of an amount determined 
        under paragraph (3), in the same manner as disability benefits 
        are paid pursuant to the Public Safety Officers' Benefits 
        Program under subpart 1 of part L of title I of the Omnibus 
        Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et 
        seq.) 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).
            ``(2) Death benefit.--Subject to the succeeding provisions 
        of this subsection, in the case of an eligible individual whose 
        death is determined, in accordance with the procedures 
        established under subsection (c), to have directly resulted 
        from a covered injury or injuries a death benefit in the amount 
        determined under paragraph (3) shall be payable by the 
        Secretary to the survivor or survivors in the same manner as 
        death benefits are paid pursuant to the Public Safety Officers' 
        Benefits Program under subpart 1 of part L of title I of the 
        Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 
        3796 et seq.) with respect to an eligible deceased 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).
            ``(3) Benefit amount.--The amount of the disability or 
        death benefit under paragraph (1) or (2) in a fiscal year 
        shall, subject to paragraph (5)(B), equal the amount of the 
        comparable benefit calculated under the Public Safety Officers' 
        Benefits Program under subpart 1 of part L of title I of the 
        Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 
        3796 et seq.) in such fiscal year, without regard to any 
        reduction attributable to a limitation on appropriations.
            ``(4) Reduction for payments for lost employment income.--
        The amount of the benefit as determined under paragraph (3) 
        shall be reduced by the total amount of any benefits paid under 
        subsection (f) with respect to lost employment income.
            ``(5) Limitations.--
                    ``(A) Disability benefits.--Except as provided in 
                subparagraph (C), no benefit is payable under paragraph 
                (1) with respect to the disability of an eligible 
                individual if--
                            ``(i) a disability benefit is paid or 
                        payable with respect to such individual under 
                        Public Safety Officers' Benefits Program under 
                        subpart 1 of part L of title I of the Omnibus 
                        Crime Control and Safe Streets Act of 1968 (42 
                        U.S.C. 3796 et seq.); or
                            ``(ii) a death benefit is paid or payable 
                        with respect to such individual under paragraph 
                        (2) or the Public Safety Officers' Benefits 
                        Program under subpart 1 of part L of title I of 
                        the Omnibus Crime Control and Safe Streets Act 
                        of 1968 (42 U.S.C. 3796 et seq.).
                    ``(B) Death benefits.--Except as provided in 
                subparagraph (C), no benefit is payable under paragraph 
                (2) with respect to the death of an eligible individual 
                if--
                            ``(i) a disability benefit is paid with 
                        respect to such individual under paragraph (1) 
                        or the Public Safety Officers' Benefits Program 
                        under subpart 1 of part L of title I of the 
                        Omnibus Crime Control and Safe Streets Act of 
                        1968 (42 U.S.C. 3796 et seq.); or
                            ``(ii) a death benefit is paid or payable 
                        with respect to such individual under the 
                        Public Safety Officers' Benefits Program under 
                        subpart 1 of part L of title I of the Omnibus 
                        Crime Control and Safe Streets Act of 1968 (42 
                        U.S.C. 3796 et seq.).
                    ``(C) 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 Public Safety Officers' 
                Benefits Program under subpart 1 of part L of title I 
                of the Omnibus Crime Control and Safe Streets Act of 
                1968 (42 U.S.C. 3796 et seq.) are reduced because of a 
                limitation on appropriations, and such reduction would 
                affect the amount that would be payable under 
                subparagraph (A) or (B) without regard to this 
                subparagraph, benefits shall be available under 
                paragraph (1) or (2) to the extent necessary to ensure 
                that such individual (or the survivor or survivors of 
                such individual) receives a total amount equal to the 
                amount described in paragraph (3).
    ``(h) Administration.--
            ``(1) Administration by agreement with other agency or 
        agencies.--The Secretary may administer any or all of the 
        provisions of this section through Memorandum of Agreement with 
        the Attorney General or the Secretary of Labor.
            ``(2) Regulations.--The head of the agency administering 
        this section or any provisions thereof (including any agency 
        head administering such section or provisions through a 
        Memorandum of Agreement under paragraph (1)) may promulgate 
        such implementing regulations as may be determined necessary 
        and appropriate. Initial implementing regulations may be 
        interim final regulations.
    ``(i) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for fiscal year 2003 and 
each succeeding fiscal year to carry out this section, to remain 
available until expended, including administrative costs and costs of 
provision and payment of benefits.
    ``(j) Relationship to Other Laws.--
            ``(1) No preemption of individual rights.--Except as 
        otherwise provided in this section, nothing in this section 
        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.
            ``(2) Relationship to the federal tort claims act.--
                    ``(A) Exhaustion requirement.--An individual may 
                not seek any remedy that may be available under section 
                224(p) (providing a cause of action under the Federal 
                Tort Claims Act for injuries resulting from 
                administration of smallpox countermeasures under such 
                section 224(p)) unless such individual has first filed 
                a claim for payment or compensation under this section 
                and has received a final determination with respect to 
                such claim, except that if the Secretary fails to make 
a final determination on a claim for payment or compensation filed in 
accordance with the requirements of this section within 240 days after 
such claim was filed, the individual may seek any remedy that may be 
available under section 224(p).
                    ``(B) Offset of compensation against federal tort 
                claims act recovery.--The value of any compensation or 
                benefits paid to an individual, or the survivor, 
                survivors, or the estate of such an individual with 
                respect to an injury, pursuant to a claim under this 
                section, shall be offset against any award to such 
                individual or to the individual's survivor, survivors, 
                or estate under section 224(p) with respect to the same 
                injury.''.

SEC. 3. EXHAUSTION; EXCLUSIVITY; OFFSET.

    Paragraph (3) of section 224(p) of the Public Health Service 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 exhausted such remedies as are available 
                        under the Smallpox Emergency Personnel 
                        Protection Act of 2003.
                            ``(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 claim under the Smallpox Emergency 
                        Personnel Protection Act of 2003.
                            ``(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 civil action or 
                proceeding under such Act.
                    ``(C) Offset.--The value of all compensation or 
                benefits paid to an individual, or to the survivor, 
                survivors, or the estate of the individual with respect 
                to an injury, pursuant to a claim under this section, 
                shall be offset against any award to such individual or 
                to the individual's survivor, survivors, or estate 
                under this subsection with respect to the same 
                injury.''.
                                 <all>