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.

March 26, 2003

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

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.'.

END