I 

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Smallpox Vaccine 

5 Compensation and Safety Act of 2003’’. 
2

•HR 865 IH 

1 SEC. 2. SMALLPOX VACCINATIONS. 

2 The Public Health Service Act (42 U.S.C. 201 et 

3 seq.) is amended by adding at the end the following: 

4 ‘‘TITLE XXIX—ADDITIONAL 

5 VACCINE PROVISIONS 

6 ‘‘SEC. 2901. COVERED COUNTERMEASURE. 

7 ‘‘For purposes of this title, the terms ‘‘covered coun8 termeasure’’ and ‘‘covered countermeasure against small9 pox’’ have the meanings given to those terms in section 

10 224(p)(7)(A). 

11 ‘‘SEC. 2902. GRANTS TO ASSIST STATE AND LOCAL GOVERN12 MENTS IN MEETING THE COSTS OF SMALL13 POX INOCULATION PROGRAMS. 

14 ‘‘(a) IN GENERAL.—

15 ‘‘(1) GRANTS.—For the purposes described in 

16 paragraph (2), the Secretary shall make an allot17 ment each fiscal year for each State in an amount 

18 determined in accordance with subsection (e). The 

19 Secretary shall make a grant to the State of the al20 lotment made for the State for the fiscal year if the 

21 State submits to the Secretary an application at 

22 such time, in such manner, and containing such in23 formation as the Secretary may require. 

24 ‘‘(2) PURPOSES.—A funding agreement for a 

25 grant under this section is that the State involved 
3

•HR 865 IH 

1 will expend the grant only for the following pur2 poses: 

3 ‘‘(A) Providing for the administration of 

4 covered countermeasures against smallpox. 

5 ‘‘(B) Monitoring the health of individuals 

6 receiving covered countermeasures against 

7 smallpox or individuals in close contact with in8 dividuals receiving such countermeasures. 

9 ‘‘(C) Providing for the conduct of epide10 miological studies related to the administration 

11 of covered countermeasures against smallpox. 

12 ‘‘(b) SUPPLEMENT NOT SUPPLANT.—A funding 

13 agreement for a grant under this section is that the State 

14 involved will use the grant to supplement and not supplant 

15 funds received from other sources for the purposes de16 scribed in subsection (a). 

17 ‘‘(c) LOCAL INVOLVEMENT.—A funding agreement 

18 for a grant under this section is that the State involved 

19 will ensure that a suitable portion of the amount received 

20 under the grant is expended at the local level. 

21 ‘‘(d) REQUIREMENTS.—

22 ‘‘(1) IN GENERAL.—A funding agreement for a 

23 grant under this section is that the State involved 

24 will comply with the requirements of this subsection. 

25 ‘‘(2) EDUCATION PROGRAM.—
4

•HR 865 IH 

1 ‘‘(A) ESTABLISHMENT.—Each State that 

2 receives a grant under this section shall estab3 lish an education program to provide to each in4 dividual to whom a covered countermeasure 

5 against smallpox is proposed to be administered 

6 an explanation of—

7 ‘‘(i) the screening and medical surveil8 lance and evaluation programs available 

9 under paragraphs (3) and (4); 

10 ‘‘(ii) the risks and benefits from ad11 ministration of such countermeasure for 

12 such individuals and those individuals with 

13 whom they have close contact; 

14 ‘‘(iii) the availability of the compensa15 tion program under section 224(q); 

16 ‘‘(iv) the eligibility of the individual to 

17 receive health care as described in this Act; 

18 ‘‘(v) the right of the individual to 

19 refuse the administration of any covered 

20 countermeasure against smallpox; 

21 ‘‘(vi) the right of an individual who 

22 exercises the option described in clause (v) 

23 to be protected from disciplinary action 

24 under section 2903; and 
5

•HR 865 IH 

1 ‘‘(vii) the general functions and duties 

2 that such individual may be expected to 

3 carry out if there is a smallpox outbreak. 

4 ‘‘(B) EXPLANATIONS.—Explanations pro5 vided under subparagraph (A)—

6 ‘‘(i) shall be made available in a form 

7 that is easily read and understood; 

8 ‘‘(ii) shall be provided, as appropriate, 

9 in languages other than English; 

10 ‘‘(iii) shall be made available to those 

11 individuals who reside with individuals to 

12 whom such covered countermeasure is pro13 posed to be administered and, as appro14 priate, to patients treated by individuals 

15 who have received a covered counter16 measure; and 

17 ‘‘(iv) shall be made available without 

18 charge or loss of wages or benefits to an 

19 individual to whom a covered counter20 measure against smallpox is proposed to be 

21 administered and to the individuals de22 scribed in clause (iii). 

23 ‘‘(3) SCREENING PROGRAM.—

24 ‘‘(A) IN GENERAL.—Each State that re25 ceives a grant under this section shall, for each 
6

•HR 865 IH 

1 individual to whom a covered countermeasure 

2 against smallpox is proposed to be adminis3 tered—

4 ‘‘(i) provide without charge counseling 

5 services that describe conditions which may 

6 exacerbate the risks of receiving such coun7 termeasure; and 

8 ‘‘(ii) offer on a voluntary basis, 

9 screening and testing that can identify 

10 health conditions that can reasonably be 

11 expected to significantly increase risks to 

12 the health of such individual, including 

13 screening and testing for human immuno14 deficiency virus, eczema or other signifi15 cant chronic skin irritation, pregnancy, 

16 and such other conditions as determined 

17 appropriate by the Secretary. 

18 ‘‘(B) RESULTS.—The results or other in19 formation (including information concerning an 

20 individual’s refusal to be screened or tested) 

21 generated or obtained from the screening and 

22 testing described in subparagraph (A)—

23 ‘‘(i) shall be deemed protected health 

24 information under the meaning of the term 

25 in the regulations promulgated pursuant to 
7

•HR 865 IH 

1 the authority of section 264(c) of the 

2 Health Insurance Portability and Account3 ability Act of 1996; 

4 ‘‘(ii) shall not be made available to an 

5 employer; and 

6 ‘‘(iii) shall be provided without charge 

7 to the individual receiving such screening 

8 and testing. 

9 ‘‘(4) MEDICAL SURVEILLANCE AND EVALUA10 TION PROGRAM.—If the Secretary declares vaccinia 

11 vaccine or any other measure to be a covered coun12 termeasure under section 224(p), each State that re13 ceives a grant under this section shall ensure that an 

14 ongoing active medical surveillance and evaluation 

15 program is provided to all individuals to whom such 

16 countermeasure is administered and to the close con17 tacts of such individuals. Such program shall—

18 ‘‘(A) be provided from the date that 

19 vaccinia vaccine or another covered counter20 measure is administered to a date that is not 

21 less than 60 days from the date of administra22 tion; 

23 ‘‘(B) include evaluation of any adverse 

24 health effect that may reasonably appear to be 

25 due to vaccinia vaccine or another covered
8

•HR 865 IH 

1 countermeasure and shall provide prompt med2 ical treatment or referral of any individual re3 quiring health care as a result of such adverse 

4 health effect; and 

5 ‘‘(C) be provided without charge to any in6 dividual to whom vaccinia vaccine or another 

7 covered countermeasure is administered and to 

8 the close contacts of such individuals. 

9 ‘‘(5) NEEDLES.—If the Secretary declares 

10 vaccinia vaccine to be a covered countermeasure 

11 under section 224(p), each State that receives a 

12 grant under this section shall ensure that for any 

13 administration of such vaccine, the individual admin14 istering such vaccine shall use a sheathed bifurcated 

15 needle—

16 ‘‘(A) to the extent that such needle is ap17 proved under the Federal Food, Drug, and Cos18 metic Act; and 

19 ‘‘(B) to the extent that such sheathed bi20 furcated needle is available in such State. 

21 ‘‘(e) FUNDING.—

22 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—

23 For carrying out this section, there are authorized 

24 to be appropriated $850,000,000 for fiscal year 
9

•HR 865 IH 

1 2003 and such sums as may be necessary for each 

2 subsequent fiscal year. 

3 ‘‘(2) ALLOCATION.—From the amounts appro4 priated and available for allotment under this sub5 section for any fiscal year, the Secretary shall allot 

6 to each State that submits an application in accord7 ance with subsection (a)(1) an amount that is the 

8 greater of—

9 ‘‘(A) the base amount as determined under 

10 paragraph (3); or 

11 ‘‘(B) the minimum amount as determined 

12 under paragraph (4). 

13 ‘‘(3) BASE AMOUNT.—For each State receiving 

14 an award under this section, the Secretary shall de15 termine the base amount, which shall be equal to the 

16 product of—

17 ‘‘(A) the amount appropriated under this 

18 subsection for the fiscal year, less an amount 

19 equal to the sum of all minimum amounts de20 termined for the States under paragraph (4); 

21 and 

22 ‘‘(B) the percentage constituted by the 

23 ratio of an amount equal to the population of 

24 the State over an amount equal to the total 

25 population of the States (as indicated by the 
10

•HR 865 IH 

1 most recent data collected by the Bureau of the 

2 Census). 

3 ‘‘(4) MINIMUM AMOUNT.—For each State re4 ceiving an award under this subsection, the min5 imum amount is—

6 ‘‘(A) in the case of each of the several 

7 States, the District of Columbia, and the Com8 monwealth of Puerto Rico, an amount equal to 

9 the lesser of—

10 ‘‘(i) $5,000,000; or 

11 ‘‘(ii) if the amount appropriated under 

12 this subsection is less than $667,000,000, 

13 an amount equal to 0.75 percent of the 

14 amount appropriated under this sub15 section; or 

16 ‘‘(B) in the case of each of American 

17 Samoa, Guam, the Commonwealth of the 

18 Northern Mariana Islands, and the United 

19 States Virgin Islands, an amount determined by 

20 the Secretary to be appropriate, except that 

21 such amount may not exceed the amount deter22 mined under subparagraph (A). 

23 ‘‘SEC. 2903. PROTECTION FROM DISCIPLINARY ACTION. 

24 ‘‘(a) FINDING.—The Congress finds that unlawful 

25 employment practices described in subsection (b) are det-
11

•HR 865 IH 

1 rimental to the general public health and an interference 

2 with the interstate control of infectious disease. 

3 ‘‘(b) IN GENERAL.—It shall be an unlawful employ4 ment practice for an employer—

5 ‘‘(1) to fail or refuse to hire or to discharge any 

6 individual, or otherwise to discriminate against any 

7 individual with respect to the compensation, terms, 

8 conditions, or privileges of employment of the indi9 vidual, because of a refusal or inability to receive the 

10 administration of a covered countermeasure against 

11 smallpox or because of an adverse reaction or reac12 tions to such countermeasure; or 

13 ‘‘(2) subject to subsection (c), to limit, seg14 regate, or classify the employees of the employer in 

15 any way that would deprive or tend to deprive any 

16 individual of employment opportunities or otherwise 

17 adversely affect the status of the individual as an 

18 employee, because of a refusal or inability to receive 

19 a covered countermeasure against smallpox or be20 cause of an adverse reaction or reactions to such 

21 countermeasure. 

22 ‘‘(c) EXCEPTION.—

23 ‘‘(1) IN GENERAL.—This section does not pro24 hibit an employer from limiting, segregating, or 

25 classifying for a period of 30 days or less an em-
12

•HR 865 IH 

1 ployee to whom a covered countermeasure against 

2 smallpox has been administered for the purpose of 

3 protecting the close contacts (including patients) of 

4 such employee. 

5 ‘‘(2) REGULAR WAGES AND BENEFITS RE6 QUIRED.—Nothing in paragraph (1) shall be con7 strued to permit an employer to reduce the wages or 

8 benefits of an employee because a covered counter9 measure against smallpox has been administered to 

10 such employee. 

11 ‘‘(d) DEFINITIONS OF EMPLOYEE AND EMPLOYER.—

12 The terms ‘employee’ and ‘employer’ have the meanings 

13 given such terms in section 701 of the Civil Rights Act 

14 of 1964 (42 U.S.C. 2000e), except that the terms ‘em15 ployee’ and ‘employer’ shall also include the meanings 

16 given such terms in section 717 of the Civil Rights Act 

17 of 1964 (42 U.S.C. 2000e–16). 

18 ‘‘(e) FILING COMPLAINTS AND PROCEDURES.—

19 ‘‘(1) COMPLAINT.—

20 ‘‘(A) IN GENERAL.—Not later than 180 

21 days after an alleged violation of subsection (b) 

22 has occurred, the employee alleging such viola23 tion or another individual at the employee’s re24 quest, may file a complaint with the Secretary.
13

•HR 865 IH 

1 ‘‘(B) NOTICE.—Not later than 15 days 

2 after receipt of a complaint described in sub3 paragraph (A), the Secretary shall notify the 

4 employer alleged in the complaint to have com5 mitted a violation of subsection (b) of the filing 

6 of such complaint. 

7 ‘‘(2) FINDINGS AND PRELIMINARY ORDER.—

8 ‘‘(A) IN GENERAL.—Not later than 60 

9 days after receiving a complaint described in 

10 paragraph (1), the Secretary shall—

11 ‘‘(i) conduct an investigation of the 

12 matters alleged in the complaint; 

13 ‘‘(ii) determine whether it is reason14 able to believe that the complaint has 

15 merit; and 

16 ‘‘(iii) notify the complainant and the 

17 employer alleged to have committed the 

18 violation of subsection (b) of the deter19 mination. 

20 ‘‘(B) REASONABLE BELIEF THAT A VIOLA21 TION HAS OCCURRED.—If the Secretary deter22 mines pursuant to subparagraph (A) that it is 

23 reasonable to believe that a violation of sub24 section (b) has occurred, the Secretary shall in25 clude with the notice under such subparagraph 
14

•HR 865 IH 

1 findings and a preliminary order for the relief 

2 provided under paragraph (3). 

3 ‘‘(C) OBJECTIONS.—

4 ‘‘(i) IN GENERAL.—Not later than 30 

5 days after receipt of the notice under sub6 paragraph (A), the complainant and the 

7 employer alleged to have committed the 

8 violation of subsection (b) may file objec9 tions to the findings or the preliminary 

10 order and request a hearing on the record. 

11 ‘‘(ii) REINSTATEMENT.—The filing of 

12 objections under clause (i) does not stay a 

13 reinstatement ordered in the preliminary 

14 order. 

15 ‘‘(iii) FAILURE TO OBJECT.—If a 

16 hearing is not requested pursuant to the 

17 requirements of clause (i), the preliminary 

18 order is final and not subject to judicial re19 view. 

20 ‘‘(D) HEARINGS AND FINAL ORDER.—

21 ‘‘(i) HEARINGS.—A hearing under 

22 this subsection shall be conducted expedi23 tiously. 

24 ‘‘(ii) FINAL ORDER.—Not later that 

25 120 days after the end of a hearing under 
15

•HR 865 IH 

1 this subsection, the Secretary shall issue a 

2 final order. 

3 ‘‘(iii) SETTLEMENT.—At any time 

4 prior to the issuance of a final order, any 

5 further action under this subsection may 

6 be ended by a settlement agreement made 

7 by the complainant and the employer al8 leged to have committed the violation of 

9 subsection (b), and approved by the Sec10 retary. 

11 ‘‘(3) RELIEF.— 

12 ‘‘(A) IN GENERAL.—If the Secretary deter13 mines on the basis of a complaint, that an em14 ployer violated subsection (b) of this section, 

15 the Secretary shall order such employer to pro16 vide relief including—

17 ‘‘(i) taking affirmative action to abate 

18 the violation; 

19 ‘‘(ii) reinstating the complainant to 

20 the former position with the same pay and 

21 terms and privileges of employment; and 

22 ‘‘(iii) paying compensatory damages, 

23 including back pay. 

24 ‘‘(B) COSTS INCURRED IN BRINGING A

25 COMPLAINT.—If the Secretary issues an order 
16

•HR 865 IH 

1 under subparagraph (A), and the complainant 

2 so requests, the Secretary may order that the 

3 employer who violated subsection (b) pay the 

4 costs (including attorney’s fees) reasonably in5 curred by the complainant in bringing the com6 plaint, as determined by the Secretary. 

7 ‘‘(f) JUDICIAL REVIEW AND VENUE.—

8 ‘‘(1) IN GENERAL.—Not later than 60 days 

9 after an order has been issued under subsection (e), 

10 a party adversely affected by such order may file a 

11 petition for review in the United States circuit court 

12 for the circuit in which the violation occurred or in 

13 which the party resided on the date of the violation. 

14 ‘‘(2) REVIEW.—A review conducted pursuant to 

15 this subsection shall be heard and decided expedi16 tiously. 

17 ‘‘(3) REVIEW IN OTHER PROCEEDINGS.—An 

18 order of the Secretary subject to review under this 

19 subsection is not subject to judicial review in a 

20 criminal or other civil proceeding. 

21 ‘‘(g) CIVIL ACTIONS TO ENFORCE.—If an employer 

22 fails to comply with an order issued under subsection (e), 

23 the Secretary shall bring a civil action to enforce such 

24 order in the United States district court for the district 

25 in which the violation occurred.
17

•HR 865 IH 

1 ‘‘SEC. 2904. MEDICAL LEAVE FOR CERTAIN VACCINE RE2 CIPIENTS. 

3 ‘‘(a) IN GENERAL.—In accordance with regulations 

4 promulgated by the Secretary, an employee (as defined in 

5 section 3 of the Fair Labor Standards Act of 1938) shall 

6 be entitled to a total of not more than 4 workdays of paid 

7 leave because of a health condition that makes the em8 ployee unable to perform the functions of the position of 

9 such employee that arose as a result of the employee hav10 ing received or come into close contact with an individual 

11 who received a covered countermeasure against smallpox. 

12 ‘‘(b) APPLICATION OF CERTAIN PROVISIONS.—Leave 

13 shall be provided under subsection (a) in accordance with 

14 the provisions of the Family and Medical Leave Act of 

15 1993 except that—

16 ‘‘(1) such leave shall be provided for a condition 

17 described in subsection (a) regardless of whether 

18 such condition requires inpatient care or continuing 

19 treatment; 

20 ‘‘(2) such leave shall be fully paid; and 

21 ‘‘(3) this section shall apply to all employers re22 gardless of size. 

23 ‘‘(c) REIMBURSEMENT FROM THE PROGRAM.—

24 ‘‘(1) NON-FEDERAL EMPLOYEES.—Any em25 ployer, other than a Federal agency, that provides 

26 paid leave to an employee for the reasons described 
18

•HR 865 IH 

1 in subsection (a) may seek reimbursement for such 

2 leave from the compensation program under section 

3 224(q). 

4 ‘‘(2) FEDERAL EMPLOYEES.—A Federal agency 

5 that provides leave under this section shall treat 

6 such leave as paid administrative leave. 

7 ‘‘SEC. 2905. RESPONSIBILITIES OF THE SECRETARY. 

8 ‘‘(a) SUPPLIES OF VACCINIA IMMUNE GLOBULIN.—

9 If the Secretary declares vaccinia vaccine to be a covered 

10 countermeasure under section 224(p), the Secretary shall 

11 ensure that adequate supplies of vaccinia immune globulin 

12 are made available to any individual to whom vaccinia vac13 cine is administered during the period of such declaration. 

14 ‘‘(b) UNIFORM SYSTEM OF REPORTING.—

15 ‘‘(1) IN GENERAL.—The Secretary shall estab16 lish a uniform system for reporting adverse re17 sponses to any covered countermeasure against 

18 smallpox to the Secretary. 

19 ‘‘(2) REPORT TO CONGRESS.—Not later than 1 

20 year after the date of enactment of this Act and 

21 every year in which covered countermeasures against 

22 smallpox are administered, the Secretary shall sub23 mit to the Committee on Health, Education, Labor, 

24 and Pensions of the Senate and the Committee on 

25 Energy and Commerce of the House of Representa-
19

•HR 865 IH 

1 tives, a report that describes for the preceding 

2 year—

3 ‘‘(A) the number of individuals to whom a 

4 covered countermeasure against smallpox was 

5 administered; and 

6 ‘‘(B) the number and kind of adverse reac7 tions caused by the administration of a covered 

8 countermeasure against smallpox. 

9 ‘‘SEC. 2906. PROVISION OF NEEDLES. 

10 ‘‘The Director of the Centers for Disease Control and 

11 Prevention shall provide needles to States that receive a 

12 grant under section 2902 for the purpose of administering 

13 vaccinia vaccine in accordance with section 2902(d)(5).’’. 

14 SEC. 3. HEALTH CARE FOR HEALTH CARE WORKERS AND 

15 FIRST RESPONDERS SUFFERING ADVERSE 

16 REACTIONS OR COMPLICATIONS FROM 

17 SMALLPOX VACCINE; CONTINUED INSUR18 ANCE COVERAGE. 

19 (a) PAYMENTS FOR PROVISION OF MEDICAL ASSIST20 ANCE.—Title XXIX of the Public Health Service Act (as 

21 added by section 2) is amended by adding at the end the 

22 following: 
20

•HR 865 IH 

1 ‘‘SEC. 2907. HEALTH CARE FOR INDIVIDUALS SUFFERING 

2 ADVERSE REACTIONS OR COMPLICATIONS 

3 FROM SMALLPOX VACCINE. 

4 ‘‘(a) PAYMENT.—

5 ‘‘(1) IN GENERAL.—The Secretary shall pay to 

6 each State with an agreement described in sub7 section (b) an amount equal to the costs incurred by 

8 that State to provide medical assistance described in 

9 subsection (b)(1), subject to paragraph (2). 

10 ‘‘(2) LIMITATION ON PAYMENT.—The Secretary 

11 shall not make any payment under paragraph (1) 

12 for costs for medical assistance insofar as such costs 

13 may reasonably be reimbursed from a third party 

14 under the terms of the agreement described in sub15 section (b)(2). Any payment under this section to a 

16 State with respect to medical assistance shall be con17 ditioned on reimbursement to the Secretary when 

18 notice or other information is received that payment 

19 for such medical assistance has been or could be 

20 made by a third party under subsection (b)(2). 

21 ‘‘(b) AGREEMENT.—An agreement described in this 

22 subsection is an agreement between a State and the Sec23 retary in which the State—

24 ‘‘(1) agrees to provide such medical assistance 

25 as may be medically necessary to—
21

•HR 865 IH 

1 ‘‘(A) any health care worker or first re2 sponder who—

3 ‘‘(i) has suffered any adverse reaction 

4 or complication as a result of a covered 

5 countermeasure against smallpox or expo6 sure to vaccinia virus or any other sub7 stance administered for the prevention or 

8 treatment of smallpox; and 

9 ‘‘(ii) has not received compensation 

10 under the National Smallpox Vaccine In11 jury Compensation Program established 

12 under section 224; and 

13 ‘‘(B) any individual who—

14 ‘‘(i) has suffered any adverse reaction 

15 or complication as a result of contact with 

16 another person who received a covered 

17 countermeasure; and 

18 ‘‘(ii) has not received compensation 

19 under the National Smallpox Vaccine In20 jury Compensation Program established 

21 under section 224; and 

22 ‘‘(2) agrees to take all reasonable measures to 

23 obtain reimbursement for the costs of providing such 

24 assistance from any third party (including health in-
22

•HR 865 IH 

1 surers and group health plans (as defined in section 

2 2791)) with responsibility for such costs. 

3 ‘‘(c) STATE ENTITLEMENT.—This section constitutes 

4 budget authority in advance of appropriations Acts and 

5 represents the obligation of the Federal Government to 

6 provide for the payment to States of amounts provided 

7 under this section. 

8 ‘‘(d) RULE OF CONSTRUCTION.—

9 ‘‘(1) INSURANCE COVERAGE.—Nothing in this 

10 section shall be construed to invalidate or otherwise 

11 abridge any provision of law or any contractual obli12 gation that otherwise obligates a health insurance 

13 issuer to provide reimbursement or otherwise defray 

14 the cost to an individual of health care needed to 

15 treat the health consequences of the administration 

16 of or exposure to a covered countermeasure against 

17 smallpox or exposure to vaccinia virus. 

18 ‘‘(2) HEALTH CARE FACILITIES.—Nothing in 

19 this section shall be construed to invalidate or other20 wise abridge any provision of law or any contractual 

21 obligation that otherwise obligates a health care fa22 cility to provide health care or other health services 

23 to an individual that are needed to treat the health 

24 consequences of the administration of a covered 
23

•HR 865 IH 

1 countermeasure against smallpox or exposure to 

2 vaccinia virus. 

3 ‘‘(3) EMPLOYERS.—Nothing in this section 

4 shall be construed to invalidate or otherwise abridge 

5 any provision of law or any contractual obligation 

6 that otherwise obligates an employer to provide 

7 leave, wages, vacation time, or any other benefit to 

8 an individual. 

9 ‘‘(4) STATE OR LOCAL GOVERNMENTS.—Noth10 ing in this section shall be construed to invalidate or 

11 otherwise abridge any provision of law or any con12 tractual obligation that otherwise obligates a State 

13 or local government to provide health care, workers’ 

14 compensation, or any other benefit to an individual. 

15 ‘‘(e) AUTHORIZING UTILIZATION OF MEDICAID IN

16 PROVIDING MEDICAL ASSISTANCE.—Nothing in this sec17 tion shall be construed to prevent a State from utilizing 

18 its medicaid program under title XIX of the Social Secu19 rity Act in order to provide medical assistance under this 

20 section. The Secretary shall waive such provisions of such 

21 Act as are necessary to permit a State to so utilize such 

22 program under this subsection.’’. 

23 (b) CONTINUED COVERAGE OF BENEFITS FOR

24 SMALLPOX VACCINE SIDE EFFECTS.—
24

•HR 865 IH 

1 (1) STATE MAINTAINED PLANS.—Section 2907 

2 of the Public Health Service Act (as added by sub3 section (a)) is amended by adding at the end the fol4 lowing: 

5 ‘‘(f) CONTINUED COVERAGE OF BENEFITS FOR

6 SMALLPOX VACCINE SIDE EFFECTS.—

7 ‘‘(1) IN GENERAL.—In accordance with regula8 tions which the Secretary shall prescribe, each group 

9 health plan that is maintained by any State that re10 ceives funds under this Act, by any political subdivi11 sion of such State, or by any agency or instrumen12 tality of such State or political subdivision, shall pro13 vide coverage of benefits for side effects resulting 

14 from covered countermeasures against smallpox at 

15 the level of such coverage it provided as of Sep16 tember 10, 2001. 

17 ‘‘(2) ENFORCEMENT.—For purposes of section 

18 2207, the requirement of paragraph (1) is deemed a 

19 requirement of title XXII.’’. 

20 (2) PRIVATE PLANS.—

21 (A) AMENDMENT TO TAX CODE.—

22 (i) IN GENERAL.—Paragraph (1) of 

23 section 4980B(f) of the Internal Revenue 

24 Code of 1986 is amended by inserting be25 fore the period at the end the following: ‘‘, 
25

•HR 865 IH 

1 and (C) only if the coverage of the side ef2 fects from covered countermeasures 

3 against smallpox (as such term is defined 

4 in section 224(p) of the Public Health 

5 Service Act) is not less than the level of 

6 coverage provided by the plan as of Sep7 tember 10, 2001’’. 

8 (ii) CONFORMING AMENDMENTS.—

9 Section 4980B(f)(1) of such Code is 

10 amended—

11 (I) by inserting ‘‘(A)’’ before 

12 ‘‘only if’’ the first place it appears, 

13 and 

14 (II) by striking ‘‘and only if’’ and 

15 inserting ‘‘, (B) only if’’. 

16 (iii) EFFECTIVE DATE.—The amend17 ments made by this section shall apply to 

18 covered countermeasures against smallpox 

19 taken after the date of the enactment of 

20 this Act. 

21 (B) AMENDMENT TO ERISA.—Section 

22 609 of the Employee Retirement Income Secu23 rity Act of 1974 (29 U.S.C. 1169) is amend24 ed—
26

•HR 865 IH 

1 (i) by redesignating subsection (e) as 

2 subsection (f); and 

3 (ii) by inserting after subsection (d) 

4 the following: 

5 ‘‘(e) CONTINUED COVERAGE OF BENEFITS FOR

6 SMALLPOX VACCINE SIDE EFFECTS.—A group health 

7 plan shall provide coverage of the side effects from covered 

8 countermeasures against smallpox (as such term is defined 

9 in section 224(p) of the Public Health Service Act) at the 

10 level of coverage provided by the plan as of September 10, 

11 2001.’’. 

12 SEC. 4. NATIONAL SMALLPOX VACCINE INJURY COMPENSA13 TION PROGRAM. 

14 (a) ESTABLISHMENT.—Section 224 of the Public 

15 Health Service Act (42 U.S.C. 233), as amended by sec16 tion 304(c) of Public Law 107–296 (116 Stat. 2135), is 

17 amended by adding at the end the following: 

18 ‘‘(q) NATIONAL SMALLPOX VACCINE INJURY COM19 PENSATION PROGRAM.—

20 ‘‘(1) ESTABLISHMENT.—The Secretary shall es21 tablish the National Smallpox Vaccine Injury Com22 pensation Program (referred to in this subsection as 

23 the ‘Smallpox Program’) under which compensation 

24 may be paid for injury or death related to the ad-
27

•HR 865 IH 

1 ministration of any covered countermeasure against 

2 smallpox. 

3 ‘‘(2) PROCEDURES AND STANDARDS.—The Sec4 retary shall by regulation establish procedures and 

5 standards applicable to the Smallpox Program that 

6 follow the procedures and standards applicable 

7 under the National Vaccine Injury Compensation 

8 Program established under section 2110, except for 

9 the following: 

10 ‘‘(A) A person may not file a civil action 

11 under subsection (p) unless the person has first 

12 filed a petition for compensation under the 

13 Smallpox Program under section 2111. 

14 ‘‘(B) After filing a petition under section 

15 2111, a person may elect to instead bring a 

16 civil action under subsection (p) if the person 

17 would be authorized under clause (i) or (ii) of 

18 section 2111(a)(2)(A) and under section 2121 

19 to elect to bring a civil action. 

20 ‘‘(C) Notwithstanding section 

21 2111(c)(1)(A), a person who did not receive a 

22 covered countermeasure against smallpox or 

23 any other substance administered for the pre24 vention or treatment of smallpox (including 

25 vaccinia virus) may receive compensation under 
28

•HR 865 IH 

1 the Smallpox Program if the person was injured 

2 as a result of contact with another person who 

3 received such a countermeasure or substance. 

4 ‘‘(D) Section 2111(c)(1)(D) (requiring pe5 titioner to demonstrate death, residual effects 

6 for more than 6 months, or inpatient hos7 pitalization and surgical intervention) shall not 

8 apply. 

9 ‘‘(E) Notwithstanding section 2115(a)(2), 

10 in the event of a death related to the adminis11 tration of vaccinia virus or other substance or 

12 medication administered for the purpose of pre13 venting or treating smallpox (including any cov14 ered countermeasure against smallpox), com15 pensation under the Smallpox Program shall in16 clude an award for the estate of the deceased 

17 of $850,000, in addition to any other com18 pensation to which the petitioner is entitled 

19 under this section. 

20 ‘‘(3) VACCINE INJURY TABLE.—

21 ‘‘(A) INCLUSION.—For purposes of receiv22 ing compensation under the Smallpox Program, 

23 the Vaccine Injury Table under section 2114 is 

24 deemed to include the following table of inju25 ries, disabilities, illnesses, conditions, and 
29

•HR 865 IH 

1 deaths resulting from the administration of the 

2 smallpox vaccine, and the time period in which 

3 the first symptom or manifestation of onset or 

4 of significant aggravation of such injuries, dis5 abilities, illnesses, conditions, and deaths is to 

6 occur after administration of vaccinia virus or 

7 other substance or medication administered for 

8 the purpose of preventing or treating smallpox 

9 (including a covered countermeasure against 

10 smallpox):

‘‘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 

11 ‘‘(B) RULE OF CONSTRUCTION.—Section 

12 13632 (a)(3) of Public Law 103–66 (107 Stat. 

13 646) (making revisions by Secretary to the Vac14 cine Injury Table effective on the effective date 

15 of a corresponding tax) shall not be construed 

16 to apply to the revision to the Vaccine Injury 

17 Table made by this paragraph.
30

•HR 865 IH 

1 ‘‘(4) PROHIBITION.—The Secretary may not 

2 provide any compensation under the Smallpox Pro3 gram for any minor scarring or minor local reaction. 

4 ‘‘(5) APPLICATION.—The Smallpox Program 

5 applies to any injury or death associated with the 

6 administration of any covered countermeasure on or 

7 after November 25, 2002. 

8 ‘‘(6) REIMBURSEMENT.—Notwithstanding para9 graph (4), the Secretary may reimburse under this 

10 section an employer who seeks reimbursement pur11 suant to section 2904. 

12 ‘‘(7) SPECIAL MASTERS.—

13 ‘‘(A) HIRING.—In accordance with section 

14 2112, the judges of the United States Claims 

15 Court shall appoint a sufficient number of spe16 cial masters to address claims for compensation 

17 under this subsection. 

18 ‘‘(B) BUDGET AUTHORITY.—There are ap19 propriated to carry out this paragraph such 

20 sums as may be necessary for fiscal year 2003 

21 and each fiscal year thereafter. This subpara22 graph constitutes budget authority in advance 

23 of appropriations and represents the obligation 

24 of the Federal Government. 
31

•HR 865 IH 

1 ‘‘(8) COVERED COUNTERMEASURE.—For pur2 poses of this subsection, the terms ‘covered counter3 measure’ and ‘covered countermeasure against 

4 smallpox’ have the meanings given to those terms in 

5 subsection (p)(7)(A). 

6 ‘‘(9) FUNDING.—Compensation made under the 

7 Smallpox Program shall be made from the same 

8 source of funds as payments made under subsection 

9 (p).’’. 

10 (b) RELATION TO FEDERAL TORT CLAIMS ACT.—

11 Paragraph (3) of section 224(p) of the Public Health 

12 Service Act (42 U.S.C. 233(p)) is amended to read as fol13 lows: 

14 ‘‘(3) EXHAUSTION; EXCLUSIVITY.—

15 ‘‘(A) NATIONAL SMALLPOX VACCINE IN16 JURY COMPENSATION PROGRAM.—A person 

17 may not bring a claim under this subsection un18 less the person has first filed a petition for 

19 compensation under the program established 

20 under subsection (q) and made a proper elec21 tion under sections 2111(a)(2)(A) and 2121. 

22 ‘‘(B) EXCLUSIVITY.—Except for filing a 

23 petition for compensation under the program 

24 established under subsection (q), the remedy 

25 provided by subsection (a) shall be exclusive of 
32

•HR 865 IH 

1 any other civil action or proceeding for any 

2 claim or suit this subsection encompasses, dur3 ing the effective period of a declaration by the 

4 Secretary under paragraph (2)(A).’’. 

5 (c) PERSONS SUSCEPTIBLE TO VACCINE-RELATED

6 INJURY.—Subsection (b) of section 2114 of the Public 

7 Health Service Act (42 U.S.C. 300aa–14) is amended by 

8 adding at the end the following: 

9 ‘‘(5) A petitioner shall be considered to have 

10 suffered an injury related to the administration of a 

11 covered countermeasure even if the petitioner might 

12 not have suffered the injury absent an infection, dis13 ease, or other condition that made him or her more 

14 susceptible to the injury.’’. 

15 SEC. 5. TECHNICAL MODIFICATION. 

16 (a) CIRCUMSTANCES IN WHICH PRESUMPTION IN

17 CASES OF ACCIDENTAL VACCINIA INOCULATION AP18 PLIES.—Section 224(p)(2)(C)(ii)(II) of the Public Health 

19 Service Act (42 U.S.C. 233(p)(2)(C)(ii)(II)) is amended 

20 by striking ‘‘resides or has resided with’’ and inserting 

21 ‘‘has had close contact with’’. 

22 (b) COVERED COUNTERMEASURE.—Subparagraph 

23 (A) of section 224(p)(7) of the Public Health Service Act 

24 (42 U.S.C. 233(p)(7)(A)) is amended to read as follows: 
33

•HR 865 IH 

1 ‘‘(A) COVERED COUNTERMEASURE.—The 

2 term ‘covered countermeasure’, or ‘covered 

3 countermeasure against smallpox’, means a sub4 stance specified in a declaration under para5 graph (2) that is—

6 ‘‘(i) a substance used to prevent or 

7 treat smallpox (including vaccinia or an8 other vaccine); or 

9 ‘‘(ii) a substance (including vaccinia 

10 immune globulin and cidofovir) used to 

11 control or treat the adverse effects of 

12 vaccinia inoculation or administration of 

13 any other countermeasure against small14 pox.’’. 

15 (c) COVERED PERSON.—Section 224(p)(7)(B)(ii) of 

16 the Public Health Service Act (42 U.S.C. 

17 233(p)(7)(B)(ii)) is amended to read as follows: 

18 ‘‘(ii) a health care entity, a State, or 

19 a political subdivision of a State under 

20 whose auspices such countermeasure was 

21 administered;’’. 

22 (d) EFFECTIVE DATE.—This section shall take effect 

23 as of November 25, 2002 (the date of enactment of the 
34

•HR 865 IH 

1 Homeland Security Act of 2002 (Pub. L. 107–296; 116 

2 Stat. 2135)).

Æ