Smallpox Vaccine Injury Compensation
CRS Report for Congress
Smallpox Vaccine Injury Compensation
June 13, 2003
Specialist in Social Legislation
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress
Smallpox Vaccine Injury Compensation
Four and a half months after announcing his decision to vaccinate military
personnel and front-line civilian health workers against smallpox, President George
W. Bush, on April 30, 2003, signed the Smallpox Emergency Personnel Protection
Act of 2003 (P.L. 108-20). Under the new law, the federal government will provide
— to eligible individuals (or their survivors), for covered injuries — payment for
related medical care, lost employment income, and death benefits.
Compensation had emerged as a major obstacle to the successful
implementation of the Administration’s smallpox vaccination program. Worker
groups, public health experts, and others cited the lack of a clear and comprehensive
compensation program as a primary reason for the lower than expected volunteer
vaccination rate among health care workers.
The enacted legislation is modeled after the Public Safety Officers’ Benefits
Program. It provides for compensation of individuals injured by vaccinations given
as part of a countermeasure plan declared by the Secretary of Health and Human
Services in preparation for potential hostile activities involving the smallpox virus.
This report will be updated as warranted.
In troduction ......................................................1
Need for Legislation................................................1
Components Suggested for Legislation.................................3
Existing Federal Compensation Programs...............................5
Public Safety Officers’ Benefits Program...........................5
National Vaccine Injury Compensation Program.....................6
Legislative History of P.L. 108-20.....................................8
Senate — S. 719...............................................8
House — H.R. 1770, H.R. 1463, and H.R. 865.......................9
P.L. 108-20 — The Smallpox Emergency Personnel Protection Act of 2003...11
Lost Employment Income..................................12
Death (Survivor’s Benefit)..................................12
Learn and Proceed............................................14
Smallpox Vaccine Injury Compensation
Four and a half months after announcing his decision to vaccinate military
personnel and front-line civilian health workers against smallpox, 3 months after the
vaccination program officially began, and 7 weeks after Senator Gregg introduced
the administration smallpox vaccine injury compensation proposal, President George
W. Bush, on April 30, 2003, signed the Smallpox Emergency Personnel Protection
Act of 2003 (P.L. 108-20).
Compensation had emerged as a major obstacle to the implementation of the
Administration’s smallpox vaccination program soon after it began. The number of
workers volunteering for vaccination was far smaller than the White House had
anticipated. One frequently cited reason was the concern of health workers that they
would not be compensated if they experienced adverse reactions to the vaccine.
Under the Administration’s original plan, vaccinees who suffered adverse
consequences and sought redress had two options: apply to their state’s workers’
compensation program or sue the federal government for negligence.
Some Members from across the political spectrum favored responding with
legislation. While they differed on what should be in that legislation, there was
bipartisan agreement that, given the President’s request that health and safety workers
volunteer for vaccination, the federal government should guarantee to protect them
against the possible adverse effects of smallpox vaccination. Some legislators
articulated a two-fold rationale: it is right to protect volunteers and, to recruit those
volunteers, it is necessary.
This report first presents the reasons some Members of Congress, health care
worker organizations, and others felt legislation was necessary; summarizes the range
of approaches that Congress considered; and describes the smallpox vaccine injury
compensation provisions Congress actually passed. Finally, it presents issues that
Congress might consider if it revisits the new legislation.
Need for Legislation
On December 13, 2002, President Bush announced his decision to vaccinate
military personnel and front-line civilian health workers against smallpox. The
Department of Defense began the process in early January 2003 and, as of March 31,
2003, has vaccinated over 350,000 military personnel.1 The civilian program, which
is voluntary in contrast to the military program, did not begin until January 24, 2003,
to coincide with the start of liability protections provided by Congress in the
Homeland Security Act of 2002 (P.L. 107-296) to smallpox vaccine manufacturers
and the institutions and individuals who administer the vaccine. The President had
hoped to vaccinate 500,000 civilians, but, by June 6, 2003, only 37,478 civilians had
To explain the reluctance of many health workers to volunteer to be vaccinated,
many, including Senator Gregg,3 pointed to the absence of a compensation program
for people who are injured by the vaccine. Until the mid-1970s when the World
Health Organization announced the eradication of naturally occurring smallpox, it
was accepted that, in the face of endemic infection, the side effects of the smallpox
vaccine4 are dwarfed by the benefits of immunization. It is difficult for some,
however, to accept the risks of vaccine-associated illness and death when the risk of
infection is perceived as theoretical. The President, backed by many health and
defense experts, sought an immunized core of first-responder and public-health
personnel as a public good, allowing treatment and vaccination of larger groups
should smallpox infections appear. At the same time, many public health officials,
infectious disease experts, lawyers, and health care personnel unions noted the need
for a compensation mechanism.
The Administration has said that it expected workers’ compensation programs
to cover claims for the rare but anticipated side effects of the smallpox vaccinations.5
Soon, however, people noticed gaps in this approach. Other than the program that
covers federal workers, workers’ compensation in the United States is handled at the
state level. Scope-of-employment and line-of-duty definitions differ, as do rules of
eligibility, coverage, and benefits. In general, courts have found that workers’
compensation is available for injuries resulting from employment-related
vaccination.6 However, not all employees are covered by workers’ compensation
1 Assistant Secretary of Defense, DOD Smallpox Vaccination Program as of Mar. 31, 2003,
link at CDC website [http://www.cdc.gov/od/oc/media/smpxrprt.htm], visited May 12, 2003.
2 Centers for Disease Control and Prevention, Smallpox Vaccination Report: Status and
Adverse Events [http://www.cdc.gov/od/oc/media/smpxrprt.htm], visited June 13, 2003.
3 Senator Gregg’s opening statement at the Senate Health, Education, Labor and Pensions
(HELP) Committee hearing on the smallpox vaccination plan, Jan. 30, 2003.
4 See CRS Report RL31694, Smallpox Vaccine Stockpile and Vaccination Policy, by Judith
Johnson, for a discussion of smallpox, U.S. vaccination policy, vaccine availability, and
current research activities.
5 CDC Director Julie Gerberding, in response to questions, Senate HELP Committee,
transcript of Jan. 30, 2003 committee hearing.
6 See Lampkin v. Harzfeld’s, 407 S.W.2d 894 (Mo. 1966) (injuries sustained by a sales
woman following an influenza inoculation were compensable); Saintsing v. Steinbach Co.,
64 A.2d 99 (N.J. 1949), aff’d, 66 A.2d 158 (N.J. 1949) (injuries resulting from smallpox
vaccination were compensable because vaccination was mutually beneficial to employer and
employees); Monette v. Manatee Memorial Hospital, 579 So.2d 195 (Fla. 1991) (injuries
programs and not all first-response health care providers are employees. Workers’
compensation programs, as their names indicate, cover the worker and not an
individual whom the worker, because of the worker’s injury, injures. This latter is
a concern in planning for smallpox compensation because of the potential for
secondary transmission of vaccine-related infection to contacts of those vaccinated.
Furthermore, even for workers who do qualify for workers’ compensation, the lost
income benefit of most of these programs is two-thirds of income up to a yearly cap.
Employers are the primary contributors to workers’ compensation funds and would
be acquiring a new burden if called upon to cover smallpox vaccine injuries.7
Some suggested that the Homeland Security Act of 2002 (P.L. 107-296)
provided access to compensation through the Federal Tort Claims Act, but it
addresses only injuries associated with negligence. Although necessary in certain
circumstances, this coverage is not suitable for the injuries anticipated from the
nonnegligent administration of vaccine.8
Components Suggested for Legislation
A month after the President announced the vaccination program and 1 week
before the liability protection provisions from the Homeland Security Act were to9
begin, the Institute of Medicine of the National Academies issued a letter report in
response to questions from the Centers for Disease Control and Prevention (CDC).
The expert committee made two compensation-related recommendations:
... that CDC and its state and local public health partners immediately work to
clarify each state’s worker’s compensation program’s position on coverage for
smallpox vaccine-related injuries and illnesses for workers covered under their
... that CDC and the Department of Health and Human Services support all
efforts, some of which might be administratively or legislatively bold and
creative, to bring this issue of compensation for smallpox vaccine adverse
reactions — including those reactions that occur despite non-negligent
manufacture and administration of the vaccine — to speedy resolution. (p. 9)
resulting from influenza vaccination were compensable because vaccination flowed as a
natural consequence of employment).
7 Bertram Cohen, Workers’ Compensation Management Programs (Chapter 14), in
Occupational Health & Safety, 3rd Edition, Marci Balge and Gary Krieger, editors, National
Safety Council, 2000.
8 See CRS Report RL31649, Homeland Security Act of 2002: Tort Liability Provisions, by
9 Institute of Medicine, Review of the Centers for Disease Control and Prevention’s
Smallpox Vaccination Program Implementation, Letter Report #1 of the Committee on
Smallpox Vaccination Program Implementation, Board on Health Promotion and Disease
Prevention, Washington, D.C., Jan. 16, 2003.
Many other groups weighed in with other options. The Association of State and
Territorial Health Officials, the American Public Health Association (APHA), and
the National Association of County and City Health Officials issued a joint press
release urging Congress to create a national program to protect individuals or their
survivors from the costs of illness, disability, and death associated with vaccine
injury.10 In a March 2003 press release, APHA specified the need for compensation
of medical costs, lost wages, a no-fault system that could provide quick
compensation, health insurance, and the more basic assurance that health care would
be available to those without health insurance or with inadequate coverage.11
In oral and written testimony to the Senate Health, Education, Labor and
Pensions (HELP) Committee and in press releases, representatives of employee
unions suggested numerous components for Congress to consider in creating a
smallpox vaccine injury compensation program.12 Some items appeared on many
lists, some remained the focus of one speaker.
One set of points involved vaccine policy not explicitly related to injury
compensation policy yet the recommendations fit within a discussion of
compensation. These included free confidential pre-vaccination screening for
contraindications; consistent pre-vaccination education; freedom to decline vaccine
without employment discrimination; access to free medical treatment; availability of
countermeasures — such as vaccinia immune globulin (often referred to as VIG) —
to vaccine effects; safe needle use; liability protection of vaccinee for injury of
patients; need for active and ongoing surveillance and reporting; and sufficient
federal funding to states.
Other suggestions addressed the structure, administration, and content of a
compensation program: a fair, easily accessible, no-fault compensation program;
establishment of a vaccine injury table for presumptive causation; establishment of
a mechanism to assert causation of other injuries; compensation of unreimbursable
medical costs; compensation for pain and suffering; paid sick leave; lost earnings;
permanent, total disability benefit; a death benefit; and attorney fees.
10 Association of State and Territorial Health Officials, National Public Health Associations
Urge Legislative Action to Protect Smallpox Vaccine Volunteers, Mar. 7, 2003
[http://www.astho.org/templates/display_pub.php?pub_id=618&admin=1], visited June 13,
11 American Public Health Association, National Public Health Associations Urge
Legislative Action to Protect Smallpox Vaccine Volunteers, Mar. 7, 2003
[http://www.apha.org/news/press/2003/smallpoxvolunteers.htm], visited June 13, 2003.
12 Service Employees International Union, AFL-CIO (SEIU)
[ ht t p: / / www.sei u.or g/ heal t h/ s ma l l pox_r esponse.cf m? pr i nt e r = 1]
and [http://www.seiu.org/health/smallpox_concern.cfm?printer=1], visited June 13, 2003.
See also testimony of Martha Baker, RN, on behalf of the Service Employees International
Union, AFL-CIO, before the U.S. Senate Committee on Health, Education, Labor, and
Pensions, On the Administration’s Smallpox Vaccination Plan: Challenges and Next Steps,
Thursday, Jan. 30, 2003; and attachment to testimony prepared by the AFL-CIO, American
Federation of State and County Municipal Employees (AFSCME), the American Federation
of Teachers (AFT) and the Service Employees International Union (SEIU), Jan. 8, 2003.
Beyond the testimony taken by the Senate HELP Committee, several existing
compensation programs appear to have provided models for legislation.
Existing Federal Compensation Programs
In addition to relying on workers’ compensation and traditional health insurance
policies, Congress has devised several national programs to meet unique
compensation needs in particular sets of circumstances, usually involving the concept
of no-fault. These programs have defined benefits, funding structures, and eligibility
rules. Two — the Public Safety Officers’ Benefits (PSOB) program and the National
Vaccine Injury Compensation (NVICP) Program — are particularly relevant because
they appear as model structures for the smallpox vaccine compensation injury
Public Safety Officers’ Benefits Program
Administered by the Bureau of Justice Assistance in the Department of Justice,
the PSOB program provides one-time payments to survivors of public safety officers
who are killed and to officers who are permanently and completely disabled in the
line of duty.13 The Administration based its proposal on this structure.
The Public Safety Officers’ Benefits Act (P.L. 94-430) initially covered state
and local law enforcement officers and firefighters. Subsequently, Congress added
federal law enforcement officers and firefighters; members of federal, state, and local
public rescue squads and ambulance crews; Federal Emergency Management Agency
personnel; and state, local and tribal emergency management and civil defense
agency employees.14 At its 1976 inception, PSOB provided only a death benefit; in
1990, the program added the permanent, total disability benefit.15 The Act
established the payment level at $50,000 in 1976; in 1988, the benefit level was
changed to $100,000 pegged to increases in the Consumer Price Index (42 USC
allowed in 2003 is $262,100. Benefits are reduced for individuals receiving certain
other death or disability benefits; certain benefit programs reduce benefits if PSOB
payment is received. PSOB benefits are not subject to federal income or estate
The PSOB death benefit program “was designed to offer peace of mind to men
and women seeking careers in public safety and to make a strong statement about the
value American society places on the contributions of those who serve their
13 The Public Safety Officers’ Benefits (PSOB) program fact sheet is at
[http://www.ncjrs.org/pdffiles1/bja/fs000271.pdf], visited June 13, 2003.
14 PSOB fact sheet.
15 PSOB fact sheet.
16 PSOB fact sheet.
communities in potentially dangerous circumstances.”17 Congress, in keeping with
that intent, established the PSOB benefit as a supplement, rather than as an insurance
or compensation program. PSOB manages claims administratively, rather than
within a legal framework. Because the program does not include lost-income
benefits or long-term survivor support, it need not debate questions such as projected
earnings or other claims that might require review and appeal procedures. Although
the smallpox vaccine compensation program in P.L. 108-20 is based on the PSOB
structure, the smallpox vaccine injury compensation program does include longer
term medical and lost income benefits and, therefore, will require a different structure
to efficiently accommodate the complex determination of the possible range of
claims following smallpox vaccine injuries.
National Vaccine Injury Compensation Program
In response to public concerns about vaccine safety and manufacturer concern
about liability, Congress enacted the National Childhood Vaccine Injury Act
(NCVIA) of 1986 (P.L. 99-660).18 A core piece of that Act is the National Vaccine
Injury Compensation Program (VICP), begun in 1988, to handle vaccine injury
claims in a no-fault, non-adversarial, and, consequently, more streamlined manner.
VICP covers the vaccines that CDC, through the National Vaccine Program and the
Advisory Committee on Immunization Practices, recommends for routine
administration to all children in the United States. Although located in the Health
Resources and Service Administration (HRSA) of the Department of Health and
Human Services (HHS), VICP administration is actually shared among HHS, the
U.S. Court of Federal Claims, and the U.S. Department of Justice.19 A proposal for
smallpox vaccine injury compensation introduced as H.R. 865 by Representative
Waxman based its plan on the VICP.
The basic tool of the VICP is its Table of Injuries. For each covered vaccine,
the table lists each specific injury and the time period, relative to vaccination, during
which that injury must have occurred in order to be considered for compensation. If
a person presents a claim that corresponds to a listed vaccine — injury — time-
period item, VICP is to assume that that person’s injury was caused by that
vaccination. In theory, this streamlines the entire claims process. Claims involving
other injuries from listed vaccines or any injury from other vaccines require proof
that the vaccine aggravated or caused the condition.
For vaccine-related injury, VICP allows reasonable compensation for past and
future unreimbursable medical, custodial care, and rehabilitation costs; actual and
projected pain and suffering and emotional distress — capped at $250,000; lost
earnings; and reasonable attorneys’ fees and costs. For a vaccine-related death, VICP
awards $250,000 to the estate of the deceased, and reasonable attorneys’ fees and
17 PSOB fact sheet.
18 Subtitle 2 of Title XXI of the Public Health Service Act.
19 VICP fact sheet [http://www.hrsa.gov/osp/vicp/fact_sheet.htm], visited June 13, 2003.
NCVIA authorized the use of federal tax dollars for compensation awarded for
vaccination that occurred before the program began and authorized an excise tax on
every dose of covered vaccine to cover compensation of future vaccine injuries. As
of March 2003, “an excise tax of 75 cents on every dose of covered vaccine that is
purchased” goes to the Vaccine Injury Compensation Fund.20
According to the VICP Monthly Statistics Report dated May 31, 2003, 8,813
petitions were filed since the program began (4,262 for pre-1988 vaccinations and
4,551 for post-1988 vaccinations), resulting in 3,507 awards that total
$1,428,300,000. Awards for post-1988 vaccinations averaged $772,675 (73 cases)
in FY2002 and $1,240,143 (48 cases) so far in FY2003.21
Although VICP was established as a no-fault system and is not structured as an
adversarial process, the U.S. Court of Federal Claims handles its claims. The
program’s extensive experience gained over its 15-year existence is concentrated on
compensation for injuries incurred by children. How well it could adapt to the
adjudication of adult-focused compensation issues, such as temporary lost income
or dependent survivors, is not clear.
Standard government programs of compensation include benefits to service-
disabled veterans and workers injured on the job. Occasionally, Congress acts to
ensure compensation for specific groups of people or their survivors in specific
circumstances of death, injury, or medical condition. Examples include the programs
instituted to compensate individuals seen as having been injured by the swine flu
vaccinations in 1976;22 veterans of military service with illnesses presumed by law
or regulation to be caused by certain radiation, chemical, or military service
exposures;23 people with presumed exposure to ionizing radiation by nature of being
“downwind” of atomic test fallout, and adverse health effects of radiation;24
Department of Energy employees and contractors with certain radiation-related
20 Commonly Asked Questions About The National Vaccine Injury Compensation Program,
updated Dec. 18, 2002 [http://www.hrsa.gov/osp/vicp/qanda.htm#7], visited June 13, 2003.
21 VICP Monthly Statistics Report [http://www.hrsa.gov/osp/vicp/monthly.htm], visited June
22 The National Swine Flu Immunization Program of 1976 (P.L. 94-380); and David Brown,
A Shot in the Dark: Swine Flu’s Vaccine Lessons, Washington Post, May 27, 2002.
23 The 1984 Veterans’ Dioxin and Radiation Exposure Compensation Standards Act (P.L.
24 The 1990 Radiation Exposure Compensation Act (P.L. 101-426), as amended by P.L. 106-
conditions;25 miners with black lung disease;26 and people with hemophilia infected
with HIV through blood transfusions.27
Legislative History of P.L. 108-20
Representative Waxman introduced H.R. 865, the Smallpox Vaccine
Compensation and Safety Act of 2003, on February 13, 2003. Subsequently, Senator
Gregg introduced the Administration’s proposal, which went on to form the basis of
the new legislation.
Senate — S. 719
Senator Gregg initially offered the smallpox compensation provisions as Title
I of S. 15, a bill that also included the Administration’s proposal for Project
BioShield and changes to VICP. Faced with Senator Kennedy’s intention to offer 75
amendments to the smallpox compensation title,28 HELP Committee Chairman Gregg
deleted Title I at the mark-up on March 11, 2003, and used it as the basis of S. 719.29
S. 719 proposed a compensation program to cover people (health care and other
workers who volunteered) with smallpox vaccine-related injury subsequent to
vaccination or contact with a vaccinated person in response to the HHS Secretary’s
declaration of need. It included a timeframe for claims; assigned regulatory and
administrative responsibility to the HHS Secretary; allowed no judicial review of the
Secretary’s decisions; excluded Medicare-eligible people from the medical care
benefit; and made benefits secondary to most other coverage.
Benefits categories under S. 719 included medical; lost employment income;
and death and permanent, total disability. The medical benefit covered “medical
items and services as reasonable and necessary to treat a covered injury.”
Compensation for lost employment income would be two-thirds of lost income for
a person with no dependents and 75% otherwise. The proposed total lifetime benefit
for lost employment income was $50,000. The coverage would not cover the first
five lost work days. Following the amount specified by the PSOB legislation on
which it was modeled, S. 719 proposed compensation for either death or permanent,
total disability as a one-time, lump-sum payment of $262,100 (April 2003 amount)
minus payments made for lost employment income.
25 The Energy Employees Occupational Illness Compensation Program Act of 2000 (P.L.
26 The Federal Coal Mine Health and Safety Act (P.L. 91-173).
27 The Ricky Ray Hemophilia Relief Fund Act of 1998 (P.L. 105-369).
28 Kate Schuler, Senate Committee Drops Smallpox Vaccine Provision and Approves
Measure, CQ Today, March 19, 2003 [http://www.cq.com], visited June 13, 2003.
29 Senator Gregg first introduced the smallpox vaccine compensation provisions as Title I
of S. 15 on Mar. 11, 2003. On Mar. 26, 2003, he reintroduced them as S. 719.
The Senate HELP Committee marked-up S. 719 on April 2, 2003. The version
it ordered reported included an amendment offered by Senator Mikulski to authorize
the Secretary of HHS to award grants to states to administer the smallpox vaccine
and provide related education, screening, and medical surveillance of vaccinees.
The committee-approved bill did not include three amendments that Senator
Kennedy offered. One covered elements of medical care, disability, and lost income
benefits. The amendment (1) would have specified that covered medical care include
such services as rehabilitation, special education, custodial care, and special
equipment; and (2) would have struck the provision in S. 719 that excludes
Medicare-eligible people from any smallpox vaccine compensation medical benefit.
Senator Kennedy’s amendment also introduced new categories that would qualify for
disability benefits: permanent disfigurement and permanent, partial disability. For
lost employment income compensation, Senator Kennedy would have (1) maintained
the committee bill’s two-third, or three-quarter, lost income benefit, but calculated
the base income taking into account future earnings, especially significant to a child
injured by the smallpox vaccine; (2) modified the restriction on receiving death
benefits and lost income benefits by allowing the lost income benefit to continue for
the life of the spouse or until minor children reach the age of 22; and (3) increased
the lifetime cap from $50,000 to $75,000.
Senator Kennedy’s second amendment would have allowed the Secretary
flexibility in applying the 180-day window in which to receive the vaccine and be
eligible for benefits in this program. His third amendment sought to change the
authorizing language of the reported bill into authorizing and appropriating language,
making the funding mandatory rather than discretionary.
The Senate HELP Committee-reported bill was not brought to the Senate for a
House — H.R. 1770, H.R. 1463, and H.R. 865
Representative Burr, the vice-chair of the House Energy and Commerce
Committee, introduced H.R. 1463 on March 27, 2003, replacing H.R. 1413 that he
had introduced on March 25, 2003. Both versions closely followed the
Administration proposal, which also formed the basis of S. 719. The House
Republican leadership brought H.R. 1463, which had not been discussed in
committee, directly to the House floor on March 31, 2003. It lost 184-206, 84 votes
short of the two-thirds vote required under suspension of the rules. Its content,
however, formed the basis of the bill that was enacted into law.
Some House Democrats had offered a significantly different proposal in H.R.
865, Representative Waxman’s Smallpox Vaccine Compensation and Safety Act of
2003. That bill differed from the Administration proposal both in its treatment of
elements common to it and in its inclusion of elements not mentioned. Both contain
the basic provisions for compensation for the costs of medical care, permanent and
total disability, and death, and cover both the vaccinee and individuals infected
following contact with a vaccinee.30 The major differences involve the mechanism
established for adjudication of claims, whether the authorized appropriation is
mandatory or discretionary, and the level of benefits. This report includes details of
H.R. 865 because its alternative approach serves to identify issues that may resurface
as the new compensation program is implemented.
H.R. 865 is patterned after VICP, which is structured differently from PSOB on
which the Administration program is modeled. While requiring the Secretary to issue
implementation regulations, the proposed VICP-modeled program would rely on
special masters appointed in the U.S. Court of Federal Claims to hear claims.
H.R. 865 would allow for actual (rather than a percentage of) lost wages and
does not cap the benefit. It would provide paid leave for the first 4 days out of work
to cover the period before the lost-income disability benefit begins. H.R. 865 would
provide a permanent disability benefit of unreimbursed actual lost wages and
unreimbursed medical costs not subject to any limitations, plus a one-time $250,000
payment for non-economic damages. H.R. 865 would award a death benefit of
H.R. 865 would require the Secretary to make grants to state and local
governments to help meet the costs of their smallpox vaccination activities. The bill
text specifies that each state “... agrees to provide such medical assistance as may be
medically necessary ....” This differs from the new law’s making the Secretary
responsible for not only the overall program but also all implementation decisions.
Finally, H.R. 865 would mandate appropriations in addition to authorizing them.
In addition, H.R. 865 would go beyond establishing a mechanism to compensate
people whom the smallpox vaccine injures. H.R. 865 addresses others concerns
outlined by worker groups, such as needle safety requirements; access to free medical
care; paid sick leave for up to four days, and reimbursement of those costs to non-
federal employers; prohibition against discrimination against an employee who
declines or is ineligible for vaccination; procedures for filing complaints and judicial
review; funding to states to cover cost of mandatory state activities in pre-vaccination
education and screening, and post vaccination surveillance and treatment; and
establishment of a uniform national reporting system of adverse reactions to the
vaccine and a report to Congress from the Secretary of Health and Human Services.
H.R. 876 was referred to the Energy and Commerce Committee with no further
Following negotiation, Members reached the compromise that Representative
Burr introduced as H.R. 1770, the Smallpox Emergency Personnel Protection Act of
H.R. 1770 reflected revisions of H.R. 1463; S. 719, ordered reported from the Senate
30 A bill introduced by Senator Daschle at the beginning of the 108th Congress, S. 6,
includes a section titled “Smallpox Injury Compensation Program” and would authorize
$750 million in FY 2004 for compensation. It does not offer the program details that these
HELP Committee; selected language that Senator Kennedy had offered in committee
as amendments to S. 719; and items raised in negotiations by others. President Bush
signed the Smallpox Emergency Personnel Protection Act of 2003 on April 30, 2003.
P.L. 108-20 — The Smallpox Emergency
Personnel Protection Act of 2003
The new law addresses injuries incurred from activities of an immunization plan
declared by the HHS Secretary as a national response to threat of biologic agent
attack on the United States. It covers injuries that the Secretary finds to be vaccine-
related that occur in people who volunteer for vaccination under that plan or people
who are infected after contact with those volunteers.
The new law specifies compensation for three things: (1) medical expenses; (2)
lost employment income due to temporary and permanent, partial and total disability;
and (3) death.
The new compensation program uses the PSOB program as its base and adapts
the structure of that program to address concerns specifically related to smallpox
vaccine injuries. The Secretary of Health and Human Services will establish
regulations and will run the compensation program. The law permits no judicial
review of the Secretary’s actions. It also directs the Secretary to promulgate, and
revise when desired, a vaccine injury table listing specific conditions of presumptive
causality — meaning that if someone had one of those conditions and had received
the vaccine in a certain time period, the law would presume a causal connection. In
this respect, it uses the VICP model. The Secretary may also consider claims
regarding other adverse effects. The law directs the Secretary to develop a process
that an individual could use to request reconsideration of the Secretary’s
Responding to concerns raised by Senator Kennedy, the final version of the
legislation gives the Secretary flexibility when requiring that claims to this
compensation program be made within specific time periods relative to vaccination,
symptom identification, and changes in eligibility.
This compensation program applies to injuries related to the Secretary’s
declared “response plan detailing actions to be taken in preparation for a possible
smallpox-related emergency during the period prior to the identification of an active31
case of smallpox either within or outside the United States.” Civilian participation
in that plan must be voluntary. Screening for contraindications to vaccination must
also be voluntary, but it must be offered. The enacted legislation does not include
Senator Mikulski’s amendment that was accepted by the HELP committee in the
31 42 USC Section 239, amended by Section 2 of P.L. 108-20.
mark-up of S. 719, although it does direct the Secretary to ensure “appropriate post-
inoculation medical surveillance.”
Medical Care. P.L. 108-20 directs the HHS Secretary to provide
... payment or reimbursement for medical items and services as reasonable and
necessary to treat a covered injury of an eligible individual, including the
services, appliances, and supplies prescribed or recommended by a qualified
physician, which the Secretary considers likely to cure, give relief, reduce the
degree or the period of disability, or aid in lessening the amount of monthly
compensation. (Section 264)
The legislation includes a more detailed description of medical items and
services than had H.R. 1463 and S. 719. It also does not include the Senate bill’s
exclusion of Medicare-eligible individuals from the new program’s payment for
medical care. It does, however, maintain the requirement that its benefits be
secondary to other federal, other government, and private payors (e.g., private health
insurers, state workers’ compensation programs, and Medicare).
Lost Employment Income. For lost employment income resulting from the
covered injuries of a covered person, the program would provide — subject to certain
caps — two-thirds of the usual employment income, which includes income from
self-employment. If the person injured had “one or more dependents,” that rate
would increase to 75% of usual employment income. The law, but not the
predecessor bills, specifies that employment income refers to “... income at the time
As with the medical care benefits to be provided by this program, lost
employment income benefits are to be secondary to other federal, governmental, and
private programs to provide employment-based benefits. The program will pay lost
employment income compensation in addition to payment for covered medical care,
but survivors cannot receive both lost income and death benefits. The lost income
compensation begins after 5 missed work days.
A person considered by the program to be permanently and totally disabled
could receive up to $50,000 per year in lost employment income compensation. For
disabilities that are temporary or partial, the lifetime cap — accrued at up to $50,000
per year — is the amount, $262,100 in May 2003, set by the PSOB legislation.
Payments, subject to the lifetime cap if appropriate, would continue until the injured
person reaches age 65.
Death (Survivor’s Benefit). The Smallpox Emergency Personnel Protection
Act of 2003, P.L. 108-20, provides a one-time, lump-sum death benefit in the amount
specified by the PSOB program, now $262,100. Any death benefit to survivors
would be reduced by the amount that the smallpox vaccine injury compensation
program had paid as lost employment income benefits to the deceased. Neither could
this death benefit be in addition to a PSOB disability or death benefit. The death
benefit would, however, be made in addition to any payment or reimbursement for
medical care it had made to that person.
When a survivor is a minor, the legal guardian can choose between receiving a
lump sum death benefit (the amount in May 2003 is $262,100) or the calculated
amount of lost employment income compensation (75% of actual income at the time
of the injury up to $50,000 per year) until the youngest dependent survivor reaches
While Congress was considering smallpox vaccine injury compensation bills,
both houses issued their FY 2003 emergency supplemental packages. P.L. 108-11,
the Emergency Wartime Supplemental Appropriations Act, 2003, included $42
million for HRSA to administer the smallpox vaccine injury compensation program,
in addition to the $100 million it provided through the Public Health and Social
Services Emergency Fund to CDC for the smallpox vaccination program.32 P.L. 108-
20 authorizes the appropriation of “such sums as may be necessary for each of the
fiscal years 2003 through 2007" and does not include language appropriating funding
in advance of appropriations acts.
In discussing the need for legislation, many Members and their constituents
described the absence of a smallpox vaccine injury compensation package as a major
obstacle to volunteering. Will the new law make people more likely to volunteer?
Has the end of the war in Iraq lessened the sense of urgency that may have compelled
the Congress to enact P.L. 108-20?
An announcement from CDC the week after the bill’s passage might also
influence volunteer recruitment. The agency now estimates the nation needs only
50,000 immunized public health and health care people to be prepared for a smallpox
outbreak, not the 500,000 figure that had been made up by summing the estimates
that each state had submitted to CDC in December.33 This new target is closer to the
32 The Senate Appropriations Committee version, passed Apr. 3, 2003, included $35 million
for smallpox vaccine administration; the House Appropriations Committee had earlier
included in its war supplemental bill $50 million that would go for smallpox vaccine injury
compensation if and when a program were authorized.
33 Alicia Ault, Smallpox Shot Refusers Say Compensation a Concern, Reuters Health, May
2003; and David McGlinchy, CDC Says It Never Aimed for 500,000 Smallpox
Vaccinations, Global Security Newswire, Feb. 26, 2003, link at GovExec.com
[http://www.govexec.com/dailyfed/0203/022603gsn1.htm], visited June 13, 2003.
yet whether those volunteers are appropriately distributed across states and
professions to meet the program goals.
Regardless of the size of the program, the HHS Secretary may need to clarify
details that the law does not explicitly cover in order to implement the law.
Examples include definitions, regulatory treatment of standards of medical evidence,
and federal tax law.
The law describes a contact case as “... (iii) the individual has been in contact
with an individual who is (or who was accidentally inoculated by) a covered
individual.”34 What evidence of contact will the Secretary require? How would an
unvaccinated person who nevertheless appears with vaccinia infection demonstrate
that, for example, a particular, anonymous subway rider was the source of infection?
Because vaccinia infection would come only from a vaccinia vaccine source, it may
not be necessary — for compensation determination — to show that the person had
contact with someone who had received the vaccine. (Knowing the chain of contact
would be important, however, for public health reasons.)
The law gives the HHS Secretary authority to create the Table of Injuries to list
injuries presumed by law to be vaccine-related. Because the rules — and art — of
causal inference that epidemiologists use do not easily line up with legislative needs
to assign responsibility, drafters of legislation turn to phrases such as “preponderance
of the evidence standard”; “taking into consideration of relevant medical and
scientific evidence”;35 or “credible evidence for the association is equal to or
outweighs the credible evidence against the association.”36 The scientist’s language
includes an uncertainty that the law’s presumptions override. Whether the new
legislation provides sufficient guidance to the Secretary remains to be seen. One
could anticipate that individual claimants will question whatever list the HHS
Questions are also likely to arise regarding the tax status of the various benefit
categories for various groups of recipients. Whether clarification responsibility rests
with the HHS Secretary or with the Internal Revenue Service, the issues may involve
input from both or require Congressional clarification.
Learn and Proceed
Finally, some Members of Congress may want to consider what lessons they
could learn from the nation’s unprecedented foray into civilians’ taking health risks
to prepare to protect the U.S. homeland from risks of uncertain likelihood but certain
(and terrible) potential consequence. The public may have somewhat relaxed its
34 42 USC Section 239, amended by Section 2 of P.L. 108-20.
35 Section 2 of S. 719.
36 38 USC Section 1116(b)(3), amended by P.L. 102-4, the Agent Orange Act of 1991.
concern, but, for public health and intelligence experts, the risks to the public remain
P.L. 108-20 addresses compensation of health care and emergency workers who
volunteer and receive smallpox vaccine-related injuries resulting from an HHS
Secretary’s declaration of the need to prepare for bioterrorist actions. It does not,
however, cover members of the general public who choose vaccination and it applies
only to vaccinia infections that occur before any smallpox case is reported. Should
future events make the Secretary’s precaution unfortunately predictive and post-
attack vaccination be recommended to the general population, how might Congress
view vaccine-injury compensation for that group? Congress may choose to discuss
how it might modify this legislation to allow its use in as yet unknown
ci rcum st ances.37
The President’s pursuit of Project BioShield legislation38 to encourage private
sector participation in the development of other medical countermeasures to the
intentional use of biologic agents against the U.S. population is one indication of a
widespread view that new products are necessary.39 As health care workers face (or
are asked to face) each new product — whether vaccine or antitoxin, whether to
37 In response to a multi-state outbreak of monkeypox, CDC, on June 11, 2003,
recommended smallpox vaccination for people who are investigating monkeypox cases and
for those who are caring for or are in close contact with already infected people or animals.
The smallpox vaccine would be administered “under FDA special procedures to allow such
emergency use in association with individual patient informed consent and approval by an
... ethics committee....” A June 12, 2003 CDC Health Alert states that the “risk of
monkeypox disease for persons intimately exposed to symptomatic monkeypox cases is
believed to be greater than the risk of adverse events resulting from vaccinia exposure for
most persons for whom smallpox vaccination would be otherwise contraindicated in the pre-
event smallpox setting.” The alert continues that in this situation “...neither age, pregnancy
nor a history of eczema are contraindications to receipt of smallpox vaccination” (CDC,
Interim Guidance for Use of Smallpox Vaccine, Cidofovir, and Vaccinia Immune Globulin
[VIG] for Prevention and Treatment in the Setting of Outbreak of Monkeypox Infections,
June 12, 2003, at the CDC website
[http://www.cdc.gov/ncidod/monkeypox/vaccination.htm], visited June 13, 2003). Although
the CDC press release quotes HHS Secretary Thompson, the comment regards “the
importance of preparedness” and neither a declaration or plan, which would trigger
eligibility for compensation, nor an explicit reference to smallpox vaccine injury
compensation [http://www.cdc.gov/od/oc/media/pressrel/r030611.htm], visited June 13,
38 See CRS Report RS21507, Project BioShield, by Frank Gottron, for a discussion of S. 15,
the Biodefense Improvement and Treatment for America Act; H.R. 2122, the Project
BioShield Act of 2003; and related issues.
39 Other expert-group reports attesting to the need for enhanced development include DOD,
“Department of Defense Acquisition of Vaccine Production, Report to the Deputy Secretary
of Defense by the Independent Panel of Experts,” F.H. Top Jr., panel chair, December 2000,
distributed as Appendix B of the Report on Biological Warfare Defense Vaccine Research
and Development Programs, July 2001 [http://www.acq.osd.mil/cp/bwdvrdp-july01.pdf],
visited May 23, 2003; and Institute of Medicine, Accelerating the Research, Development,
and Acquisition of Medical Countermeasures Against Biological Warfare Agents: Interim
Report, National Academies Press, 2003
[http://www.search.nap.edu/books/N1000499/html], visited June 13, 2003.
protect against a viral hemorrhagic fever, tularemia, or glanders40 — they will ask
about compensation for potential injuries.
40 NIAID Category A, B & C Priority Pathogens
[http://www.niaid.nih.gov/biodefense/bandc_priority.htm], visited June 13, 2003.