Four and a half months after announcing his decision to vaccinate military personnel and front-line civilianhealth workers against smallpox, 3 months after the vaccination program officiallybegan, and 7 weeks after Senator Gregg introduced the administration smallpox vaccine injurycompensation proposal, President George W. Bush, on April 30, 2003, signed the SmallpoxEmergency 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 forvaccination was far smaller than the White House had anticipated. One frequently cited reason wasthe concern of health workers that they would not be compensated if they experienced adversereactions to the vaccine. Under the Administration's original plan, vaccinees who suffered adverseconsequences and sought redress had two options: apply to their state's workers' compensationprogram 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 thePresident's request that health and safety workers volunteer for vaccination, the federal governmentshould guarantee to protect them against the possible adverse effects of smallpox vaccination. Somelegislators articulated a two-fold rationale: it is right to protect volunteers and, to recruit thosevolunteers, 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 thatCongress considered; and describes the smallpox vaccine injury compensation provisions Congressactually passed. Finally, it presents issues that Congress might consider if it revisits the newlegislation. On December 13, 2002, President Bush announced his decision to vaccinate military personneland front-line civilian health workers against smallpox. The Department of Defense began theprocess in early January 2003 and, as of March 31, 2003, has vaccinated over 350,000 militarypersonnel. (1) The civilian program, which is voluntaryin contrast to the military program, did notbegin until January 24, 2003, to coincide with the start of liability protections provided by Congressin the Homeland Security Act of 2002 ( P.L. 107-296 ) to smallpox vaccine manufacturers and theinstitutions and individuals who administer the vaccine. The President had hoped to vaccinate500,000 civilians, but, by June 6, 2003, only 37,478 civilians had been immunized. (2) To explain the reluctance of many health workers to volunteer to be vaccinated, many, including Senator Gregg, (3) pointed to the absence ofa compensation program for people who areinjured by the vaccine. Until the mid-1970s when the World Health Organization announced theeradication of naturally occurring smallpox, it was accepted that, in the face of endemic infection,the side effects of the smallpox vaccine (4) are dwarfedby the benefits of immunization. It is difficultfor some, however, to accept the risks of vaccine-associated illness and death when the risk ofinfection 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, allowingtreatment 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 unionsnoted 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 noticedgaps in this approach. Other than the program that covers federal workers, workers' compensationin the United States is handled at the state level. Scope-of-employment and line-of-duty definitionsdiffer, 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 programs and not all first-response healthcare providers are employees. Workers' compensation programs, as their names indicate, cover theworker and not an individual whom the worker, because of the worker's injury, injures. This latteris a concern in planning for smallpox compensation because of the potential for secondarytransmission of vaccine-related infection to contacts of those vaccinated. Furthermore, even forworkers who do qualify for workers' compensation, the lost income benefit of most of theseprograms is two-thirds of income up to a yearly cap. Employers are the primary contributors toworkers' compensation funds and would be acquiring a new burden if called upon to cover smallpoxvaccine 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 withnegligence. Although necessary in certain circumstances, this coverage is not suitable for the injuriesanticipated from the nonnegligent administration of vaccine. (8) A month after the President announced the vaccination program and 1 week before the liabilityprotection provisions from the Homeland Security Act were to begin, the Institute of Medicine ofthe National Academies issued a letter report (9) inresponse to questions from the Centers for DiseaseControl and Prevention (CDC). The expert committee made two compensation-relatedrecommendations: ... 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 forsmallpox vaccine-related injuries and illnesses for workers covered under theirprograms. ... that CDC and the Department of Health and Human Services support all efforts, some of which might be administratively or legislatively bold andcreative, to bring this issue of compensation for smallpox vaccine adverse reactions -- includingthose reactions that occur despite non-negligent manufacture and administration of the vaccine --to speedy resolution. (p. 9) 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 ofCounty and City Health Officials issued a joint press release urging Congress to create a nationalprogram to protect individuals or their survivors from the costs of illness, disability, and deathassociated with vaccine injury. (10) In a March 2003press release, APHA specified the need forcompensation 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 withouthealth 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 numerouscomponents 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 confidentialpre-vaccination screening for contraindications; consistent pre-vaccination education; freedom todecline vaccine without employment discrimination; access to free medical treatment; availabilityof countermeasures -- such as vaccinia immune globulin (often referred to as VIG) -- to vaccineeffects; safe needle use; liability protection of vaccinee for injury of patients; need for active andongoing 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 injurytable 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. Beyond the testimony taken by the Senate HELP Committee, several existing compensation programs appear to have provided models for legislation. 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 setsof 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 particularlyrelevant because they appear as model structures for the smallpox vaccine compensation injuryproposals. 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 toofficers who are permanently and completely disabled in the line of duty. (13) The Administrationbased 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 enforcementofficers and firefighters; members of federal, state, and local public rescue squads and ambulancecrews; Federal Emergency Management Agency personnel; and state, local and tribal emergencymanagement and civil defense agency employees. (14) At its 1976 inception, PSOB provided only adeath benefit; in 1990, the program added the permanent, total disability benefit. (15) The Actestablished the payment level at $50,000 in 1976; in 1988, the benefit level was changed to $100,000pegged to increases in the Consumer Price Index (42 USC 3796). The total benefit payment -- foreither death or permanent, total disability -- allowed in 2003 is $262,100.