Smallpox Vaccine Injury Compensation
Released: 2003-06-13T00:00:00

Introduction

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.

Need for Legislation

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)

Components Suggested for Legislation

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.

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 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.

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 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. Benefits are reduced forindividuals receiving certain other death or disability benefits; certain benefit programs reducebenefits if PSOB payment is received. PSOB benefits are not subject to federal income or estatetaxes. (16)

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 societyplaces on the contributions of those who serve their communities in potentially dangerouscircumstances." (17) Congress, in keeping with thatintent, established the PSOB benefit as asupplement, rather than as an insurance or compensation program. PSOB manages claimsadministratively, rather than within a legal framework. Because the program does not include lost-income benefitsor long-term survivor support, it need not debate questions such as projectedearnings or other claims that might require review and appeal procedures. Although the smallpoxvaccine compensation program in P.L. 108-20 is based on the PSOB structure, the smallpox vaccineinjury compensation program does include longer term medical and lost income benefits and,therefore, will require a different structure to efficiently accommodate the complex determinationof 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) Acore 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 streamlinedmanner. VICP covers the vaccines that CDC, through the National Vaccine Program and theAdvisory Committee on Immunization Practices, recommends for routine administration to allchildren 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 actuallyshared among HHS, the U.S. Court of Federal Claims, and the U.S. Department of Justice. (19) Aproposal for smallpox vaccine injury compensation introduced as H.R. 865 byRepresentative 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 haveoccurred in order to be considered for compensation. If a person presents a claim that correspondsto a listed vaccine -- injury -- time-period item, VICP is to assume that that person's injury wascaused by that vaccination. In theory, this streamlines the entire claims process. Claims involvingother injuries from listed vaccines or any injury from other vaccines require proof that the vaccineaggravated 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 andsuffering and emotional distress -- capped at $250,000; lost earnings; and reasonable attorneys' feesand costs. For a vaccine-related death, VICP awards $250,000 to the estate of the deceased, andreasonable attorneys' fees and costs.

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 vaccineto cover compensation of future vaccine injuries. As of March 2003, "an excise tax of 75 cents onevery 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-1988vaccinations), resulting in 3,507 awards that total $1,428,300,000. Awards for post-1988vaccinations 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 experiencegained 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 temporarylost income or dependent survivors, is not clear.

Others

Standard government programs of compensation include benefits to service-disabled veterans and workers injured on the job. Occasionally, Congress acts to ensure compensation for specificgroups 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 bythe swine flu vaccinations in 1976; (22) veterans ofmilitary service with illnesses presumed by law orregulation to be caused by certain radiation, chemical, or military service exposures; (23) people withpresumed exposure to ionizing radiation by nature of being "downwind" of atomic test fallout, andadverse health effects of radiation; (24) Departmentof Energy employees and contractors with certainradiation-related conditions; (25) miners with blacklung disease; (26) and people with hemophiliainfectedwith HIV through blood transfusions. (27)

Legislative History of P.L. 108-20

Representative Waxman introduced H.R. 865 , the Smallpox VaccineCompensation and Safety Act of 2003, on February 13, 2003. Subsequently, Senator Greggintroduced 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 andchanges to VICP. Faced with Senator Kennedy's intention to offer 75 amendments to the smallpoxcompensation title, (28) HELP Committee ChairmanGregg 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 contactwith a vaccinated person in response to the HHS Secretary's declaration of need. It included atimeframe 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 themedical 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 asreasonable and necessary to treat a covered injury." Compensation for lost employment incomewould be two-thirds of lost income for a person with no dependents and 75% otherwise. Theproposed total lifetime benefit for lost employment income was $50,000. The coverage would notcover the first five lost work days. Following the amount specified by the PSOB legislation onwhich 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 paymentsmade for lost employment income.

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 Secretaryof 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, specialeducation, custodial care, and special equipment; and (2) would have struck the provision in S.719 that excludes Medicare-eligible people from any smallpox vaccine compensationmedical benefit. Senator Kennedy's amendment also introduced new categories that would qualifyfor disability benefits: permanent disfigurement and permanent, partial disability. For lostemployment income compensation, Senator Kennedy would have (1) maintained the committee bill'stwo-third, or three-quarter, lost income benefit, but calculated the base income taking into accountfuture earnings, especially significant to a child injured by the smallpox vaccine; (2) modified therestriction on receiving death benefits and lost income benefits by allowing the lost income benefitto continue for the life of the spouse or until minor children reach the age of 22; and (3) increasedthe 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. Histhird amendment sought to change the authorizing language of the reported bill into authorizing andappropriating language, making the funding mandatory rather than discretionary.

The Senate HELP Committee-reported bill was not brought to the Senate for a vote.

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 introducedon March 25, 2003. Both versions closely followed the Administration proposal, which also formedthe basis of S. 719. The House Republican leadership brought H.R. 1463, whichhad 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 billdiffered from the Administration proposal both in its treatment of elements common to it and in itsinclusion of elements not mentioned. Both contain the basic provisions for compensation for thecosts of medical care, permanent and total disability, and death, and cover both the vaccinee andindividuals infected following contact with a vaccinee. (30) The major differences involve themechanism established for adjudication of claims, whether the authorized appropriation is mandatoryor 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 compensationprogram 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 implementationregulations, the proposed VICP-modeled program would rely on special masters appointed in theU.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 periodbefore the lost-income disability benefit begins. H.R. 865 would provide a permanentdisability benefit of unreimbursed actual lost wages and unreimbursed medical costs not subject toany limitations, plus a one-time $250,000 payment for non-economic damages. H.R. 865would award a death benefit of $850,000.

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 ...." Thisdiffers from the new law's making the Secretary responsible for not only the overall program but alsoall implementation decisions. Finally, H.R. 865 would mandate appropriations in additionto 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 outlinedby worker groups, such as needle safety requirements; access to free medical care; paid sick leavefor up to four days, and reimbursement of those costs to non-federal employers; prohibition againstdiscrimination against an employee who declines or is ineligible for vaccination; procedures forfiling complaints and judicial review; funding to states to cover cost of mandatory state activities inpre-vaccination education and screening, and post vaccination surveillance and treatment; andestablishment of a uniform national reporting system of adverse reactions to the vaccine and a reportto Congress from the Secretary of Health and Human Services.

H.R. 876 was referred to the Energy and Commerce Committee with no further action.

Following negotiation, Members reached the compromise that Representative Burr introduced as H.R. 1770 , the Smallpox Emergency Personnel Protection Act of 2003, on April 11,2003; the full House and then the full Senate passed it that day. H.R. 1770 reflectedrevisions of H.R. 1463 ; S. 719, ordered reported from the Senate HELPCommittee; 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 SmallpoxEmergency 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 bythe HHS Secretary as a national response to threat of biologic agent attack on the United States. Itcovers injuries that the Secretary finds to be vaccine-related that occur in people who volunteer forvaccination 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.

Administrative Mechanisms

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 ofHealth and Human Services will establish regulations and will run the compensation program. Thelaw 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 certaintime 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 theSecretary to develop a process that an individual could use to request reconsideration of theSecretary's determination.

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 withinspecific 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 theperiod prior to the identification of an active case of smallpox either within or outside the UnitedStates." (31) Civilian participation in that plan mustbe voluntary. Screening for contraindications tovaccination must also be voluntary, but it must be offered. The enacted legislation does not includeSenator Mikulski's amendment that was accepted by the HELP committee in the mark-up of S. 719 , although it does direct the Secretary to ensure "appropriate post-inoculationmedical surveillance."

Benefit Levels

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 theservices, appliances, and supplies prescribed or recommended by a qualified physician, which theSecretary considers likely to cure, give relief, reduce the degree or the period of disability, or aid inlessening 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 exclusionof 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, andMedicare).

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 fromself-employment. If the person injured had "one or more dependents," that rate would increase to75% of usual employment income. The law, but not the predecessor bills, specifies that employmentincome refers to "... income at the time of injury."

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 provideemployment-based benefits. The program will pay lost employment income compensation inaddition to payment for covered medical care, but survivors cannot receive both lost income anddeath 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 temporaryor partial, the lifetime cap -- accrued at up to $50,000 per year -- is the amount, $262,100 in May2003, set by the PSOB legislation. Payments, subject to the lifetime cap if appropriate, wouldcontinue 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 deathbenefit in the amount specified by the PSOB program, now $262,100. Any death benefit to survivorswould be reduced by the amount that the smallpox vaccine injury compensation program had paidas lost employment income benefits to the deceased. Neither could this death benefit be in additionto a PSOB disability or death benefit. The death benefit would, however, be made in addition to anypayment 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 incomecompensation (75% of actual income at the time of the injury up to $50,000 per year) until theyoungest dependent survivor reaches age 18.

Appropriations

While Congress was considering smallpox vaccine injury compensation bills, both houses issued their FY 2003 emergency supplemental packages. P.L. 108-11 , the Emergency WartimeSupplemental Appropriations Act, 2003, included $42 million for HRSA to administer the smallpoxvaccine injury compensation program, in addition to the $100 million it provided through the PublicHealth 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 years2003 through 2007" and does not include language appropriating funding in advance ofappropriations acts.

Next Steps

Assess

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 thesense 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 andhealth care people to be prepared for a smallpox outbreak, not the 500,000 figure that had been madeup by summing the estimates that each state had submitted to CDC in December. (33) This new targetis closer to the 39,000 who have already volunteered for vaccination, but Congress does not knowyet whether those volunteers are appropriately distributed across states and professions to meet theprogram goals.

Clarify

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 contactwill the Secretary require? How would an unvaccinated person who nevertheless appears withvaccinia infection demonstrate that, for example, a particular, anonymous subway rider was thesource 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 contactwith 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 thatepidemiologists use do not easily line up with legislative needs to assign responsibility, drafters oflegislation turn to phrases such as "preponderance of the evidence standard"; "taking intoconsideration of relevant medical and scientific evidence"; (35) or "credible evidence for the associationis equal to or outweighs the credible evidence against the association." (36) The scientist's languageincludes an uncertainty that the law's presumptions override. Whether the new legislation providessufficient guidance to the Secretary remains to be seen. One could anticipate that individualclaimants will question whatever list the HHS Secretary promulgates.

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 orwith the Internal Revenue Service, the issues may involve input from both or require Congressionalclarification.

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. Thepublic may have somewhat relaxed its concern, but, for public health and intelligence experts, therisks to the public remain real.

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 needto prepare for bioterrorist actions. It does not, however, cover members of the general public whochoose vaccination and it applies only to vaccinia infections that occur before any smallpox case isreported. Should future events make the Secretary's precaution unfortunately predictive and post-attack vaccinationbe recommended to the general population, how might Congress view vaccine-injury compensation for that group? Congress may choose to discuss how it might modify thislegislation to allow its use in as yet unknown circumstances. (37)

The President's pursuit of Project BioShield legislation (38) to encourage private sectorparticipation in the development of other medical countermeasures to the intentional use of biologicagents against the U.S. population is one indication of a widespread view that new products arenecessary. (39) As health care workers face (or areasked to face) each new product -- whether vaccineor antitoxin, whether to protect against a viral hemorrhagic fever, tularemia, or glanders (40) -- theywill ask about compensation for potential injuries.