United States General Accounting Office GAO Report to the Chairman, Committee on Health, Education, Labor and Pensions, U.S. Senate December 1999 VACCINE INJURY COMPENSATION Program Challenged to Settle Claims Quickly and Easily GAO/HEHS-00-8 United States GAO General Accounting Office Washington, D.C. 20548 Health, Education, and Human Services Division B-281968 December 22, 1999 The Honorable James M. Jeffords Chairman, Committee on Health, Education, Labor and Pensions United States Senate Dear Mr. Chairman: Infectious diseases are responsible for nearly half of all deaths worldwide of people under the age of 44. In the United States, vaccinating children against such diseases is considered to be one of the most effective public health initiatives ever undertaken. Since vaccination programs began, the number of people contracting vaccine-preventable diseases in the United States has been reduced by more than 95 percent. In some instances, however, a vaccine can have severe side effects, including death or disabling conditions requiring lifetime medical care. In the 1980s, lawsuits stemming from such incidents threatened to affect the availability and cost of vaccines as well as the development of new ones. To address this issue, the Congress, beginning in 1986, created a different approach for compensating people injured by certain vaccines routinely provided in childhood. Instead of suing vaccine manufacturers and vaccine administrators, people—including adults—who believe they have been injured by these vaccines must first file a claim under the Vaccine Injury Compensation Program (VICP).1 VICP contains a vaccine injury table, which is designed to minimize difficulties petitioners have in proving that their injury resulted from a vaccine. The injuries listed on this table are presumed to have been caused by certain vaccines, unless the government can prove otherwise. By contrast, in a lawsuit filed under the civil tort system, the injured party bears the burden of proving that the vaccine caused injury. Administered by the Department of Health and Human Services (HHS), the program pays claims from a trust fund supported by an excise tax on each dose of vaccine that is covered by the program.2 As of February 1999, 5,355 1 When VICP became effective in October 1988, it covered vaccines required for immunizing children against seven infectious childhood diseases: diphtheria, pertussis (whooping cough), tetanus, polio, measles, mumps, and rubella (German measles). Vaccines against hepatitis B, hemophilus influenzae type b (Hib), and varicella (chicken pox) were added to the program in August 1997; and a vaccine against rotavirus was added, effective October 1998. 2 Claims arising from vaccinations administered prior to October 1, 1988, are paid from general fund appropriations. Page 1 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 claims had been filed under VICP and close to $1 billion had been awarded since October 1988, when the program became effective. The majority of claims filed and compensation paid have been for neurological injuries associated with the DTP (diphtheria, tetanus, and pertussis) vaccine. Although VICP was created to provide compensation “quickly, easily, with certainty and generosity,”3 there is debate surrounding how well the program meets this purpose. Some contend that the claims process takes too long and that recent changes to the program’s vaccine injury table make compensation too difficult to obtain. Another concern is the VICP trust fund, which had a balance of $1.3 billion at the end of fiscal year 1998 and has been collecting much more than it pays out in claims. To help with congressional oversight of the management and financing of the program, you asked us to determine • how long it takes to process a claim through VICP; • the extent that recent changes to the program’s injury table have made it easier or more difficult for petitioners to obtain compensation for vaccine-related injuries; and • why the trust fund continues to grow, and what budgetary effect proposed options for addressing the growing trust fund balance would have. Our work included analyses of claims data from HHS’ VICP database from the inception of the program to February 1999. We supplemented our analyses with interviews and information from the federal agencies responsible for the VICP claims process and financial accounting of the VICP trust fund, petitioner advocates, members of the scientific community, and a pediatric physician professional organization. (See app. I for more on our scope and methodology.) We conducted our work from January through November 1999 in accordance with generally accepted government auditing standards. Overall, while the program appears to provide an easier process for Results in Brief obtaining compensation than the traditional civil tort system, the process has not been as quick or as easy as expected. Processing most VICP claims takes more than 2 years. The Congress expected the program to process claims in 1 year or less, but only about 14 percent of claims met this expectation. In 1988 and 1989, the program received about 200 claims and processed nearly all of them within 2 years. But in 1990, when a filing 3 Report of the House Committee on Energy and Commerce accompanying the legislation establishing VICP, H.R. Rep. No. 99-908, p. 3 (1986). Page 2 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 deadline neared for injury claims relating to vaccinations received before October 1988, the number of claims filed jumped to over 3,200. This influx created an immediate and large backlog of claims, which HHS is still working to resolve. Another factor significantly increasing processing times is that as the program received additional funding for staff and experts to defend claims, the government increasingly challenged claims in which the cause of injury was in doubt. As a result, petitioners needed more information and time to prepare cases, which resulted in processing times that were much longer than envisioned when the program began. HHS’ recent changes to the vaccine injury table will make the process easier for some people to obtain compensation, but will make it more difficult for a larger number to do so. This is because far more claims have historically been associated with injuries HHS removed from the table than with injuries HHS added to it. For example, about half of the awards made since the program’s inception have been for neurological injuries that HHS later removed from the table in 1995 and 1997. Removing these injuries shifts the burden of proof to the petitioner, making it more difficult to qualify for compensation under VICP. HHS based its decisions to add or remove table injuries on various factors but did not have a clear and transparent methodology to demonstrate that these factors were consistently applied for each injury table change. Without such transparency, changes that make compensation more difficult for petitioners may continue to be questioned by some, regardless of their merit. We are making a recommendation to HHS to develop and apply a consistent methodology for its decisionmaking process for making changes to the vaccine injury table. The VICP trust fund has grown to $1.3 billion, primarily because the income from vaccine excise taxes has been higher than payments for claims and associated administrative costs and interest has been accruing on the fund balance. The excess tax revenue—$948 million, as of 1998—has been loaned to the Treasury and used for other federal programs and activities. Vaccine manufacturers, federal agencies, and petitioner advocates have expressed concerns about the rising balance and have proposed options to decrease the vaccine excise tax or increase trust fund spending. Exercising these options, however, would have implications for the overall federal budget, possibly requiring new or higher taxes elsewhere or a decrease in spending for other programs and activities. Page 3 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 All 50 states require that virtually all children be vaccinated against Background common childhood diseases before they enter school,4 and HHS reports that over 12 million vaccinations are given to children each year. These laws have dramatically reduced many infectious diseases in the United States. For example, the number of reported cases of measles, which can lead to brain damage and death, has dropped from about half a million in 1960 to about 100 in 1998. For most children, freedom from the effects of measles, diphtheria, polio, tetanus, pertussis, and other diseases is a decided benefit. But immunization programs also carry a human cost. A small number of children who receive immunizations have serious and unexpected reactions to them. These reactions can be devastating— paralysis, permanent disability, and even death. Affected families without adequate insurance coverage may face significant expenses, because the costs for residential or home care, therapy, medical equipment, and drugs needed to care for an injured child over a lifetime can exceed several million dollars. Prior to VICP, families could seek compensation for damages only through the civil tort system or through a settlement agreement with the vaccine manufacturer or health care provider. Filing a lawsuit in the civil tort system was considered to be unsatisfactory for those claiming to have suffered an adverse reaction to a vaccine. Petitioners had difficulty proving vaccine-related injuries because studies and medical evidence needed to definitively link vaccines with various medical conditions were often insufficient to establish the level of proof required for compensation in the legal system.5 Establishing this link can be difficult because most injuries that can be caused by vaccines can be caused by other things as well. For example, symptoms of neurological disorders often show up in the first year of life, which is the same time that most vaccines are administered. Petitioners are not the only ones who found the legal system difficult. As the number of lawsuits increased, particularly for the DTP vaccine, vaccine manufacturers became concerned not only with problems of time and expense but also with the availability and affordability of product liability insurance. The federal government, in turn, became concerned that if 4 States generally require vaccination against each of the original seven childhood diseases covered by the program, but there is some variation. Six states, for example, do not require the pertussis vaccine and six others do not require the mumps vaccine. 5 For example, the Institute of Medicine studied 75 specific relationships between vaccines and adverse events and concluded that medical evidence was insufficient to prove or disprove a relationship in two-thirds of the cases. See a discussion of Institute of Medicine studies in Research Strategies for Assessing Adverse Events Associated With Vaccines: A Workshop Summary (National Academy Press, 1994). Page 4 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 manufacturers withdrew from the market, vaccine shortages would result and infectious diseases would reemerge as serious health threats. VICP Represented a New VICP established a new system for vaccine injury compensation that was Approach to Injury expected to be fair, simple, and easy to administer. Rather than filing a Compensation lawsuit against the vaccine manufacturer or vaccine administrator in the civil tort system, an individual claiming injury from vaccines covered by the program must first file a petition for “no-fault” compensation with the U.S. Court of Federal Claims.6 Special masters of the court—attorneys appointed by the judges of the court—conduct informal hearings as necessary to determine whether the petitioner is entitled to compensation from VICP, and if so, how much. HHS, as overall administrator of VICP, is represented by Department of Justice (DOJ) attorneys, while the petitioner may be represented by a private attorney.7 (See app. II for a description of the claims process.) To ensure access to the program, VICP pays attorney fees and costs for the petitioner, regardless of whether the petitioner is awarded compensation.8 VICP features designed to expedite the process include a relaxation of the rules of evidence, discovery, and other legal procedures that can prolong cases in the legal system. Features designed to control costs include a legislated $250,000 payment for compensable deaths. For compensable injuries, the program purchases annuities covering the lifetime costs of care not covered by insurance and compensates for pain and suffering and lost wages. VICP does not pay punitive damages. Compensation is available for reasonable attorney fees and costs, which generally reflect the actual time and expense devoted to the case. Program’s Injury Table Is There are two ways a petitioner can qualify for compensation under VICP. Its Most Important Feature Similar to the civil tort system, petitioners must be able to prove that a vaccine caused an injury or, unique to VICP, the petitioner must have an injury listed on the program’s injury table. The number of vaccines and injuries listed on the table have changed over time. Legislation establishing 6 Lawsuits may be filed against manufacturers or health care providers if a petition is dismissed or judged noncompensable under VICP and the judgment is rejected by the petitioner, if the award granted by VICP is rejected by the petitioner, or if the vaccine is not covered under VICP. 7 The vaccine manufacturer and whoever administered the vaccine are not involved as parties to the proceedings. 8 Attorney fees and costs are paid if the court determines there is a reasonable basis for the petition and the petition was filed in good faith. Page 5 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 the original injury table included five different medical conditions related to vaccines against seven diseases (see table 1). Table 1: Original Vaccine Injury Table Vaccine and injurya Time periodb Vaccines against diphtheria,c tetanus, and pertussis Anaphylaxis 24 hours Residual seizure disorder 3 days Shock-collapsed 3 days Encephalopathy 3 days Vaccines against measles, mumps, and rubella Anaphylaxis 24 hours Residual seizure disorder 15 days Encephalopathy 15 days Vaccines against polio Paralytic polioe 30 days/6 monthsf g Anaphylaxis 24 hours Note: For current vaccine injury table, see app. III. a Injuries are defined in “Qualifications and Aids to Interpretation,” reprinted in app. III. b For first symptom, onset, or aggravation of injury after vaccination. c Administered with tetanus and/or pertussis vaccines. d For vaccines against pertussis. e Injury related to oral polio vaccine. f Time intervals are for immunocompetent/immunodeficient individuals who receive oral poliovirus. Contact cases have no limit. g Injury related to inactivated polio vaccine. Filing a claim using the injury table relieves petitioners from some of the uncertainty caused by gaps in medical knowledge. Under VICP, vaccines on the injury table are presumed to have caused the listed injury if incurred within specific time periods. For example, under the original table, someone suffering neurological damage from seizures within 3 days after receiving a vaccine against pertussis would receive compensation if HHS could not prove that the condition was due to factors unrelated to the administration of the vaccine. Thus, for the petitioner, VICP’s injury table may provide a benefit over the civil tort system. Page 6 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 Funding for Compensation VICP finances awards and attorney payments differently, depending on Has Come From Two when the vaccine causing the alleged injury was administered. For Sources vaccines administered prior to October 1, 1988, payments are made from general revenues appropriated by the Congress each year. For vaccines administered on or after this date, payments are made from the VICP trust fund, which is supported by a $.75 excise tax on each dose of vaccine sold9 and interest accumulating on the trust fund balance. As of February 1999, VICP had paid close to $1 billion for awards and attorney payments— 75 percent from appropriated general funds rather than from the trust fund (see table 2). Table 2: Financing for VICP Claim Payments Number of Awards/ claims filed attorney as of Feb. paymentsa as VICP claims Filing deadline Funding source 1999 of Feb. 1999 Vaccines Jan. 31, 1991 Annual 4,245 $742,244,679 administered appropriations prior to Oct. 1, 1988 Vaccines Within 24 Vaccine excise tax 1,110b 250,296,568 administered on months from or after Oct. 1, date of death or 1988 36 months from date of injury a The maximum award paid was close to $8 million while the median paid was $318,943. b Includes five cases where the data field for date of vaccination was blank. Processing VICP claims continues to take longer than expected. When the Processing VICP Congress established VICP, the expectation was that the court would take 1 Claims Takes Longer year or less10 to judge whether a claim was entitled to compensation and, Than Expected if so, how much that compensation would be. The program became effective on October 1, 1988, and as of February 1999, 5,355 claims had been filed. Of this number, about 14 percent received judgment within 1 year (see fig. 1). Most did not receive judgment within 2 years. Of the total 9 This uniform rate of taxation became effective Aug. 6, 1997 (P.L. 105-34). Prior to this date, the excise tax rate varied by vaccine in accordance with the expected compensation payments associated with each covered vaccine. 10 The original legislation required a judgment on claims no later than 365 days after the claim was filed. This was subsequently amended to require a judgment by the special master within 240 days exclusive of suspended time. Either party may appeal the decision to a judge of the court, which would add time to the process. (See app. II.) If the special master fails to make a decision within 240 days or if appealed and a judgment is not rendered within 420 days, petitioners are allowed to withdraw from VICP and sue the manufacturer or health care provider directly. Page 7 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 claims filed during this period, 10 percent had not received a judgment as of February 1999 and remained open. Figure 1: Status of VICP Claims 1 Year or Less 19% Between 1 and 2 Years 14% 39% Between 2 and 5 Years 10% 18% 5 Years or More Pending Casesa Closed Cases Note: Data are for cases filed as of February 1999. a The length of time pending cases had been in process ranged from less than 1 month to more than 8 years. Two interrelated reasons are central to explaining these longer than expected processing times. The first was a large influx of claims filed a few years after the program began. The second was that as more funding became available to defend claims, HHS increasingly challenged the ones it regarded as not clearly meeting the statutory criteria. Page 8 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 Delays Due to Volume When VICP took effect on October 1, 1988, it gave claimants 2 years and 4 months (until January 31, 1991) to file claims on injuries for vaccines administered prior to October 1988. As people began responding to the deadline, the number of claims filed under VICP jumped from 125 claims in 1989 to 3,263 claims in 1990. Nearly 800 more claims were filed in the month before the deadline. As table 3 shows, this large influx of claims created an immediate backlog. The number of pending claims rose to as high as 3,548 at the end of 1991 and remained above 1,000 until the end of 1995. Table 3: VICP Claims Filed, Adjudicated, and Pending, by Calendar Year Claims filed Claims adjudicated Claims pending Year 1988 79 0 79 1989 125 61 143 1990 3,263 153 3,253 1991 968 673 3,548 1992 174 735 2,987 1993 119 637 2,469 1994 121 612 1,978 1995 164 707 1,435 1996 92 573 954 1997 107 332 729 1998 131 309 551 1999a 12 25 538 Total 5,355 4,817 a Data as of February 1999. As might be expected, processing times began to increase as HHS worked to respond to the influx of claims. Before 1990, nearly all claims were processed within 2 years. Starting in 1990, however, only about 30 to 40 percent of claims filed each year have been processed this quickly (see fig. 2). Page 9 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 Figure 2: Percentage of Claims Filed in Calendar Years 1988 to 1997 With 100 Judgment Received Within 2 Years 90 80 70 60 50 40 30 20 10 0 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 Percentage with judgment received in first year Percentage with judgment received in second year Note: Second-year data for 1997 are incomplete. In addition, only data for 1988 through 1991 include claims for vaccinations given prior to October 1988 because the filing deadline for such claims was January 31, 1991. Data for 1992 through 1997 include claims for vaccinations on or after October 1988. Delays Due to Change in As figure 2 shows, the percentage of claims processed within 1 or 2 years Program Implementation changed somewhat from year to year but has not increased much since 1992. Although table 3 shows that the number of claims filed since the 1991 deadline dramatically decreased, the number of claims adjudicated generally declined in following years. A key reason is because in 1990, HHS and DOJ began to increasingly scrutinize claims of vaccine injury as funding to fully implement their legislated authority under the program became available. DOJ established a cadre of attorneys specializing in vaccine injury to represent HHS in hearings, and HHS established an expert witness program to help assess whether alleged vaccine injuries such as seizure disorders may have been present from birth or were due to other causes. Full implementation of HHS’ statutory authority to defend claims had implications for claims processing times, making it more difficult for Page 10 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 claims to be processed within the 1-year period originally envisioned or even a 2-year period. For example, HHS data show that more than half of all petitioners were requested to provide supplementary medical records or other information, and most took at least a year to do so. Both sides often made use of expert witnesses to review the evidence and report on their findings. After all the information was received, in most cases, it took the court over another year to reach its decision. Steps Taken to Expedite HHS, DOJ,and the U.S. Court of Federal Claims have taken some steps to Claims Processing expedite the claims process, including the following: • Since 1990, HHS has cut its average time for completing its medical review and submitting its recommendation to the court from nearly 6 months11 to about 3 months. • In 1990, the court produced a guide for petitioners and their attorneys explaining how to process claims through VICP, and in 1994, DOJ published steps to expedite the resolution and payment of compensation and attorney fees. • Starting in the fall of 1997, the court initiated a practice of holding conference calls between the special masters and attorneys within 30 to 45 days after the filing of a petition to discuss any deficiencies in the petition, such as absence of pertinent medical records, and ways to remedy them.12 The chief special master said that while the court could process claims more quickly, delays are granted primarily to benefit petitioners who need more time to gather information, have medical tests performed, or identify costs related to an injured child’s developmental needs. If a judgment is not received within 240 days, petitioners can withdraw their claim from VICP and file a lawsuit in the civil tort system. Yet HHS, DOJ, and court officials stated that none have done so. 11 Data for 1990 are for claims relating to vaccines administered after Sept. 30, 1988. The 1990 average for all claims is over 2 years. 12 For example, DOJ states that where appropriate, it will subpoena medical records on behalf of the petitioner. Page 11 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 Of the 4,817 petitioners receiving judgment under the program as of Injury Table Changes February 1999, close to 30 percent received compensation for a family May Increase member’s injury or death. Most compensated claims alleged injuries listed Difficulty Petitioners on the program’s vaccine injury table. Since the program began, HHS has made two sets of changes to the table, removing some injuries and adding Face in Obtaining other injuries and vaccines. However, far more claims are associated with Compensation for injuries removed from the table than with injuries that were added. As a result, more petitioners now must prove that a vaccine caused the injury, Vaccine-Related rather than HHS having to prove that the injury was due to factors Injuries unrelated to the vaccine. Number of Petitioners Most of the petitioners who filed claims and received awards under VICP Potentially Covered by the alleged injuries listed on the program’s vaccine injury table. Petitioners Vaccine Injury Table Has who did not claim injuries listed on the injury table—about 28 percent—had the burden of proving that a vaccine caused the injury; of Decreased these petitioners, only 13 percent were able to obtain compensation. The remaining 72 percent claiming injuries on the table had compensation rates nearly three times higher. Table 4: VICP Petitions Claiming Table/Off-Table Injuries Percent table claims Percent off-table claims Vaccine Filed Compensated Filed Compensated Vaccines against diphtheria, 83 32 17 15 tetanus, and pertussis Vaccines against measles, mumps, 53 43 47 25 and rubella Vaccines against polio 39 60 61 3 a a Vaccines against hepatitis B 7 93 b a Vaccines against varicella 0 100 b Unspecified/nonqualifying 0 100 0 Total 72 35 28 13 a Judgment pending. b Not applicable. Under the act that created VICP, HHS has rulemaking authority to change the injury table and has done so on two occasions. The act established the first injury table, with HHS to make future changes as more information became available. The act further called for the Institute of Medicine, of the National Academy of Sciences, to assist HHS in this regard by reviewing existing medical studies and literature related to a set of specific Page 12 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 conditions that might be related to vaccines covered by the program. After the reviews were completed in 1991 and 1994, the Institute of Medicine identified certain conditions that were consistent or inconsistent with a causal relationship, those that favored or did not favor a causal relationship, and those where evidence was insufficient to indicate the presence or absence of a causal relationship.13 HHS used these findings—in conjunction with public policy considerations provided by the Advisory Commission on Childhood Vaccines, scientific issues raised by its National Vaccine Advisory Committee, and input from the public—to add seven injuries and remove three others from the table in 1995 and 1997 (see table 5).14 In addition, HHS refined the supporting guidance to the table, “Qualifications and Aids to Interpretation.” This document provides definitions for injuries and the specific circumstances under which the table injuries must occur (see app. III for the current injury table and interpretation aids). Table 5: Injuries Added to and Removed From the VICP Vaccine Vaccine Injury added Injury removed Injury Table Effective Mar. 10, 1995 Vaccines against pertussis Shock-collapse Vaccines against pertussis Residual seizure disorder and tetanus Vaccines against rubella Chronic arthritis Effective Mar. 24, 1997 Vaccines against measles, Residual seizure disorder mumps, and rubella Vaccines against measles — Thrombocytopenic purpura — Vaccine-strain measles Vaccines against polioa Vaccine-strain polio Vaccines against hepatitis B Anaphylaxis Vaccines against hemophilus Early-onset Hib influenzae type b (Hib) Vaccines against tetanus Brachial neuritis Encephalopathy a Applies to oral polio vaccine. 13 Most conditions fell in the third category, as the Institute of Medicine concluded that there was insufficient medical evidence to prove or disprove a relationship between vaccines and two-thirds of the 75 medical conditions studied. 14 HHS publishes the proposed and final rules of injury table changes in the Federal Register. HHS must allow 180 days for public comment on a proposed rule. HHS must also provide 90 days for review of proposed rule by the Advisory Commission on Childhood Vaccines, comprised of parents of injured children, health professionals, and attorneys appointed by HHS. The National Vaccine Advisory Committee is comprised of representatives from state and local health departments, vaccine companies, academia, and consumer groups. Page 13 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 Although HHS added more injuries than it removed from the original injury table, fewer petitioners now have the potential to use it. Where 74 percent of petitioners filed claims alleging injuries on the injury table prior to the 1995 and 1997 changes, only 55 percent filed such claims after the table was revised.15 To some extent, this decrease is because more claims were associated with the injuries removed from the table than were associated with the injuries that were added. Significantly, as shown in table 6, about 45 percent (611) of the 1,368 claims awarded compensation under VICP were for injuries subsequently removed from the table. These claims accounted for about half of the $974 million awarded thus far under the program. These numbers are significant because petitioners with injuries not listed on the injury table historically have had a lower probability of being compensated than those with injuries that were listed. Table 6: Claims Associated With Injuries Added to and Removed From the VICP Vaccine Injury Table Claims for injuries added to injury Claims for injuries removed from table injury table Number Number Vaccine Injury compensated Total awarded compensated Total awarded a a Vaccines against rubella Chronic arthritis 9 $622,101 a a Vaccines against tetanus Brachial neuritis 0 0 Vaccines against measles Thrombocytopenic a a purpura 0 0 a a Vaccines against measles Vaccine-strain measles 0 0 a a Vaccines against polio Vaccine-strain polio 0 0 a a Vaccines against hepatitis B Anaphylaxis 0 0 Vaccines against hemophilus Early-onset Hib a a influenzae type b (Hib) 0 0 a a Vaccines against pertussis Shock-collapse 61 $27,228,905 Vaccines against measles, Residual seizure mumps, pertussis, rubella, disorder a a and tetanus 547 452,141,726 a a Vaccines against tetanus Encephalopathy 3 529,074 Total claims compensated/amounts awarded for injuries added/removed from the table 9 $622,101 611 $479,899,705 Percent of all claims compensated/amounts awarded 0.7 0.0 44.7 49.3 a Not applicable. 15 The actual percentages of claims qualifying as table injuries are lower due to restrictions in the definition of an injury or time of onset listed in “Qualifications and Aids to Interpretation.” (See app. III.) Page 14 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 Lack of Clear Methodology HHS has published its rationale for each revision to the injury table in the for Table Changes Raises Federal Register but has not published an overall method of applying the Questions of Consistency criteria it uses in conjunction with the Institute of Medicine findings. Because HHS’ modifications of the table determine whether the government or petitioner has the burden of proof for affected claims, table changes that make compensation more difficult for petitioners have been questioned by some. Defining the criteria related to the level of program and financial risk that the government will bear is controversial and there is disagreement about what the Congress intended in this regard. For example, HHS interprets the legislative history as directing it to recognize table injuries where there is definitive information linking vaccines to injuries, while others cite the same legislative history as directing that, until definitive information is available, the benefit of doubt should remain with the petitioner. Particularly because of these differences, establishing a clearly defined, transparent decisionmaking process is important to help advance the appearance of fairness. HHS has not produced such a methodology, and its actions do not always convey a sense of consistency, as illustrated in the following examples: • The Institute of Medicine found that existing scientific evidence favored acceptance of a causal relationship between tetanus vaccines and brachial neuritis, and HHS added that condition to the injury table. On the other hand, the Institute also found evidence of a causal relationship between the tetanus and oral polio vaccines and Guillain-Barre syndrome, but HHS did not add this condition to the injury table. • The Institute of Medicine found the evidence inadequate to accept or reject a causal relation between vaccines and residual seizure disorder, and HHS removed this condition from the injury table. The Institute also found evidence inadequate to accept or reject a causal relation between the measles and mumps vaccines and encephalopathy, yet HHS left this condition on the injury table.16 HHS stated in the Federal Register that decisions not to add injuries, such as Guillain-Barre syndrome, or to remove injuries, such as residual seizure disorder, were based to some extent on the level of risk in compensating an inordinate number of non-vaccine-related cases for the extremely rare vaccine-related case. In applying this criterion, however, HHS’ assumptions about the number of potential claims and thresholds for deciding the 16 HHS narrowed the definition of encephalopathy in the “Qualifications and Aids to Interpretation,” which would preclude use of the table for some petitioners. Page 15 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 reasonable level of financial risk for compensating non-vaccine-related injuries were not defined. The VICP trust fund has grown to $1.3 billion primarily because the income Trust Fund Income from vaccine excise taxes is higher than claims payments and because the Exceeds Need for government pays interest on the trust fund balance. Program participants Claims Payments have expressed concerns about the rising balance and have proposed options to address them. Exercising these options, however, would have implications for the overall federal budget, possibly requiring new or higher taxes elsewhere or a decrease in spending for other federal programs and activities. VICP Trust Fund Continues The VICP trust fund has historically received more in vaccine excise taxes to Grow than it has paid out for claims and related administrative costs. Since the program began, the Treasury reported it has collected over $1.6 billion in vaccine excise taxes: $.4 billion of this amount went directly to the general fund to offset income and payroll taxes lost to the general fund as a result of the excise tax.17 The remaining $1.2 billion went to the VICP trust fund for claims payments and related administrative costs. Because the trust fund has spent only about $290 million of the $1.2 billion received, the remaining $948 million was loaned to the Treasury and used for other federal programs and activities. In exchange, the trust fund received Treasury securities to be redeemed if needed to pay future claims.18 Interest on these Treasuries held by the trust fund totaled about $374 million by the end of fiscal year 1998. This $374 million in interest and the $948 million loaned to the Treasury comprise the $1.3 billion trust fund balance existing as of the end of fiscal year 1998. 17 The 25-percent factor is the standard offset used when excise tax provisions are scored for budget purposes during the legislative process. Budget estimating conventions are that gross domestic product and the price level are fixed. Therefore, any increase in excise taxes must reduce payments to labor and capital (such as wages and rents) and, therefore, reduce income and payroll taxes deposited to the general fund. 18 As provided in section 9602(b) of the Internal Revenue Code for management of trust funds in general. Page 16 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 Figure 3: Money Flows Attributable to Vaccine Excise Taxes Collected From Fiscal Year 1989 Through Fiscal Year 1998 Excise Tax on Each Dose of Vaccine $1.2 Billion $.4 Billion Unused Surplus $.9 Billion Vaccine Injury General Fund Compensation Program Trust Fund Special Treasuries $.9 Billion Interest Paid on Special Treasuries $.4 Billion $.3 Billion Injury Claims and Administrative Costs At current rates, the Congressional Budget Office (CBO) estimates that the VICP trust fund balance will reach $2.6 billion within the next decade and Page 17 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 the program will generate almost three times more revenue than will be used to pay annual claims and administrative costs. However, the vaccine excise tax rate is not based on an empirical risk assessment set to fund future benefits, and HHS officials do not believe that there is an outstanding liability requiring a large trust fund balance to meet future claims payments.19 If this expectation holds true, the trust fund balance reflects the amount of vaccine excise taxes and interest on Treasury securities that is not expected to be needed for VICP purposes. Options to Address Vaccine manufacturers, parent groups, and others involved with VICP have Concerns About the expressed concerns about the large trust fund balance and have proposed Growing Trust Fund options to address them. These options generally involve cutting the excise tax supporting the trust fund or spending more of the money Balance received on designated vaccine-related activities. Views and options include the following: • Some vaccine manufacturers view the trust fund balance as an indicator that the vaccine excise tax rate is too high. They support legislative proposals to reduce the tax rates. • Parent groups view the trust fund balance as an indicator of the government’s unwillingness to recognize vaccine injuries and compensate people fairly for these injuries. They advocate a less restrictive injury table that would increase the number of petitioners compensated from the trust fund. • HHS officials from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) responsible for monitoring vaccine safety view the trust fund balance as a source of potential revenue if the Congress decides to expand trust fund spending to vaccine-related activities. Although the Administration has not submitted formal proposals to increase support of these activities or taken a position on the potential use of the trust fund, FDA and CDC officials we contacted supported dedicating a portion of the trust fund revenue not needed for claims payment to provide funding for vaccine injury surveillance systems and for research examining links between vaccines and delayed onset or chronic diseases. Budgetary Implication of Because excise tax revenue received by the VICP trust fund and not spent Options to Reduce the on the program is invested in Treasury securities and these proceeds are Trust Fund Balance used by the general fund, implementing options to control the growth of 19 See Budget Issues: Budgeting for Federal Insurance Programs (GAO/AIMD-97-16, Sept. 30, 1997) for further information on budget issues for federal insurance programs. Page 18 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 the trust fund balance not only affect the trust fund but also affect revenue and spending for the overall federal budget. Options requiring a change in legislation are also affected by requirements of the Budget Enforcement Act (BEA).20 Under BEA, the Congress has to offset the cost of legislation that reduces revenue or increases spending by establishing new or higher taxes elsewhere or by decreasing spending for other programs.21 For example, if the Congress had passed a law in 1998 that either lowered the vaccine excise tax rate to match claims payments or allowed the trust fund to spend the annual excess for new activities, funding for other federal programs and activities would have to have been reduced by $59 million.22 Had legislation been enacted in 1998 allowing new spending beyond the annual income received by the trust fund, the trust fund would have had to draw upon the $1.3 billion trust fund balance by redeeming its Treasury securities. In this case, BEA would have required a reduction in spending for other federal programs—or an increase in other taxes—to offset the new spending by the trust fund. While VICP was expected to provide compensation for vaccine-related Conclusions injuries quickly and easily, these expectations have often not been met. In establishing the vaccine injury table as a desirable alternative for petitioners over the civil tort system, the Congress was initially willing to accept the risk that some compensation would be provided for injuries where the role of vaccines is uncertain. But in administering and refining the injury table, HHS is in the position of determining how much of this uncertainty the program will continue to bear. When HHS removes or does not add injuries to the vaccine injury table, the petitioner bears the burden of proof rather than the government. Where science is insufficient to determine causal relationships between a vaccine and injuries, it is not clear that HHS’ criteria and approach to making injury table changes are consistent. Establishing a standard method with criteria that will be used consistently for all table changes may help eliminate questions regarding HHS’ programmatic decisions. 20 The Budget Enforcement Act of 1990 and subsequent amendments (the Omnibus Budget Reconciliation Act of 1993 and the Budget Enforcement Act of 1997) are collectively referred to as the Budget Enforcement Act. These acts amended the Balanced Budget and Emergency Deficit Control Act of 1985, sometimes called Gramm-Rudmann-Hollings. 21 The act requires that all legislation that increases mandatory spending or decreases receipts be fully offset—or paid for—so that it is deficit neutral. The Balanced Budget Act of 1997 requires that the impact of spending and receipts legislation be offset in the current year, the budget year, and the following 4 fiscal years. A point of order may be raised in the Senate if the change is not deficit neutral in the second 5 years. This provision is enforced through sequestration, which is done annually. 22 This result assumes that if vaccine excise taxes were reduced, the manufacturer would not decrease vaccine prices to pass on the tax savings to purchasers. If the tax savings were passed on to the vaccine purchaser, funding for other federal programs would need to have been reduced by $30 million. Page 19 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 We recommend that the Secretary of HHS develop and apply a consistent Recommendation to methodology for evaluating and reporting on the various factors used to the Secretary of HHS add injuries to or remove injuries from VICP’s injury table. This methodology should include specific scientific and public policy considerations and their relative weight in the decisionmaking process and should be applied to any future table changes. Both HHS and DOJ provided written comments on our draft report. Their Agency Comments comments are reprinted as appendix IV and appendix V, respectively. We and Our Evaluation summarized their comments and provide our response below. Both HHS and DOJ raised issues with our analysis of claims processing times. In addition, HHS did not concur with our recommendation regarding the need to establish a clear methodology for revising the vaccine injury table and said that the Administration has not taken a position on potential uses of the VICP trust fund surplus. Claims Processing Times HHS commented on what it considered an inappropriate use of the original legislated criteria of 1 year to measure VICP performance. HHS pointed out that subsequent legislation allows petitioners additional time, as needed, to obtain medical records and bolster the sufficiency of their cases. We made several modifications to the final report to reduce the perceived focus on historical expectations. Nevertheless, while the legislation was amended to provide petitioners with the flexibility to keep the case open longer, there is no indication that the Congress changed its expectation that claims would be processed quickly. In fact, the law was amended to require a special master decision within 240 days, exclusive of suspended time.23 HHS also commented that our analysis should more clearly differentiate adjudication times between claims related to vaccinations administered prior to October 1988 (pre-1988 claims) and claims related to vaccinations on or after this date (post-1988 claims). HHS stated that pre-1988 claims are not representative of current and future processing times and should be reported on separately. HHS said the average processing time for post-1988 claims was 2 years. To clarify that our analysis did differentiate between pre- and post-1988 claims, we added a note to figure 2 to indicate that the years 1992 through 1997 include only post-1988 claims. We also note that 23 Either party may file an appeal of the special master decision, which would add time to the process (see app. II). Page 20 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 HHS’ 2-year number is the average time for only those cases that have been closed. However, after 2 years, a majority of the cases filed each year are still open. HHS and DOJ said that the draft report implied that HHS’ increased propensity to defend claims is a result of a significant change of position rather than the result of the Congress providing funding for DOJ attorneys to defend claims that HHS had defaulted on for the first 2 years of the program. We added language to clarify that HHS’ increased level of defense in implementing its statutory authority was related to the availability of additional resources. DOJ also commented that some statements in the draft may convey an incorrect understanding of why some cases have taken longer to resolve than originally anticipated. DOJ said a significant factor was that the court suspended claims processing in 1991 when an overwhelming number of claims were received. Legislation does allow the court to suspend proceedings when the volume of claims is onerous, and our report does state that the large volume of cases was a primary factor in delayed processing times. However, we also point out that volume is not the only factor. For example, we report that even though caseloads declined between 1992 and 1997, the percentage of new claims processed within 2 years has remained relatively the same. We have added wording to the report text to help clarify this point. HHS also pointed out that our draft report did not discuss recent legislative proposals to improve VICP. In our view, the legislative proposals advanced by HHS in June 1999 do not directly address the findings related to our report objectives; therefore, we did not include them. The proposals primarily cover technical aspects of the program, such as expanding the statute of limitations for filing claims and clarifying statutory terms that define entitlement to compensation. Vaccine Injury Table HHS did not concur with our recommendation that in considering future changes to the vaccine injury table, HHS formalize and apply a set of standard criteria for making decisions to add or remove injuries. HHS stated that it is inappropriate to reduce the scientific basis for decisions to the application of weighted criteria and that a standard approach in making such decisions is not possible because the scientific and public policy considerations vary on a case-by-case basis. Further, HHS stated that the Institute of Medicine had cautioned against using a “formula” Page 21 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 approach, and HHS had gone to great lengths to explain its rationale for each table decision when it published the proposed and final rules in the Federal Register. We recognize that HHS has a difficult task of applying judgment when scientific uncertainties exist about the causal links between vaccines and injuries, and we did not question the table changes that were made. However, using a variety of criteria on a case-by-case approach does not, in our view, clearly communicate to the public that HHS is acting consistently in applying its judgment. For example, in discussing its rationale for each change in the Federal Register, HHS generally cites some combination of four factors in controlling its decision. These factors include Institute of Medicine findings (and subsequent medical studies), biologic plausibility, recommendations from the Advisory Council on Childhood Vaccines and the National Vaccine Advisory Committee, and prevalence of the condition in the population attributable to vaccines. However, in communicating its decisions to the public, HHS does not uniformly discuss each of these factors, and the reasons why the relative importance of each factor varies among the decisions is not apparent in all cases. As HHS indicated in its comments, it is important to maintain public confidence in the fairness of the program. Our recommendation is being made with this objective in mind. Further, we disagree that it is not practical for HHS to adopt a standard methodology to evaluate the available evidence and that doing so would constitute use of a formula. For example, the Institute of Medicine developed such a methodology to perform its review and evaluation of the available scientific evidence linking vaccines to adverse events. The Institute considered four types of scientific evidence (biologic plausibility, case reports, case series, and uncontrolled observational studies) and used qualitative and quantitative approaches to weight each type of evidence. The results were summarized in a matrix with narrative on how each factor was applied in the decisionmaking process. HHS could develop a similar decisionmaking methodology that includes the public policy considerations and other relevant criteria it uses in addition to the Institute’s findings. We have reworded our recommendation to make it clearer that, in the future, HHS should apply a consistent methodology for evaluating and reporting on the factors used to make vaccine injury table changes. HHSalso commented that the reason compensation numbers significantly dropped for DTP after the vaccine injury table changes was not because of Page 22 GAO/HEHS-00-8 Vaccine Injury Compensation Program B-281968 the table changes, as we reported, but because of a decrease in the use of this vaccine. HHS also stated that our report should reflect the fact that VICP’s future workload will be primarily for vaccines other than DTP. Our point about the changes to the table does not relate to the use of the DTP vaccine or VICP’s workload. Instead, our discussion concludes that, regardless of the vaccine in question, people have historically had a higher chance of being compensated for injuries that are on the table than for injuries that are not on the table. Since a higher percentage of people filed claims off-table after the table changes were implemented, the future percentage of claims compensated under the program may be lower. Trust Fund Growth HHS said the Administration has not submitted formal proposals to increase support of vaccine safety and research activities or taken a position on the potential use of the trust fund. We have added language to clarify that these options have not been formally endorsed by the Administration. As agreed with your office, unless you publicly announce its contents earlier, we plan no further distribution of this report until 30 days from the date of this letter. At that time, we will send copies of this report to the Honorable Donna E. Shalala, Secretary of HHS; the Honorable Janet Reno, Attorney General; the Honorable Loren A. Smith, Chief Judge, U.S. Court of Federal Claims; and other interested parties. We will also make copies available to interested congressional committees and others upon request. This report was prepared by Frank Pasquier, Assistant Director; Lacinda Baumgartner; and Linda Bade. Please call me at (202) 512-7118 if you or your staff have any questions. Sincerely yours, Kathryn G. Allen Associate Director, Health Financing and Public Health Issues Page 23 GAO/HEHS-00-8 Vaccine Injury Compensation Program Contents Letter 1 Appendix I 26 Scope and Methodology Appendix II 29 VICP Claims Process Appendix III 32 Current VICP Injury Table and “Qualifications and Aids to Interpretation” Appendix IV 38 Comments From the Department of Health and Human Services Appendix V 43 Comments From the Department of Justice Tables Table 1: Original Vaccine Injury Table 6 Table 2: Financing for VICP Claim Payments 7 Table 3: VICP Claims Filed, Adjudicated, and Pending, by 9 Calendar Year Table 4: VICP Petitions Claiming Table/Off-Table Injuries 12 Table 5: Injuries Added to and Removed From the VICP Vaccine 13 Injury Table Table 6: Claims Associated With Injuries Added to and Removed 14 From the VICP Vaccine Injury Table Table II.1: Claims Process Steps and Time Frames 30 Table III.1: VICP Vaccine Injury Table 32 Page 24 GAO/HEHS-00-8 Vaccine Injury Compensation Program Contents Figures Figure 1: Status of VICP Claims 8 Figure 2: Percentage of Claims Filed in Calendar Years 1988 to 10 1997 With Judgment Received Within 2 Years Figure 3: Money Flows Attributable to Vaccine Excise Taxes 17 Collected From Fiscal Year 1989 Through Fiscal Year 1998 Figure II.1: Time Line of VICP Claims Processed in U.S. Court of 31 Federal Claims Without an Appeal Figure III.1: “Qualifications and Aids to Interpretation” 33 Abbreviations BEA Budget Enforcement Act CBO Congressional Budget Office CDC Centers for Disease Control and Prevention DOJ Department of Justice DTP diphtheria, tetanus, and pertussis FDA Food and Drug Administration HHS Department of Health and Human Services VICP Vaccine Injury Compensation Program Page 25 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix I Scope and Methodology To obtain information on VICP, we interviewed (1) officials at HHS, DOJ, and the U.S. Court of Federal Claims involved in the VICP claims process; (2) a representative of the Institute of Medicine responsible for analyzing existing scientific evidence for HHS use in revising the VICP vaccine injury table; (3) officials at CDC and FDA responsible for the national immunization program and monitoring vaccine safety; (4) an attorney and a parent group representing the interests of people injured by vaccines; (5) a representative of a professional association representing pediatric physician interests; (6) Treasury officials responsible for the financial accounting and reporting for the VICP trust fund; and (7) the CBO official responsible for budgeting aspects of the trust fund and presentation in the federal budget. We also reviewed relevant legislation, financial reports, budget documents, and reports evaluating various aspects of VICP operation. We obtained and analyzed data from HHS on claims filed under VICP from 1988 to February 1999. In addition, we obtained the Federal Register notices discussing HHS changes to the VICP injury table and reviewed the Institute of Medicine’s analysis of information available to link vaccines to various medical conditions. We conducted our work from January through September 1999 in accordance with generally accepted government auditing standards. Claims Processing To determine how long it took to process claims through VICP, we analyzed HHS’ VICP claims database. This database included data fields on when the claim was filed and a history of processing steps through when the claim was settled. We did not perform a reliability assessment of the data system. The Effect of Table We used HHS’ VICP claims database to identify compensation rates for Changes on Compensation claims that did and did not allege injuries on the vaccine injury table. We Rates identified such claims by comparing injuries on the injury table with those listed in the HHS claims database for each claim. We provided a list of the injuries in the database to HHS officials, and they confirmed those injuries that they would consider as potentially being on or off each of the three injury tables. Because three different injury tables were in effect over the life of the program, we first grouped the claims according to the injury table that was applicable at the time the claims were filed. We then computed the number and proportion of claims in each group that did or Page 26 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix I Scope and Methodology did not allege injuries on the injury table. Compensation rates and associated awards for alleged table and non-table claims were then identified using the data fields for the U.S. Court of Federal Claims’ judgment and award amounts in the HHS database. Budgetary Effect of To determine the budgetary effect of options proposed to reduce the trust Options to Address fund balance, we first obtained financial statements for the VICP trust fund Growing Trust Fund from the Treasury. These financial statements identified the revenue that flowed into the trust fund from vaccine excise taxes and interest accrued Balance on Treasury securities, as well as expenditures that flowed out of the trust fund for claims and associated administrative expenses. We did not audit the trust fund financial statements. Because of the interrelationship between the trust fund and the general fund in the federal budget, we used the trust fund financial information to identify the amounts that flowed directly and indirectly through the Treasury to the general fund as a result of the program. Direct general fund revenue includes 25 percent of all vaccine excise taxes collected by the Treasury. As discussed with Treasury and CBO officials, we backed into the total tax collected by the Treasury by dividing the vaccine excise tax provided to the VICP trust fund by 75 percent. We then subtracted the trust fund share of the tax from the total tax collected to get the amount of tax available to finance general fund programs and activities. Indirect general fund revenue includes amounts derived from Treasury securities issued to the trust fund. The Treasury securities balances were listed on the trust fund financial statements. To demonstrate how proposed legislative changes to reduce the excise tax rate or increase trust fund spending would affect the overall budget, we used a rolling average of trust fund revenue and expenses in 1997 and 1998 (hereafter referred to as 1998). We used a rolling average to minimize timing differences in accounting for revenue and expenses. We assumed that if new legislation had resulted in a match between trust fund revenues and expenditures in 1998, the amount of offset required by the Budget Enforcement Act for 1998 would have been the difference between the total excise tax actually received and expended by the trust fund in that year.24 Our computation reflects the assumption that vaccine manufacturers would not decrease vaccine prices to pass on the tax savings to vaccine purchasers because HHS officials said that they did not 24 This excludes loss of the 25 percent in vaccine excise taxes provided directly to the general fund because budget scoring convention assumes these taxes will be recouped through commensurate increases in income and payroll tax revenue. Page 27 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix I Scope and Methodology reduce prices when VICP took on the burden of liability. However, we also computed the somewhat lesser effect on the general fund if the manufacturer had passed on the savings. The effect is less because CDC information on federal vaccine purchases shows that nearly half of all vaccine purchases are made by the federal government. Therefore, lower vaccine prices to federal agencies purchasing vaccines would offset the decrease in excise tax. We computed the government’s loss as the percentage of excess in the trust fund that was related to state and private vaccine purchases. Page 28 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix II VICP Claims Process Three federal agencies are involved in the VICP claims process: HHS, DOJ, and the U.S. Court of Federal Claims. The process consists of several steps. (See table II.1.) Page 29 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix II VICP Claims Process Table II.1: Claims Process Steps and Time Frames Step Time frame Petition filed An individual or representative claiming injury or death from a — In the case of an injury, the claim must be filed within 36 vaccine files a petition for compensation with the court. months after the first symptoms appeared, and the effects must have continued at least 6 months after vaccination. — In the case of a death, the claim must be filed within 24 months of the death and within 48 months after the onset of the vaccine-related injury causing the death. Physician review A physician at the Division of Vaccine Injury Compensation, HHS, — Court rules require the report to be sent to the court within 90 reviews each petition to determine whether it meets the medical days from the date the claim was filed. This deadline is subject to criteria for compensation. This recommendation is provided to the change depending on a petitioner’s ability to obtain all relevant court through a report filed by DOJ, although it is not binding. medical records and file a complete petition. Special master decision A “special master” of the court is required to make the initial The special master is required to issue a judgment within 240 decision for compensation under the program. A special master is days (exclusive of suspended time) from the date a claim is filed, an attorney appointed by the judges of the court. At hearings before or petitioners are allowed to withdraw their claim from VICP and the special master, HHS is represented by a DOJ attorney and the file a lawsuit against the vaccine manufacturer or vaccine petitioner is represented by a private attorney. administrator in the civil tort system. Acceptance or rejection of special master decision The petitioner and HHS accept or reject the special master’s — Either party has 30 days to file a motion for review by the decision. court. If a motion is filed, an additional 30 days is provided to the other party to respond. — Instead of filing a motion for review, if a petitioner files an election to reject a special master’s judgment within 90 days after entry of judgment, the petitioner may proceed to file a lawsuit in the civil tort system. Court judgment The court issues a judgment on the special master’s decision. — The court is required to enter a judgment within 420 days from the date the claim was filed (exclusive of the time spent on remand to the special master). — Within 60 days, either party may file a petition for review of the judgment with the U.S. Court of Appeals for the Federal Circuit. Final appeal from the Federal Circuit is to the U.S. Supreme Court through a petition seeking a writ of certiorari. Within 90 days of the conclusion of the appeals process, if a petitioner files with the court an election to reject the judgment, the petitioner may proceed to file a lawsuit in the civil tort system. If the petitioner takes no action within 90 days, the judgment is deemed “accepted” by law. Payment of award Petitioners accepting the judgment and awarded compensation are Agency criteria requires HHS to pay petitioners within 60 days paid from the VICP trust fund if the vaccine was administered on or after payment is authorized by the court and DOJ. after October 1, 1988, or from annual appropriations if administered before this date. Page 30 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix II VICP Claims Process Figure II.1: Time Line of VICP Claims Processed in U.S. Court of Federal Claims Without an Appeal Deadline for Deadline Deadline special for Deadline to for HHS to master of U.S. petitioner authorize complete U.S. court to court to accept payment if Petitioner medical reach a finalizes or appeal judgment files claim review decision a judgment b judgment c accepted 0 90 240 270 360 420 Elapsed time (days) a Parties can request suspensions adding up to 180 days to the time before the special master reaches a decision. In addition, for claims related to vaccines administered before Oct. 1, 1988, the special master can suspend proceedings an additional 900 days. b Parties may expedite this step by waiving their right to file a motion for review. If parties file a motion for review of the special master’s decision, the deadline for the court to render judgment is extended by 150 days. c The petitioner may expedite this step by immediately electing judgment. Page 31 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix III Current VICP Injury Table and “Qualifications and Aids to Interpretation” Table III.1: VICP Vaccine Injury Table Vaccine Injury/adverse eventa Time periodb Tetanus-containing Anaphylaxis or anaphylactic shock 4 hours Brachial neuritis 2-28 days Pertussis-containing Anaphylaxis or anaphylactic shock 4 hours Encephalopathy (or encephalitis) 72 hours Measles, mumps, rubella in any combination Anaphylaxis or anaphylactic shock 4 hours Encephalopathy (or encephalitis) 5-15 days Measles-containing Thrombocytopenic purpura 7-30 days Vaccine-strain measles in an immunodeficient recipient 6 months Rubella-containing Chronic arthritis 7-42 days Polio live virus-containing Paralytic polio —In a nonimmunodeficient recipient 30 days —In an immunodeficient recipient 6 months —In a vaccine-associated community case Not applicable Vaccine-strain polio viral infection —In a nonimmunodeficient recipient 30 days —In an immunodeficient recipient 6 months —In a vaccine-associated community case Not applicable Polio inactivated virus-containing Anaphylaxis or anaphylactic shock 4 hours Hepatitis B Anaphylaxis or anaphylactic shock 4 hours Hemophilus influenzae type b (Hib), unconjugated Early-onset Hib disease 7 days Hib, conjugated No condition specified Not applicable Varicella No condition specified Not applicable Rotavirus No condition specified Not applicable New vaccines recommendedc No condition specified Not applicable a Injuries also include any acute complication or sequela (including death) of the listed events (for all but the conjugated Hib, varicella, and new vaccines). b For first symptom, onset, or aggravation of injury after vaccination. c Any new vaccine recommended by CDC for routine administration to children, after publication by the Secretary of HHS of a notice of coverage. Page 32 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix III Current VICP Injury Table and “Qualifications and Aids to Interpretation” Figure III.1: “Qualifications and Aids to Interpretation” Page 33 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix III Current VICP Injury Table and “Qualifications and Aids to Interpretation” Page 34 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix III Current VICP Injury Table and “Qualifications and Aids to Interpretation” Page 35 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix III Current VICP Injury Table and “Qualifications and Aids to Interpretation” Page 36 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix III Current VICP Injury Table and “Qualifications and Aids to Interpretation” Page 37 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix IV Comments From the Department of Health and Human Services Page 38 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix IV Comments From the Department of Health and Human Services Now on p. 2. Page 39 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix IV Comments From the Department of Health and Human Services Now on p. 11. Now on p. 2. Page 40 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix IV Comments From the Department of Health and Human Services Now on p. 15. Page 41 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix IV Comments From the Department of Health and Human Services Now on p. 18. Now on p. 15. Page 42 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix V Comments From the Department of Justice Page 43 GAO/HEHS-00-8 Vaccine Injury Compensation Program Appendix V Comments From the Department of Justice (108396) Page 44 GAO/HEHS-00-8 Vaccine Injury Compensation Program Ordering Information The first copy of each GAO report and testimony is free. Additional copies are $2 each. Orders should be sent to the following address, accompanied by a check or money order made out to the Superintendent of Documents, when necessary. 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Vaccine Injury Compensation: Program Challenged to Settle Claims Quickly and Easily
Published by the Government Accountability Office on 1999-12-22.
Below is a raw (and likely hideous) rendition of the original report. (PDF)