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

GAO United States

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
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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.

Results in Brief Overall, while the program appears to provide an easier process for

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).

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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
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Background All 50 states require that virtually all children be vaccinated against

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

Approach to Injury

Compensation

VICP established a new system for vaccine injury compensation that was

expected to be fair, simple, and easy to administer. Rather than filing a

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

Its Most Important Feature

There are two ways a petitioner can qualify for compensation under VICP.

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
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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

Anaphylaxisg 24 hours

Note: For current vaccine injury table, see app. III.

aInjuries are defined in “Qualifications and Aids to Interpretation,” reprinted in app. III.

bFor first symptom, onset, or aggravation of injury after vaccination.

cAdministered with tetanus and/or pertussis vaccines.

dFor vaccines against pertussis.

eInjury related to oral polio vaccine.

f

Time intervals are for immunocompetent/immunodeficient individuals who receive oral poliovirus.

Contact cases have no limit.

gInjury 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

Has Come From Two

Sources

VICP finances awards and attorney payments differently, depending on

when the vaccine causing the alleged injury was administered. For

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

VICP claims Filing deadline Funding source

Number of

claims filed

as of Feb.

1999

Awards/

attorney

paymentsa as

of Feb. 1999

Vaccines

administered

prior to Oct. 1,

1988

Jan. 31, 1991 Annual

appropriations

4,245 $742,244,679

Vaccines

administered on

or after Oct. 1,

1988

Within 24

months from

date of death or

36 months from

date of injury

Vaccine excise tax 1,110b 250,296,568

aThe maximum award paid was close to $8 million while the median paid was $318,943.

bIncludes five cases where the data field for date of vaccination was blank.

Processing VICP

Claims Takes Longer

Than Expected

Processing VICP claims continues to take longer than expected. When the

Congress established VICP, the expectation was that the court would take 1

year or less10 to judge whether a claim was entitled to compensation and,

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.

10The 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

Between 1 and 2 Years

Between 2 and 5 Years

5 Years or More

Pending Casesa

Closed Cases

14%

39%

10%

18%

19%

Note: Data are for cases filed as of February 1999.

aThe 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

Year Claims filed Claims adjudicated Claims pending

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

aData 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

Judgment Received Within 2 Years

0

10

20

30

40

50

60

70

80

90

100

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

Program Implementation

As figure 2 shows, the percentage of claims processed within 1 or 2 years

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

Claims Processing

HHS, DOJ, and the U.S. Court of Federal Claims have taken some steps to

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.

11Data for 1990 are for claims relating to vaccines administered after Sept. 30, 1988. The 1990 average

for all claims is over 2 years.

12For 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
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Injury Table Changes

May Increase

Difficulty Petitioners

Face in Obtaining

Compensation for

Vaccine-Related

Injuries

Of the 4,817 petitioners receiving judgment under the program as of

February 1999, close to 30 percent received compensation for a family

member’s injury or death. Most compensated claims alleged injuries listed

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

other injuries and vaccines. However, far more claims are associated with

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,

rather than HHS having to prove that the injury was due to factors

unrelated to the vaccine.

Number of Petitioners

Potentially Covered by the

Vaccine Injury Table Has

Decreased

Most of the petitioners who filed claims and received awards under VICP

alleged injuries listed on the program’s vaccine injury table. Petitioners

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

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,

tetanus, and pertussis

83 32 17 15

Vaccines against measles, mumps,

and rubella

53 43 47 25

Vaccines against polio 39 60 61 3

Vaccines against hepatitis B 7 a 93 a

Vaccines against varicella 0 b 100 a

Unspecified/nonqualifying 0 b 100 0

Total 72 35 28 13

aJudgment pending.

bNot 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
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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

Injury Table

Vaccine Injury added Injury removed

Effective Mar. 10, 1995

Vaccines against pertussis Shock-collapse

Vaccines against pertussis

and tetanus

Residual seizure disorder

Vaccines against rubella Chronic arthritis

Effective Mar. 24, 1997

Vaccines against measles,

mumps, and rubella

Residual seizure disorder

Vaccines against measles — Thrombocytopenic

purpura

— Vaccine-strain measles

Vaccines against polioa Vaccine-strain polio

Vaccines against hepatitis B Anaphylaxis

Vaccines against hemophilus

influenzae type b (Hib)

Early-onset Hib

Vaccines against tetanus Brachial neuritis Encephalopathy

aApplies to oral polio vaccine.

13Most 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.

14HHS 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
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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

table

Claims for injuries removed from

injury table

Vaccine Injury

Number

compensated Total awarded

Number

compensated Total awarded

Vaccines against rubella Chronic arthritis 9 $622,101 a a

Vaccines against tetanus Brachial neuritis 0 0 a a

Vaccines against measles Thrombocytopenic

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 a a

Vaccines against hemophilus

influenzae type b (Hib)

Early-onset Hib

0 0 a a

Vaccines against pertussis Shock-collapse a a 61 $27,228,905

Vaccines against measles,

mumps, pertussis, rubella,

and tetanus

Residual seizure

disorder a a 547 452,141,726

Vaccines against tetanus Encephalopathy a a 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

aNot applicable.

15The 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
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Lack of Clear Methodology

for Table Changes Raises

Questions of Consistency

HHS has published its rationale for each revision to the injury table in the

Federal Register but has not published an overall method of applying the

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

16HHS 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.

Trust Fund Income

Exceeds Need for

Claims Payments

The VICP trust fund has grown to $1.3 billion primarily because the income

from vaccine excise taxes is higher than claims payments and because the

government pays interest on the trust fund balance. Program participants

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

to Grow

The VICP trust fund has historically received more in vaccine excise taxes

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.

17The 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.

18As 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

Vaccine Injury

Compensation

Program Trust Fund

$1.2 Billion $.4 Billion

 General Fund

Unused Surplus

$.9 Billion

Special Treasuries

$.9 Billion

Interest Paid on Special

Treasuries

$.4 Billion

Injury Claims and

Administrative Costs

$.3 Billion

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

Concerns About the

Growing Trust Fund

Balance

Vaccine manufacturers, parent groups, and others involved with VICP have

expressed concerns about the large trust fund balance and have proposed

options to address them. These options generally involve cutting the

excise tax supporting the trust fund or spending more of the money

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

Options to Reduce the

Trust Fund Balance

Because excise tax revenue received by the VICP trust fund and not spent

on the program is invested in Treasury securities and these proceeds are

used by the general fund, implementing options to control the growth of

19See 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.

Conclusions While VICP was expected to provide compensation for vaccine-related

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.

20The 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.

21The 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.

22This 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 

Recommendation to

the Secretary of HHS

We recommend that the Secretary of HHS develop and apply a consistent

methodology for evaluating and reporting on the various factors used to

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.

Agency Comments

and Our Evaluation

Both HHS and DOJ provided written comments on our draft report. Their

comments are reprinted as appendix IV and appendix V, respectively. We

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

23Either 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.

HHS also 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 

Scope and

Methodology

26

Appendix II 

VICP Claims Process

29

Appendix III 

Current VICP Injury

Table and

“Qualifications and

Aids to Interpretation”

32

Appendix IV 

Comments From the

Department of Health

and Human Services

38

Appendix V 

Comments From the

Department of Justice

43

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

Calendar Year

9

Table 4: VICP Petitions Claiming Table/Off-Table Injuries 12

Table 5: Injuries Added to and Removed From the VICP Vaccine

Injury Table

13

Table 6: Claims Associated With Injuries Added to and Removed

From the VICP Vaccine Injury Table

14

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

1997 With Judgment Received Within 2 Years

10

Figure 3: Money Flows Attributable to Vaccine Excise Taxes

Collected From Fiscal Year 1989 Through Fiscal Year 1998

17

Figure II.1: Time Line of VICP Claims Processed in U.S. Court of

Federal Claims Without an Appeal

31

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

Changes on Compensation

Rates

We used HHS’ VICP claims database to identify compensation rates for

claims that did and did not allege injuries on the vaccine injury table. We

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

Options to Address

Growing Trust Fund

Balance

To determine the budgetary effect of options proposed to reduce the trust

fund balance, we first obtained financial statements for the VICP trust fund

from the Treasury. These financial statements identified the revenue that

flowed into the trust fund from vaccine excise taxes and interest accrued

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

24This 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

vaccine files a petition for compensation with the court.

— In the case of an injury, the claim must be filed within 36

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,

reviews each petition to determine whether it meets the medical

criteria for compensation. This recommendation is provided to the

court through a report filed by DOJ, although it is not binding.

— Court rules require the report to be sent to the court within 90

days from the date the claim was filed. This deadline is subject to

change depending on a petitioner’s ability to obtain all relevant

medical records and file a complete petition.

Special master decision

A “special master” of the court is required to make the initial

decision for compensation under the program. A special master is

an attorney appointed by the judges of the court. At hearings before

the special master, HHS is represented by a DOJ attorney and the

petitioner is represented by a private attorney.

The special master is required to issue a judgment within 240

days (exclusive of suspended time) from the date a claim is filed,

or petitioners are allowed to withdraw their claim from VICP and

file a lawsuit against the vaccine manufacturer or vaccine

administrator in the civil tort system.

Acceptance or rejection of special master decision

The petitioner and HHS accept or reject the special master’s

decision.

— Either party has 30 days to file a motion for review by the

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

paid from the VICP trust fund if the vaccine was administered on or

after October 1, 1988, or from annual appropriations if administered

before this date.

Agency criteria requires HHS to pay petitioners within 60 days

after payment is authorized by the court and DOJ.

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

0 90 240 270 360

Elapsed time (days)

Deadline

for HHS to

complete

medical

review

Deadline for

special

master of

U.S. court to

reach a

decision

U.S.

court

finalizes

judgment

Deadline

for

petitioner

to accept

or appeal

judgment a b c

Deadline to

authorize

payment if

judgment

accepted

Petitioner

files claim

420

aParties 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.

bParties 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.

cThe 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

Brachial neuritis

4 hours

2-28 days

Pertussis-containing Anaphylaxis or anaphylactic shock

Encephalopathy (or encephalitis)

4 hours

72 hours

Measles, mumps, rubella in any combination Anaphylaxis or anaphylactic shock

Encephalopathy (or encephalitis)

4 hours

5-15 days

Measles-containing Thrombocytopenic purpura

Vaccine-strain measles in an immunodeficient recipient

7-30 days

6 months

Rubella-containing Chronic arthritis 7-42 days

Polio live virus-containing Paralytic polio

—In a nonimmunodeficient recipient

—In an immunodeficient recipient

—In a vaccine-associated community case

Vaccine-strain polio viral infection

—In a nonimmunodeficient recipient

—In an immunodeficient recipient

—In a vaccine-associated community case

30 days

6 months

Not applicable

30 days

6 months

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

aInjuries also include any acute complication or sequela (including death) of the listed events (for

all but the conjugated Hib, varicella, and new vaccines).

bFor first symptom, onset, or aggravation of injury after vaccination.

cAny 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
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