Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

THE NATIONAL VACCINE INJURY 

COMPENSATION PROGRAM: A 

PROGRAM REVIEW 

DECEMBER 1992 
OFFICE OF INSPECTOR GENERAL 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services’ (HHS) 

programs as well as the health and welfare of beneficiaries served by those programs. This 

statutory mission is carried out through a nationwide network of audits, investigations, and 

inspections conducted by three OIG operating components: the Office of Audit Services, the 

Office of Investigations, and the Office of Evaluation and Inspections. The OIG also informs 

the Secretary of HHS of program and management problems and recommends courses to 

correct them. 

OFFICE OF AUDIT SERVICES 

The OIG’S Office of Audit Sefices (OAS) provides all auditing services for HHS, either by 

conducting audits with its own audit resources or by overseeing audit work done by others. 

Audits examine the performance of I-II-Hprograms and/or its grantees and contractors in 

carrying out their respective responsibilities and are intended to provide independent 

assessments of HHS programs and operations in order to reduce waste, abuse, and 

mismanagement and to promote economy and efficiency throughout the Department. 

OFFICE OF INVESTIGATIONS 

The OIG’S Office of Investigations (01) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries and of 

unjust enrichment by providers. The investigative efforts of 01 lead to criminal convictions, 

administrative sanctions, or civil money penalties. The 01 also oversees State Medicaid fraud 

control units which investigate and prosecute fraud and patient abuse in the Medicaid program. 

OFFICE OF EVALUATION AND INSPEC130NS 

The OIGS Office of Evaluation and Inspections (OEI) conducts short-term management and 

program evaluations (called inspections) that focus on issues of concern to the Department, 

the Congress, and the public. The findings and remmmendations contained in these inspection 

reports generate rapid, accurate, and up-todate information on the efficiency, vulnerability, 

and effectiveness of departmental programs. 

This report was prepared in the New York Regional Office under the direction of Regional 

Inspector General Thomas F. Tully and Deputy Regional Inspector General Alan S. Meyer. 

Project staff included: 

New York Headquarters 

Renee C. Dunn (Project Leader) Maruta Zitans 

Nanq T. Harrison (Lead Analyst) W. Mark Krushat 

Demetra Arapakos Brian T. Ritchie 

To obtain a copy of this repo~ call the New York Regional Office at (212)-264-1998. 
Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

THE NATiONAL VACC NE INJURY 

COMPENSATION PROGRAM: A 

PROGRAM REVIEW 

+SERWCJ$ ,+b 6. 

DECEMBER 1992 02-914)1460

EXECUTIVE SUMMARY


PURPOSE 

The purpose of this inspection is to review the structure and operations of the 

National Vaccine Injury Compensation Program (VICP). 

BACKGROUND 

The VICP is a Federal “no-fault” system which was intended to stabilize the vaccine 

manufacturing industxy and to establish a streamlined process to compensate persons 

who have suffered injuries due to certain vaccines. The VICP involves three 

government entities: the Public Health Service (PHS) in the Department of Health 

and Human Semites (HHS), the Department of Justice (DOJ), and the United States 

Court of Claims (Claims Court). After a claim is submitted to the Claims Court, 

physicians at PHS review each case based on the Vaccine Injury Table and send their 

recommendations for or against compensation to the Claims Court, where a hearing 

takes place. With DOJ attorneys representing the government and private attorneys 

representing petitioners, a special master, appointed by the Claims Court, makes a 

final ruling and determines the amount of the award. 

In conducting the inspection, policies, written procedures and operational guidelines 

for the program were reviewed to determine how the program is organized and how it 

attempts to meet its legislative and regulatory goals. F1OWcharts of the processes 

were constructed. Next, from the universe of 2,347 cases in the PHS database a 

statistical analysis was done and 90 cases were selected for review. The team also 

interviewed 23 key government officials and 31 petitioners and their attorneys. 

FINDINGS 

The tiogram k Cwendy Struggling To HandleA Lurgg Unanticipated Influx of 

Retrospective Castts 

At the current production level of approximately 37 cases a month, it will take 

approximately seven years to complete all of the retrospective cases. As of February 

1992, 739 retrospective cases had been completed, leaving 3,356 cases to handle. 

Some government officials feel that the current production rate will increase due to 

changes in legislation, the increased experience of the program staff, and an 

anticipated increase in case dismissals. 

Cases are Delayed Due To a Frons-endBacklogResu.3tingFrom SchedulingCorwrainfs 

and Lack of Resoums 

The large influx of retrospective cases has necessitated that the chief special master 

control intake into the system, resulting in a backlog. No guidelines exist for the 

i 
special master’s scheduling of cas,es. They are not necessarily assigned in order of 

filing. Approximately 2,500 cases have not been scheduled and are backlogged. 

Respondents identify specific resources which they consider insufficient to handle the 

backlog. The chief special master recommends more staff attorneys at the Claims 

Court and the chief medical officer suggests additional reviewers. The PHS staff also 

cite a shortage of both pediatric neurologists and infectious disease specialists willing 

to testi~. 

l%e Case l%ocess is Eflcient Ercept for the Front-End Backlog 

An analysis of the flow of cases in the PHS database shows that once a case is 

assigned, it is handled efficiently. Delays exist only at the front end for retrospective 

cases. The program is meeting deadlines for prospective cases, handling them in a 

timely and efficient manner. 

Our review of program policies and procedures, reinforced by the responses of 

government officials, shows the program to be well-organized. Each step in the 

process is clearly delineated and no unnecessary duplication is apparent, Coordination 

and communication among the Federal agencies is strong. . Their roles and 

responsibilities are clearly defined. Petitioners and their attorneys are generally 

satisfied with their experience in the program. 

A SignificantPortionof PHS MedicalReview RecommendationsNot To Compensateare 

Overturnedby the Special Mzrten 

A review of all completed cases, as of August 1991, reveals that 58 percent of the 

cases that the PHS medical staff recommended not be compensated were 

compensated. Several government officials cite two major factors which account for 

the reversal rate: lack of corroboration of evidence and various interpretations of the 

Vaccine Injury Table. 

The Iksent VaccineInjwy TableDotx Not Rej7ectl%e Lutest ScientificEvidence 

A recent Institute of Medicine (IOM) study found a lack of causal relationship 

between certain vaccines and injuries on the existing Vaccine Injury Table. Some 

government officials estimate that if future cases are decided only on the basis of the 

latest scientific evidence, the compensation rate would be significantly lower. 

Government Oficiak We Inteniewed Support Annuitk and The Use of Brokem 

Most government officials believe annuities are the best way to pay the award and 

brokers are needed to buy the annuities. Annuities assure long-term benefits, avoid 

mismanagement of funds, and are less expensive for the government. 

ii 
RECOMMENDATIONS 

The PHS, DOJ and Claims Court should: 

Inventory the Backlog to Set l+ioritia and Be~er EstimateFutureResourceNeeds 

The Claims Court, in consultation with PHS and DOJ, should evaluate the existing 

workload to determine which cases it should handle first, what mix of resources will be 

needed to handle them, and how best to handle more complicated cases. 

FurtherStreamhkethe Process 

Some suggestions include: assuring more complete filing of petitions, appointing one 

objective expert witness per case, processing damage determinations more quickly, and 

using past damage decisions as a basis for future ones. 

Use Latest Sa”entijic Information 

The HHS should support proposed legislation to revise the Vaccine Injury Table to 

reflect the latest scientific information available, particularly changes recommended by 

the IOM. 

Improve Contact withPetitioned and theuAttorneys 

Emphasize Use of Annuities 

COMMENTS


Comments on the draft report received from PHS, the Assistant Secretary for


Planning and Evaluation and the Assistant Secretary for Management and Budget


generally concur with the recommendations of this report. However, PHS pointed out


that its role in the process is a limited one. We agree. We have directed our


recommendations to the Department of Justice and the Claims Court as well as PHS.


Suggestions for changes in the wording, clarifications of the text and any technical


changes have for the most part been incorporated into the final report. The actual


comments received are in Appendix D.


... 

111

TABLE OF CONTENTS


EXECUTIVE SUMMARY 

INTRODLK130N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . . . . ..1


FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...8


IYogramkSq@ngwithatiqe InjluxofCases . . . . . . . . . . . . . . . . . . . . . . . 8


Backlogkin theFront-endofthe l%x.w.. . . . . . . . . . . . . . . . . . . . . . . . . . ...9


~w&gofAssi.gned Cas~kEfictint . . . . . . . . . . . . . . . . . . . . . . . . . . . ...10


Medical Recommendation,sove~ed bySpecialMasten . . . . . . . . . . . . . . . . . 15


VacczkeTableDoGNotR#ect Lat@Sa”er@c Evi&nce . . . . . . . . . . . . . . . . . 16


Opkions aboutAnnuitiesandBrotim . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...17


RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...18


APPENDICES 

iv 
INTRODUCTION


PURPOSE 

The purpose of this inspection is to review the structure and operations of the 

National Vaccine Injury Compensation Program (VICP). 

BACKGROUND 

Immunkah”onGoak and VaccineInjuries 

State laws generally require that children be immunized against seven infectious


childhood diseases (diphtheria, tetanus, pertussis [whooping cough], measles, mumps,


rubella and polio) before entering day care or SC1-iOOl.If a large enough proportion of


the population is immunized, the disease will not spread significantly and the entire


population will benefit. Thus, it is important that vaccines in this country remain in


adequate supply and be fairly priced.


Since the advent of these vaccines the occurrence of the diseases they prevent has


decreased substantially in the general population. People are often no longer aware


of the dangers of the diseases. Before the vaccines, epidemics of the diseases they


prevent caused widespread death and disability.


Immunization is not entirely without risk, however. While severe adverse reactions


rarely occur, they are a tragedy for the individual children and families who suffer


them. Parents of these injured and deceased children originally sought damages from


vaccine manufacturers through tort litigation. Tort law requires that the plaintiff


prove negligence on the part of the manufacturer or person who administered the


vaccine. This process often took years and consumed inordinate amounts of money.


The rapid growth of lawsuits and the increased manufacturer liability adversely


affected the vaccine supply. Vaccine prices rose and some manufacturers left the


business. By the mid-1980s there was only one manufacturer for polio vaccine, one for


measles, mumps and rubella (MMR) vaccine, and two for diphtheria, tetanus and


pertussis (DTP) vaccine.


LegMtion 

In response to this mounting public health concern, several bills were introduced and 

debated in congressional hearings on the issues of fair compensation and adequate 

vaccine supply. Ultimately, the National Childhood Vaccine Injury Act of 1986 (the 

Act) became law. This legislation attempted to ensure both fairness to injured 

persons and protection for the Federal immunization program. It was designed to 

serve two vital public purposes: (1) to provide prompt and fair compensation to the 

few children who died or were injured as a result of routine immunization; and (2) to 

1 
reduce the adverse impact of the tort system on vaccine supply, cost and innovation. 

To fulfill the part of the Act that deals with fair compensation, the VICP (Subtitle 2 of 

Title XXI of Public Health Service Act) became effective on October 1, 1988. Subtitle 

2 was later amended by the Omnibus Reconciliation Act (OBRA) of 1987, by the 1988 

and 1989 amendments, by the Vaccine and Immunization Amendments of 1990, and 

most recently by the Health Information, Health Promotion, and Vaccine Injury 

Compensation Amendments of 1991, signed into lasv on November 26, 1991. 

Subtitle 1 of Title XXI of the PHS Act also establishes the National Vaccine Program 

(NVP) to achieve prevention of infectious diseases through immunization and 

prevention of adverse reaction to vaccines. The National Vaccine Advisory 

Committee (NVAC) (Section 2105 of the PHS Act) advises and makes 

recommendations to the director of the NVP. 

Another legislated activity, the Advisory Commission on Childhood Vaccines (Section 

2119 of the PHS Act) advises the Secretary on how the VICP is being implemented 

and how it is accomplishing its goals. It has prepared a policy paper which discusses 

options to be considered for the future direction of the program. 

The Assistant Secretary for Health has also established a PHS-wide task force to make 

recommendations on the future direction of the VICP, including proposing legislation 

to deal with the influx of claims, as well as the long-range future of the program. 

Program Description 

The VICP is a Federal “no-fault” system which compensates families whose children 

have had serious adverse reactions to vaccines for the following childhood diseases: 

diphtheria, tetanus, whooping cough, poliomyelitis, measles, mumps and rubella. 

The program, which began to consider petitions as of February 1, 1989, differentiates 

between claims based on immunization prior to the Act’s effective date of October 1, 

1988 (retrospective cases), and those based on immunizations on or after that date 

(prospective cases). A deadline of January 31, 1991 was set for filing claims in 

retrospective cases. 

Retrospective and prospective cases are subject to different rules and remedies as 

described in Table I below. Compensation for retrospective cases comes from an 

annual appropriation of $80 million. Compensation for prospective cases is given to a 

maximum of 150 claimants per year, and is financed through an excise tax on 

childhood vaccines. In both types of cases, awards for death cases are fLxed at 

$250,000 plus attorney fees and costs. 

2

TABLE 1: COMPARISON OF RETROSPE~ AND PROSPECI’IVE CASES


RETROSPECHVE 

DATE OF VACCINE Prior to 10/1/88 

SCHEDULING Non-sequentially 

DEADLINE FOR 32 months 

DECISION ON CASE 

# OF CLAIMS FILED BY 2/18/92 4,095 

# OF	 DECISIONS BY 2/18/92 

COMPENSATED 

NOT COMPENSATED 

DISMISSED 

AWARDS BY 2/18/92 

FUNDING SOURCE 

ALLOWED 

1NJUR% 

DEATH 

ATI’ORNEY’S FEES & COSTS 

BASIS OF AWARDS 

789 

303 (38.4%)* 

90 (11.4%)” 

396 (50.2%)” 

$192 million 

Annual 

Congressional 

appropriation of 

$80,000,000 

AWARD AMOUNTS: 

Unlimited 

$250,000phJS 

attorney fees & costs 

$30,000*** 

Estimated future 

unreimbursable 

rehabilitative and 

related medical 

expenses; actual and 

future loss of 

earnings; attorney’s 

fees & costs. 

PROSPECHVE 

On or after 10/1/S8 

Sequentially 

14 months 

220 

50 

21 (40%)”” 

7 (14%)*” 

22 (4470)’” 

$10.5 million 

Vaccine Injury 

Compensation Trust 

Funded by vaccine 

excise tax 

Unlimited 

Up to $250,000 after 

pain and suffering + 

attorney fees & costs 

Unlimited 

Actual past and 

estimated future 

unreimbursable 

rehabilitative and 

related medical 

expenses; actual and 

future loss of 

earnings; actual and 

projected pain and 

suffering; attorney’s 

fees & costs. 

iJfarr@rit.3ma -4 nnrnnla*,a A .-+. -.. --,.4...- ,.. .-.. 1 *LQ~llL=~G U1 UU1ll~lb LGU 1 GLI U3~GULlVG ~cl>C3. 

** Percentage of completed prospective cases. 

*** This amount also includes petitioner’s actual and projected pain and suffering 

and loss of earnings. 

3

The VICP consists of three government entities: the Public Health Service (PHS) in 

the Department of Health and Human Setices (HHS), the Department of Justice 

(DOJ), and the United States Court of Claims (Claims Court) which work together to 

process the cases. 

Families of injured or deceased children submit petitions for compensation to the 

Claims Court which sends a copy to the PHS. The petitioner must prove program 

entitlement as well as losses and expenses. After a petition is filed, the chief special 

master in the Claims Court assigns the case to a special master and puts it on the 

schedule of upcoming cases. 

The PHS medical experts, in the Division of Vaccine Injury Compensation (DVIC), 

evaluate the case and offer an opinion as to whether or not the petitioner is eligible. 

The PHS Office of General Counsel (OGC) reviews this opinion and forwards it to 

DOJ. Within 90 days of the original filing, DOJ writes a report incorporating the PHS 

medical evaluation with a legal response; extensions may, however, be requested and 

due to the backlog of retrospective cases almost always occur for these. Attorneys 

from the DOJ and petitioner attorneys then argue the case before a special master in 

a formal hearing. Prior to the hearing, a great deal of factual and expert preparation 

is undertaken by the DOJ attorneys and petitioner’s attorneys in order to present the 

case. 

Both the PHS medical experts and the special masters are required by statute to use 

the Vaccine Injury Table when deciding whether an injury is compensable. This table 

outlines the injuries compensable under the program and the time-frames in which 

they must have occurred. This table is intended to avoid controversy over which 

disabilities are potentially caused by vaccines. It is accompanied by “Qualifications and 

Aids to Interpretation” to allow for easier interpretation. 

The final decision on a case is made by a special master of the Claims Court. This 

decision will become a final judgement if no motion for review is filed within 30 days 

or if the Claims Court affirms the decision of the special master. A case may be 

compensated or not compensated or it may be dismissed. When a case is dismissed it 

is no longer under consideration for a potential award. Their judgement is final, 

unless either the claimant or HHS requests a review by a Claims Court judge. Further 

review is available in the United States Court of Appeals. 

The Act gives special masters a great deal of leeway as decision-makers. They are not 

bound by common law or statutory rules of evidence, but are guided by them. They 

can tailor each hearing to the individual circumstances as they choose, but are 

constrained by the principle that their decisions may be reversed. 

Once a decision is made to compensate, the award amount is negotiated. A life-care 

planner assesses the present and future needs of the disabled pe~son and their costs, 

and recommends an award amount. The special master determines the actual 

amount. The entire process for retrospective cases, from time of initial petition to 

4 
final decision, originally was to occur in 14-months, was increased to 20-months in 

1990 and, since the 1991 amendments to 32 months. The entire process for 

prospective cases must occur in 14 months. 

It should be noted that compensation for retrospective cases begins at date of 

judgement and the petitioner is not paid for any expenses incurred before then. 

However, compensation for prospective cases is for past and estimated future 

expenses. 

Amendments to the Act signed November 1991, delete a provision which terminates 

the entire program if funding is insufficient. These amendments also change the due 

date for an evaluation report on the program to January 1, 1993; extend the 

adjudication time for retrospective cases an additional 12 months for a total of 32 

months; allow for compensation to be paid in one installment instead of four; and 

give the petitioner the option to stay in the program if the deadline is not met. Before 

the latter change, the Claims Court lost jurisdiction over the case and the petitioner 

could then seek recourse only in the tort system. 

The January 31, 1991 deadline for filing retrospective cases resulted in more than 

3,500 cases being filed in the five preceding months. AS of February 1992, 4,095 pre1988 and 220 post-1988 petitions were filed. Of these, 739 retrospective cases have 

been adjudicated: 281 in favor of the petitioner, 84 against and 374 dismissed. 

Individual awards total $192 million. Of the 220 prospective cases filed, 50 have been 

adjudicated: 21 in favor of the petitioner, 7 against, and 22 dismissed. Individual 

awards total $10.5 million, well within the amount in the trust fund. 

Repom 

A Boston University recently completed a report for the Administrative Conference of 

the United States, which summarized the first year of the VICP program and included 

recommendations for its improvement. Also, the Committee on Governmental 

Processes of the Administrative Conference as a result of the Boston University study 

has made a series of recommendations for improvements in the VICP. Some call for 

more effective dissemination of information, simplification of the eligibility process, 

new guidelines for determining award amounts, and extensions in time frames for 

completing cases. 

In 1991, the Assistant Secretary for Planning and Evaluation (ASPE) contracted with 

an actuarial firm to generate estimates on the costs of retrospective awards, The 

estimates reflect different assumptions with respect to the number of cases 

compensated, but uniform assumptions on award amounts by claim type and vaccine 

category. The estimates range from a high of $2.6 billion to a low of $1.6 billion. 

The Secretary, as mandated by law, requested the Institute of Medicine (IOM) to 

form a committee to conduct a review to determine whether pertussis and rubella 

vaccines cause adverse effects and what those effects are. Its report, completed in 

5

August 1991, found a lack of causal relationship between these vaccines and certain


injuries on the vaccine table.


Finally, the Office of Inspector General (C)IG) Office of Audit Semites (OAS)


conducted two related studies. The first looked at the timeliness of attorney fee


payments in the VICP. It found the average time for PHS to process attorney


payments was 22.6 days. The second reviewed an alleged conflict-of-interest involving


the above mentioned IOM committee. The OAS jnitially verified the conflict-of-


interest of two committee members. One person resigned. After further review in the


second case, it was determined that no con-flict actual~ existed, although there was an


appearance of possible conflict-of-interest.


Concerns about several program operation issues which have direct impact on the


program’s cost, prompted ASPE to request the OIG to review the program’s


operations. Additionally, OGC requested the OIG to examine PHS’S use of brokers.


METHODOLOGY


We reviewed policies, written procedures and operational guidelines for the program


to determine how the program is organized and how it attempts to meet its legislative


and regulatory goals. A flow chart was constructed to show the agency roles and


processes involved in handling cases. Another flow chart was created to show the


process of damage deterrnination.


The universe of 2,347 cases in PHS’S database as of August 1991 (1,800 petitions filed


had not yet been entered into the database) was stratified by whether the case was


open or closed. A random sample of 4S cases was then selected from each strata.


The inspection team reviewed these 90 case files to: veri~ data contained in the PHS’S


database; get a clearer understanding of how the VICP process works, including the


operational process used for decision-making in each case; and identify specific


attorneys and petitioners to be interviewed during the study. The 90 cases are


described in greater detail in Appendix B.


A survival analysis of all 2,347 cases included in PHS’S database through August 1991


was done to evaluate timeliness of decisions and trends in awards. See Appendi.. C.


With respect to this analysis, it should be kept in mind that this data set did not


include all the cases received by PHS. Eighteen hundred cases filed had not yet been


entered into the computer. Therefore, the results of this analysis should be


interpreted with caution. Once a complete data set is developed, the relationships


noted here may change appreciably.


The team interviewed 23 key government officials or those acting on behalf of the


government from HHS, DOJ, the Claims Court, and the National Vaccine Adviso~


commission. They include five administrators, four physicians, five agency attorneys,


two special masters, three other government officials, two brokers and two life-care


6

planners. They were asked their tiewsof andtheir e~erience with the program and


their recommendations for its improvement.


Additionally, the team interviewed by telephone 31 non-government individuals.


These included 17 petitioners’ attorneys, 12 parents (6 of whom represented


themselves, known as pro se) selected from the closed cases reviewed, a medical


expert, and a parents; advocate. They were asked their views of the program and


their recommendations for its improvement. Althdugh an effort was made to


interview all 33 attorneys and their clients identified from the closed cases, 16


attorneys could not be reached or did not want to be interviewed. Also, many


attorneys did not agree to having their clients interviewed for a variety of reasons. For


example, some attorneys had lost contact with their clients, some clients spoke no


English, and some clients did not want to speak with us. Many attorneys said their


clients would become unnecessarily distraught if they had to discuss the painful subject


of their disabled children.


7

FINDINGS


THE PROGRAM IS CURRENTLY STRUGGLING TO HANDLE A LARGE, 

UNANTICIPATED INFLUX OF RETROSPECTIVE CASES 

At the cument productionikvelit willtakeapproximatelysevenyearnto completeall of the . retrospeca”vecases. 

The program is currently struggling to deal with a large, unanticipated influx of 

retrospective cases. An analysis of PHS’S FY 1991 and 1992 program output status 

reports shows that the VICP adjudicates an average of 37 retrospective cases a month. 

This includes compensated, not compensated and dismissed cases. As of February 

1992, 739 retrospective cases had been completed, leaving an additional 3,356 cases to 

handle. If the number of cases completed monthly does not change, it will take 

approximately seven years to complete all the retrospective cases. 

However, some government officials feel that the production rate will increase due to 

changes in legislation, the increased experience of the program staff, and an 

anticipated increase in dismissals. The chief special master believes the production 

rate has already increased since he has accelerated the assignment of cases. More 

experience will be needed to ascertain the effects. However, if this increase continues, 

the time needed to complete the retrospective cases would be substantially reduced. 

Allhoughthe statutorydeadlinewar extendedfor an additional12 months, theprogram 

willonly be able to completeone-thirdof the retrospectivecasesby the new deadline. 

Because the greatest number of retrospective cases were filed in September 1990, we 

used June 1993, 32 months, later as the deadline for completion of all these cases. 

With an average adjudication rate of 37 cases a month, 1,368 retrospective cases of 

the total 4,095 filed will be adjudicated by the deadline, leaving 2,727 cases to be 

completed. Were the deadline to be extended another twelve months, an additional 

444 cases would be completed within the deadline. 

If program output were to double, half the retrospective cases would still not be 

completed by the deadline; if it were to triple, 35 percent would not be completed. 

Actually, completing 95 percent of the retrospective cases by the statutory deadline 

would require a five-fold increase in the production rate. 

These projections are approximations based simply on experience. Completed cases 

have been scheduled and adjudicated in a variety of ways which may not necessarily be 

typical of future case development. 

Although most government respondents feel positive about having time requirements 

for handling cases, almost one-half consider these requirements unrealistic in light of 

the large number of pending cases. 

8 
Almost one-half (45 percent) of government officials could not even give an estimate 

of how long it will take to complete the cases. Those who answered offered estimates 

ranging from two to five years. 

The delays are of concern to petitioners and their attorneys because of the lack of 

retrospective payment. 

Ilhetime requiredtoprocess the remainingcases will&pend inpart on the case mix 

The results of the survival analysis indicate that, for the cases found on the PI-IS data 

set as of August 26, 1991, the median time to completion of a case is approximately 15 

months, well within the statutory time frames. Further, the results indicate that some 

aspects of the cases, including whether the patient died, the type of vaccine involved. 

when the case was filed, and whether the case was handled pro se or not, significantly 

affect the length of time it takes to handle a case. 

It should be kept in mind that this data set did not include all of the cases filed. A 

number of cases had yet to be entered into the computer. It is possible that the 

addition of these cases may increase the median time to completion if it were found 

that cases were entered into the data set in a differential manner. This may indeed be 

the case given the large influx of cases that occurred during September 1990. 

CASES ARE DELAYED DUE TO A FRONT-END BACKLOG RESULTING 

FROM SCHEDULING CONSTRAINTS AND LACK OF RESOURCES 

me large i.nj?ux of 3,500 retrospectivecaseshus rwcdated that the chi~ specialmaster 

controlintakeinto the system 

This large influx of cases, filed in or around September 1990 and January 1991, has 

compelled the chief special master to decide the order in which they are handled. No 

guidelines exist for this ordering and cases are not necessarily assigned in order of 

filing. The chief special master must consider available resources throughout the 

program when scheduling cases. 

h order to handle the large number of cases, the chief special master has: held 

several informal meetings with representatives from DOJ and PHS and petitioner’s 

counsel to develop a schedule; grouped cases according to type of vaccine; grouped 

cases geographically so that attorneys with many cases can have them heard at the 

same time in the same place; and dismissed many cases for lack of information. 

The approximately 2,500 cases which have not been scheduled make up the front-end 

backlog. In March 1992, the chief special master estimated that the Claims Court had 

begun assigning 40 to 60 cases a month and dismissing an additional 40 a month after 

preliminary review of the petitions. As this preliminary review is a new development 

in the process, its effect is not yet reflected in any available data. 

9

It is not yet clear what will happen if this front-end bottleneck is opened. We can 

anticipate the system would get backed up in other places, but cannot predict exactly 

where or how much. 

Specijic resoumes considered insu.cient to handk the backlog are staff attorneys, 

pediizm”ciarq pediatrii neurologk, and rnfectzks direase specidk 

According to the chief special master, more staff attorneys at the Claims Court would 

be a key addition. Staff attorneys conduct prelimina~ reviews of cases to determine 

whether or not they meet statutory requirements and to ensure that complete case 

files are forwarded to the chief special master. This facilitates scheduling and leads to 

appropriate dismissal of cases at an early stage. 

According to the PHS chief medical officer, the medical review staff of six 

pediatricians reviews approximately 60 cases a month, an average of two days per case 

per doctor. The time needed for this initial review, further review required after 

additional information is submitted, discussions with DOJ, and for other activities 

leaves no buffer in the system. Additional reviewers would be necessary if the case 

load increases. Difficulty recruiting competent pediatricians has currently left three 

positions vacant. The PHS staff attribute these vacancies to the unwillingness of many 

physicians to do such worlq because it removes them from patient care and requires 

them to make review decisions in a controversial area. 

The PHS staff cite a shortage of both pediatric neurologists and infectious disease 

specialists willing to testi~. The PHS staff also believe the small number of available 

expert witnesses is and will continue to be a limiting factor. Recently, five cases were 

dismissed in one month because the petitioners could not find experts to testi~ in 

support of their cases. Some petitioners also mention difficulty in finding attorneys 

willing to represent them. 

THE CASE PROCESS IS EFFICIENT EXCEPT FOR THE FRONT-END 

BACKLOG 

Once a case is assI”gni@it k handkd @kiently. 

An analysis of the flow of cases in the PHS database as of August 1991, from the date 

the claim was filed to the date of judgement, shows that delays exist with retrospective 

cases only at the front-end of the process. Once filed, entered into the PHS database 

and scheduled for review, the median time for both retrospective and prospective 

cases to reach a special master decision is 15 months. However, our analysis indicates 

that most of the processing time appears to be absorbed in the early stages, from the 

time a case is fded to the PHS OGC report date. This analysis is explained further in 

appendix C. 

This 15-month completion period is well ahead of the current 32-month statutory 

deadline for retrospective cases. Of the 594 retrospective cases adjudicated by August 

10

1991, fifty-four percent were completed tithin 10months; 91 percent within 15 

months; and 96 percent within 20 months. 

The program is meeting deadlines for prospective cases and handling them in a timely 

and efficient manner. Of the 126 prospective cases filed before August 1991, none 

have missed the 14-month statutory requirement. 

While agreeing that cases are handled in a timely manner, government officials, 

petitioners and their attorneys mention factors which delay a case once it is in the 

system. Most frequently mentioned is the long time it takes for a case to be assigned 

and to get into the system, because of the large influx of retrospective cases. 

Government officials often cite incomplete records submitted with the initial petitions 

as a cause of delay. Petitioners and their attorneys agree that delays in getting 

evidence and medical records occasionally slow the process. Ninety percent of 

petitioners and attorneys say they were required to submit additional material or 

evidence after the case was filed. Sixty-tSVOpercent of petitioners and attorneys report 

that getting medical records was the most common problem they encountered in 

preparing their petition. 

The review of 90 cases shows that additional information, mostly medical records, was 

requested in fifty-six percent of the closed cases. 

A PHS official reports cases are sometimes stalled at the point where damages are 

determined. Another government official reflects the views of many when he says, 

“once entitlement is determined, damage determination should not go through this 

lengthy process. Too much time is taken here.” 

l%e program appeam to be generally weI.1-organkedwith good procedures. 

Our review of program policies and procedures shows the program structure to be 

well-organized, with each step in the process clearly delineated. This is demonstrated 

in flow chart I. 

Three-quarters of government officials and half the petitioners and their attorneys 

consider the program to be well-organized with a sound and logical structure. 

Government officials most frequently mention that the program has developed 

effective procedures and guidelines, that roles have evolved more clearly over time, 

and that staff have gained more experience. Petitioners’ attorneys note that the 

program is less costly and faster than State and Federal courts; some also feel that it 

has improved over time with better procedures. Thirty-five percent of petitioners and 

their attorneys say that the program is not well-organized, most frequently mentioning 

that the Claims Court is overrun. 

Almost three-quarters (74 percent) of government officials feel the program is 

operating efficiently. They most frequently cite the program’s effective processes. 

11 
Some also mention that under the circumstances, with limited staff and a large 

caseload, the system is working as well as it can. 

Half the petitioners and their attorneys agree the program is operating efficiently. 

Several say that it works better than the Federal and State court systems; others 

remark that, in their experience, the process has been relatively smooth. Those who 

do not think the program is operating efficiently (32 percent) voice concerns about its 

lack of consistency, timeliness and overly bureaucratic process. The remaining 

respondents did not render an opinion. 

No unnecessaq duplication of ej$oti exists. 

A review of program policies and procedures reveals very little duplication of effort.


It is, however, required at certain points in the process. For example, PHS, DOJ, and


the Claims Court each review a case. This is necessary since each party must come to


an independent conclusion in order to negotiate and resolve the case.


Most government officials who believe duplication of effort exists agree it is necessary


to fairly adjudicate a case. Some government officials, however, identi~ areas where


duplication of effort is perhaps not necessary, such as double data entry and the flow


of papenvork between the PHS and DOJ.


Roks and responsibilti are clearly defined 

Flow chart I shows that the functions and responsibilities of each government entity 

are, for the most part, clearly outlined. 

All government officials, except the special masters, feel their office role is clearly 

defined. Most say the Act is vex-yspecific and that clear written procedures are 

available. 

The special masters interviewed do not feel their office role is clearly defined. One 

asks, “Should [1] be inquisitor or traditional judge?” Special masters can question 

witnesses, call their own expert and generally be more involved throughout the whole 

process than a judge usually is. 

All government officials, including the special masters, think that their individual roles 

in the program are clearly defined. All feel they have clear job descriptions and 

performance plans and know what is expected of them. Although the special masters 

say the role of their office may not be well-defined, they believe their personal 

responsibilities in the program have evolved more clearly because of their increased 

case experience. 

12

.

FLOW CHART I 

claimto court 

\ 

.. . . . . .. .


: DWC Recaves Clatm ~ I Oauns CcW Fdes Cam I 

DAY 1
 . . . . . . . . . . . . . . .. . . . . . . . ..
 ~ 

Staff attorney 

rewews case 

gves to chef S&l 

m 

. X 

DOJ assqw Chef SM assgns case 

case to an to SM gives 

attorney + Sch&d-dO to DVC. C@J< 

. . . . . . . . . . . . . . . . . . . . . 

‘~ ;ee$e:~ : 

nfcrnatlon .. . . . . . . . . . . . . . . . . . . . .. 

. . . . . . . . . . . . . . . . . .. . . 

DVIC physlaan ~ 

cticts Wial :< review of case . . . . . . . . . . . . . . . . . . . . .. 

[
 . .
 . .


.- M~e -..


DAY 30.; ::~: :; -.,.% 

.. case ..’ 

7 .’ 

.“, ” ,, 

No ,’ 

*“IS’... ,. DVIC ,, 

m 

DOJ files 

motion to 

dismiss \ 

/ 

\ 

‘.......... . . ...”.... 

l== B 

drsmtssed ‘~ I D&l drafts and files D


rescordent’s rewt W fwk!s status E


with Caut ccmfefeme
 : 

y-. ‘iatlsfa W/info’ .5 

4 received ,‘ 

‘? ,. 

,. 

. . . . . . . . .Y. . . . . . . . . . . . ., 

: DVIC physaan j 

: conducts complete : 

~review. fmms oprnon ; . . . . . . . . . . . . . . . . . . . .. 1

,i 

.,, 

.“DVIC’. 

,‘recorrmemis. , ~e~ 

.’jo compensate, 4 

-. 7.’ ., 

.........

‘(’W.............. 

Case sent to c +.:+L%$:” 

outsde expert : 

. . . . . . . . . . . . . . . . . . . . . . 

~ ‘;:’ 

.. . . . . . . . . . . . . . . . ...\ 

13GCrevtews nwdcal: 

sends to CCJ 

.. . . . . . . . . . . . . . . . . . . . .. 

DAY 90 @El 

SM 

deadesto Yes 

Ccmpae r

Dam* are 

determmed 

No 

I Q--

v 

13 

DAY 270 &’

.. .. . . . 

........; DVIC (PHS and OGC) 

c1 DOJ 

~	 CIAIMS COURT 

(SM = SPECIAL MASTER) 

* Letters A - F above are explained 

in Appendix A 
FLOW CHART II 

DAMAGE DETERMINATION 

In injury case, 

petiticmr ~esents 

Ilfe-care plan of the 

treatment, care and 

costs of injwed 

party’s Ilfetime 

/ 

Spec!ai Mastef 00J, with cjovernmen 

sets award, life-care pkmner and 

as determmed by broker, evaluates 

statute, at $250,00C and responds to plan 

Spec!al Master Po!ds 

NO evident[ary hearing 

with petitioner’s 

and goverrrnent’s 

life-care planner 

Special Master ‘ 

conslcWs ev!dence 

~esented and 

makes dec tslon on i 

award amount I 

Coordination and cornrnunicah”onamongthe Federalagerm”e$k strong. 

Flow chart I demonstrates clear-cut avenues for coordination. For example, should a


PHS doctor require additional records to complete the medical review, the request will


be made to the petitioner through DOJ to help assure compliance.


Almost three-quarters (74 percent) of government officials rate communication among


all parties as good (22 percent) or excellent (52 percent). The PHS staff feel


particularly positive about communication within their own division. Many


government officials say that, while there is room for improvement, they respect each


other’s efforts and work at keeping communication open. One states, “there are real


attempts by the heads of different parts to keep communication open.” Several


consider the new total quality management (TQM) group, which includes members


from PHS, DOJ, and OGC, an excellent mechanism for communication and


cooperation.


14

Status conferences between the special master and both sides involved in the case also 

facilitate open communication. Once a case is assigned, these conferences are held to 

speed up and simplify the decision-making process. The special master conducts these 

informal conferences with the petitioners’ attorneys, possibly the petitioners, and the 

DOJ attorneys, either by teIephone or in person, to focus issues and to give each party 

the opportunity to address the other’s position. 

A majority of government officials rate coordination between government agencies 

good or excellent. They know where responsibilities lie and who to call on specific 

issues. 

Petitkmm and theirattorneysaregenerallysa&@d withtheirexperienceh theprogram. 

The experience of petitioners and attorneys has been positive. Seventy-six percent say 

that government officials have been generally helpful. They mention that the 

representatives were cooperative, readily available and promoted a good working 

relationship. A majority (79 percent) also say they were kept informed about their 

case while it was being decided. On the other hand, some petitioners and their 

attorneys report that before a case is assigned to a DOJ attorney, they are unable to 

find out its status. They would like a contact person for that purpose. Other 

petitioners believe that the program should be better publicized. 

A SIGNIFICANT PORTION OF PHS MEDICAL REVIEW


RECOMMENDATIONS NOT TO COMPENSATFj ARE OVERTURNE D BY THE


SPECIAL MASTERS


A review of all completed cases as of August 1991 reveals that 58 percent of cases 

that the PHS medical staff recommended not be compensated were compensated. 

During the seven-month period from June 1989 to January 1990 (when DOJ was not 

representing the government), eighty percent of the medical rew-ew recommendations 

not to compensate were compensated. In contrast, when DOJ has argued the case, 52 

percent of recommendations not to compensate have been compensated. 

One special master believes the reversal rate is currently lower than 52 percent. He 

feels that, with experience, the special masters have become more comfortable in their 

role and in making decisions, leading to fewer compensated cases. Additionally, he 

believes that cases which had more substantive evidence submitted with the original 

petition were put into the system first, and were more likely to have been 

compensated. 

Several government officials cite two major factors which account for the reversal rate: 

lack of corroborating evidence and differing interpretations of the Vaccine Injury 

Table. Disputes occur over what constitutes appropriate evidence. Additionally, the 

character of expert witnesses and the potential conflict between testimony and records 

or legal evidence also lead to disagreement. A related reason is the interpretation of 

the Vaccine Injury Table. Although the Aids to Interpretation assist with the 

15

interpretation of the table, there is still room for differences of opinion. Therefore, 

each special master may interpret the table differently. The DOJ and HHS both 

support stronger corroboration of evidence requirements. 

Of those who have an opinion, government officials are almost evenly divided about 

whether they believe cases have generally been decided appropriately. Many 

government officials who feel cases have been decided appropriately mention that, 

with DOJ’S involvement, decisions are more balanced and fairer. Some also believe 

that decisions have been appropriate within the framework of the present Vaccine 

Injury Table and the evidence presented. 

Most government officials who feel cases have not generally been decided 

appropriately do not believe all compensated decisions have been scientifically based. 

Many also think that too much emphasis has been given to petitioners’ testimony, as 

opposed to medical records. One government respondent notes that PHS medical 

decisions and special master decisions are based on two different sets of factors: the 

former relies primarily on medical records, while the latter additionally considers 

testimony and affidavits. 

Of those petitioners and their attorneys with an opinion, a majority (78 percent) feel 

that, based on their own experience, cases have generally been decided appropriately. 

More than half feel satisfied with the final decision in their own case. However, none 

of the petitioners who represented themselves (pro se) are satisfied: all of their cases 

have been dismissed for lack of evidence. 

Only a small percentage of cases are appealed which could be interpreted to mean 

petitioners and their attorneys are generally satisfied with their case outcomes. TO 

appeal a case after the special master decision, either party files a motion for review 

with the Claims Court judge. A of November 1991, 86 motions for review were filed, 

60 by the petitioner and the remaining 26 by DOJ. After the judge’s decision either 

party has 60 days to file a further appeal to the United States Court of Appeals for 

the Federal Circuit. Since the program’s inception, very few cases have actually gone 

to the next appeal step. Currently, there are approximately five DOJ appeals and 15 

petitioner appeals at this level. 

THE PRESENT VACCINE INJURY TABLE DOES NOT REFLECT THE 

IATEST SCIENTIFI C EVIDENCE 

A recent Ihstie of Medicine(IOiU)studyfound a hck of causalrehtionrhipbetween 

certainvaccinesand injurikson the erirtingVaccineInjmy Table. 

The IOM committee sponsored a public meeting to solicit medical and scientific data 

and comments on the nature, frequency, and circumstances of adverse events following 

pertussis and rubella vaccines. It then reviewed existing research about 17 adverse 

events for pertussis vaccine and three adverse events for rubella vaccine. The 

16

committee organized its conclusions into five categories reflecting the causal 

relationships between the vaccines and the adverse events. 

Based on the study findings the HHS and the Advisory Commission have made 

recommendations for changes. The primary changes would remove seizure disorder 

and shock-collapse from the presumption of causation for pertussis vaccines. On the 

other hand, chronic arthritis would be added for rubella vaccine, but only on a 

showing of vaccine involvement. Some government officials estimate that if future 

cases are decided only on the basis of the latest scientific evidence, the compensation 

rate would be significantly lower. 

GOVERNMENT OFFICIALS WE INTERVIEWED SUPPORT ~ m 

THE USE OF BROKERS 

Of those government officials offering opinions, almost all believe that annuities are 

the best way to pay the award. Eighty-three percent say annuities alone are best; the 

remaining 17 percent think that the award should be paid in a combination of lump 

sum and annuity. According to those who favor annuities, annuities assure long-term 

benefits for the child, avoid mismanagement of funds, are less expensive for the 

government because the insurance company assumes some of the risk, and give the 

petitioner tax benefits. 

Although all government officials agree certified brokers are necessary to buy the 

annuities, some express concerns that their costs are too high. Many mention that 

brokers perform a necessary function by shopping for the best deal, actually servicing 

the annuity during the course of the petitioner’s life, and providing support to DOJ 

during damage determinations. 

The brokers have recently demonstrated their value. Originally, the program had to 

pay compensation in death and injury cases in four equal installments. This restriction 

limited the number of insurance companies willing to sell annuities to PHS. Those 

companies charged higher than normal rates because they were not getting the full 

cost of the annuity up front. The November 1991 Amendments to the Act, which 

allow for compensation to be paid in one installment instead of four, have made it 

possible for the brokers to renegotiate several annuities. Brokers were able to arrange 

for the program to make the remaining payments on several annuities and to 

renegotiate many annuity proposals. In total, the PHS has reportedly saved $7.7 

million through these actions. The brokers’ fees had already been paid by the 

insurance companies, so PHS did not incur any additional costs to achieve the savings. 

If annuities are to be the preferred payment approach, brokers are essential since 

insurance companies only deal with credentialed individuals. 

17

APPENDIX A


FLOW CHART NOTES 

17ME FRAMES 

Generally, prospective and retrospective cases should be resolved in 420 days (14 

months): 240 days from filing date to the special master’s decision plus the maximum 

allowable suspension time of 180 days. However, the special master can suspend 

proceedings in any case several times and at various stages in the process. Also, due 

to the unexpected influx of retrospective cases, the retrospective cases have been given 

the 420 days plus additional extensions of 18 months, for a total of 32 months from 

filing date to the special master decision. Since the suspension times may differ from 

case to case, the time frames incorporated into this flow chart do not include any 

suspensions. 

A: SUBMI17YNG C-S AND “FRONT-LOADING” 

The VICP was designed to get all the case information at the time of filing (called 

“front loading” the information) so all the issues and evidence are presented at the 

start. The petitioner’s initial claim (the petition) must be complete in that it clearly 

outlines the petitioner’s full case. This petition must include all medical and 

potentially relevant records and affidavits. A complete petition is essential: it reduces 

delays that occur when additional information has to be requested; permits a detailed 

evaluation of the case by the respondent (DOJ) and the special master; and is 

necessary for the timely adjudication of the case. 

B: DISMISSALS 

The special master may dismiss a case at any time during the process. Dismissal can 

occur if the petitioner received an award in the tort system, if no evidence was offered 

for a doctor to form an opinion, or if the Claims Court does not have jurisdiction over 

the case. 

c: OUXSLDE EXPERT 

Whenever the PI-IS staff physician decides a case is not compensable, it is sent to an


outside medical expert who is not on the PHS staff. The expert may request


additional information, especially medical tests, just as the staff physician does in order


to form an opinion on the case. This opinion becomes the official PHS decision,


referred to as the “internal report.”


1


———— 
D: RESPONDENT’S REPORT 

Prepared by DOJ attorneys, this document seines as PHS’S answer to the petition. It 

incorporates the medical arguments made by the PHS physician or outside expert on 

whether or not PHS considers a case compensable and any relevant legal issues. 

E: STATUS CONFERENCE 

After reviewing the petition and respondent’s report, the special master conducts an 

informal, “of-the-record,” Rule 5 conference either by telephone or in person. The 

purpose of the conference is to speed and simplify the decision-making process. 

During the conference each party is given the opportunity to address the other’s 

position. The special master offers his or her tentative view as to the merits of the 

case. Also, the petitioner, respondent, and special master establish which issues 

remain to be addressed. These conferences occasionally lead to settlement. 

The special master often holds additional status conferences, usually by telephone, to 

expedite the processing of the case. Either party may request such a conference at 

any time. At these conferences, the parties may either suggest ways to process the 

case more efficiently, or make the special master aware of new case developments. 

F: SPECL4L MASTER ORDERS CLERK TO ENTER JUDGEMENT 

Within 240 days of the claim’s filing date, the special master must issue a final decision 

determining whether or not an award of compensation shall be made and, if so, its 

amount. If neither party files a motion for review within 30 days of the special 

master’s decision, the clerk enters judgement by day 270. Compensation, in awarded 

retrospective cases, is paid from this date of judgement. 

NOTE: 

In all cases the processes and time frames presented both in the flow chart and in the 

flow chart notes are those set forth in regulations and procedures; they may be 

different due to requested extensions or other unknown factors. 

A -2

APPENDIX B


DESCRIPTION OF 90 CASES IN THE CASE FILE REVIEW 

number Percent 

Case Status: 

Closed (case went through hearing) 25 28T0 

Dismissed early in process (no hearing) 

Open, awaiting PHS review 

Open, in or past PHS review 

20 

28 

17 

22% 

31% 

1970 

Other Charactefitics: (not mutually exclusive) 

Pro se 18 20% 

Outside expert used 

DPT 

15 

66 

1770 

7370 

Injun”ex(not mutual~ exclusive) 

Seizure disorder 53 5970 

Encephalopathy 39 4370 

Mental retardation/developmental delay 16 18% 

Death 14 1670 

Hypotonic/hyporesponsive collapse 11 1270 

Anaphylactic shock 3 3% 

Other 25 28% 

Date Vaccine Admimktered: (closest appmxiinahon to akte of hjv) 

1972 and before 

1973 to 1982 

1983 to present 

Special Master Deciiiox 

Compensate


Not Compensate


Dismiss


Other


Information Not Available


Not Applicable (case still open)


32 35.570 

32 35.5% 

26 29V0 

18 2070 

8 9% 

~o ‘2~70 

1 1% 

2 2% 

41 46??0 

B-1

APPENDIX C


DESCRIPTION OF THE ANALYSIS OF THE PHS DATABASE 

To supplement the field work for this inspection, coded data were obtained that 

described a portion of the claims filed with the U.S. Public Health Service (PHS) 

Vaccine Injury Compensation Program (VICP). This data was analyzed to describe 

the program and delineate the effects on completion times of different characteristics 

ascribed to each case. This Appendix describes the results of that analysis. 

Description of Data Set 

We received from the PHS a copy of their automated data that was current to August 

26, 1991. A total of 2,478 cases were represented by the data in the file. 

This analysis is structured on the presumed flow of cases filed with the VICP. 

Although up to 13 milestone dates are possible on the files provided, we have 

concerned ourselves with only four of these dates. These four dates include the date 

the claim was filed (Date Claim Filed), the later of the date of the internal report or 

the OGC (Office of General Counsel) report date (Intex-nal/OGC Report Date), the 

DOJ (Department of Justice) report date (DOJ Report Date), and the Special Master 

(SM) report date (Special Master Report Date). This last date also seined to define 

when a case was closed. We then defined internals, measured in months, between 

each of these dates. These intervals are shown in the schematic drawing presented in 

Figure A. Cases were dropped that did not adhere to this sequence or were missing 

other important data. Of the original 2,478 cases, 60 were dropped because either 

the patients birth date was missing or the birth date followed a case’s filing date. A 

further 71 cases were dropped because other dates in their file were out of sequence. 

Thus a total of 131 cases, 5.3 percent, were dropped due to bad dates. Except for 

unknown values in the individual variables that may lead to dropping a case from a 

specific analysis, the resulting 2,347 cases were included in the analysis presented here. 

This analysis will show median times, in months, for each of the intervals illustrated in 

the figure. The most important is the internal Iabelled FS, the time from filing the 

claim until the Special Master report date. The analysis will concentrate on this 

interval. Results for the intexvals labelled FD, the time from filing until the DOJ 

report date, and FIO, the time from filing until the internal or PHS report date, IOD. 

the time form internal or OGC report date until DOJ report date, DS, the time from 

DOJ report date until SM report date and 10S, the time from internal or PHS report 

data until SM report date, will be presented briefly in Table III. 

c-1 
Figure 1 

Schematic Definition of Time Intervals 

r


Date Claim FIO internal/OGC 

\ 

Filed Report Date 

I 00 

DOJ Report 

~f) I 0s 

Date \ 

FS 

Ds 

T 

Special Master 

.1 

Report Date 

I 

For this analysis, one other variable, besides theintemals, was constructed to encode 

information ~ot originally available on the file provided byPHS. During the period 

June 1, 1989 to December 31, 1989 the Department of Justice withdrew from the 

process. An indicator variable was created for cases completed during this period, 

whether they were dismissed, compensated or not compensated. Sixty-one completed 

cases fell into this group. 

Eleven other indicator variables were created for this analysis, generally for use in the 

models applied to the data. These were constructed from data available in the files 

supplied by PHS. These additional variables define the type of vaccine given, the 

dates of filing for the cases, whether the patient died and whether the case was filed 

pro se or not. 

For the cases represented in this data set, four outcomes can be defined as of Aug. 26, 

1991. At this point in time the cases were either; (1) still open; (2) dismissed; (3) 

closed and compensated; or (4) closed and not compensated. Cases were designated 

as still open if no SM report date was recorded on the file. The other categories were 

determined by the coding found in the SM recommendation variable. Table I presents 

the status of the cases used in this analysis by these four categories. For the analysis 

presented here, ~o classes of completed cases were defined. One class included all 

completed cases, compensated, not compensated and dismissed. A second class 

c-2 
excluded the dismissed cases. This applied mostly to the analysis involving linear 

models, to be discussed below. 

SM Recommendation


Not Completed


Compensated


Not Compensated


Dismissed


Total


Methods 

Table I 

N % of Tot. 

1728 73.6 

246 10.5 

94 4.0 

279 11.9 

2347 100.0 

The main thrust of this analysis was to describe the time its takes to complete a case. 

We also wanted to know what factors associated with these cases might account for 

changes or differences in these completion times. To do this, methods associated with 

the analysis of sum-ival times were employed. Ordinarily, these methods are concerned 

with the time elapsed to the failure of a study element from some selected starting 

time. For this analysis, we defined a failure as the closing of a case. Thus, the 

survival time is the interval from when the case is first filed until one of our endpoints 

is reached. For the most part, this will be the special master report date. 

To determine median times to completion, we obtained Kaplan-Meier (KM) 

estimates. This analysis provides estimates of the time it takes for 50 percent of the 

cases to reach the end of the defined time interval using censored data. Censored 

data occurs because, as of Aug. 26, 1991,cases were still open and at varying points in 

the process. We do not know when these cases will close. This approach is necessary 

because any estimate that relies solely on completed cases will give biased estimates. 

The results are expressed as the median time to completion, in months, for all cases. 

The KM estimates were obtained using PROC LIFETEST from the SAS statistics 

package for personal computers. 

To test the effects of concomitant variables on the time it takes to complete a case, 

Cox regression techniques for life table data are used 3. These techniques take the 

form of what is known as proportional hazards (PH) regression models. Using the 

interval from when the claim was filed until the Special Master report date (The 

interval labeled FS in Figure A.) as an example, once a claim is filed, it is at “risk” of 

being settled (receiving a SM recommendation) at any time following the filing date. 

This risk of settlement can be a function of certain characteristics of the cases in the 

data set. For example, are pro se cases settled sooner or later than non pro se cases’? 

c-3 
Is there a similar difference for cases where the patient died? And how does the 

interaction of these two variables (pro se and death of the patient) effect the time to 

settlement? The PH regression model allows USto put all of these variables into a 

single equation and attempt to determine the independent affect of each of these 

characteristics. For each of the characteristics, we will be estimating the relative 

increase in risk of settlement for those with the characteristic as opposed to those 

without the characteristic. If the value of the relative risk is greater than one, then the 

presence of the variable increases the hazard rate; that is, decreases the length of time 

to complete a case. If the value is less than one, then the variable is likeIy to decrease 

the hazard rate, or increase the length of time to complete a case. 

The SAS statistical program PROC PHREG for the personal computer was used to fit 

these models4. With this proportional hazards model, the exponential of the 

coefficients gives the relative risk described above. The model also assumes that the 

risk is constant over the follow up period. To test for the significance of each variable 

(and the ensuing relative risk), Wald chi-square statistics with the appropriate 

degrees of freedom are calculated. Given p values of less than 0.05 would indicate that 

the relative risk is significantly different from 1.0. 

Results 

The results presented in Table II indicate that 50 percent of the cases are completed 

within 15 months of the filing date. This is true whether or not dismissed cases are 

included. The data also indicate that most of this time appears to be absorbed in the 

early stages of the process, from the time the case is filed until the Internal or PHS 

report date. 

OveraIl, the characteristics of the cases analyzed here do not seem to change the totaI 

time it takes to complete a case except in two areas. Table IV provides the KM 

estimates of the median time to completion for each of the characteristics separately, 

using the interval from the date filed to the SM report date. Where no data is 

indicated in the table, less than SOpercent of the cases were completed as of Aug. 26, 

1991. The first horn this generalization involves the pro se cases. When the dismissed 

cases are included, half the cases handled pro se are completed within 13 months. 

When the dismissed cases are excluded, this median time to completion increases to 

18 months. These results would indicate that the pro se cases are handled differently. 

It is possl%le that they are dismissed sooner and when not dismissed, take longer to 

complete. 

The second area of difference stems from the type of vaccine used. Those cases 

involving the intravenous polio vaccine (IPV) vaccine look to take longer to complete. 

The median time to completion is 20 months, with or without the dismissed cases. 

Looking at Figure B, approximately 80 percent of the dismissed cases close within 10 

months. This compares to about 39 percent of the closed cases. Ninety-nine percent 

of the open cases are younger than 21 months. This data would indicate that for the 

c-4 
cases found in the data set, the vast majority are being handled within the statutory


limits of 32 months.


The results of the proportional hazards regression analysis (Table IV.) show that cases


filed before 7/90 (variable B790) are more likely to be completed earlier


(approximately 5 times more likely) than cases filed during the third quarter of 1990


(the referent category.) Conversely, cases involving the WV vaccine are less likely to


be settled earlier that cases involving the DTP vaccine (approximately a quarter as


likely.) Both of these variables are statistically significant.


Including dismissed cases, all of the variables indicating when the case was filed are


significantly related to the time it take to close a case. This is also true for type of


vaccine (IVP compared to DPT) and pro se status. These results are essentially


consistent with the univanate results presented in Table 111. However, the


multivariate model indicates that death is significantly related to the time to close a


case. When the dismissed cases are excluded, death remains significant. When


dismissed cases are excluded, only cases filed before July, 1990 take significantly


shorter lengths of time to complete. Those cases associated with the IVP vaccine take


significantly longer. The effect of pro se cases also becomes non-significant. Again an


indication that pro se cases are probably more likely to be dismissed.


c-5 
Table II 

Median Time Between Internals 

To Date 

From Date Internal OGC 

Report 

DOJ 

Report 

Special Master 

Report 

Date Filed I 12 13 15 

Internal OGC Report 3 11 

no data 

DOJ Report 

(Dismissed cases included.) 

To Date 

Internal OGC DOJ Special Master 

From Date Report Report Report 

Date Filed 13 13 15 

Internal OGC Report 3 11 

no data 

DOJ Report 

(Dismissed cases excluded.) 

C-6

Table III 

Median Number of Months to Completion 

All Cases 

Period Filed 

Before 7/90 

7/90-9/90 

10/90-12/90 

1991 

Date Vaccine Administered 

Prior to 10/88 

After 10/88 

Patient Died 

Yes 

No 

Case is pro se 

Yes 

No 

Vaccination Type 

DPT 

IPV 

Measles 

Other, Unkn. 

Dismissed Cases


Included Excluded


15 15


13 13


no data no data


no data no data


no data no data


15 15


14 14


14 14


15 1.5


13 18


15 15


14 15


20 20


16 16


37 no data


C-7

....................................................

Figure A 

Distribution of Cases by Status 

AS of Aug. 26, 1991 

Interval : Fi I ing Date to SM Report Date 

1,0, 

I 

o.


c .......... .......... ............. ...... .. ............................. 00

.—


$ 

L 

0 :::;:\\....................................................."""""..".'"""."""""" 

:0 

.
 k \!::t ...."""""".""".".""."""""".."".. 

0 , l_..................................... ......+.....EW.Y””’””””1 

Categories Of Time Since Filing in Months 

off ,c.a d Eva lmt 10. ana InsoMx low. � Q,. ~ closed ~ D,sm, s’=ed 

OIG FeO 21, 1992 

C-8

---

Table IV


Proportional Hazards Regression


Date Filed to Special Master Report Date


Dismissed Cases Included


Variable 

Prospective Case 

Case Filed before 7/90


Case Filed 4th Qrt.,FY1990


Case Filed During FY1991


Patient Died


IPV Vaccine Given


MMP Vaccine Given


Other Vaccine Given


PRO SE Case


Claim Filed after 1/31/91


95% conf. int. 

Relative P 

Risk Lower Upper Value 

1.10 0.60 1.99 0.641 

5.17 4.03 6.62 <0.001 

4.79 3.70 6.~o <0.001 

14.40 6.79 30.53 <0.001 

1.31 1.06 1.63 0.013 

0.25 0.17 0.35 <0.001 

0.76 0.58 0.99 0.045 

0.98 0.59 1.64 0.949 

3.05 2.44 3.81 <0.001 

0.13 0.02 1.05 0.055 

Variable 

Prospective Case 

Case Filed before 7/90 

Dismissed Cases Excluded 

95% conf. int. 

Relative P 

Risk Lower Upper Value 

1.55 1.04 2.33 0.031 

Case Filed 4th Qrt.,FY1990 

Case Filed During FY1991 

Patient Died 

PV Vaccine Given 

MMP Vaccine Given 

Other Vaccine Given 

PRO SE Case 

Claim Filed after 1/31/91 

5.26 4.02 6.87 <0.001 

1.26 0.80 1.98 0.319 

2.45 0.57 10.47 0 77s 

1.43 1.13 1.81 0.003 

0.47 0.?9 0.75 0.002 

0.75 0.52 1.0s o.l~j 

1.47 0.46 4.71 0.514 

1.47 0.95 2.2s 0.0s4 

0.89 0.08 9.93 (39’24 

c-9 
---

~teratureCited 

1.� Kaplan, E.L. and Meier, P. 1958. Nonparametric Journal Of 

estimation from incomplete observations. 

the American Statistical Assoclatlon. 53:457-481. 

2. SAS Institute Inc. 1988. SAS Technical RePoti:

6.03. 

P-179Cary , Release Additional SAS/STAT Procedures,. 

NC. 

D.R. 1972. Regression models and life tables (with

3. cox, 

discussion)�. Journal of the Roval Statistical 

Societv B. 34:187-220. 

4. SAS Institute Inc. 1991. SAS Technical Report P-217, Version 6-

SAS/STAT Software: The P~EG Procedure, 

cary, NC1980. ~ 5.	 Kalbfleisch, J.D. and P;entice, R.L. 

Statistical Analvsls of Failure Time Data, New York, 

John Wiley & Sons, Inc. . 

... .
 C-lo -..


.-

APPENDIX D 

COMMENTS TO THE D- REPORT 

D-1 
-----

--

----

F~crr Assistant Secrets.~ for Health 

Office of Inspector Sub]ec: General (OIG) Draft Report +.Review’”“The Naticnal 

Vaccine Inju~ Compensation Program: 

TO Acting Inspector General, OS 

on the subject

Attached are the Public Health Senice comments 

OIG repOrl. we agree that the changes r~co=ended in t~:s. 

report would improve the management and ~nczeaseOur� the comments efz~c~encY

of the Vaccine Inju~ry Compensation Progr-. 

describe the ac=ions unde=~ay or planned to address these

of technical ccmments

changes . “In addition, we offer a series 

for your consideration. 

/? 

Attachment 

l;:. :1 .-. 

. . . . -----”: .- ‘-. s-.. -. . . . . . 
PUBLIC HEALTH SERVZCE (p~s ) COMMENTS ON THE OFFICE OF INSPECTOR 

GE3JEWUJ (OIGI DRAFT REPORT “THE NATIONW VACCINE INXJRY 

COMPENSATION PROG-V: A REVIEW,” OEI-02-91-01460 

OIG Recommendation:


The PHS, Department of Justice, and Claims Court should:


o� inventory the backlog (of petitions for compensation? 

submitted to the U.S. Court of Claims) to set priorities 

and better estimate future resource needs, 

0 further streamline the process, 

0 use latest scientific evidence, 

0	 improve contacts with petitioners and their attorneYs/ 

and 

0 emphasize use of amuities. 

PHS Comments 

While this recommendation is not directed specifically to PfiS, we 

nevertheless concur that the recommended changes would improve 

the management and increase the efficiency of the Vaccine Injury 

Compensation Program (VICP). The PHS components involved in the 

VICP will continue to work with the Department of Justice and the 

Claims Court to resolve the retrospective cases as quickly as the 

availability of resources will petit andt concurren~~Yt aPP~Y 

improved skills and techniques to xnaintaining the efficient 

processing of prospective cases. 

The program has been working with a PHS Task Force on the VICP to 

change the Vaccine Injury Table and the Qualifications and Aids 

to Inte.rpretation to reflect current science. The Task Force 

finalized its recommendations for changes to the Table and Mds 

after intensive review by several scientific and policy groups” 

The Office of Management and Budget recently approved these 

proposed revisions both as part of a Notice of Proposed 

Rulemaking and a legislative package. 

We agree with the objective of the recommendation to improve 

contact with petitioners and their attorneys. However, PHS is 

limited by its role in the process. The Claims Court has the 

sole authority to assign cases for adjudication. As such, they 

should provide information to petitioners and their attorneys on 

the status of unassigned cases. PHS’ Division of Vaccine Injury 

Compensation (DVIC) regularly receives calls from cla~~ts or 

their attorneys on active cases and responds = info=at~on 

allows . 
2


The DVIC has been workinq with the Advisory Committee on 

Childhood Vaccines’ (XCV) newly formed Subcommittee on Process. 

This Subcommittee is responsible for seeking, receiving, and 

analyzing systematic feedback from interested parents’ groups, 

petitioners’ attorneys, and others on impl~entation of the VICE’. 

The ACCV has also offered petitioners and their attorneys the 

opportunity to communicate concerns and suggestions for improving . the process. 

In addition to our comments on the recommendation, we suggest 

that two subjects be clarified in the final report. First, on 

pages 10 and C-4, the report indicates that the Iongest period of 

time for processing cases is the time from the date a claim is 

filed to the date of the Office of the General Caunsel/PHS 

report. This incorrectly suggests that PHS is delaying the 

processing of claims. It would be more appropriate to track from 

the time the clati is filed to the date the Special Master 

assigns the case and schedules the respondent report date. OIG 

may not be able to determine this inte~al since this information 

is not in the program’s database. Therefore, we suggest that the 

report simply indicate that the program does not begin to process 

cases until they axe scheduled by the Court, and that is the 

reason for the delay, 

. 

The second clarification recommended would be to delete the 

sentence on page 19 regarding the need to better publicize the 

HHS Hotline telephone number. A lawsuit was filed, and 

subsequently withdrawn, charging that there was insufficient 

publicity for this special number. Even though this suit was 

withdrawn, the program has recently distributed a new poster 

along with a set of questions and answers regarding the progr-. 

These materials, which were developed to further inform vaccine 

administrators throughout the country about programmatic issues, 

include the 800-Hotline number. 

Technical Comments 

Paae 2, first DaZaa~aDh, fi~st sentence. The words “Section 

2110” should be replaced with “Subtitle 2 of Title XXI.* 

Paqe 2, first ~araqraph, second sentence. The following changes 

should be made: 

o ‘Section 2110” should be replace by “Subtitle 2,” 

Q	 the phxase “by the 1988 and 1989 amendments,- should be 

inserted after “1987,” and 
and ‘“ 

o	 the words ‘Health Inf~rmation, Health PxcmotLon~ 

shculd be insezzed before “Vaccine Inju.~ Compensation 

Amen&ents of 1951.” 

The phzase ‘(in

Paae 2, second paraffranh , first sentence. 

should be inse.+-ed after 

Subtitle 1 of Title XXI of the PHS Act)”

“Act. “ . 

The phrase “(Section

Paae 2t second n.araaraDhl second sentence.

after “(NVAC).” 

2105 of the PHS Act)” should be inserted


Paae 2, second paraaraDh, last sentence. This sentence should be


deleted from the final report. 

Paae 2r third ~aracraDh, first sentence. The plxcase.“(Section “ 

2119 of the PHS Act)’” should be inse~ed after “Vacc~nes. 

Paae 3, Table I. Cells in the table should be revised as 

follows: 

“ cells 

the o� for both the “retrospective” and “prospect~ve. words “of rehab~litative,

under ‘basis of awards,” 

and related” .should be insetied between “medical 

expense6~ “ 

“basis of awards” should be 

o� the “prospective” cell under 

revised by adding “up to $250,000” after “pain and 

suffering, “ and 

the word “and loss of earnings” should be added at the 

o 

end of footnote ‘***.Ic 

Paqe 5, second Daracranh, first sentence. The word “enti=e””

,* ...Pxogr=m if funding is

should be inserted before the phrase 

insufficient. “ 

The end of this 

Paae 5r seccnd naraaranh, last sentence. “..and the petitioner “ sentence should be rewritten as follows: 

could then seek recourse only in the tort system. 

Paae 5, third Daxaaxaoh last sentence. A comma should be 

inserted after the word “millicn.” 

The beginning cf this 

Paae 5f fcuz=~ Darac=a?ht f~~s= ‘entencelA ~cs=an university fellows: 

senter.ce should be revxsed as 

professor recentlY completed. ...” 

first sentence. 

Paqe 9, second naracranh from bottom of paae, 

should be inserted after The words “and petitioner’s counsel­

“from DOJ and PHS.” 
4 

8econd sentence. 

Paae 10, second Daraaranh from bottom of Daae, “Once scheduled 

This sentence should be rewritten as follows: 

for review, the medim tine for both retrospective and Is 

prospective cases to reach a special master decision is 

months. “ 

Paue 10, second ~araaraph from bottom of paae, third sentence. 

The words “date the case is scheduled by..the M Court” should be

inserted in place of “PHS OGC report date. 

Paae 14, last paraqrauh, last sentence. Insert “PHS” in p~aCe of 

“VICP.” 

Paae 15, second paraaraph , last sentence. The sentence begimin~ 

“Representatives from HHS, DOJ and the Clads Cou~. ..” should be 

deleted since this is an inaccurate stat-ent. 

Paae 17, first Dazaarauh, first sentence. The wurds “the PHS 

Task Force has” should be replaced with “KHS and the Adv~sorY 

Commission have.” . 

Paffe 17, first paraaranh , second sentence. The word 

I’should be 

“encephalopathy” and the comma after “seizure disorder 

deleted. . 

Paae 17, last naraaranh. In the three places it is shown, “VICF” 

should be replaced with “PHS.” 

Paae C-1, third ~araaranh, second sentence. In the two places it 

is shown, “OGC”” should be replaced with “PHS.” 

Paqe C-4, third paraarauh , last sentence. “OGC “ should be 

replaced with “PHS.” 
--

TO: 

FROM : 

SUBJECT: 

Thank you 

report on 

A Program 

(PHS) have 

Compensation 

operation. 

Br’Yan B. Mitchell


Prhcipal Depury Inspectcr G-er~~


Assistant Secretar” 

for Planning and Evaluation 

OIG Draft Repcrr: l~TheNational Vaccine Injury 

Compensation Program: A Pragram Review,to 0E1-~2-~i01460 COMMEiW3 

for submitting far my review and comment the draft 

‘sThe National Vaccine Injur’~ Compensation Prcgr=n: 

Review.” As you know, we and &he Public Health Se.rvic= 

been ver~ interested in examining the Vaccine Inlur~ 

Program (VICP) and looking for improvements in i~= 

Your report was informative on t!!ese issues and will 

help as we proceed to propose changes. We suggest that upon 

completion of this report that it be made available to t-he 

Advisory Commission on Childhood Vaccines as its charge is to 

advise Secretary Sullivan on issues facing the VIcP. 

We do, howev=r, have a technical comment. On page 16, tYAe 

sentence discussing the Depar”~ent or Justice (DOJ) proposal ta 

provide for s~-onger corroboration of evidence should be 

mcdified ta ~C~S and DO~- suPPort st=cnger corroboration of 

evidence requirements.” 

If You have any questions, please call Elise Smith on 690-6870. 

Martin H. Gerry 

cc:� Michael Mangano :G ---.-

91UG —--- / IXG-AS —_ 

OIG-EX ~ 

DIWI 

A.IGMP ‘~ 

OGC~IG / 

1::: -.. ““ ,j	 .-.. 

... ,-. 
--

o� Bath page i of t!!e Executive suama-~ and pa~e 9 of Me 

report cantain a secticn headed by ‘Cases are delayed due 

a fxcnt-e.nd backlog resuiting fscn sc5.edulir.cccns--=+nts 

ar.cl lac!.c of resou~ces.ft The primary cause c; t!!e &~~lcq
 the laqe Uiianticipated influx cf cases filed azaund tie


stati~tory deadline. While


rescurces did not rnacc~. well ad.mittedlv, adzi.nistzati-;e
 with khls in~lu:c, these =Sy~~=S Fe= S2 tier= r.ct the prinar-y iss”de. 

acldlt~cnal resc~~ces c~ t-his ~~.e were availz=le ~renar.di:all 

cases had keen processed immediatel’~, the


t!!i.s level of claims is nei~her authcri=ed r~sccsces to pa.;
 lx law K2cr ­

aFprc~riated. This t!!en, is the t--~e liaiti~.c sten. . 

v se? 

h 

:G-AE 

“G.= 

GaI 

G~ 

C/’IG 

: SEC 

— .-— 

—-


=


——
 .,. , ,_

J?ecmmer.datiens�

o� Disc”sssion akcut reascns why SFecial Masters overtxrn ‘~!e 

recommendations of t!!egovernments medical and legal SC2S: 

c=uld be st~er.@aened. In cnly cne inssance is an incerziex 

with a Special Master cited. To u~derstand as clearl-y as 

Fcssible why decisi.cns are overturned, CIG shccld intsr-~iew 

all Scecial Masters and attempt to quanti.2;/t!!e reascrAs ZGZ 

disagreement. Understanding the reascns why gavernnenc 

ex~erz sta?f is successful in cnly fif~y Fercent cf Lie 

cases may sugqest additional refcms. 

Cn Fage 18, scme of the recarmendaticns a~~ear to be 

resolving ncn-e:<istenc prablens or seen inccm~atible Win-: 

each ct!!er. Fcr exazple, recac.aendaticns� include acticn Es 

stxeaaline Lie pracess. The “m:-q idea is t= first st=ez?all..-..

assu=e more cc=plete filing of Lhe Fetiticns at t!!e fycnt 

end in order to avoid t!!e backlcq. Hcwever, Qhe cnly 

backlcg which has been er~erienced in &he prz~san is fcr the 

pre -198a Clakls, not fcr the pest-1~~~ clai=s. All F=e-19as 

Claizs have al:ead;~ keen filed and it is e.~ected that cc 

add i=icnal pre-198a clai~s will Ee accepted. Ancther 

streamlining reca~endaticn is ta “use past c?anacjes 

decisions as a basis for fut~re cries.” This appears ta be 

incc=patible wit!! the reco~endaticn to “use latest 

scientific information” ta c!etemine c==pensation. The OIG 

reFcr= recc=~ends re*/isicns to t!!e vaccine inj~-y table as 

0 
-. 

. . 
RECOMMENDATIONS


The PHS, DOJ and Claims Court should: 

Inventov the Backkhg.to Set Priorities and Better IMikate Future Rerource Neeak

The Claims Court, in consultation with PHS and DOJ, should evaluate the existing


workload to determine which cases it should handle first, what mix of resources will be


needed to handle them, and how best to handle more complicated cases. In


particular, Claims Court staff attorneys could be added to identify priority cases and


those likely to be dismissed. A medical review contract may be an option if more


medical review expertise is required.


Our analysis of case characteristics and handling times (See Appendix C) indicates


that some aspect of cases, such as whether the patient died, the type of vaccine used,


when the case was filed, and whether itwas handled pro se, affect the length of time


to process the case. Perhaps these and other factors can be used to schedule the


cases more efficiently or to help determine the expertise required.


Further Streamline the I+mx..w

To help make the process more expeditious and non-adversarial, the agencies should 

review the following ideas: 

* Assure more complete filing of petitions, particularly medical evidence 

by giving more guidance to petitioners and their attorneys. * Due to the scarcity of expert witnesses, have one objective expert 

witness per case appointed by the special master, as opposed to one for 

the petitioner and one for the government. * Use past damages decisions as a basis for future ones. 

* Process damages determinations more quickly. 

Use Latixt Scientific Information

The Department of Health and Human Sewices should support its Task Force’s 

proposed legislation to revise the Vaccine Injury Table to reflect the latest scientific 

information available, such as the IOM study. The Aids to Interpretation should 

include sufficient detail so the table can be interpreted more consistently. 

Improve Contact with Petitimem and their Attorneys

The program should designate a contact person in the Claims Court to respond to the 

questions and concerns of petitioners and their attorneys, especially those questions 

about cases not yet assigned. 

18


—. 
Emphasize Use of Annuities

The special mastersshouldcontinue usingannuities astheprimarysettlement
 option


ininjury
cases.


COMMENTS


Comments on the draft report received from PHS; the Assistant Secretaxy for Policy 

and Evaluation and the Assistant Secretary for Management and Budget (ASMB) 

generally concur with the recommendations of this report. However, PHS pointed out 

that its role in the process is a limited one. We agree. We have directed our 

recommendations to the DOJ and the Claims Court as well as PHS. Suggestions for 

changes in the wording, clarifications of the text and any technical changes have for 

the most part been incorporated into the final report. The actual comments received 

are in Appendix D. 

The PHS stated that the report incorrectly suggests that PHS is delaying the 

processing of claims because we did not track the date the claim is filed to the date 

the special master assigns and schedules the case. We are aware that delays were 

experienced from the time of the case filing to scheduling. However, those dates are 

not included in the program’s database. We thus were unable to include it in our 

analysis. 

Lastly, ASMB stated that the true limiting step of the program is that the resources to 

pay the level of claims submitted are neither authorized by law nor appropriated. We 

understand their point. We nevertheless believe that a more effective process can 

shed light on the extent of the problem and the true extent of the resources needed. 

In response to ASMB’S recommendation to develop a methodology to compensate 

parties in an equitable manner, we note that this was not within the scope of the 

inspection. The ASMB also observed that since all retrospective cases have been filed 

at this time, the recommendation to assure more complete filing of petitions at the 

front end, and to give more guidance to petitioners and their attorneys is not 

necessary. However, many retrospective cases require additional information after the 

initial filing. To clarify matters we have eliminated the phrase “at the front end” from 

the recommendation. 

19