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 OIGS 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 OIGS 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 
+
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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.3tinFgrom 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  masters  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 MedicalReviewRecommendationsNot 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 Setl+ioritia andBe~erEstimateFutureResourceNeeds 
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 Saentijic 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@Saer@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 
ImmunkahonGoak 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-iOOlI.f 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  Acts 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  PROSPECIIVE  CASES

RETROSPECHVE  PROSPECHVE 
DATE  OF  VACCINE  Prior  to  10/1/88  On  or after  10/1/S8 
SCHEDULING  Non-sequentially  Sequentially 
DEADLINE  FOR  32 months  14 months 
DECISION  ON  CASE 
#  OF  CLAIMS  FILED  BY 2/18/92  4,095  220 
#  OF	 DECISIONS  BY 2/18/92  789  50 
COMPENSATED  303 (38.4%)*  21 (40%) 
NOT  COMPENSATED  90 (11.4%)  7 (14%)* 
DISMISSED  396 (50.2%)  22 (4470) 
AWARDS  BY  2/18/92  $192 million  $10.5 million 
Annual  Vaccine  Injury 
FUNDING  SOURCE  Congressional  Compensation  Trust 
appropriation  of  Funded  by vaccine 
$80,000,000  excise  tax 
ALLOWED  AWARD  AMOUNTS: 
1NJUR%  Unlimited  Unlimited 
DEATH  $250,000phJS  Up  to $250,000  after 
attorney  fees  & costs  pain  and  suffering  + 
attorney  fees  & costs 
ATIORNEYS  FEES  & COSTS  $30,000***  Unlimited 
Estimated  future  Actual  past  and 
unreimbursable  estimated  future 
BASIS  OF  AWARDS  rehabilitative  and  unreimbursable 
related  medical  rehabilitative  and 
expenses;  actual  and  related  medical 
future  loss of  expenses;  actual  and 
earnings;  attorneys  future  loss of 
fees  & costs.  earnings;  actual  and 
projected  pain  and 
suffering;  attorneys 
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  petitioners  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  petitioners  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 pre-
1988 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

programs  cost,  prompted  ASPE  to request  the  OIG  to review  the  programs

operations.  Additionally,  OGC  requested  the  OIG  to examine  PHSS 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 PHSS 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  PHSS

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 PHSS 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 willtakeapproximatelsyevenyearnto completeallof the 
.
retrospecavceases. 
The  program  is currently  struggling  to deal  with a large,  unanticipated  influx of 
retrospective  cases.  An  analysis  of PHSS 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. 
Allhoughthestatutorydeadlinewarextendedfor anadditional12 months,theprogram 
willonlybe ableto completeone-thirdof theretrospectivecasesby thenewdeadline. 
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 requiredtoprocesstheremainingcaseswill&pend inparton thecasemix 
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 retrospectivecaseshusrwcdated  thatthechi~ specialmaster 
controlintakeintothesystem 
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  petitioners 
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, 
pediizmciarq 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 assIgni@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  programs  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 
\ 
.........

:.  ..D.W..C. . R..e.c.a.ve.s. ..C.l.a.tm.. ...~
  I  Oauns  CcW  Fdes Cam  I  DAY1

~ 
Staff  attorney 
rewews  case 
gves  to chef  S&l 
m 
.  X 
..................... 
DVIC physlaan  ~  DOJ assqw  Chef  SM assgns  case 
cticts  Wial  :<  case  to an  to SM gives 
review  of case  .  attorney  +  Sch&d-dO to DVC. C@J< 
. ......  .............. 
[

. .

. .

.- M~e  -..
 ..................... 
DAY  30.; ::~:  :;  -.,.%  ~  ;ee$e:~  : 
..  case  ..  .. . . . . .n .f c. r.n .a .t l.o n.  . .. .. . ... 
7  .  m 
.,    , 
,, 
No  *SI... 
,. DVIC  ,,  DOJ  files 
y-.  iatlsfa  W/info .5  motion  to 
4  received  ,  dismiss 
?  ,.  \ 
,. 
.........Y............  ., 
/ 
:  DVIC physaan  j 
: conducts  complete  : 
~review.  fmms  oprnon  ; 
..........  ...........
1
,i 
.,, 
.DVIC. 
,recorrmemis.  , ~e~ 
\ 
.jo  compensate, 
4 
-.  7. 
., 
(W
....................... 
Case  sent  to c  +.:+L%$:  ..........  . . ....... 
outsde  expert  : 
......................  l== 
B 
I drsmtssed
~  ;:  ~ 
...........  .........\ 
13GCrevtews nwdcal:  D&l drafts and files  D

rescordents  rewt  W  fwk!s  status E

ccmfefeme

sends to CCJ  :  with  Caut 
.. . . . . .. . . . . . . . . . . . . . .. 
@El 
DAY 90 
....... 
Q-
.........;  DVIC (PHS and OGC) 
SM  r
deadesto  Yes 
c1  Ccmpae 
DOJ 
Dam*  are 
determmed 
No 
~	 CIAIMS  COURT 
I -
& v 
(SM = SPECIAL  MASTER) 
DAY 270 
* Letters A - F above are explained 
in Appendix  A 
13  FLOW  CHART  II 
DAMAGE  DETERMINATION 
In injury case, 
petiticmr  ~esents 
Ilfe-care plan of the 
treatment,  care and 
costs of injwed 
partys  Ilfetime 
/ 
Spec!ai Mastef  00J, with cjovernmen 
sets award,  life-care pkmner and 
as determmed by  broker, evaluates 
statute,  at $250,00C  and responds to plan 
Spec!al Master Po!ds  Special Master   
NO  evident[ary hearing  conslcWs ev!dence 
with petitioners  ~esented  and 
and goverrrnents  makes dec tslon on  i 
life-care planner  award amount  I 
Coordination  and cornrnunicahonamongtheFederalagerme$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

others  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  others  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 andtheirattorneysaregenerallysa&@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 DOJS 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 judges  decision  either 
party  has  60 days to file a further  appeal  to the  United  States  Court  of Appeals  for 
the  Federal  Circuit.  Since  the  programs  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  petitioners  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  masters  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  petitioners  initial  claim  (the  petition)  must  be  complete  in that  it clearly 
outlines  the  petitioners  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:  RESPONDENTS  REPORT 
Prepared  by DOJ  attorneys,  this document  seines  as PHSS 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  respondents  report,  the  special  master  conducts  an 
informal,  off-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  others 
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  claims 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 
masters  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)  20  22% 
Open,  awaiting  PHS  review  28  31% 
Open,  in or past  PHS  review  17  1970 
Other Charactefitics:  (not mutually exclusive) 
Pro  se  18  20% 
Outside  expert  used  15  1770 
DPT  66  7370 
Injunex(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 akteof hjv) 
1972 and  before  32  35.570 
1973 to  1982  32  35.5% 
1983 to  present  26  29V0 
Special Master Deciiiox 
Compensate
 18  2070 
Not  Compensate
 8  9% 
~o  2~70 
Dismiss

Other
 1  1% 
Information  Not  Available
 2  2% 
Not  Applicable  (case  still open)
 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 cases 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. 
Table  I 
SM Recommendation
 N  % of Tot. 
Not  Completed
 1728  73.6 
Compensated
 246  10.5 
Not  Compensated
 94  4.0 
Dismissed
 279  11.9 
Total
 2347  100.0 
Methods 
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 
Special  Master 
Internal  OGC  DOJ 
From  Date 
Report  Report  Report 
15 
Date  Filed  I  12  13 
3  11 
Internal  OGC  Report 
no data 
DOJ  Report 
(Dismissed  cases  included.) 
To  Date 
Special  Master 
Internal  OGC  DOJ 
From  Date  Report  Report  Report 
15 
Date  Filed  13  13 
3  11 
Internal  OGC  Report 
no data 
DOJ  Report 
(Dismissed  cases  excluded.) 
C-6
 Table  III 
Median  Number  of Months  to Completion 
Dismissed  Cases

Included  Excluded

All Cases  15  15

Period  Filed 
Before  7/90  13  13

7/90-9/90  no data  no  data

10/90-12/90  no data  no data

1991  no data  no  data

Date  Vaccine  Administered 
Prior  to  10/88  15  15

After  10/88  14  14

Patient  Died 
Yes  14  14

No  15  1.5

Case  is pro  se 
Yes  13  18

No  15  15

Vaccination  Type 
DPT  14  15

IPV  20  20

Measles  16  16

Other,  Unkn.  37  no data

C-7
 Figure  A 
Cases  by  Status 
Distribution  of 
AS  of  Aug.  26,  1991 
Interval  :  Fi  I ing  Date  to  SM  Report  Date 
1,0, 
I 
o.

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

$ 
L0   :::;:\\....................................................."""""..".'"""."""""" 
:0 
k  \..!..:.
..:...t.... ........................................
..."""""".""".".""."""""".."".. 
0 ,  l_..................................... ......+.....EW.Y1 
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

95%  conf.  int. 
Relative  P 
Variable  Risk  Lower  Upper  Value 
Prospective  Case  1.10  0.60  1.99  0.641 
Case  Filed  before  7/90
 5.17  4.03  6.62  <0.001 
Case  Filed  4th  Qrt.,FY1990
 4.79  3.70  6.~o  <0.001 
Case  Filed  During  FY1991
 14.40  6.79  30.53  <0.001 
Patient  Died
 1.31  1.06  1.63  0.013 
IPV  Vaccine  Given
 0.25  0.17  0.35  <0.001 
MMP  Vaccine  Given
 0.76  0.58  0.99  0.045 
Other  Vaccine  Given
 0.98  0.59  1.64  0.949 
PRO  SE  Case
 3.05  2.44  3.81  <0.001 
Claim  Filed  after  1/31/91
 0.13  0.02  1.05  0.055 
Dismissed Cases  Excluded 
95%  conf.  int. 
Relative  P 
Variable  Risk  Lower  Upper  Value 
Prospective  Case  1.55  1.04  2.33  0.031 
Case  Filed  before  7/90  5.26  4.02  6.87  <0.001 
Case  Filed  4th  Qrt.,FY1990  1.26  0.80  1.98  0.319 
Case  Filed  During  FY1991  2.45  0.57  10.47  0 -7--7s 
Patient  Died  1.43  1.13  1.81  0.003 
PV  Vaccine  Given  0.47  0.?9  0.75  0.002 
MMP  Vaccine  Given  0.75  0.52  1.0s  o.l~j 
Other  Vaccine  Given  1.47  0.46  4.71  0.514 
PRO  SE  Case  1.47  0.95  2.2s  0.0s4 
Claim  Filed  after  1/31/91  0.89  0.08  9.93  (3924 
c-9  ~teratureCited 
1958.  Nonparametric 
1. Kaplan,  E.L.  and  Meier,  P.  Journal  Of 
estimation  from  incomplete  observations. 
the  American  Statistical  Assoclatlon.  53:457-481. 
1988.  SAS  Technical  RePoti: P-179
2.  SAS Institute  Inc.  Release 6.03.  Cary  ,
Additional  SAS/STAT  Procedures. ,
NC. 
and life tables  (with
3.  cox,  D.R.  1972.  Regression  models 
discussion) .  Journal  of the Roval  Statistical 
Societv  B.  34:187-220. 
1991.  SAS Technical  Report  P-217,
4.  SAS Institute  Inc.  Version  6-
The P~EG  Procedure, 
SAS/STAT  Software: 
cary,  NC-
1980. ~ 
5.	 Kalbfleisch,  J.D.  and P;entice, R.L. 
of Failure Time  Data, New York, 
Statistical  Analvsls 
John Wiley  & Sons,  Inc.  . 
... .

C-lo 
-..

---
.-
 APPENDIX  D 
COMMENTS  TO  THE  D- REPORT 
D-1  F~crr  for Health 
Assistant  Secrets.~ 
Sub]ecO:f fice  of  Inspector  General  (OIG)  Draft+ .RReepvoiretwThe 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 tchoem meenftzs~ c~encY
of the Vaccine  Inju~ry Compensation  Progr-. 
unde=~ay  or planned  to address  these
describe  the ac=ions 
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 
First,  on 
that  two  subjects  be clarified  in the final report. 
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 
OIG 
assigns  the case and  schedules  the respondent  report  date. 
may  not  be able to determine  this  inte~al  since  this  information 
is not  in the programs  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, 
the phxase  by the  1988 and 1989 amendments,- should  be 
Q	
inserted  after  1987,  and  and  
Health  Inf~rmation,  Health  PxcmotLon~ 
o	 the  words  Vaccine  Inju.~  Compensation 
shculd  be insezzed  before 
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
second  sentence.
Paae  2t second  n.araaraDhl  after  (NVAC). 
2105 of the  PHS Act)  should  be inserted

This  sentence  should  be

Paae  2, second  paraaraDh,  last sentence. 
deleted  from  the  final  report. 
third  ~aracraDh,  first  sentence.  The  plxcase.(Sect ion
Paae  2r 
should  be inse~ed  after  Vacc~nes. 
2119 of the  PHS Act) 
Paae  3, Table  I.  Cells  in the table  should  be revised  as 
follows: 
 cells 
o for both  the  retrospectiveth eanwdo rdsp rospoecft~ vree. hab~litative,
under  basis  of awards, 
and  related .should  be insetied  between  medical 
expense6~  
basis of awards  should  be 
o the  prospective  cell under 
up to $250,000  after  pain and 
revised  by adding 
suffering,  and 
should  be added at the 
o  the word  and loss of earnings 
end  of  footnote  ***.Ic 
The  word  enti=e
first  sentence. 
Paqe  5, second  Daracranh,  ,*. ..Pxogr=m  if funding is
should  be  inserted  before  the phrase 
insufficient.   
The  end of this 
last sentence. 
Paae  5r seccnd  naraaranh,  ..and  the  petitioner
 
sentence  should  be rewritten  as follows: 
could  then  seek  recourse  only  in the tort  system. 
A  comma  should  be 
last  sentence. 
Paae  5, third  Daxaaxaoh 
inserted  after  the word  millicn. 
The  beginning  cf this 
fcuz=~  Darac=a?ht  f~~s= entencelA  ~cs=an  university
Paae  5f 
fellows: 
senter.ce should  be revxsed  as 
recentlY  completed. ... 
professor 
paae,  first  sentence. 
Paqe  9,  second  naracranh  from  bottom  of 
should be  inserted  after
The  words  and petitioners  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.  
paae,  third  sentence. 
Paue  10, second  ~araaraph  from bottom of 
The words  date  the case  is scheduled  by..tMh e Court  should  be
inserted  in place  of  PHS OGC report date. 
Insert  PHS in p~aCe  of 
Paae  14, last paraqrauh,  last sentence. 
VICP. 
Paae  15, second  paraaraph , last sentence.  The  sentence  begimin~ 
Representatives  from HHS,  DOJ and the Clads  Cou~.  .. should  be 
is an inaccurate  stat-ent. 
deleted  since  this 
The wurds  the PHS 
first  sentence. 
Paae  17, first  Dazaarauh, 
Task  Force  has  should  be replaced  with  KHS and the Adv~sorY 
Commission  have. 
. 
The word 
Paffe 17, first  paraaranh , second  sentence.  Ishould  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. 
In the two places  it 
third  ~araaranh,  second  sentence. 
Paae C-1, 
is shown,  OGC should  be replaced  with  PHS. 
OGC  should  be 
Paqe C-4,  third  paraarauh , last sentence. 
replaced  with  PHS.  TO:  BrYan B. Mitchell

Prhcipal  Depury  Inspectcr  G-er~~

FROM :  Assistant  Secretar 
for Planning  and Evaluation 
SUBJECT:  OIG  Draft  Repcrr:  l~TheNational  Vaccine  Injury 
Compensation  Program:  A Pragram  Review,to 0E1-~2-~i-
01460  -- COMMEiW3 
Thank  you  for submitting  far my review  and comment  the draft 
report  on  sThe National  Vaccine  Injur~ Compensation  Prcgr=n: 
A Program  Review.  As you know,  we and  &he Public  Health  Se.rvic= 
(PHS) have  been  ver~  interested  in  examining  the  Vaccine  Inlur~ 
Compensation  Program  (VICP) and  looking  for  improvements  in  i~= 
operation.  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
 ad.mittedlv, adzi.nistzati-;e

rescurces  did  not  rnacc~.  well  with  khls  in~lu:c, 
these
=Sy~~=S  Fe=  S2  tier=  r.ct the prinar-y issde.  ~ren i:
acldlt~cnal  resc~~ces  c~  t-his  ~~.e  were  availz=le  ar.d all 
--
cases  had  keen  processed  immediatel~,  the

r~sccsces  to  pa.;

t!!i.s  level  of  claims  is nei~her  authcri=ed  lx  law K2cr  
aFprc~riated. 
This  t!!en, is the t--~e liaiti~.c sten. 
. 
se? 
v 
h 
:G-AE 
G.= 
GaI 
-

G~ 
C/IG 
:SEC  =

  .-  .,.
 , ,_
 J?ecmmer.datiens
o Discsssion  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. 
0  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 first  st=ez?all.m.:--.q.  idea  is  t=
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  -. 
. .  RECOMMENDATIONS

The  PHS, DOJ and Claims Court should: 
Inventov  the Backkhg.to Set Prioritiesand Better IMikate  Future Rerource Neeak(cid:1)
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(cid:1)
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(cid:1)
The  Department  of Health  and  Human  Sewices  should  support  its Task  Forces 
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 theirAttorneys(cid:1)
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(cid:1)
The speciamla stersshouldcontinuues ingannuitieass theprimarysettlemenotp
tion

ininjurcya
 ses.

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  programs  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 ASMBS 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