Strategic
Plan
April
2006
Prepared by the
Division of Vaccine Injury Compensation
Executive Summary
In
the early 1980s, reports of harmful side effects
following the DTP (diphtheria, tetanus, pertussis)
vaccine posed major liability concerns for vaccine
companies and health care providers, and caused
many to question the safety of the DTP vaccine.
Many parents began filing lawsuits against vaccine
companies and health care providers. The dilemma
facing the Nation was so great that Congress
created the National Vaccine Injury Compensation
Program (VICP). The VICP, which went into effect
on October 1, 1988, is a “no-fault”
alternative to the traditional tort system for
resolving certain vaccine injury claims.
Within
the Executive Branch of the Federal Government,
the VICP is administered by the Department of
Health and Human Services (HHS), and the Department
of Justice (DOJ). The HHS component of the VICP
is located organizationally in the Health Resources
and Services Administration (HRSA), Healthcare
Systems Bureau (HSB), Division of Vaccine Injury
Compensation (DVIC). The DOJ, Civil Division,
Torts Branch, Vaccine Litigation represents
the Secretary of HHS in proceedings before the
U.S. Court of Federal Claims (Court). The Court
decides which claims will be compensated.
The mission of the
VICP is to process claims expeditiously and
fairly utilizing current vaccine safety research
to determine injuries thought to be caused by
vaccines, and raise awareness about the existence
of the VICP. Since its inception, the VICP has
been a key component in stabilizing the U.S.
vaccine market by providing liability protection
to both vaccine companies and health care providers.
Not only does it provide a more streamlined
and less adversarial alternative to the traditional
tort system for resolving claims, the VICP encourages
research and development of new and safer vaccines.
Following
are the critical issues facing the VICP over
the next five years (2005-2010):
-
dramatic shift in claims from nearly all alleging
a Vaccine Injury Table (Table) condition to
the majority now alleging a non-Table (or
off-Table) condition, which creates a more
difficult burden for petitioners and raises
questions as to how the current causation
standard is applied to VICP claims;
-
the claims process is difficult for stakeholders
to understand; and
-
many parents, the general public, attorneys,
and health care professionals are not aware
of the existence of the VICP.
To address these critical issues, the VICP developed
a 5-year Strategic Plan. Over the next 5 years,
the VICP will implement the following strategic
goals to work toward achieving its vision. The
vision of the VICP
is to fairly compensate individuals injured
by covered vaccines quickly, easily and with
certainty, and create an environment that fosters
the production and use of existing vaccines
and the development of new, safe and effective
vaccines.
Strategic Theme 1
• Examine alternative approaches for adjudication
of off-Table claims.
Strategic
Theme 2
• Assure that the VICP is responsive to
evolving science, medicine and policy actions.
Strategic
Theme 3
• Assess and streamline the claims process
to make it quicker, more user-friendly, and
fair to all parties.
Strategic
Theme 4
• Increase knowledge about the VICP among
all stakeholders.
The
VICP will develop a plan to implement its strategic
goals and objectives. This Strategic Plan will
be updated periodically.
Introduction
In
the early 1980s, reports of harmful side effects
following the DTP (diphtheria, tetanus, pertussis)
vaccine posed major liability concerns for vaccine
companies and health care providers, and caused
many to question the safety of the DTP vaccine.
Many parents began filing lawsuits against vaccine
companies and health care providers. This, in
turn, caused many of the companies that developed
and produced vaccines to leave the marketplace,
creating significant vaccine shortages and a
real threat to the Nation’s health.
The
dilemma facing the nation was so great that
Congress acted. A coalition of parents, physician
groups, and policy makers participated in the
development of a solution. The National Vaccine
Injury Compensation Program (VICP), which went
into effect on October 1, 1988, is a “no-fault”
alternative to the traditional tort system for
resolving certain vaccine injury claims.
Within
the Executive Branch of the Federal Government,
the VICP is administered by the Department of
Health and Human Services (HHS), and the Department
of Justice (DOJ). The HHS component of the VICP
is located organizationally in the Health Resources
and Services Administration (HRSA), Healthcare
Systems Bureau (HSB), Division of Vaccine Injury
Compensation (DVIC). The DOJ, Civil Division,
Torts Branch, Vaccine Litigation represents
the Secretary of HHS in proceedings before the
U.S. Court of Federal Claims (Court) and reviews
petitions to determine whether they meet the
legal requirements for compensation. The Court
also has a role in administering the VICP. The
Court has two primary functions: 1) claims management,
which involves overseeing the collection of
information and setting time frames for its
submission; and 2) decision making, which involves
determining the types of proceedings necessary
for presenting the relevant evidence, and ultimately,
weighing the evidence in rendering a final determination
on whether petitioners are entitled to an award,
and if so, how much will be paid in individual
claims.
Since
its inception, the VICP has been a key component
in stabilizing the U.S. vaccine market by providing
liability protection to both vaccine companies
and health care providers. Not only does it
provide a more streamlined and less adversarial
alternative to the traditional tort system for
resolving claims, the VICP encourages research
and development of new and safer vaccines. The
VICP covers all vaccines recommended by the
Centers for Disease Control and Prevention (CDC)
for routine administration to children. The
vaccines currently covered include: diphtheria,
tetanus, pertussis (DTP, DTaP, Tdap,
DT, TT or Td), measles, mumps, rubella
(MMR or any component), polio
(OPV or IPV), hepatitis A (HAV),
hepatitis B (HBV), Haemophilus
influenzae type b (Hib), varicella
(VZV), rotavirus (RV), pneumococcal
conjugate (PCV), and influenza
[trivalent] (TIV, LAIV).
VICP Mission Statement
To
process National Vaccine Injury Compensation
Program (VICP) claims expeditiously and fairly
utilizing current vaccine safety research
to determine injuries thought to be caused
by vaccines, and raise awareness about the
existence of the VICP.
VICP Vision Statement
To
fairly compensate individuals injured by covered
vaccines quickly, easily and with certainty,
and create an environment that fosters the
production and use of existing vaccines, and
the development of new, safe and effective
vaccines.
VICP Values
Accountability
We strive to ensure the financial integrity
of the Vaccine Injury Compensation Trust Fund.
Collaboration
We strive to work harmoniously with our immunization
partners.
Communication
We strive to promote the availability of the
VICP.
Compassion
We strive to compensate individuals with sensitivity
and in consideration of the situation of each
petitioner.
Fairness
We strive to adjudicate claims fairly and
efficiently.
Improvement
We strive to work with all of our stakeholders
to improve the VICP.
Protecting
Public Health
We strive to create an environment to stabilize
vaccine supply and foster vaccine research
and development by protecting vaccine administrators
and companies from liability for vaccine-related
injuries and deaths.
Science-based
We strive to review claims based on all available
scientific evidence.
Timeliness
We strive to process claims, and compensate
individuals expeditiously.
Vaccine Safety Research
We strongly encourage continued research to
ensure the safety of current and future vaccines.
Critical
Issues Facing the VICP
Following
are the critical issues facing the VICP over
the next five years:
-
dramatic shift in claims from nearly all alleging
a Vaccine Injury Table (the Table) condition
to the majority now alleging a non-Table (or
off-Table) condition, which creates a more
difficult burden for petitioners and raises
questions as to how the current causation
standard is applied to VICP claims;
-
the claims process is difficult for stakeholders
to understand; and
-
many parents, the general public, attorneys,
and health care professionals are not aware
of the existence of the VICP.
VICP Strategic Goals and Objectives
Strategic
Theme 1
• Examine alternative approaches for adjudication
of off-Table claims.
Objectives:
1.1 Identify alternative
approaches for adjudication of off-Table claims.
1.2 Evaluate these approaches.
1.3 Obtain a consensus on
the best approach(es) to pursue.
Strategic Theme 2
• Assure that the VICP is responsive to
evolving science, medicine and policy actions.
Objectives:
2.1 Request the Institute
of Medicine (IOM) or other appropriate body
to review possible vaccine adverse events
and make recommendations to the Secretary
of Health and Human Services periodically.
2.2 Update the Table using
findings from vaccine adverse event research.
Revise the Table periodically after considering
the recommendations of the Advisory Commission
on Childhood Vaccines (ACCV).
2.3 Evaluate the viability
of recommendations to cover additional categories
of vaccines under the VICP.
Strategic
Theme 3
• Assess and streamline the claims process
to make it quicker, more user-friendly, and
fair to all parties.
Objectives:
3.1 Evaluate the current
claims process to ensure continuous process
improvements.
3.2 Obtain and assess feedback
from petitioners and their attorneys about
making improvements to the claims process.
3.3 Ensure that the claims
processing requirements of the Act are implemented
and followed, such as submitting medical records
at the same time that the claim is filed.
3.4 Consider additional proposals
for making improvements to the VICP after
consultation with the ACCV and appropriate
stakeholders.
Strategic Theme 4
• Increase knowledge about the VICP among
all stakeholders.
Communication about the existence of the VICP,
while necessary, can be frightening to people.
It is vitally important to communicate to the
public the message that, while vaccines are
safe, the VICP’s goal is to compensate
the small number of people who suffer rare,
but serious adverse events related to covered
vaccines.
Objectives:
4.1 Evaluate current VICP
communications and outreach materials, and
simplify and improve their effectiveness.
4.2 Develop and implement
a marketing plan to increase awareness of
the VICP among stakeholders.
4.3 Create communications
materials that are easily understood by the
public, health care providers, and attorneys.
Long Term and Annual Performance Measures
and Data
A Program Assessment Rating Tool (PART) review
of the VICP was conducted for the Fiscal Year
2007 Budget. HRSA and DOJ went through the PART
process jointly. The VICP received an overall
rating of Adequate. During this review, the
VICP developed a new set of performance measures
that support the mission, visions and values
of the VICP. These measures focus on the timely
adjudication of vaccine injury claims and award
settlements.
Long Term and Annual Measure 1:
Percentage of cases in which judgment awarding
compensation is rejected and an election to
pursue a civil action is filed
Explanation: Once a determination
has been made that petitioners are eligible
for compensation, they are able to reject an
award and pursue a traditional civil lawsuit.
This measure tracks the number of individuals
who pursue civil litigation following a determination
that they are eligible for compensation. This
is a measure of petitioners' satisfaction with
the VICP and the VICP's ability to protect vaccine
companies from civil action. The actual data
for this measure will be collected and reported
by DOJ.
Fiscal Year |
Target |
Actual Data |
2002 |
Historical |
0% |
2003 |
Historical |
1.5% |
2004 |
Baseline |
0% |
2005 |
0% |
0% |
2006 |
0% |
|
2007 |
0% |
|
2008 |
0% |
|
Long Term and Annual Measure 2:
Average claim processing time
Explanation: The measure tracks the
average length of time from the date a claim
is filed until payment is authorized for compensable
cases and the date of filing to judgment for
dismissed cases. This measure encompasses total
claim processing time, which is influenced by
all program participants. These program participants
(particularly petitioners, petitioners' counsel,
and the Special Masters) do influence the speed
with which VICP proceedings take place and impact
the program's ability to achieve success under
this measure. * Longer processing times reflect
the expectation that over 5,000 cases currently
pending in several omnibus proceedings will
begin to be resolved in the coming years. As
these cases are finally resolved, they will
increase significantly the average processing
time for all cases completed during these years.
The actual data for this measure will be collected
and reported by the HRSA.
Fiscal Year |
Target |
Actual Data |
2002 |
Historical |
995 days |
2003 |
Historical |
1021 days |
2004 |
Baseline |
738 days |
2005 |
990 days |
894 days |
2006 |
1005 days* |
|
2007 |
1213 days* |
|
2008 |
1433 days* |
|
Annual Measure 3: Percentage
of cases where the deadline for the Rule 4(b)
report is met once the case has been deemed
complete
Explanation: A Rule 4(b) report is
similar to the government's "answer"
in a traditional civil lawsuit. Its purpose
is to explain the government's position as to
why an award should or should not be granted,
provide a medical analysis of petitioner's claims,
and assert any applicable legal arguments. The
actual data for this measure will be collected
and reported by DOJ.
Fiscal Year |
Target |
Actual Data |
2004 |
Baseline |
75.3% |
2005 |
78% |
83.7% |
2006 |
80% |
|
2007 |
83% |
|
2008 |
86% |
|
Annual Measure 4: Percentage
of cases in which case settlements are completed
within the court-ordered 15 weeks
Explanation: This measure tracks the
percentage of claims in which settlements are
completed within 15 weeks from the date of a
tentative agreement between the parties and
the settlement proposal is submitted to petitioner
for his/her concurrence. This measure is calculated
by determining the amount of time between a
tentative agreement between the parties and
the date on which the settlement stipulation
is approved by appropriate officials at HRSA
and DOJ. The actual data for this measure will
be collected and reported by DOJ.
Fiscal Year |
Target |
Actual Data |
2002 |
Historical |
80% |
2003 |
Historical |
92% |
2004 |
Baseline |
80% |
2005 |
85% |
95% |
2006 |
90% |
|
2007 |
92% |
|
2008 |
92% |
|
Annual Measure 5: Median time
to process an award for damages
Explanation: Once a petitioner has
been found eligible for compensation, whether
by decision or order of a special master or
by the Federal government's concession of a
claim, the amount of damages must be determined.
The measure tracks the median time it takes
to complete this process. The actual data for
this measure will be collected and reported
by DOJ.
Fiscal Year |
Target |
Actual Data |
2002 |
Historical |
533 days |
2003 |
Historical |
564.5 days |
2004 |
Baseline |
529.5 days |
2005 |
529.5 days |
483.9 days |
2006 |
500 days |
|
2007 |
485 days |
|
2008 |
475 days |
|
Annual Measure 6: Decrease
the average time settlements are approved from
the date of the receipt of the DOJ settlement
proposal
Explanation: Approving settlements
for petitioners as efficiently as possible will
help to ensure they are satisfied with the processing
of their claim. HRSA is unable to reduce the
average time any further because of factors
inherent in the approval system, such as the
necessary legal review and opinion by the Department
of Health and Human Services Office of the General
Counsel. Therefore, for FY 2008 and beyond,
the annual target will be to maintain the program
performance at 10.0 days. The actual data for
this measure will be collected and reported
by HRSA.
Fiscal Year |
Target |
Actual Data |
2002 |
Historical |
16 days |
2003 |
Historical |
15 days |
2004 |
Baseline |
11 days |
2005 |
10 days |
18 days |
2006 |
10 days |
|
2007 |
10 days |
|
2008 |
10 days |
|
Annual Measure 7: Decrease
the average time that lump sum only awards are
paid from the receipt of a DOJ clearance letter
Explanation: Paying petitioners as
efficiently as possible will help to ensure
they are satisfied with the processing of their
claim. HRSA is unable to reduce the average
time any further because of factors inherent
in the payment system, such as obtaining petitioner’s
social security numbers which are required by
the U.S. Department of Treasury to issue a payment,
as well as approvals and payment authorization
procedures. Therefore, for FY 2008 and beyond,
the annual target will be to maintain the program
performance at 5.0 days. The actual data for
this measure will be collected and reported
by HRSA.
Fiscal Year |
Target |
Actual Data |
2002 |
Historical |
7 days |
2003 |
Historical |
6 days |
2004 |
Baseline |
6 days |
2005 |
5 days |
11 days |
2006 |
5 days |
|
2007 |
5 days |
|
2008 |
5 days |
|
Appendices
Appendix A: The Planning Process
In 2002, the Workgroup was formed and conducted
its first meeting in May of that year. The Workgroup
represents key stakeholders with interest in
the VICP. The eight Workgroup members, guided
in the process by staff from Vantage Inc. (a
training consulting company under contract with
HRSA), gathered data and developed draft documents
(e.g., vision and mission statements). These
data and documents were discussed at the Retreat
held in October 2002.
Participants
in the Retreat included a larger representative
sample of stakeholders with interest in the
VICP. The draft Strategic Plan was presented
to participants at the Retreat for their review
and comments. Stakeholders unable to attend
the Retreat provided their review and comments
to the strategic planning process in writing
and through phone interviews conducted by members
of the Workgroup. Based on these comments, the
draft documents developed by the Workgroup were
used by the Division of Vaccine Injury Compensation
staff to develop the Strategic Plan, Communications
Plan, and Implementation Plan.
All
of the stakeholders, including the Workgroup,
who participated in the development of the Strategic
Plan were free to express their independent
views, experiences and opinions. (A list of
the Workgroup members and Vantage staff is included
in Appendix C, and the list of Retreat attendees
is included in Appendix D.) The Strategic Plan
was completed in June 2004.
Appendix B: Stakeholders of the VICP
Stakeholders
are significantly affected by any changes to
the VICP. Stakeholders are allowed to participate
in the decision making process that affects
the operations of the VICP, and participate
in the development of new ideas for the VICP.
The stakeholders of the VICP are listed below:
Department
of Health and Human Services (HHS), Health Resources
and Services Administration, Healthcare Systems
Bureau, Division of Vaccine Injury Compensation;
Department
of Justice, Civil Division, Torts Branch, Vaccine
Litigation;
U.S.
Court of Federal Claims;
U.S.
Department of the Treasury (collects the excise
tax on childhood vaccines, administers the Trust
Fund, and makes payments as authorized by the
VICP);
Advisory
Commission on Childhood Vaccines (see Appendix
F for a description of the responsibilities);
Petitioners;
Parents
and legal guardians of injured children;
Petitioners’
attorneys;
Vaccine
companies;
Healthcare
providers;
Centers
for Disease Control and Prevention;
National
Institutes of Health;
Food
and Drug Administration;
National
Vaccine Program Office;
HHS
Office of the General Counsel;
Congress;
and
State
and local health departments.
Appendix C: VICP Strategic Planning
Workgroup Members
Doris
Cooper
Program Analyst
Medical and Operations Branch
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857
|
Gabrielle
Fielding, J.D.
Assistant Director
Torts Branch
Civil Division
Department of Justice
P.O. Box 146
Ben Franklin Station
Washington, DC 20044 |
Arnold
D. Gale, M.D.
Associate Clinical Professor
Department of Neurology and Neurological
Sciences
Department of Pediatrics
Stanford University School of Medicine
300 Pasteur Drive
Stanford, California 94305
|
Professor
Peter H. Meyers, J.D.
Director, Vaccine Injury Project
George Washington University Law School
2000 G Street NW
Washington, DC 20052 |
Deborah
Harris, J.D. (Deceased)
Senior Attorney
Office of the General Counsel
Department of Health and Human Services
5600 Fishers Lane, Room 4A-53
Rockville, Maryland 20857 |
Ward
Sorensen
Chief, Medical and Operations Branch
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857
|
Bronwen
Kaye
Wyeth
1667 K Street NW, Suite 1270
Washington, DC 20006 |
Lois
Ann Swartzlander
ACCV Vice Chair (2002-03)
59 Oakpoint Drive
Holiday Island, Arkansas 72631 |
Division of Vaccine Injury Compensation
Staff
Tamara
Overby, M.B.A.
Chief, Policy Analysis Branch
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857
Carol
Konchan, R.N.
Nurse Officer
Medical and Operations Branch
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857
Vantage
Consultant Staff
George
Reed
Allan Jones
Ana Rodriguez
Appendix D: VICP Strategic Planning
Retreat Attendees
Remy
Aronoff
Deputy Director
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857 |
Peter
H. Meyers, J.D.
Director, Vaccine Injury Project
George Washington University Law School
2000 G Street NW
Washington, D.C. 20052 |
Thomas
E. Balbier, Jr.
Executive Secretary of the Advisory Committee
for Organ Transplantation
and Former Director,
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 12C-06
Rockville, Maryland 20857 |
Laurie
Michel
Senior Director, Government Relations
Merck & Co., Inc.
601 Pennsylvania Avenue, N.W.
North Building, Suite 1200
Washington, D.C. 20004 |
Norman
Baylor, Ph.D.
Associate Director for Regulatory Policy
Office of Vaccine Research and Review
Center for Biologics and Evaluation Research
Food and Drug Administration
1401 Rockville Pike, HFM 400
Rockville, Maryland 20852 |
Barbara
Mulach
Division of Microbiology
and Infectious Diseases, NIAID
NIH 6700B Rockledge Drive, Room 3142
MSC 7630
Bethesda, Maryland 20892-7630 |
Werten
F.W. Bellamy, Jr., J.D.
Celera Genomics
45 W. Gude Drive
Rockville, Maryland 20850 |
David
A. Neumann, Ph.D.
Director, National Coalition for Adult Immunization
Director, National Partnership for Immunization
4733 Bethesda Avenue, Suite 750
Bethesda, Maryland 20814 |
Dr.
Joseph Brice
312 Councill Lane
Pasadena, Maryland 21122 |
Elizabeth
J. Noyes, M.A.
Chair, Advisory Commission on Childhood
Vaccines
American Academy of Pediatrics
601 13th Street, N.W., Suite 400 North
Washington, D.C. 20005 |
Vito
Caserta, M.D., M.P.H.
Team Leader, Medical and Operations Branch
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857 |
Marcia
O’Malley
Family Voices
3411 Candelaria N.E., Suite M
Albuquerque, New Mexico 87107 |
Judy
Ceresa
Program Analyst
Office of Management and Program Support
Office of the Administrator
Health Resources and Services Administration
5600 Fishers Lane, Room 13-07
Rockville, Maryland 20857 |
Georges
Peter, M.D.
Division of Pediatric Infections Disease,
Rhode Island Hospital
593 Eddy Street
Providence, Rhode Island 02903 |
Nichole
Chamberlain
Nurse Medical Review Officer
Medical Affairs Branch
Office of Commissioned Corps Support Services
Program Support Center
5600 Fishers Lane, Room 4C-03
Rockville, Maryland 20857 |
Geoffrey
Peterson
Director of Government Affairs
Aventis Pasteur
801 Pennsylvania Avenue, N.W.
Suite 725
Washington, D.C. 20004 |
Kevin
Conway, Esq.
Conway, Homer & Chin-Caplan, P.C.
16 Shawmut Street
Boston, Massachusetts 02116 |
Amy
Pisani, M.S.
Executive Director
Every Child By Two
666 11th Street, N.W., Suite 202
Washington, D.C. 20001-4542 |
Dr.
Laurajean Councill
312 Councill Lane
Pasadena, Maryland 21122 |
Elizabeth
Rezai-zadeh
Public Health Analyst
Office of Global Health
Health Resources and Services Administration
5600 Fishers Lane, Room 16C-26
Rockville, Maryland 20857 |
Carol
Cummings (Retired)
Legislative Analyst
Office of Legislation
Health Resources and Services Administration
5600 Fishers Lane, Room 14-36
Rockville, Maryland 20857 |
Mary
Jean Schumann, MSN, RN, MBA, CNP
Director, Nursing Practice and Policy
American Nurses Association
600 Maryland Avenue, S.W.
Suite 100 West
Washington, D.C. 20024 |
Luisita
C. Dela Rosa
Lab Associate
Department of Chemical Engineering
Iowa State University
2114 Sweeney Hall
Ames, Iowa 50011-2230 |
Ben
Schwartz, M.D.
Associate Director for Science
Epidemiology and Surveillance Division
National Immunization Program
Centers for Disease Control and Prevention,
Mailstop E-61
1600 Clifton Road, N.E.
Atlanta, Georgia 30333 |
Sherry
K. Drew, Esq.
McDowell & Drew, Ltd.
35 E. Wacker Drive, Suite 1212
Chicago, Illinois 60601 |
Kristine
Severyn, R.Ph., Ph.D.
Director, Vaccine Policy Institute
251 West Ridgeway Drive
Dayton, Ohio 45459 |
Leon
Epstein, M.D.
Neurology Department
Children’s Memorial Hospital
2300 Children’s Plaza, Box 51
Chicago, Illinois 60614-3394 |
Martin
Smith, M.D.
3801 Village View Drive, Apt. 1327
Gainesville, Georgia 30506 |
Geoffrey
Evans, M.D.
Medical Director
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857 |
Joel
Soodak
Program Analyst
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857 |
Barbara
Loe Fisher
National Vaccine Information Center
Dissatisfied Parents Together
421 East Church Street
Vienna, Virginia 22180 |
Robin
Spector
Staff Attorney
Clerk’s Office
U.S. Court of Federal Claims
717 Madison Place NW
Washington, D.C. 20005 |
Thomas
P. Gallagher, J.D.
Gallagher & Gallagher
822 Shore Road
Somers Point, New Jersey 08244 |
Paul
F. Strain, J.D.
Venable, Baetjer and Howard, LLP
Two Hopkins Plaza, Suite 1800
Baltimore, Maryland 21201 |
Bruce
Gellin, M.D., M.P.H.
Director, National Vaccine Program Office
Department of Health and Human Services
200 Independence Ave., S.W., Room 736E
Washington, D.C. 20201-0004 |
Susan
Van Cleve
National Association of Pediatric Nurse
Practitioners (NAPNAP)
1101 Kings Highway, North
Suite 206
Cherry Hill, New Jersey 08034-1912 |
Claire
Hannon
Senior Director for Immunization Policy
Association of State and Territorial Health
Officials
1275 K Street, N.W., Suite 800
Washington, D.C. 20005-4006 |
J.
Thomas and Suzanne Vaughn
5223 Holly Street
Bellaire, Texas 77401-4803 |
Ronald
C. Homer, Esq.
Conway, Homer & Chin-Caplan, P.C.
16 Shawmut Street
Boston, Massachusetts 02116 |
Curtis
R. Webb, Esq.
Webb, Webb & Guerry
155 2nd Avenue, North
Twin Falls, Idaho 83301 |
Laurent
Latapie
Clerk
Program Support Center
5600 Fishers Lane, Room 1B-17
Rockville, Maryland 20857 |
Robert
Weibel, M.D.
Senior Medical Officer
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
Public Ledger Building, Suite 421
150 S. Independence Mall West
Philadelphia, Pennsylvania 19106 |
Cheryl
Lee
Program Analyst
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857 |
Kathi
Williams
Director
National Vaccine Information Center
Dissatisfied Parents Together
421 East Church Street
Vienna, Virginia 22180 |
Mario
Lombre
Public Health Analyst (Trainee)
Division of Vaccine Injury Compensation
Healthcare Systems Bureau
Health Resources and Services Administration
5600 Fishers Lane, Room 11C-26
Rockville, Maryland 20857 |
Elizabeth
York
Manager, Federal Government Relations
GlaxoSmithKline
1500 K Street, N.W., Suite 650
Washington, D.C. 20005
|
Emily
Marcus Levine, J.D.
Office of the General Counsel
Department of Health and Human Services
5600 Fishers Lane, Room 4A-53
Rockville, MD 20857 |
Herbert
Young, M.D., M.A., F.A.A.F.P.
Director, Scientific Activities American
Academy of Family Physicians
11400 Tomahawk Creek Parkway Leawood, Kansas
66211-2672 |
Appendix E: Additional VICP Stakeholders
Providing Written Comments on the Strategic
Plan
Department of Justice
Torts Branch
Civil Division
Department of Justice
P.O. Box 146
Ben Franklin Station
Washington, DC 20044
Department
of Health and Human Services
Office of the General Counsel
5600 Fishers Lane, Room 4A-85
Rockville, Maryland 20857
Health
Resources and Services Administration
Office of Legislation
5600 Fishers Lane, Room 14-36
Rockville, Maryland 20857
National
Partnership for Immunization
4733 Bethesda Avenue, Suite 750
Bethesda, Maryland 20814
Appendix F: Summary of Major VICP Statutory
Responsibilities
The
VICP strives to compensate vaccine-injured individuals
quickly, easily, and fairly. The three means
by which a petitioner may qualify for compensation
are: 1) proof that an injury listed on the Table
occurred within the specified timeframe; 2)
proof that the vaccine significantly aggravated
a pre existing condition; or 3) proof that the
vaccine caused the injury.
The
Table lists specific injuries or conditions
and the time frames in which they must occur
after vaccine administration. The Table is a
legal mechanism for defining complex medical
conditions, and allows a statutory "presumption
of causation." The Table serves as the
basis for presumptions of causation for vaccines
covered under the VICP. It is much easier to
demonstrate a Table injury than to prove that
the vaccine caused the condition. However, if
an adverse event is not listed on the Table,
an individual may still file a claim, but must
prove that the vaccine did "in fact"
cause the alleged injury. Compensation may not
be awarded if the Court determines that the
injury or death was due to an alternative cause
unrelated to the vaccine, even if a Table injury
is demonstrated.
The
VICP promulgates revisions of the Table as appropriate.
The
VICP compiles and disseminates information about
the VICP.
The
VICP promotes safer childhood vaccines.
The
VICP awards compensation.
The
Court adjudicates VICP claims.
The
ACCV has the following responsibilities: advises
the Secretary on the implementation of the VICP;
recommends changes in the Table; advises the
Secretary in implementing the Secretary’s
responsibilities regarding the need for childhood
vaccination products that result in fewer or
no significant adverse reactions; surveys Federal,
state and local programs and activities relating
to the gathering of information on injuries
associated with the administration of childhood
vaccines; and recommends to the Director of
the NVPO research related to vaccine injuries
needed to implement the VICP.
The
Act specifies the level of administrative funding
for the VICP. Funding is provided by an excise
tax on each "dose" (disease prevented)
of covered vaccine purchased. Under rules authorized
by the Department of Treasury, 75 percent of
excise tax collections are deposited into the
Trust Fund, which is used to pay compensation
for vaccine-related injuries and death.
The
VICP authorizes payments from the Trust Fund.
Appendix G: Expectations of VICP by
Stakeholders
The
development of safe and effective vaccines against
diseases represents one of the major success
stories of public health. Vaccines prevent thousands
of deaths and associated illnesses each year
in the United States. With that success comes
the reality that vaccines can result in rare,
but serious adverse events, perhaps even death,
in those who receive them.
Childhood
immunization comprises the largest portion of
our National immunization program. Vaccines
are unique in that they are administered to
healthy individuals to prevent disease, not
only in the recipient, but also in society as
a whole. When a vaccine is given to a healthy
individual, there is less tolerance of adverse
events, especially when a child is affected.
Since state governments mandate that children
be vaccinated for school or daycare entry, it
is believed that society has an obligation to
care for those relatively few individuals who
are injured by vaccines.
When
individuals are injured by vaccines, they or
their legal guardians expect that injuries will
be identified quickly and treated appropriately.
They also expect to be informed about the VICP
so that they may file a timely claim.
The
legislative history of the VICP states that
compensation is to be provided “quickly,
easily and with certainty and generosity.”
Individuals injured by vaccines or their legal
guardians, Congress and other stakeholders have
different opinions about what this statement
means. In addition, all stakeholders expect
the VICP staff to be compassionate when delivering
services.
Vaccine
companies play a key role in ensuring a steady
supply of vaccines. The increase in the number
of individuals pursuing litigation against vaccine
companies could drastically reduce the supply
of vaccines, as well as increase the cost of
vaccines. Such a situation would negatively
affect the Nation’s immunization rates
and public health.
Society
expects to be free from the threat of vaccine-preventable
diseases by having a readily available supply
of safe, cost-effective vaccines and ongoing
vaccine research and development. Society also
expects to be adequately informed of the risks
of vaccines, as well as the benefits.
Society
expects that the Trust Fund will be used for
the purpose it was intended - to compensate
individuals injured by vaccines covered by the
VICP.
The
medical and scientific communities expect that
the latest available science will be applied
when deciding if a specific injury or death
is vaccine-related.
Health
officials expect that the VICP, by providing
adequate, fair and efficient compensation to
the few individuals injured by vaccines, will
continue to play a critical role in ensuring
high immunization rates for recommended childhood
vaccines, thus preventing the spread of vaccine-preventable
diseases and associated morbidity and mortality.
Healthcare
providers who administer vaccines to children
and vaccine companies expect that they will
be protected against lawsuits when vaccines
are administered in accordance with currently
accepted standards. They also expect to have
a continued adequate supply of vaccines.
The
Office of Special Masters of the Court, attorneys
representing petitioners, and HHS expect that,
in each case, complete documentation and evidence
will be presented. Completed documentation permits
prompt and fair evaluation of the merits of
each claim, and when appropriate, allows a determination
to be made as to the amount of compensation
to be awarded to each petitioner.
In
short, every segment of our society has come
to expect the benefits of successful immunization
efforts. Society now expects resolution to the
problems and concerns associated with the few,
but sometimes serious adverse events resulting
from vaccines.
Appendix H: Strengths, Weaknesses, Opportunities
and
Threats (SWOT) Analysis
The
Workgroup conducted an analysis of the current
strengths and weaknesses of the VICP which were
recognized as follows.
Strengths
•
The Act provides the VICP with a clear mission.
The
VICP personnel are passionate about and dedicated
to the VICP’s mission, enabling outcomes
that consistently meet or exceed expectations
for both quality and volume.
•
The VICP is generally well-regarded as a program
that compensates those injured by vaccines.
•
The VICP endeavors to be science-based in its
assessment of claims.
•
The VICP usually processes claims in a timely
manner.
•
Funding of the VICP through the excise tax,
coupled with restrictions on the use of funds,
provides financial stability to the VICP.
•
The ACCV oversight of the VICP and the Trust
Fund affords additional protection and stability.
•
Reversionary trust agreements further ensure
financial stability.
•
Comprehensive data are available concerning
case adjudication and compensation.
•
The Expert Witness Program provides the VICP
with an excellent source of evidence-based,
objective medical and scientific opinion. It
has also proven itself a valuable resource in
related public health programs (e.g. Anthrax
Vaccine Expert Committee).
•
The VICP pays petitioner attorneys’ fees
and costs regardless of outcome as long as the
claim was reasonable and brought on a good faith
basis; and thus, enhancing access to the VICP.
The
Table relieves the burden of having to prove
that the vaccine caused an injury.
The
VICP collaborates with other health agencies,
such as the CDC, FDA, NIH and NVPO, as well
as the U.S. Department of Defense.
The
VICP has been instrumental in stabilizing the
vaccine market.
The
VICP is a generous, expeditious and more certain
alternative to the civil court system.
The
special masters are perceived as fair.
The
VICP has the ability to make changes to the
Table through the regulatory process, instead
of the legislative process.
Weaknesses
•
The VICP’s standards for deciding off-Table
cases need to be reviewed and possibly made
less burdensome to petitioners.
•
The VICP’s procedures need modification
and improvement, as recommended by the ACCV
and others. Some of the improvements suggested
by various stakeholders include: allowing interim
payment of attorneys' fees and costs so that
petitioners can make timely payments to experts;
refining and shortening the life care planning
process; extending the statute of limitations
from 3 to 6 years; and possibly allowing flexibility
when compensation can be given to a petitioner,
such as permitting a partial payment after entitlement,
but before the life care planning process is
complete.
•
Efforts to educate the public about the VICP
are inadequate.
• The public’s lack of understanding
of science and medicine, coupled with the frequent
dissemination of inaccurate information by the
media and special interest groups, results in
the formation of opinions lacking a basis in
science.
•
The decisions of the Court are inconsistent.
•
There is the perception that the VICP is responsible
for delays in the processing of claims when,
in many instances, the delays result from meeting
the needs of the petitioner.
•
Petitioners and attorneys lacking experience
with the VICP must confront experienced government
attorneys, fostering the view of “government
as enemy.”
•
The very existence of the VICP communicates
a mixed message that while vaccines are beneficial
and safe, they may, in rare instances, cause
injury or death.
•
The VICP lacks enforcement authority to ensure
that awards are used for their intended purposes.
•
Some petitioners perceive the Act, or its interpretation,
as too rigid.
•
The VICP data have potential public health applications,
but are underutilized for this purpose.
•
The acceptance by the Court of experts who testify
using non-evidence based opinions undermines
the credibility of the VICP.
•
The number of claims filed varies from year
to year; and thus, it is a challenge to plan
for adequate resources to process claims.
•
Individuals and families filing claims with
the VICP do not have access to a support system
to help them navigate through the claims process.
•
The Act has loopholes which some people believe
allows claims alleging injuries from vaccines
and components of licensed vaccines to be filed
in civil courts before first being filed with
the VICP.
•
There is no formal mechanism for petitioners
to provide feedback on their perspectives of
the VICP at the end of the adjudication process.
Similarly,
the Workgroup assessed the VICP’s potential
opportunities, as well as threats, posed by
both internal and external factors. These opportunities
and threats were recognized as follows.
Opportunities
The
VICP could be instrumental in influencing the
adoption of new legal and medical standards
for determining entitlement to compensation
for off-Table claims, which represents an increasing
proportion of newly filed claims.
•
The VICP could assume a leadership role in public
education about vaccine safety by clearly communicating
the benefits and risks of immunization.
•
The VICP can continue to provide protection
from tort liability to vaccine companies and
healthcare providers that administer vaccines.
•
The VICP could enhance vaccine safety research.
• In the face of the potential threat
of bioterrorism, the VICP could serve as a model
for the compensation of those injured by vaccines
administered in response to, or anticipation
of, biological weapons.
•
The VICP has the potential to serve as a model
for the broad reform of medical malpractice
and civil litigation.
•
The VICP could be expanded to cover all vaccines,
such as adult vaccines.
•
The VICP could develop new and more effective
methods to raise awareness about the existence
of the VICP, and educate petitioners, attorneys
and health care providers about the process
of filing a claim with the VICP.
Threats
The
introduction of newer, safer vaccines results
in fewer claims alleging Table injuries and
more claims for off-Table injuries which creates
conflict. Adjudicating off-Table claims is more
adversarial or litigious than adjudicating Table
injuries because the burden of proof that the
vaccine caused the injury is higher.
Relaxed
standards for assessing causation of vaccine-related
injury could jeopardize the public’s trust
of, and reliance upon, vaccines as the first
line defense against serious infectious diseases.
The relaxed standard may lead to more claims
being compensated; and therefore, the public
may think that vaccines are not safe.
Confidence
in the VICP may be eroded by uninformed, misinformed
or politically-motivated negative opinions of
the VICP expressed by public figures.
Not
unlike other Federal programs, the VICP is affected
by the public’s mistrust of the Federal
government.
•
The dramatic increase of thimerosal-related
litigation in the civil courts, as well as the
VICP, may call into question the purpose and
value of the VICP and overly utilize program
resources and funding.
• The VICP is threatened generally by
the public’s relative lack of education
in science, medicine, and law. As a corollary,
if the VICP is not firmly grounded in evidence-based
science, the respect and support of the scientific
and medical communities will be threatened.
•
The public’s unwillingness to accept even
a small degree of risk threatens its level of
immunity against serious infectious disease,
and, hence, threatens the VICP. Because of successful
vaccination programs, society has not experienced
the morbidity associated with vaccine-preventable
diseases which plagued previous generations.
Therefore, society, as a whole, seems less willing
to accept the risk of an adverse event resulting
from a vaccine given to a healthy child.
•
Since the balance in the Trust Fund is currently
over $2 billion, various stakeholders want to
use these funds for purposes other than compensating
individuals injured by vaccines. This results
from a lack of understanding of the need for
risk reserves.
Appendix
I: Glossary
Adjudication
- hearing and settling a case by judicial procedure
Causation-in-fact-
standard of proof which relies on a factual
determination that a vaccine actually caused
an injury or death
Covered
vaccine - a vaccine which is eligible for
compensation under the VICP
Factor
unrelated - a medical condition that is
not linked to the vaccine and is the cause of
the injury that is alleged to be vaccine-related
Off-Table
claims - claims alleging injuries which
are not on the Vaccine Injury Table, or fall
outside the prescribed time intervals
Reversionary
trust agreements - A reversionary trust
is a secure, economical mechanism for the receipt,
management, investment, and disbursement of
a vaccine injury award on behalf of the injured
party. A trust provides protection of the award
by a private corporate trustee from mismanagement,
dissipation or premature exhaustion of award
proceeds. Unlike a guardianship or conservatorship,
a reversionary trust is the tax-free accumulation
of income, which inures to the benefit of the
beneficiary. If unused funds remain in the trust
upon the death of the beneficiary, the funds
"revert," or are returned to the Vaccine
Injury Compensation Trust Fund for disbursement
to future claimants.
Expert
witness program - VICP medical experts
who testify at vaccine injury hearings on behalf
of HHS
Special
master - A special attorney similar to
a judge that is appointed by the U.S. Court
of Federal Claims to preside over vaccine injury
cases
Stakeholder - “one who has a
share or an interest, as in an enterprise”
according to the American Heritage Dictionary.
Stakeholders include individuals and organizations
with an interest in and/or who have direct involvement
with the VICP (e.g., parents and legal guardians
of injured children, petitioners’ attorneys,
vaccine companies, healthcare providers).
Vaccine
Injury Compensation Trust Fund - the funding
source for compensating claims for a vaccine-related
injury or death filed after October 1, 1988
and is funded by a $.75 tax on each “dose”
(disease prevented) contained in a covered vaccine
Vaccine
Injury Table - lists specific injuries
or conditions and the time frames in which they
must occur after vaccine administration and
is a legal mechanism that allows a statutory
"presumption of causation" for vaccines
covered under the VICP
Acronyms/Abbreviations
Act |
National
Childhood Vaccine Injury Act of 1986, as
amended |
ACCV |
Advisory
Commission on Childhood Vaccines |
CDC |
Centers
for Disease Control and Prevention |
Court |
U.S.
Court of Federal Claims |
DVIC |
Division
of Vaccine Injury Compensation |
DOJ |
Department
of Justice |
FDA |
Food
and Drug Administration |
HHS |
Department
of Health and Human Services |
HRSA |
Health
Resources and Services Administration |
IOM |
Institute
of Medicine |
NIH |
National
Institutes of Health |
NPI |
National
Partnership for Immunization |
NVPO |
National
Vaccine Program Office |
Retreat |
VICP
Strategic Planning Retreat |
Secretary |
Secretary
of Health and Human Services |
Table |
Vaccine
Injury Table |
Trust
Fund |
Vaccine
Injury Compensation Trust Fund |
VICP |
National
Vaccine Injury Compensation Program |
Workgroup |
VICP
Strategic Planning Workgroup |
Acknowledgements
The
Division of Vaccine Injury Compensation (DVIC),
Special Programs Bureau, Health Resources and
Services Administration thanks the National
Vaccine Injury Compensation Program Strategic
Planning Workgroup (the Workgroup) for its valuable
time, commitment, and diligent efforts in gathering
data for and developing this Strategic Plan.
The list of Workgroup members is included in
Appendix C. DVIC would also like to thank all
of the stakeholders who were able to participate
in the Retreat (Appendix D), and who contributed
to the development of the Strategic Plan (Appendix
E). In addition, DVIC would to thank the attorneys
at the Department of Justice, Civil Division,
Torts Branch, Vaccine Litigation and the Department
of Health and Human Services, Office of the
General Counsel, Public Health Division for
their review of this plan. This plan was made
possible by the dedication of the Workgroup
and stakeholders.
This
information reflects the current thinking of the United States Department
of Health and Human Services on the topics addressed. This information is
not legal advice and does not create or confer any rights for or on any
person and does not operate to bind the Department or the public. The ultimate
decision about the scope of the statutes authorizing the VICP is within
the authority of the United States Court of Federal Claims, which is responsible
for resolving claims for compensation under the VICP.
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