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HEALTH
RESOURCES AND SERVICES ADMINISTRATION
(Vaccine Injury Compensation Program)
FY
2009 Proposed Appropriation Language
For payments from the Vaccine Injury Compensation
Program Trust Fund, such sums as may be necessary
for claims associated with vaccine-related injury
or death with respect to vaccines administered after
September 30, 1988, pursuant to subtitle 2 of title
XXI of the Public Health Service Act, to remain
available until expended: Provided, That for necessary
administrative expenses, not to exceed $4,528,000
shall be available from the Trust Fund to the
Vaccine
Injury Compensation Program
Amounts Available for Obligation
|
FY 2007
Actual |
FY
2008
Enacted |
FY
2009
Estimate |
Unobligated
Balance, Start of Year |
$2,371,000,000
|
$2,610,000,000
|
$2,806,000,000
|
|
Receipts |
241,000,000 |
218,000,000 |
219,000,000 |
Interest
Income |
109,000,000 |
113,000,000 |
117,000,000 |
Total,
Receipts/Collections |
$350,000,000
|
$331,000,000
|
$336,000,000 |
|
Total
Balance/Net Collections |
$2,721,000,000
|
$2,941,000,000
|
$3,142,000,000
|
|
Claims
Appropriation (Obligation) |
98,000,000 |
119,000,000 |
257,000,000 |
Total
Admin.DOJ/Claims Ct/HRSA |
14,000,000 |
16,000,000 |
16,000,000 |
Total
New Obligations |
$112,000,000
|
$135,000,000
|
$273,000,000
|
|
Unobligated
Balance, End of Year |
$2,610,000,000
|
$2,806,000,000
|
$2,869,000,000
|
Budget
Authority by Activity
|
FY
2007
Actual |
FY
2008
Enacted |
FY
2009
Estimate |
Trust
Fund Obligations:
Post-10/1/88 claims |
$98,081,069
|
$119,000,000
|
$257,423,653 |
Administrative
Expenses:
HRSA Direct Operations |
3,982,000 |
5,404,000 |
4,528,000 |
Total
Obligations |
$102,063,069
|
$124,404,000
|
$261,951,653 |
Budget
Authority by Object
|
FY 2008
Enacted |
FY
2009
Estimate |
Increase
or
Decrease |
Insurance
claims and indemnities |
$119,000,000
|
$257,423,653 |
$138,423,653 |
Other
Services (25.2) |
5,404,000 |
4,528,000 |
-876,000 |
Total |
$124,404,000
|
$261,951,653 |
$137,547,653 |
Salaries and
Expenses
|
FY
2008
Enacted |
FY
2009
Estimate |
Increase
or
Decrease |
Other
Services (25.2) |
$5,404,000
|
$4,528,000 |
($876,000) |
Authorizing Legislation
Vaccine
Injury Compensation Program: |
FY
2008
Amount Authorized |
FY
2008 Enacted |
FY
2009
Amount Authorized |
FY
2009 Estimate |
(a)
PHS Act, Title XXI, Subtitle 2, Parts A and
D: |
Pre-FY
1989 Claims |
$110,000,000
|
—
|
$110,000,000
|
—
|
Post-FY
1989 Claims |
Indefinite |
$119,000,000 |
Indefinite |
$257,423,653 |
(b)
Sec. 6601 (r)d ORBA of 1989 (P.L. 101-239):
HRSA Operations |
Indefinite |
$5,404,000
|
Indefinite |
$4,528,000
|
Appropriation
History Table (Pre-1988 Claims Appropriation)
|
Budget
Estimate
to Congress |
House
Allowance |
Senate
Allowance |
Appropriation |
1995 |
110,000,000 |
110,000,000 |
110,000,000 |
110,000,000 |
1996 |
110,000,000 |
110,000,000 |
110,000,000 |
110,000,000 |
1997 |
110,000,000 |
110,000,000 |
110,000,000 |
110,000,000 |
1998 |
--- |
--- |
--- |
--- |
1999 |
--- |
--- |
100,000,000 |
100,000,000 |
2000 |
--- |
--- |
--- |
--- |
2001 |
--- |
--- |
--- |
--- |
2002 |
--- |
--- |
--- |
--- |
2003 |
--- |
--- |
--- |
--- |
2004 |
--- |
--- |
--- |
--- |
2005 |
--- |
--- |
--- |
--- |
2006 |
--- |
--- |
--- |
--- |
2007 |
--- |
--- |
--- |
--- |
2008 |
--- |
--- |
--- |
--- |
National
Vaccine
Injury Compensation Program
|
FY
2007
Actual |
FY
2008
Enacted |
FY
2009
Estimate |
FY
2009 +/-
FY 2008 |
Claims
BA |
$98,081,000
|
$119,000,000
|
$257,423,653
|
$138,423,653
|
Admin
BA |
3,982,000 |
5,404,000 |
4,528,000 |
-876,000 |
Total
BA |
$102,063,000
|
$124,404,000
|
$261,951,653
|
$137,547,653
|
FTE |
16 |
17 |
17 |
--- |
Authorizing
Legislation – Title XXI, Subtitle 2, Parts
A and D, of the Public Health Service Act as amended,
and related legislation.
FY
2009 Authorization |
Such
Sums as Necessary |
Allocation
Method |
Other
|
Program Description and Accomplishments
The National Childhood Vaccine Injury Act of 1986
(the Act) established the National Vaccine Injury
Compensation Program (VICP) to equitably and expeditiously
compensate individuals, or families of individuals,
who have been injured by childhood vaccines, and
to serve as a viable alternative to the traditional
tort system. The Health Resources and Services
Administration (HRSA) administers the VICP in
conjunction with the Department of Justice (DOJ)
and the U.S. Court of Federal Claims (Court).
HRSA has been delegated the authority to administer
Parts A and D of Subtitle 2. Consistent with this
delegation, HRSA:
- receives
petitions for compensation served on the Secretary
of HHS (the Secretary);
-
arranges for medical review of each petition
and supporting documentation by physicians with
special expertise in pediatrics and adult medicine,
and develops recommendations to the Court regarding
the eligibility of petitioners for compensation;
-
publishes notices in the Federal Register of
each petition received;
-
promulgates regulations to modify the Vaccine
Injury Table;
-
provides administrative support to the Advisory
Commission on Childhood Vaccines (ACCV), composed
of nine voting members, including health professionals,
attorneys, and parents of children who have
suffered a vaccine-related injury or death,
and specified HHS agency heads (or their designees);
-
processes award payments to petitioners, and
attorneys for judgments entered by the Court;
and
-
informs the public of the availability of the
VICP.
As
of October 2007, over 2,000 families and individuals
have been awarded compensation totaling over $1.7
billion. FY 2007 resulted in the largest discharged
outlays since the VICP’s inception, with
over $98 million in compensation awards to more
than 80 families and individuals.
This Program's performance measures focus on the
timely adjudication of vaccine injury claims and
monetary awards. From FY 2005-2007, the target
for the percentage of eligible claimants who were
awarded compensation, but opted to reject awards
and elect to pursue civil action has been zero
percent, and the VICP has met its target each
of these fiscal years. Since 2005, the VICP average
time to process claims has been less than its
targets. However, in FY 2007, the VICP did not
meet its target of 1,213 days for this measure
due to petitioner and Court-driven delays in adjudicating
claims. For this period, the performance outcome
was 1,337 days. Since 2005, the VICP has exceeded
its targets for the percentage of cases where
the deadline for the Rule 4(b) report is met once
the case has been deemed complete. In FY 2007,
the Rule 4(b) report deadline was met for 89.3
percent of the cases that were deemed complete
which exceeded the target of 83 percent. Quickly
and efficiently processing settlements is a top
priority for the VICP. In FY 2007, the percentage
of cases in which settlements are processed within
15 weeks was 96.4 percent which surpassed the
target of 92 percent.
In 2007, the VICP was successful in reducing the
average time to approve settlements and to pay
lump sum only awards. The average time that settlements
were approved from the date of receipt of the
DOJ settlement proposal was 9.6 days, which was
less than the target of 10 days. The average time
to pay a lump sump only award from the receipt
of all required documentation to make a payment
was 3.9 days, which was less than the target of
5 days.
A Program Assessment Rating Tool (PART) review
of the VICP was conducted in 2005. The VICP received
a rating of Adequate. The assessment found that
the VICP serves as a favorable alternative to
the traditional tort system, the VICP had data
from 2002-2004 to reflect its progress in achieving
most of its long-term and annual performance measures,
and suggested an independent, comprehensive evaluation
of the VICP be conducted on a regular basis. During
this review, the Program developed a new set of
performance measures that support the purpose
of the VICP which is to fairly compensate individuals
who have been injured by vaccines, and to protect
vaccine manufacturers and administrators from
civil lawsuits.
To improve performance in FY 2007 and beyond,
the VICP is conducting a survey of petitioners
who have had their cases compensated and dismissed
to obtain their views about the VICP. Obtaining
the views of petitioners is critical to improving
the operations of the VICP. In addition, the VICP
is increasing the use of electronic file-sharing
between agencies, expert witnesses, and other
interested parties with the intent of decreasing
the average time to process a claim. The VICP
also plans to continue to delegate executive authority
to sign and discharge compensation payments down
one organization level which expedites outlays
by eliminating one full layer of approval. HRSA
has also obtained the commitment of partners,
such as the HHS Office of the General Counsel
(OGC), to meeting and exceeding all of the VICP
performance goals.
Funding History
VICP
Awards - |
FY
2004 |
$64,023,491
|
FY
2005 |
$59,196,482
|
FY
2006 |
$54,243,624
|
FY
2007 |
$98,081,069
|
FY
2008 |
$119,000,000
|
Budget Request
The FY 2009 Budget Request of $257,423,653 is
an increase of $138,423,653 over the FY 2008 Enacted
Budget and will fund the National Vaccine Injury
Compensation Program (VICP) claims and necessary
administrative costs. The request will fund the
following:
VICP Awards - The VICP awards
payments to individuals, or families of individuals,
who have been injured, or have died, as the result
of receiving a vaccine(s) recommended by the Centers
for Disease Control and Prevention for routine
administration to children. In FY 2009, HRSA estimates
that $257,423,653 will be paid out of the Vaccine
Injury Compensation Trust Fund (Trust Fund) for
payment of awards due to vaccine-related injuries
or deaths. Increased funding levels are necessary
to account for potential outlays resulting from
the 2007-2008 Autism Omnibus hearings, the surge
of retrospective influenza claims which were filed
by July 1, 2007, and the addition of two new vaccines--the
meningococcal and the human papillomavirus vaccines--for
coverage under the VICP which were added February
1, 2007.
This funding level will ensure adequate funds
are available to pay awards allowing the VICP
to continue to meet its zero percent target for
the percentage of eligible claimants who opt to
reject awards and elect to pursue civil action.
Furthermore, this level will enable the VICP to
meet or exceed its target of 5 days for the average
time to pay a lump sump only awards from the receipt
of all required documentation to make a payment
and 12 days for the average time that settlements
are approved from the date of receipt of the DOJ
settlement proposal. The latter target was changed
from 10 to 12 days in order to reflect the maximum
efficiency possible in view of inherent delays
in the process. In preparing a legal opinion for
VICP management, OGC must often consult with the
DOJ attorney to clarify or amend elements in the
settlement proposal. Additionally, the OGC no
longer has an attorney exclusively working on
VICP correspondence and issues. Since OGC attorneys
serve a number of HHS clients, shifting work priorities
and time commitments lead to delays in the process.
Administrative Expenses -HRSA
is anticipating using $4,528,000 from the Trust
Fund for administrative expenses to cover costs
borne by HHS that are associated with the internal
medical review of claims, external medical review
of claims by outside consultants (including, where
warranted, expert testimony to the Court), professional
and administrative support to the ACCV, meeting
specific administrative requirements of the Act,
processing award payments, maintaining necessary
records, and informing the public of the availability
of the VICP. Over 5,200 petitioners have filed
claims under the Autism Omnibus Proceeding, which
is a unique, multi-year adjudicative process to
determine whether vaccines can cause autism or
Autism Spectrum Disorder. Most claims were filed
without medical records, and only a small number
of claims have had HRSA medical review. General
causation hearings on each of three theories of
causation, including representative test cases
for each theory, began in 2007, and are scheduled
to continue through 2008. Regardless of the outcome
of these hearings, the DOJ, who represents the
Secretary, believes HRSA will be required by the
Court to perform medical reviews of the majority
of individual claims currently filed. It is expected
that the Court will begin assigning cases for
review in FY 2008 which would significantly increase
the VICP workload from 235 in FY 2007 to 410 in
FY 2009 (an increase of 43 percent). Claims must
be reviewed within 90 days of assignment by the
Court. A finding of entitlement will also likely
lead to the filing of many additional claims by
petitioners.
#
|
Key
Outcomes |
FY
2004 Actual |
FY
2005 Actual |
FY
2006 |
FY
2007 |
FY
2008 Target |
FY
2009 Target |
Out-Year
Target |
Actual
|
Target |
Target |
Actual
|
Long-Term
Objective 1: II. IMPROVE HEALTH OUTCOMES A.
Expand availability of health care resources
to underserved, vulnerable, and special needs
populations - |
26.II.A.1
|
Percentage
of cases in which judgment awarding compensation
is rejected and an election to pursue a civil
action is filed |
0%
(baseline) |
0% |
0% |
0% |
0% |
0% |
0% |
0% |
- |
26.II.A.2
|
Average
claim processing time |
738
days (baseline) |
894
days |
1005
days |
834
Days |
1213
days |
1337
days |
1433a
days |
1653
days |
- |
26.II.A.3
|
Percentage
of cases where the deadline for the Rule 4(b)
report is met once the case has been deemed
complete. |
75.3%
(baseline) |
83.70% |
80% |
82.40% |
83% |
89.30% |
86% |
86% |
- |
26.II.A.4
|
Decrease
the average time settlements are approved
from the date of receipt of the DOJ settlement
proposal. |
11
days (baseline) |
18
days |
10
days |
11
Days |
10
days |
9.6
days |
10
days |
12b
days |
- |
26.II.A.5
|
Decrease
the average time that lump sum only awards
are paid from the receipt of all required
documentation to make a payment. (Note: OMB
approved this measure change from the “date
of the DOJ clearance letter” to the above
language. FY 06 data is only available from
May-September as the VICP database was modified
in May 2006 to capture data for this revised
measure.) |
5
days (baseline) |
11
days |
5
days |
3
Days |
5
days |
3.9
days |
5
days |
5
days |
- |
# |
Key Outputs |
FY 2004 Actual |
FY 2005 Actual |
FY 2006 |
FY 2007 |
FY 2008 Target/ Est. |
FY 2009 Target/ Est. |
Out-Year Target/ Est. |
Target/ Est. |
Actual |
Target/ Est. |
Actual |
Long-Term Objective
1: II. IMPROVE HEALTH OUTCOMES
A. Expand availability of health care resources
to underserved, vulnerable, and special needs
populations |
Efficiency Measure |
26.E. |
Percentage of cases in which case settlements
are completed within 15 weeks. |
80% (baseline) |
95% |
90% |
97.9% |
92% |
96.4% |
92% |
92% |
|
|
Appropriated Amount ($ Million) |
3.19 |
3.150 |
|
3.562 |
|
3.982 |
5.404 |
4.528 |
|
Notes:
a |
The targets for 26.II.A.2. are increasing
because some claims have been stayed (i.e.,
the Court has stopped the adjudication process
at the request of the petitioner) for several
years and when they are finally resolved,
they will significantly increase processing
times. |
b
|
The increase in targets for 26.II.A.4. reflect
the maximum efficiency possible in view of
the inherent delays in the process |
|