HEALTH RESOURCES AND SERVICES ADMINISTRATION
(Vaccine Injury Compensation Program)

• Appropriation Language
• Amounts Available for Obligation
• Budget Authority by Activity
• Budget Authority by Object
• Salaries and Expenses
• Authorizing Legislation
• Appropriation History Table
• Vaccine Injury Compensation Program

Appropriation History Table (Pre-1988 Claims Appropriation)

National Vaccine Injury Compensation Program

Authorizing Legislation – Title XXI, Subtitle 2, Parts A and D, of the Public Health Service Act as amended, and related legislation.

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

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.