Vaccines Covered by the Program and on the Vaccine Injury Table

VICP includes a vaccine injury table that lists the vaccines covered by the  program and the injuries associated with each those vaccines. HHS, as the respondent in the process, receives a copy of the petition,  including medical records, and other documentation filed with the  USCFC. Negotiated settlement. Most Claims Filed Since Fiscal Year 1999 Have Taken Multiple Years to Adjudicate

VICP claims filed since fiscal year 1999 took an average of about 5 and a  half years to adjudicate, according to USCFC data for the nearly 8,800  claims filed since fiscal year 1999 that were adjudicated as of March 31,  2014. More than 1,000 (11 percent) of the claims filed since  fiscal year 1999 were still in process (pending) as of March 31, 2014;  most of these had been pending for 2 years or less (see fig. For claims filed since fiscal year 2009, a greater percentage of claims  were resolved within 1 or 2 years. HHS has reported the program has met its annual target of 1,300 days  (about 3.5 years) for the average time to adjudicate non-autism claims in  all but 1 year since fiscal year 2009. Six Vaccines Have Been Added to the Vaccine Injury Table since Fiscal Year 1999 without Covered Injuries; HHS Is Considering Additional Changes

Since fiscal year 1999, HHS has added six vaccines to the vaccine injury  table (but has not added covered injuries associated with these vaccines  to the table). This means that while individuals may file VICP claims for  those vaccines, each petitioner must demonstrate that the vaccine that  was administered caused the alleged injury. Trust Fund Balance Has Increased since 2009, As Has Petitioner and Attorney Compensation and Other VICP-Related Spending

The Vaccine Injury Compensation Trust Fund balance increased to more  than $3 billion in fiscal year 2013 despite increased spending by HRSA,  DOJ, and USCFC on petitioner compensation, attorneys’ fees and costs,  and other VICP-related expenses. From Fiscal Year 2009 to 2013 the Trust Fund Balance Gradually Increased to More than $3 Billion

The balance in the trust fund increased from $2.9 billion at the end of  fiscal year 2009 to nearly $3.3 billion at the end of fiscal year 2013. As required by applicable law pertaining to the  management of trust funds, Treasury oversees the investment of part of  the net revenue from vaccine excise taxes. Petitioners’ compensation  paid by HRSA using appropriations from the trust fund increased to over  $254 million in fiscal year 2013. For example, HRSA reported obligating about $9.6 million for  medical experts to review petitioner claims and provide expert testimony  during adjudication proceedings for fiscal years 2009 through 2013. In  that time, the program has awarded more than $2.8 billion to thousands  of petitioners. Several aspects of the program have changed over the  years. HHS and USCFC agreed with our findings and provided written  comments, which are reprinted in appendixes IV and V, respectively. HHS, USCFC, DOJ,  and Treasury also provided technical comments that were incorporated,  as appropriate. Appendix I: Vaccine Injury Table, September 2014

Vaccine  Vaccines against tetanus (e.g., DTaP, DTP, DT, Td, or TT)
Vaccines against pertussis (e.g., DTP, DTaP, P, DTP-Hib)
Anaphylaxis or anaphylactic shock  Encephalopathy (or encephalitis)
Vaccines against measles, mumps, rubella in any combination   (e.g., MMR, MR, M, R)
Encephalopathy (or encephalitis)
Vaccines against measles (e.g., MMR, MR, M)
Vaccines against rubella (e.g., MMR, MR, R)
Vaccines against polio (polio live virus-containing (OPV))
Vaccines against polio (polio inactivated virus-containing (IPV))
Vaccines against hemophilus influenzae type b   (Hib conjugate vaccine)
Vaccines against varicella  Vaccines against rotavirus  Vaccines against pneumococcal disease   (pneumococcal conjugate vaccine)  Vaccines against influenza (trivalent vaccine)  Vaccines against meningococcal disease  Vaccines against human papillomavirus (HPV)

Appendix II: Covered Vaccines and Injuries on the Vaccine Injury Table, Fiscal Years 1999-2014

	Vaccine Vaccines and Injuries Added to the Table before Fiscal Year 1999 Tetanus- containing

	Human Papillomavirus Vaccines and Injuries Added and Removed from the Table since Fiscal Year 1999 Hib polysaccharide (unconjugated)

Appendix III: Compensation to Petitioners and Attorneys’ Fees and Costs, Fiscal Years 1999-2013

This appendix shows the total amount paid in compensation to petitioners  under the National Vaccine Injury Compensation Program and the  number of compensated claims in fiscal years 1999-2013 (see table 2).
Why GAO Did This Study

Vaccines save lives by preventing disease in the people who receive them. In some instances, however, a vaccine can have severe side effects, including death or an injury requiring lifetime medical care. VICP provides compensation to people for injuries and deaths associated with certain vaccines for medical and other costs. The program includes an injury table that lists the injuries that are presumed to be caused by vaccines covered by the program. The program may also compensate individuals for injuries not on the table; however, in those cases causation is not presumed. In both cases, medical and other records are required. VICP pays claims from a trust fund. Since the program began in 1988, it has awarded more than $2.8 billion in compensation.
GAO was asked to review the program. GAO examined (1) how long it has taken to adjudicate claims and how claims have been adjudicated, (2) the changes to the vaccine injury table, and (3) how the balance of and spending from the Vaccine Injury Compensation Trust Fund have changed, among other objectives.
GAO examined data and interviewed officials from HHS, DOJ, and USCFC, including data on claims filed since fiscal year 1999 and their status as of March 31, 2014; reviewed laws and agency documents; and reviewed Treasury data and agency data on compensation and obligations for other VICP-related expenses for fiscal years 2009 through 2013.
HHS and USCFC agreed with GAO's findings, and HHS, USCFC, DOJ, and Treasury provided technical comments that were incorporated as appropriate.

What GAO Found

Most of more than 9,800 claims filed with the National Vaccine Injury Compensation Program (VICP) since fiscal year 1999 have taken multiple years to adjudicate (see fig.). More than 1,000 (11 percent) of claims filed since fiscal year 1999 were still in process (pending) as of March 31, 2014; most of these were pending for 2 years or less. A greater percentage of the claims filed since fiscal year 2009 were resolved within 1 or 2 years. In all but 1 year since fiscal year 2009, the program has met the target for the average time to adjudicate claims (about 3.5 years) tracked by the Department of Health and Human Services (HHS), which administers the program. Officials from the U.S. Court of Federal Claims (USCFC), where VICP claims are adjudicated, report that delays may occur while petitioners gather evidence for their claims. Since 2006, about 80 percent of compensated claims have been resolved through a negotiated settlement.
Since fiscal year 1999, HHS has added six vaccines to the vaccine injury table, but it has not added covered injuries associated with these vaccines to the table. This means that while individuals may file VICP claims for these vaccines, each petitioner must demonstrate that the vaccine that was administered caused the alleged injury. HHS is considering adding covered injuries associated with these vaccines; but as of September 2014, it had not published any final rules to do so.
The balance of the Vaccine Injury Compensation Trust Fund, managed by the Department of the Treasury (Treasury) increased from $2.9 billion in fiscal year 2009 to nearly $3.3 billion at the end of fiscal year 2013 as the trust fund's income (from net revenues from vaccine excise taxes and interest on investments) outpaced its disbursements to HHS, USCFC, and the Department of Justice (DOJ), which represents HHS in VICP proceedings. VICP compensation, funded by the trust fund, increased from less than $126 million in each of fiscal years 1999 to 2009 to over $254 million in fiscal year 2013.