In general, individuals seeking compensation for a vaccine-related injury or death must first file a petition making a claim for compensation under Several federal agencies—HHS, DOJ, VICP before suing in civil court.and USCFC, are involved in administering VICP, and Treasury manages the trust fund which funds compensation for successful claims. VICP includes a vaccine injury table that lists the vaccines covered by the program and the injuries associated with each those vaccines. (See app. I for the table.) Vaccines are added to the list covered by the program after the Centers for Disease Control and Prevention recommends them for routine administration to children and they are made subject to an excise tax that funds the Vaccine Injury Compensation Trust Fund. When individuals submit a claim for an injury listed on the table (called an on- table injury), they do not need to prove that the injury was caused by the vaccine. Instead, if they submit documentation showing that they received a particular vaccine and that they sustained the associated covered injury within the time interval specified on the table, they may receive compensation based on a presumption of causation (unless there is evidence that the injury is due to other factors).compensation may submit claims for injuries not listed on the table (called Individuals seeking off-table injuries) but they need to demonstrate by the preponderance of the evidence that the vaccine caused the alleged injury. HHS has authority to promulgate rules to modify the vaccine injury table when certain criteria are met. HHS is also required to amend the table to include a vaccine within 2 years of the Centers for Disease Control and Prevention’s recommending it for routine administration to children. The Advisory Commission on Childhood Vaccines, which was established by the act creating the program, is required to make recommendations concerning changes to the table. In 1999, GAO reported that HHS added seven injuries and removed three others from the table in 1995 and 1997, respectively, using findings from Institute of Medicine reviews conducted in 1991 and 1994—in conjunction with public policy considerations provided by the Advisory Commission on Childhood Vaccines, scientific issues raised by HHS’s National Vaccine Advisory Committee, and input from the public. Individuals who believe they or their child have been injured by or a death resulted from a vaccine covered by the program may file a petition making a claim with the USCFC. In general, to be eligible for compensation, a petition must be filed (1) for a vaccine-related injury within 3 years of the first symptom of the injury (or significant aggravation of an injury), or (2) for a death within 2 years of the death and within 4 years after the first symptom of the vaccine-related injury (or signification aggravation of an injury) from which the death resulted. HHS, as the respondent in the process, receives a copy of the petition, including medical records, and other documentation filed with the USCFC. HRSA sends a report of its medical review including HHS’s recommendation regarding the claim to DOJ. DOJ lawyers, representing HHS in the proceedings, review the HRSA report and the legal aspects of the claim and produce a report that outlines the government’s position as to why compensation should or should not be awarded, provides a summary and medical analysis of the petitioner’s claims, and asserts applicable legal arguments. After the claim is filed in USCFC, it is assigned to a special master, a judicial officer who examines the evidence and adjudicates the claim. The special master reviews the petition and may order the petitioner to provide additional records if they are missing or if they are insufficient.Additionally, petitioners and DOJ may file expert reports including additional medical evidence from scientific literature or studies. The special master then determines whether a claim should be compensated. For claims that are compensated, there are three adjudication categories: Concession. In a concession, HHS’s review of medical records, scientific literature, and other documents finds that the petitioner is entitled to compensation, because the evidence meets the criteria of the vaccine injury table or because it is more likely than not that the vaccine caused the injury. Negotiated settlement. In a negotiated settlement, the petition is resolved via negotiation between HHS (represented by DOJ) and the petitioner. Contested decision in favor of the petitioner. If HHS does not concede that a petition should be compensated or if both parties do not agree to settle, the special master issues a decision after weighing the evidence presented by both sides, which may involve conducting a hearing. If the petitioner is entitled to compensation as a result of a concession or contested decision in favor of the petitioner, the proceeding then moves to the damages phase, in which the amount of compensation is determined. In a negotiated settlement, the amount of compensation is included in the settlement presented to the special master. VICP may also pay for attorneys’ fees and costs deemed reasonable even for unsuccessful petitioners, and the amounts of these fees and costs may be part of a settlement between the parties or determined by the special masters. After the claim has been adjudicated within VICP, the petitioner may choose to file a suit in civil court. Even if found to be entitled to compensation, the petitioner may elect to reject the compensation awarded and file a suit in civil court. The Vaccine Injury Compensation Trust Fund, managed by Treasury, is funded by an excise tax imposed on each dose of vaccine sold in the United States that is routinely recommended for administration to children. Appropriations from the trust fund to HRSA pay compensation awarded under VICP for vaccine-related injury or death to the petitioner and may also pay for petitioner attorneys’ fees and costs. Appropriations from the trust fund to HRSA, DOJ, and USCFC (for the Office of Special Masters) also pay for administrative and other expenses associated with processing VICP claims. USCFC has managed large influxes of similar vaccine injury claims through omnibus proceedings or groupings of claims. According to the Office of Special Masters, many of the claims alleging that a particular vaccine caused the same injury will rely on similar evidence, so by using omnibus proceedings or groupings to examine evidence for similar claims, the courts can more efficiently review the evidence. In omnibus proceedings, petitioners select a lead claim in each category of injury, and develop these lead claims while the remaining petitioners choosing to participate in the omnibus elect for their remaining claims to be stayed, or put on hold, until the lead claim reaches a final disposition. HHS is required to include a statement of the availability of VICP in the vaccine information materials that health care providers are to distribute to the parent or legal representatives of a child or to any other individual to whom the provider intends to administer a covered vaccine. These materials—referred to as vaccine information statements by HHS—are intended to explain both the benefits and risks of a vaccine covered by VICP. HHS is also required to undertake reasonable efforts to inform the public of the availability of the program. Most of the VICP claims filed since fiscal year 1999 have taken multiple years to adjudicate, but those filed since fiscal year 2009 have taken less time. For many claims, the parties have concluded the proceeding through a negotiated settlement, rather than a contested decision adjudicated by a special master or the courts. Additionally, certain claims were addressed along with similar claims as part of an omnibus proceeding or informal grouping. 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. There was wide variation in the amount of time to adjudicate these claims. The claim that took the shortest time to adjudicate was filed in fiscal year 1999 and took 2 days, and the claim that took the longest time to adjudicate was filed in fiscal year 1999 and took 5,276 days (more than 14 years). 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. 1.) For claims filed since fiscal year 2009, a greater percentage of claims were resolved within 1 or 2 years. One possible reason is that the vast majority of claims alleging autism as the injury were filed prior to fiscal year 2009. Autism claims may have taken longer because they were part of an omnibus proceeding, which suspended activity on most autism claims for a period of time. According to USCFC data, for the more than 1,400 claims filed since fiscal year 2009 that were adjudicated as of March 31, 2014, the average amount of time to adjudicate a claim was 587 days (about 1.6 years). More than 900 (40 percent) of the claims filed since fiscal year 1999 were still pending, which could cause this average to increase over time as these pending claims are resolved (see fig. 2). Of the pending claims, nearly half had been pending for 1 year or less as of March 31, 2014. 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. This target (1,300 days) has been in place since fiscal year 2009, and applies to claims concluded in a given fiscal year, regardless of the year they were filed, excluding claims that alleged autism as the vaccine-related injury. HRSA has reported meeting this goal since fiscal year 2009, except in fiscal year 2012, when VICP claims concluded that year took an average of 1,309 days to complete. Organizations representing petitioners have criticized the program for taking a long time to resolve claims. Petitioners report that long processing times delay receiving compensation to pay medical bills and other expenses related to the alleged injury.