Vaccine Injury Compensation: Most Claims Took Multiple Years and Many Were Settled through Negotiation
Released: 2014-11-21T00:00:00


Highlights: section_title: Why GAO Did This Study
paragraphs: 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.

section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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. In the  1980s, lawsuits stemming from such incidents threatened to affect the  availability and cost of vaccines as well as the development of new ones.

VICP was established by the National Childhood Vaccine Injury Act of 1986. Pub. L.   No. 99-660, title III, §§ 301 et seq., 100 Stat. 3743, 3755 (amending the Public Health  Service Act by inserting a new title XXI; codified, as amended, at 42 U.S.C. 300aa-1 et  seq.). began in 1988, more than 15,000 claims had been filed and more than  $2.8 billion has been awarded to petitioners.

In 1999, we reported that while the program appears to provide an easier  process for obtaining compensation than through the civil court system,  the claims process was not as quick or easy as expected. Recently,  concerns have been raised about the timeliness for adjudicating VICP  claims and making changes to the vaccine injury table, how the funds in  the Vaccine Injury Compensation Trust Fund have been spent, and  petitioner experiences and awareness of the program. You asked that we  examine these issues. Specifically, this report examines (1) how long it  has taken to adjudicate VICP claims and how claims have been  adjudicated, (2) the changes to the vaccine injury table and in the types of  claims filed, (3) how the balance of and spending from the trust fund have  changed, and (4) available information on petitioner experience with VICP  and how HHS has informed the public of the availability of VICP.

For the purposes of this report, we use the term claim to refer to the petition and case  filed under VICP. We refer to the individuals filing the claims as petitioners. HRSA  administers the program in conjunction with DOJ and USCFC.

1999, and interviewed officials from HRSA and members of its Advisory  Commission on Childhood Vaccines. We also examined HRSA data on  the numbers of claims filed, by vaccine, and USCFC data on the number  of claims alleging injuries on the vaccine injury table. To examine the  balance of and spending from the Vaccine Injury Compensation Trust  Fund, we reviewed reports from the Department of the Treasury  (Treasury), which manages the trust fund, to determine the income into  and disbursements from the trust fund for fiscal years 2009-2013. We  also analyzed HRSA data on the amounts the agency reported for  petitioner compensation and attorneys’ fees and costs, and data from  HRSA, DOJ, and USCFC on the amounts they obligated for  administrative and other expenses related to processing VICP claims for  those fiscal years using appropriations from the trust fund. Finally, to  examine available information on petitioner experience with VICP and  how HHS has informed the public of the availability of VICP, we reviewed  documents, including the Public Health Service Act, agencies’  congressional budget justifications, agency strategic plans, and studies  prepared for HHS. We also reviewed statements and interviewed officials  from HRSA, DOJ, and USCFC and stakeholders (from organizations  representing providers, petitioners’ attorneys, and parents) regarding  available information on petitioner experiences with VICP and steps HHS  has taken to inform the public about the availability of the program. We  determined that the data we used from HRSA, DOJ, and USCFC and  from Treasury reports on the trust fund were sufficiently reliable for our  purposes by discussing data collection processes and limitations of the  data with agency officials, conducting electronic data checks, and  comparing the data against other published sources.

We conducted this performance audit from February 2014 to November  2014 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: 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.
subsections: section_title: Vaccines Covered by the Program and on the Vaccine Injury Table
paragraphs: 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.

section_title: VICP Claims Process
paragraphs: 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.

section_title: Requirements for Disseminating Information on the Program
paragraphs: 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.

section_title: Most Claims Took Multiple Years to Adjudicate and Many Were Adjudicated by Settlement or Addressed by an Omnibus Proceeding
paragraphs: 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.
subsections: section_title: Most Claims Filed Since Fiscal Year 1999 Have Taken Multiple Years to Adjudicate
paragraphs: 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. A HRSA-contracted survey  of petitioners whose claims were adjudicated (regardless of whether or  not they received compensation under VICP), found that nearly two-thirds  of the 103 respondents indicated they were somewhat or very dissatisfied  with the length of the process. decision is not made on their claim within specific time periods but  according to the Office of Special Masters, petitioners rarely exercise this  option.

Altarum Institute, Determining the Feasibility of Evaluating the National Vaccine Injury  Compensation Program, Final Report, a report prepared for the Health Resources and  Services Administration, June 15, 2009. Of 716 petitioners the researchers identified as  meeting their inclusion criteria,107 responded to their survey and 103 responded to this  question on the length of the process. The results of this study cannot be generalized to  the population of all petitioners who completed the VICP process; instead, they reflect only  the VICP petitioners who responded to the survey. According to HRSA, petitioners were  included in the sample if they (1) had filed a claim that had been compensated or  dismissed in fiscal years 2004-2008 and (2) were represented by an attorney. that the time petitioners spend gathering supporting documentation or  evidence can add significantly to the amount of time required to process a  claim. These delays may occur at multiple points in the claims process,  from petitioners needing to gather sufficient documentation for the court  to begin an initial review, to the court needing documentation to  determine the amount of compensation that a successful petitioner will  receive. According to HRSA, for claims adjudicated as of March 31,  2014, its medical review process averaged over 700 days for claims filed  in fiscal year 2010. HRSA attributes the length of time for medical review  primarily to time spent waiting for petitioners to submit requested  documentation. During the medical review, HRSA may also consult with  external experts, who require additional time to review the details of the  case; HRSA’s data indicate that over 1,200 outside reviews were  conducted from fiscal years 2009 to 2014. Additionally, when special  masters are reviewing the claim, a party may request that the special master delay a decision until additional documentation is available.Special masters may also request additional information from  petitioners—such as a specialist physician’s opinion.

section_title: Many Claims Were Adjudicated through Settlement or Grouped in an Omnibus Autism Proceeding
paragraphs: According to HRSA data for claims filed since 2006, most compensated  claims were adjudicated through negotiated settlement rather than a  concession or a contested decision. HRSA’s data indicated that about   80 percent of the more than 1,500 non-autism VICP claims filed since  2006 for which compensation was awarded were adjudicated through a  negotiated settlement between the parties, compared to about 10 percent  involving a contested decision in favor of the petitioner and about   10 percent conceded by HHS. According to HRSA, claims which HHS  does not concede may be resolved via a negotiated settlement for several  reasons, including a desire by both parties to resolve a case quickly and  efficiently. According to the Office of Special Masters, a special master  may recommend parties settle as an expeditious and efficient method of  resolving certain claims.

The Office of Special Masters created an omnibus proceeding in order to  address thousands of autism cases systematically and efficiently.  Beginning in 1999, parents began filing petitions for compensation under  VICP alleging that autism or neurodevelopmental disorders similar to  autism were caused by the measles-mumps-rubella vaccine or vaccines  containing thimerosal, a mercury-containing preservative used in some  vaccines, covered by the program, or both. In 2002, the Office of Special  Masters held a series of meetings with an informal advisory committee,  including attorneys who represented many potential petitioners and legal  and medical representatives of HHS, to address the task of dealing with  these claims. The Office of Special Masters decided to utilize a two-step  procedure: first, looking into whether the vaccinations in question can  cause autism and, if so, the circumstances under which this occurs, and  second, applying the conclusions from the first step to the individual  claims. The omnibus autism proceeding included test cases for two  different theories by which vaccines were alleged to cause autism.  Some petitioners withdrew from the omnibus proceeding and elected to  proceed within the vaccine program on other theories of causation. Some  petitioners withdrew from the program entirely, as was their statutory  right, which enabled them to pursue claims against vaccine  manufacturers in civil court.

The influx of new VICP claims for autism continued in fiscal years 2002- 2005, while the number of new non-autism claims remained relatively  stable (see fig. 3). HRSA data show that during this period, nearly   90 percent of VICP claims filed alleged autism as the vaccine-related  injury. Ultimately, the special masters did not award compensation in any  of the test cases, and most remaining omnibus autism proceeding  claims were dismissed. However, according to the Office of Special  Masters, some petitioners who had been part of the omnibus autism  proceeding continued with claims separate from the omnibus  proceeding.

section_title: Vaccines Have Been Added to the Vaccine Injury Table since Fiscal Year 1999 without Covered Injuries, Resulting in More Off-Table Claims
paragraphs: HHS has added vaccines to the vaccine injury table without adding  covered injuries associated with those vaccines. Following their addition  to the table, more claims were filed for off-table injuries.
subsections: section_title: Six Vaccines Have Been Added to the Vaccine Injury Table since Fiscal Year 1999 without Covered Injuries; HHS Is Considering Additional Changes
paragraphs: 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. In general, each of the six  vaccines was added within 2 years of the Centers for Disease Control  and Prevention’s recommending it for routine administration to children  and having an excise tax imposed. Since 1999, two vaccines, both of  which had covered injuries associated with them, were removed from the  vaccine injury table. See appendix II for the vaccines and injuries added  and removed from the vaccine injury table since 1999. At the end of the  fiscal year 2014, 16 vaccines were covered by the program, 8 of which  did not have associated covered injuries on the table.

HHS has been considering adding injuries to the table in association with  the eight vaccines that are listed without covered injuries. HRSA officials said they are working on a final rule to add an injury  associated with one vaccine and a proposed rule that would add injuries  associated with several other vaccines.

HHS has also been considering adding injuries in association to covered vaccines that  already have associated injuries on the vaccine injury table. vaccine.injury claims attributed to another vaccine that protected against  rotavirus but had been removed from the table in fiscal year 2009.  According to HRSA, the agency is working on a final rule to add this  injury.

In proposing the addition, HRSA considered reviews and

HRSA officials said they are developing a proposed rule to add  covered injuries for all seven of the remaining vaccines on the table  without covered injuries. For example, HRSA is considering proposing  to add Guillain-Barré Syndrome (a disorder in which the body’s  immune system attacks part of the nervous system and is  characterized by muscle weakness and paralysis), as an injury  associated with the influenza vaccine. The agency is also considering  proposing to add other injuries associated with the influenza,  hemophilus influenza type b conjugate, varicella, pneumococcal  conjugate, hepatitis A, meningococcal, and human papillomavirus  vaccines.

According to HRSA officials, the factors informing the table changes that  they are considering proposing include (1) an Institute of Medicine study  of certain vaccines; (2) HHS’s independent review of vaccine causation  and medical and scientific evidence; (3) the need to clarify injury  definitions on the table; and (4) recent studies related to injuries  associated with the influenza vaccine.

As of September 30, 2014, HRSA had not promulgated regulations to  make these changes to the vaccine injury table. According to HRSA  officials, the agency plans  to publish the final rule to add the injury associated with the rotavirus  vaccine to the table by July 2015, and  to publish a proposed rule for the other injuries it is considering adding  to the table by August 2015.

According to HRSA officials, the process to publish such a proposed rule  can take about 9 months to 1.5 years. The officials also said that the  process for publishing such a final rule can take about 1.5 years to   2.5 years after the proposed rule is published. In its justification  accompanying its fiscal year 2013 budget request, HRSA acknowledged  that many stakeholders, including Congress, have voiced interest and  concern over keeping the injury table in line with current science. At that  time, HRSA reported that other VICP activities, including medical reviews  and court deadlines, have taken priority over updating the table.

While the injuries HRSA is considering have not yet been added to the  table, HRSA and DOJ officials report that many claims alleging these  injuries that HRSA is considering adding to the table have been conceded  or settled. For example, according to DOJ officials, there have been  numerous settlements for cases alleging Guillain-Barré Syndrome as an  injury associated with the influenza vaccine.

section_title: Changes in the Vaccine Injury Table Contributed to More Claims for Off-Table Injuries and for Injuries in Adults
paragraphs: The addition of the six vaccines to the vaccine injury table without  associated injuries has contributed to an increase in off-table claims.  When we reported on this program in 1999, 2 of the 12 vaccines on the  injury table were without associated injuries listed on the table. We  reported that about one-quarter (28 percent) of claims filed as of February  1999 were for off-table injuries. In contrast, of the 3,007 claims filed  since fiscal year 2005 (the year that trivalent influenza vaccine was added  to the table) for which the covered vaccine associated with the alleged  injury was specified, at least 59 percent were associated with one of five  vaccines added to the table without associated table injuries, according to  HRSA data.would not have the presumption of causation associated with an on-table  claim. Overall, since 2009, more than 98 percent of the new claims filed  alleged off-table injuries that required the petitioner to prove their injury  was caused by the vaccine they received, according to the Office of  Special Masters.

To receive compensation, the petitioners in these claims  Claims alleging injuries to adults also increased as a result of the addition  of vaccines that are recommended for administration in adults (as well as  children) to the vaccine injury table. Several of the vaccines added to the  injury table—in particular, the vaccine to prevent influenza—are  recommended for routine administration to adults as well as children. As  a result, although the vaccines were added to the table because they  were recommended for children, adults who are vaccinated with them are  also eligible for compensation under VICP. More than half (51 percent) of  the 4,402 VICP claims filed since fiscal year 1999 (for which the covered  vaccine associated with the alleged injury was specified) were for injuries  to adults and 1,287 (29 percent) were for adults alleging injuries in  association with influenza vaccine, according to HRSA data.

section_title: Trust Fund Balance Has Increased since 2009, As Has Petitioner and Attorney Compensation and Other VICP-Related Spending
paragraphs: 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.
subsections: section_title: From Fiscal Year 2009 to 2013 the Trust Fund Balance Gradually Increased to More than $3 Billion
paragraphs: 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. The  balance increased because the trust fund’s income outpaced its  disbursements to HRSA, DOJ, and USCFC, although disbursements   also increased during this period (see fig. 4). Treasury reported over   $200 million in net revenues from the vaccine excise tax in each of fiscal  years 2009-2013. 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. Interest from these  investments ranged from about $49 million in fiscal year 2012 to about  $126 million in fiscal year 2011.

section_title: Spending on Compensation to Petitioners and Attorneys Has Increased since Fiscal Year 1999
paragraphs: Total compensation to petitioners and the number of claims compensated  have both increased since fiscal year 1999. Petitioners’ compensation  paid by HRSA using appropriations from the trust fund increased to over  $254 million in fiscal year 2013. With the exception of fiscal year 2000,  the total amount spent on compensation awarded to petitioners remained  under $125 million between fiscal years 1999 and 2009. The total amount  spent on compensation to petitioners increased to nearly $180 million in  fiscal year 2010 and to more than $250 million in fiscal year 2013 (see   fig. 5 and app. III).

According to the Office of Special Masters, the increase in the total  amount paid to petitioners in compensation and number of compensated  claims is related to the addition of the influenza vaccine to the vaccine  injury table. The influenza vaccine, which is administered to millions of  people each year, was added to the injury table in fiscal year 2005.

The annual amount the VICP program paid for attorneys’ fees and costs  remained relatively steady from fiscal year 1999 to fiscal year 2007, but  started to increase in fiscal year 2008, consistent with an increase in the  total number of payments to attorneys (see fig. 6 and app. III). In order to  help ensure access to the program, VICP may pay for reasonable  attorney fees and costs upon a determination that the petition was  brought in good faith and there was a reasonable basis for the claim for  which the petition was brought, regardless of whether the petitioner’s  claim is compensated or dismissed. The majority of VICP payments for  attorneys’ fees and costs have been for compensated or dismissed  claims; however, since fiscal year 2008, VICP has also paid some interim  attorneys’ fees and costs for selected ongoing claims at the special  master’s discretion. Compensation for attorneys’ fees and costs must be  reasonable such that it generally reflects the actual time and expense  devoted to the case.

section_title: Spending on Agency Staff and Other VICP-Related Expenses Has Increased
paragraphs: The total amount obligated by HRSA, DOJ, and USCFC (for the Office of  Special Masters) to pay for staff and other expenses related to processing  VICP claims increased from $17 million in fiscal year 2009 to about   $19 million in fiscal year 2013. The three departments obligated a total  of about $91 million for expenses associated with processing VICP claims  during those 5 fiscal years. About two-thirds of VICP-related expenses  ($61 million) was obligated to pay the salaries and benefits of full-time  equivalent (FTE) agency staff and about one-third ($30 million) was  obligated for other VICP-related expenses (see table 1).

The amounts obligated for FTE salaries and benefits were for staff of  HRSA, DOJ, and USCFC’s Office of Special Masters who process the  claims and represent the government’s interest in legal proceedings. For  example, USCFC’s Office of Special Masters paid the salaries and  benefits for special masters and clerks. The average number of full-time  equivalent (FTE) staff supported across the three agencies was 81 per  fiscal year.

Each agency also had other VICP-related spending reimbursed by the  trust fund. 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.  HRSA also obligated funds to support the Advisory Commission on  Childhood Vaccines, including compensation and travel expenses for  commission members. The departments reported obligating funds for  costs for travel, processing documents, maintaining records, rent,  supplies, and equipment. For example, obligations include rental  payments to the General Services Administration by DOJ and the cost of  court reporters funded by USCFC’s Office of Special Masters.

section_title: Information on VICP Petitioner Experience Is Limited; HHS Is Taking Steps to Address Criticism of Its Outreach Efforts
paragraphs: Information on petitioners’ experience with VICP is limited. HRSA has  taken some steps to undertake outreach activities, but the agency has not  yet assessed the effect of these efforts.
subsections: section_title: Information on Petitioners’ Experiences with VICP Is Limited
paragraphs: Other than a study for HRSA on petitioners’ satisfaction with VICP, the  agency officials and stakeholders we interviewed and the documents we  reviewed did not identify any data or studies regarding the experience of  individuals who have filed VICP claims. The study prepared for HRSA,  dated 2009, reported the responses from 107 petitioners whose claims  were compensated or dismissed in fiscal years 2004-2008. Because this  was a voluntary survey with a low response rate, its results cannot be  generalized to all petitioners who completed the VICP process; instead, it  reflects only the experience of the VICP petitioners who responded to the  survey. We also obtained comments from stakeholders, including  officials from organizations representing providers, petitioners’ attorneys,  and parents. These stakeholder comments, while providing insight into  petitioner experiences, are anecdotal and do not represent the  experience of all petitioners who have filed VICP claims. Members of the  Advisory Commission on Childhood Vaccines we interviewed expressed  interest in obtaining additional information on petitioner’s experience with  VICP; however, they told us they had not done so, citing concerns about  confidentiality and other issues.

The limited comments on petitioners’ experience from those who  responded to the survey prepared for HRSA and from stakeholders  included the following:

Some petitioners responding to the HRSA survey reported being  dissatisfied with the claims process and some commented that the  process places too great a burden on petitioners and family members,  with requests for additional information after the claims were filed.  Similarly, one stakeholder said that petitioners view the vaccine injury  claims process as confusing, time-consuming, too lengthy, and  traumatic. Another stakeholder, on the other hand, commented that  while vaccine-related injuries do not happen often, the program  handles them efficiently and fairly when they do happen.

Other comments from petitioners responding to the HRSA survey and  stakeholders were related to the payment process and amount of  compensation. More than half of the 61 petitioners who responded to  a question on the method of payment in the HRSA survey reported  being somewhat or very satisfied with the method of award payment;  however, 14 respondents suggested more timely and flexible payment  mechanisms. About half of the 63 respondents to the question on the  amount of compensation reported the award amount was inadequate  to cover past and future medical care. Similarly, stakeholders we  interviewed reported concerns with the amounts petitioners receive,  the method of payment, and a perceived lack of transparency  regarding how the money from the Vaccine Injury Compensation Trust  Fund has been spent. For example, one stakeholder told us that  petitioners felt forced to settle for less than what it will cost them to  care for their children or themselves for their lifetimes, and another  stakeholder raised concerns about the choice of annuities for  petitioners.

Other comments on the program from stakeholders were related to  the perception of an adversarial or unfriendly environment throughout  the process, the use of settlements and perceived pressure to settle  claims, the use of omnibus proceedings to group claims together, and  concerns about confidentiality of the medical information filed by the  petitioner. Some petitioners responding to the HRSA survey and  some stakeholders also reported difficulties finding an attorney to  represent petitioners in the process; however, petitioners responding  to the survey were split on this issue—about the same number  reported that finding an attorney was difficult as reported that finding  an attorney was easy.

section_title: HHS Is Taking Steps to Address Criticism of Its Efforts to Inform the Public of the Program
paragraphs: HRSA has acknowledged being criticized for years for not adequately  promoting public awareness of VICP, and has recently taken some steps,  such as developing and starting to implement an outreach plan for fiscal  year 2014 and developing an outreach plan for fiscal year 2015, to  improve its efforts to reach out to providers and the public. In its 2006  VICP strategic plan, HRSA noted that one of the critical issues facing the  program from 2005 to 2010 was that many parents, the general public,  attorneys, and health care professionals were not aware VICP existed.  In 2009, HRSA contracted for the development of a comprehensive  national marketing and outreach communication plan; the contactor  presented the plan to HRSA in November 2010. According to HRSA,  the agency used this plan to guide outreach efforts. Prior to the fiscal  year 2014 plan, HRSA also reported exhibiting at professional  conferences; updating the VICP website and the VICP booklet that is  available from the website (including translating the booklet into Spanish);  facilitating the review of vaccine information statements (which include a  statement on VICP) by the Advisory Commission on Childhood Vaccines;  and responding to media inquiries and inquiries received via e-mail,  letters, and the program’s toll-free number. HRSA officials also noted  the need to carefully balance messages that increase awareness of VICP  with public health messages that encourage and promote immunizations.

HRSA shared an overview of its outreach plans with its Advisory  Commission on Childhood Vaccines in September 2014. HRSA reported  that many of the activities in the agency’s 2014 outreach plan were in  process at the end of the fiscal year. These activities included reviewing  the VICP booklets to use plain language and make them more user- friendly, reviewing and upgrading the VICP website to improve navigation,  developing VICP message points for target audiences and slides about  the program to be used in speeches and other presentations by HRSA  staff, and requesting federal websites to provide information on the  program and to link to the VICP website. In its outreach plan for fiscal  year 2015, the agency is targeting health care providers, parents and  expectant parents, adults aged 50 years and older (including Spanish- speaking older adults), and civil litigation and health attorneys, with the  goal of informing target audiences of the availability of the program.  According to HRSA, these target audiences were selected because they  include individuals who administer vaccines and individuals (or their  caregivers) who receive vaccinations. HRSA has identified a number of  measures to assist in tracking performance of its fiscal year 2015 plan,  including website metrics, the number of “retweets” and “shares” from  social media initiatives, the number of media inquiries, and the number of  attendees or participants at outreach events. Because the agency has not  completed many of its planned efforts to improve how it informs the public  of the availability of the program, it is too early to determine the effect of  HRSA’s current and planned outreach efforts.

Without awareness of the program, individuals who might otherwise  receive compensation for a vaccine-related injury or death could be  denied compensation because of a failure to file their claim within the  statutory deadlines. One stakeholder commented that the public is largely  unaware of the program, and this lack of awareness contributes to  missing filing deadlines and individuals being denied the opportunity for  compensation. Members of the Advisory Commission on Childhood  Vaccines also told us that many individuals may not know there is a  statute of limitations on filing a claim and many miss the opportunity to file  a claim because of the statute of limitations. In December 2013, the  commission recommended extending the statute of limitations for  vaccine-related injuries and deaths. Extending the statute of limitations  would require amending the applicable statutory provision.

section_title: Concluding Observations
paragraphs: It has been more than 25 years since VICP went into effect in 1988. 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. First, while claims alleging injuries on the vaccine injury table made  up the majority of claims filed in the first decade of the program, today— after the addition of new vaccines, particularly influenza vaccine, to the  table without associated injuries—the majority of the claims filed involve  off-table injuries. Stakeholders report that the program has an adversarial  environment, as petitioners are required to demonstrate a covered  vaccine caused the injury on their VICP claim when there are no  associated injuries on the table. The extent to which this will change if  HHS updates the vaccine injury table to include more injuries, as  expected, is yet to be seen. Second, most of the compensated cases are  now adjudicated through negotiated settlement, rather than contested  decisions before the special master. And while the vaccines covered by  the program are included because they are recommended for children,  many of the program’s petitioners in recent years are adults who received  covered vaccines.

Addressing one criticism of the program by stakeholders—specifically the  need to increase the statute of limitations—would require a statutory  change in the program. Regardless of whether the statute of limitations is  increased, HHS’s efforts to increase awareness of the availability of the  program will be important to help ensure that potential petitioners are  aware of the program and can file claims in time. While HHS has recently  taken or planned steps to improve its outreach activities, what effect, if  any, these efforts will have remains to be seen. As the agency moves  forward, it will be important for HRSA to identify which activities are  reaching its target audiences.

section_title: Agency Comments
paragraphs: We provided a draft of this report to HHS, DOJ, USCFC, and Treasury.  HHS and USCFC agreed with our findings and provided written  comments, which are reprinted in appendixes IV and V, respectively. In  its comments, HHS emphasized that it administers VICP jointly with DOJ  and USCFC, with HHS responsible for reviewing petitioners’ claims,  providing recommendations for entitlement to compensation, and making  payments to petitioners and attorneys. In commenting on our  identification of its efforts on VICP outreach, HHS noted that it is  strengthening its outreach efforts by implementing its fiscal year 2015  VICP outreach plan, which increases outreach to target populations and  includes performance measures. In its written comments, USCFC noted  that the Administrative Office of the United States Courts and USCFC  both supply administrative support to the Office of Special Masters and  VICP without reimbursement from the trust fund. The court also  commented that, while considerable strides have been made in reducing  the average processing time for claims in recent years, the climbing and  changing nature of the caseload, coupled with the statutory cap on the  number of special masters, present a continuing challenge to the Office of  Special Masters’ ability to continue to reduce average processing times.  USCFC also commented that following omnibus proceedings, claims  have been resolved more expeditiously in recent years, and often through  settlements. USCFC also commented that the Office of Special Masters  strives to resolve all cases fairly and expeditiously. HHS, USCFC, DOJ,  and Treasury also provided technical comments that were incorporated,  as appropriate.

We are sending copies of this report to the Secretary of Health and  Human Services, the Attorney General of the United States, the Chief  Judge of the United States Court of Federal Claims, and the Secretary of  the Treasury. In addition, the report is available at no charge on the GAO  website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or crossem@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix VI.

section_title: Appendix I: Vaccine Injury Table, September 2014
paragraphs: 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)

section_title: Appendix II: Covered Vaccines and Injuries on the Vaccine Injury Table, Fiscal Years 1999-2014
subsections: section_title: Vaccine Vaccines and Injuries Added to the Table before Fiscal Year 1999 Tetanus- containing

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

section_title: Appendix III: Compensation to Petitioners and Attorneys’ Fees and Costs, Fiscal Years 1999-2013
paragraphs: 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). It  also shows the amounts the program paid in attorneys’ fees and costs for  those same fiscal years (see table 3).

section_title: Appendix IV: Comments from the Department of Health and Human Services

section_title: Appendix V: Comments from the United States Court of Federal Claims

section_title: Appendix VI: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact

section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Kim Yamane, Assistant Director;  George Bogart; Carolyn Garvey; Cathleen Hamann; Katherine Perry;  Fatima Sharif; and Eric Wedum made key contributions to this report.


Question-summary annotations: questions: question: Why might delays on adjudicating claims occur?
answer: 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.
child_questions: question: To what extent have vaccine injury compensation claims experienced delays?
answer: 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.

question: How is the program attempting to ensure that claims are meeting the target time?
answer: 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.

questions: question: How has HHS changed its vaccine injury table since 1999?
answer: 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.
child_questions: question: What is the consequence of not adding covered injuries?
answer: 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.
child_questions: question: What are some steps the HHS is doing to deal with possible injuries?
answer: 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.

questions: question: What are the benefits and risks of vaccines?
answer: 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.
child_questions: question: What can people do when such instances happen?
answer: VICP provides compensation to people for injuries and deaths associated with certain vaccines for medical and other costs.

question: What is the role of the injury table provided by the program?
answer: The program includes an injury table that lists the injuries that are presumed to be caused by vaccines covered by the program.
child_questions: question: What is the process for injuries not covered by the table?
answer: 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.

question: What is the nature of VICP's compensation fund?
answer: VICP pays claims from a trust fund. Since the program began in 1988, it has awarded more than $2.8 billion in compensation.