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

Letter

Background

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.

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. (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.

VICP Claims Process

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.

Requirements for Disseminating Information on the Program

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 Claims Took Multiple Years to Adjudicate and Many Were Adjudicated by Settlement or Addressed by an Omnibus Proceeding

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.

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. 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.

Many Claims Were Adjudicated through Settlement or Grouped in an Omnibus Autism Proceeding

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.

Vaccines Have Been Added to the Vaccine Injury Table since Fiscal Year 1999 without Covered Injuries, Resulting in More Off-Table Claims

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.

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. 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.

Changes in the Vaccine Injury Table Contributed to More Claims for Off-Table Injuries and for Injuries in Adults

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.

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. 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.

Spending on Compensation to Petitioners and Attorneys Has Increased since Fiscal Year 1999

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.

Spending on Agency Staff and Other VICP-Related Expenses Has Increased

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.

Information on VICP Petitioner Experience Is Limited; HHS Is Taking Steps to Address Criticism of Its Outreach Efforts

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.

Information on Petitioners’ Experiences with VICP Is Limited

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.

HHS Is Taking Steps to Address Criticism of Its Efforts to Inform the Public of the Program

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.

Concluding Observations

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.

Agency Comments

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.

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). It also shows the amounts the program paid in attorneys’ fees and costs for those same fiscal years (see table 3).

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

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

Appendix VI: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

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.