FR 2021-01211

The document marks a significant development in U.S. health policy, specifically regarding the National Vaccine Injury Compensation Program (VICP). The Department of Health and Human Services (HHS) has finalized a rule to amend the Vaccine Injury Table by removing Shoulder Injury Related to Vaccine Administration (SIRVA) and vasovagal syncope. This rule is scheduled to take effect on February 22, 2021. The rule change stems from the belief that these injuries are not directly linked to the vaccines themselves but to improper administration techniques. This final rule and its outcomes are discussed in detail, bringing several issues and potential impacts to light.

General Summary

The central focus of this document is to adjust the Vaccine Injury Table under the VICP. HHS has removed certain injury categories based on the understanding that the injuries result from improper vaccine administration techniques, rather than the vaccine contents themselves. Despite public opposition, the department has argued that this update ensures that VICP resources are used for injuries directly caused by vaccines, aligning with the program’s initial objectives.

Significant Issues and Concerns

Several concerns arise from these changes. Firstly, the lengthy and complex nature of the document may hinder the public’s understanding. Secondly, the removal of SIRVA and vasovagal syncope from the Vaccine Injury Table may increase the risk of litigation in state courts, which could disproportionately impact individuals without the resources to pursue such legal action.

There is also a concern that these changes might be viewed as misaligned with the original purpose of the VICP, especially as they might primarily impact adults, given that 99.2% of SIRVA cases involved adults. This potentially shifts the focus from children, which was the original intent of the program.

Furthermore, the technical language within the document can be challenging for non-experts, reducing accessibility for the general audience. There seems to be conflicting opinions among stakeholders, which suggests a need for more inclusive engagement prior to rule finalization. Finally, the rule’s enactment during an administrative transition raises questions about whether it was rushed or thoroughly considered.

Impact on the Public

The public's understanding of vaccine-related compensation could be substantially impacted by this rule change. By shifting the onus of compensation from the federal program to potential state court actions, individuals may face additional barriers in seeking redress for injuries perceived to be the result of vaccination. The public might also experience confusion regarding what injuries are covered under the VICP, which could influence attitudes toward vaccination.

Impact on Specific Stakeholders

Healthcare professionals, particularly those administering vaccines, could experience a shift in liability. The rule aims to encourage proper administration techniques by redirecting potential negligence claims from the federal program to state courts. This liability shift might raise concerns among healthcare providers about personal risk and professional accountability.

For those who have suffered from SIRVA or vasovagal syncope, accessing compensation may become more challenging, as these individuals would need to engage with the civil tort system rather than the VICP. This may serve as a deterrent for some to seek rightful compensation due to the complexities and costs involved in litigation.

In conclusion, while the rule attempts to realign the VICP with its foundational goals, it also presents potential challenges related to legal accessibility and public understanding. The decision reflects broader issues involved in health policy adjustments, particularly when multiple stakeholders have varied and sometimes conflicting perspectives.

In reviewing the financial references within the document, several key aspects can be highlighted regarding how money is used or referenced in the National Vaccine Injury Compensation Program (VICP) changes.

Financial Impacts and Expenditures

Throughout the document, various financial statistics are provided to give context to the decisions being made. For instance, it is noted that the VICP paid out an average of $30,893,481.90 per year to petitioners alleging Shoulder Injury Related to Vaccine Administration (SIRVA) claims between FY 2017 and FY 2019. Meanwhile, $124,489.56 per year was paid out to petitioners alleging vasovagal syncope claims. These figures indicate substantial financial allocations, demonstrating the significant costs associated with compensating these particular claims under the program.

Budgetary Considerations

The document refers to the economic thresholds under regulatory guidelines. A "significant regulatory action" is mentioned as an action likely to have an annual effect on the economy of $100 million or more. The claim is made that the rule changes in question are not anticipated to reach this threshold, thus not qualifying as "economically significant" under Executive Order 12866. Additionally, there's an emphasis on the Unfunded Mandates Reform Act's requirement for any rule that mandates expenditures of $154 million or more to have a budgetary impact statement, which the current changes do not surpass.

Concerns and Implications

One commenter raised concerns regarding the financial impact by citing statistics from a US Treasury Bulletin, stating that the balance of the VICP's Trust Fund increased from $3.85 billion at the end of FY 2018 to $3.95 billion at the end of FY 2019. This challenges the argument put forward by the rule that financial reasons justify the removal of SIRVA and vasovagal syncope from the Vaccine Injury Table. They argue that SIRVA payouts, making up only 1% of the $4 billion life-to-date total paid by the program, do not pose a significant threat to the Trust Fund.

Potential Implications for Stakeholders

The decision to remove certain injuries from the table might pivot individuals towards litigating in state courts rather than through the VICP, potentially leading to increased costs in legal fees and burdens on personal resources for the affected individuals. The financial burden accompanying these changes raises questions about accessibility, especially for those lacking the means to pursue state court litigation effectively.

In essence, while the rule aims to align financial allocations with what is considered the original intent of the VICP, reflecting on these financial references and implications is crucial to understand the broader economic impact on stakeholders, particularly those directly affected by the removed injuries from the table.