About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

GAO-25-107368 1 (2024-12-18)

handle is hein.gao/gaorgb0001 and id is 1 raw text is: Why This Matters Key Takeaways Medical countermeasures, such as vaccines and drugs, are developed to save lives during a public health emergency or security threat, such as the COVID-19 pandemic. Most people who receive a medical countermeasure have no serious problems, but like any medicine, there is a rare chance that a medical countermeasure can cause serious physical injuries or deaths. Individuals who die or are seriously injured by the administration or use of certain medical countermeasures may be eligible to receive compensation. To encourage the development of countermeasures, the Public Readiness and Emergency Preparedness Act (PREP Act) limited the legal liability of manufacturers, distributors, health care providers, and others for losses related to the administration or use of covered countermeasures. It also authorized the Department of Health and Human Services (HHS) to establish the Countermeasures Injury Compensation Program (CICP), which began accepting claims in October 2009. Instead of suing manufacturers or others, individuals can apply to CICP for compensation for serious physical injuries or deaths resulting from covered countermeasures. CICP is operated by the Health Resources and Services Administration (HRSA)-an agency within HHS. Foreign countries also operate medical injury compensation programs. The CARES Act includes a provision for us to report on the federal government's ongoing monitoring and oversight efforts related to the COVID-19 pandemic.II n this report we describe CICP, including its claims adjudication process, and similar programs in selected foreign countries. * HRSA received a large influx of claims in response to the COVID-19 pandemic. Specifically, HRSA received approximately 27 times more claims in response to the COVID-19 pandemic than it had received in the entire first decade of the program-13,333 compared to 491 claims, respectively. * Of the 13,824 total CICP claims received since the start of the program, HRSA had completed the adjudication process for 3,483 of them (25 percent), as of June 2024 (the most recent data available at the time of our analysis). The remaining 10,341 claims were under review or pending HRSA's review. Of the adjudicated claims, 3 percent (92) were found eligible to receive compensation for a serious injury or death directly caused by a covered countermeasure. Most of the claims eligible to receive compensation were for serious injuries or deaths caused by COVID-19 countermeasures (52) or for serious injuries caused by the H1 N1 vaccine (37). * Nearly all the challenges HRSA experienced operating CICP stem from the large influx of claims related to COVID-19 countermeasures and limited Page 1 GAO-25-107368 Medical Countermeasures Injury Compensation Page 1 GAO-25-107368 Medical Countermeasures Injury Compensation

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most