Page 1 GAO-25-107368 Medical Countermeasures Injury Compensation
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.
1
In
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 H1N1 vaccine (37).
• Nearly all the challenges HRSA experienced operating CICP stem from the
large influx of claims related to COVID-19 countermeasures and limited
U.S. Government Accountability Office
VID-19: Information on HHS’s Medical
s Injury Compensation
-25-107368
Report to Congressional Committees
