GAO-25-107368, COVID-19: Information on HHS’s Medical Countermeasures Injury Compensation Program

Report — GAO-25-107368, COVID-19: Information on HHS’s Medical Countermeasures Injury Compensation Program, dated 2024-12-18, issued by Government Accountability Office.

Full text

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
COVID-19: Information on HHS’s Medical
Countermeasures Injury Compensation
Program
GAO-25-107368
Q&A Report to Congressional Committees
December 18, 2024
Why This Matters
Key Takeaways

Page 2
GAO-25-107368 Medical Countermeasures Injury Compensation
resources prior to fiscal year 2022, according to HRSA officials. These
challenges included having to handle the surge of claims with a shortage of
staff and outdated information systems as well as having limited scientific
evidence concerning whether injuries or deaths were directly caused by
COVID-19 countermeasures. To address these challenges, HRSA hired more
full-time staff and contractors and launched a web portal for online claims
submissions.
•
Thirty-eight foreign countries operate medical injury compensation programs,
including nine developed during the COVID-19 pandemic, according to
research. Additionally, there are three international medical injury
compensation programs. These foreign programs primarily focus on harm
from vaccines, and not from other drugs or medical devices.

There are three categories of individuals eligible to receive compensation
through CICP, according to HRSA regulations: (1) injured countermeasure
recipients; (2) survivors of deceased injured countermeasure recipients who died
as a direct result of the administration or use of a covered countermeasure; and
(3) executors or administrators on behalf of the estates of deceased injured
countermeasure recipients (regardless of their cause of death).2 Compensation
under CICP may include medical expenses, a portion of lost employment
income, and a survivor death benefit.3

To be eligible for compensation, individuals must file a request for benefits form
or letter of intent within one year of the administration or use of a covered
countermeasure and provide medical documentation to support that a covered
countermeasure directly caused a serious physical injury or death.4 Generally,
only injuries warranting hospitalization or those leading to a significant loss of
function or disability are considered serious, according to HRSA regulations. For
HRSA to determine the type and amount of eligible benefits, the individual must
provide documentation, which may include payments made or bills for medical
items or services, lost employment income documentation, or a death certificate.
In general, benefits under CICP are only paid after an individual has made a
good faith attempt to obtain coverage from third-party payers, such as health
insurance.

CICP compensation is only available when the Secretary of Health and Human
Services issues a PREP Act declaration for a specific public health threat,
thereby limiting legal liability for losses related to a covered countermeasure.5 In
March 2020, for example, the Secretary issued such a declaration for COVID-19
(see table 1).6

Who is eligible to
receive compensation
under CICP for injuries
or deaths caused by
vaccines or other
covered
countermeasures?

Page 3
GAO-25-107368 Medical Countermeasures Injury Compensation
Table 1: Public Health Threats Triggering Eligibility for Compensation through the
Countermeasures Injury Compensation Program (CICP), by Public Readiness and
Emergency Preparedness Act (PREP Act) Declaration Date, as of December 2024
Eligible public health threats  Effective date of PREP Act
declaration
Expiration date of PREP Act
declaration
Anthrax
October 1, 2008
December 31, 2027
Acute radiation syndrome
October 10, 2008
December 31, 2027
Botulinum toxin
October 10, 2008
December 31, 2027
Pandemic influenza
October 10, 2008
December 31, 2027
Smallpox and other
orthopoxviruses (e.g., mpox)
October 10, 2008
December 31, 2032
Ebola
December 3, 2014
December 31, 2028
Zika
August 1, 2016
December 31, 2027
Nerve agents and certain
insecticides
April 11, 2017
December 31, 2027
COVID-19
February 4, 2020
December 31, 2029
Marburg
November 25, 2020
December 31, 2028
Source: GAO analysis of declarations made by the Secretary of Health and Human Services.  I  GAO-25-107368

Once a CICP claim is submitted, HRSA adjudicates each claim individually.
HRSA’s adjudication process includes an administrative review with an initial
eligibility check and, if the claim is found eligible to proceed, a medical review to
assess a claimant’s medical records against medical and scientific evidence,
such as published peer-reviewed literature and government reports. See figure 1
for more details on HRSA’s process.
What is HRSA’s
process for
adjudicating a CICP
claim?

Page 4
GAO-25-107368 Medical Countermeasures Injury Compensation
Figure 1: Health Resources and Services Administration’s (HRSA) Process for Adjudicating Countermeasures Injury
Compensation Program (CICP) Claims

aPrior to September 2021, claimants could only submit a request for benefits form, or letter of intent, and supporting documentation to HRSA by mail. For
claimants who have set up an account through the CICP web portal, HRSA is able to provide an electronic status update.
bTo be eligible for compensation, an individual must submit a request for benefits form, or letter of intent, within one year of the administration or use of a
covered countermeasure, which is a countermeasure that is covered by a Public Readiness and Emergency Preparedness Act (PREP Act) declaration.
cThe claimant can request reconsideration of HRSA’s eligibility benefits decisions or the type and amount of benefits decision by submitting a request for
reconsideration postmarked within 60 days of the original decision.
dUnder the PREP Act, direct causation must be based on compelling, reliable, valid, medical and scientific evidence. 42 U.S.C. § 247d-6e(b)(4).

The PREP Act requires the Secretary of Health and Human Services to develop
countermeasure injury tables that list and explain injuries that are presumed to
be directly caused by a covered countermeasure on the basis of medical and
scientific evidence and within set parameters.7 For example, in the Pandemic
Influenza Countermeasures Injury Table, Guillain-Barré syndrome, a condition
that results in numbness and often paralysis, is listed as a serious physical injury
caused by the H1N1 vaccine. The use of a countermeasure injury table may
decrease the time and resources to review a claim as it is already determined
that the injury can be directly caused by the administration or use of the

Page 5
GAO-25-107368 Medical Countermeasures Injury Compensation
countermeasure, according to HRSA officials. HRSA has established
countermeasure injury tables for pandemic influenza and smallpox, effective as
of September 8, 2015, and September 15, 2021, respectively.8 HRSA officials
said they are in the process of developing countermeasure injury tables for other
public health and security threats, such as COVID-19.

If a claimant believes that HRSA wrongly deemed their claim to be ineligible for
compensation, or if they disagree with the amount of compensation, the claimant
can request HRSA to reconsider its decision by submitting a request in writing.9
According to HRSA regulations, no additional documentation may be submitted
along with the request for reconsideration.
When HRSA receives a request for reconsideration, it convenes an independent,
qualified panel to review HRSA’s original determination. HRSA officials told us
that the panels do not include CICP employees and are instead staffed with
either contracted staff or U.S. Public Health Service Commissioned Corps
officers, which may include physicians and nurses. The panel submits its findings
and recommendations to the Associate Administrator of HRSA’s Health Systems
Bureau, who reviews the panel's recommendations and makes a final decision.
This decision is sent to the claimant and is HRSA’s final action on the request for
reconsideration. Claimants may not seek additional administrative or judicial
review of a decision made on a reconsideration.10
HRSA officials told us that a panel’s review caseload often depends on the
reason for the reconsideration. For example, for reconsiderations of an
administrative review decision, such as missing a filing deadline or missing
paperwork, a panel reviews 10 to 12 cases at a time. For reconsiderations of a
medical review decision, however, officials told us that a panel typically reviews 2
to 3 cases at a time because of the significant amount of medical documentation
to assess. According to HRSA officials, there have been 59 panels from March
2021 (when HRSA began receiving requests for reconsideration related to
COVID-19) through June 2024.

Since CICP began accepting claims in October 2009, the program has received
13,824 claims, with the vast majority in response to the COVID-19 pandemic.
Specifically, HRSA received about 27 times more claims in response to the
COVID-19 pandemic than in the entire first decade of the program—13,333
compared to 491 claims, respectively. (See fig. 2.) Prior to the COVID-19
pandemic, HRSA received claims related to countermeasures administered or
used for pandemic influenza (e.g., H1N1) and smallpox viruses, among other
things.
How many and what
types of claims has
CICP received from
2009 through 2024?

Page 6
GAO-25-107368 Medical Countermeasures Injury Compensation
Figure 2: Countermeasures Injury Compensation Program (CICP) Total Claim Submissions, by Fiscal Year, as of June 2024

Notes: Data reflect October 2009, when the agency began accepting CICP claims, through June 2024, the most recent data available when we
conducted our analysis. Fiscal year 2024 includes claims through June.
Decisions. HRSA made claims decisions for 3,483 of the 13,824 total CICP
claims (25 percent) as of June 2024, the most recent data available at the time of
our analysis. Of the 3,483 claims that have completed HRSA’s adjudication
process, 3 percent (92) were found eligible to receive compensation for a serious
injury or death directly caused by a covered countermeasure. Fifty-two of the
claims that received compensation were for serious injuries or deaths caused by
COVID-19 countermeasures, 37 were for serious injuries caused by the H1N1
vaccine, and the remaining 3 were for serious injuries or deaths caused by
smallpox and anthrax countermeasures. Missing the filing deadline was the most
common reason for ineligible claim decisions. (See fig. 3.)

Page 7
GAO-25-107368 Medical Countermeasures Injury Compensation
Figure 3: Countermeasures Injury Compensation Program (CICP) Claims Decisions, All Covered Countermeasures, as of June
2024

Note: Data reflect October 2009, when the agency began accepting CICP claims, through June 2024, the latest data available when we conducted our
analysis.

Adjudication time frames. As of June 2024, HRSA data show that it took the
agency 24 months on average (range of 5 to 39 months) to complete both the
initial eligibility check and medical review needed to make a claim decision.11 For
those claims that were deemed ineligible after the initial eligibility check, HRSA
took 14 months on average (range of 2 days to 38 months) to make that
determination, as of June 2024.12 HRSA officials noted that these review time
frames include back-and-forth communication with claimants if additional
documentation is necessary to make a determination, and claimants have 60
days to respond to each request. HRSA began tracking adjudication time frames
in the summer of 2021.

Compensation awarded. As of June 2024, HRSA had paid 51 of the 92 claims
eligible for compensation, totaling about $6,495,000. Most of the payments
($6,100,000) were for deaths or serious injuries, such as Guillain-Barré
syndrome, caused by the H1N1 vaccine. These payments ranged from $31 to
$2,295,930 per claim. About $419,000 in payments went to 14 claimants for
serious injuries caused by COVID-19 countermeasures, such as myocarditis or
myopericarditis, which are inflammatory heart conditions that can cause a decline
in heart function. The payments related to COVID-19 countermeasures ranged
from $1,032 to $370,376 per claim. As of June 2024, 41 claims eligible for
compensation were pending a decision on the benefit amount.

Page 8
GAO-25-107368 Medical Countermeasures Injury Compensation

HRSA data showed that of the 3,484 claims that completed HRSA’s adjudication
process, 486 requests had been submitted to HRSA to reconsider CICP claim
decisions, as of July 2024.13 Nearly all of the requests were related to COVID-19
countermeasures and over 80 percent (394) were related to a claimant
disagreeing with a decision made during the administrative review, such as
missing a filing deadline or not providing supporting documentation.
Of these requests, HRSA’s independent reconsideration panel reviewed 392 (81
percent) as of July 2024. Of these, the panel found that 389 (99 percent)
remained ineligible for compensation and 3 claims (1 percent) had the decision
reversed and were sent back to CICP to conduct a medical review. Forty-nine of
these requests to reconsider claim decisions were waiting to be reviewed or
pending a decision from HRSA.

Nearly all of the challenges HRSA experienced operating CICP stem from the
large influx of claims the agency received related to COVID-19 countermeasures
and limited resources prior to fiscal year 2022, according to HRSA officials.
These challenges were:

Shortage of staff to adjudicate large influx of claims. The agency did not
have the number of staff needed to conduct administrative and medical reviews
for the large volume of COVID-19 claims, according to HRSA officials. Officials
told us that CICP had four staff at the start of the COVID-19 pandemic.

Outdated information systems to process large number of claims. HRSA
officials told us that, at the beginning of the COVID-19 pandemic, individuals
mailed claims to HRSA because there was no way for them to electronically
submit them. Officials said when a mailed claim was received, staff manually
entered the information into the claims management system. Additionally, a time-
intensive step of the claims adjudication process—the medical review—is
manually tracked outside of the agency’s claims management system because it
involves multiple steps to ensure a rigorous review, according to agency officials.
Lastly, officials told us that all of HRSA’s official communications with claimants,
such as claim decisions and requests for additional information, are conducted
via certified mail because HRSA does not have a secure direct two-way
electronic mailbox to email claimants.

Limited medical and scientific evidence to base decisions about injuries or
deaths allegedly caused by novel COVID-19 countermeasures. HRSA
officials told us there was limited medical and scientific evidence concerning
whether injuries or deaths were directly caused by covered COVID-19
countermeasures, in part, because the disease and related countermeasures
were novel at the time. HRSA officials also told us the lack of medical and
scientific evidence was challenging for medical reviewers to quickly determine
whether there was causality between COVID-19 countermeasures and injuries
and death. Instead, reviewers carefully considered the facts on a case-by-case
basis to determine eligibility for benefits, adding time to the claim adjudication
process.

HRSA took several actions to address challenges related to adjudicating the
large influx of COVID-19 countermeasure injury claims. These actions generally
responded to challenges related to staffing shortages, outdated information
systems, and limited COVID-19 medical and scientific evidence.

How many requests
has HRSA received to
reconsider its claim
decisions?
What challenges has
HRSA experienced
operating CICP,
including those related
to COVID-19?
What actions has HRSA
taken to address
challenges operating
CICP, including those
related to COVID-19?

Page 9
GAO-25-107368 Medical Countermeasures Injury Compensation
Actions to address staffing challenges

Hired and contracted additional staff to expand capacity. HRSA hired 32
additional full-time staff in fiscal year 2022—an increase of 800 percent from the
previous fiscal year—to help adjudicate the large influx of claims related to
COVID-19 countermeasures. In addition to these 32 staff, HRSA officials told us
they contracted with companies to expand the agency’s ability to quickly scale
medical review capacity as needed (see table 2).

Table 2. Countermeasures Injury Compensation Program (CICP) Staff Hiring and Attrition,
Fiscal Years 2021-2024

2021
2022
2023
2024a
Number of staff at
start of year
4
4
35
36
Staff new hires
0
32
2
1
Staff attrition
0
1
1
8
Number of staff at
end of year
4
35
36
29
Contracted
medical reviewers
0
0
30
15
Source: GAO analysis of Health Resources and Services Administration information.  I  GAO-25-107368
aFiscal year 2024 information is as of August 1, 2024.

These additional staff allowed CICP to initiate the adjudication of about 600
claims in fiscal year 2022 compared to 30 claim adjudications initiated in fiscal
year 2021, according to HRSA’s budget justification for fiscal year 2024. HRSA
officials told us that with the current number of staff (29) as of fiscal year 2024,
HRSA’s target is to adjudicate 2,000 claims per year. According to HRSA data,
the agency adjudicated 91 claims in fiscal year 2022, 1,177 claims in fiscal year
2023, and 1,924 claims in fiscal year 2024 (as of August 1, 2024). Assuming that
HRSA can continue to retain enough staff to adjudicate 2,000 claims per year,
the agency would finish reviewing all of the claims it has as of June 2024 in the
next five years.

In September 2021, HRSA began contracting with a call center to expand its
ability to provide claimants with general program information and update a
claimant’s email or mailing address. At the beginning of the COVID-19 pandemic,
CICP had one staff member available for these purposes. According to HRSA
documents, HRSA has the option to use these call center services through
September 2026.

Developed new staff guidance and support program. HRSA developed
guidance and flowcharts for administrative and medical review processes to
quickly onboard new staff. For example, HRSA created instructions to determine
if a claim was filed within the appropriate time period and checklists for medical
reviewers to write recommendations consistently and efficiently. HRSA also
developed a peer-to-peer support system pairing new staff during training to
discuss guidance and elevate questions to leadership when appropriate. HRSA
officials told us they took these actions to quickly train a large number of new
staff in a program with few experienced staff.

Actions to address information system challenges

Launched web portal for claim submissions and status updates. In
September 2021, HRSA launched a web portal where individuals can submit and
check the status of their claim, according to officials. Officials told us that

Page 10
GAO-25-107368 Medical Countermeasures Injury Compensation
information submitted through the web portal is automatically uploaded into
HRSA’s claims management system. Individuals can still submit claims via mail.
From October 2009 through May 2024, HRSA officials said they received about
41 percent of claims through the CICP web portal and about 59 percent via mail.

Implemented software to upload mailed submissions. In September 2023,
HRSA implemented a software system that automatically uploads information
from mailed claims into HRSA’s claims management system. According to HRSA
officials, staff scan the submission and the software uploads the information in
seconds compared to the 20-to-30 minutes it previously took for staff to manually
enter information into the claims management system.

Actions to address COVID-19 medical and scientific evidence challenges

Started developing COVID-19 Countermeasure Injury Table. HRSA officials
said the agency began initial development of a countermeasure injury table to
facilitate quicker reviews of medical evidence for COVID-19 countermeasure
injury and death claims in February 2022. In developing the table, HRSA
requested the National Academies of Sciences, Engineering, and Medicine
review and report on the evidence regarding specific potential harms related to
COVID-19 vaccines in September 2022. This report was issued in April 2024.14
HRSA planned to publish the proposed injury table in November 2024, according
to the Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions, the
most recent agenda available as of December 2024.15

Developed medical report template. To promote consistency in writing medical
recommendations across COVID-19 countermeasure injury claims, HRSA
developed a medical report template in September 2023. The template enables
medical reviewers to more easily assess alleged injuries or death against
available peer-reviewed medical and scientific literature. HRSA officials told us
this template was incorporated as part of training to onboard new staff and helps
medical reviewers efficiently and consistently apply the standard of evidence
required by the PREP Act to each claim.

HRSA has taken steps to better prepare CICP to adjudicate medical
countermeasure injury compensation claims for future public health emergencies
and risks of such emergencies. Specifically, HRSA has taken steps to 1) improve
its claims management system; 2) ensure staffing can be scaled up quickly; and
3) increase coordination with other public health emergency response agencies.

Improving claims management system. According to HRSA documents and
officials, the agency plans to launch a new claims management system in 2025
that will track and upload information from the medical review into the system,
which is not possible with the agency’s current system.

HRSA officials told us that the new claims management system will include a
secure electronic inbox that allows for direct two-way communication with
claimants. According to officials, the only secure way HRSA can currently
communicate claim decisions and requests for additional information with
claimants is through mail that requires a signature upon receipt. HRSA officials
told us this two-way communication will speed up the review process and allow
claimants to receive personal responses to case-specific questions in real time.

Ensuring staffing is quickly scalable. In July 2022, HRSA established a
blanket purchase agreement for contracted medical expert services that can be
used on an as-needed basis, such as when the program needs additional
What steps has HRSA
taken to prepare CICP
for future public health
emergencies?

Page 11
GAO-25-107368 Medical Countermeasures Injury Compensation
medical reviewers to support processing an influx of CICP claims. HRSA officials
said that the agency can only execute this blanket purchase agreement if there is
funding available to pay for these services. According to HRSA officials, CICP is
funded through appropriations, of which the first direct appropriation was
received in fiscal year 2022. This means HRSA must wait for additional
appropriations or transfer funds to increase spending. If funding is available,
however, this agreement would provide HRSA flexibility to respond to future
public health emergencies (or risks of such emergencies), for example, by
quickly increasing staffing to meet program needs.16

HRSA officials told us different potential CICP funding models may better
position CICP to quickly scale up staffing during future public health
emergencies. For example, officials told us a funding model similar to the
agency’s Vaccine Injury Compensation Program (VICP) would allow HRSA to
scale its CICP operations in proportion to need during a future public health
emergency. VICP pays for compensation of injuries or deaths from certain
routine vaccines and operations through a trust fund that is financed by an excise
tax on vaccines covered by the program.17 (See app. I for information about VICP
and how it compares to CICP).

Increasing interagency coordination. HRSA is increasing its participation in
interagency workgroups to help ensure that CICP is included in discussions
about timely and coordinated responses to public health emergencies (or risks of
such emergencies), according to HRSA officials. For example, officials told us
they are involved in working groups with the Administration for Strategic
Preparedness and Response, within HHS, addressing emerging H5N1 and mpox
outbreaks. Through participation in these workgroups, officials told us they are
learning what types of covered countermeasures may be deployed if these
outbreaks become public health emergencies so they can prepare for potential
injury or death claims.

Additionally, HRSA officials told us they are working with an interagency vaccine
working group headed by the Office of the Assistant Secretary for Health to
include information on HRSA’s vaccine-related compensation programs, CICP
and VICP, in the next iteration of the Vaccines National Strategic Plan. This
interagency vaccine working group includes agencies such as the Centers for
Disease Control and Prevention, the Food and Drug Administration, and the
National Institutes of Health.

As of October 2024, 38 foreign countries and three international programs
operate medical injury compensation programs for injuries or deaths from
COVID-19 vaccines, according to research from the University of Oxford.18 Nine
of the 38 programs in foreign countries were formed during the COVID-19
pandemic. Additionally, some of these 38 programs provide compensation for
injuries or deaths from routinely administered vaccines or pharmaceuticals, such
as Canada’s Vaccine Injury Support Program and the Swedish Pharmaceutical
Insurer, according to program documents and officials.

The five selected medical injury compensation programs we reviewed—four from
foreign countries and one international program representing 92 foreign
countries—have an administrative process for adjudicating claims. Under this
process, claimants submit a form and supporting documentation to prove
eligibility and compensation amounts and can appeal a claim decision about
compensation. The five programs have varying standards for the causal link
required between the vaccine and claimed injury. These five programs also differ
by date of implementation, filing deadline, and available benefits (see table 3).
What programs exist in
foreign countries to
compensate individuals
for injuries or deaths
related to COVID-19
vaccines?

Page 12
GAO-25-107368 Medical Countermeasures Injury Compensation
Table 3. Description of Select Foreign Countries’ and International Medical Injury Compensation Programs

Name of Program
(Country or
International)
Year of
implementation
Program
administrator
Products covered
Filing deadline
Benefits available
Vaccine Injury Support
Program (Canada)
2021 Contracted claims
administrator
COVID-19 and
routinely
administered
vaccines
3 years from
vaccine
administration or
adverse event
occurrence
Health care
provider fees and
uncovered medical
expenses, financial
losses, death
benefits, funeral
costs
Vaccine Injury Financial
Assistance Programme for
COVID-19 Vaccination
(Singapore)
2021 Federal government COVID-19 vaccines
3 years from
adverse event
occurrence
Fixed sum for
severe disability,
death, inpatient
hospital carea
Swedish Pharmaceutical
Insurer (Sweden)
1978 Independent
pharmaceutical
insurerb
COVID-19 and
routinely
administered
vaccines, and
pharmaceutical
products
10 years from
vaccine
administration or
use of drug
Loss of income,
pain and suffering
compensation,
permanent injury
compensation
Compensation and
Satisfaction for Loss or
Damage as a
Consequence of
Vaccination (Switzerland)
2016c Federal government COVID-19 and
officially ordered or
officially
recommended
vaccines
5 years from
vaccine
administration or by
age 21
Compensation and
satisfaction for loss
and damage (e.g.,
loss of income and
cost for treatment)
COVAX No-Fault
Compensation Program
for Advance Market
Commitment Eligible
Economiesd (International)
2021 Contracted claims
administrator
COVID-19 vaccines
Up to 5 years from
vaccine
administratione
Fixed sum for
permanent injury,
death, hospital caref
Source: GAO analysis of the University of Oxford’s COVID-19 Vaccine No-Fault Compensation Schemes Program and selected foreign countries’ and international medical injury compensation program
information and interviews with officials.  |  GAO-25-107368
aPayments depend on the severity of the adverse reaction.
bSweden’s independent claims administrator (Swedish Pharmaceutical Insurer) was created for companies and organizations that work with
pharmaceuticals in Sweden. Owning a share in this company ensures patients using any shareholder’s pharmaceutical product the right to have their
injury investigated by the Swedish Pharmaceutical Insurer and if relevant, receive compensation. Almost all companies and organizations that provide
pharmaceutical products in Sweden (99.7 percent) are shareholders.
cSwitzerland had a pre-existing injury compensation program for mandatory or officially recommended vaccines starting in 1970, which was administered
at the canton (i.e., state) level. In 2016, the program was transferred to the federal level and the federal government became the administrator.
dThe COVAX No-Fault Compensation Program for Advanced Market Commitment Eligible Economies (COVAX) receives claims related to serious
injuries or deaths from COVID-19 vaccines earmarked for delivery through the COVAX facility to 92 middle- and low-income countries up to and
inclusive of June 30, 2023.
eClaimants must have received the vaccine within 2 years from the date on which the vaccine was first put into circulation by the manufacturer in any
country (whether within or outside the framework of the COVAX facility) following regulatory approval or an emergency use authorization of such vaccine
by any regulator. Depending on the date of administration of a vaccine, claimants have 5 years from the date of administration to file a claim. All claims
must be submitted before June 30, 2027, when the program’s application process will come to an end.
fCalculations to determine payment include factors such as the severity of injury and cost of living and a fixed per-day payment for hospital stays up to
60 days.

Officials from the selected foreign countries told us about some unique
characteristics of their medical injury compensation programs. For example:

•
A Swedish official told us that claimants can provide the program with power
of attorney to obtain medical records needed to adjudicate their claim, which
speeds up the process.

•
Canadian officials told us that while the Public Health Agency of Canada
funds and sets the policies for Canada’s medical injury compensation
program, this program is administered by a third-party for-profit organization.

•
Singaporean officials told us compensation through their program is based on
severity of the injury with three different payment tiers. The highest amount of

Page 13
GAO-25-107368 Medical Countermeasures Injury Compensation
compensation, according to officials, is reserved for permanent severe
disability and death.

•
Swiss officials told us claims are not adjudicated in the context of a dedicated
program, but by cross-disciplinary staff from the federal Department of Home
Affairs.

Officials from three of the four selected foreign countries said they have taken or
plan to take actions in response to their experiences operating these programs
during the COVID-19 pandemic. For example, according to officials, two
programs experienced a large influx of claims in response to the COVID-19
pandemic and one program balanced adjudicating claims while simultaneously
setting up their medical injury compensation program. According to officials,
actions in response to experiences during the pandemic will help prepare their
medical compensation programs for future public health emergencies, and
include the following:

Creating contracts to quickly hire staff. An official from Sweden, for example,
told us it was important to have contracts in place to hire additional medical
reviewers as needed. According to this official, because their program had these
contracts in place prior to the COVID-19 pandemic, they were able to quickly hire
additional staff without disrupting the average time for adjudicating claims despite
experiencing an influx of claims for COVID-19 vaccines.
Evaluating programs. Officials from Singapore and Canada told us they plan to
evaluate their newly created programs, which were created during the COVID-19
pandemic, to prepare for future public health emergencies. Officials from Canada
told us that setting up their program was particularly difficult due to the large
influx of claims they experienced during the pandemic. Additionally, officials from
Canada told us that they plan to meet with other countries to learn more about
their medical injury compensation programs and what these countries have
learned in response to their experiences operating these programs during the
COVID-19 pandemic. Officials from Singapore told us their evaluation will include
communications on complex topics like adverse events and causation.

We provided a draft of this report to HHS for review and comments. We also
provided excerpts of this report to the five foreign selected medical injury
compensation programs we examined for their review and comment. HHS and
the five foreign programs provided technical comments, which we incorporated
as appropriate.

We reviewed relevant HRSA documentation, including regulations, policies,
guidance, training materials, and budget documents. We also interviewed agency
officials about CICP.

We analyzed HRSA data on CICP claims submitted from October 2009 (the date
CICP began accepting claims) through June 2024 (the most recent data
available at the time of our analysis). Additionally, we analyzed HRSA data on
requests to reconsider CICP claim decisions from January 2022 (the date CICP
established a comprehensive data set for reconsideration requests) through July
2024 (the most recent data available at the time of our analysis). To assess the
reliability of these data, we reviewed relevant documentation, interviewed HRSA
officials, and performed electronic testing for missing values and obvious errors.
We found these data to be sufficiently reliable for our reporting purposes.

To what extent have
selected foreign
countries taken actions
to prepare their medical
injury compensation
programs for future
public health
emergencies?
Agency Comments
How GAO Did This
Study

Page 14
GAO-25-107368 Medical Countermeasures Injury Compensation
In addition, we reviewed documentation from University of Oxford’s COVID-19
Vaccine No-Fault Compensation Schemes Project that identifies and describes
all known medical injury compensation programs that include COVID-19
vaccines worldwide. We identified this as the only available source that mapped
and categorized all known worldwide medical injury compensation programs.

We conducted interviews with officials and reviewed documents from a non-
generalizable sample of four foreign countries—Canada, Singapore, Sweden,
and Switzerland—that have medical injury compensation programs that include
COVID-19 vaccines. We selected these countries for variation in length of time of
program operation and claim filing deadlines, and variation in COVID-19 vaccine
administration rates. These selection factors provided context for a variety of
program experiences and actions. For example, programs in countries with
higher COVID-19 vaccination rates may have higher claims volumes, and
therefore, different experiences than programs in countries with lower vaccination
rates.

We also interviewed officials from one international program—the COVAX No-
Fault Compensation Program for Advanced Market Commitment Eligible
Economies. We selected this program because of the three international
programs, it covered the largest number of low- and middle-income countries.
Information from these interviews cannot be generalized to COVID-19 medical
injury compensation programs in other countries.

We conducted this performance audit from February 2024 to December 2024 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.

The Honorable Patty Murray
Chair
The Honorable Susan Collins
Vice Chair
Committee on Appropriations
United States Senate

The Honorable Ron Wyden
Chairman
The Honorable Mike Crapo
Ranking Member
Committee on Finance
United States Senate

The Honorable Bernard Sanders
Chair
The Honorable Bill Cassidy, M.D.
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate

List of Addressees

Page 15
GAO-25-107368 Medical Countermeasures Injury Compensation
The Honorable Gary C. Peters
Chairman
The Honorable Rand Paul, M.D.
Ranking Member
Committee on Homeland Security and Governmental Affairs
United States Senate

The Honorable Tom Cole
Chairman
The Honorable Rosa L. DeLauro
Ranking Member
Committee on Appropriations
House of Representatives

The Honorable Cathy McMorris Rodgers
Chair
The Honorable Frank Pallone, Jr.
Ranking Member
Committee on Energy and Commerce
House of Representatives

The Honorable Mark E. Green, M.D.
Chairman
The Honorable Bennie G. Thompson
Ranking Member
Committee on Homeland Security
House of Representatives

The Honorable James Comer
Chairman
The Honorable Jamie Raskin
Ranking Member
Committee on Oversight and Accountability
House of Representatives

The Honorable Jason Smith
Chairman
The Honorable Richard Neal
Ranking Member
Committee on Ways and Means
House of Representatives

We are sending copies of this report to the appropriate congressional committees
and the Secretary of Health and Human Services. In addition, the report is
available at no charge on the GAO website at https://www.gao.gov.

For more information, contact: Mary Denigan-Macauley, Director, Health Care,
DeniganMacauleyM@gao.gov, (202) 512-7114.
Sarah Kaczmarek, Managing Director, Public Affairs, KaczmarekS@gao.gov,
(202) 512-4800.
A. Nicole Clowers, Managing Director, Congressional Relations,
ClowersA@gao.gov, (202) 512-4400.
Staff Acknowledgments: Rebecca Hendrickson (Assistant Director), Courtney
Liesener (Analyst-in-Charge), Myra Bowling, Laura Elsberg, Kaitlin Farquharson,
GAO Contact
Information

Page 16
GAO-25-107368 Medical Countermeasures Injury Compensation
Angela Marler, and Brian Schmidt made key contributions to this report. Also
contributing were Sang Lee, Diona Martyn, Eric Peterson, and Roxanna Sun.
Connect with GAO on Facebook, Flickr, Twitter, and YouTube. Subscribe to our
RSS Feeds or Email Updates. Listen to our Podcasts.
Visit GAO on the web at https://www.gao.gov.
This is a work of the U.S. government but may include copyrighted material. For
details, see https://www.gao.gov/copyright.

The Health Resources and Services Administration (HRSA), an agency within
the Department of Health and Human Services, administers two injury
compensation programs. The Countermeasures Injury Compensation Program
(CICP) compensates individuals for serious physical injuries or deaths directly
caused by the administration or use of covered countermeasures, including
certain vaccines and other medical products. The National Vaccine Injury
Compensation Program (VICP) compensates individuals for injuries or deaths
related to certain vaccines recommended for routine administration to children or
pregnant women, such as measles, mumps, and rubella vaccines. While HRSA
administers both programs, they differ in authorization, operation, and funding
(see table 4).

Table 4: Health Resources and Services Administration’s (HRSA) Countermeasures Injury
Compensation Program (CICP) and National Vaccine Injury Compensation Program (VICP)

Program elements
CICP
VICP
Program authorization
Public Readiness and
Emergency Preparedness Act
(PREP Act)
National Childhood Vaccine
Injury Act of 1986
Program funding
Appropriations
Excise taxes on covered
vaccines, which are
appropriated from the Vaccine
Injury Compensation Trust
Fund to HRSA, the Department
of Justice, and the U.S. Court
of Federal Claims
Products covered
Covered countermeasures,
which are defined in statute
and described in PREP Act
declarations for public health
threats (e.g., COVID-19)a
Vaccines included in HRSA’s
Vaccine Injury Table (e.g.,
measles vaccine)b
Claim submission
Submit request form and
documentation to HRSA
File petition and documentation
with the U.S. Court of Federal
Claims and HRSA
Claim adjudication
Administrative process
Judicial process
Claim decisions
HRSA makes decision (under
delegated authority from the
Secretary of Health and Human
Services)
Special Masters (or judges) of
U.S. Court of Federal Claims
make decision
Claim appeals
Administrative reconsideration
upon request. No judicial
appeal permitted
Appeal by either party to the
U.S. Court of Appeals for the
Federal Circuit
Source: GAO review of HRSA information and relevant statutes and regulations.  I  GAO-25-107368

aSee 42 U.S.C. § 247d-6e(e)(1) (referring to 42 U.S.C. § 247d-6d(i)(1)) and 42 C.F.R. § 110.3(f) (2023). The
Secretary of Health and Human Services may issue a PREP Act declaration for a specific public health threat
limiting legal liability for losses related to a covered countermeasure. 42 U.S.C. § 247d-6d.
bThe Vaccine Injury Table is set forth in statute under 42 U.S.C. § 300aa-14. The Secretary of Health and
Human Services is authorized to issue regulations to modify the Vaccine Injury Table and is required to revise
the table when the Centers for Disease Control and Prevention recommends a vaccine for routine
Appendix I:
Comparison of
Countermeasures
Injury Compensation
Program and National
Vaccine Injury
Compensation Program

Page 17
GAO-25-107368 Medical Countermeasures Injury Compensation
administration to children or pregnant women. A federal tax must be imposed on a category of vaccine for a
vaccine to receive VICP coverage.

1Specifically, the CARES Act requires us to monitor and oversee the federal government’s efforts to
prepare for, respond to, and recover from the pandemic. Pub. L. No. 116-136, § 19010(b), 134
Stat. 281, 580 (2020). The American Rescue Plan Act of 2021 also includes a provision for us to
conduct oversight of the COVID-19 response. Pub. L. No. 117-2, § 4002, 135 Stat. 4, 78. See
https://www.gao.gov/coronavirus for our reports related to the COVID-19 pandemic.

242 C.F.R. § 110.10 (2023). Covered countermeasures can include vaccines, medications, devices
or other items used to prevent diagnose, mitigate, treat, cure, or limit the harm of a pandemic or
epidemic, or a chemical, biological, radiological, nuclear agent threat. Countermeasures covered
under CICP are defined in statute and regulation and are described in PREP Act declarations. See
42 U.S.C. § 247d-6e(e)(1) (referring to 42 U.S.C. § 247d-6d(i)(1)) and 42 C.F.R. § 110.3(f) (2023).

3Injured countermeasure recipients may be eligible for medical benefits or benefits for lost
employment income, or both. Survivors of countermeasure recipients who died as a direct result of
covered injuries may be eligible for death benefits. Executors or administrators on behalf of the
estate of deceased injured countermeasure recipients may be eligible for medical benefits or
benefits for lost employment income, or both. See 42 C.F.R. § 110.30 (2023). HRSA regulations
use the term “requester” to refer to an injured countermeasure recipient, survivor, or the estate of a
deceased injured countermeasure recipient. In this report, we refer to these parties as individuals
or claimants.

4Under the PREP Act, direct causation must be based on compelling, reliable, valid, medical and
scientific evidence. 42 U.S.C. § 247d-6e(b)(4). See also 42 C.F.R. § 110.20(c) (2023). In this
report, we use the term “medical and scientific evidence” to refer to compelling, reliable, valid,
medical and scientific evidence.

5The PREP Act was enacted as part of the Department of Defense, Emergency Supplemental
Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006,
Pub. L. No. 109-148, div. C, 119 Stat. 2680, 2818–32 (2005) (codified as amended at 42 U.S.C. §§
247d-6d and 247d-6e).The Secretary of Health and Human Services may make a PREP Act
declaration if the Secretary determines that a disease or other health condition or other threat to
health constitutes a public health emergency, or that there is a credible risk that the disease,
condition, or threat may constitute an emergency in the future. 42 U.S.C. § 247d-6d(b)(1). This
determination is separate from a public health emergency declaration under section 319 of the
Public Health Service Act.

685 Fed. Reg. 15,198 (Mar. 17, 2020). The declaration was effective as of February 4, 2020.

7See 42 U.S.C. § 247d-6e(b)(5). Countermeasure injury tables list injuries that are presumed to be
caused by a covered countermeasure. If the first sign or symptom of an injury occurs within the
listed time period and at the level of severity required, there is a presumption that the covered
countermeasure caused the injury, unless another more likely cause is demonstrated.

8See 42 C.F.R. § 110.100 (2023) for the Pandemic Influenza Countermeasures Injury Table and
Smallpox Countermeasures Injury Table.

9To request reconsideration of HRSA’s claim decision, the claimant must submit a request for
reconsideration in writing that is postmarked within 60 calendar days of the original decision. The
request must describe the reasons why the decision should be reconsidered. 42 C.F.R. § 110.90
(2023).

10See 42 U.S.C. § 247d-6e(b)(4) and 42 C.F.R. § 110.92(a) (2023).

11The median review time was 25 months. HRSA does not have time frames for the medical review
for claims adjudicated prior to June 2021.

12The median review time was 13 months. HRSA does not have time frames for the initial eligibility
check for claims adjudicated prior to August 2021.

13HRSA does not have a comprehensive data set on requests for reconsideration prior to January
2022.

Endnotes

Page 18
GAO-25-107368 Medical Countermeasures Injury Compensation

14National Academies of Sciences, Engineering, and Medicine, 2024 Evidence Review of the
Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration (Washington,
D.C.: The National Academies Press, 2024).

15HRSA officials told us that CICP countermeasure injury tables must be published through the
federal rulemaking process. This process includes periods of review, public comment, and
response, which can make timelines difficult to predict.

16CICP is funded by the Covered Countermeasure Process Fund, which covers HRSA’s costs for
operating CICP and for paying eligible claims for compensation.

17The Department of the Treasury collects the excise taxes for VICP and manages the trust fund.

18The University of Oxford’s COVID-19 Vaccine No-Fault Compensation Scheme Project mapped
out all known medical injury compensation programs worldwide that cover COVID-19 vaccines and
identified 38 countries with vaccine injury compensation programs, including Hong Kong and
Taiwan.

File and source

File

25-107368-covid-19-information-on-hhs-039-s.pdf

Size

859,284 bytes

SHA-256

4b98008ac25d63a24d299f9bc71e2802969995520982707e8ad9b717cf633815

Our copy

25-107368-covid-19-information-on-hhs-039-s.pdf

Original

www.gao.gov