I 
117TH CONGRESS 
1ST SESSION H. R. 5745 
To clarify Medicare coverage for COVID–19 testing and to provide support 
for cellular immune response research for COVID–19, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 27, 2021 
Mr. DUNN (for himself and Mr. JACKSON) introduced the following bill; which 
was referred to the Committee on Energy and Commerce, and in addition 
to the Committee on Ways and Means, for a period to be subsequently 
determined by the Speaker, in each case for consideration of such provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To clarify Medicare coverage for COVID–19 testing and 
to provide support for cellular immune response research 
for COVID–19, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘COVID–19 Access to 
Testing and Support for Immune Response Research Act 
of 2021’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
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(1) A public health emergency regarding the 
COVID–19 pandemic was first declared on January 
31, 2020, and has been subsequently renewed re-
peatedly, most recently on July 19, 2021, by the 
Secretary of Health and Human Services under both 
Republican and Democratic administrations. 
(2) In the spring of 2020, the only tests avail-
able to determine whether a person had a recent or 
prior infection of SARS–CoV–2 were serology tests 
which could identify whether a person had antibodies 
specific to the SARS–CoV–2 virus. 
(3) On May 8, 2020, the Centers for Medicare 
& Medicaid Services (CMS), citing the ongoing 
COVID–19 public health emergency, issued an in-
terim final rule which recognized on an interim basis 
that certain Food and Drug Administration-author-
ized serology tests fall under the Medicare benefit 
category for diagnostic laboratory tests. 
(4) On March 5, 2021, the Food and Drug Ad-
ministration issued the first authorization for the 
emergency use of a cellular (T-cell) immune re-
sponse COVID–19 test intended for use as an aid in 
identifying individuals with an adaptive T-cell im-
mune response to SARS–CoV–2, indicating recent or 
prior infection with SARS–CoV–2. 
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(5) CMS has yet to update its May 8, 2020, in-
terim final rule or provide separate guidance to clar-
ify that Medicare coverage extends to other Food 
and Drug Administration-authorized tests, including 
T-cell tests, that are intended for diagnosing recent 
or prior infection with SARS–CoV–2. 
(6) In research and development related to in-
fectious diseases and vaccines, including SARS– 
CoV–2, historically the antibody response, which is 
only half of the adaptive immune system, has been 
the primary tool for assessment. 
(7) The other half of the adaptive immune re-
sponse, the T-cell response, has historically been 
more difficult to assess, but scientific and techno-
logical advances now allow for standardized and sen-
sitive methods to measure T-cells. 
(8) The National Institutes of Health have inte-
grated T-cell testing into certain studies regarding 
the impact of T-cells in detecting and defending 
against SARS–CoV–2 variants, and there exist addi-
tional research opportunities regarding the cellular 
immune response to SARS–CoV–2, including— 
(A) identifying the type and duration of T- 
cell response that confers immunity (including 
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to variants) following natural infection, vaccina-
tion, or both; 
(B) understanding the T-cell response in 
different populations, including children, the el-
derly, and immunocompromised individuals; and 
(C) understanding the T-cell response in 
patients facing long-term COVID–19 symp-
toms. 
(9) Evidence shows T-cells play an important 
role in the immune response to COVID–19 and 
points to the need for a concerted research effort, 
which could have profound consequences on public 
health, such as policies on boosters or the develop-
ment of therapeutics for patients suffering from 
post-acute sequelae of COVID–19 infection. 
SEC. 3. CLARIFYING MEDICARE COVERAGE OF COVID–19 DI-
AGNOSTIC LABORATORY TESTS. 
(a) IN GENERAL.—The Administrator of the Centers 
for Medicare & Medicaid Services shall by interim rule, 
subregulatory guidance, or otherwise, provide for coverage 
of T-cell diagnostic laboratory tests furnished during the 
period beginning on January 1, 2022, and ending on the 
last date of the public health emergency period (described 
in section 1135(g)(1)(B) of the Social Security Act (42 
U.S.C. 1320b–5(g)(1)(B))) for beneficiaries with current 
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or known prior COVID–19 infection or suspected current 
or suspected past COVID–19 infection. 
(b) T-CELL DIAGNOSTIC LABORATORY TEST DE-
FINED.—For purposes of subsection (a), the term ‘‘T-cell 
diagnostic laboratory test’’ means a clinical laboratory test 
that is— 
(1) intended to identify an adaptive T-cell im-
mune response to SARS–CoV–2 indicative of recent 
or prior infection with SARS–CoV–2; and 
(2) cleared, approved, or otherwise authorized 
pursuant to the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.). 
SEC. 4. NATIONAL STRATEGY FOR COVID–19 CELLULAR IM-
MUNE RESPONSE RESEARCH. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’)— 
(1) shall— 
(A) expand, intensify, and coordinate the 
programs and activities of the National Insti-
tutes of Health and the Centers for Disease 
Control and Prevention with respect to sci-
entific and clinical research on the cellular im-
mune response related to COVID–19; 
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(B) develop and implement a national 
strategy to research the cellular immune re-
sponse to SARS–CoV–2, which shall include re-
search on— 
(i) the type and duration of T-cell re-
sponses to COVID–19 vaccines and how 
such responses confer immunity and con-
tribute to protection from infection with 
SARS–CoV–2 variants of concern; 
(ii) the type and duration of T-cell re-
sponses in patients who have recovered 
from COVID–19 and how such responses 
may confer immunity; 
(iii) the type and duration of T-cell 
immune responses in patients facing long- 
term COVID–19 symptoms; and 
(iv) the type and duration of T-cell re-
sponses to vaccination and natural infec-
tion in certain populations, such as chil-
dren, the elderly, and immunocompromised 
individuals; and 
(C) update the strategy under subpara-
graph (B) as appropriate; and 
(2) subject to the availability of appropriations, 
may make grants to States, political subdivisions, 
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public-private partnerships, academic institutions, 
and other public entities to carry out scientific and 
clinical research on the cellular immune response re-
lated to COVID–19 and to implement the strategy 
under paragraph (2). 
(b) CONSULTATION.—In carrying out subsection (a), 
the Secretary shall consult with relevant individuals, as 
appropriate, such as— 
(1) clinicians, public health professionals, and 
others with expertise in cellular immune response; 
(2) representatives of patient advocacy and re-
search organizations with interest in cellular immune 
research; 
(3) researchers with expertise in cellular immu-
nology; and 
(4) epidemiologists with experience in cellular 
immune response. 
(c) PUBLIC MEETING.—Not later than 3 months 
after the date of the enactment of this Act, the Secretary, 
acting through the Director of the National Institutes of 
Health, shall convene a public meeting composed of sub-
ject matter experts and stakeholders to identify research 
needs and opportunities. 
(d) PUBLICATION
OF STRATEGY.—The Secretary 
shall make public the strategy under subsection (a)(1)(B), 
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including initial funding opportunity announcements, 
within 6 months of the date of enactment of this Act. 
Æ 
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