COVID–19 Access to Testing and Support for Immune Response Research Act of 2021
Bill: H.R.5745 | Sponsor: Rep. Dunn, Neal P. (R-FL)
Policy area: Health

Summary:
COVID-19 Access to Testing and Support for Immune Response Research Act of 2021
This bill requires the Centers for Medicare & Medicaid Services to provide for coverage during the COVID-19 public health emergency of T-cell diagnostic laboratory tests for individuals with a current or prior COVID-19 infection. In addition, the Department of Health and Human Services must develop a national strategy to research the immune response to COVID-19 and may award research grants.

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 Representatives 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:
            (1) A public health emergency regarding the COVID-19 
        pandemic was first declared on January 31, 2020, and has been 
        subsequently renewed repeatedly, 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 available 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 interim final rule which recognized on an 
        interim basis that certain Food and Drug Administration-
        authorized serology tests fall under the Medicare benefit 
        category for diagnostic laboratory tests.
            (4) On March 5, 2021, the Food and Drug Administration 
        issued the first authorization for the emergency use of a 
        cellular (T-cell) immune response COVID-19 test intended for 
        use as an aid in identifying individuals with an adaptive T-
        cell immune response to SARS-CoV-2, indicating recent or prior 
        infection with SARS-CoV-2.
            (5) CMS has yet to update its May 8, 2020, interim final 
        rule or provide separate guidance to clarify 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 infectious 
        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 response, the T-
        cell response, has historically been more difficult to assess, 
        but scientific and technological advances now allow for 
        standardized and sensitive methods to measure T-cells.
            (8) The National Institutes of Health have integrated T-
        cell testing into certain studies regarding the impact of T-
        cells in detecting and defending against SARS-CoV-2 variants, 
        and there exist additional 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 to variants) 
                following natural infection, vaccination, or both;
                    (B) understanding the T-cell response in different 
                populations, including children, the elderly, and 
                immunocompromised individuals; and
                    (C) understanding the T-cell response in patients 
                facing long-term COVID-19 symptoms.
            (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 development of therapeutics for patients suffering from 
        post-acute sequelae of COVID-19 infection.

SEC. 3. CLARIFYING MEDICARE COVERAGE OF COVID-19 DIAGNOSTIC 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 or known prior COVID-19 
infection or suspected current or suspected past COVID-19 infection.
    (b) T-Cell Diagnostic Laboratory Test Defined.--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 immune 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 IMMUNE RESPONSE 
              RESEARCH.

    (a) In General.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'')--
            (1) shall--
                    (A) expand, intensify, and coordinate the programs 
                and activities of the National Institutes of Health and 
                the Centers for Disease Control and Prevention with 
                respect to scientific and clinical research on the 
                cellular immune response related to COVID-19;
                    (B) develop and implement a national strategy to 
                research the cellular immune response to SARS-CoV-2, 
                which shall include research on--
                            (i) the type and duration of T-cell 
                        responses to COVID-19 vaccines and how such 
                        responses confer immunity and contribute to 
                        protection from infection with SARS-CoV-2 
                        variants of concern;
                            (ii) the type and duration of T-cell 
                        responses 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 
                        responses to vaccination and natural infection 
                        in certain populations, such as children, the 
                        elderly, and immunocompromised individuals; and
                    (C) update the strategy under subparagraph (B) as 
                appropriate; and
            (2) subject to the availability of appropriations, may make 
        grants to States, political subdivisions, public-private 
        partnerships, academic institutions, and other public entities 
        to carry out scientific and clinical research on the cellular 
        immune response related 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 research 
        organizations with interest in cellular immune research;
            (3) researchers with expertise in cellular immunology; 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 subject 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), including initial funding 
opportunity announcements, within 6 months of the date of enactment of 
this Act.
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