Title: Free At-Home Tests for All Act
Policy area: Health

Summary:
Free At-Home Tests for All Act
This bill requires the Department of Health and Human Services (HHS) to provide free antigen diagnostic tests for COVID-19 (i.e., rapid tests) to U.S. residents. The bill also automatically grants emergency use authorization for rapid tests approved by certain foreign regulators.
Specifically, HHS must purchase a sufficient quantity of rapid tests to provide two tests per week at no cost to each resident for the 12 months following the bill's enactment. The President may use authorities available under the Defense Production Act of 1950 to obtain the tests. That act confers upon the President a broad set of authorities to influence domestic industry in order to provide essential materials and goods needed for the national defense.
In addition, HHS must conduct outreach about the availability of free rapid tests to Medicare and Medicaid participants and make the tests available through those programs.
The bill also automatically grants emergency use authorization during the public health emergency for rapid tests that are listed for emergency use by (1) the World Health Organization (WHO), or (2) a foreign regulator that is a stringent regulatory authority as defined by the WHO for purposes of medicine procurement. The Food and Drug Administration (FDA) may rescind authority for, or otherwise regulate, a rapid test that was automatically authorized.
Additionally, the FDA must establish a permanent advisory committee focused on diagnostic and serological testing for public health needs.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6377 Introduced in House (IH)]

<DOC>






117th CONGRESS
  2d Session
                                H. R. 6377

 To direct the Secretary of Health and Human Services to purchase and 
   make available for free rapid tests for SARS-CoV-2, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 12, 2022

    Mr. Beyer (for himself, Ms. Titus, Mr. Morelle, and Mr. Kahele) 
 introduced the following bill; which was referred to the Committee on 
  Energy and Commerce, and in addition to the Committees on Financial 
     Services, and Ways and Means, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
 To direct the Secretary of Health and Human Services to purchase and 
   make available for free rapid tests for SARS-CoV-2, 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 ``Free At-Home Tests for All Act''.

SEC. 2. FREE RAPID TEST PROGRAM.

    (a) Bulk Purchases.--The Secretary of Health and Human Services (in 
this Act referred to as the ``Secretary'') shall purchase in bulk a 
sufficient quantity of rapid tests for SARS-CoV-2 to provide two such 
tests per week to every resident of the United States over the 12-month 
period beginning on the date of enactment of this Act.
    (b) Free Availability.--The Secretary shall make the tests 
purchased pursuant to subsection (a) available for free--
            (1) at pharmacies, including online pharmacies 
        participating in a pharmacy partnership program;
            (2) at public schools; and
            (3) by online order or phone call directly from the 
        Department of Health and Human Services.
    (c) Proctoring; Return Envelopes.--The tests purchased pursuant to 
subsection (a) shall--
            (1) each be proctored without charge; and
            (2) be made available together with a free postage-paid 
        envelope for delivering completed tests to the Centers for 
        Disease Control and Prevention or a relevant public health 
        laboratory for genomic sequencing.
    (d) Materials for Individuals Who Test Positive.--The Secretary 
shall--
            (1) distribute to proctors of tests purchased pursuant to 
        subsection (a) informational materials about social distancing, 
        treatment, and further testing for individuals who test 
        positive; and
            (2) require such proctors to provide such materials to such 
        individuals.
    (e) Relation to Defense Production Act.--In making purchases 
authorized under this section, the President may utilize the 
authorities provided under title I of the Defense Production Act of 
1950 (50 U.S.C. 4511 et seq.).
    (f) Definition.--In this section, the term ``rapid test'' means an 
antigen diagnostic test.
    (g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated such sums as may be necessary. 
The amounts authorized to be appropriated by the preceding sentence are 
in addition to amounts otherwise available to carry out this section.

SEC. 3. COORDINATION WITH MEDICARE AND MEDICAID PROGRAMS.

    The Secretary shall--
            (1) conduct outreach to individuals entitled to benefits 
        under the Medicare or Medicaid programs regarding the 
        availability of rapid tests (as defined in section 2); and
            (2) make such tests available through the Medicare and 
        Medicaid programs at no cost to such individuals, including by 
        mail.

SEC. 4. FOOD AND DRUG ADMINISTRATION.

    (a) Automatic EUA.--
            (1) In general.--Subject to paragraph (2), during the 
        period of the public health emergency for COVID-19 in effect 
        under section 319 of the Public Health Service Act (42 U.S.C. 
        247d), including any extensions thereof, an antigen diagnostic 
        test for SARS-CoV-2 is deemed to have in effect an emergency 
        use authorization under section 564 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360bbb-3) if the test is listed for 
        emergency use by--
                    (A) the World Health Organization; or
                    (B) a stringent regulatory authority (as defined by 
                the World Health Organization for purposes of medicine 
                procurement decisions).
            (2) Continued authority.--Upon the deeming of an emergency 
        use authorization by paragraph (1) for a test, the Secretary of 
        Health and Human Services and the Commissioner of Food and 
        Drugs shall continue to have all authorities vested in such 
        officials by the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 301 et seq.) and other applicable law to rescind such 
        emergency use authorization or otherwise regulate such test.
    (b) Advisory Committee on Diagnostic and Serological Testing.--The 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall establish and maintain a permanent advisory 
committee to advise the Department of Health and Human Services 
regarding the development, manufacture, distribution, and use of 
diagnostic and serological testing for public health needs.
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