To provide for quality assurance of COVID-19 reimbursements and reporting.
Bill: H.R.311 | Sponsor: Rep. Posey, Bill (R-FL)
Policy area: Health

Summary:
This bill (1) establishes documentation requirements for testing, treatment, and reporting related to COVID-19 (i.e., coronavirus disease 2019); and (2) makes it unlawful to knowingly report a false diagnosis of COVID-19. To receive a federal reimbursement for the cost of a COVID-19 diagnostic test or treatment, the request for reimbursement must document that the administered COVID-19 test has been approved, cleared, or authorized by the Food and Drug Administration.  Further, the Centers for Disease Control and Prevention must exclude from its official COVID-19 case and death counts any person who tested positive and requested federal reimbursement without the required documentation.  Additionally, any person who knowingly reports a false diagnosis of COVID-19 is subject to criminal fines and imprisonment for not more than 10 years.

To provide for quality assurance of COVID-19 reimbursements and 
                               reporting.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. QUALITY ASSURANCE OF COVID-19 REIMBURSEMENTS AND REPORTING.

    (a) In General.--Notwithstanding any other provision of law, no 
Federal funds shall be used for a reimbursement or payment for--
            (1) COVID-19 testing of any individual unless the request 
        for such reimbursement or payment is accompanied by evidence 
        that the individual was tested using a test that was approved, 
        cleared, or authorized under section 510(k), 513, 515, or 564 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 
        360c, 360e, 360bbb-3) for COVID-19 diagnosis; or
            (2) COVID-19 treatment of any individual unless the request 
        for reimbursement or payment is accompanied by evidence that 
        the person tested positive for COVID-19 using a test that was 
        approved, cleared, or authorized under section 510(k), 513, 
        515, or 564 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360(k), 360c, 360e, 360bbb-3) for COVID-19 diagnosis.
    (b) Quality Assurance of Reimbursements.--For purposes of 
subsection (a), notwithstanding any other provision of law, the head of 
any Federal agency authorized to make a reimbursement or payment for 
COVID-19 testing or treatment of individuals shall review each request 
presented for such reimbursement or payment and--
            (1) deny any request for such a reimbursement or payment 
        for COVID-19 testing of an individual or, if reimbursement or 
        payment has already been made, cause to be recovered such 
        reimbursement or payment, unless the request is accompanied by 
        evidence that the individual was tested using a test that was 
        approved, cleared, or authorized under section 510(k), 513, 
        515, or 564 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360(k), 360c, 360e, 360bbb-3) for COVID-19 diagnosis as 
        of the date of the review of the head of the agency;
            (2) deny any request for such a reimbursement or payment 
        for COVID-19 treatment of an individual or, if reimbursement or 
        payment has already been made, cause to be recovered such 
        reimbursement or payment, unless the request is accompanied by 
        evidence that the individual tested positive for COVID-19 using 
        a test that was approved, cleared, or authorized under section 
        510(k), 513, 515, or 564 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360(k), 360c, 360e, 360bbb-3) for 
        COVID-19 diagnosis as of the date of the review of the head of 
        the agency; and
            (3) provide to the Director of the Centers for Disease 
        Control and Prevention the results of such review.
    (c) Correction of Reports.--The Director of the Centers for Disease 
Control and Prevention shall apply the results provided to the Director 
under subsection (b)(3) to--
            (1) exclude from the official United States count of cases 
        of COVID-19 any individual reported to have been positive for 
        COVID-19 in a request subject to review in subsection (b) but 
        where the agency head involved found the request was not 
        accompanied by evidence that the individual had been tested 
        positive for COVID-19 using a test that was approved, cleared, 
        or authorized under section 510(k), 513, 515, or 564 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 360c, 
        360e, 360bbb-3) for diagnosis of COVID-19; and
            (2) exclude from the official United States count of deaths 
        due to COVID-19 any individual who died and was reported to 
        have been treated or tested positive for COVID-19 in a request 
        subject to review under subsection (b) but where the agency 
        head involved found the request was not accompanied by evidence 
        that the individual had been tested positive for COVID-19 using 
        a test that was approved, cleared, or authorized under section 
        510(k), 513, 515, or 564 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360(k), 360c, 360e, 360bbb-3) for 
        diagnosis of COVID-19.
    (d) Penalty.--Any person who knowingly reports a false diagnosis of 
COVID-19 shall be imprisoned not more than 10 years and fined under 
title 18, United States Code, or both.
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