I 117th CONGRESS 1st Session H. R. 311 IN THE HOUSE OF REPRESENTATIVES January 13, 2021 Mr. Posey introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on the Judiciary , 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 provide for quality assurance of COVID–19 reimbursements and reporting.

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.