This part implements section 3202(b)(1) of the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136, March 27, 2020) (CARES Act), which requires that during the emergency period declared under section 319 of the PHS Act (42 U.S.C. 247d), providers of diagnostic tests for COVID-19 make public the cash price for such tests on a public internet website of such provider. This part also implements section 3202(b)(2) of the CARES Act, which authorizes the Secretary to impose a civil monetary penalty (CMP) on any provider of a diagnostic test for COVID-19 that does not comply with section 3202(b)(1) of the CARES Act and that has not completed a corrective action plan to comply with that section, in an amount that does not exceed $300 per day that the violation is ongoing.

The following definitions and abbreviated terms apply to this part:

Cash price means the charge that applies to an individual who pays cash (or cash equivalent) for a COVID-19 diagnostic test.

COVID-19 for purposes of this part is the abbreviated term for the virus called SARS-CoV-2 and the disease it causes, called coronavirus disease 2019.

Diagnostic test for COVID-19 (“COVID-19 diagnostic test”) means a COVID-19 in vitro diagnostic test described in section 6001 of the Families First Coronavirus Response Act (Pub. L. 116-127, March 18, 2020), as amended by section 3201 of the CARES Act (Pub. L. 116-136, March 27, 2020).

Provider of a diagnostic test for COVID-19 (“provider”) means any facility that performs one or more COVID-19 diagnostic tests.

(a) General applicability. The requirements of this part apply to each provider of a diagnostic test for COVID-19 as defined at § 182.20.

(b) Duration of requirements. The requirements of this part are applicable during the public health emergency (PHE) determined to exist nationwide as of January 27, 2020, by the Secretary of Health and Human Services pursuant to section 319 of the PHS Act on January 31, 2020, as a result of confirmed cases of COVID-19, including any subsequent renewals.