2
and issuers must provide this coverage without imposing any cost-sharing requirements
(including deductibles, copayments, and coinsurance), prior authorization, or other medical
management requirements.
The CARES Act was enacted on March 27, 2020.
3
Section 3201 of the CARES Act amended
section 6001 of the FFCRA to include a broader range of diagnostic items and services that plans
and issuers must cover without any cost-sharing requirements, prior authorization, or other
medical management requirements.
4
Section 3202(a) of the CARES Act requires plans and
issuers providing coverage to reimburse a provider that has a negotiated rate with the plan or
issuer for COVID-19 diagnostic testing an amount that equals that negotiated rate; or, if the plan
or issuer does not have a negotiated rate with such provider, the cash price for such service that
is listed by the provider on a public website. (The plan or issuer may negotiate a rate with the
provider that is lower than the cash price.) Additionally, during the public health emergency
related to COVID-19 declared under section 319 of the Public Health Service Act (PHS Act),
section 3202(b) of the CARES Act and implementing regulations at 45 CFR Part 182 require
providers of diagnostic tests for COVID-19 to make public the cash price of a COVID-19
diagnostic test on the provider’s public internet website or face potential enforcement action
including civil monetary penalties.
Under section 6001(c) of the FFCRA, the Departments are authorized to implement the
requirements of section 6001 of the FFCRA through sub-regulatory guidance, program
instruction, or otherwise. The Departments have previously issued four sets of FAQs to
implement provisions of the FFCRA and CARES Act and to address other health coverage issues
related to COVID-19.
5
Due to the urgent need to continue to facilitate the nation’s response to
the public health emergency posed by COVID-19, the Departments believe that this guidance is
a statement of policy not subject to the notice and comment requirements of the Administrative
Procedure Act (APA).
6
For the same reasons, the Departments additionally find that, even if this
guidance were subject to the public participation provisions of the APA, prior notice and
3
Pub. L. No. 116-136 (2020).
4
For purposes of this document, references to section 6001 of the FFCRA include the amendments made by section
3201 of the CARES Act, unless otherwise specified.
5
See FAQs about Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security
Act Implementation Part 42 (Apr. 11, 2020), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-
ebsa/our-activities/resource-center/faqs/aca-part-42.pdf and https://www.cms.gov/files/document/FFCRA-Part-42-
FAQs.pdf (FAQs Part 42); FAQs about Families First Coronavirus Response Act and Coronavirus Aid, Relief, and
Economic Security Act Implementation Part 43 (June 23, 2020), available at
https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-43.pdf and
https://www.cms.gov/files/document/FFCRA-Part-43-FAQs.pdf (FAQs Part 43); FAQs about Families First
Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 44 (Feb.
26, 2021), available at https://w
ww.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-
center/faqs/aca-part-44.pdf and https://www.cms.gov/files/document/faqs-part-44.pdf (FAQs Part 44); and FAQs
about Affordable Care Act Implementation Part 50, Health Insurance Portability and Accountability Act and
Coronavirus Aid, Relief, and Economic Security Act Implementation (Oct. 4, 2021), available at
https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-50.pdf and
https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-50.pdf (FAQs Part 50).
6
5 U.S.C. § 553(b)(A).