The Department of Labor (DOL), Department of Health and Human Services (HHS), and the Department of the Treasury (collectively, the Departments), issued frequentlyaskedquestions (FAQs) regarding implementation of the Families First Coronavirus Response Act (the FFCRA), the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), and other health coverage issues related to coronavirus disease 2019 (COVID-19). These FAQs are in addition to the frequently asked questions the Departments previously released regarding health plan coverage under the FFCRA and CARES Act.
Below is a summary of the Departments’ answers to the most recently released FAQs.
Coverage Under the FFCRA, as Amended by the CARES Act
Under the FFCRA, plans and issuers, including grandfathered health plans, must provide coverage for an in vitro diagnostic test for the detection of SARS-CoV-2 or the diagnosis of COVID-19, and the administration of such a test that meets one of the following four requirements when those items or services are furnished on or after March 18, 2020, through the applicable HHS public emergency period. Plans and issuers must provide this coverage without imposing any cost-sharing requirements (including deductibles, copayments, and coinsurance), prior authorization, or other medical management requirements. Note, HHS has sent a letter to state governors that the HHS public health emergency will likely remain in place for all of 2021 and that HHS will provide states with 60 days’ notice prior to termination of the public health emergency.
1.The test is approved, cleared, or authorized under the Federal Food, Drug, and Cosmetic Act (FFDCA).
All in vitro diagnostic tests for COVID-19 that have received an emergency use authorization (EUA) under the FFDCA are listed on the EUA webpage of the FDA website.
2.The developer has requested, or intends to request, EUA under the FFDCA, unless and until the EUA request has been denied or the developer of such test does not submit a request within a reasonable time.
The FDAwebsite provides a list of clinical laboratories and commercial manufacturers that have notified the FDA that they have validated their own COVID-19 test and are offering the test as outlined in FDA guidance. Plans and issuers must cover in vitro diagnostic tests for COVID-19 that are included on this list. A plan or issuer may take reasonable steps to verify that a test offered by a developer meets the statutory criteria. For example, a plan or issuer may request that a laboratory or commercial manufacturer provide documentation, such as a copy of the EUA request or pre-EUA submitted to the FDA, to demonstrate that it has requested or intends to request an EUA. These requests will not be considered to violate the FFCRA prohibition on medical management requirements if they are reasonable and necessary to verify that a COVID-19 test meets the statutory criteria.
3.The test is developed in and authorized by a state that has notified the Secretary of HHS of its intention to review tests intended to diagnose COVID–19.
States and territories that have notified the FDA that they choose to use this flexibility are listed on the FDAwebsite.
4.Other tests that the Secretary of HHS determines appropriate in guidance.
COVID-19 Diagnostic Testing
The FAQs provide that plans and issuers are prohibited from using medical screen criteria to deny a claim for COVID-19 diagnostic testing for an asymptomatic person who has no known or suspected exposure to COVID-19 when the purpose of the testing is for individualized diagnosis or treatment of COVID-19. While state and local public health authorities retain the authority to direct providers to limit eligibility for testing based on clinical risk or other criteria to manage testing supplies and access to testing, responsibility for implementing such limits on testing falls on health care providers, not on plans and issuers. However, plans and issuers are not required to provide coverage of testing such as for public health surveillance or employment purposes when the testing is not primarily intended for individualized diagnosis or treatment of COVID-19.