Text of Agency FAQs, Part 51: FFCRA and CARES Act Implementation, COVID-19 Diagnostic Testing and Coverage of Preventive Services (PDF)
U.S. Department of Health and Human Services [HHS]; U.S. Department of Labor [DOL]; and U.S. Department of the Treasury
[Official Guidance]
Jan. 10, 2022
(16 pages.)
- Under section 6001 of the [Families First Coronavirus Response Act (FFCRA)], are plans and issuers required to cover OTC COVID-19 tests available without an order or individualized clinical assessment by a health care provider?
A1 Yes....
- Q2 If a plan or issuer provides direct coverage of OTC COVID-19 tests, may it limit coverage to only tests that are provided through preferred pharmacies or other retailers?
A2 No....
- If a plan or issuer otherwise provides coverage without cost sharing for COVID-19 diagnostic tests, may a plan or issuer set limits on the number or frequency of OTC COVID-19 tests covered without cost sharing under a plan or coverage?
A3 Yes, but only if the plan or issuer meets the conditions for the safe harbor described in this Q3....
- When providing coverage of OTC COVID-19 tests, are plans and issuers permitted to address suspected fraud and abuse?
A4 Yes....
- How can plans and issuers facilitate access to, effective use of, and prompt payment for OTC COVID-19 tests?...
- When must plans and issuers begin providing coverage without cost-sharing, prior authorization, or other medical management requirements for OTC COVID-19 tests available without an order or individualized clinical assessment by a health care provider?
A6 Plans and issuers must provide coverage without cost-sharing requirements, prior authorization, or other medical management requirements ... with respect to OTC COVID-19 tests available without an order or individualized clinical assessment by a health care provider purchased on or after January 15, 2022, and during the public health emergency....
- Are plans and issuers required to cover, without the imposition of any cost sharing, a follow-up colonoscopy conducted after a positive non-invasive stool-based screening test or direct visualization test (e.g., sigmoidoscopy, CT colonography)?
A7 Yes....
- When must plans and issuers begin providing coverage without cost sharing for a follow-up colonoscopy after a positive non-invasive stool-based screening test or direct visualization test based on the new USPSTF recommendation? ...
A8 [P]lans and issuers must provide coverage without cost sharing for plan or policy years beginning on or after May 31, 2022....
- What is expected of non-exempt plans and issuers regarding compliance with the requirement to cover contraceptive services under PHS Act section 2713?"
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