On February 26, 2021, the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments) released further guidance on the coverage of COVID-19 testing and vaccines as required under the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief, and Economic Security (CARES) Act. This guidance (Part 44) supplements two sets of FAQs (Part 42 on April 11, 2020 and Part 43 on June 23, 2020) previously issued by the Departments.


The FFCRA generally requires group health plans (including fully insured, self-insured, and level funded plans) and health insurance issuers to provide benefits for items and services related to the testing and diagnosis of COVID-19 as of March 18, 2020 and through the applicable emergency period. This coverage must be provided without cost-sharing requirements (including deductibles, copayments, and coinsurance), prior authorization, or other medical management techniques. The CARES Act amended the FFCRA to include a broader range of items and services that must be covered, including coverage for approved COVID-19 vaccines.

FAQs on COVID-19 Testing, Vaccinations, and Notice Requirements

Below we highlight important guidance from the three FAQs on COVID-19 testing, vaccination, and notice requirements.

COVID-19 Diagnostic Testing

  • At-Home Testing: COVID-19 tests intended for at-home testing (including tests where the individual performs self-collection of a specimen at home) must be covered when the test is ordered by a health provider who has determined the test is medically appropriate. The coverage must be provided without cost-sharing, prior authorization, or other medical management requirements. See Q4 of Part 43.
  • Multiple Tests: Coverage is not limited with respect to the number of tests as long as the tests are diagnostic and medically appropriate for the individual. See Q6 of Part 43.
  • Covered Items and Services: Plans and issuers must cover items and services provided during a visit that relates to the furnishing or administration of a COVID-19 test or relates to the evaluation of an individual for purposes of determining their need for a test. For example, if an individual’s provider determines that other tests (e.g., flu tests, blood tests, etc.) should be performed during a visit to determine whether the individual needs a COVID-19 test, the plan or issuer must provide coverage for the related tests, as well. See Q5 of Part 42.
  • Facility Fee: If a facility fee is charged for a visit that results in the order or administration of a COVID-19 test, the plan or issuer must cover the facility fee without cost-sharing. This includes health provider visits (including in-person and telehealth visits), urgent care center visits, and emergency room visits. See Q7 of Part 43.
  • Out-of-Network Providers: Plans and issuers are required to cover COVID-19 tests that are provided by out-of-network providers. The provider must be reimbursed the negotiated rate (if applicable) or, if there is no negotiated rate, the amount listed by the provider on a public website (the CARES Act requires providers to publish the cost of COVID-19 tests on a public website). See Q7 of Part 42.
  • Balance Billing: Since plans and issuers are required to reimburse out-of-network providers for COVID-19 tests (see above), plan participants should not be balance billed for tests. However, the CARES Act does not address out-of-network reimbursement for items and services related to COVID-19 testing, and therefore, it is possible plan participants may be balance billed for these related items or services (though balance billing may be precluded by other state laws). See Q9-11 of Part 43.
  • Testing for Employment Purposes: Plans and issuers are not required to provide coverage of testing for public health surveillance or employment purposes (e.g., testing conducted to screen for general workplace health and safety such as “return to work” programs). However, there is no prohibition or limitation on plans and issuers providing coverage for such tests. See Q5 of Part 43, Q2 of Part 44).
  • Asymptomatic Individuals: Plans and issuers must provide coverage without cost-sharing, prior authorization, or other medical management requirements for COVID-19 testing of asymptomatic individuals when the purpose is for individualized diagnosis or treatment of COVID-19. See Q1 of Part 44. However, plans and issuers may distinguish between COVID-19 testing of asymptomatic individuals that must be covered and testing for general workplace safety (which is not required to be covered, as outlined above).
  • State/Local Test Sites: Plans and issuers are required to cover COVID-19 tests provided through state or locally administered testing sites (e.g., “drive through” sites and sites that do not require appointment).

COVID-19 Vaccinations

The CARES Act requires all non-grandfathered group health plans (whether fully insured, self-insured or level funded) to cover COVID-19 vaccines without cost sharing within 15 business days of a recommendation by the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP). The Departments note that the Pfizer-BioNTech and Moderna COVID-19 vaccines have received approval by the ACIP (the Johnson & Johnson vaccine also received approval after the publication of the FAQs).

  • Coverage of Vaccines: Plans and issuers must provide coverage without cost sharing for a COVID-19 vaccine no later than 15 days after the date the ACIP makes a recommendation and it is adopted by the Director of the CDC. See Q8 of Part 44.
  • Vaccine Administration Fee: Plans and issuers must cover the vaccine administration fee, regardless of how the administration is billed, whether the vaccine requires multiple doses, and whether the plan or issuer is billed for the vaccine. See Q9 of Part 44.
  • Priority Categories for Vaccination: Plans and issuers may not deny coverage of a vaccine because a plan participant received the vaccine during the initial phases of the vaccination program when they did not fall into a category that was prioritized for early vaccination. See Q10 of Part 44.
  • Employer-Provided Vaccines: Employers may offer benefits for COVID-19 vaccines under an employee assistance program (EAP) or an on-site medical clinic, as long as they comply with applicable laws. See Q12 and 13 of Part 44. For more on employer-provided COVID-19 vaccine clinics and incentives, see our blog.

Notice Requirements

Generally, if a plan or issuer makes a material modification in any terms of the plan or coverage that would affect the Summary of Benefits and Coverage (SBC), the plan must provide notice 60 days prior to the date in which the modification becomes effective. The Departments announced temporary enforcement relief from this 60-day advance notice requirement where the plan or issuer adds benefits or reduces/eliminates cost sharing for the diagnosis and treatment of COVID-19 or other telehealth services during the COVID-19 Public Health Emergency (PHE). Instead, plans and issuers must provide notice of the changes as soon as reasonably practicable. See Q14 of Part 42.

If a plan or issuer reverses these changes once the COVID-19 PHE is no longer in effect, the Departments will consider the plan or issuer to have satisfied its obligation to provide advance notice of a material modification if they previously notified plan participants of the general duration of the additional benefits coverage or reduced cost sharing (e.g., the increased coverage only applies during the COVID-19 PHE) or if they notify plan participates within a reasonable timeframe of the reversal of changes. See Q13 of Part 43.

Additional Resources

Disclaimer: This content is intended for informational purposes only and should not be construed as legal, medical or tax advice. It provides general information and is not intended to encompass all compliance and legal obligations that may be applicable. This information and any questions as to your specific circumstances should be reviewed with your respective legal counsel and/or tax advisor as we do not provide legal or tax advice. Please note that this information may be subject to change based on legislative changes. © 2021 Sequoia Benefits & Insurance Services, LLC. All Rights Reserved

Emerald Law – Emerald is a Client Compliance Consultant for Sequoia, where she works with our clients to optimize and streamline benefits compliance. In her free time, Emerald enjoys stand-up comedy, live music and writing non-fiction.