By Trip VanderWal

On February 26, 2021, the Departments of Labor, Health and Human Services, and Treasury (collectively the “Departments”) issued additional FAQs with respect to the implementation of the Families First Coronavirus Response Act (“FFCRA”) and the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), which are available here. These FAQs (Part 44) address a “grab bag” of issues related to the impact of the FFCRA and the CARES Act on employer-sponsored group health plans, but focus on the coverage of COVID-19 testing and vaccinations.


Beginning March 18, 2020 and lasting until the expiration of the public health emergency declared by the Department of Health and Human Services (which is expected to last for at least the entirety of 2021), the FFCRA generally requires all group health plans, including grandfathered group health plans, to cover certain items and services related to the testing for COVID-19 without participant cost-sharing (i.e., deductibles, copayments or coinsurance). In addition, these group health plans are prohibited from imposing prior authorization requirements or other medical management requirements on the required COVID-19 testing items and services.

The CARES Act amended the FFCRA to expand the range of COVID-19 testing items and services that were required to be covered without participant cost-sharing, prior authorization or other medical management requirements. The CARES Act also requires group health plans to reimburse providers for COVID-19 testing at the negotiated rate with the provider and, if no negotiated rate, at the cash price for the COVID-19 test published by the provider on a public website. Similarly, the CARES Act requires providers to publish this cash price on a public website.

Finally, the CARES Act requires non-grandfathered group health plans to cover “qualifying coronavirus preventive services” without participant cost-sharing. A qualifying coronavirus preventive service includes an item, service, or immunization that is intended to prevent or mitigate COVID-19 that is:

  • An evidence-based item or service that has in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force (“USPSTF”); or
  • An immunization that has in effect a recommendation from the Advisory Committee on Immunization Practices (“ACIP”) of the CDC.

Non-grandfathered group health plans are required to cover these items and services within 15 business days of the item or service receiving the required rating from the USPSTF or recommendation from the ACIP.

FAQs Part 44 Guidance on COVID-19 Testing

  • Group health plans must cover the required COVID-19 testing even for an asymptomatic individual with no known or suspected exposure to COVID-19. The FAQs clarify that “[w]hen an individual seeks and receives a COVID-19 diagnostic test from a licensed or authorized health care provider, or when a licensed or authorized health care provider refers an individual for a COVID-19 diagnostic test, [group health] plans … generally must assume that the receipt of the test reflects an ‘individual clinical assessment’ and the test should be covered without cost sharing, prior authorization, or other medical management requirements.”

In a news release issued along with FAQs Part 44, the Departments clarified that this includes “covered individuals wanting to ensure they are COVID-19 negative prior to visiting a family member.” This requirement does not, however, require group health plans to cover without participant cost-sharing, prior authorization, or other medical management requirements COVID-19 tests that are required for public health surveillance or employment purposes. For example, if an employer requires an individual to receive a COVID-19 test in order to enter the workplace, group health plans may impose participant cost-sharing, prior authorization or other medical management requirements on the COVID-19 test (but plans are still encouraged to waive these requirements).

  • The requirement to cover COVID-19 tests without participant cost-sharing, prior authorization, or other medical management requirements includes those tests provided by a state- or locality-administered site, such as a “drive through” site or other site that doesn’t require appointments, as long as the test is received from a health care provider acting within the scope of the provider’s license. These requirements under the FFCRA, as amended by the CARES Act, also apply to “point-of-care” tests, such as real-time RT-PCR tests.
  • Group health plans are encouraged to “maintain their claims processing and other information technology systems in ways that protect participants, beneficiaries, and enrollees from inappropriate cost sharing and … document any steps that they are taking to do so.” This requirement will largely fall on insures for fully insured plans and, indirectly, on third-party administrators of self-funded plans.
  • The Departments are aware that some providers are not publishing the cash price of COVID-19 tests on a public website and are, instead, “using the public health emergency as an opportunity to impose extraordinarily high prices.” Group health plans that become aware of these providers are encouraged to report the provider to

FAQs Part 44 Guidance on COVID-19 Vaccinations

  • The FAQs clarify that non-grandfathered group health plans are required to cover all COVID-19 vaccinations without participant cost-sharing that have received an interim recommendation from the ACIP within 15 business days of the date of the ACIP’s recommendation. Currently, this means that non-grandfathered group health plans must cover without participant cost-sharing the Pfizer BioNTech vaccine as of January 5, 2021 and the Moderna vaccine as of January 12, 2021. On February 27, 2021, the U.S. Food and Drug Administration issued an Emergency Use Authorization for the Johnson & Johnson COVID-19 vaccine. We suspect that the Johnson & Johnson vaccine’s ACIP recommendation is imminent and, as a result, non-grandfathered group health plans must cover the Johnson & Johnson vaccine without participant cost-sharing beginning around March 19, 2021.
  • A non-grandfathered group health plan cannot deny covering a COVID-19 vaccine without participant cost-sharing just because the individual receiving the vaccine is not in a category recommended for early vaccination. For example, if a participant receives a COVID-19 vaccine from a provider because the provider would otherwise be required to dispose of the vaccine due to potential spoilage, a non-grandfathered group health plan must still cover the vaccine without participant cost-sharing, even if the participant is not otherwise eligible to receive the vaccine under the state’s or locality’s recommended distribution guidelines.

If, however, a provider declines to provide a COVID-19 vaccine to a participant who is not in the recommended prioritization category, the provider’s decision is not an “adverse benefit determination” that is subject to ERISA’s internal claims and appeals requirements, or external review requirements.

Part 44 Guidance on SBCs

The Departments continued their previous enforcement relief related to the requirement to provide an advance notice of a Summary of Benefits and Coverage (“SBC”) in certain circumstances. Under this continued relief, the “Departments will not take enforcement action against any plan…that does not provide at least 60 days’ advance notice of a material modification regarding the addition of coverage for qualifying coronavirus preventive services.” However, plans are still required to provide notice of any change as soon as reasonably practicable.

The FAQs acknowledge that this advanced SBC requirement only applies where a “material modification…would affect the content of the SBC, that is not reflected in the most recently provided SBC, and that occurs other than in connection with a renewal or reissuance of coverage.” We are still unclear, based on the generic information that is required to be included in the SBC, when the addition of coverage for qualifying coronavirus preventive services would change the content of the SBC. Employers and plan sponsors should work with their insurers (of fully insured plans) or third-party administrators (of self-funded plans) to review their current SBCs to determine if a new SBC is necessary due to the coverage of required COVID-19 items and services.

Part 44 Guidance on Excepted Benefits

In previous guidance, the Departments clarified that employers may offer benefits for the diagnosis and testing of COVID-19 under an Employee Assistance Program (“EAP”) that qualifies as an excepted benefit.  In Part 44’s FAQs, the Departments extended this guidance to indicate that an EAP may offer benefits for COVID-19 vaccines (including their administration) without the EAP losing its status as an excepted benefit.  Similarly, on-site medical clinics may provide benefits for COVID-19 vaccines without losing the clinic’s status as an excepted benefit.

This is an important clarification because if an EAP or on-site clinic loses its status as an excepted benefit, the EAP or on-site clinic must comply with all of the Affordable Care Act’s (“ACA”) insurance market reforms, which would likely be impossible without integrating the EAP or on-site clinic with the employer’s group health plan that otherwise complied with the ACA. In Part 44, the Departments confirm that employers may cover COVID-19 vaccines for all employees under an EAP or on-site medical clinic, regardless of whether the employer offers an ACA-compliant group health plan or whether an employee is enrolled in the employer’s ACA- compliant group health plan.


The Departments’ FAQs offer a range of helpful guidance to employers, and the insurers or third-party administrators of their group health plans related to the requirements under the FFCRA and the CARES Act. However, this appears to be just a “blip” on the radar with respect to what we expect in the future. Click here for more on the Department of Labor’s and Department of Treasury’s guidance related to the extension of certain deadlines during the “outbreak period.” Additionally, we suspect that the American Rescue Plan Act of 2021 will be passed shortly, which will also impact employer-sponsored group health plans and other benefits.


[SOURCE: Miller Johnson]