Coverage Requirements of COVID-19 Tests & Vaccinations
By: Birch

NEW FEDERAL FAQS EXPLAINS COVERAGE REQUIREMENTS OF COVID-19 TESTS AND VACCINATIONS

Recently, the Biden Administration released another round of FAQs regarding health coverage provisions in the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The guidance was prepared jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), and sheds light on group health plans coverage requirements for services related to COVID-19.

Diagnostic Testing

Questions and answers 1-6 explain the FFCRA and CARES Act requirements for health plans to cover certain COVID-19 testing and diagnosis items and services. Coverage includes testing provided by in network or out-of-network providers, or from any licensed or authorized provider, including from a state- or locality-administered site, a “drive-through” site, and/or a site that does not require appointments. There may be no prior authorization, cost sharing or other medical management requirements applied when it comes to these tests and services.

The requirement to cover COVID-19 testing at the first-dollar level includes when an individual is asymptomatic with no known or suspected exposure to COVID-19. All health plans (except retiree only) must generally assume that tests reflect an “individualized clinical assessment” and must cover the test without cost-sharing, prior authorization, or other medical management requirements unless the request for a COVID-19 test is for general workplace health and safety or for public health surveillance.

The FAQs also strengthens the departments’ earlier guidance which requires plans and issuers to
cover items and services furnished during office visits (including in-person visits and telehealth visits),
urgent care center visits, and emergency room visits that result in an order for or administration of an
in vitro diagnostic product. However, coverage must only be to the extent that the items and services
relate to the furnishing or administration of the product or to the evaluation of the individual for
purposes of determining the need of the individual for that product.

The Departments will take enforcement action where appropriate to ensure providers are pricing
COVID-19 tests at reasonable levels and not overcharging for their services or otherwise violating the
law. Plans and issuers that identify providers violating the cash price posting requirements should
report violations to COVID19CashPrice@cms.hhs.gov.

Vaccinations & Preventive Services

The CARES Act requires non-grandfathered group and individual health insurance issuers to cover any
“qualifying coronavirus preventive service” without applying cost-sharing. This means all COVID-19
vaccines recommended by the United States Preventive Services Task Force (USPSTF) or by the
Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and
Prevention (CDC) must be covered without cost-sharing no later than 15 business days after the date
the USPSTF or ACIP makes an applicable recommendation. A recommendation from ACIP is
considered in effect after it has been adopted by the Director of the CDC.

Group health plan sponsors need to be aware of the effective date for coverage with all COVID-19
vaccinations as they are approved and made available to the public. It’s critical to make sure that
your group plan is processing these claims correctly. The requirement to cover the Pfizer BioNTech
COVID-19 vaccine became effective January 5, 2021. The requirement to cover the Moderna COVID19 vaccine became effective January 12, 2021. The requirement to cover the Johnson & Johnson
Janssen COVID-19 vaccine went into effect on March 19, 2021.

The first-dollar vaccination coverage requirement applies regardless of how the administration is
billed, and regardless of whether a COVID-19 vaccine or any other immunization requires the
administration of multiple doses in order to be complete.

A plan or issuer also may not deny coverage of recommended COVID-19 vaccines because a
participant, beneficiary, or enrollee is not in a category recommended for early vaccination. Group
health plan sponsors and insurers also have to be careful to not imply in plan communications that
coverage is limited only to individuals who are recommended for early vaccination. Instead, group
health plans and health insurance carriers are to assume that each individual’s provider made the
appropriate determination about the person’s prioritization and need for a vaccination and cover any
vaccination issued accordingly.

Similarly, if an individual’s provider decides not to administer the vaccine to someone outside of the
prioritization category, this is not an adverse benefit determination subject to the plan’s claims and
appeals requirements.

Notice Requirements – Summary of Benefits and Coverage

Consistent with FAQs issued in April of 2020, Question 11 explains in detail how a plan must provide a
revised summary of benefits and coverage (SBC) to plan participants as soon as reasonably
practicable if applicable benefits have changed recently due to the global pandemic. Enforcement
relief is available that allows plans to add benefits or reduce or eliminate cost sharing for the
diagnosis and treatment of COVID-19 or for telehealth and other remote care services during the
Public Health Emergency for COVID-19 or national emergency declaration period without providing
60 days’ advance notice generally required for material modifications.

Excepted Benefits: On-Site Medical Clinics and Employee Assistance Programs

Earlier guidance clarified that an employer may offer benefits for diagnosis and testing for COVID-19
under an Employee Assistance Program (EAP) that constitutes an excepted benefit and not a group
health plan (i.e., one which does not provide benefits that are significant in the nature of medical
care). Companies may also offer benefits for diagnosis and testing for COVID-19 at an on-site medical
clinic, and that coverage is considered to be an excepted benefit in all circumstances. Questions 12
and 13 of the most recent FAQs expands on the previous guidance, allowing employers to offer
benefits for COVID-19 vaccines (and their administration) at an on-site medical clinic and under an
EAP that constitutes an excepted benefit.