Background

The FFCRA and Cares Act require group health plans, including grandfathered health plans, to provide benefits for certain items and services related to testing for the detection of SARS-CoV-2, the virus that causes COVID-19, when those items or services are provided during the public health emergency declared under the Public Health Service Act in response to COVID-19. The benefits must be provided without cost sharing, prior authorization or other medical management.

The CARES Act also includes requirements related to provider charges for COVID-19 diagnostic testing. In addition both the CARES Act and the ACA preventive services rules require coverage of COVID-19 vaccinations under certain circumstances. The Departments have issued two prior sets of FAQs to implement these provisions. (We discussed those FAQs in compliance insights published on April 14, 2020 and June 24, 2020.)

Diagnostic testing

The latest FAQs clarify that plans cannot impose specific medical screening criteria or require the presence of symptoms or a recent known or suspected exposure to COVID-19 to cover COVID-19 diagnostic testing. Rather, plans must cover the test without cost sharing when an individual receives a COVID-19 test from a licensed or authorized health care provider, or when a licensed or authorized health care provider refers an individual for such a test.

The Departments state that while testing must be covered for asymptomatic individuals for the purposes of individualized diagnosis of COVID-19, plans are not required to provide coverage of testing such as for employment purposes or public health surveillance.

The FAQs clarify that diagnostic tests covered at a drive-through site or at a site that does not require appointments, including state or locally administered testing sites, must be covered when provided by a licensed or authorized provider. Plans are directed to assume that the receipt of the test reflects an individualized clinical assessment.

If a plan identifies a provider violating the requirements related to cash price posting of COVID-19 tests, the Departments request plans to report the violation to COVID19CashPrice@cms.hhs.gov. Plans are encouraged to provide individuals with information about providers who have negotiated rates for COVID-19 testing with the plan or about other providers who adhere to best practice standards.

Vaccines

The FAQs reiterate that non-grandfathered plans must provide coverage without cost sharing for all qualifying coronavirus preventive services, including COVID-19 vaccines approved by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC). Coverage is required in-network permanently, and out-of-network during the public health emergency.

Plans are not permitted to exclude coverage or impose cost sharing on these vaccines. Plans must cover the administration of the vaccine, including in instances where a third party, such as the federal government, pays for the vaccine itself.

The vaccines must be covered no later than 15 business days (not including weekends or holidays) after the date the director of the CDC adopts a vaccine recommendation from the ACIP. The effective date for covering the Pfizer-BioNTech vaccine is January 5, 2021, and the Moderna vaccine is January 12, 2021. Two days after the publication of these FAQs, on February 28, 2021, the director of the CDC adopted the ACIP’s recommendation of a third COVID-19 vaccine, the Janssen (Johnson & Johnson) vaccine.

Non-grandfathered plans must cover COVID-19 vaccines without cost sharing even when the individual may not be within the vaccination category being prioritized in a particular jurisdiction. Nonetheless, a provider’s decision not to vaccinate a particular individual is not an adverse benefit determination and does not invoke claims and appeals rights.

EAPs and on-site clinics

The guidance provides direction for employers that want to offer vaccines through an employee assistance program (EAP) or on-site clinic. The Departments will not consider an EAP to provide benefits that are significant in the nature of medical care (and, therefore, no longer an “excepted benefit”) solely because it offers benefits for COVID-19 vaccines and their administration (including when offered in combination with benefits for diagnosis and testing for COVID-19), as long as there is no cost sharing and the EAP complies with other applicable laws.

COVID-19 vaccines can also be offered at on-site medical clinics without disrupting the on-site clinic being considered an excepted benefit.

Plan sponsors actions

Plan sponsors should review coverage of diagnostic testing and vaccines to ensure that impermissible medical management is not being imposed and that benefits are being provided consistent with federal guidance.

The Departments recommend that plans maintain their claims processing and other information technology systems in ways that protect participants and beneficiaries from inappropriate cost sharing and document any steps that they are taking to do so. Plan administrators may continue to employ programs designed to detect and address fraud and abuse, including with respect to COVID-19 diagnostic testing.