On April 11, 2020, the Departments of Labor (DOL), Health and Human Services (HHS) and the Treasury (the “Departments”) issued a set of FAQs regarding Section 6001 of the Families First Coronavirus Response Act (FFCRA). This provision generally requires group health plans and health insurance issuers to provide benefits for certain items and services related to diagnostic testing for the detection or the diagnosis of COVID-19 on or after March 18, 2020. The coverage must be provided without any cost-sharing requirements. Section 6001 was expanded under Section 3201 of the CARES Act to require a broader range of COVID-19 related items and services.
This set of FAQs provides further guidance and clarification on the following:
Health Insurance Plan Requirements
The FAQ makes it clear that this requirement is applicable to all group health plans and health insurance coverage. This includes both fully insured and self-funded plans. It also includes private employer group health plans, plans sponsored by states and local governments and church plans.
Plans and issuers must comply with the requirements of Section 6001 as of March 18, 2020. Plans and issuers must continue to comply with section 6001 of the FFCRA for applicable items and services furnished during the public health emergency related to COVID-19.
Required Items and Services
The following items and services must be provided without cost sharing in relation to COVID-19:
- An in vitro diagnostic test  for the detection of SARS-CoV-2 or the diagnosis of COVID-19, and the administration of such a test, that:
- is approved, cleared, or authorized by the Federal Drug Administration
- the developer has requested, or intends to request, emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act, unless and until the emergency use authorization request has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe;
- is developed in and authorized by a state that has notified the Secretary of HHS of its intention to review tests intended to diagnose COVID–19; or
- other tests that the Secretary of HHS determines appropriate in guidance.
- Items and services furnished to an individual during healthcare provider office visits (in-person, telehealth, urgent care center, emergency room) that result in an order for or administration of an in vitro diagnostic product but only to the extent 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 such product.
- This includes items or services furnished in non-traditional settings, as well as when provided in traditional settings.
Typically any material modification to the group health plan or coverage, as amended in the Summary of Benefits and Coverage (SBC), requires a 60-day notice prior to the effective date of the change. However, the Departments will not take enforcement action against any plan or issuer that makes such modification to provide greater coverage related to the diagnosis and/or treatment of COVID-19, including additional telehealth services, without providing at least 60-days advance notice. Plans and issuers must provide notice of the changes as soon as reasonably practicable. To the extent a plan or issuer maintains any such changes beyond the emergency period, plans and issuers must comply with all other applicable requirements to update plan documents or terms of coverage. The Departments note that plans and issuers may either provide an updated SBC reflecting the modification or provide a separate notice describing the material modifications.
Nothing in the FFCRA prevents a state from imposing additional standards or requirements on health insurance issuers with respect to the diagnosis or treatment of COVID-19, to the extent that such standards or requirements do not prevent the application of a federal requirement.
EAPs and On-site Medical Clinics
Employers are allowed to offer COVID-19 related services during a public health emergency under an Employee Assistance Program (EAP) or at an on-site medical clinic without affecting the “excepted benefit” status of the EAP or on-site clinic.
This FAQ from the federal government helps employers further understand their coverage requirements as a result of the FFCRA and the CARES Act. If you have further questions, please contact your health insurance carrier, third party administrator or your M3 account team.
 “In vitro diagnostic tests” include serological tests for COVID-19 used to detect antibodies against the SARS-CoV-2 virus, and are intended for use in the diagnosis of the disease or condition of having current or past infection with SARS-CoV-2, the virus which causes COVID-19.