Following the release of the Departments of Labor, Health and Human Services (HHS) and the Treasury (collectively, the Departments) FAQ Part 51, a significant number of unanswered questions remain regarding the coverage of over-the-counter (OTC) COVID-19 tests. In addition, we are seeing insurance carriers, third-party administrators (TPAs) and pharmacy benefit managers (PBMs) implement solutions that differ based on varying interpretations of the guidance, which can create additional confusion for plan sponsors, who must make decisions regarding how their plans should be amended to comply with the new coverage requirements. The Brown & Brown Regulatory and Legislative Strategy Group has compiled frequently asked questions highlighting common concerns facing employers.

Q1. Are employers required to notify their employees with respect to coverage of OTC COVID-19 tests?

FAQ Part 51 does not describe any specific requirement under section 6001 of the FFCRA to notify employees of the information contained within the guidance. However, under certain circumstances, plan sponsors may be required to furnish a summary of material modifications (see Q2 below).

The Departments do state that plans and issuers may provide education and information resources so long as the resources “make clear that the plan or issuer provides coverage for, including reimbursement of, all OTC COVID-19 tests that meet the statutory criteria under section 6001(a) (1) of the FFCRA (subject to the safe harbors in Q2 and Q3), and such information is consistent with the test’s emergency use authorization (EUA).”

Q2. Are plans required to furnish a summary of material modifications (SMM) with respect to plan changes for coverage of OTC COVID-19 tests that meet the criteria under section 6001(a) (1) of the FFCRA and are obtained without the involvement of a health care provider?

Possibly. If a plan has a general exclusion for OTC medicines and supplies without a health care provider’s order, a change in coverage to include OTC COVID-19 tests without a health care provider’s order may trigger the requirement to provide an SMM. In addition, if a plan sponsor chooses to impose a limit on the number of COVID-19 tests purchased by participants, beneficiaries or enrollees during a specified amount of time, these restrictions should be reflected in the SPD (and/or SMM).

Regulatory and Legislative Strategy Group