Employers have more clarity on COVID-19 testing coverage requirements—including new details on at-home tests, return-to-work testing, and out-of-network pricing—under new guidance that the U.S. Department of Health and Human Services (HHS), U.S. Department of Labor (DOL) and the U.S. Department of the Treasury jointly prepared.

The guidance—in the form of frequently asked questions (FAQs)—further interprets testing requirements that originally appeared in the Families First Coronavirus Response Act (FFCRA) and that were expanded in the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The FFCRA requires group health plans to cover U.S. Food and Drug Administration (FDA)-approved COVID-19 tests and services related to the furnishing or administration of the tests on a first-dollar basis, meaning before a participant’s deductible is met and without requiring any other cost-sharing such as copayments or coinsurance. In addition, plans may not impose medical management requirements such as prior authorization on tests and related services. These requirements took effect March 18, 2020, and end when the national emergency period ends. The CARES Act later expanded the scope of covered COVID-19 tests to include tests:

• for which “[t]he developer has requested, or intends to request, [FDA] emergency use authorization”;

• “[that are] developed in and authorized by a State that has notified the Secretary of HHS of its intention to review” COVID-19 tests; or

• that are specifically approved by further HHS guidance.

The FDA maintains a list of tests that have received FDA emergency use authorization and a list of states that have authorized COVID-19 tests. Previous DOL guidance clarified that the federal requirements covered serological (antibody) tests. Under the CARES Act, plans must also reimburse providers for COVID-19 tests at either a negotiated rate or the cash price, which providers are required to publish on a public website.

The new FAQ guidance, released June 23, 2020, provides a number of clarifications to the COVID-19 testing coverage requirement:

• Plans, or their third-party administrators, can reasonably request evidence of a test developer’s FDA emergency use authorization request or intent to make such a request before paying a provider for a test. If no evidence is provided, a plan can treat the cost of the test under the plan’s pre-FFCRA terms, including requiring cost-sharing by the participant. The FDA maintains a list of laboratories and manufacturers that have validated their own COVID-19 tests and are preparing to or have requested emergency use authorization.

• Earlier DOL guidance had required plans to cover testing and related services that were determined to be medically appropriate by an attending health care provider. The guidance defined an “attending [health care] provider” as “an individual … licensed under applicable state law … acting within the scope of [his or her] license, and … directly responsible for providing care to a patient.” The new FAQs specify that the attending provider need not be the patient’s primary care physician or directly administer the test—he or she need only make an individualized clinical assessment of medical appropriateness for the patient.

• Plans must cover on a first-dollar basis at-home COVID-19 tests that otherwise fall under the scope of the CARES Act and that are determined to be medically appropriate by an attending provider.

• Plans are required only to cover on a first-dollar basis COVID-19 tests primarily intended for individualized diagnosis or treatment. Tests administered to screen employees returning to work are not covered by the FFCRA and CARES Act requirements.

• Plans are required to cover an unlimited number of COVID-19 tests per individual that otherwise meet the requirements of the FFCRA, CARES Act, and agency guidance.

• Only COVID-19 tests—and not related services—need to be reimbursed at a negotiated rate or at the published cash price. The FAQs also state that participants should not be balance billed for COVID-19 tests, indicating that providers should accept the plan’s payment of a negotiated rate or the cash price as payment in full. As a result, participants may end up being balance billed by providers for services related to COVID-19 tests.

• Plans are required to reimburse the negotiated cost or the published price of a test, even if that test is received in an out-of-network hospital emergency room. The FAQs indicate that the CARES Act requirements supersede the standard Affordable Care Act rules on out-of-network emergency services.

• Upon the end of the national emergency period, plans must notify participants if they are going to discontinue covering COVID-19 tests and related services on a first-dollar basis. Ordinarily, plans would have to provide 60 days’ prior notice of a benefit reduction that would affect the summary of benefits and coverage, or SBC. But the FAQs indicate that this notice requirement would not apply if the plan previously notified participants of the temporary nature of the expanded coverage or provided notice “within a reasonable timeframe” that the coverage was ending.