Employer health plans and health insurers will be required to cover over-the-counter (OTC) COVID-19 tests, even without a health care provider’s order or an individualized clinical assessment, and generally without cost sharing or medical management, beginning with tests purchased on or after January 15, 2022.

That is the basic coverage requirement set forth in the frequently asked question (FAQ) guidance jointly issued on January 10, 2022, by the U.S. Department of Labor (DOL), U.S. Department of the Treasury, and U.S. Department of Health and Human Services (HHS). It marks a significant break with prior guidance under the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief, and Economic Security (CARES) Act that required coverage only when a medical professional had made an individualized assessment that diagnostic testing was medically appropriate.

The FAQ guidance comes in response to a White House directive on OTC COVID-19 testing issued on December 2, 2021. Other key points covered under the FAQ guidance include the following:

• Testing for employment purposes would still not have to be covered by health plans or health insurers. This is consistent with prior guidance that distinguished testing primarily intended for the individual diagnosis or treatment of COVID-19 from testing, such as worksite testing, that is not primarily intended for individual diagnosis and treatment. Note: It is not clear how plan administrators will be able to distinguish requests related to worksite testing, which may not be eligible for reimbursement, from requests related to individual diagnosis and treatment, which would have to be covered.

• Health plans and insurers would not be permitted to limit reimbursement for OTC COVID-19 tests to those provided only through network pharmacies or other retailers. Certain limitations on reimbursements, however, would be allowed under a safe harbor. The FAQ guidance states that the DOL, HHS, and Treasury Department will not take enforcement action against a plan or health insurer that meets its FFCRA requirement to cover testing through both a pharmacy network and a direct-to-consumer shipping program, but otherwise limits reimbursement for tests from a non-network pharmacy or other retailer to the lesser of $12 per test or the actual price of the test.

• To use this reimbursement safe harbor, health plans or insurers would also have to take reasonable steps to ensure “adequate access” to OTC COVID-19 tests through online and brick-and-mortar retail locations. Whether there is adequate access would be evaluated on the basis of all relevant facts and circumstances.

• Another safe harbor set by the FAQ guidance would permit health plans or health insurers to limit the number of tests covered by a plan or policy to 8 tests per 30 days per participant or beneficiary. Lower limits over shorter periods (such as 4 tests in 15 days) would not be allowed.

• The guidance “strongly encourage[s],” but stops short of requiring, health plans and health insurers to pay providers for tests directly, rather than reimbursing participants. Such “direct coverage” would facilitate greater access to testing and would improve health equity, according to the FAQ guidance.

• The FAQ guidance permits health plans and health insurers to take certain actions to prevent fraud and abuse. For example, the guidance states that a plan or insurer may take reasonable steps—such as requiring an attestation—to ensure that tests have been purchased for personal use, provided that any anti-fraud measures do not create “significant barriers” to participants and beneficiaries obtaining tests. A plan or insurer could also require reasonable documentation of a proof of purchase for reimbursement of the cost of an OTC COVID-19 test.