This week, the Department of Labor, Health and Human Services and the Treasury issued a new set of Frequently Asked Questions (FAQs) confirming that group health plans and issuers must provide 100% coverage of over-the-counter (OTC) COVID-19 diagnostic tests beginning January 15, 2022.

The FAQs are further interpretation of the coverage mandate required by the Families First Coronavirus Response Act (FFCRA), as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Under this new guidance, 100% of the cost for COVID-19 tests purchased by an individual for diagnostic purposes on or after January 15, 2022, must be covered without cost-sharing or medical management requirements—even if the test was purchased OTC without a provider prescription or clinical assessment. This requirement continues for the duration of the national public health emergency.

The FAQs confirm that, per prior guidance that remains unchanged, the plan or issuer is generally not required to cover COVID-19 tests obtained for employment purposes or for other purposes that are not primarily intended for individualized diagnosis or treatment. Also, these new FAQs are separate from the U.S. government’s purchase of 500 million rapid tests and its commitment to mail tests free of charge to Americans who request them.

Per the FAQs, plans and issuers would be permitted to impose certain limitations that pertain to cost and quantity and that are intended to protect against fraud and abuse:

  • Where the plan or issuer provides direct coverage of OTC COVID-19 tests (i.e., pays the seller directly and does not require members to seek reimbursement post-purchase), coverage cannot be limited to only those tests provided through its program or by its preferred/in-network sellers. However, the plan or issuer may limit reimbursement of tests purchased outside its direct coverage program to the lower of $12 or the actual cost of the test.
  • With respect to OTC COVID-19 tests purchased during the public health emergency and without provider clinical assessment or involvement, the plan or issuer may limit the number of tests covered to no less than eight tests per covered individual per 30-day period (or calendar month).
  • The plan or issuer may take action to prevent, detect, and address fraud and abuse, provided that these do not create a significant barrier to obtaining tests. Examples include requiring proof of purchase or an attestation that a test was purchased for the member’s personal use (or their covered dependent’s use).

Plans or issuers who have questions about these FAQs should contact experienced counsel to ensure compliance.