By continuing to access our website, you agree to our privacy policy and use of cookies.

Skip to Main Content

Press "Enter" to search


Agencies Issue Guidance on Coverage of OTC COVID Tests

January 13, 2022

On January 10, 2022, the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments) released a set of FAQs implementing President Biden’s directive that health plans and issuers cover at-home COVID-19 diagnostic tests.


The Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) require group health plans and health insurance issuers to provide benefits for COVID-19 diagnostic tests without any member cost-sharing. This requirement was effective March 18, 2020 and is applicable throughout the duration of the public health emergency.

Under guidance issued in June 2020, at-home COVID-19 tests had to be covered only if they were ordered by an attending health care provider who determined that the test was medically appropriate for the individual. At that time, the FDA had not yet authorized any at-home COVID-19 diagnostic tests. Since then, several types of at-home tests have been approved and are available either by a prescription or over-the-counter (OTC).

On December 2, 2021, President Biden announced that the Departments would issue guidance to clarify that individuals who purchase OTC COVID-19 diagnostic tests during the public health emergency will be able to seek reimbursement from their health plan or health insurance issuer.

Covered Tests

Plans and issuers must cover any OTC COVID-19 diagnostic test authorized by the FDA, including tests obtained without the involvement of a health care provider. This coverage must be provided without imposing any cost-sharing requirements, prior authorization, or other medical management requirements.

A plan or issuer may, but is not required to, provide direct coverage to individuals by establishing a preferred pharmacy (and/or retailer) network as well as a direct-to-consumer shipping program. Under this arrangement, the plan or issuer must reimburse the sellers directly so that members do not have to make any payment upfront and seek reimbursement. If a plan or issuer does elect to provide direct coverage as described more fully in the FAQ, then the plan or issuer can limit the amount reimbursed for tests that members purchase outside of this program to no less than the actual price, or $12 per test, whichever is lower.

Limit on Tests

Plans and issuers must cover at least eight OTC COVID-19 tests per person per 30-day period (or per calendar month). Therefore, a family would have coverage for at least 32 tests per month. The test limit applies to each individual test, regardless of how they are packaged (e.g., two tests are often packaged in one box).

The FAQs states that plans and issuers are not required to provide coverage of tests for employment purposes. A plan or issuer could require an attestation, such as a signature on a brief attestation document, that the OTC COVID-19 test was purchased by the member for personal use (not for employment purposes), has not been (and will not be) reimbursed by another source, and is not for resale.

Plans and issuers generally must continue to cover unlimited tests, including at-home diagnostic tests, ordered or administered by a health care provider.

Compliance Deadline

Health plans and issuers must begin covering FDA-approved OTC COVID-19 tests purchased on or after January 15, 2022. Coverage may, but is not required to, be provided for OTC COVID-19 tests purchased prior to this date.

Additionally, because this requirement takes effect so quickly, we anticipate some health plans and issuers will experience delays at the onset of this new requirement.

More Information

Reach out to your Hylant representative for further information. Don’t have one? Contact us here.

The above information does not constitute advice. Always contact your employee benefits broker or trusted advisor for insurance-related questions.

Holly Wahl Senior Vice President, Employee Benefits Compliance Leader

Holly leads Hylant’s ongoing efforts to provide our clients with compliance consulting services on new developments as well as ongoing requirements affecting health and welfare plans. She possesses a deep understanding of federal and state regulations pertaining to employee benefit plans, as well as extensive experience in group benefit plan operation.

Related Insights