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Yesterday, the federal government issued guidance in the form of <a href="https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf" target="_blank" rel="noreferrer noopener">FAQs</a> that implement President Joseph Biden’s earlier announcement that individuals who purchase over-the-counter (OTC) COVID-19 diagnostic tests for personal use during the public health emergency will be able to seek reimbursement from their health plan.

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The FAQs imply that not all OTC COVID-19 tests need to be covered. The coverage requirement applies only to OTC COVID-19 tests that meet the requirements of section 6001 of the Families First Coronavirus Response Act, which applies to tests that: (1) are approved, cleared, or authorized under certain sections of the Federal Food, Drug and Cosmetic Act; (2) the developer has requested or intends to request emergency use authorization under section 564 of the Federal Food, Drug and Cosmetic Act; (3) are developed in and authorized by a state that has notified the Secretary of HHS of its intention to review COVID-19 diagnostic tests; or (4) other tests that the Secretary of HHS determines are appropriate. Thus, part of the claim substantiation process could include requiring a copy of the product’s UPC so that the health plan can determine whether the test qualifies for coverage. But if a health plan intends to limit which OTC COVID-19 tests qualify for coverage, they will need to carefully evaluate and identify which tests (including new tests entering the market) meet these requirements and provide appropriate guidance to participants.   Employers should work with their health plan insurers or third party administrators to implement coverage for OTC COVID-19 tests, such as setting up technology and systems to process payments for direct coverage, and/or to process individual reimbursement requests from plan participants. Employers should also communicate to participants how the health plan will handle coverage for OTC COVID-19 tests, including any limits on tests and specific claims procedures. Plan documents and summary plan descriptions should also be reviewed to see if they need to be amended.   If you need assistance in working with your health plan regarding coverage for OTC COVID-19 tests, Warner can help! Please contact Stephanie Grant, Norbert Kugele or any other member of Warner’s Employee Benefits/Executive Compensation Practice Group.

Senior Counsel

Stephanie H. Grant

Employee Benefits

New Guidance on Health Plan Coverage of OTC COVID Tests

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New Guidance on Health Plan Coverage of OTC COVID Tests

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