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New Guidance on Health Plan Coverage of OTC COVID-19 Tests

By Stephanie H. Grant posted 01-13-2022 13:17

  

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. The federal government has issued guidance in the form of FAQs that implement this new policy. Here are some highlights of the FAQs:

  • Health plans must provide coverage for OTC COVID-19 tests purchased for a participant’s personal use on and after January 15, 2022, and during the public health emergency.
  • Health plans are not required to provide coverage of OTC COVID-19 tests for employment purposes, and the health plan may require the participant to sign an attestation that the test was purchased for personal use only.
  • Health plans must provide coverage for OTC COVID-19 tests without cost-sharing, prior authorization, or other medical management requirements and without involvement by a health care provider.
  • Health plans may limit OTC COVID-19 tests to eight individual tests per plan participant per calendar month.
  • Health plans are strongly encouraged to provide “direct coverage” of OTC COVID-19 tests. “Direct coverage” means that the health plan reimburses the retailer (e.g., a pharmacy) directly, and the plan participant is not required to seek reimbursement postpurchase. Health plans may limit direct coverage of OTC COVID-19 tests to the health plan’s pharmacy networks and direct-to-consumer shipping program, as well as otherwise limit reimbursement for OTC COVID-19 tests from nonpreferred pharmacies or other retailers to no less than the actual price or $12 per individual test, whichever is less. Health plans must take reasonable steps to ensure that plan participants have adequate access to OTC COVID-19 tests through an adequate number of retail locations (in-person and online) when offering direct coverage of OTC COVID-19 tests.
  • Health plans may also require plan participants to submit a claim for reimbursement (along with reasonable proof of purchase) to the health plan consistent with the health plan’s internal claim procedures. Health plans must make this reimbursement option available at any time the health plan cannot meet the requirements of the permissible direct coverage limitation described above.

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 (1) tests approved, cleared, or authorized under certain sections of the Federal Food, Drug, and Cosmetic Act; (2) tests that the developer has requested or intends to request emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act; (3) tests developed in and authorized by a state that has notified the secretary of the U.S. Department of Health and Human Services (HHS) of its intention to review COVID-19 diagnostic tests; and (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, it 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.

Note that this article was originally published on the Warner Norcross + Judd website, and was co-authored by Norbert F. Kugele.

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