February 6, 2022


On Feb. 4, 2022, the Departments of Labor (DOL), Health and Human Services (HHS) and the Treasury (Departments) jointly issued FAQs (FAQs Part 52) regarding coverage of over-the-counter (OTC) COVID-19 tests.

These FAQs modify and clarify the guidance in FAQs Part 51, which specified that plans and issuers must cover OTC COVID-19 tests available without an order or individualized clinical assessment by a health care provider.

The new FAQs include the following guidance:

  • Plans and issuers have flexibility in how they establish a direct-to-consumer shipping program and direct coverage through an in-person network in order to qualify for the safe harbor.
  • The Departments will not take enforcement action against a plan or issuer that is temporarily unable to provide adequate access to OTC COVID-19 tests through its direct coverage program due to a supply shortage.
  • Plans and issuers are permitted to take reasonable steps to prevent, detect and address fraud and abuse.
  • The OTC test coverage requirements do not apply to tests that use a self-collected sample but require processing by a laboratory or other health care provider to return results.

The FAQs also address how a plan’s or issuer’s coverage of OTC COVID-19 tests impacts health flexible spending arrangements (FSAs) and similar account-based plans.

To read the complete ACA Bulletin, download the document.


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