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Legal Update: Agencies Issue Guidance on Coverage of OTC COVID-19 Tests

On Jan. 10, 2022, the Depts. of Labor, Health and Human Services (HHS), and the Treasury issued FAQ guidance regarding the requirements for group health plans and health insurance issuers to cover over-the-counter (OTC) COVID-19 diagnostic tests. 


Legal Requirements

Plans and issuers must cover the costs of COVID-19 tests during the COVID-19 public health emergency without imposing any cost-sharing requirements, prior authorization, or other medical management requirements.

Under guidance issued in June 2020, at-home COVID-19 tests had to be covered only if they were ordered by a 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 OTC at-home tests have been approved.

As of Jan. 15, 2022, the cost of these tests must be covered, even if they are obtained without the involvement of a health care provider. However, the FAQs do not require tests to be covered if they are not for individualized diagnosis (such as tests for employment purposes).  


Plan Options

Plans and insurance issuers may place some limits on coverage, such as:

  • Requiring individuals to purchase a test and submit a claim for reimbursement, rather than providing direct coverage to sellers.
  • Providing direct coverage though pharmacy networks or direct-to-consumer shipping programs and limiting reimbursements to other sources (the actual cost of the test, or $12, whichever is lower).
  • Setting limits on the number or frequency of OTC COVID-19 tests that are covered (no less than 8 tests per month or 30-day period).
  • Taking steps to prevent, detect and address fraud and abuse. 


Important Dates

Dec. 2, 2021 - President Biden announced that guidance would be issued clarifying coverage of OTC COVID-19 tests.

Jan. 10, 2022 - Federal agencies issued guidance implementing the requirements for coverage of OTC COVID-19 tests. 

Jan. 15, 2022 - Deadline for plans and issuers to provide coverage for OTC COVID-19 tests available without health care provider order or assessment.




This Legal Update is not intended to be exhaustive nor should any discussion or opinions be construed as legal advice. Readers should contact legal counsel for legal advice. ©2022 Zywave, Inc. All rights reserved.


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