Guidance Released on Coverage for OTC COVID-19 Tests

COVID-19 Update

Date: January 11, 2022

On January 10 the Departments of Labor, Health and Human Services, and the Treasury (collectively, the “Departments”) issued FAQs Part 51 providing further guidance on the requirement that group health plans and insurers must cover, without cost-sharing, over-the-counter (OTC) COVID-19 tests.1 The FAQs are intended to clarify President Biden’s December 2 announcement that individuals who purchase OTC COVID-19 diagnostic tests during the public health emergency will be able to seek reimbursement from their plan or insurer.

The Families First Coronavirus Response Act (FFCRA), enacted on March 18, 2020, generally requires group health plans and insurers, including grandfathered group health plans, to provide benefits for certain items and services related to diagnosing COVID-19 infections during the applicable emergency period. The Coronavirus Aid, Relief, and Economic Security Act, enacted on March 27, 2020, further amended the FFCRA to require plans and insurers to provide a broader range of diagnostic items and services related to COVID-19 without cost-sharing, prior authorization, or other medical management requirements.

Required Coverage

FAQs Part 51 clarify that health plans and insurers are required to cover OTC COVID-19 tests intended for diagnostic purposes without cost-sharing, prior authorization, or other medical management requirements if purchased on or after January 15, 2022 and during the public health emergency. The requirement applies to OTC COVID-19 tests purchased for covered individuals, regardless of whether they are symptomatic, for the purpose of diagnosis or treatment of COVID-19. Previous guidance from the Departments requires health plans and insurers to provide coverage for at-home COVID-19 tests when ordered by an attending health care provider. This guidance expands the coverage requirement to include at-home COVID-19 testing purchased without the involvement of a health care provider.

Direct Payment for Tests

Though not required, the Departments strongly encourage health plans and insurers to provide coverage for OTC COVID-19 tests through “direct coverage,” meaning the health plan or insurer pays the cost of the OTC COVID-19 test directly to the seller rather than requiring an employee to purchase the test and submit a request for reimbursement.

Coverage Limits

A health plan or insurer may limit the amount it will pay for an OTC COVID-19 test as described below:

  • If a health plan provides direct coverage (see above) of OTC COVID-19 tests through both its pharmacy network and a direct-to-consumer shipping program, and
  • If the plan takes reasonable steps to ensure covered persons have access to OTC COVID-19 tests through an adequate number of retail locations (including both in-person and online locations);
  • Then the plan may impose a limit of $12 (or, if less, the actual cost of the test) on reimbursement for an OTC COVID-19 test purchased in any other manner.

Regardless of whether a health plan or insurer provides direct coverage, the plan or insurer may limit coverage of OTC COVID-19 tests that are purchased without the involvement of a health care provider to eight per 30-day period or per calendar month.

Tests Purchased for Employment or Public Health Purposes

Health plans and insurers may, but are not required to, cover OTC COVID-19 tests that are purchased for employment or public health purposes. Accordingly, if an employer requires unvaccinated employees to submit to regular testing, including in accordance with OSHA’s Emergency Temporary Standard, a health plan or insurer is not required to provide coverage for such testing.

Verification Requirements

To prevent abuse and fraud, health plans and insurers may require a signature on a brief attestation providing that the purchased OTC COVID-19 test will be used by the individual or a covered family member for diagnostic purposes and not for any other purpose, such as for employment or public health surveillance.

Health plans and insurers may also require documentation of proof of purchase (such as submission of a UPC code and/or receipt) before providing reimbursement.

Communication Requirements

If a health plan or insurer provides educational resources to covered persons seeking OTC COVID-19 tests, such resources must:

  • Make clear that the health plan or insurer provides the required coverage for OTC COVID-19 tests; and
  • Be consistent with the test’s emergency use authorization.

For more information, please contact:

Megan S. Glowacki

Stephen R. Penrod

Kim Wilcoxon

Beth A. Mandel

Tenechia D. Lockhart

Additional Resources

We have assembled a firmwide multidisciplinary task force to address clients’ business and legal concerns and needs related to the COVID-19 pandemic. Please see our COVID-19 Task Force page for additional information and resources.

This advisory bulletin may be reproduced, in whole or in part, with the prior permission of Thompson Hine LLP and acknowledgment of its source and copyright. This publication is intended to inform clients about legal matters of current interest. It is not intended as legal advice. Readers should not act upon the information contained in it without professional counsel. This document may be considered attorney advertising in some jurisdictions.


1 FAQs Part 51 also provide further guidance on specific preventive services (colonoscopies and contraceptive services) that certain group health plans and health insurance issuers are required to cover under Section 2713 of the Public Health Service Act.