Beginning January 15, 2022, and continuing throughout the duration of the public health emergency, group health plans and insurers are required to cover over-the-counter (OTC) at-home COVID-19 tests (OTC Tests), including tests not ordered by a health care provider, without participant cost-sharing, preauthorization, or medical management, according to Frequently Asked Questions (FAQs) recently issued by the Departments of Labor, Treasury and Health and Human Services.
The Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) require group health plans and insurers to cover testing for COVID-19, which limited coverage to COVID-19 tests ordered by a health care provider.
When the prior guidance was issued, OTC Tests were generally unavailable. Since then, FDA-approved at-home COVID-19 tests that can be self-administered and self-read have become widely available, either with prescription or over-the-counter, and it was unclear whether the OTC Tests were subject to the same coverage requirements that applied to COVID-19 testing with an order or individualized clinical assessment from a health care provider.
On December 2, 2021, President Biden announced that the Departments would issue guidance clarifying that individuals who purchase OTC Tests during the public health emergency will be able to seek reimbursement from their group health plan or insurer. These FAQs confirm that group health plans and insurers must provide coverage of OTC Tests without participant cost-sharing, preauthorization, or medical management.
The FAQs provide the following guidance:
- The coverage requirement applies with respect to OTC Tests purchased on or after January 15, 2022, and during the public health emergency. Coverage may, but is not required to, be provided for OTC Tests purchased without a provider order or individualized clinical assessment before January 15, 2022.
- Group health plans can make OTC Tests free to participants by directly reimbursing sellers of OTC Tests (referred to as “direct coverage”). Under direct coverage, the plan will make available tests through its pharmacy network or other retailers (including a direct-to-consumer shipping program) without any out-of-pocket cost to the participant. Alternatively, group health plans can reimburse participants who purchase an OTC Test from a pharmacy or other retailer and submit a claim for reimbursement. The guidance strongly encourages direct coverage of OTC Tests.
- Group health plans that provide direct coverage may not limit coverage to preferred pharmacies or retailers. However, if a plan provides direct coverage, the guidance provides a safe harbor allowing plans to limit reimbursement for tests purchased from non-preferred pharmacies or retailers to $12 per test or the cost of the test, whichever is less. In order to rely on this safe harbor, the plan must take reasonable steps to ensure participants have adequate access to OTC Tests by providing an adequate number of retail locations to obtain the tests (both in-person and online). If a plan does not establish a direct coverage program, the plan may not limit the amount of reimbursement and must cover the participant’s actual cost to purchase the OTC Tests.
- Group health plans are required to cover at least 8 OTC Tests per 30 day period (or per calendar month) for each participant, beneficiary or other family member enrolled in the plan. Plans cannot limit participants, beneficiaries, or enrollees to a smaller number of tests over a shorter period (for example, limiting individuals to 4 tests per 15-day period), but may set more generous limits. Where multiple tests are sold in one packet, plans may count each test separately.
- Group health plans are required to reimburse OTC Tests intended for individualized diagnosis or treatment of COVID-19 only. The FAQs confirm that the new requirements do not modify prior guidance stating that group health plans are not required to cover OTC Tests purchased for employment purposes (such as employer-mandated testing).
- Group health plans may take reasonable steps to address fraud and abuse as long as such steps do not create “significant barriers” for participants to obtain the tests. For example, a plan may require an attestation, such as a signature on a brief attestation document, that the OTC Test was purchased for personal use and not employment purposes, will not be reimbursed by another source or resold. Additionally, a plan may request proof of purchase, such as a receipt and/or UPC code.
Group health plans will need to act quickly to ensure compliance with this new guidance. For fully-insured plans, employers should contact the insurer to determine how they will comply with this change. For self-insured plans, employers should contact the pharmacy benefit managers and/or third party administrators to determine which vendor will be responsible for compliance. Plans should also consider how best to communicate this benefit change to participants.