New COVID-19 Guidance: Government Requires Health Plans to Cover At-Home COVID-19 Tests

On January 10, 2022, the Departments of Health and Human Services, Labor and Treasury issued guidance addressing a group health plan’s obligation to cover the cost of over-the-counter, at-home COVID-19 tests starting January 15, 2022. The new coverage requirement means that enrolled individuals can go online or to a pharmacy and buy an over-the-counter FDA-approved COVID-19 diagnostic test and either have it paid for up front by their health plan or be reimbursed by submitting a claim without any cost-sharing requirements (such as deductibles, co-payments or co-insurance). The guidance provides that beginning January 15, 2022 through the end of the declared public health emergency, plans must cover at least eight (8) over-the-counter at-home tests per enrolled individual per 30-day (or calendar-month) period without an assessment or provider involvement. This does not affect the obligation to provide coverage for COVID-19 tests with a provider’s involvement or prescription.

The table below provides more details about the required coverage of at-home COVID-19 tests as well as a snapshot of the required coverage of other COVID-19-related testing, vaccines and treatment.

Required Coverage of COVID-19 Related Benefits as of January 15, 2022
COVID-19-Related Benefit	*Are Group Health Plans Required to Cover this Benefit?**	Is the Benefit Required to be Provided without Cost-Sharing, Prior Authorization or Other Medical Management Requirements?	Comments
COVID-19 Vaccinations (including Boosters)	Yes – Plans must cover any FDA-authorized or approved COVID-19 vaccine immediately upon approval or authorization	Yes, regardless of whether it is administered by an in-network or out-of-network provider	Considered preventive care for purposes of determining whether a health plan qualifies as a high deductible health plan (“HDHP”)
COVID-19 Testing and Related Diagnostic Services (other than OTC Tests)	Yes (for the duration of the public health emergency) – Tests/related services performed for diagnostic purposes must be covered Tests/related services performed for workplace safety, return to work or for other purposes not intended for diagnosis or treatment are not required to be covered Plans cannot require the presence of symptoms or suspected exposure as condition of coverage Plans can require a health care provider’s order or clinical assessment (even though these requirements cannot be required for OTC Tests)	Yes – Plans cannot use medical-screening criteria to impose cost-sharing	HDHPs may provide benefits associated with testing and treatment for COVID-19 prior to satisfying the applicable HDHP minimum deductible without adversely affecting covered individuals’ Health Savings Account eligibility.
COVID-19 FDA-Approved Over-the-Counter At-Home Tests (“OTC Tests”)	Yes (as of 1/15/22) – A health care provider’s order or clinical assessment cannot be required by the Plan Coverage cannot be limited to OTC Tests purchased at preferred pharmacies or retailers Plans are not required to provide coverage of OTC Tests that are for employment purposes.	Yes – Plans can limit the number of OTC Tests covered without cost sharing but must allow at least eight (8) tests per 30-day period (or per calendar month) per individual covered Plans can limit the amount paid for OTC Tests obtained from non-network pharmacies and retailers to the lesser of the actual price of the test, or $12; provided that (i) the Plan makes direct coverage of OTC Tests available through its pharmacy network and a direct-to-consumer shipping program at no cost to participants; and (ii) access to an adequate number of OTC Tests is available through direct coverage (based on facts and circumstances – this can be discussed with the Plan’s pharmacy manager, e.g. currently there are likely not enough OTC Tests available to meet this test)	Plans can choose whether to pay sellers of OTC Tests directly (“direct coverage”) or require the covered individual to pay for it at the point of sale and then submit a claim for reimbursement Plans may take steps to prevent, detect, and address fraud and abuse (provided the requirements are not overly burdensome to participants) – the Plan could require participant attestations that the OTC Tests were purchased for personal use and not for employment-based or resale purposes, and require documentation showing the purchase price and date
COVID-19 Treatment	No – there is no federal requirement to cover specific items and services needed to treat complications due to COVID-19.	No – the Plan’s rules related to cost-sharing, prior authorization and other medical management are permitted (although some Plans waived cost sharing, at least prior to the availability of the COVID-19 vaccines)	HIPAA’s prohibition against discrimination based on a health factor would prohibit denying eligibility for benefits or coverage based on whether an individual obtains a COVID-19 vaccination

* Different rules may apply to group health plans that are grandfathered under the Affordable Care Act (ACA) or that are retiree-only or provide only excepted benefits.

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Required Coverage of COVID-19 Related Benefits as of January 15, 2022