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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