U.S. Department of Health and Human Services

I. Biden Administration Requirement for Insurance Companies to Cover Cost of At-Home COVID-19 Tests

On January 10, 2022, the U.S. Department of Health and Human Safety (HHS) announced that the Biden-Harris administration will be requiring insurance companies and group health plans to cover the cost of over-the-counter, at-home COVID-19 tests, so people with private health coverage can get them for free starting January 15, 2022. This new coverage requirement means that most consumers with private health insurance will be able to purchase an at-home COVID-19 test (online or at a pharmacy) and it will either be paid for directly by their health plan or the consumer can submit a claim for reimbursement.

Starting January 15, 2022, insurance companies and health plans will be required to cover eight (8) free over-the-counter at-home tests per covered individual per month, and there will be no limit on the number of tests that are covered if they are ordered or administered by a health care provider following an individualized clinical assessment.

As part of the new requirement, the administration is incentivizing insurers and group health plans to create programs that allow people to get the over-the-counter tests directly through preferred pharmacies, retailers, or other entities with no out-of-pocket costs. Retailers and other entities providing access to consumers for over-the-counter testing should be aware of the requirements. Even if plans and insurers make tests available through preferred pharmacies or retailers, such plans and insurers are still required to reimburse tests purchased by consumers outside of that network, at a rate of up to $12 per individual test (or, if less, the cost of the test)
Continue Reading New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing Practices

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for COVID-19 laboratory developed tests (LDTs). This prior policy, which waived premarket review requirements aimed at increasing broad public access to COVID-19 tests, was generally consistent with the FDA’s historical stance allowing laboratories to not seek approval of LDTs. With the policy announced by the Trump administration, laboratories again began offering their tests prior to or without an emergency use authorization (EUA) after the test was validated and a notification was provided to the FDA. While this policy expedited the availability of tests, the FDA contends that the policy also led to some poorly-performing tests being offered prior to FDA review. Notably, this prior policy did not apply to at-home or point of care collection tests, which have always required FDA review.
Continue Reading HHS Again Requires FDA Premarket Review for COVID-19 Tests