COVID-19 Public Health Emergency to End May 11, 2023

As we have reported, the Biden Administration announced plans to end the Public Health Emergency (PHE) on May 11, 2023. Since then the Department of Health and Human Services (HHS) has released a fact sheet laying out the COVID-19 PHE Transition Roadmap. Highlights of this document for laboratories include:

  • Emergency Use Authorizations (EUA) for COVID-19 vaccines, tests, and treatments will not be impacted by the end of the PHE. Existing EUAs will remain in effect under the Food and Drug Administration’s (FDA) 564 authority, and FDA may continue to issue future EUAs if necessary.

  • Coverage policies for COVID-19 testing are subject to change.
    • Medicare beneficiaries who are enrolled in Part B will continue to enjoy access to COVID-19 testing without cost-sharing after the end of the PHE. However, Medicare beneficiaries will no longer have access to free at-home COVID-19 test kits.

    • State Medicaid programs will continue to provide coverage without cost-sharing for COVID-19 testing until at least September 30, 2024, after which time Medicaid coverage of testing will vary by state.

    • The requirement for private insurance plans to provide coverage without cost-sharing of both laboratory testing for COVID-19 and at-home tests will end when the PHE expires. Plans may continue to provide coverage if they choose to.

  • HHS will no longer have the authority to require the reporting of COVID-19 laboratory data. Laboratories must continue to follow state reporting requirements.

  • Manufacturers of certain devices used for treatment and diagnosis of COVID-19 will no longer be required to notify FDA of discontinuance or interruptions in manufacturing that may lead to supply chain disruptions. Thus, FDA’s ability to anticipate supply shortages may become limited. FDA is seeking authorization from Congress to extend these reporting requirements for manufacturers.

NILA will continue to report on the unwinding of the PHE as these policies are developed and finalized.