The End of the Public Health Emergency: Updated Guidance

On February 9, 2023, the U.S. Department of Health and Human Services (“HHS”) announced that the Public Health Emergency (“PHE”) arising from the COVID-19 pandemic, declared under Section 319 of the Public Health Service Act, will officially end May 11, 2023. The Biden administration will attempt to advance a number of priorities that resulted from COVID-19, including ensuring continued access to (i) COVID-19 vaccines and treatments, (ii) pharmaceutical companies’ access to pathways for emergency use authorizations for COVID-19 products and (iii) major telehealth flexibilities for individuals participating in Medicare or Medicaid.

Key items that will not be affected are:

  • The process for states to begin eligibility redeterminations for Medicaid
  • Access to buprenorphine for opioid use disorder treatment in Opioid Treatment Programs (“OTP”)
  • Access to expanded methadone take-home doses for opioid use disorder treatment (however, this flexibility was extended to May 11, 2024 to allow the U.S. Substance Abuse and Mental Health Services Administration time to make the flexibilities permanent in accordance with the proposed OTP regulations published in December 2022

Key items that will be affected are:

  • Certain Medicare and Medicaid waivers and flexibilities for health care providers are no longer necessary and will end (see below for further discussion)
  • For Medicaid, some additional COVID-19 PHE waivers and flexibilities will end May 11, 2023, while others will remain in place for six months following the end of the PHE (however, many of the Medicaid waivers and flexibilities, including those that support home and community-based services, are available should a state decide to continue beyond the PHE)
  • Coverage for COVID-19 testing will change, including as follows:
    • Medicare Part B beneficiaries will continue to have coverage without cost sharing for laboratory-conducted COVID-19 tests ordered by a provider, but current access to free over-the-counter (“OTC”) COVID-19 tests will end
    • The requirement for private insurance companies to cover COVID-19 tests without cost sharing, both for OTC and laboratory tests, will end
    • State Medicaid programs must provide coverage without cost sharing for COVID-19 testing until September 30, 2024, after which coverage may vary by state
  • Reporting of COVID-19 laboratory results and immunization data to CDC will change
  • Certain FDA COVID-19-related guidance documents for industries that affect clinical practice and supply chains will end or be temporarily extended, as the FDA will announce plans for each guidance prior to the end of the PHE
  • FDA’s ability to detect early shortages of critical devices related to COVID-19 will be more limited (however, the FDA is seeking congressional authorization to extend the requirement for device manufacturers to notify FDA of significant interruptions and discontinuances of critical devices outside of a PHE, which the FDA claims will strengthen its ability to help prevent or mitigate device shortages)
  • Public Readiness and Emergency Preparedness Act liability protections may be impacted in that liability protections for countermeasure activities that are not related to any U.S. Government agreement (e.g., products entirely in the commercial sector or solely a state or local activity) will end unless another federal, state or local emergency declaration is in place for areas where countermeasures are administered
  • The ability of health care providers to safely dispense controlled substances via telemedicine without in-person interaction is affected, but there will be rulemaking that will propose to extend these flexibilities. The U.S. Drug Enforcement Administration will provide additional guidance to practitioners soon

Presently, CMS COVID-19 waivers and flexibilities for providers include:

In the coming weeks, CMS will host office hours to provide additional information and will continue to update the CMS Emergencies Page regarding PHE sunsetting guidance.