Since January 31, 2020, the United States has operated under the COVID-19 Public Health Emergency ("PHE") in connection with COVID-19. Declared pursuant to Section 319 of the Public Health Service Act, the PHE granted the federal government broad emergency rulemaking and funding powers to address COVID-19. Every ninety days since January 31, 2020, the Secretary of Health and Human Services ("HHS") has renewed the PHE.

However, on February 9, 2023, HHS announced that it was renewing the PHE for the last time. In its recent Letter to U.S. Governors, HHS announced that the PHE would expire on May 11, 2023, providing states 90 days’ notice to prepare for the policy waivers and flexibilities that will end concurrently with the PHE.

HHS has issued a fact sheet summarizing the COVID-19 policies and programs that will be affected by the end of the PHE. In general, federal agency rule waivers and flexibilities issued pursuant to the PHE are set to expire unless they have been specifically extended or codified in prior rulemaking. Examples of specific programs and policies that HHS anticipates will be affected by the end of the PHE include:

• Coverage for COVID-19 Testing: The requirement for private insurance companies to cover the costs of diagnostic COVID-19 testing without cost sharing, both for OTC and laboratory tests, will end. Medicare beneficiaries who are enrolled in Part B will continue to have coverage without cost sharing for laboratory-conducted COVID-19 tests when ordered by a provider, but their current access to free over-the-counter COVID-19 tests will end. Additionally, State Medicaid programs must provide coverage without cost sharing for COVID-19 testing until the last day of the first calendar quarter that begins one year after the last day of the COVID-19 PHE (September 30, 2024), after which coverage may vary by state.
• PHE-Related Payment Rates: Certain changes to provider payment rates and reimbursement guidelines are set to terminate concurrently with the end of the PHE. For example, under the CARES Act, hospitals received a 20% increase in Medicare payment rates under the hospital inpatient prospective payment system ("IPPS") for the treatment of COVID-19 payments. The heightened hospital-IPPS reimbursement rate for treating COVID-19 patients will terminate concurrently with the PHE on May 11, 2023.
• COVID-19 Data Reporting: At the end of the COVID-19 PHE, HHS will no longer have the authority to require COVID-19 testing and immunization data from labs. However, hospital data reporting will continue as required by the CMS conditions of participation through April 30, 2024, though reporting frequency may be subject to change.
• Prescription of Controlled Dangerous Substances ("CDS") via Telemedicine: The ability of health care providers to dispense controlled substances via telemedicine without an in-person interaction would return to pre-PHE restrictions. However, HHS and the Drug Enforcement Agency ("DEA") are planning rulemaking to extend these flexibilities.
• Public Readiness and Emergency Preparedness ("PREP") Act Liability Protections: PREP Act liability protections for countermeasure activities that are not related to any federal 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 the area where countermeasures are administered.
• Certain FDA COVID-19-related guidance documents that affect clinical practice and supply chains will end or be temporarily extended. FDA published several dozen guidance documents to address challenges presented by the COVID-19 PHE, including limitations in clinical practice or potential disruptions in the supply chain. FDA is in the process of addressing which policies are no longer needed and which should be continued, with any appropriate changes, and the agency will announce plans for each guidance prior to the end of the PHE.

Moreover, HHS emphasized that many programs and policies initiated during the PHE will not end concurrently with the PHE. Such programs and policies include the revised telehealth flexibilities under Medicare (extended through December 2024 by the 2023 Consolidated Appropriations Act) and the existing EUAs for COVID-19 vaccines, tests, and treatments (issued pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act and not subject to expire with the PHE).

Additionally, certain agencies have previously issued guidance anticipating the end of the PHE, such as the CMS Roadmap for the End of the COVID-19 Public Health Emergency which was released in August 2022. On February 27, 2023, CMS issued another PHE Fact Sheet providing further clarification on the end of the PHE.