In October of 2020, the Office for Human Research Protections (OHRP), issued an exception to 2018 Requirements’ single IRB mandate, in response to the COVID-19 Public Health Emergency (PHE). When the PHE for COVID-19 expires on May 11, 2023, this exception will not be applicable to additional studies. Let’s explore some other key factors affected by the expiration of the PHE for COVID-19.
Examples of what will change:
- Specific Medicare and Medicaid waivers and flexibilities for health care providers will end
- Medicare beneficiaries who are enrolled in Part B will no longer have access to free over-the-counter COVID-19 tests
- Private insurance companies will no longer be required to cover COVID-19 tests without cost sharing for over-the-counter and laboratory tests.
- HHS will no longer have the authority to require lab test reporting for COVID-19
- Certain guidance documents for industry that affect clinical practice and supply chains will end or be temporarily extended
- Device manufacturers will no longer required to report on discontinuance or interruption to certain devices related to the diagnosis and treatment of COVID-19
Examples of what will not change:
- Access to COVID-19 vaccinations and certain treatments, such as Paxlovid and Lagevrio, will generally not be affected
- Current coverage of COVID-19 vaccinations under Medicare Part B will continue to be covered without cost sharing
- Medicaid programs will continue to cover COVID-19 treatments without cost sharing through September 30, 2024
- FDA’s EUAs for COVID-19 products (including tests, vaccines, and treatments) will not be affected.
- Major Medicare and Medicaid telehealth flexibilities will not be affected.
See the HHS fact sheet for a detailed list of what changes and remains unchanged.
Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap
Additional Details
