The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023.
COVID-19 EUA medical products and policies
As FDA has clarified in its draft transition guidance for medical devices, the Emergency Use Authorizations (EUAs) of COVID-19 medical products may remain in effect regardless of the PHE declaration status. FDA’s EUA authority is based on the emergency use declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (the “EUA declaration”), whereas the PHE declaration is under section 319 of the Public Health Service Act. Currently, there are active COVID-19 EUA declarations including those for in vitro diagnostics (IVDs), medical devices, and drugs and biological products. These EUA declarations could remain active for many years without the PHE declaration, to support existing COVID-19 EUAs and subject to FDA’s policy, new EUAs.
Whether FDA’s policies for COVID-19 medical products will remain in effect, however, may depend on whether these policies are tied to the PHE declaration. For example, FDA has recently decoupled two guidance documents on COVID-19 tests from the PHE declaration, as we discussed here. On the other hand, many COVID-19 policies, such as those for vaccines and treatments, are still tied to the PHE declaration. We will need to wait and see whether FDA will decouple all or part of these policies from the PHE declaration before its termination, and that may have implications for how CBER and CDER exercise their emergency use authority for COVID-19 therapeutics and vaccines, including products to treat long COVID.
COVID-19 test, treatment, and vaccine reimbursement and coverage
Termination of the PHE declaration will change reimbursement and coverage requirements for COVID-19 tests, treatments, and vaccines. For example, traditional Medicare will no longer cover COVID-19 over-the-counter (OTC) tests once the PHE declaration ends, and will continue to cover diagnostic laboratory tests for COVID-19 only if ordered by a physician or other applicable practitioner. Medicaid is expected to cover all COVID-19 tests at no cost to patients until September 2024 if the PHE declaration ends in May 2023, as planned. After September 2024, however, Medicaid will cover diagnostic laboratory tests for COVID-19 only if ordered by a physician or other applicable practitioner, and its coverage of COVID-19 OTC tests will be determined by each state. In the private sector, coverage of COVID-19 tests will again be up to the discretion of the private payors once the PHE declaration ends.
Regarding COVID-19 treatments, Medicare may no longer cover certain COVID-19 treatments such as monoclonal antibody infusion therapies with EUAs once the PHE declaration ends. However, Medicare will continue to cover prescription-only oral antiviral drugs under EUAs until December 31, 2024, regardless of the PHE declaration status. Medicaid will cover COVID-19 treatments at no cost to patients until September 2024 if the PHE declaration ends in May 2023, as planned. After September 2024, however, states may implement cost-sharing.
Regarding vaccines, Medicaid may continue to cover COVID-19 vaccines after the PHE declaration ends, as the Inflation Reduction Act requires coverage of “approved vaccines” recommended by the Advisory Committee on Immunization Practices (ACIP). However, whether the COVID-19 vaccines under EUAs would qualify as “approved vaccines” for Medicaid coverage depends on the ACIP. Private payors will no longer be required to cover COVID-19 vaccines after the PHE declaration ends.
Telehealth
For telehealth services, the U.S. Department of Health & Human Services (HHS) Secretary, through the U.S. Centers for Medicare and Medicaid Services (CMS) has temporarily expanded Medicare coverage of telehealth services, based on the authorities granted to the Secretary by the CARES Act and the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020. These temporary measures will no longer be effective once the PHE declaration ends. However, the Consolidated Appropriations Act, 2023 extends certain flexibilities until December 31, 2024, including: (i) removing geographic requirements and expanding originating sites; (ii) expanding eligible practitioners; (iii) extending telehealth services for federally qualified health centers and rural health clinics; (iv) delaying the in-person requirements under Medicare for mental health services furnished through telehealth and telecommunications technology; (v) allowing for the furnishing of audio-only telehealth services; and (vi) using telehealth to conduct face-to-face encounters prior to recertification of eligibility for hospice care during emergency period.
The additional flexibility in prescribing and dispensing schedule II–V controlled substances via telehealth, based on subsection 102(54)(D) of the Controlled Substances Act, will end once the PHE declaration ends.
Please reach out to MoFo’s FDA + Healthcare Regulatory and Compliance practice for a more detailed analysis and discussion of the implications of these developments.