Weekly Policy Blog: COVID-19 Public Health Emergency to Terminate on May 11
By: Colorado BioScience Association Date: 02/20/2023
On February 9, the Department of Health and Human Services (HHS) Secretary Xavier Becerra announced that the federal Public Health Emergency (PHE) for COVID-19 will expire at the end of the day on May 11, 2023. The announcement included a Letter to U.S. Governors and a fact sheet with a COVID-19 Public Health Emergency Transition Roadmap.
HHS stated that the PHE, declared under Section 319 of the Public Health Service (PHS) Act, will be ended because of improvements in COVID-19 trends. However, the Biden Administration emphasized that its response to the spread of COVID-19 remains a significant public health priority. Over the coming months, they intend to work closely with partners, including industry, to ensure an orderly transition of COVID-19 policies, as well as the current flexibilities enabled by the COVID-19 emergency declarations, into improving standards of care for patients.
For life sciences companies, it’s important to note that certain FDA COVID-19-related guidance documents for industry that affect clinical practice and supply chains will end or be temporarily extended. For example, the requirement that manufacturers of certain devices related to the diagnosis and treatment of COVID-19 notify the FDA of supply chain disruptions will end, but the FDA is seeking congressional authorization to extend this requirement. In addition, PREP Act liability protections for manufacturers’ countermeasure activities that are not related to any U.S. government agreement (e.g., products entirely in the commercial sector) will end unless another relevant emergency declaration is in place. Other key aspects of the COVID-19 response will not change, though. For example, existing EUAs for COVID-19 products will remain in effect and the FDA may continue to issue new EUAs going forward. More information about the rationale for termination of the PHE, what will be affected, and what will not be affected is below.
Rationale for Termination of the PHE
HHS cited the following statistics as its rationale for terminating the COVID-19 PHE. Since the peak of the Omicron surge at the end of January 2022:
- Daily COVID-19 reported cases are down 92%,
- COVID-19 deaths have declined by over 80%, and
- New COVID-19 hospitalizations are down nearly 80%.
What Will be Affected
HHS’ fact sheet confirms that some of the flexibilities and policies implemented during the COVID-19 PHE will expire, while HHS will continue to review others to determine whether they can and should remain in place, even for a temporary duration.
“Certain FDA COVID-19-related guidance documents for industry 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.
- FDA’s ability to detect early shortages of critical devices related to COVID-19 will be more limited. During the PHE, manufacturers of certain devices related to the diagnosis and treatment of COVID-19 have been required to notify the FDA “of a permanent discontinuance in the manufacture of the device” or “an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States.” This requirement will end when the PHE ends. While FDA will still maintain its authority to detect and address other potential medical product shortages, it 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 will strengthen the ability of FDA to help prevent or mitigate device shortages.
“Public Readiness and Emergency Preparedness (PREP) Act liability protections…may be impacted.”
- Currently, the amended PREP Act declaration provides liability immunity to manufacturers, distributors, public and private organizations conducting countermeasure programs, and providers for COVID-19 countermeasure activities related to a U.S. government agreement (e.g., manufacturing, distribution, or administration of the countermeasures subject to a federal contract, provider agreement, or memorandum of understanding). That coverage will not be affected by the end of the PHE.
- However, PREP Act 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 an area where countermeasures are administered. HHS is currently reviewing whether to continue to provide this coverage going forward.
“Coverage for COVID-19 testing for Americans will change.”
- Medicare: Medicare beneficiaries 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 (OTC) COVID-19 tests will end, consistent with the statute on Medicare payment for OTC tests set by Congress.
- Private insurance: The requirement for private insurance companies to cover COVID-19 tests without cost sharing, both for OTC and laboratory tests, will end. However, coverage may continue if plans choose to continue to include it.
- Medicaid: State Medicaid programs must provide coverage without cost sharing for COVID-19 testing until September 30, 2024, after which coverage may vary by state.
- Dependent on supply and resources, the federal government may continue to distribute free COVID-19 tests from the Strategic National Stockpile through the United States Postal Service, states, and other community partners. Pending resource availability, the CDC’s Increasing Community Access to Testing (ICATT) program will continue working to provide equitable access to testing for the uninsured and areas of high social vulnerability through pharmacies and community-based sites.
“Reporting of COVID-19 laboratory results and immunization data to CDC will change.”
- At the end of the COVID-19 PHE, HHS will no longer have the express authority to require lab test reporting for COVID-19, which may affect the reporting of negative test results and impact the ability to calculate percent positivity for COVID-19 tests in some jurisdictions.
- CDC has been working to sign voluntary Data Use Agreements (DUAs), encouraging states and jurisdictions to continue sharing vaccine administration data beyond the PHE.
- Hospital data reporting will continue as required by the CMS conditions of participation through April 30, 2024, but reporting may be less frequent.
“Certain Medicare and Medicaid waivers and broad flexibilities for health care providers are no longer necessary and will end.”
- During the COVID-19 PHE, CMS has used a combination of emergency authority waivers, regulations, and sub-regulatory guidance to ensure and expand access to care and to give healthcare providers needed flexibilities. Many of these waivers that affect care delivery and payment were necessary to expand facility capacity, but this excess capacity is no longer necessary.
- For Medicaid, some additional COVID-19 PHE waivers and flexibilities will end on May 11, while others will remain in place for six months following the end of the PHE. But many of the Medicaid waivers and flexibilities, including those that support home and community-based services, are available for states to continue beyond the PHE, if they choose to do so.
“The ability of health care providers to safely dispense controlled substances via telemedicine without an in-person interaction is affected; however, there will be rulemaking that will propose to extend these flexibilities.”
- During the PHE, the DEA and HHS adopted policies to allow practitioners to prescribe controlled substances to patients without an in-person interaction. These policies allowed for audio-only modalities to initiate buprenorphine prescribing. DEA plans to initiate rulemaking that would extend these flexibilities under certain circumstances without any gap in care and will provide additional guidance to practitioners soon.
What Will Not be Affected
As HHS’ fact sheet lays out, while the termination of the federal COVID-19 PHE will mark the end of the current phase of the government’s response to the pandemic, not all federal actions and flexibilities will be affected.
“[T]he Administration is committed to ensuring that COVID-19 vaccines and treatments will be widely accessible to all who need them…Access to COVID-19 vaccinations and certain treatments…will generally not be affected.”
- There will be a transition later this year to the use of traditional healthcare coverage for COVID-19 vaccines and treatments. This transition is not tied to the ending of the PHE, but it is partly due to Congress not allocating additional funds to the federal government to purchase more vaccines and treatments.
- Private Insurance: When this transition occurs, many Americans will continue to pay nothing out-of-pocket for the COVID-19 vaccine. Vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service for most private insurance plans and will be fully covered without a co-pay. Out-of-pocket expenses for certain treatments may change, depending on an individual’s healthcare coverage.
- Medicare: Currently, COVID-19 vaccinations are covered under Medicare Part B without cost sharing, and this will continue.
- Medicaid: Medicaid will continue to cover all COVID-19 vaccinations without a co-pay or cost sharing through September 30, 2024, and will cover ACIP-recommended vaccines for most beneficiaries thereafter. Medicaid will continue to cover COVID-19 treatments without cost sharing through September 30, 2024. After that, coverage and cost sharing may vary by state.
“There will also be continued access to pathways for emergency use authorizations (EUAs) for COVID-19 products (tests, vaccines, and treatments) through the [FDA].”
- The ending of the COVID-19 PHE will not affect the FDA’s ability to authorize various products, including tests, treatments, or vaccines for emergency use.
- Existing EUAs for COVID-19 products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the FDA may continue to issue new EUAs going forward when criteria for issuance are met.
“[M]ajor telehealth flexibilities will continue to exist for those participating in Medicare or Medicaid.”
- Medicare: The vast majority of current Medicare telehealth flexibilities that Americans have come to rely upon over the past two years will remain in place through December 2024 due to the bipartisan Continuing Appropriations Act, 2023 passed by Congress in December 2022.
- Medicaid: Medicaid telehealth flexibilities will not be affected. States already have significant flexibility with respect to covering and paying for Medicaid services delivered via telehealth. This flexibility was available prior to the COVID-19 PHE and will continue to be available after the COVID-19 PHE ends.
- The process for states to begin eligibility redeterminations for Medicaid will not be affected.
Access to buprenorphine and methadone
- Access to buprenorphine for opioid use disorder treatment in Opioid Treatment Programs (OTPs) will not be affected.
- Access to expanded methadone take-home doses for opioid use disorder treatment will not be affected.