Based on current COVID-19 trends, the Department of Health and Human Services (HHS) is planning for the expiration of the federal COVID-19 public health emergency (PHE). , declared under Section 319 of the Public Health Services (PHS) Act. at the end of the day on May 11, 2023.
FromFebruary 9, 2023 Letter from HHS Secretary Xavier Becerra to GovernorsIn announcing the planned end of the COVID-19 PHE, the Department has been working closely with partners, including Governors; state, local, tribal and territorial agencies; industry; and advocates, to ensure an orderly transition of the PHE from COVID-19.
Today, HHS is publishing a fact sheet updating the current flexibilities enabled by the COVID-19 emergency declaration and how they will be affected by the end of the COVID-19 PHE on May 11.
What has been achieved:
Due to the Biden-Harris Administration's whole-of-government approach to combating COVID-19, we are now in a better place in our response than at any time during the pandemic and well-positioned to move out of the emergency phase and end to COVID-19 PHE. Over the past two years, the Biden-Harris Administration has effectively implemented the largest adult vaccination program in US history, with more than 270 million people receiving at least one injection of the vaccine against COVID-19. The Administration has also made life-saving treatments widely available, with more than 15 million courses administered. And through COVIDTests.gov, the Administration has distributed more than 750 million free COVID-19 tests shipped directly to more than 80 million households. The Administration has also administered more than 50 million in-person diagnostic tests at pharmacies and community sites. As a result of these and other efforts, COVID-19 is no longer the disruptive force it once was. Since January 2021, deaths from COVID-19 have decreased by 95% and hospitalizations have decreased by almost 91%.
As we near the end of the COVID-19 PHE:
- We have successfully organized a whole-of-government response to make historic investments in widely available vaccines, tests, and treatments to help us fight COVID-19.
- Our health care system and public health resources across the country can now better respond to any potential surge in COVID-19 cases without significantly impacting a person's ability to access resources or care.
- Our public health experts have issued guidance that enables people to understand mitigation measures such as masking and testing to protect themselves and those around them.
- We have the tools to detect and respond to the potential emergence of a high consequence variant as we continue to monitor the evolutionary status of COVID-19 and the emergence of virus variants.
Still, we know that many people continue to be affected by COVID-19, particularly the elderly, the immunocompromised, and people with disabilities. That is why our response to the spread of SARS-CoV-2, the virus that causes COVID-19, remains a public health priority. To guarantee an orderly transition, we have been working for months to continue meeting the needs of those affected by COVID-19.
Even beyond the end of the COVID-19 PHE, we will continue to work to protect Americans from the virus and its worst impacts by supporting access to COVID-19 vaccines, treatments, and testing, including for the uninsured. We will continue to advance research for new and innovative vaccines and treatments through a $5 billion investment in Project NextGen, a program dedicated to accelerating and optimizing the rapid development of the next generation of vaccines and treatments, including investments in research, development and manufacturing capacity and the advancement of critical science. And we continue to invest in efforts to better understand and address the long COVID, and to help mitigate the impacts.
What will not be affected by the end of PHE COVID-19:
The Administration's ongoing response to COVID-19 is not entirely contingent on the emergency declaration for the COVID-19 PHE, and significant flexibilities and actions exist that will not be impacted when we transition from the current phase of our response on 9/11. of May.
Access to COVID-19 vaccines and certain treatments, such as Paxlovid and Lagevrio, will generally not be affected.To help keep communities safe from COVID-19, HHS remains committed to maximizing continued access to COVID-19 vaccines and treatments.
At the end of the COVID-19 PHE on May 11, Americans will continue to be able to access COVID-19 vaccines at no cost, just as they have during the COVID-19 PHE, due to the requirements of theCDC COVID-19 Vaccination Program Provider Agreement.people will also continue to be able to access COVID-19 treatments just as they have during the COVID-19 PHE.
Once the federal government no longer purchases or distributes COVID-19 vaccines and treatments, payment, coverage, and access may change. To prepare for that transition, USG partners are planning and have been developing plans to ensure a smooth transition for the provision of COVID-19 vaccines and certain treatments as part of from the traditional healthcare market, which will occur in the coming months.
When that transition to the traditional healthcare market occurs, to protect families, the Administration has made it easier for nearly everyone to have access to COVID-19 vaccines at no out-of-pocket cost and will continue to ensure that effective COVID-19 treatments -19, like Paxlovid, are widely accessible.
The Department announced theHHS Bridge Access Program for COVID-19 Vaccines and Treatments” (“Bridge Program”) on April 18, to maintain broad access to COVID-19 vaccines and treatments for uninsured Americans after the transition to the traditional health care market. For those with most types of private insurance, COVID-19 vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service and will be covered in full with no copay when provided by an in-network provider . COVID-19 vaccines are currently covered under Medicare Part B with no cost sharing, and this will continue. Medicare Advantage plans must also cover in-network COVID-19 vaccines with no cost sharing, and this will continue. Medicaid will continue to cover COVID-19 vaccines with no copay or cost-share through September 30, 2024 and will generally cover ACIP-recommended vaccines for most beneficiaries thereafter.
After the transition to the traditional healthcare market, out-of-pocket costs for certain treatments, such as Paxlovid and Lagevrio, can change, depending on a person's healthcare coverage, similar to the costs one may experience for other drugs. covered. Medicaid programs will continue to cover COVID-19 treatments without cost sharing through September 30, 2024. After that, coverage and cost sharing may vary by state.
For more information about the “Puente” Program, visitFact Sheet: HHS Announces "HHS Bridge Access Program for COVID-19 Vaccines and Treatments" to Maintain Access to COVID-19 Care for the Uninsured. For more information on access to COVID-19 vaccines and treatments, visitWaivers, Flexibilities, and the End of the CMS COVID-19 Public Health Emergency.
Emergency Use Authorizations (EUAs) from the Food and Drug Administration (FDA) for COVID-19 products (including tests, vaccines, and treatments) will not be affected.The FDA's ability to authorize various products, including tests, treatments, or vaccines for emergency use, will not be affected by the end of the COVID-19 PHE. For more information, visitFDA FAQ: What happens to the EUA when a public health emergency ends?
Core telehealth flexibilities will not be affected.The vast majority of the current Medicare telehealth flexibilities that people with Medicare, particularly those in rural areas and others struggling to find access to care, have come to rely on during the COVID-19 PHE, will remain in place until December 2024. In addition, states already have significant flexibility regarding coverage and payment for Medicaid services delivered through telehealth. This flexibility was available prior to the COVID-19 PHE and will continue to be available after the COVID-19 PHE ends. For more information, visit the Centers for Medicare & Medicaid Services (CMS)Waivers, Flexibilities, and the End of the CMS COVID-19 Public Health Emergency.
Our whole-of-government response to Long COVID will not change.The Department has coordinated and will continue to coordinate a whole-of-government response to the long-term effects of COVID-19, including Long COVID and associated conditions. On April 5, HHS released thisfact sheetdescribing the progress made in response to Long COVID and the actions the Department is taking to address the needs of the growing population with Long COVID and associated conditions.
What will be affected by the end of PHE COVID-19:
Many COVID-19 PHE flexibilities and policies have already been made permanent or extended for some time, with others expiring after May 11.
Certain Medicare and Medicaid waivers and extensive flexibilities for health care providers are no longer necessary and will end.During the COVID-19 PHE, CMS used a combination of emergency authority waivers, regulations, and sub-regulatory guidance to ensure and expand access to care and provide health care providers with the flexibilities necessary to help keep safe people. States, hospitals, nursing homes and others currently operate under hundreds of these waivers that affect the delivery and payment of care and are integrated into provider and patient care systems. Many of these waivers and flexibilities were necessary to expand facility capacity for the health care system and allow the health care system to withstand the increased stress created by COVID-19; given the current state of COVID-19, this excess capacity is no longer necessary.
For Medicaid, some waivers and additional flexibilities of the COVID-19 PHE will end on May 11, while others will remain in effect for six months after the end of the COVID-19 PHE. But many of the Medicaid waivers and flexibilities, including those that support in-home and community-based services, are available for states to continue beyond the COVID-19 PHE, if they choose. For example, states have used flexibilities related to the COVID-19 PHE to increase the number of people served under a waiver, expand provider qualifications, and other flexibilities. Many of these options may extend beyond the COVID-19 PHE. For more information, visitWaivers, Flexibilities, and the End of the CMS COVID-19 Public Health Emergency
Coverage of COVID-19 tests will change, but USG maintains a strong pipeline and distribution channels so tests remain accessible at no cost at certain community locations, and USG will continue to distribute tests through COVIDtests.gov until the end of May.People with traditional Medicare can continue to receive COVID-19 PCR and antigen tests with no cost sharing when the lab tests are ordered by a doctor or other health care providers, such as physician assistants and advanced practice registered nurses. People enrolled in Medicare Advantage plans can continue to receive COVID-19 PCR and antigen tests when the test is covered by Medicare, but your cost sharing may change when the COVID-19 PHE ends. In addition, the program that allowed Medicare coverage and payment for over-the-counter (OTC) COVID-19 tests will end when the COVID-19 PHE ends on May 11; Medicare Advantage plans may continue to cover the tests and beneficiaries should check with their plan for details.
State Medicaid programs must provide coverage without cost sharing for COVID-19 testing through the last day of the first calendar quarter beginning one year after the last day of the COVID-19 PHE. That means with the COVID-19 PHE ending on May 11, 2023, this mandatory coverage will end on September 30, 2024, after which coverage may vary by state.
The requirement for private insurance companies to cover COVID-19 tests without cost sharing, for both OTC and laboratory tests, will end upon expiration of the PHE. However, coverage can be continued if the plans so choose. The Administration encourages private insurers to continue to provide such coverage in the future. For more information visitCoverage for COVID-19 Testing,Frequently Asked Questions: Waivers, Flexibilities, and the End of the CMS Public Health Emergency,Frequently Asked Questions about the Families First Coronavirus Response Act, the Coronavirus Aid, Relief, and Economic Security Act, and the Health Insurance Portability and Accountability Act Implementation Part 58.
In addition, the United States Government may continue to distribute free COVID-19 tests from the Strategic National Stockpile through states and other community partners. Pending the availability of resources, the Centers for Disease Control and Prevention's (CDC) Increasing Community Access to Testing (ICATT) program will continue to focus on no-cost testing for individuals without insurance and areas of high social vulnerability through pharmacies and community sites. For more information visitCDC ICATT website.
Certain COVID-19 data and surveillance reporting will change.CDC data surveillance on COVID-19 has been the cornerstone of our response and, during the PHE, HHS had the authority to require laboratory test reports for COVID-19. At the end of the COVID-19 PHE, HHS will no longer have this express authority to request these data from laboratories, which will affect the reporting of negative test results and affect the ability to calculate percent positivity for tests of COVID-19 in some jurisdictions. . Hospital data reporting will continue as required by the CMS conditions of participation through April 30, 2024, but reporting will be reduced from the current daily reports to weekly reports.
Despite these changes, CDC will continue to report valuable data to understand COVID-19 trends and to inform individual and community public health actions to protect people most at risk of severe COVID-19. In fact, CDC will still have access to more data than is currently collected for other respiratory diseases to inform public health action at all levels, and hospital data, which is available at the county level, will become a primary data source to indicate severe cases of COVID-19. 19 in a community. For more information, visit this CDC resource:End of the Federal Declaration of Public Health Emergency (PHE) for COVID-19.
In March, the FDA announced a transition plan for certain COVID-19-related guidance documents related to topics such as medical devices, clinical practice, and supply chains, including policies that will be temporarily terminated or extended.For more information, visitFDA COVID-19 related guidance documents for industry, FDA staff, and other stakeholders.
FDA's ability to detect critical device shortages related to COVID-19 will be more limited.While the FDA will continue to retain its authority to detect and address other potential medical product shortages, it is seeking Congressional authorization to extend the requirement that device manufacturers notify the FDA of discontinuations and discontinuations of critical devices outside of a PHE. , which will strengthen the capacity of the FDA. to help prevent or mitigate device shortages.
The liability protections of the Public Preparedness and Emergency Preparedness (PREP) Act will be amended.On April 14, 2023, HHS Secretary Becerrasent a letteryfact sheetto the nation's governors announcing their intent to amend the PREP Act statement to extend certain important protections that will continue to make it easier for people to access convenient and timely COVID-19 vaccines, treatments, and tests. The Secretary intends to amend the PREP Act statement for COVID-19 countermeasures to extend the protections referenced in that fact sheet and others and publish the amendment in the Federal Register as required by the Act. PREP.