Fact Sheet: End of the COVID-19 Public Health Emergency (2023)

Based on current COVID-19 trends, the Department of Health and Human Services (HHS) is planning to have a federal Public Health Emergency (PHE) for COVID-19 declared in Section 319 of the Public Health Service Act ( PHS), expires at the end of May 11, 2023.

FromLetter from HHS Secretary Xavier Becerra, February 9, 2023, to Governorsannouncing the planned end of PHE COVID-19, the Department has been working closely with partners – including Governors; state, local, tribal, and territorial agencies; industry; and advocates - to ensure an orderly COVID-19 PHE transition.

Today, HHS is releasing a fact sheet with an update on the current flexibilities allowed by the COVID-19 emergency declaration and how they will be impacted by the end of the COVID-19 PHE on May 11.

What was accomplished:

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 point in the pandemic and well positioned to move out of the emergency phase and bring COVID-19 to an end. ESP. 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 shot of the COVID-19 vaccine. The Administration has also made life-saving treatments widely available, with more than 15 million courses administered. And through COVIDTests.gov, the government has distributed more than 750 million free COVID-19 tests shipped directly to more than 80 million homes. Administration has also administered more than 50 million diagnostic tests in person 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 declined by 95% and hospitalizations have dropped by nearly 91%.

As we approach the end of PHE COVID-19:

  • 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 are now better able to respond to any potential increase in COVID-19 cases without significantly impacting an individual's ability to access resources or care.
  • Our public health experts have issued guidance that allows individuals 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-impact variant as we continue to monitor the evolving state 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, immunocompromised people and people with disabilities. That's why our response to the spread of SARS-CoV-2, the virus that causes COVID-19, remains a public health priority. To ensure an orderly transition, we have been working for months to continue to address the needs of those affected by COVID-19.

Even after PHE COVID-19 ends, 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 people without health insurance. We will continue to advance research into innovative vaccines and treatments through a $5 billion investment in Project NextGen, a program dedicated to accelerating and simplifying the rapid development of next-generation vaccines and treatments, including investments in research, development and making and advancing critical science. And we continue to invest in efforts to better understand and address Long COVID and help mitigate impacts.

What will not be affected by the end of PHE COVID-19:

The Administration's ongoing response to COVID-19 does not fully depend on the emergency declaration for the COVID-19 PHE, and there are significant flexibilities and actions that will not be affected when we transition from the current phase of our response on May 11.

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 ongoing access to COVID-19 vaccines and treatments.

At the end of PHE COVID-19 on May 11, Americans will continue to be able to access COVID-19 vaccines at no cost, just like during PHE COVID-19, due to the requirements of theCDC COVID-19 Vaccination Program Provider Agreement.people will also continue to have access to COVID-19 treatments, as they have during the COVID-19 PHE.

Since the federal government is no longer purchasing or distributing COVID-19 vaccines and treatments, payment, coverage, and access may change. In order to prepare for this transition, partners across the US Government (USG) are planning and developing plans to ensure a smooth transition to the provision of COVID-19 vaccines and certain treatments as part of the traditional healthcare market, which will take place in the coming months.

When this transition to the traditional healthcare market occurs, to protect families, the government has facilitated access to COVID-19 vaccines at no direct cost for nearly all individuals and will continue to ensure effective COVID-19 treatments such as 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 transitioning into the traditional healthcare market. For those with most types of private insurance, the COVID-19 vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service and will be fully covered with no copayment when provided by an in-network provider. Currently, COVID-19 vaccines are covered by Medicare Part B with no cost sharing, and that will continue. Medicare Advantage plans must also cover in-network COVID-19 vaccines without cost-sharing, and that will continue. Medicaid will continue to cover COVID-19 vaccines without co-payment or cost-sharing through September 30, 2024 and will generally cover ACIP-recommended vaccines for most recipients thereafter.

After the transition to the traditional healthcare market, out-of-pocket expenses for certain treatments such as Paxlovid and Lagevrio can change depending on an individual's healthcare coverage, similar to the costs someone might incur for other covered medications. 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 “Bridge” 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 about accessing COVID-19 vaccines and treatments, visitCMS Exemptions, Flexibilities, and the End of the COVID-19 Public Health Emergency.

Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs) 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 COVID-19 PHE. To learn more, visitFDA FAQ: What happens to the EUAs when a public health emergency ends?

Key telehealth flexibilities will not be affected.The vast majority of the current Medicare telehealth flexibilities that people with Medicare — especially those in rural areas and others struggling to find access to care — have come to rely on during PHE COVID-19, will remain in effect through December 2024. In addition, states already have significant flexibility with regard to coverage and payment for Medicaid services delivered via telehealth. This flexibility was available prior to PHE COVID-19 and will continue to be available after PHE COVID-19 ends. To learn more, visit the Centers for Medicare and Medicaid Services (CMS)CMS Exemptions, Flexibilities, and the End of the COVID-19 Public Health Emergency.

Our whole 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 thisInformative filedescribing the progress made in the response to Long COVID and the actions the Department is taking to meet 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 policies and flexibilities have already become permanent or extended for some time, with others expiring after May 11th.

Certain Medicare and Medicaid waivers and broad flexibilities for health care providers are no longer required and will end.During the COVID-19 PHE, CMS used a combination of emergency authority waivers, regulations, and sub-regulatory guidance to secure and expand access to care and give healthcare providers the flexibilities needed to help maintain safe people. States, hospitals, nursing homes and others are currently operating under hundreds of these waivers that affect the delivery and payment of care and that are built into care systems and care providers. Many of these waivers and flexibilities were necessary to expand the capacity of health system facilities and allow the health system to withstand the increased strain created by COVID-19; given the current state of COVID-19, this excess capacity is no longer needed.

For Medicaid, some additional COVID-19 PHE waivers and flexibilities will end on May 11, while others will remain in effect for six months after the end of COVID-19 PHE. But many of Medicaid's waivers and flexibilities, including those that support home and community services, are available for states to continue beyond COVID-19 PHE if they so choose. For example, states have used flexibilities related to the COVID-19 PHE to increase the number of individuals served under exemption, expand provider qualifications, and other flexibilities. Many of these options can be extended beyond the COVID-19 PHE. To learn more, visitCMS Exemptions, Flexibilities, and the End of the COVID-19 Public Health Emergency

COVID-19 test coverage will change, but the USG is maintaining strong inventory and distribution channels so that testing remains accessible at no cost in certain community locations, and the 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 no-cost-sharing antigen testing when lab tests are ordered by a physician or other healthcare professionals, such as physician assistants and advanced practice registered nurses. People enrolled in Medicare Advantage plans can continue to receive PCR for COVID-19 and antigen testing when testing is covered by Medicare, but their cost sharing may change when COVID-19 PHE ends. Additionally, the program that allowed Medicare coverage and payment for over-the-counter (OTC) COVID-19 testing will end when the COVID-19 PHE ends on May 11; Medicare Advantage plans may continue to cover testing, and beneficiaries should check with their plan for details.

State Medicaid programs must provide non-cost-sharing coverage for COVID-19 testing by the last day of the first calendar quarter beginning one year after the last day of the COVID-19 PHE. This means that with PHE COVID-19 ending on May 11, 2023, this mandatory coverage will end on September 30, 2024, after which coverage may vary by state.

The obligation for private insurers to cover COVID-19 testing without cost sharing, both for OTC and laboratory testing, will end with the termination of the PHE. However, coverage can continue if plans choose to do so. Management is encouraging private insurers to continue to provide this coverage going forward. For more information visitCoverage for COVID-19 tests,FAQ: CMS exemptions, flexibilities, and the end of the COVID-19 public health emergency,Families Coronavirus Response Act FAQ, Coronavirus Relief, Economic Relief and Security Act, and Health Insurance Portability and Accountability Act, Part 58.

In addition, the USG can continue to distribute free COVID-19 testing from the Strategic National Stockpile through states and other community partners. Pending resource availability, the Centers for Disease Control and Prevention's (CDC) Increased Community Access to Testing (ICATT) program will continue to focus on free testing for uninsured individuals and areas of high social vulnerability through pharmacies. and community websites. For more information visitSite da ICATT do CDC.

Certain reporting and surveillance of COVID-19 data will change.Surveillance of CDC COVID-19 data has been the cornerstone of our response, and during the PHE, HHS had the authority to require reports of lab tests for COVID-19. At the end of the COVID-19 PHE, HHS will no longer have that express authority to require this data from labs, which will affect reporting of negative test results and affect the ability to calculate the percentage of positivity for COVID-19 tests 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, the CDC will continue to report valuable data to understand COVID-19 trends and inform individual and community public health actions to protect those most at risk of severe COVID-19. Indeed, the CDC will still have access to more data than currently collected for other respiratory diseases to inform public health action at all levels, with hospital data available at the county level becoming a primary source of data for indicate severe cases of COVID-19. 19 in a community. To learn more, visit this CDC resource:End of Federal Declaration of Public Health Emergency (ESP) 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 which policies will be terminated or temporarily extended.To learn more, visitFDA COVID-19 Related Guidance Documents for Industry, FDA Officials, and Other Stakeholders.

The FDA's ability to detect shortages of critical COVID-19-related devices will be more limited.While the FDA still retains its authority to detect and resolve other potential shortages of medical products, it is seeking congressional authorization to extend the requirement that device manufacturers notify the FDA of interruptions and discontinuities of critical devices outside of a PHE, the that will strengthen the FDA's ability to help prevent or mitigate device shortages.

Public Readiness and Emergency Preparedness (PREP) liability protections will change.On April 14, 2023, the secretary of HHS Becerrasent a lettereInformative fileto the nation's governors announcing their intention to amend the PREP Act statement to extend certain important protections that will continue to facilitate access to convenient and timely COVID-19 vaccines, treatments and tests for individuals. The Secretary intends to amend the PREP Act statement for COVID-19 countermeasures to extend the protections mentioned in this newsletter, as well as others, and to publish the amendment in the Federal Register as required by the PREP Act.


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