Factsheet: The COVID-19 public health emergency is over (2023)

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

zLetter to the Governor from HHS Secretary Xavier Becerra, February 9, 2023In announcing plans to end the COVID-19 PHE, the department worked closely with partners including the governor, state, local, tribal and territory agencies, industry and advocates to ensure a smooth transition mandated by the COVID-19-19 PHE.

HHS today released a fact sheet that updates the current flexibilities introduced in response to the COVID-19 emergency declaration and how they will change when the COVID-19 PHE ends on May 11.

What has been achieved:

Thanks to the Biden-Harris Administration's holistic approach to tackling COVID-19, we are now in a better position than ever during the pandemic, with the ability to move to the emergency phase and end COVID-19. -19. 19 19 Department of Public Health. Over the past two years, the Biden-Harris administration has successfully implemented the largest adult immunization program in U.S. history, with more than 270 million people receiving at least one injection of the COVID-19 vaccine. The government has also made life-saving treatments widely available, with more than 15 million sessions recommended. Through COVIDTests.gov, the government has distributed over 750 million free COVID-19 tests that have been sent directly to over 80 million households. The government has also conducted more than 50 million personal diagnostic tests in pharmacies and public places. Thanks to these and other efforts, COVID-19 is no longer the destructive force it once was. Since January 2021, COVID-19 deaths have fallen by 95% and hospitalizations by almost 91%.

We are nearing the end of COVID-19 PHE:

• We have managed to orchestrate a government-wide response by making historic investments in widely available vaccines, tests and therapies to help us fight COVID-19.
• Our national health system and public health resources can now better respond to any potential increase in COVID-19 cases without significantly affecting a person's ability to access resources or care.
• Our public health experts have issued guidance for people to understand mitigation measures such as wearing a mask and getting tested to protect themselves and those around them.
• As we continue to monitor the evolutionary status of COVID-19 and the emergence of virus variants, we have the tools to detect and respond to variants with potentially serious consequences.

Despite this, we know that COVID-19 continues to affect many people, especially the elderly, the immunocompromised and people with disabilities. Therefore, our response to the spread of SARS-CoV-2, the virus that causes COVID-19, remains a public health priority. We have been working for several months to ensure an orderly transition so that we can continue to meet the needs of those affected by COVID-19.

Even after the end of COVID-19 PHE, we will continue our efforts to protect Americans from the virus and its worst impacts, including those without health insurance, by supporting access to COVID-19 vaccines, treatment, and testing. We will continue to research new and innovative vaccines and treatments by investing $5 billion in the NextGen program, a dedicated program designed to accelerate and simplify the rapid development of next-generation vaccines and treatments, including research, development and investment in treatment. Production capabilities and the advancement of critical science. We will continue to work to better understand and respond to COVID debts and help mitigate its impact.

What will not affect the conclusion of PHE COVID-19:

The ongoing government response to COVID-19 is not entirely dependent on PHE declaring a COVID-19 emergency, and there is a lot of flexibility and movement that will not be impacted when we transition from the current response phase on November 11.

Access to COVID-19 vaccines and certain treatments such as Paxlovid and Lagevrio are generally unaffected.To help communities stay safe from COVID-19, HHS remains committed to maximizing continued access to COVID-19 vaccines and treatments.

When COVID-19 PHE ends on May 11, Americans will be able to continue to receive the COVID-19 vaccine at no cost as during COVID-19 PHE due to the requirements during COVID-19 PHE. -19.CDC Agreement with COVID-19 Vaccine Program Provider.People will also continue to have access to COVID-19 treatment as they did during the COVID-19 PHE.

When the federal government stops buying or distributing COVID-19 vaccines and treatments, payments, coverage, and access may change. To prepare for this transition, partners in the United States Government (USG) are planning and working on plans to ensure a smooth transition to the provision of COVID-19 vaccines and certain treatments within the healthcare market. It occurred within a few months.

To protect families during the transition to the traditional healthcare market, the government has provided free access to the COVID-19 vaccine for virtually everyone, and will continue to ensure the wide availability of effective COVID-19 treatments such as Paxlovid.

The department reported that "HHS COVID-19 Vaccine and Treatment Bridging Program(the "Bridge" program) was launched on April 18 to maintain widespread access to COVID-19 vaccines and treatments for uninsured Americans as they transition to the traditional healthcare market. The Advisory Committee on Immunization Practices (ACIP) recommended vaccine is a preventive health service that is fully covered with no co-pay if offered by an in-network provider. COVID-19 vaccines are currently covered by Medicare Part B without cost-sharing, and Medicare Advantage plans must also cover COVID-19 vaccines online without cost-sharing and will continue until 2024. Medicaid will continue to cover COVID-19 vaccines without co-pay or cost-sharing on September 30, 2019, and will generally cover recommended by ACIP vaccination for most beneficiaries.

The out-of-pocket costs of some treatments (such as Paxlovid and Lagevrio) may change after transitioning to the traditional healthcare market, depending on the extent of a person's healthcare, as will the cost of other covered medications. Medicaid plans will continue to provide unshared COVID-19 treatment until September 30, 2024. After that, coverage and cost sharing may vary by state.

More information about the Bridges program can be found on the websiteFact Sheet: HHS Announces “HHS Bridging Access Program for COVID-19 Vaccines and Treatments” to Maintain Access to COVID-19 Uninsured Care.More information on vaccination and treatment of COVID-19 can be found on the websiteCMS Waivers, Flexibility, and Ending the COVID-19 Public Health Emergency.

U.S. Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs) for COVID-19 products, including tests, vaccines, and therapies, will not be affected.The FDA's ability to authorize various products, including vaccines for testing, treatment or emergency use, will not change after the end of the COVID-19 PHE. For more information visitFDA FAQ: What happens to the EUA after the Public Health Emergency ends?

The flexibility of basic telehealth will not be affected.During the COVID-19 PHE, the vast majority of the current flexible Medicare telehealth solutions that Medicare beneficiaries have relied on (particularly in rural and other low-care areas) will remain in place until December 2024. In addition, states already have considerable flexibility to cover and pay for Medicaid services provided through telehealth. This flexibility was available before COVID-19 PHE and will continue to be available after COVID-19 PHE ends. For more information, visit the Center for Medicare and Medicaid Services (CMS)CMS Waivers, Flexibility, and Ending the COVID-19 Public Health Emergency.

Our whole government response to COVID debts will not change.The Department has coordinated and will continue to coordinate the government-wide response to the long-term effects of COVID-19, including long-term COVID-19 and related conditions. On April 5, HHS released itinformation sheetDescribe the progress made in responding to COVID debt and the actions the Department is taking to address the needs of the growing population living with long COVID and related diseases.

What will affect the end of COVID-19 PHE:

Many COVID-19-related PHE flexibility and policies have been made permanent or extended for a period of time, while others expire after May 11.

Some exemptions from Medicare and Medicaid and a lot of flexibility for providers are no longer needed and will no longer apply.During COVID-19, PHE CMS has combined emergency authorization waivers, regulations and sub-regulatory guidance to ensure and expand access to care and give healthcare providers the flexibility they need to keep people safe. . States, hospitals, nursing homes, and other facilities now operate with hundreds of these exemptions that affect the delivery and payment of care and are integrated into provider and patient care systems. Many of these exemptions and flexibility were necessary to increase the capacity of healthcare facilities and enable the healthcare system to withstand the increased stress caused by COVID-19; given the current state of COVID-19, this overcapacity is no longer needed.

For Medicaid, some additional COVID-19 PHE exemptions and flexibility will expire on May 11, while others will remain in effect for six months after the end of the COVID-19 PHE. However, many Medicaid exemptions and flexibility, including those to support home and community services, are available for states to continue using PHE post-COVID-19 if states choose to do so. For example, states have used COVID-19 PHE flexibility to increase the number of people exempted from providing services, expand provider powers, and other flexibility. Many of these options may extend beyond COVID-19 PHE. For more information visitCMS Waivers, Flexibility, and Ending the COVID-19 Public Health Emergency

COVID-19 testing coverage will vary, but USG maintains extensive inventory and distribution channels, so tests remain freely available in certain community locations, and USG will continue to distribute tests through COVIDtests.gov through the end of May.People with traditional health insurance may continue to receive PCR and antigen tests for COVID-19 at no cost if the laboratory tests are ordered by a physician or other healthcare professionals (such as physician assistants and registered advanced practice nurses). People covered by Medicare Advantage plans can continue to have COVID-19 PCR testing and antigen testing while Medicare covers these tests, but cost sharing may change when the COVID-19 PHE ends. In addition, the program that allows Medicare to cover and pay for over-the-counter (OTC) COVID-19 tests will end with the completion of the COVID-19 PHE on May 11; Medicare Advantage plans may still cover these tests, and beneficiaries should review their plans to learn more.

State Medicaid programs must provide free COVID-19 testing coverage prior to the last day of the first calendar quarter beginning in the year following the last day of the COVID-19 PHE. This means that with the end of the COVID-19 PHE on May 11, 2023, this mandatory coverage will end on September 30, 2024, after which coverage may vary by state.

The requirement for private insurers to cover COVID-19 tests without cost sharing, including laboratory and over-the-counter tests, will expire when the PHE expires. However, protection can continue if the plan so decides. The government encourages private insurance companies to continue offering such coverage in the future. For more information please visitScope of testing for COVID-19,Frequently Asked Questions: CMS Waivers, Flexibility, and Ending the COVID-19 Public Health Emergency,FAQs on the Families First Coronavirus Response Act, the Coronavirus Aid, Relief and Economic Security Act, and HIPAA Part 58 Implementation.

In addition, USG may continue to distribute free COVID-19 tests from Strategic National Stock through states and other community partners. Until funds become available, the Centers for Disease Control and Prevention (CDC) Increasing Community Access to Testing (ICATT) program will continue to focus on free testing for the uninsured and high-community areas through pharmacies and community sites. For more information please visitWitryna CDC ICATT.

Some methods of monitoring and reporting COVID-19 data will change.CDC COVID-19 Data Monitoring has been the cornerstone of our response, and during PHE, HHS has the right to request COVID-19 lab test reports. Once COVID-19 ends, PHE HHS will no longer have the express authority to require laboratories to provide this data, which will affect the reporting of negative test results and the ability to calculate the percentage of COVID-19 positive tests in certain jurisdictions. Hospital data reporting will continue until April 30, 2024 as required by the CMS Terms of Participation, but reporting will be reduced from ongoing daily reports to weekly reports.

Despite these changes, the CDC continues to provide valuable data to understand COVID-19 trends and inform individual and community public health efforts to protect those most at risk of severe COVID-19. In fact, the CDC still has more data available to inform public health efforts at all levels than is currently collected for other respiratory diseases, and hospital data available at the county level will be the primary data pointing to a major source of COVID-19. 19 in the community. For more information, visit this CDC resource:The federal declaration of public health emergency (PHE) for COVID-19 expires.

In March, the FDA announced transition plans for some COVID-19-related guidance on topics such as medical devices, clinical practice, and the supply chain, including rules that will be temporarily suspended or extended.For more information visitFDA guidance on COVID-19 for industry, FDA personnel and other stakeholders.

The FDA's ability to detect critical equipment shortages related to COVID-19 will be more limited.While the FDA will retain its authority to detect and correct other potential defects in medical products, it is seeking permission from Congress to extend the requirement for device manufacturers to notify the FDA of critical business interruptions and product discontinuations beyond PHE, which would strengthen the FDA's ability to help prevent or alleviate equipment shortages.

Liability protection under the Public Preparedness and Emergency Preparedness Act (PREP) will be changed.April 14, 2023 Secretary of HHS Becerrasent a letteryinformation sheetTo the Governor of the Nation, announcing his intention to amend the declaration of the PREP Act to extend some important protections that will continue to facilitate individual access to convenient and timely COVID-19 vaccines, treatments and testing. The Secretary intends to amend the PREP COVID-19 Mitigation Statement to expand the protections listed in this factsheet and elsewhere, and to post the changes to the Federal Register as required by the PREP.