Based on current trends related to COVID-19, the Department of Health and Human Services (HHS) plans to issue a federal Public Health Emergency (PHE) declared under Section 319 of the Public Health Act (PHS) for COVID-19. Ends May 11, 2023.
fromLetter to the Governor from HHS Secretary Xavier Becerra, February 9, 2023.In announcing plans to phase out PGOs for COVID-19, the department worked closely with partners including the Governor; state, local, tribal, and territorial agencies; industry; and advocates - to ensure an orderly transition from PBL for COVID-19.
Today, HHS issued a fact sheet updating the current flexibilities created by the COVID-19 emergency declaration and how they will be affected by the end of PHE for COVID-19 on May 11.
What was achieved:
Thanks to the Biden-Harris administration's government-wide approach to combating COVID-19, we are now better equipped than at any time during the pandemic to respond and have the ability to exit the emergency phase and end the COVID-19 PGO. 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 government has also made life-saving treatments widely available, with more than 15 million treatments prescribed. Through COVIDTests.gov, the government has distributed more than 750 million free COVID-19 tests, which have been sent directly to more than 80 million homes. The government has also conducted more than 50 million in-person diagnostic tests in pharmacies and community facilities. Thanks to these and other efforts, COVID-19 is no longer the devastating force it once was. Since January 2021, deaths from COVID-19 have fallen by 95% and hospitalizations have decreased by almost 91%.
Nearing the end of COVID-19 PHE:
- We successfully convened a whole-of-government response to make historic investments in widely available vaccines, tests and treatments to help us fight COVID-19.
- Our nation's healthcare and public health systems are now better able to handle potential surges in COVID-19 cases without significantly impacting individuals' ability to access resources or care.
- Our public health experts have developed guidance to help individuals understand risk-reducing measures, such as wearing a mask and testing, to protect themselves and those around them.
- As we continue to monitor the evolving status of COVID-19 and the emergence of virus variants, we have the tools to detect and respond to high-impact variants that may emerge.
However, we know that many people are still affected by COVID-19, especially the elderly, people with weakened immune systems 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 hard for several months to ensure an orderly transition to continue meeting the needs of those affected by COVID-19.
Even after the COVID-19 PHE is over, we will continue our efforts to protect Americans from the virus and its worst effects by supporting access to COVID-19 vaccines, treatments and testing, including for those without health insurance. We will continue to advance research into new and innovative vaccines and treatments through our $5 billion investment in Project NextGen, a dedicated program designed to accelerate and streamline the rapid development of next-generation vaccines and treatments, including research, development and investment in manufacturing capacity, and promoting critical sciences. We will continue to work to better understand and respond to Lung COVID and help mitigate the impact.
What will not be affected by the end of PBL due to COVID-19:
The government's current response to COVID-19 is not entirely dependent on PHE declaring a state of emergency for COVID-19, and there is important flexibility and movement that will not be affected by the transition from the current phase of the response on 11 May.
Access to the COVID-19 vaccine and certain treatments, such as Paxlovid and Lagevrio, is usually unaffected.To help protect the community from COVID-19, HHS remains committed to maximizing continued access to vaccines and treatments for COVID-19.
When the COVID-19 PHE ends on May 11, Americans will continue to receive free COVID-19 vaccines, as they did during the COVID-19 PHE, because of the requirement during the COVID-19 PHE.CDC COVID-19 Vaccine Program Supplier Agreement.People will also continue to receive treatment for COVID-19, as they did during PBL for COVID-19.
Once the federal government stops buying or distributing vaccines and treatments for COVID-19, payments, coverage, and access may change. To prepare for this transition, partners in the United States Government (USG) are planning and developing plans for a smooth transition in the supply of COVID-19 vaccines and certain therapies that are part of the traditional health care market, which will be introduced in future individual month. to appear.
To protect families during the transition to traditional health care, the government has provided free delivery of the COVID-19 vaccine to nearly all individuals and will continue to ensure that effective treatments for COVID-19, such as Paxlovid, are widely available.
The department announced that "HHS COVID-19 Vaccine and Treatment Bridging Program(“Bridge” program) on April 18 to maintain broad access to COVID-19 vaccines and treatments for uninsured Americans after transitioning to the traditional health care market. For those with most types of private insurance, the ACIP-recommended COVID-19 vaccine is a preventive health service that is fully covered at no copay if offered by an in-network provider. Amount insurance. Currently, vaccinations against COVID-19 are covered by Medicare Part B without cost sharing and will continue to be so. Medicare Advantage plans must also cover in-network COVID-19 vaccinations without cost sharing and will continue to do so. Medicaid will continue to cover COVID-19 vaccinations without copayments or cost-sharing until September 30, 2024, after which ACIP-recommended vaccines will generally be covered for most beneficiaries.
After transitioning to the traditional health care market, out-of-pocket costs for certain treatments (such as Paxlovid and Lagevrio) may vary depending on an individual's health insurance coverage, similar to costs that may occur for other covered drugs. Medicaid plans will continue to cover treatment for COVID-19 without cost-sharing until September 30, 2024. After that, coverage and cost-sharing may vary by state.
For more information about the Bridges program, visitFacts: 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 vaccination and treatment against COVID-19, visitCMS waivers, flexibility, and the end of the public health emergency caused by the COVID-19 virus.
This does not affect US Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs) for COVID-19 products, including tests, vaccines and treatments.FDA's ability to approve various products, including vaccines for testing, treatment, or emergency use, is not affected by the end of PHE's COVID-19. For more information visitFDA FAQ: What happens to an EUA when a public health emergency passes?
This will not affect the flexibility of primary telehealth.During the COVID-19 PHE, the vast majority of current Medicare telehealth flexibilities that people with Medicare rely on (especially those in rural areas and others who have difficulty accessing care) will remain in place until December. 2024. In addition, states already have significant flexibility in coverage and payment for Medicaid services provided through telehealth. This flexibility was available before the COVID-19 PBL and will be available after the end of the COVID-19 PBL. For more information, visit the Centers for Medicare and Medicaid Services (CMS)CMS waivers, flexibility, and the end of the public health emergency caused by the COVID-19 virus.
Our whole-of-government response to Long COVID will not change.The department has and will continue to coordinate the whole-of-government response to the long-term effects of COVID-19, including Lung COVID and related conditions. On April 5, HHS announced thisIntroductionAn overview of the progress made in the response to Pulmonary COVID-19 and the Department's activities to meet the needs of the growing population with Pulmonary COVID and related diseases.
What will be affected by the end of COVID-19 PBL:
Many of the PBL's COVID-19 flexibilities and rules have been made permanent or otherwise extended for a period of time, while others expire after May 11.
Certain Medicare and Medicaid exemptions and broad flexibility for health care providers are no longer needed and will end.During the COVID-19 PHE, CMS combined emergency authorization waivers, regulations, and subregulatory guidance to ensure and expand access to care and give health care providers the flexibility they need to keep people safe. States, hospitals, nursing homes and other facilities currently operate under hundreds of such waivers, which affect the delivery and payment of care and are integrated into patient and provider systems of care. Many of these exemptions and flexibilities were needed to expand the capacity of health system facilities and allow the health system to withstand the increased pressure caused by COVID-19; given the current state of COVID-19, such excess capacity is no longer needed.
For Medicaid, some additional exemptions and flexibilities of the PGO for COVID-19 end on May 11, while others remain in effect for six months after the PGO for COVID-19 ends. But many Medicaid waivers and flexibilities, including those supporting home and community-based services, are available to states to opt out of the COVID-19 PHE if they so choose. For example, states have used flexibilities associated with PBLs for COVID-19 to increase the number of people covered by waivers, expand eligibility for providers, and other flexibilities. Many of these opportunities can be extended beyond the COVID-19 PBL. For more information visitCMS waivers, flexibility, and the end of the public health emergency caused by the COVID-19 virus
Coverage of the COVID-19 tests will vary, but USG maintains a robust inventory and distribution channel to keep tests available free of charge at select community locations, and USG will continue to distribute tests through COVIDtests.gov through the end of May.People with traditional health insurance can continue to receive PCR and antigen testing for COVID-19 without cost sharing when lab tests are ordered by a physician or other health care providers, such as physician assistants and registered nurses. People in Medicare Advantage plans can continue to get PCR and antigen testing for COVID-19 while Medicare covers the testing, but their cost sharing may change when PGO for COVID-19 ends. In addition, when the COVID-19 PGO ends on May 11, programs that support Medicare coverage and payment for over-the-counter (OTC) testing for COVID-19 will end; Medicare Advantage plans may continue to cover these tests, and customers should review their programs for more information.
State Medicaid programs must provide cost-sharing coverage for COVID-19 testing by the last day of the first calendar quarter beginning in the year following the last day of the PGO for COVID-19. This means that as the COVID-19 PGO ends on May 11, 2023, this mandatory coverage ends on September 30, 2024, after which coverage may vary by state.
The obligation of private insurers to cover non-cost-sharing COVID-19 testing, including OTC and laboratory testing, ends when the PGO expires. However, coverage may continue if the plan so chooses. The government encourages private insurers to continue to offer such coverage in the future. For more information visitCoverage of COVID-19 testing,Frequently Asked Questions: CMS exemptions, flexibility, and the end of the public health emergency due to COVID-19,Frequently Asked Questions about the Families First Coronavirus Response Act, the Coronavirus Relief, Assistance and Economic Security Act, and the Health Insurance Portability and Accountability Act Implementation 第 58 免费.
In addition, USG can continue to distribute free COVID-19 tests from the Strategic National Stockpile through states and other community partners. Until resources are available, the Centers for Disease Control and Prevention's (CDC) ICATT program will continue to focus on free testing for uninsured and high-risk areas through pharmacies and community sites. For more information visitICATT web stranica CDC-a.
The reporting and tracking of certain data about the COVID-19 disease will change.CDC surveillance of COVID-19 data has been a cornerstone of our response, and during PHE, HHS has the authority to request laboratory test reports for COVID-19. Upon completion of the PHE for COVID-19, HHS will no longer have the express authority to request this data from laboratories, which will affect the reporting of negative test results and the ability to calculate positive rates of COVID-19 tests in certain jurisdictions. .Reporting of hospital data will continue through April 30, 2024 in accordance with the CMS Terms of Participation, but reporting will be reduced from the current daily reports to weekly reports.
Despite these changes, CDC continues to report valuable data to understand trends related to COVID-19 and inform public health actions by individuals and communities to protect those most at risk of severe illness from COVID-19. In fact, CDC still has access to more data than is currently collected for other respiratory diseases to inform public health actions at all levels, and hospital data available at the county level will be the primary source of data for severe COVID-19 in municipality. For more information, visit this CDC resource:The federal declaration of a public health emergency (PGO) related to COVID-19 is ending.
In March, the FDA announced transition plans for certain guidance documents related to the disease COVID-19 covering topics such as medical devices, clinical practice and the supply chain, including rules that will be discontinued or temporarily extended.For more information visitFDA's COVID-19 Guidance for Industry, FDA Staff, and Other Stakeholders.
The FDA's ability to detect critical equipment defects related to COVID-19 will be more limited.While FDA retains authority to identify and address other potential medical product shortages, it is seeking Congressional approval to expand requirements for device manufacturers to notify FDA of critical device outages and outages outside of the PGO, which would strengthen FDA's ability to help prevent or mitigate equipment shortages .
Liability protection from the Public Preparedness and Emergency Preparedness Act (PREP) will be amended.April 14, 2023, HHS-Secretary Becerrasent a letterexistIntroductionTo the governor announcing his intention to amend the PREP Act statement to expand certain key 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 Act's statement on COVID-19 countermeasures to expand the protections referenced in this fact sheet and other materials, and to publish the amendments in the Federal Register as required by the PREP Act.