As COVID-19 public health emergency ends, HHS outlines what changes, what remains in health care

© Production Perig - stock.adobe.com

The COVID-19 public health emergency (PHE) ends today, creating a shift in how physicians, patients, and policy makers deal with the pandemic.

The U.S. Department of Health and Human Services (HHS) has differentiated between rules and practices that will change and some that will remain in place in the post-pandemic world.

HHS Secretary Xavier Becerra claimed credit for the administration of President Joe Biden for efforts of the last two years. He did not mention work under President Donald Trump, who was in office when COVID-19 first emerged.

“Due to the Biden-Harris Administration’s whole-of-government approach to combatting COVID-19, and through partnerships with you and others, we are now in a better place in our response than we were three years ago, and we can transition away from the emergency phase,” Becerra said in his May 10 letter to U.S. governors about the transition out of the PHE.

“For example, over the last two years, the Biden administration has effectively implemented the largest adult vaccination program in U.S. history, with over 270 million people receiving at least one shot of a COVID-19 vaccine,” Becerra said. “As a result of these and other efforts, since January 2021, COVID-19 deaths have declined by 95% and hospitalizations are down nearly 91%.

“Still, we know so many people continue to be affected by COVID-19, particularly seniors, people who are immunocompromised, and people with disabilities,” Becerra said. “That is why our response to the spread of SARS-CoV-2, the virus that causes COVID-19, remains a public health priority.”

HHS this week published a list of public health provisions that will change and some that will remain in place after May 11.

Continuing measures

Access to COVID-19 vaccinations and certain treatments, such as Paxlovid and Lagevrio, will generally not be affected, according to HHS.

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 the CDC 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 is no longer purchasing or distributing COVID-19 vaccines and treatments, payment, coverage, and access may change.

Partners across the U.S. government are developing plans to ensure a smooth transition for the provision of COVID-19 vaccines and certain treatments as part of the traditional health care market, which will occur in the coming months, according to HHS.

The department on April 18 also announced the “HHS Bridge Access Program For COVID-19 Vaccines and Treatments” 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 fully covered without a co-pay when provided by an in-network provider.

COVID-19 vaccinations are covered under Medicare Part B without cost sharing, and this will continue. Medicare Advantage plans must also cover COVID-19 vaccinations in-network without cost sharing, and this will continue. Medicaid will continue to cover COVID-19 vaccinations without a co-pay or cost sharing through Sept. 30, 2024, and will generally cover ACIP-recommended vaccines for most beneficiaries thereafter.

After the transition to the traditional health care market, out-of-pocket expenses for certain treatments, such as Paxlovid and Lagevrio, may change, depending on an individual’s health care coverage, similar to costs that one may experience for other covered drugs. 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, visit Fact 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 access to COVID-19 vaccinations and treatments, visit CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency.

The U.S. Food and Drug Administration’s (FDA) emergency use authorizations (EUAs) for COVID-19 products, including tests, vaccines, and treatments, will not be affected.

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. To learn more, visit FDA’s FAQs: What happens to EUAs when a public health emergency ends?

Major telehealth flexibilities will not be affected.

The vast majority of current Medicare telehealth flexibilities that people with Medicare – particularly those in rural areas and others who struggle to find access to care – have come to rely upon throughout the COVID-19 PHE, will remain in place through December 2024.

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. To learn more, visit the Centers for Medicare & Medicaid Services’ (CMS) CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency.

The whole-of-government response to Long COVID will not change.

The Department has and will continue to coordinate a whole-of-government response to the longer-term effects of COVID-19, including Long COVID and associated conditions. On April 5, HHS released this fact sheet outlining the progress made in responding to Long COVID and actions the Department is taking to address the needs of the growing population with Long COVID and associated conditions.

Plans for changes

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 used a combination of emergency authority waivers, regulations, and sub-regulatory guidance to ensure and expand access to care and to give health care providers the flexibilities needed to help keep people safe. Many of these waivers and flexibilities were necessary to expand facility capacity for the health care system and to allow the health care system to weather the heightened strain created by COVID-19; given the current state of COVID-19, 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 COVID-19 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 COVID-19 PHE, if they choose to do so.

Coverage for COVID-19 testing will change, but the U.S. government is maintaining a strong stockpile and distribution channels so that tests remain accessible at no cost in certain community locations. The U.S. government will continue to distribute tests through COVIDtests.gov through the end of May.

People with Traditional Medicare can receive COVID-19 PCR and antigen tests with no cost-sharing when the lab tests are ordered by a physician or certain 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 their cost-sharing may change when the COVID-19 PHE ends. Additionally, 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 until the last day of the first calendar quarter that begins 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, both for OTC and laboratory tests, will end at the expiration of the PHE. However, coverage may continue if plans choose to do so. The Administration is encouraging private insurers to continue to provide such coverage going forward.

Additionally, the USG may continue to distribute free COVID-19 tests from the Strategic National Stockpile through states and other community partners. Pending resource availability, 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 uninsured individuals and areas of high social vulnerability through pharmacies and community-based sites.

Certain COVID-19 data reporting and surveillance will change.

COVID-19 data surveillance has been a cornerstone of our response, and during the PHE, HHS had the authority to require. At the end of the COVID-19 PHE, HHS will no longer have this express authority to require lab test reporting for COVID-19 data, which will affect the reporting of negative test results and impact the ability to calculate percent 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 reporting to weekly.

FDA’s ability to detect shortages of critical devices related to COVID-19 will be more limited. 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 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 will be amended. On April 14, 2023, HHS Secretary Becerra sent a letter and Fact Sheet to the nation’s governors announcing his intention to amend the PREP Act declaration to extend certain important protections that will continue to facilitate access to convenient and timely COVID-19 vaccines, treatments, and tests for individuals.