Federal and state unwinding of COVID-19 rules

On January 20, 2023, President Biden announced that his administration will end the COVID-19 national emergency and public health emergency (PHE) on May 11, 2023. While the industry has waited for the eventual unwinding, much of the focus has remained on federal flexibilities and waivers that will expire with the conclusion of the PHE. Less attention has been paid to the equally important state flexibilities and a failure to attend to their conclusion will create regulatory and enforcement risk.

Unwinding at the federal level

Since the initial declaration of a PHE on January 31, 2020, the healthcare industry experienced a myriad of federal and state statutory and regulatory waivers and operational flexibilities in response to the COVID-19 pandemic, in some ways fundamentally changing the way healthcare is delivered and received in the United States. Patients and providers have incorporated and relied on these regulatory flexibilities in implementing a number of programs, from telemedicine to licensing of physicians to reliance for payment and coding instructions, many of which will come to an end when the PHE terminates on May 11, 2023. The administration sought to prepare the industry for some of these changes by decoupling those regulatory flexibilities on which many healthcare providers and Americans have come to rely in the Consolidated Appropriations Act, 2023.

• Susan Feigin Harris and Jeff Wurzburg discussed in our earlier client alert that between now and May 11, providers need to be proactive in evaluating the various operational and reimbursement changes implemented as result of the pandemic to ensure they do not face compliance risk come May 12. As a reminder, the CMS coronavirus waivers & flexibilities website posts provider-specific fact sheets that identify those waivers and flexibilities that will end versus those that will transition.

With the end of the PHE will come the end of immunity in the administration of COVID-19 countermeasures for some healthcare providers. On March 10, 2020, the Secretary of the Department of Health and Human Services (HHS) issued a declaration invoking the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act limits legal liability for losses that occur in connection with the administration of COVID-19 countermeasures, including diagnostics, treatments and vaccines, excepting only "willful misconduct" from immunity. For manufacturers, distributors, and organizations conducting countermeasure programs and providers conducting countermeasure activities as part of a government public health response related to a federal government agreement, PREP Act immunity will extend through October 1, 2024. For COVID-19 countermeasures administered as part of a government public health response but not in connection with federal agreement, immunity will extend through either the end of the PHE or through the final day that the applicable declaration of emergency (at the local or state level) is in effect.

Unwinding at the state level

However, healthcare providers should also be mindful of states ending their public health emergency declarations and the resulting sunset of state specific regulatory and licensure flexibilities relied upon during this period. As of March 9, 2023 only five (5) states have active COVID-19 emergency orders in effect: Connecticut, Illinois, New Mexico, Rhode Island, and Texas. Interestingly, on January 15, 2023, Texas Governor Greg Abbott renewed the Texas COVID-19 Disaster Declaration. The Governor emphasized that he intended to keep the Declaration in place "until the [Texas] Legislature can enact laws this session to prohibit local governments from imposing restrictions like mask mandates and vaccine mandates."

Healthcare providers should be on the lookout for updates to rules loosening COVID-19 restrictions applicable to healthcare facilities. On February 10, 2023, the New York Department of Health announced the end of a masking mandate for hospitals, nursing homes and treatment centers. The end of the masking mandate became effective on February 12, 2023. In the announcement, the Department of Health specifically noted their view of the importance of masking in healthcare settings, but maintained that masking would no longer be required and would be left to internal policies.

More recently, on March 3, 2023, California, Oregon and Washington all announced the rollback of COVID-19 era rules.

The California Department of Public Health announced updates to public health orders put in place in connection with the COVID-19 pandemic, effective April 3, 2023. Among the updates, California will no longer require masks in indoor high-risk and healthcare settings. The state will no longer require vaccinations for healthcare workers, including those in adult care, direct care, correctional facilities and detention centers. Hospitals in California will no longer be required to accept transfer patients from facilities with limited intensive care unit capacity. Healthcare providers in California will no longer be required to ask patients for their email addresses and/or mobile phone numbers when receiving a COVID-19 vaccination. Still, California legislation requires healthcare providers who administer vaccines to collect information about patients, including phone numbers, race and ethnicity.

Similarly, the Oregon Health Authority announced that they would rescind Oregon Administrative Rule 333-019-1011, which went into effect on January 31, 2022. Healthcare workers, patients and visitors will no longer be required to wear masks in healthcare settings, including hospitals, mobile clinics, ambulances, outpatient facilities, dental offices, urgent care centers and counseling offices, among others, as of April 3, 2023.

The Washington State Department of Health announced the end of the Secretary of Health Mask Order which was signed by the Washington Secretary of Health on October 27, 2022. The end of this masking order will mean that universal masking will no longer be required in healthcare, long-term care and adult correctional facilities, effective April 3, 2023.

These announcements leave healthcare providers in California, Oregon and Washington with a month to adjust to the rollback in COVID-19 era requirements and revise internal policies as desired. Still, healthcare providers should look to local ordinances to ensure compliance with requirements at the local level.

Norton Rose Fulbright lawyers are continuing to monitor these state updates and advising clients on their related operational and reimbursement challenges.