By Randena Hulstrand, Vizient
While today, May 11, marks the official end of the COVID-19 Public Health Emergency (PHE), innovative healthcare delivery will continue, albeit with additional limitations — some familiar, some new. As you may remember, COVID-19 was declared a national PHE in January 2020 and was repeatedly extended until earlier this year when the administration announced its intent to bring the PHE to a close.
Emily Jones, a regulatory affairs and administration policy director at Vizient, emphasizes why it’s critical for healthcare organizations and providers to understand what the end of the PHE means for them, including upcoming deadlines and changes that will affect how they care for patients.
“It’s important for providers to remember that even though May 11 marks the ‘end’ of the PHE, it's the catalyst for a transition period that is going to stretch months and years into the future, depending on the specific areas of the PHE-related changes,” Jones said. “They need to be aware of the biggest changes affecting them now, but also remain vigilant of the changes ahead so they can adequately prepare.”
Read the following Q & A discussion with Jones, who offers perspectives from her experience identifying and responding to regulatory developments related to the COVID-19 PHE. She outlines which key flexibilities are now expiring along with an explanation of other changes to come.
Q: While the PHE ending does not mean that every flexibility granted under the PHE immediately ends, are there policies that will terminate on May 11 that hospitals should know about?
There are many different policies that will terminate on May 11, so asking leaders within your institution about specific changes will be critical, as some healthcare organizations may have already begun transitioning away from pandemic-era policies. That being said, one common question I receive relates to reimbursement changes that went into effect during the PHE. It’s important for organizations to understand that the 20% increase to the MS-DRG payment for discharges of patients diagnosed with COVID-19 will immediately end at midnight May 11. This means that even if a patient is admitted to a hospital May 10, diagnosed with COVID-19 and then discharged May 12, the organization will not receive the positive 20% payment adjustment for that discharge. During a public webinar, the Centers for Medicare & Medicaid Services (CMS) explained that there is no transition period because of the statutory language granting this flexibility — which specifies that this payment increase is only for “an individual diagnosed with COVID-19 discharged during the COVID-19 PHE.” However, other add-on payments, such as the 20% add-on for use of new COVID-19 technology (NCTAP) is expected to continue until Sept. 30, 2023. These nuances highlight the importance of actively checking guidance and regulations from CMS and other agencies.
Q: Which CMS waivers and flexibilities will terminate at the end of the PHE?
During the pandemic, CMS frequently used authority under the Social Security Act to provide blanket waivers for healthcare providers. These included, among other types of changes, waivers of certain aspects of Medicare Conditions of Participation (CoPs) and easing certain Emergency Medical Treatment & Labor Act (EMTALA) requirements to allow offsite patient screening. While some waivers, specifically for skilled nursing facilities, have already been terminated and reverted to pre-PHE requirements, many are still in place and will expire end of day May 11 without a transition period. These waivers may seem like small operational requirements — they include practices such as the storage of alcohol-based hand sanitizer, where on-site construction can be located in relation to a patient or how often a facility is required to conduct fire drills — but together, such requirements are extensive, and, if not followed, could have significant impacts on healthcare organizations.
CMS developed a roadmap for the eventual end of the COVID-19 PHE in August 2022. These documents, and others, are helpful resources for information on what healthcare facilities and providers need to know about COVID-19 PHE flexibilities.
Q: During the PHE, providers could prescribe controlled substances via telehealth without the need for an in-person visit. Will this change?
The Drug Enforcement Administration (DEA) released two proposed rules earlier this year that would extend some, but not all, of the telemedicine flexibilities adopted during the COVID-19 PHE. Flexibilities granted during the PHE have effectively allowed providers to prescribe controlled substances through telehealth without an in-person visit; such prescribing was not possible before the PHE. While the proposed rules, if finalized, would have been more stringent than policies provided during the PHE, on May 3, the DEA Administrator indicated DEA will be temporarily extending the COVID-19 telehealth prescriber flexibilities while working with stakeholders on future rulemaking. The flexibilities established during the PHE will be extended until Nov. 11, 2023 while DEA works with stakeholders to craft future guidelines for prescribing controlled substances that also include appropriate safeguards.
Q: What is ‘enforcement discretion’ and how has it affected telehealth?
Enforcement discretion is one way that agencies provide flexibility by indicating they will not enforce certain requirements during a given time period. Because the nation had to create a telehealth infrastructure so quickly during the COVID-19 pandemic, the Office for Civil Rights (OCR) waived Health Insurance Portability and Accountability Act (HIPAA) requirements for telehealth using enforcement discretion. Currently, hospitals can use certain non-HIPAA-compliant platforms to provide telehealth services. This flexibility allowed providers to be able to quickly offer telehealth services to connect with patients on a range of platforms while minimizing infection risk. With the PHE ending, OCR announced recently that providers will have 90 days from the end of the PHE to begin complying with HIPAA, and enforcement of these provisions will begin on Aug. 9, 2023.
Q: How will the end of the PHE affect the cost and purchasing of vaccines?
Since COVID-19 vaccines have been authorized and subsequently approved, the federal government has been the sole purchaser of COVID-19 vaccines. While federal government funding for vaccines is not dependent on the PHE, the government anticipates that these vaccines will need to be commercially purchased starting in the fall of 2023. As such, hospitals and healthcare providers are likely already asking about how best to plan for their supply of vaccines. The administration fee for the COVID-19 vaccine is currently $40 per vaccination. This rate will continue for vaccines administered through the end of the 2023 calendar year. Calendar year 2024 rates will be determined by CMS through rulemaking.
The Federal Drug Administration (FDA) Emergency Use Authorizations (EUAs) related to vaccines and treatments, specifically, that were provided during the COVID-19 pandemic are not impacted by the end of the PHE and will not expire. They will remain in effect for COVID-19 vaccines and treatments for patients. Both the FDA’s vaccine advisory committee and Advisory Committee on Immunization Practices (ACIP) at CDC will meet in June to discuss the updated recommendations for the COVID-19 vaccines for the 2023-2024 vaccination campaign. More guidance should be available for purchasing and planning after these meetings.
On May 2, the Administration announced its intent to end the vaccine requirement for healthcare workers in CMS-certified facilities on May 11. This requirement has been in place since Nov. 5, 2021, and CMS released a final rule withdrawing these requirements on May 31. The rule states that while the provisions do not go into effect for 60 days from final publication, CMS will not enforce any vaccine requirements going forward. It’s important to note that healthcare provider vaccination measures in quality programs, such as the Inpatient Quality Reporting Program, will remain in place..
Q: What is the Public Readiness and Emergency Preparedness (PREP) Act and will it terminate at the end of the PHE?
While related to the national COVID-19 emergency, the PREP Act is a fully separate declaration from the PHE. The PREP Act declaration provides immunity from liability for the use of certain medical countermeasures such as the COVID-19 vaccines and treatments. During the COVID-19 pandemic, the PREP Act provided liability immunity for manufacturers of COVID-19 countermeasures and providers, and was used to expand the vaccination workforce during the initial stages of mass vaccination. While the PREP Act protection ends Oct. 1, 2024, it has been continually updated as the COVID-19 pandemic evolved, including a recent amendment that walked back some of the eligibility for practitioners administering the vaccine. The PREP Act may continue to evolve over the course of the next year until its expiration.
Q: What other changes and deadlines tied to the end of the PHE should providers expect?
CMS's annual rulemaking cycle has already begun. For example, the FY 2024 Inpatient Prospective Payment System (IPPS) proposed rule was released and it addresses COVID-19 related policies, such as the COVID-19 staff vaccination measure and reiterates that the NCTAP is expected to end Sept. 30, 2023. The Physician Fee Schedule (PFS) and Outpatient Prospective Payment System (OPPS) proposed rules, which are traditionally released in the summer, are expected to contain several COVID-related policies, including addressing the extension of telehealth services until Dec. 31, 2024. The Consolidated Appropriations Act (CAA) that was passed in December 2022 included telehealth extensions and extensions for the Acute Care Hospital at Home Program (both until Dec. 31, 2024), with potential future extensions made legislatively.
Additionally, many states are already in the process of unwinding the Medicaid continuous eligibility provisions mandated by the Families First Coronavirus Response Act (FFCRA). This provision was decoupled from the PHE through the CAA, 2022. The temporary Federal Medical Assistance Percentage (FMAP) increase will also wind down through the end of this year.
As with the pace of change in 2020, we anticipate that the end of the PHE will bring a whirlwind of policy changes, rules and deadlines. Vizient’s team will continue to monitor and update members as the federal government shares guidance. As always, we welcome feedback on your experiences unwinding the PHE in your facility.