The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of Health and Human Services (HHS) on January 31, 2020, and subsequently renewed several times, provided the basis for numerous flexibilities upon which the healthcare and life sciences industries have relied to furnish patient care during the pandemic. With the PHE coming to an end, organizations may need to make drastic changes as the regulatory enforcement returns to “normal.”
For example, the US Food and Drug Administration (FDA) granted emergency use authorizations to certain medical (particularly COVID-19 testing) devices to support the nation’s response to the pandemic.
The HHS Office of Inspector General (OIG) announced that it would exercise enforcement discretion with respect to certain administrative enforcement authorities to provide flexibility and minimize burdens for the healthcare industry as it faced the challenges of the pandemic that, among other things, increased the availability and coverage of telehealth services. The HHS Office for Civil Rights (OCR) similarly announced HIPAA enforcement discretion waivers.
Additionally, the Centers for Medicare & Medicaid Services (CMS) addressed impediments to the delivery of patient care by providing an array of waivers and flexibilities to help alleviate administrative burdens.
In conjunction with the administration’s announcement of the May 11 termination of the PHE, various regulatory agencies issued guidance with respect to the termination concurrent with the end of the PHE, sunsetting at some point after the end of the PHE, or continuation of these regulatory flexibilities.
This series of complicated guidance documents related to the end of the PHE affects almost every component of the healthcare and life sciences industry, including but not limited to medical device and pharmaceutical manufacturers; telehealth innovators and providers; long-term care providers, such as long-term care and skilled nursing facilities; and home-based care providers, such as home health agencies and hospice organizations.
These various transition guidance documents address requirements related to Medicare coverage and screening; Medicare claims appeals; provider licensure and enrollment; patient and provider safety; COVID-19 testing protocols; recordkeeping and data reporting; and Stark Law waivers and related enforcement discretion under the federal antikickback statute.
The FDA also issued guidance introducing a multi-phase framework for transitioning medical devices previously granted emergency use authorizations or subject to particular enforcement policies or discretion to permanent marketing authorizations.
Morgan Lewis, led by our FDA and healthcare practice, has published a continuing series of articles to help the industry understand the impact of the end of the PHE on their business brought about by the termination, extension, or sunsetting of these various regulatory flexibilities and waivers and by the return to pre-pandemic government enforcement priorities. These publications provide insights on what businesses should expect in the weeks and months following May 11, 2023; explore the implications of the termination of the PHE, such as additional administrative burdens and elevated enforcement risk; and furnish practical perspectives on how to transition back to normal operations.
Healthcare and life sciences industry stakeholders should take immediate and ongoing steps to ensure that they assess existing procedures, policies, and relationships that have been shaped by the flexibilities afforded pursuant to the PHE and to remediate as necessary business and care practices to ensure they comply with the myriad regulatory guidances.
This Insight compiles articles discussing the effect of the PHE’s termination on the following topics:
The end of the PHE will trigger the wind down of many blanket waivers affecting hospitals’ operations and reimbursement. Hospitals should review the 15 key waivers discussed here and other waivers that will be ending on May 11 to inform their preparation for upcoming changes. While the majority will terminate on May 11 when the PHE ends, other waivers will remain in effect through December 31, 2023 or beyond.
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Our LawFlash, “What Hospitals Need to Know – 15 Key PHE-Related Waivers Ending May 11,” covers these waivers and offers insight into CMS guidance for each.
Long-term care facilities, skilled nursing facilities, and nursing facilities were at the epicenter of the COVID-19 pandemic. During the PHE, CMS implemented an array of waivers and flexibilities to ensure patients could access acute care needs. As the PHE ends, long-term care facilities should review which of these flexibilities will end, which state regulations will change, and what interim rules are in effect.
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In our LawFlash “Long-Term Care Facilities: What to Expect when the COVID-19 PHE Ends,” we cover which flexibilities will end on May 11, which will be temporarily extended, and which will continue without a set end date.
Home-based care providers such as home health agencies and hospices benefited significantly from Medicare program regulatory flexibilities during the PHE. However, by their nature as hands-on nursing and care providers, they will face significant changes as telehealth begins to revert to pre-COVID-19 regulatory status.
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Our blog post for Health Law Scan, “HHA’s and Hospices: What to Expect When the COVID-19 PHE Ends” offers in-depth analysis of CMS guidance for home-based care providers, as well as the direct implication of the end of the PHE.
On February 24, 2023, CMS and HHS OIG confirmed that following the end of the PHE, healthcare providers must comply with all Stark Law requirements, and that HHS OIG’s enforcement discretion with respect to certain renumeration covered by the Stark Law blanket waivers would also come to an end.
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In our LawFlash, “End of the PHE: Preparing for Return to Normal for Stark Law and Anti-Kickback Statute,” we discuss the changes to Stark Law Waivers and anti-kickback statute enforcement discretion in depth, and what elements were changed to accommodate COVID-19 restrictions.
As with the rest of the healthcare landscape, telehealth providers will face certain complexities as a result of the end of the PHE. However, unlike in-person care, much of the telehealth regulatory landscape will remain status quo for the next several months, as certain flexibilities are extended.
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Our blog post, “Saved by the Bell? Telehealth Remains Largely Intact When PHE Ends,” discusses the recent legislation that’s currently affecting telehealth, and when new regulatory realities will take effect.
During the COVID-19 pandemic, the OCR issued four Notifications of Enforcement Discretion (waivers) designed to help healthcare providers dealing with the virus. With the end of the PHE, these waivers are also coming to an end. As such, healthcare providers must ensure that their organizations are compliant with existing HIPAA requirements.
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In our blog post for Health Law Scan, “Back to Business: Adapting to the Expiration of 4 HIPAA Enforcement Discretion Waivers,” we discuss each waiver, what they covered, and what organizations need to do to ensure compliance after they sunset.
The FDA has finalized the framework for transitioning medical devices previously granted emergency use authorization (EUA) or subject to particular enforcement policies to obtaining permanent marketing authorization. Released through two guidance documents that were finalized on March 27, 2023, the FDA’s latest action is in response to the feedback and public comments the agency received for the draft guidance documents, which, as discussed in a previous LawFlash, were issued in December 2021. Through these final transition guidance documents, the FDA provides recommendations and clarity for medical device manufacturers that either intend to continue marketing their devices or wish to discontinue distribution after the relevant EUA declaration or enforcement policies are no longer in effect.
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Our LawFlash, “FDA Finalizes Framework for Transitioning from COVID-Related Medical Devices EUA/Enforcement Discretion to Permanent Marketing Authorization,” discusses in more detail the two guidance documents that were recently finalized and what manufacturers can expect during the 180-day transition period and beyond.
The regulatory flexibilities implemented during the PHE allowed physician organizations and other healthcare providers to focus on providing care on the front lines of the COVID-19 pandemic instead of on burdensome regulatory requirements. As these regulations return to pre-pandemic status, physician organizations should take stock of these changes and adapt accordingly.
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Our LawFlash “What Physician Organizations Need to Know: Key Considerations for the End of the PHE” discusses the enrollment, enforcement, and operational considerations that physician groups should evaluate to ensure ongoing regulatory compliance.
The Medicaid Continuous Enrollment Condition has already ended and significant enrollment terminations are expected. Various disaster waivers and SPAs that allow flexibilities for enrollment, eligibility, and cost sharing will expire on May 11, 2023 or December 11, 2023. Vaccine and treatment coverage will not change but COVID-19 testing coverage may vary after September 30, 2024.
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Our blog post, “Medicaid Changes Now and Later: What to Expect at the End of the PHE and Beyond” details the relevant changes in coverage and who will be affected.
If you have any questions or would like more information on the issues discussed in this Insight, please contact any of the following: