In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a national declaration of public health emergency (PHE) that would largely shape the healthcare response. health in the public and private sectors. stakeholders in the spread of COVID-19 in the United States and the business and operational challenges that have resulted from the pandemic. Between January 2020 and January 2021, the PHE was renewed four times. In addition to renewing the PHE in January 2021, Acting HHS Secretary Norris Cochran said in a letter to state governors that HHS would provide states with 60 days notice before terminating the PHE. The letter also stated that the PHE would likely extend until the end of 2022, which turned out to be true, with the current PHE extension effective until January 11, 2023.
The PHE Statement aimed to connect, streamline and increase accessibility to various aspects of health services that had been disrupted or disrupted due to the COVID-19 pandemic (the Pandemic). Specifically, through Section 1135 of the Social Security Act, the PHE has permitted the Secretary of HHS to remove or modify certain requirements for benefits provided under Medicare, Medicaid, health insurance and the requirements of the confidentiality rules of the Health Insurance Portability and Accountability Act. Instances where the secretary exercises this discretion by relaxing certain requirements are called § 1135 Derogations. However, much of this flexibility was meant to be temporary. Thus, waivers will generally expire with the termination of the PHE, with some exceptions.
Over the past two years, many healthcare providers and industry stakeholders have incorporated the PHE and accompanying waivers into their business practices. The end of the PHE signals the end of many of these waivers, so healthcare providers and industry stakeholders will need to know how to navigate the return to post-pandemic operations without the flexibility of the waiver. Such a transition will require significant changes, including (1) reinstated policies limiting the use of telehealth, (2) a reinstatement of reporting requirements for hospitals and long-term care facilities, and (3) a return to pre-pandemic definitions and practices. regarding the types of healthcare professionals who can provide care to Medicare patients. The expiration of these and other major waivers is described below, and the full list of waivers set to expire can be found here.
Although the range of waivers is too broad to be comprehensively reviewed here, suffice it to say that they essentially affect all types of healthcare providers, from palliative care providers to telehealth service providers and everything the rest. The § 1135 waivers allowed for sweeping changes and the necessary flexibilities to enable our healthcare system to respond quickly and function appropriately during the pandemic. Policies that made this possible included expanding the scope of practitioners who could bill Medicare for telehealth services, reducing various reporting requirements, and changing protocols for sanitation and disposal of equipment for manage scarce resources. Some waivers have already been terminated, but of those that are still in effect, the only types that will continue beyond the end of PHE are those relating to Medicare telehealth services flexibility, which are due to end 151 days after the conclusion of the PHE. PHE. Similarly, when the PHE ends, CMS will continue to defer to state law regarding licensure requirements for practitioners providing telehealth services.
Unlike these narrow exceptions, which will last beyond the PHE, hospitals, psychiatric hospitals, and critical access hospitals will need to quickly cease PHE-era practices of offsite patient screening and the liberal use of verbal orders. . These providers will need to return to more thorough reporting requirements and ensure that Medicare patients are cared for by a physician, policies that have been deviated solely out of necessity in the management of the outbreak of COVID-19 in hospitalized patients.
With the 60-day notice to the end of the PHE, companies will have some time to begin adjusting practices and policies upon the return of old requirements in some cases, while continuing to adapt to new regulations put in place in the aftermath of the pandemic. Proactive preparation is essential for all types of healthcare providers. Additionally, even with the 60-day notice period, stakeholders who have used or been affected by PHE flexibilities should start preparing now for the upcoming changes. The White House and others in Washington, DC have signaled that the end of the PHE is near.
* The authors would like to thank Tristan Smith, a legal assistant in Venable’s office in Tysons, Virginia, and Noah Holman, a partner in Venable’s office in Baltimore, MD, for their assistance in writing this article.
 https://www.asha.org/news/2022/federal-public-health-emergency-updates-for-2022/#:~:text=The%20latest%20HHS%20extension%20for,effective%20through%20January% 2011%2C%202023).
 42 USCA § 1320b-5 (West); https://aspr.hhs.gov/legal/PHE/Pages/Letter-to-Governors-on-the-COVID-19-Response.aspx
 See, for exampleCenter for Medicare and Medicaid Services (CMS), Additional policies and procedures related to emergencies and disasters that can only be implemented with a waiver of § 1135 (March 15, 2019); CMS, General COVID-19 Emergency Declaration Waivers for Healthcare Providers (Oct 13, 2022) [hereinafter Blanket Waivers].
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