August 25, 2022
CMS plays an important role in protecting the health and safety of all Americans as they journey through the health care system. This is especially true during a pandemic, natural disaster, or other emergencies. Throughout the COVID-19 public health emergency (PHE), CMS has used a combination of emergency authority waivers, regulations, enforcement discretion, and sub-regulatory guidance to ensure access to care and give health care providers the flexibilities needed to respond to COVID-19 and help keep people safer. Many of these waivers and broad flexibilities will terminate at the eventual end of the PHE, as they were intended to address the acute and extraordinary circumstances of a rapidly evolving pandemic and not replace existing requirements. To minimize any disruptions, including potential coverage losses, following the end of the PHE, HHS Secretary Becerra has committed to giving states and the health care community writ large 60 days’ notice before ending the PHE. In the meantime, CMS encourages health care providers to prepare for the end of these flexibilities as soon as possible and to begin moving forward to reestablishing previous health and safety standards and billing practices.
The impact of the COVID-19 pandemic was unprecedented, especially in the earlier days, yet CMS managed to process over 250,000 section 1135(b) of the Social Security Act (referred to as 1135 waivers) waiver requests. While the COVID-19 PHE remains in effect, we are continuing to use the CMS Pandemic Plan as a guidebook for evaluating all existing flexibilities, while developing a comprehensive long-term approach for the health care system based on recovery and resiliency. Given the importance of this effort, CMS’ strategic plan includes a cross-cutting initiative to address the current PHE and ensure that CMS has a roadmap to support a health care system that is more resilient and better prepared to adapt to future disasters and emergencies that we know we can expect. This work complements the work already underway to ensure as many eligible individuals as possible maintain a source of coverage, whether through Medicaid/CHIP, Marketplace, employer coverage, or Medicare.
Over the course of the PHE, we have learned a great deal from health care providers, facilities, insurers, and other stakeholders’ experience and use of the waivers and flexibilities. In many cases, these have proven to be especially useful during the initial challenges of the pandemic. In fact, we determined that some of these measures should remain in place even after the end of the PHE to promote innovation, maintain or improve quality, advance health equity, and expand access to care. One example is the reporting requirement for nursing homes, which initially became effective on May 8, 2020, when CMS published an interim final rule with comment. The requirement for nursing homes to report resident and staff infections and deaths related to COVID-19 would have ended with the PHE. However, in the 2023 Home Health rule, CMS revised the infection control requirements that Long-term Care (LTC) Facilities must meet to participate in the Medicare and Medicaid programs so that these facilities continue the COVID-19 reporting requirements until December 2024.
Expanding telehealth is an example of a Congressional change. The Consolidated Appropriations Act, 2021 expanded access to telehealth services for the diagnosis, evaluation, or treatment of mental health disorders after the end of the PHE. These services have been so important to the health and well-being of Americans affected by COVID-19.
Conversely, we have also identified certain flexibilities that, while useful during the initial response to COVID-19, are no longer needed in the current stage of the pandemic. For example, recent onsite LTC survey findings provided insight into issues with resident care that are unrelated to infection control, such as increases in residents’ weight-loss, depression, and incidence of pressure ulcers. As a result, it was determined that the lack of certain minimum standards, such as training for nurse aides, may be contributing to these issues. Thus, on April 7, 2022, CMS announced the termination of some temporary waivers to redirect efforts back to meeting the regulatory requirements aimed at ensuring each resident’s physical, mental, and psycho-social needs are met.
We have routinely monitored data across the health care system to inform our overall approach on ending certain flexibilities and are prioritizing the reinstatement of vital health and safety standards to protect people seeking care. As we assess ending flexibilities related to the PHE, CMS is continuously considering impacts on the communities we serve, including underserved communities, and the potential barriers and opportunities flexibilities may address. We commend the providers across the health care system that worked diligently to ensure that health and safety standards remained in place during the height of the pandemic. Yet, even with their valiant efforts, we saw patient, resident, and client safety decline as health systems were, at times, stretched to their limits, and the continued flexibilities could contribute to further decline. As mentioned by Lee A. Fleisher, M.D.; Michelle Schreiber, M.D.; Denise Cardo, M.D.; and Arjun Srinivasan, M.D., in the February 17, 2022, New England Journal of Medicine Perspective, “Safety has also worsened for patients receiving post-acute care, according to data submitted to the Centers for Medicare and Medicaid Services (CMS) Quality Reporting Programs: during the second quarter of 2020, skilled nursing facilities saw rates of falls causing major injury increase by 17.4% and rates of pressure ulcers increase by 41.8%.”[i]
CMS is continuing to support stakeholders and the people we serve during this phase of the pandemic while looking forward to a health system that successfully emerges from the PHE focused on making increased gains in quality and safety. As the agency identifies opportunities for improvement, the needs of each person and community served will be considered with a health equity lens to ensure our analysis, stakeholder engagement, and policy decisions account for health equity impacts on members of underserved communities and health care professionals disproportionately serving these communities.
In April 2022, CMS launched the CMS National Quality Strategy with a goal of ensuring that all persons receive equitable, high-quality, and value-based care. Ensuring resilience in the health care system to prepare for, and adapt to, future challenges and emergencies is a goal of the strategy, and we plan to use its levers and authority to execute it. Both the CMS National Quality Strategy and CMS Framework for Health Equity build on what we have learned in the years leading up to the COVID-19 pandemic and during pandemic itself to ensure all those who CMS serves – including members of underserved communities – have access to safe, high-quality health care services and supports.
CMS has developed a roadmap for the eventual end of the Medicare PHE waivers and flexibilities, and is sharing information on what health care facilities and providers can do to prepare for future events. Similar to the guidance CMS has made available to states, CMS is releasing fact sheets that will help the health care sector transition to operations once the PHE ends, whenever that may occur. CMS continues to seek and receive your input as we release or update regulatory requirements and sub-regulatory guidance. Additionally, we are offering technical assistance to states, as one example, and engaging in public education about the necessary steps to prepare successfully for and operate after the PHE to assist other partners.
The fact sheets we are releasing today summarize the current status of Medicare Blanket waivers and flexibilities by provider type as well as flexibilities applicable to the Medicaid community. We will continue updating these resources as needed to make sure they can be relied upon for accurate information. Throughout the PHE, CMS has also maintained a list of COVID-19 waivers, but unless otherwise specified in these fact sheets, these waivers will end with the PHE. With this information in hand, we expect that the health care system can begin taking prudent action to prepare to return to normal operations and to wind down those flexibilities that are no longer critical in nature. Emergency preparedness is top of mind for CMS, and we encourage you to revisit the Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers Final Rule and updated guidance. CMS, as always, will continue to engage with the health care community to share feedback and collaborate to provide the person-centered, safe, and high-quality care Americans expect and deserve.
CMS COVID-19 Resources:
Supporting health care resiliency cross-cutting initiative fact sheet
CMS COVID-19 webpage
Coronavirus waivers & flexibilities
CMS COVID-19 vaccine toolkits
PHE Unwinding Guidance for State Medicaid Programs
Approved Medicaid State Waivers and Amendments
CMS COVID-19 Waivers and Flexibilities for Providers
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