0938-AU91 202410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Healthcare System Resiliency and Modernization (CMS-3426)

This rule proposes revisions to the regulations for all Medicare- and Medicaid-participating providers and suppliers to ensure continuous, ongoing access to safe and effective health care services.

]]> Section 3(f)(1) Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes State, local, or tribal governments Private Sector 42 CFR 403 42 CFR 416 42 CFR 418 42 CFR 441 ... 42 U.S.C. 1395hh 42 U.S.C 1302 42 U.S.C. 1821 42 U.S.C 1832(a)(2)(F)(I) 42 U.S.C. 1861(dd)(1) 42 U.S.C. 1905(a) Yes

This proposed rule would revise and update national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, including climate-related disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems based on lessons learned during the COVID-19 public health emergency and other recent events. This rule also proposes revisions that support health
care system resiliency. The need for this rule is based on feedback and public consultations with health care providers, public health organizations and professionals,
and researchers, including multiple listening sessions. Participants described how some organizations were unprepared for extended, wide-spread, and concurrent emergencies.

They expressed that improvements to CMS requirements would support better care and outcomes for patients during and after emergencies. In addition, this rule would advance equity, increase access to person-centered care, including culturally and linguistically appropriate services, and address and improve outcomes and disparities in maternal health care. This rule would ensure that hospitals have processes to address and prevent medication shortages. Lastly, this rule would also strengthen provider resiliency and preparedness against cyberattacks that may disrupt patient care and advance equity and reduce disparities across the continuum of care for patients by improving transparency, patient education, and health literacy on the organ donation and transplantation process. The proposals are in accordance with Executive Orders 13985, 13988, 13995, and 14301 on Advancing Racial Equity and Support for Underserved Communities through the Federal Government, Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation, Ensuring an Equitable Pandemic Response and Recovery, and on Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders, respectively.

]]>

There are various sections of the Social Security Act (the Act) that define the types of providers and suppliers that may participate in Medicare and Medicaid and list the requirements that each provider and supplier must meet to be eligible for Medicare and Medicaid participation. The Act also authorizes the Secretary to establish other requirements as necessary to protect the health and safety of patients, although the wording of such authority differs slightly between provider and supplier types. Such requirements may include the CoPs for providers, CfCs for suppliers, and requirements for long term care facilities. The CoPs and CfCs are intended to protect public health and safety and promote high quality care for all persons. Additionally, under our authority to protect the health and safety of individuals in sections 1861(e)(9), 1861(kkk), 1820 and 1861(mm) of the Act, the rule proposes cybersecurity requirements for providers. The Public Health Service (PHS) Act sets forth additional regulatory requirements that certain Medicare providers and suppliers are required to meet in order to participate. The statutory authority to revise the health and safety standards for Medicare and Medicaid participating providers and suppliers is contained within Section 1102 (42 U.S.C. 1302) of the Social Security Act. In addition, this rule revises the health and safety regulations to advance health equity and reduce disparities for all individuals in accordance with Executive Orders 13985, 13988, 13995, and 14301 on Advancing Racial Equity and Support for Underserved Communities through the Federal Government, Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation, Ensuring an Equitable Pandemic Response and Recovery, and on Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders, respectively.

]]>

In developing the policies contained in this rule, we considered numerous alternatives, including maintaining existing requirements.  These alternatives will be
described in the rule.

]]>

The provisions in this rule aim to improve emergency preparedness, increase system resiliency, advance health equity, improve maternal health care, increase access to care, improve quality of care, and reduce health disparities for all individuals. This regulation will ultimately remove barriers and ensure continuous access to health care and improve quality of care for all. As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

]]>

This action furthers the goals of the Executive Orders on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (E.O. 13985), Executive Order on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation (E.O. 13988), Executive Order on Ensuring an Equitable Pandemic Response and Recovery (E.O. 13995), and Executive Order on Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders (E.O. 14301). While there may be some risks associated with an increased burden on providers as a result of these regulations, we believe benefits related to person centered care including culturally and linguistically appropriate services and improved maternal health care would far outweigh any risks.

]]> NPRM 12/00/2024 Undetermined Federal Local State Tribal Yes No No 0938-AV21 Merged with Alpha-Banu Wilson Director, Division of Acute Care Providers 0938 Centers for Medicare & Medicaid Services CMS 410 786-8687 alphabanu.wilson@cms.hhs.gov Center for Clinical Standards and Quality, 7500 Security Boulevard, Baltimore MD 21244