Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 438, 442, and 483</CFR> <DEPDOC>[CMS-3442-F]</DEPDOC> <RIN>RIN 0938-AV25</RIN> <SUBJECT>Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This final rule establishes minimum staffing standards for long-term care facilities, as part of the Biden-Harris Administration's nursing home reform initiative to ensure safe and quality care in long-term care facilities. In addition, this rule requires States to report the percent of Medicaid payments for certain Medicaid-covered institutional services that are spent on compensation for direct care workers and support staff. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> <E T="03">Effective date:</E> These regulations are effective on June 21, 2024. <E T="03">Implementation date:</E> Except as set forth in this section, these regulations must be implemented upon the effective date. • The regulations at § 483.71 must be implemented by August 8, 2024, for all facilities. • The regulations at § 483.35(b)(1) and (c)(1) must be implemented by May 11, 2026, for non-rural facilities and May 10, 2027, for rural facilities as defined by the Office of Management and Budget. • The regulations at § 483.35(b)(1)(i) and (ii) must be implemented by May 10, 2027, for non-rural facilities and May 10, 2029, for rural facilities as defined by the Office of Management and Budget. • The regulations at §§ 438.72(a) and 442.43 must be implemented by all States and territories with Medicaid-certified nursing facilities and intermediate care facilities for individuals with intellectual disabilities beginning May 10, 2028. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> The Clinical Standard Group's Long Term Care Team at <E T="03">HealthandSafetyInquiries@cms.hhs.gov</E> for information related to the minimum staffing standards. Anne Blackfield, (410) 786-8518, for information related to Medicaid institutional payment transparency reporting. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> To assist readers in referencing sections contained in this document, we are providing the following Table of Contents. <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose</FP> <FP SOURCE="FP1-2">B. Summary of Provisions</FP> <FP SOURCE="FP1-2">C. Summary of Cost and Benefits</FP> <FP SOURCE="FP-2">II. Minimum Staffing Standards for Long-Term Care Facilities in Response to the Presidential Initiative</FP> <FP SOURCE="FP1-2">A. Background</FP> <FP SOURCE="FP1-2">B. Provisions of the Proposed Regulations and Analysis of and Response to Public Comments</FP> <FP SOURCE="FP1-2">1. General Comments</FP> <FP SOURCE="FP1-2">2. Definitions</FP> <FP SOURCE="FP1-2">3. Minimum Staffing Standards</FP> <FP SOURCE="FP1-2">4. Registered Nurse 24 Hours per Day, 7 Days a Week</FP> <FP SOURCE="FP1-2">5. Hardship Exemption</FP> <FP SOURCE="FP1-2">6. Facility Assessment</FP> <FP SOURCE="FP1-2">7. Implementation Timeframe</FP> <FP SOURCE="FP1-2">8. Severability Clause</FP> <FP SOURCE="FP1-2">C. Consultation With State Agencies and Other Organizations</FP> <FP SOURCE="FP-2">III. Medicaid Institutional Payment Transparency Reporting Provision</FP> <FP SOURCE="FP-2">IV. Provisions of the Final Regulations</FP> <FP SOURCE="FP-2">V. Collection of Information Requirements</FP> <FP SOURCE="FP-2">VI. Response to Comments</FP> <FP SOURCE="FP-2">VII. Regulatory Impact Analysis</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose</HD> This final rule establishes minimum staffing standards to address ongoing safety and quality concerns for the 1.2 million  <SU>1</SU> <FTREF/> residents receiving services in Medicare and Medicaid certified Long-Term Care (LTC) facilities each day. As we have heard from residents, staff, and advocates across the country in response to the proposed rule, ensuring adequate staffing levels is essential to the safety and quality of long-term care facilities. On February 28, 2022, President Biden announced that CMS would establish minimum staffing standards that nursing homes must meet, based in part on evidence from a new research study that would focus on the level and type of staffing needed to ensure safe and quality care. <SU>2</SU> <FTREF/> This announcement was part of an overall reform plan to improve the quality and safety of nursing homes. In addition, on April 18, 2023, President Biden issued Executive Order 14095, “Increasing Access to High-Quality Care and Supporting Caregivers,”  <SU>3</SU> <FTREF/> which directs the Secretary of HHS to consider actions to reduce nursing staff turnover, which is associated with negative impacts on safety and quality of care. <E T="51">4 5</E> <FTREF/> On September 6, 2023, we published the “Medicare and Medicaid programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting”  <SU>6</SU> <FTREF/> proposed rule (referred to as the “proposed rule”). <FTNT> <SU>1</SU>   <E T="03">https://data.cms.gov/provider-data/dataset/4pq5-n9py.</E> </FTNT> <FTNT> <SU>2</SU>   <E T="03">https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/.</E> </FTNT> <FTNT> <SU>3</SU>  E.O. 14095, 88 FR 24669 (Apr. 21, 2023). </FTNT> <FTNT> <SU>4</SU>  Zheng, Q, Williams, CS, Shulman, ET, White, AJ. Association between staff turnover and nursing home quality—evidence from payroll-based journal data. <E T="03">J Am Geriatr Soc.</E> 2022; 70(9): 2508-2516. doi:10.1111/jgs.17843. <SU>5</SU>  Castle, Nicholas G, and John Engberg. “Staff turnover and quality of care in nursing homes.” <E T="03">Medical care</E> vol. 43,6 (2005): 616-26. doi:10.1097/01.mlr.0000163661.67170.b9. </FTNT> <FTNT> <SU>6</SU>  88 FR 61352 through 61429. </FTNT> The safety and quality concerns identified by the President stem, at least in part, from chronic understaffing in LTC facilities, and are particularly associated with insufficient numbers of registered nurses (RNs) and nurse aides (NAs), as evidenced from, among other things, a review of data collected since 2016 and lessons learned during the COVID-19 Public Health Emergency (PHE). Numerous studies, including a new research study commissioned by CMS as well as existing literature, have shown that staffing levels are closely correlated with the quality of care that LTC facility residents receive as well as with improved health outcomes. Higher staffing levels also provide staff in LTC facilities the support they need to safely care for residents. Minimum staffing standards can thus help prevent staff burnout, thereby reducing staff turnover, which can lead to more consistent care and improved safety and quality for residents and staff. This final rule also promotes public transparency related to the percent of Medicaid payments for certain institutional services that are spent on compensation to direct care workers and support staff. <HD SOURCE="HD2">B. Summary of Provisions</HD> We are updating the Federal “Requirements for Medicare and Medicaid Long Term Care Facilities” minimum staffing standards (“LTC requirements”). We will survey facilities for compliance with the updated LTC requirements in the rule and enforce them as part of CMS's existing survey, certification, and enforcement process for LTC facilities. In addition, consistent with the President's reform plan, we will display our determinations of facility compliance with the minimum staffing standards on Care Compare  <SU>7</SU> <FTREF/> and require facilities to post a public notice within the facility if they are out of compliance with the standards so it is easily visible for staff and residents. <FTNT> <SU>7</SU>   <E T="03">https://www.medicare.gov/care-compare/?redirect=true&providerType=NursingHome.</E> </FTNT> We are establishing Federal minimum nurse staffing standards for a number of reasons, including the growing body of evidence demonstrating the importance of staffing to resident health and safety, continued insufficient staffing, non-compliance by a subset of facilities, the need to create a consistent floor to reduce variability in the minimum floor for nurse-to-resident ratios across States, the need to support nursing home staff, and, most importantly, to reduce the risk of residents receiving unsafe and low-quality care. The regulatory updates are based on evidence we collected using a multifaceted approach, informed by multiple sources of information, including the 2022 Nursing Home Staffing Study; more than 3,000 public comment submissions from the Fiscal Year 2023 Skilled Nursing Facility Prospective Payment System proposed rule (FY2023 SNF PPS) request for information (RFI); academic and other literature; Payroll Based Journal (PBJ) System data; detailed listening sessions with residents and their families, workers, health care providers, and advocacy groups; and analyzing the 46,520 comments received on the proposed rule. Specifically, in the final rule, we are revising § 483.35(b) to require an RN to be on site 24 hours per day and 7 days per week (24/7 RN) to provide skilled nursing care to all residents in accordance with resident care plans, with an exemption from 8 hours per day of the onsite RN requirem ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 673k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━