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

Federal RegisterSep 6, 2023

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 438, 442, and 483

[CMS-3442-P]

RIN 0938-AV25

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

AGENCY:

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

ACTION:

Proposed rule.

SUMMARY:

This proposed rule would establish 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 proposes to require 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.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, by November 6, 2023.

ADDRESSES:

In commenting, please refer to file code CMS-3442-P.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

Electronically.

You may submit electronic comments on this regulation to

http://www.regulations.gov.

Follow the “Submit a comment” instructions.

By regular mail.

You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3442-P, P.O. Box 8016, Baltimore, MD 21244-8016.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

By express or overnight mail.

You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3442-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

The Clinical Standard Group's Long Term Care Team at

HealthandSafetyInquiries@cms.hhs.gov

for information related to the minimum staffing standards.

Anne Blackfield, (410) 786-8518, for information related to Medicaid institutional payment transparency reporting.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:

http://www.regulations.gov.

Follow the search instructions on that website to view public comments. CMS will not post on

Regulations.gov

public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

To assist readers in referencing sections contained in this document, we are providing the following Table of Contents.

Table of Contents

I. Executive Summary

A. Purpose

B. Summary of Major Provisions

C. Summary of Cost and Benefits

II. Minimum Staffing Standards for Nursing Homes in Response to the Presidential Initiative

A. Background

B. Provisions of the Proposed Regulations

III. Medicaid Institutional Payment Transparency Reporting Provision

IV. Collection of Information Requirements

V. Response to Comments

VI. Regulatory Impact Analysis

I. Executive Summary

A. Purpose

This proposed rule would establish minimum staffing standards to address ongoing safety and quality concerns for the 1.4 million

residents receiving care in Medicare and Medicaid certified Long-Term Care (LTC) facilities. On February 28, 2022, President Biden announced that CMS would propose minimum staffing standards that nursing homes must meet, based in part on evidence from a new research study that will focus on the level and type of staffing needed to ensure safe and quality care.

In addition, on April 18, 2023, President Biden issued “Executive Order on Increasing Access to High-Quality Care and Supporting Caregivers”,

which directs the Secretary of HHS to consider actions to encourage LTC facilities to reduce nursing staff turnover that is associated with improving safety and quality of care.

4 5

https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-service-type-reports/cms-program-statistics-medicare-skilled-nursing-facility.

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/.

Executive Order on Increasing Access to High Quality Care and Supporting Caregivers.

White House. Accessed at

https://www.whitehouse.gov/briefing-room/presidential-actions/2023/04/18/executive-order-on-increasing-access-to-high-quality-care-and-supporting-caregivers/.

Published on April 18, 2023. Accessed on April 19, 2023.

Zheng, Q, Williams, CS, Shulman, ET, White, AJ. Association between staff turnover and nursing home quality—evidence from payroll-based journal data.

J Am Geriatr Soc.

2022; 70(9): 2508-2516. doi:10.1111/jgs.17843.

Castle, Nicholas G, and John Engberg. “Staff turnover and quality of care in nursing homes.”

Medical care

vol. 43,6 (2005): 616-26. doi:10.1097/01.mlr.0000163661.67170.b9.

These safety and quality concerns 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,

inter alia,

a review of data collected since 2016 and lessons learned during the COVID-19 Public Health Emergency (PHE). Numerous studies, including our new research study as well as existing literature, have shown that staffing levels are closely correlated with the quality of care that LTC facility residents receive, and with improved health outcomes. The minimum staffing standards would also provide staff in LTC facilities the support they need to safely care for residents, help prevent staff—burnout, thereby reducing staff turnover, which can lead to improved safety and quality for residents and staff. This proposed rule would also promote 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.

B. Summary of Major Provisions

We are proposing to update the Federal participation “Requirements for Medicare and Medicaid Long Term Care Facilities” minimum staffing standards (“LTC requirements”). The updates to

the LTC requirements proposed in this rule would be used to survey facilities for compliance and enforced as part of CMS's existing survey, certification, and enforcement process for LTC facilities. In addition, consistent with the President's strategic plan, we also intend to display our determinations of facility compliance with the minimum staffing standards on Care Compare. We welcome comments on the most appropriate approach for doing so.

We are proposing to establish 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 reduce variability in the minimum floor for nurse-to-resident ratios across States by creating a consistent floor, and, most importantly, to reduce the risk of residents receiving unsafe and low-quality care.

The proposed regulatory updates are based on evidence we collected using a multifaceted approach, which included conducting a new nursing home staffing study, gathering feedback during listening sessions, considering more than 3,000 comments received from the Fiscal Year 2023 Skilled Nursing Facility Prospective Payment System proposed rule (FY2023 SNF PPS) request for information (RFI), assessing Payroll-Based Journal (PBJ) System data on nursing home staffing, and reviewing the existing literature.

Specifically, we propose to revise § 483.35(b) to require an RN to be on site 24 hours per day and 7 days per week to provide skilled nursing care to all residents in accordance with resident care plans. We also propose individual minimum staffing type standards, based on case-mix adjusted data for RNs and NAs, to supplement the existing “Nursing Services” requirements at 42 CFR 483.35(a)(1)(i) and (ii) to specify that facilities must provide, at a minimum, 0.55 RN hours per resident day (HPRD) and 2.45 NA HPRD. We note that while the 0.55 and 2.45 HPRD standards were developed using case-mix adjusted data sources, the standards themselves will be implemented and enforced independent of a facility's case-mix. In other words, facilities must meet the 0.55 RN and 2.45 NA HPRD standards, at a minimum, regardless of the individual facility's patient case-mix. RN and NA staffing can never be lower than these proposed minimum standards, and if the acuity needs of residents in a facility require a higher level of care, a higher RN and NA staffing level will also be required. CMS is also seeking comments on whether in addition to the 0.55 RN and 2.45 NA HPRD standards, a minimum total nurse staffing standard, discussed later in the rule, should also be required. For compliance, hours per resident day (HPRD) is defined as staffing hours per resident per day which is the total number of hours worked by each type of staff divided by the total number of residents as calculated by the CMS. As further described below, the proposed minimum staffing standard is supported by literature evidence, analysis of staffing data and health outcomes, discussions with residents, staff, and industry

and other factors.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

We note that each of the minimum staffing requirements independently supports resident health and safety. Therefore, compliance with the 24/7 RN requirement does not imply compliance with the minimum 0.55 RN HPRD and 2.45 NA HPRD requirements or vice versa. Specifically, as discussed elsewhere in this rule, the presence of an RN in a LTC facility on a 24-hour basis improves overall quality of care. Similarly, but separately, a minimum number of RN and NA hours per resident per day improve overall quality of care. Both independently and collaboratively, these requirements would support compliance with statutory mandates to provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care.

As noted elsewhere, this proposal is informed by multiple sources of information, including the 2022 Nursing Home Staffing Study, more than 3,000 public comment submissions, academic and other literature, PBJ System data, and detailed listening sessions with residents and their families, workers, health care providers, and advocacy groups. We recognize that some of the materials we have relied upon offer support for a higher minimum HPRD standard. For several reasons discussed later in this proposed rule, including the importance of setting achievable staffing targets as the long-term care sector recovers from the effects of the COVID-19 pandemic and the desire to preserve resident access to care as the sector expands hiring to meet staffing standards, we are proposing a set of policies that balance the urgent need to improve resident safety and quality of care alongside these practical considerations. The policies include minimum HPRD standards for direct care by nursing staff, required access to an RN 24 hours per day 7 days per week, and enhanced facility staffing assessments.

For example, the 2022 Nursing Home Staffing Study found that a total nurse staffing level of 3.67 or 3.88 HPRD was linked with additional facilities improving quality and safety relative to current low performers, and that total nurse staffing levels between 3.8 HPRD and 4.6 HPRD (including 1.4 licensed nurse HPRD) were linked with reductions in the amount of delayed or omitted clinical care. Our proposal squares these associations between higher HPRD nurse staffing levels and better care outcomes with the goal of establishing implementable minimum standards that can substantially improve quality and safety at all LTC facilities in the near-term. We also considered variation and contradiction between different information sources, including the 2022 Nursing Home Staffing Study, namely regarding the benefits of a staffing standard inclusive of or specific to LPN/LVNs. We further considered the benefits of a requirement for 24/7 on-site RN staffing and strengthened facility staffing assessments, which under this proposed rule apply independently of the HPRD requirements.

The resulting, evidence-based proposal appropriately prioritizes quality and safety of care gains from establishing minimum standards for RNs and NAs, with a particular emphasis on the direct care delivered at the bedside by NAs, and effective implementation of these new requirements. As noted elsewhere, if finalized, these new required floors would increase staffing in more than 75 percent of nursing facilities nationwide, and the proposed NA and RN HPRD requirements exceed those of nearly all States. We remain committed to continued examination of staffing thresholds, including careful work to review quality and safety data resulting from initial implementation of finalized policies, and robust public engagement. Should subsequent data indicate that additional increases to staffing minimums would be warranted and feasible, we anticipate that we will revisit the minimum staffing standards to shift them toward the higher ranges supported by the evidence, such as those described above, with continued consideration of all relevant factors.

We also propose to revise the existing Facility Assessment requirements at § 483.70(e) by moving the provisions to a standalone section and modifying the

requirements to ensure that facilities have an efficient process for consistently assessing and documenting the necessary resources and staff that the facility requires to provide ongoing care for its population that is based on the specific needs of its residents.

We are proposing to stagger the implementation dates of these requirements sufficiently to allow facilities the time needed to prepare and be in compliance with the new requirements. Specifically, we propose that the RN on site, 24 hours per day, for 7 days a week would take effect 2 years after publication of the final rule; and we propose that the individual minimum standards of 0.55 HPRD for RNs and 2.45 HPRD for NAs would take effect 3 years after publication of the final rule. Under the proposal facilities in rural areas would be required to meet the proposed RN on site 24 hours per day, for 7 days a week, 3 years after publication of the final rule; and the proposed minimum standards of 0.55 HPRD for RNs and 2.45 HPRD for NAs would take effect 5 years after publication of the final rule.

Exemption from the proposed minimum standards of 0.55 HPRD for RNs and 2.45 HPRD for NAs would be available only in limited circumstances, where all four of the following criteria are met. The four exemption criteria are: (1) where workforce is unavailable, or the facility is at least 20 miles from another long-term care facility, as determined by CMS; (2) the facility is making a good faith effort to hire and retain staff; (3) the facility provides documentation of its financial commitment to staffing; and (4) the facility has not failed to submit PBJ data in accordance with re-designated 483.70(p), is not a Special Focus Facility (SFF); has not been cited for widespread insufficient staffing with resultant resident actual harm or a pattern of insufficient staffing with resultant resident actual harm, as determined by CMS; and has not been cited at the “immediate jeopardy” level of severity with respect to insufficient staffing within the 12 months preceding the survey during which the facility's non-compliance is identified.

If finalized, enforcement actions, also called remedies, would be taken against LTC facilities that are not in compliance with these Federal participation requirements. The remedies CMS may impose include, but are not be limited to, the termination of the provider agreement, denial of payment for all Medicare and/or Medicaid individuals by CMS, and/or civil money penalties.

We are also proposing new regulations at 42 CFR 442.43 (with a cross-reference at 42 CFR 438.82) that would require that State Medicaid agencies report on the percent of payments for Medicaid-covered services in nursing facilities and intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs) that are spent on compensation for direct care workers and support staff. This proposal is designed to inform efforts to address the link between sufficient payments being received by the institutional direct care and support staff workforce and access to and, ultimately, the quality of services received by Medicaid beneficiaries. Taken together, we believe that these proposals will improve safety and quality of care for residents in Medicare and Medicaid certified LTC facilities and Medicaid certified ICF/IIDs.

C. Summary of Cost and Benefits

Table 1—Cost and Benefits

Provision description

Total transfers/costs

Comprehensive Staffing Requirement for LTC Facilities

Without accounting for any exemptions, we estimate that the overall economic impact for the proposed minimum staffing requirements for LTC facilities (that is, collection of information costs and compliance with the 24/7 RN, facility assessment, and minimum 0.55 RN and 2.45 NA HPRD requirements), which includes staggered implementation of the requirements, would result in an estimated cost of approximately for $32 million in year 1; $246 million in year 2; $4 billion in year 3; with costs increasing to $5.7 billion by year 10. We estimate the total cost over 10 years will be $40.6 billion, which was derived from

FY 2021 Part V

of the Medicare Cost Report. LTC facilities would be expected to bear the burden of these costs, unless payors increase rates to cover cost. Quantified benefits include but are not limited to, increased community discharges, reduced hospitalizations, and emergency department visits, with a minimum estimated savings of gross costs of $318 million per year for Medicare starting in year 3. Various categories of other important but hard to quantify benefits include reduced staff burnout and turnover, and increased safety and quality of care for LTC residents. Lack of quantification is also noteworthy as regards key categories of costs.

Medicaid Institutional Payment Transparency Reporting

The overall economic impact for the proposed reporting requirement is a one time cost of $38 million and ongoing annual costs of $18 million per year.

II. Minimum Staffing Standards for Long-Term Care Facilities

A. Background

1. Statutory Authority and Regulatory Requirements for Direct Care Nurse Staffing in Long-Term-Care (LTC) Facilities

Sections 1819 and 1919 of the Social Security Act (the Act) set out regulatory requirements for Medicare and Medicaid long-term care facilities, respectively. Specific statutory language at sections 1819(d)(4)(B) and 1919(d)(4)(B) of the Act permit the Secretary of the Department of Health and Human Services (the Secretary) to establish any additional requirements relating to the health, safety, and well-being

of residents in skilled nursing facilities (SNF) and nursing facilities (NF), as the Secretary finds necessary. This provision and other statutory authorities set out in section 1819 and

1919 of the Act provide CMS with the authority to issue a regulation revising the existing requirements and to mandate a staffing minimum for nursing care. Under sections 1866 and 1902 of the Act, providers of services in Long Term Care (LTC) facilities seeking to participate in the Medicare or Medicaid program, or both, must enter into an agreement with the Secretary or the State Medicaid agency, respectively. LTC facilities seeking to be Medicare or Medicaid providers of services must be certified as meeting Federal participation requirements. These Federal participation requirements are the basis for survey activities in LTC facilities for ensuring residents' minimum health and safety requirements are met and maintained, to receive payment and remain in the Medicare or Medicaid program or both. LTC facilities include SNFs for Medicare and NFs for Medicaid. The Federal participation requirements for SNFs, NFs, or dually certified facilities, are codified in the implementing regulations at 42 CFR part 483, subpart B. In addition to those provisions, sections 1819(b)(1)(A) and 1919(b)(1)(A) of the Act require that a SNF or NF must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the safety and quality of life of each resident. Section 1819(b)(4)(C)(i) of the Act requires that a SNF must provide 24-hour licensed nursing services, sufficient to meet the nursing needs of its residents, and must use the services of a registered professional nurse at least 8 consecutive hours a day. These provisions are largely paralleled at section 1919(b)(4)(C)(i) of the Act for NFs. Sections 1819(f)(1) and 1919 (f)(1) of the Act require that the Secretary assure that requirements which govern the provision of care in skilled nursing facilities under this title, and the enforcement of such requirements, are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.

Section 1819(d)(4)(B) of the Act contains the word “well-being”, which does not appear in section 1919(d)(4)(B). We do not interpret the presence of this word as requiring separate regulatory treatment of Medicare and Medicaid long term care facilities.

In addition, sections 1819(b)(2) and 1919(b)(2) of the Act require that a SNF or NF provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care. The plan of care must describe the medical, nursing, and psychosocial needs of the resident and how the needs will be met. The plan of care is developed with the resident or resident's family or legal representative, and by a team which includes the resident's attending physician and an RN with responsibility for the resident. The plan of care should be periodically reviewed and revised by the team after required assessments. Sections 1819(b)(3) and 1919(b)(3) of the Act require that a SNF or NF conduct a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity. Assessments are required to be conducted or coordinated by a registered nurse at specified frequencies.

The participation requirements for LTC facilities (Federal requirements) are set forth at §§ 483.1 through 483.95. In general, the health and safety standards for LTC facilities address facility administration, resident rights, care planning, quality assessment, performance improvement, services provided, emergency preparedness, as well as staffing requirements. Federal requirements state that LTC facilities must use the services of a registered nurse (RN) for at least 8 consecutive hours a day, 7 days a week (§ 483.35(b)(1)), and must provide the services of “sufficient numbers” of licensed nurses and other nursing personnel, which includes but is not limited to nurse aides (NAs), 24 hours a day to provide nursing care to all residents in accordance with the resident care plans (§ 483.35(a)(1)). The LTC facility must also designate an RN to serve as the director of nursing (DON) on a full-time basis (§ 483.35(b)(2)).

While these Federal requirements do specify a specific number of hours that these licensed nurses and other nursing personnel must be available, there is no requirement that those hours be specifically dedicated to direct resident care. With respect to staffing requirements specific to individual residents, such as RN staffing levels per resident, Federal regulations currently require that facilities provide staff sufficient to “assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident”. Facilities should determine whether this is met through “resident assessments and individual plans of care and considering the number, acuity, and diagnoses or the facility's resident population” (§§ 483.35 and 483.70(e)).

2. The Need for a Minimum Nurse Staffing Requirement in LTC Facilities

On October 4, 2016, we issued a final rule titled, “Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities” (81 FR 68688). This final rule significantly revised the list of requirements that LTC facilities must meet to participate in the Medicare and Medicaid programs. Prior to the final rule, LTC facilities' requirements had not been comprehensively reviewed and updated since 1991 (56 FR 48826, September 26, 1991), despite substantial changes in service delivery in this setting. The final rule included revisions that reflect advances in the theory and practice of LTC service delivery and safety. The various revisions sought to achieve broad-based improvements in the quality of care provided in LTC facilities and in resident safety. As part of this 2016 final rule, we revised LTC facilities requirements to include competency requirements for determining the sufficiency of nursing staff, based on a facility assessment requirement that LTC facilities must conduct to determine what resources are needed to competently care for their residents during both day-to-day operations and emergencies. In the 2015 proposed rule, we included a robust discussion regarding the long-standing interest in increasing the required hours of nurse staffing per day and the various literature surrounding the issue of minimum nurse staffing standards in LTC facilities (see 80 FR 42199). In the 2016 final rule, we also included a discussion of the feedback received regarding our competency-based staffing approach (see 81 FR 68688). At the time, we highlighted the importance of establishing national staffing standards to promote safe, high- quality care for residents in LTC facilities and our desire to further explore potential options, however we noted that we needed additional evidence before pursuing potential requirements. We acknowledged that additional literature evidence along with data from sources such as Payroll Based Journal (PBJ) System would be helpful in determining if and what staffing levels should be established as minimum staffing standards to improve safety and the quality of care.

Additionally, the availability of PBJ System data is essential to adequately enforcing oversight of minimum staffing standards. Since issuing the 2016 final rule and establishing a competency-based approach to staffing in the list of LTC requirements, we have collected several years of mandated PBJ System data and new evidence from the literature.

https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Staffing-Data-Submission-PBJ.

Additionally, as a part of the FY 2023 Skilled Nursing Facility Prospective Payment System Proposed Rule Request for Information (FY 2023 SNF PPS RFI) discussed later in this proposed rule, commenters provided examples of ongoing quality and safety concerns within understaffed LTC facilities. These included, but are not limited to, residents going entire shifts without receiving toileting or days without bathing assistance, increases in falls, residents not receiving basic feeding or changing services, and even abuse in cases where no one was watching. The 2022 Nursing Home Staffing Study (also discussed later in this proposed rule) corroborated these comments and identified that basic care tasks, such as bathing, toileting, and mobility assistance, are often delayed when LTC facilities are understaffed. Interviews with various nurse staff highlighted ongoing concerns that care is often rushed, including for high-acuity residents, which can often lead to errors or safety issues.

The COVID-19 Public Health Emergency (PHE) highlighted and exacerbated the long-standing concerns with inadequate staffing in LTC facilities. However, the COVID-19 PHE also yielded evidence that appropriate staffing made a difference as a part of the overall response to the COVID-19 PHE in LTC facilities. The Centers for Disease Control and Prevention (CDC) noted that nursing home residents were at high risk for infection, serious illness, and death from the COVID-19 infection and Medicare beneficiaries were disproportionately impacted by the COVID-19 infection, with 76 percent of COVID-19 related deaths attributed to the people aged 65 years and older by the end of 2021.

One study looking at 4,254 LTC facilities across eight States found that there were fewer COVID-19 cases in LTC facilities with four or five stars for nurse staffing in the Five Star Quality Rating System than in counterpart facilities with one to three stars for staffing.

These findings suggest that LTC facilities with low nurse staffing levels may have been more susceptible to the spread of the COVID-19 infection. Findings from a recent 2020 study involving all 215 nursing homes in Connecticut revealed that a 20-minute increase in RN time spent providing direct care to residents was associated with 22 percent fewer confirmed cases of COVID-19 and 26 percent fewer COVID-19 related deaths.

These findings suggest that there is a positive relationship between the hours of direct care that RNs provide and infection transmission in LTC facilities.

March 2022 Report to the Congress: Medicare Payment Policy, MEDPAC.

Figueroa JF, Wadhera RK, Papanicolas I, et al. Association of Nursing Home Ratings on Health Inspections, Quality of Care, and Nurse Staffing With COVID-19 Cases. JAMA. 2020;324(11):1103-1105. doi:10.1001/jama.2020.14709.

https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16689.

Workforce challenges have contributed to understaffing and nurse burnout. The lack of adequate staffing impedes staff members' ability to devote adequate time and attention to each resident. One study looked at the impact of nurse burnout on organization and position turnover. Findings indicated that 54 percent of the nurses sampled suffered from moderate burnout and the impact of burnout on organizational turnover was significant.

While workforce challenges have existed for years, and have many contributing factors, interested parties have reported that the COVID-19 PHE exacerbated the problem as many long-term care facilities experienced high worker turnover. Potential factors contributing to this turnover include higher rates of worker reported-stress; an inability of some workers to return to their positions held prior to the pandemic (for instance, due to difficulty accessing child care or concerns about contracting the COVID-19 infection for people with higher risk of severe illness); high rates of mortality among long-term- care workers; and lower pay and job quality in long-term care settings relative to others, such as more competitive wage increases in retail and other industry jobs that tend to draw from the same pool of workers.

13 14 15

Although the COVID-19 PHE has officially ended, the long-term care nursing workforce has been slower to recover than the nursing workforce in other healthcare settings, although it has steadily increased over the past year and a half.

16 17

Demand for direct care workers is also expected to continue rising due to the growing needs of the aging population.

18 19

Kelly LA, Gee PM, Butler RJ. Impact of nurse burnout on organizational and position turnover. Nurs Outlook. 2021 Jan-Feb;69(1):96-102. doi: 10.1016/j.outlook.2020.06.008. Epub 2020 Oct 4. PMID: 33023759; PMCID: PMC7532952.

Campbell, S., A. Del Rio Drake, R. Espinoza, K. Scales. 2021. Caring for the future: The power and potential of America's direct care workforce. Bronx, NY: PHI. Accessed at

http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf.

Gasdaska, A., Segelman, M., Porter, K.A., Huber, B., Feng, Z., Barch, D., Squillace, M., Dey, J., & Oliveira, I. Nursing Home Staffing Disparities were Exacerbated during the COVID-19 Pandemic in 2020 (Research Brief). Washington, DC: Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. September 12, 2022. Accessed at

https://aspe.hhs.gov/sites/default/files/documents/e37945b7d88efb005839a876660a59fb/nh-staffing-disparities-brief.pdf.

Ochieng, N., Chidambaram, P., Musumeci, M. Nursing Facility Staffing Shortages During the COVID-19 Pandemic. Apr 04, 2022. Kaiser Family Foundation. Accessed at

https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staffing-shortages-during-the-covid-19-pandemic/.

Refer, for example, to a report from the Kaiser Family Foundation indicating that as of March 20, 2022, 28% of nursing facilities reported a staffing shortage, as reported in Ochieng, N., Chidambaram, P., Musumeci, M. Nursing Facility Staffing Shortages During the COVID-19 Pandemic. Apr 04, 2022. Kaiser Family Foundation. Accessed at

https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staffing-shortages-during-the-covid-19-pandemic.

https://data.bls.gov/timeseries/CES6562300001?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true.

Campbell, S., A. Del Rio Drake, R. Espinoza, K. Scales. 2021. Caring for the future: The power and potential of America's direct care workforce. Bronx, NY: PHI

http://phinational.org/wp-content/uploads/2021/01/Caring-for-the-Future-2021-PHI.pdf.

Centers for Medicare & Medicaid Services. November 2020. Long-Term Services and Supports Rebalancing Toolkit. Accessed at

https://www.medicaid.gov/medicaid/long-term-services-supports/downloads/ltss-rebalancing-toolkit.pdf.

The studies discussed in this section, corroborated by public comment submissions, input provided through listening sessions, and the 2022 Nursing Home Staffing Study, demonstrate the consequences of understaffing on resident health and safety. Yet, ongoing insufficient staffing as well as the widespread variability in existing minimum staffing standards across the United States (for example, 38 States and the District of Columbia have minimum nursing staffing standards; however, there are significant variations in their requirements) highlights the need for national minimum staffing standards for direct care in LTC facilities.

Chronic understaffing continues in LTC facilities, and evidence demonstrates the benefits of increased nurse staffing in these facilities. For example, a report by the Office of the Inspector General (OIG) highlighted that in 2018, roughly 7 percent of nursing homes failed to provide 8 hours per day of RN staffing on at least 30 total days during the year.

Some studies have demonstrated that increased staffing levels were specifically beneficial to vulnerable subpopulations in nursing homes, such as residents with dementia or Alzheimer's disease. One cross sectional study of long-stay residents with Alzheimer's disease and related dementias found that residents in

nursing homes that had higher licensed nurse staffing levels had better end-of-life care and were less likely to experience potentially avoidable hospitalizations.

Yet, the literature evidence suggests that staffing levels within facilities across the United States vary considerably, with less staffed facilities more likely to be for—profit, larger, rural, and have a higher share of Medicaid residents.

Office of Inspector General (OIG), Some Nursing Homes' Reported Staffing Levels in 2018 Raise Concerns; Consumer Transparency Could Be Increased, OEI-04-18-00451, August 2020.

https://oig.hhs.gov/oei/reports/oei-04-18-00450.asp.

Jessica Orth, Yue Li, Adam Simning, Sheryl Zimmerman, Helena Temkin-Greener, End-of-Life Care among Nursing Home Residents with Dementia Varies by Nursing Home and Market Characteristics Journal of the American Medical Directors Association, Volume 22, Issue 2, 2021, Pages 320-328.e4, ISSN 1525-8610,

https://doi.org/10.1016/j.jamda.2020.06.021.

Finally, multiple studies have shown that nursing home quality is generally lower in LTC facilities that serve high proportions of minority residents.

22 23 24

Facilities that have a higher proportion of minority residents tend to have limited clinical and financial resources, low nurse staffing levels, and a high number of care deficiency citations.

25 26

Furthermore, disparities in safety and quality care exist between LTC facilities with a high number of Medicaid residents and LTC facilities that have a high number of Medicare residents.

These disparities can contribute to differences in quality across facilities' sites.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3805666/.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4108174/.

https://onlinelibrary.wiley.com/doi/epdf/10.1111/1475-6773.12079.

https://www.jamda.com/article/S1525-8610(21)00243-7/fulltext.

https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094.

Mor, Vincent et al. “Driven to tiers: socioeconomic and racial disparities in the quality of nursing home care.” The Milbank quarterly vol. 82,2 (2004): 227-56. doi:10.1111/j.0887-378X.2004.00309.x.

https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094.

As such, we believe that national minimum staffing standards in LTC facilities and the adoption of a 24/7 RN and enhanced facility assessment requirements (as discussed later in this proposed rule), will help to advance equitable, safe, and quality care for all residents. Specifically, we propose individual minimum nurse staffing standards of 0.55 hours per resident day (HPRD) for RNs and 2.45 HPRD for NAs, that were developed using case-mix adjusted data sources. There were several considerations that helped us arrive at these proposed standards (discussed in detail later in this proposed rule). First, the evidence and findings from the 2022 Nursing Home Staffing Study demonstrated that there was a statistically significant difference in safety and quality care at 0.45 HPRD for RNs and higher including 0.55 HPRD; there was a statistically significant difference in safety and quality care at 2.45 HPRD and higher for NAs. Second, we evaluated existing State requirements and note that the proposed RN requirement of 0.55 HPRD is higher than every State and only lower than the District of Columbia (DC) based on September 2022 data. Third, we aimed to strike an appropriate balance between cost and benefit that would yield the strongest improvements in quality and safety for residents. We are not proposing minimum staffing standards based on HPRD for licensed nurses, that is, RNs plus LPN/LVNs, nor for total nurse staffing, that is, RNs, LPN/LVNs, and NAs because of evidence in the literature described below.

This proposed policy is based on statistical evidence from clinical settings which suggests that more positive clinical outcomes are associated with increasing the number of RNs and NAs. We are not setting a minimum staffing standard for LPN/LVNs. In addition, as noted in the next section, it has been reported in the literature that LPN/LVNs may find themselves practicing outside their scope of practice when there is not sufficient RN staffing in a facility to provide supervision. This is concerning because LPN/LVNs require an RN or a physician's supervision to practice. Furthermore, total licensed nurse staffing standards may ensure adequate levels of licensed nurse staffing and allow nursing homes the flexibility to substitute nurse type for example LPN/LVNs for RNs, or NAs for LPN/LVNs, but may result in compromising the safety and quality of care. Multiple studies have found no evidence of a consistent relationship of quality and safety with LPN staffing.

First, literature evidence suggests that there is a negative correlation between LPN and RN staffing, indicating that nursing homes with higher LPN staffing levels tend to have lower RN staffing levels.

Second, the 2022 Nursing Home Staffing Study did not demonstrate an association between LPN/LVNs' HPRD, at any level, and safe and quality care.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

Many studies indicate that consistent, adequate nurse staffing is correlated with resident health and safety, but we seek additional information to make fully informed policy decisions. We welcome input from interested parties on the considerations and proposals discussed in this rule, and other comments that may be relevant. We encourage commenters to submit evidence and data to support any recommendations to the extent possible. We continue to seek additional information that supports our efforts for improving the safety and quality of care for residents within LTC facilities, including feedback on how to improve care transitions and discharge planning, such as information about and assistance with programs that assist with community placements.

We are soliciting comments and recommendations in this area and have also included specific information requests that are embedded throughout this rule regarding certain proposals. We seek this information in anticipation that additional comments and recommendations will assist us in ensuring that we finalize appropriate minimum staffing standards to ensure the health and safety of residents and provide staff the support they need to care for residents while also considering the limited resources including the local supply of RNs and NAs, that may exist as the long-term care sector recovers from the COVID-19 PHE and an increased demand due to a growing older population.

3. CMS Actions and Key Considerations To Inform Mandatory Minimum Staffing Standards

In February 2022, President Biden announced a comprehensive set of reforms aimed at improving the safety and quality of care within the nation's nursing homes. One key initiative within the Biden-Harris Administration's strategy is to establish a minimum nursing home staffing requirement for LTC facilities participating in Medicare and Medicaid.

Establishing minimum staffing standards improves the likelihood that all nursing home residents are provided safe, high-quality

care, and that workers have the support they need to provide high-quality care.

To help inform our efforts in establishing consistent and broadly applicable national minimum staffing standards, we launched a multi-faceted approach aimed at determining the minimum level and type of staffing needed to enable safe and quality care in LTC facilities. This effort included issuing the FY2023 SNF PPS RFI,

hosting listening sessions with various interested parties, and conducting a 2022 Nursing Home Staffing Study, which builds on existing evidence and several research studies using multiple data sources. In addition to launching our multi-faceted approach, we considered how any potential minimum staffing standards affect other CMS programs and/or initiatives as well as the enforceability of such standards. Our strategic approach and considerations are discussed later in this section.

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2023; Request for Information on Revising the Requirements for Long-Term Care Facilities To Establish Mandatory Minimum Staffing Levels. A Proposed Rule by the Centers for Medicare & Medicaid Services on 04/15/2022

https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities.

a. Request for Information in the FY 2023 Skilled Nursing Facility Prospective Payment System Proposed Rule (FY 2023 SNF PPS RFI)

We published the FY 2023 SNF PPS RFI in April 2022, soliciting public comments on minimum staffing standards. In response to the FY 2023 SNF PPS RFI, we received over 3,000 comments from a variety of parties interested in addressing LTC facilities' issues including advocacy groups, long-term care ombudsmen, industry associations (providers), labor unions and organizations, nursing home residents, staff and administrators, industry experts, researchers, family members, and caregivers of residents in LTC facilities.

Notably, industry associations and resident advocates expressed divergent views on the establishment of minimum staffing standards. Resident advocacy groups and family members of residents were strongly supportive of establishing minimum staffing standards, while industry and provider groups expressed significant concern and opposition to such standards.

Commenters supporting the establishment of minimum staffing standards voiced safety concerns regarding residents not receiving adequate care due to chronic understaffing in facilities. For example, residents going entire shifts without receiving toileting assistance, which can lead to an increase in falls or the development or worsening of pressure ulcers. Commenters noted that NAs barely have time to get each resident dressed, fed, and bathed; that residents lie for hours in wet and soiled diapers; that residents who need help to eat struggle to feed themselves; and that residents suffer abuse from staff and other residents because no one is watching. Commenters also shared stories of residents wearing the same outfit for a week without a change of clothing or a shower. Commenters highlighted the contribution of facility staff and attributed the lack of quality care to insufficient staffing levels.

Commenters also offered recommendations for implementing minimum staffing standards including staffing with a RN on every shift. Some commenters suggested that CMS focus on implementing an acuity (that is, the medical complexity and needs of a resident) staffing model per shift as part of any minimum staffing standards. Others recommended that minimum staffing standards be established for residents with the lowest care needs, assessed using the Minimum Data Set (MDS) 3.0 assessment forms, citing concerns that acuity-based minimum standards will be more susceptible to gaming around composition of the patient population (that is, avoiding taking on residents with more complex medical needs).

Concerns raised by the local ombudsmen in the 2020 OIG Report on staffing levels echoed those raised by commenters. Some of the concerns identified in the OIG Report as a result of understaffing include residents' call lights going unanswered, medication errors, untreated wounds, and inadequate bathing, including residents going a week without a shower. The ombudsmen also focused on problems related to weekend staffing below required levels, resulting in resident falls and altercations between residents; the ombudsmen attributed such outcomes to facilities' inadequate leadership, as well as insufficient numbers of NAs.

This information supports what was shared with us during the listening sessions as well as during the public comment period on the FY 2023 SNF PPS RFI.

Office of Inspector General Data Brief (August, 2020) Some Nursing Homes' Reported Staffing Levels in 2018 Raise Concerns; Consumer Transparency Could Be Increased. OEI-04-18-00450.

https://oig.hhs.gov/oei/reports/OEI-04-18-00450.pdf.

Commenters also provided information on several resident and facility factors for consideration when assessing a facility's ability to meet any mandated staffing standards, including whether the facility has a high Medicaid census, high bed count, for-profit ownership, high SNF competition within the same county, high community poverty rates, low Medicare census, and for staffing, availability of RNs specifically. Other commenters stated that resident acuity should be a primary determinant in establishing minimum staffing standards, noting that CMS pays nursing homes based on resident acuity level.

We also received comments on factors impacting facilities' ability to recruit and retain staff, with most commenters in support of creating avenues for competitive wages for nursing home staff to address issues of recruitment and retention. Other commenters, however, suggested that year-over-year reductions in skilled nursing facility payments complicate facilities' ability to increase staff wages and benefits.

Finally, we received differing comments on the study design, payment, and cost impacts of establishing minimum staffing standards. Some commenters indicated that there is variability in Medicaid labor reimbursement amounts and many States' Medicaid rates do not keep up with rising labor costs. Others, however, noted that most facilities have adequate resources to increase their staffing levels without additional Medicaid resources, and cited a recent study that suggests that most major publicly traded nursing home companies were highly profitable, even during the COVID-19 PHE. Commenters provided robust feedback on the study design and method for implementing nurse staffing standards, while others noted that resident acuity could change on a daily basis and recommended that CMS establish benchmarks rather than absolute values in staffing standards. Other commenters recommended using both minimum nurse HPRD and nurse to resident ratios.

Additionally, we note that several members of Congress have provided input regarding the establishment of minimum staffing standards. While some Members of Congress have expressed concern that requiring minimum staffing standards could create access issues for rural communities, other Members of Congress have expressed support for establishing minimum staffing

standards for LTC facilities.

We appreciate the thoughtful feedback from commenters and have considered the varying feedback that we received to inform the staffing study design and proposal for minimum staffing standards discussed in this rule.

Sen Tester, Nursing Home Staffing Mandate, 2023;

https://www.tester.senate.gov/wp-content/uploads/1-20-23-Nursing-Home-Staffing-Mandate-Letter-FINAL.pdf

; Sen Casey, Wyden, et al, Nursing Home Staffing Mandate, 2023;

https://www.aging.senate.gov/imo/media/doc/letter_to_cms_re_regulations_to_establish_minimum_staffing_levels_in_nursing_homes.pdf;

Doggett, Schakowsky Lead Effort Pressing for Strong Nursing Home Staffing Standards | Congressman Lloyd Doggett (house.gov),

https://doggett.house.gov/media/press-releases/doggett-schakowsky-lead-effort-pressing-strong-nursing-home-staffing-standards.

b. The 2022 Nursing Home Staffing Study

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

The CMS commissioned a nursing home staffing study in 2001, entitled “Appropriateness of Minimum Nurse Staffing Ratios in Nursing Homes”,

commonly referred to as the 2001 CMS Staffing Study, that focused on two empirical analyses related to the link between staffing and quality: (1) whether there is a nurse staffing ratio above which no additional improvements in quality are observed, and (2) what nurse staffing thresholds are minimally necessary to provide care processes consistent with the Omnibus Budget Reconciliation Act (OBRA) of 1987 optimal standards and related regulations.

Appropriateness of Minimum Nurse Staffing Ratios in Nursing Homes (2001)

https://www.justice.gov/sites/default/files/elderjustice/legacy/2015/07/12/Appropriateness_of_Minimum_Nurse_Staffing_Ratios_in_Nursing_Homes.pdf.

The study findings identified nursing home staffing thresholds beyond which additional staff did not lead to significant further improvements in care. These staffing levels, expressed in HPRD, varied by outcomes—short-stay or -long-stay- quality measures, by nurse staff type, and by level of nurse staffing. Depending on the nature of the nursing home population (case-mix), these thresholds ranged between: 0.55 to 0.75 HPRD for RNs; 1.15 to 1.30 HPRD for licensed nurses (RNs and LPN/LVNs); and 2.4 to 2.8 HPRD for NAs. The 2001 study also reported that “

[m]inimum

staffing levels

at any level up

these thresholds are associated with incremental quality

improvements,

with the greatest benefits as these thresholds are approached.

” In other words, 4.1 HPRD was the highest HPRD of combined NAs and licensed staff (RNs/LPN/LVN) for long-stay measures beyond which no further improvement in safety and quality was observed. The 4.1 HPRD drawn from the 2001 Study is commonly misinterpreted as the minimum total nurse staffing that is needed to protect resident health and safety.

The CMS also commissioned a simulation analysis (“time motion study”) on NA time expended for providing five key care processes,

in addition to routine care, to determine an HPRD level for NAs to provide optimal nursing care. The study findings suggest that the NA HPRD level ranged between 2.8 (low workload facility) and 3.2 HPRD (high workload facility) for NAs only, depending on the NA workload requirements which was based on the nursing home resident population.

Five care processes were the following: (1) dressing/grooming; (2) exercise; (3) feeding assistance; (4) changing and repositioning; and (5) providing toileting assistance.

Given the growing body of evidence demonstrating the importance of staffing to resident health and safety, the continued insufficient staffing, and variability in nurse-to-resident ratios across States, creating a consistent floor will reduce the risk of residents receiving unsafe and low-quality care. In 2022, given the age of the 2001 study and the persistent chronic nurse understaffing linked to poor safety and quality care, which was exacerbated by the COVID-19 PHE, we commissioned a new nursing home study that focused on a non-empirical analysis and four empirical analyses to develop minimum staffing standards using case-mix adjusted data sources, as well as staffing types and levels for improving safety and quality care in nursing homes.

These non-empirical and empirical analyses, also known as study tasks, included a systematic literature review, qualitative analysis of data collected using interviews and surveys conducted during scheduled site visits, an observation study (“similar to the time motion study”) followed by simulation modeling analysis for licensed nurses (RNs and LPN/LVNs), quantitative analyses which included descriptive and impact analyses, and cost analyses. The key takeaways from the multifaceted approach are:

• Recent literature as well as testimonials from nursing home staff, residents, and family members underscore the relationship between staffing and care quality; however, there is no clear, consistent, and universal methodology for setting specific minimum staffing standards, as evidenced by the varying current standards across certain States.

• Nurse staffing levels vary considerably nationwide by LTC facilities' characteristics, such as location, size, and profit status and States. Thirty-eight States and the District of Columbia have minimum staffing standards, which vary considerably. We note that the proposed RN requirement of 0.55 HPRD is higher than every State, and only lower than the District of Columbia (DC) based on data from September 2022. Our proposed NA requirement of 2.45 HPRD is higher than all States and DC, based on data reported in September 2022.

36 39

To reiterate, LTC facilities would be required to meet both the proposed 0.55 HPRD for RNs and the 2.45 HPRD for NAs.

Payment and Access Commission (MACPAC). (2022a). Medicaid and CHIP Payment and Access Commission (MACPAC). (2022a). Compendium: State policies related to nursing facility staffing.

https://www.macpac.gov/publication/statepolicies-related-tonursing-facility-staffing/.

Consumer Voice (The National Consumer Voice for Quality Long-Term Care) (2021). State nursing home staffing standards: Summary report

https://theconsumervoice.org/issues/otherissues-andresources/staffing.

• The relationship between staffing and quality of care and safety, varies by staff type and level as follows:

++ RN hours per resident day of 0.45 or more have a strong association with safety and quality care.

++ NA hours per resident day of 2.45 or more also have a strong association with safety and quality care.

++ LPN/LVN hours per resident day, at any level, do not have any association with safety and quality of care.

40 41 42

Akinci, Fevzi, and Diane Krolikowski. “Nurse staffing levels and quality of care in Northeastern Pennsylvania nursing homes.” Applied nursing research: ANR vol. 18,3 (2005): 130-7. doi:10.1016/j.apnr.2004.08.004.

Yang, Bo Kyum et al. “Nurse Staffing and Skill Mix Patterns in Relation to Resident Care Outcomes in US Nursing Homes.”

Journal of the American Medical Directors Association

vol. 22,5 (2021): 1081-1087.e1. doi:10.1016/j.jamda.2020.09.009.

Spilsbury, Karen et al. “The relationship between Nurse staffing and quality of care in nursing homes: a systematic review.”

International journal of

nursing

studies

vol. 48,6 (2011): 732-50. doi:10.1016/j.ijnurstu.2011.02.014.

• Increasing nursing staffing level is associated with costs, namely financial costs to LTC facilities, as well as benefits, including enhanced safety and quality to varying degrees.

In brief, the 2022 Nursing Home Staffing Study was conducted as a general framework to survey different sources of information and to conduct different types of analyses to help inform the minimum staffing decision process, while considering the potential

cost and benefit. The study

was unable to examine the relationship between staffing levels by shift and quality/patient safety because the PBJ System does not include information on staffing by shift. In addition, there was limited information on non-nurse staffing, so the study team was unable to examine minimum staffing standards for non-nurse staff.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

Unlike the 2001 CMS Staffing Study, the 2022 Nursing Home Staffing Study was guided by a conceptual model (see Figure 1), that hypothesizes that administrative practices (for example, nurse staffing levels, staffing mix, care delivery model, and organizational environment) influence the quality and safety of care provided in a nursing home, which, in turn, influences nursing home residents' outcomes (that is, clinical, safety, and disparity). Clinical outcomes were defined using Care Compare quality measures derived from the MDS and Medicare claims data. Patient safety was defined using measures from health inspection surveys.

EP06SE23.000

(1) Systematic Literature Review

The overall goal of the systematic literature review was to summarize timely and current evidence of the relationship between minimum staffing standards in nursing homes and the safety and quality of care, as well as clarify the relative strengths and weaknesses of the available literature. In addition, the systematic literature review of existing peer-reviewed and “gray literature” (that is, published outside the traditional research publications such as opinion pieces, advocacy materials, and non-statistically rigorous research published by government agencies) which includes printed articles, for the initial period 2019-2022, and prior to 2019 if needed, focused on addressing the following questions:

• What is the relationship between nurse staffing levels and safety and quality of care? What minimum staffing levels associated with safety and quality of care have been identified in previous studies, and what is the empirical basis for them?

• What are the current State and Federal standards for staffing level/types and outcomes in nursing homes for weekdays, weekends, and evenings?

• What is the role of different nurse types (that is, RNs/LPN/LVNs/NAs) in ensuring safety and quality of nursing home care?

• What are the costs associated with nurse staffing in nursing homes? What are the costs associated with implementing minimum nurse staffing standards and increasing nurse staffing levels/types?

Most importantly, an increase in nurse staffing was associated with improved quality of care. In a 2021 study, where interview data were examined, and multivariate analyses of resident outcomes were conducted, authors concluded that higher total nurse staffing had a significant correlation with a decreased number of pressure ulcers, an increase in influenza vaccination, an increase in pneumonia vaccination, and decreased number of

outpatient emergency department visits.

Wagner, L.M., Katz, P., Karuza, J., Kwong, C., Sharp, L., & Spetz, J. (2021). Medical staffing organization and quality of care outcomes in post- acute care settings. Gerontologist, 61(4),605-614.

However, the OBRA of 1987,

which amended sections 1819 and 1919 of the Act to mandate staffing standards in nursing homes, did not mandate specific numerical minimum nurse staffing standards. As such several States mandated variable staffing standards to help meet the standards in sections 1819 and 1919 of the Act.

chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/ https://static1.squarespace.com/static/602ac1a3ede5cc16ae72d619/t/6043c094b391303a2d1c1418/1615052948879/OBRA87summary.pdf.

As stated in the 2022 Nursing Home Staffing Study report,

which will be published concurrently with this proposed rule, studies found that States that established higher nurse staffing standards resulted in increased staffing within nursing homes, but the magnitude of this increase varied by the staff type. For example, authors found that when the States of California and Ohio required increased licensed nurse or total nurse staffing standards, this resulted in some actual increase in staffing levels. California required facilities to increase the hours for direct resident care per day from 3.0 to 3.2 and prohibited the previous practice of allowing RN or LPN hours to be counted twice, also known as “doubling”. The rationale for doubling was to increase the number of licensed staff. Ohio law required facilities to increase total nurse staffing (RN, LPN/LVN, and NA) direct care hours from 1.6 to 2.75. Results showed that for both California and Ohio, nursing homes that ranked in the bottom quartile at baseline on total nurse staffing significantly increased their HPRDs for all three types of nursing staff (RN, LPN/LVN, and NA). However, there was a reduction in professional skill mix, meaning there were fewer RNs relative to other direct care staff, 71 percent of the increase in nursing staff represented an increase in NA hours.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

Chen, Min M, and David C Grabowski. “Intended and unintended consequences of minimum staffing standards for nursing homes.”

Health economics

vol. 24,7 (2015): 822-39. doi:10.1002/hec.3063.

Another study, when controlling for changes in State minimum direct care staffing standards during the study period, in Arkansas, Delaware, Florida, and Ohio, found that nursing homes serving a higher share of Medicaid patients reported large increases in staffing, specifically RNs, in response to a one HPRD increase in total nurse staffing from a baseline of 2.0 HPRD requirement for total nurse staffing.

In sum, studies found that nursing homes in States with higher minimum staffing standards employed more staff.

Bowblis, John R. “Staffing ratios and quality: an analysis of minimum direct care staffing requirements for nursing homes.”

Health services research

vol. 46,5 (2011): 1495-516. doi:10.1111/j.1475-6773.2011.01274.x.

Most LTC facilities typically have nurse teams providing care to residents with very few RNs (8 percent) making up the team, compared to other nurse team members, (that is, administrative RNs, LPN/LVNs and unlicensed assisting staff)

49 50

which suggests that LPN/LVNs provide most of the clinical care with minimal supervision from RNs.

Other study findings suggest that some Directors of nursing (DONs) view the roles of RNs and LPN/LVNs interchangeably despite the difference in educational preparation and scope of practice. Yet, study findings suggest that having more RNs in LTC facilities to provide clinical skills and supervision of LPNs positively influences LPNs contributions to improved quality care.

In summary, the presence of more RNs on a team influences the quality of care provided.

American Health Care Association (2012) LTC stats: Nursing facility operational characteristics report. Retrieved from

http://www.ahcancal.org/research_data/oscar_data/Nursing%20Faciliry%20Operational%Characteristics/LTC+STATS_PVNFOPERATIONS_2012Q4_FINAL.pdf.

Siegel, Elena O et al. “Leadership in Nursing Homes: Directors of Nursing Aligning Practice With Regulations.” Journal of gerontological nursing vol. 44,6 (2018): 10-14. doi:10.3928/00989134-20180322-03.

Corazzini, Kirsten N et al. “Licensed practical nurse scope of practice and quality of nursing home care.” Nursing research vol. 62,5 (2013): 315-24. doi:10.1097/NNR.0b013e31829eba00.

Based on gray literature, a coalition of resident nursing home advocates and the National Academies of Sciences, Engineering, and Medicine recommended RN coverage, with at least one RN, for 24 hours a day, 7 days a week, with additional RN coverage if needed, as part of the minimum staffing standards.

53 54

California Advocates for Nursing Home Reform, Center for Medicare Advocacy, Justice in Aging, Long Term Care Community Coalition, Michigan Elder Justice Initiative, and The National Consumer Voice for Quality Long-Term Care. (2021). Framework. for nursing home reform post COVID-19.

https://theconsumervoice.org/uploads/files/actionsand-newsupdates/Framework_and_overview_FINAL.pdf.

National Academies of Sciences, Engineering, and Medicine.(2022).The national imperative to improve nursing home quality: Honoring our commitment to residents, families, and staff. The National Academies Press.

https://doi.org/10.17226/26526.

Several costs for increasing nurse staffing were cited in the literature, we note that these costs differ from our estimated costs as set out in this proposed rule. For example, in one study, by trade groups representing the industry, 4.1 HPRD for total nurse staffing (that is, RNs, LPN/LVNs and NAs) was found to cost the long-term care industry more than $10 billion annually.

Another study estimated that the additional staffing costs to meet the 4.1 HPRD for total nurse staffing as $7.25 billion.

In summary, several studies found that higher levels of nurse staffing, including RNs, were associated with improved resident care outcomes and increased costs.

CLA (CliftonLarsonAllen, LLC). (2022). Staffing mandate analysis. In-depth analysis on minimum nurse staffing levels and local impact. American Health Care Association and the National Center for Assisted Living (AHCA/NCAL).

https://www.ahcancal.org/News-and-Communications/Fact-Sheets/FactSheets/CLA-Staffing-Mandate-Analysis.pdf.

Hawk, T., White, E.M., Bishnoi, C., Schwartz, L.B., Baier, R.R., & Gifford, D. R. (2022). Facility characteristics and costs associated with meeting proposed minimum staffing levels in skilled nursing facilities. Journal of the American Geriatrics Society, 70(4), 1198-1207.

https://doi.org/10.1111/jgs.17678.

(2) Qualitative Analysis

Thirty-one nursing homes were selected for scheduled site visits in 14 States, specifically California, Colorado, Florida, Illinois, Massachusetts, Maryland, Missouri, North Carolina, New York, Ohio, Pennsylvania, Virginia, Washington, and Wyoming. These site visits started in September 2022, and ended in December 2022. nursing homes were selected to ensure a national representation by size, ownership type, geographic location, Medicaid population, and overall rating under the

Five-Star Quality

Rating System. Nursing homes voluntarily participated in these site visits and no incentives were offered. Site visit protocols and interview guides were reviewed and approved by Abt Associates Inc. Institutional Review Board.

Site visits were conducted under the Nursing Home Reform Law in the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) (Pub. L. 100-203), which is exempt from the Paperwork Reduction Act (PRA).

https://abtimpact.com/mission-impact-2020/ethics-and-governance/.

During site visits, interviews (n=361) were conducted with 76 nursing home leadership, 195 direct care staff

(including RNs, LPN/LVNs, and NAs), 65 residents, and 25 family members to better understand the relationship between staffing levels, staffing mix (what types of staff are present), and resident outcomes and experiences (that is, clinical outcomes, safety, health disparities). Staff completed 168 Missed Nursing Care

(MISSCARE)

surveys to determine any omitted or delayed care.

Kalish, B.J., & Williams, R.A. (2009). Development and psychometric testing of a tool to measure missed nursing care. The Journal of Nursing Administration, 39(5), 211-219.

https://doi.org/10.1097/nna.0b013e3181a23cf5.

Findings from data analyses of surveys and interviews highlighted that activities of daily living care tasks, including bathing, toileting, and mobility assistance, are the most frequently delayed tasks when shifts/units are short staffed. Family members also reported that quality of life, quality of care, and resident safety are adversely affected when nursing homes are short staffed. Some staff stated that rushing through care due to having high-acuity residents, meaning that their condition is severe and imminently dangerous, or a high number of assigned residents led to medication errors and safety issues. For example, one nurse stated that being assigned 33 patients without any other staff is not safe. Respondents also noted that different staffing requirements for NAs and licensed nurses, among other factors, should be considered when developing minimum staffing standards. Nursing home staff respondents also suggested minimum staff-to-resident ratios. NA respondents proposed a ratio of 5 to 14 residents per NA, whereas RNs and LPN/LVNs suggested ratios from 8 to 25 residents per licensed nurse (RN and LPN/LVNs). Respondents worked across a variety of shifts, units, and resident types (for example, skilled nursing/rehabilitation, long-term care, total care, dementia care, and behavioral issues), so the acuity of residents they typically supported varied as did the ratios they proposed.

(3) Observation Study/Simulation Modeling

Twenty LTC facilities were selected based on a convenience sampling method for the observation study. Time data of 8,249 unique care tasks were collected via direct observations of licensed nursing staff (that is, RN and LPN/LVNs) providing common clinical tasks including medication pass, resident assessment, wound care, and catheter/device care. Previous simulation modeling research focused on NAs providing non-clinical tasks specifically, activities of daily living (ADL) tasks,

but not on clinical tasks. Thus, this simulation study was aimed at addressing this gap in knowledge and focused exclusively on specific clinical tasks provided by licensed nurses.

Schnelle, J.F., Schroyer, L.D., Saraf, A.A., & Simmons, S.F. (2016). Determining nurse aide staffing requirements to provide care based on resident workload: A discrete event simulation model.

Journal of the American Medical Directors Association, 17

(11), 970-977.

https://doi.org/10.1016/j.jamda.2016.08.006.

These data were used to develop a simulation model to examine the impact of different levels of licensed nurses and resident acuity, on the quality and timeliness of providing certain care tasks defined as delayed and omitted care respectively. This simulation model is important to add to existing literature on delayed care and help the staffing study reflect not just what staffing levels exist currently as a descriptive model, but also what staffing levels are needed for safe, quality care for residents at varying acuity levels for the studied clinical tasks.

As stated in the 2022 Nursing Home Staffing Study report,

which will be published concurrently with this proposed rule, simulation findings suggest that a staffing level of four licensed nurses (that is, a combination of RNs and LPN/LVNs) in this setting, would reduce the amount of delayed or omitted care for the clinical tasks studied to a rate below 5 percent in a 70-resident nursing home. Five licensed nurses would virtually eliminate delayed or omitted care in this setting. The 4 to 5 licensed nurses correspond to approximately 1.4 to 1.7 HPRD at such a nursing home. However, the study has several limitations. One is that these study observations did not differentiate between RN and LPN/LVN tasks, so we are unable to separate estimates of potential delayed or omitted care for an RN versus an LPN. Most importantly, simulation studies did not incorporate any patient-level data or facility-level data from site observations. Instead, simulations estimated patient acuity using MDS data. Therefore, patient acuity in simulations were based on population-level estimates, rather than estimates at the nursing-home level or the individual patient level.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

Because the simulation did not use actual patient- or facility-level data, facilities specializing in treatment of high or low acuity residents were not properly represented in the staffing simulation models. For example, different staffing needs may arise in facilities specializing in care for persons experiencing disabilities resulting in paraplegia/quadriplegia, or in facilities specializing in persons experiencing advanced cognitive impairment. Analysis of specialized care facilities was outside of the scope of this simulation research. Furthermore, other existing simulation research focused on NAs only, so NAs were considered as part of the evidence base for this work but were not included in the analysis.

(4) Quantitative Analysis

Secondary Analysis:

The quantitative analysis used secondary data of nursing homes (n = 14,529) from the CMS' PBJ System, the MDS 3.0, Medicare cost reports, and health inspection surveys to establish minimum staffing standards for different types of nurse staff (that is, total nurse staffing and individual RNs, LVN/LPNs, and NAs) and for non-nurse staff (that is, social workers, feeding assistant, other activities staff, and physical therapy assistant among others) that is associated with an acceptable quality of care and safety in nursing homes. Quality was defined based on a total composite quality measure made up of

Short-Stay Measures

(that is, community discharge, hospital readmissions, emergency department visits, Functional improvement) and

Long-Stay Measures

(that is, activities of daily living decline, antipsychotic medication use, mobility decline, high-risk pressure ulcer, hospitalizations, and emergency department visits).

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

Safety was measured based on the relative on-site health inspection performance of nursing homes within a State using surveys for the following deficiencies: Immediate jeopardy to resident health or safety; Actual harm that is not immediate jeopardy; No actual harm with potential for more than minimal harm that is not immediate jeopardy; and, No actual harm with potential for minimal harm.

Similar to other CMS nursing home improvement quality initiatives such as Value Based Payment for nursing homes, acceptable quality and safety was defined using the 25th and 50th percentile cut-offs on the current distribution of the total quality measure (QM) score and within-State performance on health inspection survey data, based on the predicted probability of nursing homes exceeding the threshold across the full distribution of nurse staffing levels. Moreover, some

nursing homes are staffed at levels that place their residents at substantially higher risk of poor quality (for example, being in the lowest quartile of QM score, defined as the 25th percentile cut off) and low safety (for example, lowest quartile of performance on health inspection survey, defined as the 25th percentile cut off). The PBJ System data for the fourth quarter of 2019 through the first quarter of 2022, for 14,688 Medicare and/or Medicaid certified nursing homes in the United States were included in the analyses.

Descriptive analyses examined HPRD for nurse and non-nurse staff in nursing homes (n=14,529) across all States. Regression modeling analyses controlled for case-mix adjusted data for nurse staffing (that is, RN, LPN/LVN, and NA), LTC facility ownership (for example, non-profit, Government), percent of Medicaid residents, hospital-based facility, Continuing Care Retirement Community (CCRC) facility, rural location, number of certified beds (per 1-bed increase), and Special Focus Facility status. Using a correlational descriptive analysis, findings indicate that there is a consistent positive relationship between higher RN staffing and better performance, regardless of the measure (that is, total quality measure score or within-State health inspection score), the performance standard (that is, acceptable quality and safety at the 25th, or 50th percentile), or the case-mix adjusted RN staffing decile measured in HPRD.

Among all nurse staffing types, RNs exhibit the strongest association with acceptable quality (p<.0001, significant at α = 0.05) and safety (pHowever, similar to previous analyses,

62 63 64

this study found no relationship between LPN/LVNs HPRD levels and quality care and safety. This finding may be influenced by the LPN/LVN's role

and the fact that nursing homes with higher LPN/LVN staffing levels tend to have lower RN staffing levels.

The volume and number of HPRD reported in PBJ System for non-nurse staff were very low, ranging from 0.00-0.11; as such were insufficient to examine further for establishing minimum non-nurse staffing standards.

Yang, Bo Kyum et al. “Nurse Staffing and Skill Mix Patterns in Relation to Resident Care Outcomes in US Nursing Homes.”

Journal of the American Medical Directors Association

vol. 22,5 (2021): 1081-1087.e1. doi:10.1016/j.jamda.2020.09.009.

Spilsbury, Karen et al. “The relationship between Nurse staffing and quality of care in nursing homes: a systematic review.”

International journal of

nursing

studies

vol. 48,6 (2011): 732-50. doi:10.1016/j.ijnurstu.2011.02.014.

Firnhaber, G.C., Roberson, D.W., & Kolasa, K.M. (2020). Nursing staff participation in end-of-life nutrition and hydration decision-making in a nursing home: A qualitative study. Journal of Advanced Nursing, 76(11), 305-3068.

https://doi.org/10.1111/jan.14491.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

We considered findings from the 2022 Nursing Home Staffing Study, specifically that there was no statistically significant difference in safety and quality care below 2.45 HPRDs for NAs. In other words, staffing below 2.45 HPRD for NAs did not improve safety and quality care for LTC facility residents. Also, our proposed NA requirement of 2.45 HPRD which was developed using case-mix adjusted data sources, is higher than the minimum requirements in all States and DC, based on data reported in September 2022.

We also considered findings from the 2022 Nursing Home Staffing Study that there was no correlation between safety and quality care, and LVN/LPNs. We examined findings from the 2022 Nursing Home Staffing Study, that there was a statistically significant difference in safety and quality care at 0.45 HPRD for RNs and higher. We also factored the minimum RN requirements in all States and the District of Columbia, which with the exception of two States, all had less than the 0.45 HPRD for RNs, which was the lowest level presented in the 2022 Nursing Home Staffing Study. However, current State minimum RN staffing levels are associated with increased risk for unsafe and poor quality care. Therefore, we are proposing the level of 0.55 HPRD for RNs, which was developed based on case-mix adjusted data sources and the 2022 Nursing Home Staffing Study findings. In addition, 0.55 HPRD for RNs will result in a large majority (78 percent) of LTC facilities increasing staffing to provide safe and quality care. CMS is also seeking comments on whether in addition to the 0.55 RN and 2.45 NA HPRD standards, a minimum total nurse staffing standard, such as 3.48 among other alternatives, discussed later in the rule, should also be required.

Furthermore, we considered striking a balance between cost and benefit for LTC facilities, nursing staff, and residents, and the minimum number of HPRDs by staff type that will improve safety and quality care. Therefore, we proposed 0.55 and 2.45 HPRD for RNs and NAs, respectively, which were developed using case-mix adjusted data sources, because we believe that proposing lower staffing levels than current State requirements would be insufficient to meet the statutory goals of improving health and safety.

Impact Analysis:

The impact of State minimum staffing policies on nurse staffing, and safety and quality care in nursing homes during the recent COVID-19 PHE, can inform policy makers on potential outcomes to Federal minimum staffing standards. The study also provided analyses of the recently revised Massachusetts minimum staffing standards, in the wake of the COVID-19 PHE, making the findings the most timely and relevant of various State-level analyses. The researchers determined that the analysis of the Massachusetts staffing standard would be particularly informative given that the State increased its HPRD to a relatively high level and incorporated a Medicaid payment reduction of 2 percent for noncompliant facilities. As such a quasi-experimental study was conducted to determine the impact of the Massachusetts minimum staffing standards on quality of care and safety in nursing homes.

The Massachusetts nursing home minimum staffing standards requires 3.58 HPRD for total nurse staffing (that is, RN, LPN, and NA), of which 0.508 HPRD was for an RN, and provided for a financial penalty for noncompliance with the total nurse staffing standard. The study period was defined as 2015 Q3 through 2022 Q2. The Massachusetts nursing home minimum staffing policy was effective January 1, 2021. Impact analysis of existing nursing homes (n=40) data from the PBJ System data (2015Q3-2022Q2) and Care Compare (quality measure and health inspection survey data) were used. The comparison group selected from the sample of national nursing homes (n=1,617) was constructed using a synthetic control approach. Synthetic control is a statistical method for creating a comparison group of nursing homes from a region that did not experience the same health policy intervention, but closely resembles the nursing home staffing level and trend in Massachusetts using weighted estimates. Difference-in-differences regression analyses were conducted by stratified nursing home Medicaid share and staffing level. Difference-in-differences regression is a statistical method for estimating the causal effect of the Massachusetts minimum staffing standards, when compared to a region that did not experience the same policy intervention.

These regression models did not find a discernible impact on quality of care nor safety within the time period studied. They did, however, find an increase in total nurse staffing levels among low-staffed nursing homes with a high share of residents with Medicaid in Massachusetts. The observed staffing increase was significant for NAs (average treatment effect on the treated (ATT)=.179, p=0.03). The analysis thus demonstrates that nursing homes were able to expand staffing in response to the new requirement, notwithstanding workforce challenges since the pandemic.

One limitation of the analysis was the small number of nursing homes included because the analysis focused on a subset of nursing homes with the strongest incentive to respond to the new policy, that is, those with high Medicaid resident shares (≥ 75th percentile) and initial staffing levels below the new Massachusetts minimum staffing requirement (HPRD ≤ 3.58 for total nurse staffing), resulting in 1,617 out of 15,333 nursing homes nation-wide for the control group, and 40 out of 373 nursing homes in Massachusetts. Also, about one third of the nursing homes did not complete health inspection surveys due to the COVID-19 PHE, so there was a substantial amount of missing data for examining the safety outcome. Furthermore, the analysis of quality of care and safety outcomes was limited by the short post-implementation study period of Massachusetts's minimum staffing standards, which does not allow for sufficient time for a complete evaluation of the policy. Additionally, the impact analysis was focused on data from roughly the first year of implementation, which usually involves resource planning and operational changes to meet the new policy standards, and thus may not be representative.

These study results show that there was an increase in NA staffing, which supports the proposed policy to require facilities to meet the minimum staffing standards or otherwise be subject to, civil money penalties and denial of payment for all Medicare and/or Medicaid individuals among other penalties in accordance with 42 CFR 488.406.

(5) Cost and Savings Analysis

The cost analyses were conducted to determine any associated incremental costs that nursing homes would likely experience to meet minimum staffing standards, as well as any Medicare savings. Cost analyses used the 2021 Q2 PBJ System (staffing data), facility-specific information on hourly costs for RNs, LPN/LVNs, and NAs from

Worksheet S-3, FY 2021 Part V

of the Medicare Cost Report for 14,688 SNFs, and information on resident census that is available from files produced for comparison to evaluate any associated incremental costs. We note that the cost analyses were independent of a facility's case-mix.

Study findings indicate that the staffing costs for increasing RN and NA staffing levels in nursing homes to meet the minimum staffing standards ranges from $2.2 to $6.0 billion per year. The minimum estimated cost savings to Medicare, based on savings from the RN staffing requirement, are from the decreased use of acute care services (fewer hospitalizations and emergency department visits) and increased community discharges (defined as a reduction in Medicare-covered SNF days); cost savings ranges from $187 to $465 million. The decision to focus on estimated savings for RNs only, was because RN staffing levels were found to have a much stronger and a more consistent positive correlation with hospitalizations and emergency department visits than NAs or LPNs.

These quantitative analyses of savings to Medicare were limited to quality metrics for which there are extant secondary data. However, there are likely additional benefits to quality of care and life that cannot be fully identified through the analysis in the 2022 Nursing Home Staffing Study. Moreover, these analyses do not consider facilities' existing resources, ability to pay for possible staffing levels, or access to trained healthcare professionals.

Overall, the study

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

c. Listening Sessions

In addition to commissioning the 2022 Nursing Home Staffing Study and issuing the FY 2023 SNF PPS RFI, we also held two listening sessions on June 27, 2022, and August 29, 2022, to provide information on the study and solicit additional input on the study design and approach for establishing minimum staffing standards. The first listening session was attended by 18 interested parties representing various groups within the LTC community. During this session, this small group discussed several “big picture” questions about minimum staffing standards and provided input on the overall study approach. The second listening session was attended by 668 participants who offered feedback on specific questions that were included on the registration form, such as how to ensure that health equity/health care disparities are addressed when establishing minimum nurse staffing standards and how minimum staffing standards should consider differences in costs for job categories and variations across States.

During the August 2022 listening session,

participants shared their opinions that the current state of staffing standards was not adequate, and there was consensus that minimum staffing standards should be the same across the country. Participants recommended that CMS consider resident characteristics and care needs when developing staffing standards. Participants indicated that the interdisciplinary team and the care provided by non-nursing staff such as physical, occupational, speech therapists, respiratory therapists (especially with pediatric specialty/ventilator units), podiatrists, and psychiatrists also need to be considered. Others also suggested that the inclusion of non-nurse staff to meet staffing standards may positively contribute to aspects of quality of life for residents.

https://www.cms.gov/nursing-homes.

Similar to the suggestions received in the FY 2023 SNF PPS RFI, some participants suggested that CMS create a staff-to-resident ratio minimum standard, which can further support a HPRD staffing standard. Participants also suggested that facilities should report and display staff-to-resident ratios on a daily basis for all shifts. Participants in favor of a staff-to-resident ratio requirement noted that increased transparency will help residents and family members to easily determine if the facility is in compliance with minimum staffing standards.

Lastly, some participants indicated that minimum staffing standards should consider the need for consistent NA qualifications across all 50 States and to allow for more online training to eliminate the backlog of availability for NAs testing and increase the availability of classes near candidates to support staff shortages.

4. Ongoing CMS Initiatives and Programs Impacting LTC Facilities

In establishing the proposed minimum staffing standards, we also considered ongoing CMS policies, programs, and operations, including Medicaid institutional payment and transparency, the SNF prospective payment system, the SNF Value-based Purchasing Program (SNF VBP), oversight and enforcement, and CMS policies intended to enhance access to Medicaid home and community-based services and promote community-based placements.

a. Medicaid Institutional Payments and Payment Transparency

In this proposed rule we are also proposing a Medicaid Institutional Payment Transparency provision that is intended to promote public payment transparency. Greater transparency will help us assess the extent to which LTC facilities with a large Medicaid population have challenges achieving compliance with minimum staffing standards. State Medicaid Agencies would be required to publicly report the percentage of payments expended for direct care workers and support staff services in Medicaid-participating nursing facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) (see section III. of this proposed rule). We expect that as a result of this transparency requirement, some facilities would likely increase staffing independent of our proposed minimum staffing standards.

b. Medicare Skilled Nursing Facility Prospective Payment System

The Medicare Skilled Nursing Facility Prospective Payment System is a comprehensive per diem rate under Medicare for all costs for providing covered Part A SNF services (that is, routine, ancillary, and capital-related costs). There are over 15,000 Medicare-certified SNFs. The FY 2023 SNF PPS proposed rule published on April 4, 2023 updated Medicare payment policies and rates for SNFs for FY 2024. The FY2023 SNF PPS proposed rule estimated that the aggregate impact of the payment policies in the rule would result in a net increase of 3.7 percent, or approximately $1.2 billion, in Medicare Part A payments to SNFs in FY 2024. We note that Section 1888(e)(4)(E) of the Act requires the SNF PPS payment rates to be updated annually. These updates take into account a number of factors, including but not limited to, wages, salaries, and other labor-related costs. Specifics regarding the process to update SNF PPS payment rates are discussed in the rule.

https://www.federalregister.gov/documents/2023/04/10/2023-07137/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities.

c. Skilled Nursing Facility (SNF) Value-Based Payment (VBP) Program Staffing Measure

In the FY 2023 SNF PPS final rule, we adopted a new Total Nurse Staffing quality measure under the SNF VBP Program, which is used to provide an incentive to LTC facilities for improving quality of care provided to residents.

Performance on the Total Nurse Staffing measure begins in FY 2024, and payment adjustments based on performance on this measure (as well as others) occurs in FY 2026. This is a structural measure that uses auditable electronic data reported to CMS' PBJ system to calculate HPRD for total nurse staffing. Our proposal is not to be duplicative of this existing measure; rather, we expect our proposed minimum staffing standards to be complementary by establishing a consistent and broadly applicable national floor at which residents are at a significantly lower risk of receiving unsafe and low-quality care. At the same time, the Total Nurse Staffing quality measure will drive continued improvement in staffing across LTC facilities.

https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2023-skilled-nursing-facility-prospective-payment-system-final-rule-cms-1765-f.

d. Nursing Home Survey and Enforcement

The LTC minimum staffing standards proposed in this regulation are part of the Federal participation requirements for LTC facilities and these Federal participation requirements are the basis for survey activities and for the minimum health and safety requirements that must be met and maintained to receive payment and remain as a Medicare or Medicaid provider. As such compliance with these requirements will be assessed through CMS' existing survey, certification, and enforcement process.

Enforcement actions taken against LTC facilities that are not in compliance with these Federal participation requirements are called remedies. The agency that conducts on-site surveys cites deficiencies that indicate the specific Federal participation requirements that the facility did not meet. Sections 1819(h) and 1919(h) of the Act, as well as 42 CFR 488.404, 488.406, and 488.408, provide that CMS or the State may impose one or more remedies in addition to, or instead of, termination of the provider agreement when the CMS or the State finds that a facility is out of compliance with the Federal participation requirements. Specifically, enforcement remedies that may be imposed include the following:

https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationenforcement/nursing-home-enforcement.

• Termination of the provider agreement;

• Temporary management;

• Denial of payment for all Medicare and/or Medicaid individuals by CMS;

• Denial of payment for all new Medicare and/or Medicaid admissions;

• Civil money penalties;

• State monitoring;

• Transfer of residents;

• Transfer of residents with closure of facility;

• Directed plan of correction;

• Directed in-service training; and

• Alternative or additional State remedies approved by CMS.

In general, to select the appropriate enforcement remedy(ies), the scope and severity levels of the deficiencies is assessed. The severity level reflects the impact of the deficiency on resident health and safety and the scope level reflects how many residents were affected by the deficiency. The survey agency determines the scope and severity levels for each deficiency cited at a survey.

As part of these survey and enforcement activities, we currently publish data for all LTC facilities on the Care Compare website, including number of certified beds, an overall Five Star rating, and three individual star ratings in the categories of inspections, staffing, and quality measurement.

In addition, individual performance measures are included on Care Compare. With respect to staffing, this includes the following staffing data: total number of nurse staff HPRD, RN HPRD, LPN/LVN HPRD, and NA HPRD, as well as some additional staffing measures, including weekend hours. These published data are collected through a variety of mechanisms, including during CMS surveys (inspection data), through the reporting

of PBJ System and are also self-reported by LTC facilities to us.

Centers for Medicare & Medicaid Services

Medicare.gov.

Find and Compare Nursing Homes Providers near you

https://www.medicare.gov/care-compare/?providerType=NursingHome&redirect=true.

In general, facilities report employing three types of nursing staff: RNs, LPNs/LVNs, and NAs. We have been moving towards more data-driven enforcement, including use of the self-reported PBJ System data to guide monitoring, surveys and enforcement of existing staffing requirements. We continue to recognize the value of assessing the sufficiency of a facility's staffing based on observations of resident care conducted during the onsite survey. For example, while compliance with numeric minimum staffing standards could be assessed using PBJ System data, it is possible that due to a facility's layout, management, and staff assignments, a facility could meet the numeric staffing standards but not provide the sufficient level of staffing needed to protect residents' health and safety. Resident health status and acuity (for example, proportion of residents with cognitive decline or use of ventilators) are also factors in determining adequate staffing. Therefore, when assessing the sufficiency of a facility's staffing it is important to note that any numeric minimum staffing requirement is not a target and facilities must assess the needs of their resident population and make comprehensive staffing decisions based on those needs. The additional requirements proposed in this rule to bolster facility assessments are intended to address this need and guard against any attempts by LTC facilities to treat the minimum staffing standards included here as a ceiling, rather than a floor.

In summary, the benefits and success of minimum staffing standards are heavily dependent on the survey process. Therefore, in establishing numerical minimum staffing standards our goal is to ensure that they are both implementable and enforceable, as determined through both the PBJ System as well as on-site surveys.

e. Medicaid Home and Community-Based Services

We remain committed to a holistic approach to meeting the long-term care needs of Americans and their families. This requires a focus on access to high-quality care in the community while also ensuring the health and safety of those who receive care in LTC facilities. In the proposed April 2023 Ensuring Access to Medicaid Services (Access NPRM) and Medicaid and CHIP Managed Care Access, Finance, and Quality (Managed Care NPRM), we proposed several policies intended to work alongside those included in this proposed rule. These proposals require that at least 80 percent of Medicaid payments for personal care, homemaker and home health aide services be spent on compensation for the direct care workforce (as opposed to administrative overhead or profit); establish standardized reporting requirements related to health and safety, beneficiary service plans and assessments, access, and quality of care; and promote transparency through public reporting on quality, performance, compliance as well as Medicaid managed care plans' payment rates for direct care workers. Additionally, we remain committed to facilitating transfers from LTC facilities to the community through the continued implementation of the Money Follows the Person program.

Money Follows the Person | Medicaid,

https://www.medicaid.gov/medicaid/long-term-services-supports/money-follows-person/index.html.

Notably, we believe that the proposed minimum staffing standards will improve quality of care which includes facilitating the transition of care to community based care services; similar to findings that are reported in the 2022 Nursing Home Staffing Study as well as potential Medicare savings.

B. Provisions of the Proposed Regulations

As discussed above, meeting minimum staffing standards may be influenced by and/or affect existing CMS initiatives and programs, and programs within LTC facilities. Given these factors and the broad spectrum of suggestions and inputs discussed, we acknowledge that there are many considerations and potential policy options for establishing minimum staffing standards. Therefore, we propose a comprehensive staffing approach that consists of the three following elements: (1) establishing new minimum nurse staffing standards based on case-mix adjusted staffing; (2) revising the on-site RN requirement; and (3) revising the existing facility assessment requirement. We believe, when taken together, these three elements will establish a consistent and broadly applicable national minimum staffing standards as a floor, while also ensuring that LTC facilities staff beyond the minimum staffing standards as needed, based on their resident population.

While we expect LTC facilities to meet the comprehensive staffing standards, we acknowledge that there may be circumstances related to the nursing workforce that require efforts to both ensure access to care and maintain quality care and safety. Therefore, we are proposing options for exemptions and a staggered implementation of the proposal's components for meeting the minimum staffing standards. This comprehensive approach aims to strike the appropriate balance between ensuring resident health and safety, while guarding against unintended consequences, and preserving access to care.

Our goal is to protect resident health and safety and ensure that facilities are considering the unique characteristics of their resident population in developing staffing plans, while balancing operational requirements and supporting access to care. Moreover, the comprehensive staffing standards will provide staff with the support they need to safely care for residents.

We believe that the elements of the proposed comprehensive staffing standards discussed in this rule support these goals and align with the key function of the LTC facility participation requirements, which is to establish minimum standards to ensure safety and quality care for all residents.

We also acknowledge the impact that proposed minimum staffing standards will have on the LTC facility industry and recognize the potential for unintended consequences, such as facilities' misinterpretation of the minimum staffing standards. Such misinterpretation could result in inappropriate behaviors, such as choosing to staff only at the minimum RN and NA HPRD requirements, without adequate consideration of facility characteristics and resident acuity and needs; healthcare workforce substitution (hiring for one position by eliminating another); task diversion (assigning non-standard tasks to a position); or gamesmanship around composition of the patient population (avoiding residents with more complex medical needs). Such actions would not result in the improved safety, quality, and person-centered care that we seek in facilities. As such, we are soliciting public comments on the policy proposals outlined below, in particular the feasibility of the proposals, any unintended consequences, and alternatives that we should consider. We will consider all feedback to inform the final policy.

1. Nursing Services (§ 483.35)

a. Sufficient Staff (§ 483.35(a)(1))

In general, LTC facilities report employing three types of nursing staff: RNs, LPN/LVNs, and NAs. RNs are assigned both administrative roles and resident assessment and care planning, which typically results in less hands-on

time with residents and more non-clinical skills (for example, managerial and time management skills). They are able to assess resident health problems and needs, develop and implement care plans, and maintain medical records. LPN/LVNs are entry-level licensed nurses providing basic level care under a RN or physician supervision such as checking blood pressure, changing bandages and dressings, and documenting patient care records. NAs spend the most time providing care to residents by assisting with activities of daily living (for example, feeding, bathing, and dressing). Moreover, roles for NAs may differ from LPN/LVNs depending on the State.

NAs are paid on average $16.90/hour, whereas RNs and LVN/LPNs are paid an average hourly wage of $37.11 and $28.17 in Nursing Care Facilities.

While the work of NAs and other direct care workers, like home health aides and personal care assistants, requires considerable technical and interpersonal skills, these workers historically receive low pay, rarely receive benefits, and experience high injury rates.

Despite the rising demand for services, direct care workers continue to earn poverty-level low wages. Almost one-half of the direct care workforce (45 percent) live below 200 percent of the Federal poverty level and about one-half (47 percent) rely on public assistance. Recent research by the U.S. Assistant Secretary for Planning and Evaluation finds that wages for direct care workers, including NAs, lag behind workers in other industries with similar entry-level requirements, exacerbating recruitment and retention challenges. According to its findings, average hourly wages also vary considerably State to State—as low as $10.90 for NAs in Louisiana to as high as $18.66 in Alaska.

Nursing and Residential Care Facilities—May 2022 OEWS Industry-Specific Occupational Employment and Wage Estimates (bls.gov).

Wages of Direct Care Workers Lower than Other Entry Level Jobs in most States, Assistant Secretary for Planning and Evaluation, April, 2023

https://aspe.hhs.gov/reports/dcw-wages.

Current regulations at § 483.35(a)(1)(i) and (ii) require facilities to have sufficient numbers of licensed nurses and other nursing personnel, including but not limited to NAs, available 24 hours a day to provide nursing care to all residents in accordance with the resident care plans.

In the 2016 LTC final rule mentioned previously,

CMS described the complexity of establishing minimum staffing standards at that time given that the PBJ System reporting program had only been recently implemented. Therefore, we did not have adequate information in terms of facility-level staffing data that would be needed to establish minimum staffing standards. We further stated that once a sufficient amount of data was collected and analyzed, we could re-visit the establishment of minimum staffing standards in LTC facilities. As of calendar year 2022, we have access to about 6 years of self-reported data from the PBJ System which are sufficient to examine the staffing issues in LTC facilities that still persist and were exacerbated by the COVID-19 PHE.

42 CFR 483.35

Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities. (81 FR 68688)

https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities.

According to CMS survey and enforcement data, over 1,000 facilities were cited for insufficient staffing in 2022 and residents, family, ombudsmen, researchers, and others continue to report to CMS that understaffing negatively affects care. There is also considerable variation in State staffing requirements. As previously stated, a review of State staffing requirements indicates that 38 States and the District of Columbia currently have minimum staffing standards in LTC facilities, but these standards differ across States by staff types, hours and measurement across States, and more so during the COVID-19 PHE.

The proposed RN requirement of 0.55 HPRD is higher than every State, and only lower than the District of Columbia. The proposed NA requirement of 2.45 HPRD is higher than all States and the District of Columbia, based on data from September 2022.

State Policies Related to Nursing Facility (NF) Staffing

https://www.macpac.gov/wp-content/uploads/2022/03/State-Policies-Related-to-Nursing-Facility-Staffing.xlsx.

For example, only 10 States out of the 38 States have minimum HPRD standards for NAs ranging from 1.04 to 2.44 (see Table 2).

Table 2—HPRD Requirement for NAs by State

State

CNAs (HPRD)

1. California

2.4

2. Delaware

1.6

3. Florida ‡

2.0

4. Montana

1.2

5. New Jersey

1.04

6. New York

2.2

7. Oregon

2.16

8. Rhode Island

2.44

9. South Carolina

1.63

10. Vermont

2.0

Notes:

CNAs= certified nursing assistants or nursing assistants; HPRD= hours per resident day.

‡ FL revised CNA HPRD from 2.45 to 2.0 on 4/2022.

Source: RTI International, 2021, Review of State Policies Related to Nursing Facility Staffing.

Some States have implemented a total hour per resident day (HPRD) model, with some including licensed nurses in this calculation, whereas others exclude LPN/LVNs but include RNs, DONs, and NAs only. For example, the District of Columbia requires a minimum daily average of 4.1 hours of direct nursing care per resident per day (with an opportunity to adjust the requirements above or below this level, as determined by the Director of the Department of Health), an RN on site 24 hours a day, 7 days a week, plus additional nursing and medical staffing requirements.

Some States implemented a ratio of numbers of full-time equivalent NAs per resident. For example, California requires 3.5 HPRD for total nurse staffing with at least 0.24 of those hours provided by RNs, and 2.4 HPRD for NAs, and no HPRD required for LPN/LVNs. Massachusetts requires 3.58 HPRD for total nurse staffing with at least 0.508 of those hours provided by a RN.

Arkansas requires at least 3.36 average HPRD for nurse and non-nurse staff each month to include licensed nurses, NAs, medication assistants, physicians, physician assistants, licensed physical or occupational therapists or licensed therapy assistants, registered respiratory therapists, licensed speech language pathologists, infection preventionists, and other healthcare professionals licensed or certified in the State, plus requirements for minimum numbers of licensed nurses per residents per shift. There is also limited evidence on how these different staffing standards were developed and their impact.

https://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/Nursing_Facility_Regulations_Health_Care_Facilities_Improvement_2012.pdf.

https://theconsumervoice.org/uploads/files/issues/CV_StaffingReport.pdf.

The 2022 Nursing Home Staffing Study

included an analysis of PBJ System data for the fourth quarter of 2019 through the first quarter of 2022. The 2022 Nursing Home Staffing Study, as discussed previously, provided CMS with findings to inform the proposal for minimum staffing standards, and discussed trade-offs associated with balancing cost and feasibility with implications for acceptable quality care and safety, especially among the lowest performing facilities (that is, at or below the 25th percentile for total safety and quality measure scores) that are at the most risk for providing unsafe care.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare and Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

After considering all of the available evidence and extensive comments provided, we are proposing revisions to the Nursing Services regulations at § 483.35 to establish national, quantitative minimum staffing standards to ensure all facilities provide at least the same baseline level of high-quality and safe care to residents across all participating LTC facilities. We propose to revise § 483.35(a)(1)(i) and (ii) to further define “sufficient numbers” by establishing a numerical minimum level for HPRD for RNs and NAs. We also propose to revise § 483.5 to include the definition of “hours per resident day” (HPRD), that is, staffing hours per resident per day is the total number of hours worked by each type of staff divided by the total number of residents as calculated by CMS.

Specifically, at § 483.35(a)(1)(i) we propose individual nurse staffing type standards for RNs and NAs. We propose to require facilities to have minimum staffing standards of 0.55 HPRD of RNs and 2.45 HPRD of NAs as well as to maintain sufficient additional nursing personnel, including but not limited to LPN/LVNs, and other clinical and non-clinical staff, to ensure safe and quality care, based on the proposed facility assessment requirements at § 483.71. CMS is also seeking comments on a minimum total nurse staffing standard of 3.48 HPRD discussed later in the rule.

https://data.cms.gov/provider-data/dataset/4pq5-n9py.

We are not proposing minimum nurse staffing standards that include HPRD for licensed nurses (that is, RNs plus LPN/LVNs) nor for total nurse staffing (that is, RNs, LPN/LVNs, and NAs). This proposed policy is based on the 2022 Nursing Home staffing study findings and other literature evidence demonstrating that RNs and NAs have a larger effect on quality than LPN/LVNs. In addition, literature and statistical evidence suggests that improved clinical outcomes are associated with increasing the HPRD rates of RNs and NAs

especially among nursing homes that have a high reliance on Medicaid.

Moreover, when LPN/LVNs work with higher numbers of HPRD for RNs and NAs (that is, total nurse staff) it appears to reduce delayed or omitted care and increase gross cost savings to Medicare.

We believe that establishing national, numerical standards of direct care hours will improve safety and quality in many LTC facilities. By creating a consistent Federal floor for staffing expectations, we will better define the minimum number of care hours residents should receive to protect health and safety, while also facilitating strengthened oversight and enforcement.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare &and Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

Bowblis J.R. (2011). Staffing ratios and quality: an analysis of minimum direct care staffing requirements for nursing homes.

Health services research, 46

(5), 1495-1516.

https://doi.org/10.1111/j.1475-6773.2011.01274.x.

Abt Associates. (2022). Nursing Home Staffing Study Comprehensive report. Report prepared for the Centers for Medicare & Medicaid Services.

https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf.

As an example, when establishing the proposed HPRD level of 0.55 for RNs and 2.45 for NAs, we note that the minimum number of RN hours (that is 0.55 HPRD) provided in a facility that has 100 residents and runs an 8-hour shift per 24 hours, would require a total of 55 RN hours per 24 hours.

In other words, at least two RNs on staff each 8-hour shift, plus a third RN for one shift, would be necessary in this scenario although no per shift minimum is being established in this rule. Similarly, the minimum number of NA hours (that is 2.45 HPRD) provided in a facility that has 100 residents and runs an 8-hour shift per 24 hours will require at least a total of 245 NA hours per 24 hours.

In other words, at least 10 NAs on staff each 8-hour shift, plus a third NA for one shift would be necessary in this scenario although no per shift minimum is being established in this rule.

100 residents × 0.55HPRD = 55 RN hours for 24 hours; or 18 RN hours/8-hour shift; that is ~2 RNs.

100 residents × 2.45HPRD = 245 NA hours for 24 hours; or 81 NA hours/8-hour shift; that is ~10 NAs.

These proposed levels for hours of care would establish the minimum nurse staffing levels needed to provide safe and high-quality nursing services to each resident per day. We underscore that these standards reflect only the absolute minimum floor adjusting for the average acuity across all LTC facilities, and the required hours of nursing care may be greater but never lower than the proposed minimum standards, if the acuity needs of residents in a facility requires a higher level of care. Additionally, the proposed staffing levels require all facilities to meet at least this minimum floor, even if the facility has below average acuity, given that resident population can shift more rapidly than staffing plans; most facilities have either an average acuity or higher of resident population; and as noted above, the evidence can also support a higher range of staffing thresholds.

Notably, we are proposing to specify HPRD for RNs and NAs in the minimum staffing requirement at § 483.35(a) and are not proposing a total nurse staffing level under which facilities have the flexibility to decide between types of licensed nurses to meet the minimum requirement. We have taken this approach given the evidence that shows a strong positive association between RN staffing levels and safety and quality, as well as NA staffing levels at higher HPRDs. Literature evidence also indicates that the increased presence of RNs in nursing facilities would help address several issues.

First, research evidence suggests that greater RN presence has been associated with higher quality of care and fewer deficiencies. Second, it has been reported in the literature that where standards provide flexibility as between types of licensed nurses (that is, do not specify RN hours), LPN/LVNs may find themselves practicing outside of their scope of practice partly because there are not enough RNs providing direct patient care and supervision of LPN/LVNs. The specificity of this approach would increase the number of hours per day that a LTC facility must have RNs in the facility and would alleviate concerns about LPN/LVNs engaging in activities outside their scope of practice in the face of resident need during times when no RN is on site (80 FR 42168, 42200). Moreover, to prevent a high rate of unusual patient safety events, the National Academy of Medicine (NAM) (formerly the Institute of Medicine (IOM)) suggests having adequate staffing levels, specifically NAs, who provide most of the care to nursing home residents.

In addition, our proposal,

which focuses on sufficient numbers of nursing staff, does not contemplate staffing levels for non-nursing staffing because nursing staff are most critical to ensuring minimum standards of care, and there is insufficient information on non-nurse staffing levels in the PBJ System and other available data sources that limits our efforts to examine staffing requirements for non-nurse staff at this time. We solicit comment on the need to allow for substitution, such as substituting LPN/LVNs for NAs, in extraordinary cases and specifically what extreme circumstances would appropriately allow for such substitution.

Institute of Medicine (US) Committee on the Work Environment for Nurses and Patient Safety.

Keeping Patients Safe: Transforming the Work Environment of Nurses.

Edited by Ann Page, National Academies Press (US), 2004. doi:10.17226/10851.

As noted, based on the findings reported in the 2022 Nursing Home Staffing Study, information gathered through the FY2023 SNF PPS RFI, listening sessions, assessment of the PBJ System data, and review of the literature evidence, we are proposing individual minimum staffing levels at 0.55 HPRD for RNs and 2.45 HPRD for NAs. In establishing this proposal, we considered the context of substantial cost that the proposed policy may impose on LTC facilities, especially those with limited resources that may face difficult decisions in terms of how to allocate funding and resources (see Regulatory Impact Section for more detail). Likewise, the evidence from the 2022 Nursing Home Staffing Study supports the proposed minimum staffing level for RNs and NAs for improving safety and leading to higher quality care. As such, we are proposing minimum nurse staffing standards for these two types of nursing staff that we believe are reasonable and creates meaningful, positive impact on resident quality and safety. These standards will especially help ensure all facilities reach acceptable levels of safety and quality care, working in tandem with CMS' other quality improvement programs that focus on raising performance beyond minimum requirements.

The proposed minimum nurse staffing standards would create broadly applicable minimum standards at which all residents across all LTC facilities would be at a significantly lower risk of receiving unsafe and low-quality care. LTC facilities would be required to staff above these minimum adjusted baseline levels, as appropriate, to address the specific needs of their unique resident population. This additional staffing should be based at the facility level using the facility assessment and an examination of resident acuity levels.

LTC facilities are also responsible for compliance with other requirements for participation, including but not limited to § 483.24, which requires that each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with the resident's comprehensive assessment and plan of care. Therefore, we propose to add a new § 483.35(a)(1)(v) to reinforce this standard. Specifically, at § 483.35(a)(1)(v), we propose to specify that compliance with minimum HPRD for RN and NA should not be construed as approval for a facility to have fewer nursing and non-nursing staff than the number of staff with the appropriate competencies and skills sets necessary to assure resident safety, and to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments, acuity and diagnoses of the facility's resident population in accordance with the facility assessment required at current § 483.70(e)), which we propose to be redesignate as new § 483.71.

The acuity and characteristics of residents in LTC facilities has continued to evolve and change over the years. For example, there are more residents with a psychiatric diagnosis with reports showing that the proportion of residents with schizophrenia increased from 6.5 percent in 2000 to 12.4 percent in 2017.

There has also been an increase in the percentage of facilities with an Alzheimer's unit and more residents appear to need assistance with activities of daily living. For example, it was reported that on average 96 percent of residents at the facility level needed assistance with bathing in 2015, compared to the national average of 89 percent of residents in 1985.

Also the percentage of residents with bladder incontinence has also increased over the years from 49.3 to 62.1 percent.

M. Barton Laws, Aly Beeman, Sylvia Haigh, Ira B. Wilson, Renée R. Shield, Prevalence of Serious Mental Illness and Under 65 Population in Nursing Homes Continues to Grow. Journal of the American Medical Directors Association,Volume 23, Issue 7, 2022, Pages 1262-1263,

https://doi.org/10.1016/j.jamda.2021.10.020.

Fashaw, Shekinah A et al. “Thirty-Year Trends in Nursing Home Composition and Quality Since the Passage of the Omnibus Reconciliation Act.”

Journal of the American Medical Directors Association

vol. 21,2 (2020): 233-239.

doi:10.1016/j.jamda.2019.07.004.

Furthermore, there appears to be an increase in the proportion of younger residents, under 65 years of age, in part due to severe mental illness and substance use disorders, who have different needs from the traditional nursing home population.

Given the variation in resident acuity and complexity of care required for a facility's unique resident population, facilities must make thoughtful, informed staffing plans and decisions that are focused on meeting resident needs, including maintaining or improving resident safety and quality of life, which will often result in the need for a facility to staff above the minimum nurse staffing requirement. Based on the needs of its resident population, an individual facility may need to maintain levels of HPRD for RN, NA and other staffing that surpasses the proposed minimum nurse staffing HPRD.

Laws, M Barton et al. “Changes in Nursing Home Populations Challenge Practice and Policy.”

Policy, politics & nursing practice

vol. 23,4 (2022): 238-248. doi:10.1177/15271544221118315.

This need for increased staff would be evidenced by the facility assessment (§ 483.70(e)) and resident assessments (§ 483.20) which would require facilities to make staffing and care planning decisions that account for resident acuity, physical/cognitive abilities, conditions, diagnoses, etc . . . Compliance with the numerical minimum staffing requirement is necessary but not necessarily sufficient to meet staffing needs for every facility. Later in this proposed rule, we discuss an additional element of this comprehensive proposal, revising the facility assessment requirement at § 483.70(e) which we believe would help avoid the unintended consequence of facilities inappropriately staffing at the minimum staffing requirement.

We note that, as discussed previously, while the 0.55 and 2.45 HPRD standards were developed using case-mix adjusted data sources, the standards themselves will be implemented and enforced independent of a facility's case-mix. In other words, facilities must meet the 0.55 RN and 2.45 NA HPRD standards, regardless of the individual facility's patient case-mix. Based on the October 2021 Care Compare data, we estimate that approximately 6,094 facilities are staffed below a level of 0.55 for RNs, and approximately 9,998 are currently staffed below a level of 2.45 for NAs out of an estimated 14,688 total facilities with complete information. These estimates do not reflect proposed exemptions discussed below. Similarly, we recognize that there are facilities currently staffing at levels greater than or equal to 0.55 RN HPRD (n=8,594) and 2.45 NA HPRD (n=4,690) who would not be directly impacted by this proposed policy at this time. However, staffing should be assessed on an ongoing basis and we emphasize that

the facility must provide adequate nursing care to meet the needs of each resident.

Typical characteristics of LTC facilities that may need to staff up to meet this minimum requirement, based on having current staffing, below the proposed levels are:

• For-profit facilities (compared to government and non-profit facilities).

• Larger facilities.

• Freestanding LTC facilities (relative to hospital-based).

• Facilities that are part of a Continuing Care Retirement Community.

• Facilities with higher shares of Medicaid residents.

• Facilities that are Special Focus Facilities (SFF) or SFF candidates.

• Rural facilities.

We note that the existing statutory waiver for Medicaid NFs, authorized by section 1919(b)(4)(C)(ii) of the Act and implemented at § 483.35(e) for a State to waive the requirements of § 483.35(b) to provide licensed nurses on a 24-hour basis would still be in place for NFs to pursue through the current waiver process. The statutory waiver is discussed further under Section II.B. 3. “Hardship Exemption from the Minimum Hours Per Resident Day Requirements for RNs and NAs.” In addition, we propose to add new paragraphs (a)(1)(iii) and (iv) to existing § 483.35 to specify that facilities may be exempted from the minimum HPRD requirement for RNs and NAs using separate criteria, and to indicate the period of time that will be assessed to determine compliance.

At new § 483.35(a)(1)(iii), we propose facilities that are found non-compliant with the HPRD requirement for RNs and NAs and meet certain eligibility criteria may be exempted from the 0.55 HPRD for RNs and/or 2.45 HPRD for NAs requirements. The details of this exemption framework and the specific eligibility criteria are discussed further in section II.B.3. “Hardship Exemption from the Minimum Hours Per Resident Day Requirements for RNs and NAs.” of this rule. At new § 483.35(a)(1)(iv), we propose that determinations of compliance with minimum HPRD requirements for RNs and NAs will be made based on the most recent available quarter of PBJ System data submitted in accordance with the requirements at existing § 483.70(p) (“Mandatory Submission of Staffing Information Based on Payroll Data in a Uniform Format”).

We solicit comments on the timeframe used to determine compliance with the minimum HPRD, specifically if the lookback period should be longer, for example 1 year to cover a full certification period, or some other timeframe to ensure the most reliable and realistic assessment of staffing data. We also invite public comments on the following proposals discussed in this section. As highlighted throughout the discussion, we acknowledge multiple avenues for establishing a minimum nurse staffing requirement. Based on the proposed policy presented in this rule, we are seeking feedback regarding whether or not alternative policy options are necessary to meet and maintain acceptable quality and safety within LTC facilities, while balancing a facility's ability to comply and ensure access to care.

In developing the proposed rule, we considered varying staffing models that are available and different approaches we could have adopted for establishing minimum nurse staffing standards. For example, we could have adopted multiple different types of combinations of staffing requirements, such as a four-part requirement (inclusive of a total nurse staffing ratio, RNs, LPN/LVNs, and NAs) or a three-part requirement (inclusive of a total nursing staffing ratio, RNs, NAs or separate standards for RNs, LPN/LVNs, and NAs). We also considered that LTC facilities differed across States in their reliance on LPN/LVNs, which was one of the reasons that we did not set a minimum requirement for LPN/LVNs, in addition to available evidence on LPN/LVN associations with safety and high—quality care. Alternatively, we could have proposed staffing requirements for professionals such as social workers, therapists, feeding assistants and other non—nurse staff in the minimum staffing requirement. However, the HPRD reported in PBJ System data for non-nurse staff were insufficient for use in establishing minimum staffing requirements at this time.

We propose to use HPRD that LTC facilities self-report to CMS and currently reported and auditable in the CMS' PBJ System. However, we recognize that staffing levels can be measured in at least 19 different ways with HPRD being the most frequently used.

This includes measuring staffing levels as either full time equivalent per resident, full time equivalent per 100 beds, minutes per resident day, or nursing staff to resident ratios. Alternative minimum staffing policy options could also focus on the need to increase or decrease the number of HPRD or FTEs by nurse staff and/or type or on specifying the number by shift (including day, evening, night, or weekends or over a 24-hour period).

Clemes, S., Wodchis, W., McGilton, K., McGrail, K., & McMaho, M. (2021). The relationship between quality and staffing in long-term care: A systematic review of the literature 2008-2020. International Journal of Nursing Studies, 122,

https://doi.org/10.1016/j.ijnurstu.2021.104036.

We are soliciting comments on establishing a total nurse staffing standard such as 3.48 HPRD among other alternatives, in place of a requirement only for RNs and NAs, or in addition to a requirement for RNs and NAs. For example, we considered an alternative 3.48 HPRD for the total nurse staffing standard—inclusive of the 0.55 HPRD RN and 2.45 HPRD NA minimum standards—based on the evidence from the 2022 Nursing Home Staffing Study, in addition to other factors discussed throughout the proposed rule. We considered 0.55 HPRD for RNs and 2.45 HPRD for NAs as a part of this alternative total nurse staffing standard based on the evidence from the 2022 Nursing Home Staffing Study and other inputs; 0.55 HPRD for RN and 2.45 HPRD for NA staffing were found to be positively associated with safety and quality. Furthermore, NAs spend the most time providing care to residents by assisting with activities of daily living (for example, feeding, bathing, and dressing). Including an overarching minimum total staffing standard, such as 3.48 HPRD, could enable LTC facilities flexibility on staffing while protecting residents from preventable negative outcomes and would discourage facilities that currently meet the individual RN and NA minimums from decreasing total staffing. We seek comments on the necessity of a total staffing standard and whether a total staffing standard should be adopted alongside individual standards. We specifically seek comment on a standard of 3.48 HPRD among other alternatives.

To maximize the usefulness of the feedback from interested parties on alternative policy options, we emphasize that the recommended policy must support and promote acceptable quality and safety in LTC facilities as the intended goal. We seek comments on the effectiveness of a minimum staffing standard in maintaining quality and safety and ways to minimize administrative burden, both for LTC facilities and for CMS in maintaining and enforcing such a standard and enhance compliance among LTC facilities through the use of automated data collection techniques or other forms of information technology.

We encourage commenters to submit evidence and data to support their recommendations to the extent possible. All comments will be reviewed and analyzed, including consideration for

potential future rulemaking. We welcome comments on the following questions:

• What are the benefits and trade-offs associated with a two-part minimum nurse staffing standard as proposed (inclusive of RNs and NAs) relative to a three-part standard (inclusive of a 3.48 HPRD for total nurse staffing, RNs, and NAs) or a four-part standard (inclusive of a total nurse staffing ratio, RNs, LPNs/LVNs, and NAs)?

• What evidence did States rely on when they adopted their specific minimum nurse staffing standards, both with respect to HPRD and the inclusion or exclusion of certain nursing staff, and what is the rate of compliance?

• Whether we should consider a case-mix adjusted staffing HPRD for each facility to assess compliance with the minimum staffing standards? A case-mix adjusted staffing HPRD would adjust the minimum staffing levels based on the health status of the residents in each facility (known as “case-mix adjustment”). Specifically, the case-mix adjustment methodology aggregates data from each resident's assessment (the Minimum Data Set (MDS)) to identify the general level of acuity of each facility's residents. The level of acuity is then combined with the facility's self-reported (that is, unadjusted) staffing information to calculate the level of staff the facility has that is equivalent to other facilities.

If we were to adjust the minimum staffing levels based on the health status of the residents in each facility to ensure that staffing levels are adequate to meet the unique needs of the residents in each facility—

• What steps can CMS take to support LTC facilities in predicting what their case-mix adjusted staff might be and hire in expectation of that adjusted staffing level? What resources will facilities need to proactively calculate their existing HPRD for nursing staff, and what may be needed?

• What alternative policies or strategies should we consider to ensure that we enhance compliance, safeguard resident access to care, and minimize provider burden? Are there are other alternative policy strategies we should consider?

b. Registered Nurse (§ 483.35(b)(1))

The existing LTC facility staffing regulations require an RN to be on site 8 consecutive hours a day for 7 days a week (§ 483.35(b)(1)).

This requirement serves as a minimum to protect the health and safety of LTC facility residents. In other words, an RN is required to be onsite for a total of 8 consecutive hours out of 24 hours a day. The LTC facility may decide to allocate all 8 consecutive hours of RN time to one day shift or an evening shift for a 24-hour day, similarly to the HPRD proposed for RNs.

42 CFR 483.35,

However, to prevent avoidable patient safety events, some organizations have recommended higher recommendations to each RN staffing levels. For example, in 2022, the National Academies of Science, Engineering, and Medicine (NASEM) published a report that recommended direct-care RN coverage 24 hours a day, 7 days a week.

Like NASEM, we are concerned that even with minimum HPRD standards, these residents are at risk for preventable safety events when there is no RN on site, particularly during evenings, nights, weekends, and holidays. Therefore, to avoid placing LTC facility residents at risk of preventable safety events due to the absence of an RN, we are proposing to revise § 483.35(b)(1) to require LTC facilities to have an RN onsite 24 hours a day, 7 days a week.

National Academies of Sciences, Engineering, and Medicine. 2022.

The National Imperative to Improve Nursing Home Quality: Honoring Our Commitment to Residents, Families, and Staff.

Washington, DC: The National Academies Press.

https://doi.org/10.17226/26526.

LTC facilities provide care for residents with increasing medically complex and acute health conditions that require substantial resources and care. This care is provided or supervised by an RN. In the FY 2016 final rule, we indicated that CMS was proposing changes to the LTC facility participation requirements to ensure that LTC facilities are providing quality and safe care to medically complex residents among others (81 FR 68688). We noted that not only has the acuity of the resident population generally increased, but there has also been a dramatic increase in the number of residents recovering from an acute episode of major surgery, injury, or illness (sub-acute resident population).

Medicare payment policy has also contributed to higher acuity levels in LTC facilities. After Medicare implemented the prospective payment system for hospitals in 1983, there were shorter hospital stays for Medicare beneficiaries and increased funding for post-acute stays in LTC facilities (80 FR 42168, 42174-42175). This payment policy resulted in a growing sub-acute resident population in LTC facilities that would have previously experienced longer hospital stays. Also, with the increase in alternatives to LTC facilities, such as assisted-living facilities and home care, LTC facilities are caring for more dependent residents who require more complex basic medical care and rehabilitative services. In addition, LTC facilities are caring for a significant number of residents with dementia, depression, or other behavioral health issues. LTC facilities today have even been referred to as “mini-hospitals.”

Three challenges of long-term care (LTC) nursing. Health. Accessed at

https://www.wolterskluwer.com/en/expert-insights/three-challenges-of-longterm-care-ltc-nursing.

Published on May 5, 2015. Accessed on February 13, 2023.

While RNs and LPNs/LVNs appear to provide some similar nursing services, such as administering medications, there are crucial differences. Compared to LPNs and LVNs, RNs' scope of practice is broader and they receive more education.

Most importantly, RNs practice independently and are qualified to conduct clinical nursing assessments, whereas LPNs and LVNs require an RN or a physician's supervision. This is a critical feature in the RN scope of practice given the higher acuity of today's LTC facility resident population and the need to properly clinically assess residents to ensure they are receiving the appropriate care. Also, it has been reported in the literature that LPN/LVNs may find themselves practicing outside their scope of practice when there is not sufficient RN staffing in a facility to provide direct or supervised resident care (80 FR 42168, 42200). Thus, we are also proposing that the RN be available to provide direct resident care around the clock.

Jividen, S.

vs.

LPN. Nurse.org.

Accessed at

https://nurse.org/resources/rn-vs-lpn/.

Published on July 15, 2021. Accessed on February 13, 2023.

For several decades, studies and gray literature materials other than traditional research publications, such as opinion pieces, advocacy materials, and non-statistically rigorous research published by government agencies have recommended an RN onsite 24-7 in LTC facilities for similar reasons. As noted previously in this proposed rule, the 2022 NASEM report, recommended that LTC facilities have 24 hours a day, 7 days a week RN onsite coverage. NASEM noted that most LTC facilities provide care for both short-term residents who require rehabilitation or subacute care and long-term care for residents. While the acuity of short-term residents would vary greatly depending upon their reason for admission and condition, NASEM noted that the long-term care residents typically have multiple chronic conditions that require professional nursing surveillance to

monitor the residents for changes that might require hospitalization or potentially be life-threatening.

As noted previously in this rule, it is the RN that has the education, training, and qualifications to conduct clinical nursing assessments. The report also suggested that there be additional RN coverage when needed and that the DON not be counted towards this requirement.

FN #93, NASEM, p. 58.

In the 2016 LTC facility final rule,

we noted that several commenters, including the Center for Medicare Advocacy and the California Advocates for Nursing Home Reform, recommended that LTC facilities have 24-hours RN onsite coverage. These commenters argued that 24-hours RN coverage was necessary due to the increased acuity in residents and that expert nursing skill is needed to “anticipate, identify and respond to changes in [a resident's] condition,” as well as for the residents to have appropriate rehabilitation services and the best chance for being discharged home in a safe and timely manner (80 FR 68754). Other commenters noted that RN staffing was essential for safe and effective resident care.

While we agreed with the commenters on the importance of staffing, and noted that due to their education and licensure, RNs possess the skills that are “essential for timely assessment, intervention and treatment,

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we did not establish a minimum nursing staff standard at that time for the reasons noted in the 2016 final regulation. Instead, at § 483.35, we finalized an approach that required the LTC facility to have sufficient nursing staff to assure safety and well-being of each resident as determined by resident assessments and individual plans of care and considering the number and acuity of diagnoses of the facility's resident population in accordance with the facility assessment required at § 483.70(e). Among other reasons, we did not propose a 24-hour RN onsite requirement due to lack of sufficient data including PBJ System data. As discussed previously in this proposed rule, we did not yet have the data from the PBJ System or another reliable source upon which to base a minimum staffing requirement. We now also have the Abt study discussed above that demonstrated the importance of RNs to the quality-of-care residents receive. Others, including professional nursing organizations, also contended that the requirements should be focused on resident acuity and the competencies and skill sets of the nursing staff than a specific numerical requirement for categories of staff (80 FR 42168, 42200 and 42201). We were also concerned that some LTC facilities, especially those in rural and underserved areas, might find complying with such a requirement especially challenging (81 FR 68694, 68752, 68755).

Medicare and Medicaid Programs; Report of Requirements for Long-Term Care Facilities. 81 FR 68688. Published on October 4, 2016.

FN #24, p. 68754.

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FN #24, p. 68754.

We also heard these same concerns reiterated in the FY 2023 SNF PPS RFI comments and the interested parties listening sessions discussed previously. These commenters noted that RNs, by the virtue of their education and training, have diagnostic and assessment skills that other types of nurse staff do not. They noted that LTC facilities have populations with the highest needs and complex medical issues and the availability of RNs for resident assessments is necessary and could prevent avoidable resident hospitalizations. Based on comments received in the FY 2023 SNF PPS RFI, NASEM's recommendations, and other gray and peer-reviewed literature, we propose that all LTC facilities must have an RN onsite 24 hours a day, 7 days a week at § 483.35(b)(1).

An existing statutory waiver for Medicare SNFs, set out at section 1819(b)(4)(C)(ii) of the Act and implemented at § 483.35(f), permits the Secretary to waive the requirements of § 483.35(b) to provide the services of a RN for more than 40 hours a week, including the director of nursing. This waiver would still be in place for SNFs to pursue through the current waiver process. Facilities would also use this process to pursue a waiver of the 24 hours a day, 7 days a week requirement. However, we discuss certain criteria that may exempt a LTC facility (SNF or NF) from meeting the proposed HPRD levels for RNs and NAs specifically established in § 483.35(a)(1)(i) and (ii) in section III.B.4 of this rule. We welcome comments regarding our proposed requirements for each LTC facility to have an RN on site 24 hours a day, 7 days a week that is available for direct resident care.

In addition to our proposed 24-hour, 7 days a week requirement for an RN, we continue to maintain a separate requirement for the DON. All LTC facilities must designate an RN to serve as the DON on a full-time basis (§ 483.35(b)(2)). The current rule stipulates that the DON can serve as a charge nurse only if the facility has an average daily occupancy of 60 or fewer residents (§ 483.35(b)(3)). Since the DON must be an RN, the DON is included in the proposed nurse minimum staffing requirements as an RN. All RNs with administrative duties, including the DON, should be available for direct resident care when needed. However, the DON, as well as other nurses with administrative duties, would probably have limited time to devote to direct resident care. We are concerned that for some LTC facilities having the DON as the only RN on site might be insufficient to provide safe and quality care to residents. This concern was also expressed in the NASEM 2022 publication discussed previously, in which the NASEM recommended that the DON not be counted in the requirement for an RN 24 hours, 7 days a week.

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All comments regarding these questions will be reviewed and analyzed, including consideration for potential future rulemaking.

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National Academies of Sciences, Engineering, and Medicine. 2022.

The National Imperative to Improve Nursing Home Quality: Honoring Our Commitment to Residents, Families, and Staff, Recommendation 2B.

We welcome comments on the following questions:

• Does your facility, or one you are aware of, have an RN onsite 24 hours a day, 7 days a week? If not, how does the facility ensure that staff with the appropriate skill sets and competencies are available to assess and provide care as needed?

• If a requirement for a 24 hour, 7 day a week onsite RN who is available to provide direct resident care does not seem feasible, could a requirement more feasibly be imposed for a RN to be “available” for a certain number of hours during a 24 hour period to assess and provide necessary care or consultation provide safe care for residents? If so, under what circumstances and using what definition of “available”?

• Should the DON be counted towards the 24/7 RN requirement or should the DON only count in particular circumstances or with certain guardrails? Please explain why or why not.

• Are there alternative policy strategies that we should consider to address staffing supply issues such as nursing shortages?

2. Administration (§ 483.70)

We believe that a comprehensive approach to establishing staffing requirements is necessary to ensure that facilities are making thoughtful, informed staffing plans and decisions to support the health, safety, and well-being of residents. In particular, we want to avoid unintended consequences of establishing a minimum nurse

staffing requirement that could lead to a regression by those facilities currently staffing above the staffing requirement or facilities only staffing at the minimum level proposed without considering whether resident acuity or resident census, requires additional staffing above that floor. It is our expectation that LTC facilities will consider their capabilities and capacity, as well as the number, acuity, and diagnoses of their residents when developing staffing schedules.

As previously discussed, in 2016, we released a final rule that revised the requirements that LTC facilities must meet to participate in the Medicare and Medicaid Programs.

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As part of those revisions, we finalized revisions at § 483.70(e),

Administration,

to require facilities to conduct, document, and annually review a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies. This facility-wide assessment requires LTC facilities to determine adequate staffing type and level based on the number of residents, resident acuity, range of diagnoses, the content of care plans, and other factors. LTC facilities are also required to address and document in their facility assessments their resident population (that is, number of residents, overall types of care and staff competencies required by residents, and cultural aspects), resources (for example, equipment, and overall personnel), and a facility-based and community-based risk assessment.

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https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities.

While we assumed when we finalized the 2016 rule that most LTC facilities already conducted some type of facility assessment of the resident population and resources required as part of their normal strategic planning, our revisions aimed to ensure that facilities had a formal process for consistently conducting and documenting these assessments and keeping them up-to-date. The formal facility assessment process requires facilities to make thoughtful, person-centered staffing plans and decisions focused on meeting resident needs that may help improve the safety of residents. We believe this approach will help facilities comply with the requirement to have sufficient staff, which is investigated during surveys.

One of the goals of the 2016 revisions to the LTC facility participation requirements for health and safety was to ensure that our regulations align with current clinical practice and allow flexibility to accommodate multiple care delivery models to meet the needs of diverse populations that receive services in these facilities. As noted previously, given the limitations of the PBJ System data in 2016, we enacted a competency-based approach in the 2016 final rule, that focused on achieving the statutorily mandated outcome of ensuring that each resident is provided care that allows the resident to maintain or attain their highest practicable physical, mental, and psychosocial well-being. The facility assessment requirement was central to the revised 2016 LTC facility participation requirements, and was intended to be used by the facility for multiple purposes, including, but not limited to, determining adequate staffing and other resources, establishing a Quality Assurance and Performance Improvement (QAPI) program, and conducting emergency preparedness planning.

Our expectation was that the application and development of the facil

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